BCoD Access Dermatology - Summer 2024

EXPERT ADVICE What we can learn from FRMs

UNLOCKING ACCESS Overcoming barriers to biologic therapies

BEST PRACTICES EMRs and other helpful technology

SAVE THE DATE!

Join us this fall at our annual BCoD National Conference OCTOBER 27-29

SKIN SMARTS Do’s (and Don’ts)

ISSUE 9 / 2024

of skincare trends

SEE DETAILS INSIDE!

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CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

To learn more about CIBINQO efficacy, visit CIBINQOhcp.com or scan QR code.

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C JAK=Janus kinase; AD=atopic dermatitis.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.

• Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.

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Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO. Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves.

Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.

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TM

Committed to Patient Support Helping patients unlock access and reimbursement support for CIBINQO™ (abrocitinib)

With the Copay Savings Card, eligible commercially insured patients may

pay as little as $

0 per month*

Visit PDPACopayCard.com

*Eligibility required. No membership fees. This is not health insurance.

The maximum benefit per patient is $15,000 per calendar year. Only for use with commercial insurance. If you are enrolled in a state or federally funded prescription insurance program, you may not use the copay card.

See full terms and conditions below.

Copay Savings Card: TERMS AND CONDITIONS By using the Pfizer Dermatology Patient AccessTM Copay Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below: • You are not eligible to use this card if you are enrolled in a state or federally funded prescription insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).

• You must have commercial insurance. Offer is not valid for cash-paying patients.

• By using this copay card at participating pharmacies, eligible patients with commercial prescription drug insurance coverage for CIBINQO™ (abrocitinib) may pay as little as $0 per month. Eligible patients with commercial prescription drug coverage may receive a maximum benefit of $15,000 per calendar year, which is defined by the date of enrollment through December 31st of the enrollment year. After a maximum of $15,000, you will be responsible for paying the remaining monthly out-of-pocket costs.

• By using this copay card at participating pharmacies, eligible patients with commercial prescription drug insurance coverage for EUCRISA® (crisaborole) may pay as little as $10 per tube. Eligible patients with commercial prescription drug insurance coverage that does not cover EUCRISA may pay as little as $100 per tube. Individual savings are limited to $970 per tube. Individual patient savings are limited to $3,880 in maximum total savings per calendar year.

• This copay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your commercial insurance plan or any other health or pharmacy benefit program.

• You must deduct the value of this copay card from any reimbursement request submitted to your commercial insurance plan, either directly by you or on your behalf.

• You are responsible for reporting use of the copay card to any commercial insurer, health plan, or other third party that pays for or reimburses any part of the prescription filled using the copay card, as may be required. You should not use the copay card if your insurer or health plan prohibits use of manufacturer copay cards.

• This copay card is not valid where prohibited by law.

• Copay card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.

• Copay card will be accepted only at participating pharmacies.

• If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.

• This copay card is not health insurance.

• Offer good only in the United States and Puerto Rico.

• Copay card is limited to 1 per person during this offering period and is not transferable.

• A copay card may not be redeemed more than once per 30 days per patient.

• No other purchase is necessary.

• Data related to your redemption of the copay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other copay card redemptions and will not identify you.

• Pfizer reserves the right to rescind, revoke, or amend this offer at any time without notice.

• Offer expires 12/31/2025.

For questions or additional support, call 1-833-956-3376, write to Pfizer Inc. at PO Box 29387, Mission, KS 66201, or visit the CIBINQO website at www.CIBINQO.com or the EUCRISA website at www.EUCRISA.com.

Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.

For full Prescribing Information, including BOXED WARNING and Medication Guide, visit CIBINQOhcp.com.

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IMPORTANT SAFETY INFORMATION & INDICATION MORTALITY In a large, randomized postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.

MALIGNANCIES Malignancies, including non-melanoma skin cancer (NMSC), were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

In a large, randomized postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers.

CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients.

Patients who are current or past smokers are at additional increased risk.

Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

THROMBOSIS Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients.

Avoid CIBINQO in patients that may be at increased risk of thrombosis.

If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately.

CONTRAINDICATION CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤ 81 mg daily), during the first 3 months of treatment.

LABORATORY ABNORMALITIES Hematologic Abnormalities: Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia.

Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.

Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

IMMUNIZATIONS Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.

RENAL IMPAIRMENT Avoid use in patients with severe renal impairment or end stage renal disease, including those on renal replacement therapy.

HEPATIC IMPAIRMENT Avoid use in patients with severe hepatic impairment.

ADVERSE REACTIONS Most common adverse reactions (≥ 1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis.

Most common adverse reactions (≥ 1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

Inform patients that retinal detachment has been reported in CIBINQO clinical trials. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision.

DRUG INTERACTIONS Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. See Prescribing Information for clinically relevant drug interactions.

USE IN PREGNANCY Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise females of reproductive potential that CIBINQO may impair fertility.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770 or visit CIBINQOPregnancyRegistry.com.

LACTATION Advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose.

INDICATION

CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Please see full Important Safety Information throughout and full Prescribing Information, including BOXED WARNING, and Medication Guide. © 2023 Pfizer Inc. All rights reserved.

May 2023. PP-CIB-USA-0665

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CIBINQO™ (abrocitinib) tablets, for oral use

Brief Summary of full Prescribing Information; Initial Approval: January 2022

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS Serious Infections Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death; The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of CIBINQO in patients with an active, serious infection including localized infections.

The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Mortality In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.

Malignancies Malignancies were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions.

In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Major Adverse Cardiovascular Events Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Thrombosis Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death.

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers.

Avoid CIBINQO in patients at risk. If symptoms of thrombosis occur, discontinue CIBINQO and treat appropriately.

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INDICATIONS AND USAGE CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

DOSAGE AND ADMINISTRATION Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation Perform the following tests and evaluations prior to CIBINQO initiation: • Tuberculosis (TB) infection evaluation – CIBINQO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of CIBINQO • Viral hepatitis screening in accordance with clinical guidelines – CIBINQO initiation is not recommended in patients with active hepatitis B or hepatitis C • A complete blood count (CBC) – CIBINQO initiation is not recommended in patients with a platelet count <150,000/mm3, an absolute lymphocyte count <500/mm3, an absolute neutrophil count <1,000/mm3, or a hemoglobin value <8 g/dL Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to CIBINQO initiation.

Recommended Dosage The recommended dosage of CIBINQO is 100 mg orally once daily.

If an adequate response is not achieved with CIBINQO 100 mg orally daily after 12 weeks, consider increasing dosage to 200 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 200 mg once daily.

CIBINQO can be used with or without topical corticosteroids.

If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

Recommended Dosage in Patients with Renal Impairment Renal Impairment CIBINQO dosage recommendation in patients with mild renal impairment (60-89 mL/minute) is 100 mg once daily.

For patients with moderate renal impairment (30-59 mL/ minute), the recommended dosage is 50 mg once daily.

CIBINQO is not recommended for patients with severe or End-Stage Renal Disease (ESRD). Severe renal impairment and End-Stage Renal Disease include patients on renal replacement therapy.

In subjects with mild and moderate renal impairment, if an adequate response is not achieved after 12 weeks, dose of CIBINQO can be doubled.

CIBINQO is not recommended for patients with severe renal impairment or ESRD. Recommended Dosage in CYP2C19 Poor Metabolizers In patients who are known or suspected to be CYP2C19 poor metabolizers, the recommended dosage of CIBINQO is 50 mg once daily. If an adequate response is not achieved with CIBINQO 50 mg orally daily after 12 weeks, consider increasing dosage to 100 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.

Dosage Modifications due to Strong Inhibitors In patients taking strong inhibitors of cytochrome P450 (CYP) 2C19 reduce the dosage to 50 mg once daily. If an adequate response is not achieved with CIBINQO 50 mg orally daily after 12 weeks, consider increasing dosage to 100 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.

Treatment Discontinuation due to Serious Infections or Hematologic Adverse Reactions Serious or Opportunistic Infections If a patient develops a serious or opportunistic infection, discontinue CIBINQO and control the infection. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO. Hematologic Abnormalities • Discontinue CIBINQO if platelet count <50,000/mm3 and

SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

follow with CBC until >100,000/mm3 • Treatment should be temporarily discontinued if ALC is less than 500 cells/mm3 and may be restarted once ALC return above this value • Treatment should be temporarily discontinued if ANC is less than 1,000 cells/mm3 and may be restarted once ANC return above this value • Treatment should be temporarily discontinued if Hb is less than 8 g/dL and may be restarted once Hb return above this value CBC evaluations are recommended at baseline, 4 weeks after treatment initiation and 4 weeks after dosing increase of CIBINQO. Laboratory evaluations may be extended for patients on chronic CIBINQO therapy who develop hematologic abnormalities.

DOSAGE FORMS AND STRENGTHS • 50 mg: Pink, oval, film-coated tablet debossed with “PFE” on one side and “ABR 50” on the other.

• 100 mg: Pink, round, film-coated tablet debossed with “PFE” on one side and “ABR 100” on the other.

• 200 mg: Pink, oval, film-coated tablet debossed with “PFE” on one side and “ABR 200” on the other.

CONTRAINDICATIONS CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.

WARNINGS AND PRECAUTIONS Serious Infections The most frequent serious infections reported in clinical studies with CIBINQO for atopic dermatitis were herpes simplex, herpes zoster, and pneumonia. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions.

Avoid use of CIBINQO in patients with active, serious infection including localized infections.

Consider the risks and benefits of treatment prior to initiating CIBINQO in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with CIBINQO. If a patient develops a serious or opportunistic infection, discontinue CIBINQO. Initiate complete diagnostic testing and appropriate antimicrobial therapy. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO. Tuberculosis Evaluate and test patients for TB before starting CIBINQO therapy and consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO. Monitor patients for the development of signs and symptoms of TB, including patients who were tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves.

Hepatitis B virus (HBV) reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C. Monitor patients with inactive HBV for expression of HBV DNA during therapy with CIBINQO. If HBV DNA is detected during therapy with CIBINQO, consult a liver specialist.

Mortality In a large, randomized, postmarketing safety study of another JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients

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CIBINQO™ (abrocitinib) tablets, for oral use Mortality (continued) treated with the JAK inhibitor compared with TNF blockers.

CIBINQO is not approved for use in RA. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO. Malignancy and Lymphoproliferative Disorders Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical studies with CIBINQO for atopic dermatitis.

Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions. In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Major Adverse Cardiovascular Events Major adverse cardiovascular events were reported in clinical studies of CIBINQO for atopic dermatitis.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers.

CIBINQO is not approved for use in RA. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Thrombosis Deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in patients receiving CIBINQO in the clinical studies for atopic dermatitis.

Thrombosis, including DVT, PE, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. CIBINQO is not approved for use in RA. Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and evaluate and treat patients appropriately.

Laboratory Abnormalities Hematologic Abnormalities Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a CBC. CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.

Lipid Elevations Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter

COV2_07_JBCOD_Table of Contents 2 pages Summer_2024.indd 4

elevations on cardiovascular morbidity and mortality has not been determined.

Immunizations Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines including prophylactic herpes zoster vaccinations.

Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.

ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Major Adverse • Serious Infections Cardiovascular Events • Mortality • Thrombosis • Malignancy and • Laboratory Abnormalities Lymphoproliferative Disorders Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CIBINQO was evaluated in four randomized, placebo-controlled clinical trials (2 monotherapy, 1 combination therapy with topical corticosteroid, and 1 dose-ranging) and one long-term extension trial in subjects with moderate to severe atopic dermatitis (AD). A total of 1623 subjects with moderate to severe atopic dermatitis were treated with CIBINQO in these clinical trials representing 1428 patient-years of exposure. There were 634 subjects with at least 1 year of exposure to CIBINQO. In the placebo-controlled clinical trials, a total of 1198 subjects were exposed to CIBINQO with 608 subjects receiving CIBINQO 100 mg once daily and 590 subjects receiving CIBINQO 200 mg once daily for up to 16 weeks.

The median age of subjects was 33.0 years, 124 subjects (8.1%) were 12 to less than 18 years old and 94 subjects (6.1%) were 65 years of age or older. The majority of subjects were White (68.7%) and male (53.9%).

Adverse reactions occurring at ≥1% in any of the treated groups and at a higher rate than in the placebo group are presented in the table below. A total of 61 (5.1%) subjects treated with CIBINQO were discontinued from the trials due to adverse reactions. The safety profile of CIBINQO in the monotherapy and the combination trial(s) were similar.

Adverse Reactions from Placebo-Controlled Trials Reported in ≥1% of CIBINQO Treated Subjects with Moderate to Severe Atopic Dermatitis and at Higher Rate than Placebo for up to 16 Weeks Weeks 0-16 CIBINQO CIBINQO PLACEBO 200 mg 100 mg N=342 N=590 N=608 n (%a) a a n (% ) n (% ) Nasopharyngitis 51 (8.7) 75 (12.4) 27 (7.9) Nausea 86 (14.5) 37 (6.0) 7 (2.1) Headache 46 (7.8) 36 (6.0) 12 (3.5) b Herpes simplex 25 (4.2) 20 (3.3) 6 (1.8) Increased blood 17 (2.9) 14 (2.3) 5 (1.5) creatine phosphokinase Dizziness 17 (2.9) 11 (1.8) 3 (0.9) Urinary tract infection 13 (2.2) 10 (1.7) 4 (1.2) Fatigue 8 (1.3) 10 (1.6) 2 (0.5) Acne 28 (4.7) 10 (1.6) 0 (0.0) Vomiting 19 (3.2) 9 (1.5) 3 (0.9) Impetigo 3 (0.5) 9 (1.5) 1 (0.3) Oropharyngeal pain 6 (1.0) 8 (1.4) 2 (0.6) Hypertension 5 (0.8) 7 (1.2) 2 (0.7) Influenza 6 (1.1) 7 (1.2) 0 (0.0) Gastroenteritis 8 (1.3) 7 (1.1) 2 (0.6) Dermatitis contact 3 (0.5) 6 (1.1) 1 (0.3) Abdominal pain upper 11 (1.9) 4 (0.6) 0 (0.0) Abdominal discomfort 7 (1.2) 3 (0.5) 1 (0.3) Herpes zoster 7 (1.2) 2 (0.3) 0 (0.0) Thrombocytopenia 9 (1.5) 0 (0.0) 0 (0.0) a Study size adjusted percentages b Herpes simplex also includes oral herpes, ophthalmic herpes, herpes

dermatitis, genital herpes.

Specific Adverse Reactions Exposure adjusted incidence rates were adjusted by trial size for all the adverse reactions reported in this section.

SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Overall Infections In the placebo-controlled trials, for up to 16 weeks, overall infections were reported in 90 subjects (126.8 per 100 patient-years) treated with placebo, 211 subjects (168.8 per 100 patient-years) treated with CIBINQO 100 mg and 204 subjects (159.5 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, overall infections were reported in 427 subjects (91.8 per 100 patient-years) treated with CIBINQO 100 mg and 394 subjects (103.2 per 100 patient-years) treated with CIBINQO 200 mg.

Serious Infections In the placebo-controlled trials, for up to 16 weeks, serious infections were reported in 2 subjects (2.6 per 100 patient-years) treated with placebo, 6 subjects (3.9 per 100 patient-years) treated with CIBINQO 100 mg, and 2 subjects (1.3 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, serious infections were reported in 18 subjects (2.3 per 100 patient-years) treated with CIBINQO 100 mg and 16 subjects (2.3 per 100 patient-years) treated with CIBINQO 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.

Herpes Zoster In the placebo-controlled trials, for up to 16 weeks, opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster. Herpes zoster was reported in 0 subjects treated with placebo, 3 subjects (1.9 per 100 patient-years) treated with CIBINQO 100 mg and 8 subjects (5.1 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, herpes zoster was reported in 16 subjects (2.0 per 100 patient-years) treated with CIBINQO 100 mg and 35 subjects (5.2 per 100 patient-years) treated with CIBINQO 200 mg.

Malignancy In the placebo-controlled trials, for up to 16 weeks, no malignancy was reported in subjects treated with placebo or CIBINQO 100 mg and in 1 patient (0.65 per 100 patient-years) treated with CIBINQO 200 mg. In all 5 clinical trials, including the long-term extension trial, malignancy was reported in 4 subjects (0.5 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 200 mg.

Thrombosis In all clinical trials, including the long-term extension trial, pulmonary embolism was reported in 3 subjects (0.4 per 100 patient-years), who were treated with CIBINQO 200 mg. Deep vein thrombosis was reported in 2 subjects (0.3 per 100 patient-years) who were treated with CIBINQO 200 mg. No thrombosis occurred in subjects treated with CIBINQO 100 mg.

Major Adverse Cardiovascular Events In the placebocontrolled trials, for up to 16 weeks, major adverse cardiovascular event (MACE) was reported in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg.

In all 5 clinical trials, including the long-term extension trial, MACE was reported in 1 patient (0.1 per 100 patient-years) treated with CIBINQO 100 mg and 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 200 mg.

Thrombocytopenia In the placebo-controlled trials, for up to 16 weeks, treatment with CIBINQO was associated with a dose-related decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned towards baseline despite continued therapy. In all 5 clinical trials, including the long-term extension trial 6 subjects (0.9 per 100 patient-years) treated with CIBINQO 200 mg had adverse reactions of thrombocytopenia, no subjects treated with CIBINQO 100 mg had an adverse reaction of thrombocytopenia.

Lymphopenia In the placebo-controlled trials, for up to 16 weeks, confirmed ALC <500/mm3 occurred in 2 subjects (1.2 per 100 patient-years) treated with CIBINQO 200 mg and 0 subjects treated with CIBINQO 100 mg or placebo.

Both cases occurred in the first 4 weeks of exposure.

Lipid Elevations In the placebo-controlled trials, for up to 16 weeks, there was a dose-related percent increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at Week 4 which remained elevated through the final visit in the treatment period. Adverse reactions related to hyperlipidemia occurred in 1 subject (0.6 per 100 patient-years) exposed to CIBINQO 100 mg, 3 subjects (2.0 per 100 patient-years) exposed to CIBINQO 200 mg.

Retinal Detachment In the placebo-controlled trials, for up to 16 weeks, retinal detachment occurred in 1 subject (0.6 per 100 patient-years) treated with CIBINQO 100 mg. In all 5 clinical trials, including the long-term extension trial, retinal detachment occurred in 2 subjects (0.3 per 100 patient-years) treated with CIBINQO 100 mg.

5/29/24 9:43 AM

9"

CIBINQO™ (abrocitinib) tablets, for oral use Specific Adverse Reactions (continued) Creatine Phosphokinase Elevations (CPK) In the placebocontrolled trials, for up to 16 weeks, events of blood CPK increased were reported in 6 subjects (7.5 per 100 patient-years) treated with placebo, 11 subjects (6.9 per 100 patient-years) treated with 100 mg of CIBINQO and 19 subjects (12.3 per 100 patient-years) treated with 200 mg of CIBINQO. Most elevations were transient, there were no reported adverse reactions of rhabdomyolysis.

Adolescent Subjects (12 to less than 18 years of age) The safety of CIBINQO was assessed in a trial of 284 subjects 12 to less than 18 years of age with moderate-to-severe atopic dermatitis (Trial-AD-4). The safety profile of CIBINQO in these subjects, assessed through the initial treatment period of 12 weeks and the long-term period (213 with at least 52 weeks of abrocitinib exposure), was similar to the safety profile from trials in adults with atopic dermatitis.

DRUG INTERACTIONS Effects of Other Drugs on CIBINQO The table below includes drugs with clinically significant drug interactions affecting CIBINQO. Clinically Significant Drug Interactions Affecting CIBINQO

Strong CYP2C19 Inhibitors Clinical Impact

Coadministration of CIBINQO with strong CYP2C19 inhibitors increases the combined exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO.

Intervention Dosage reduction of CIBINQO is recommended when coadministered with strong CYP2C19 inhibitors.

Moderate to Strong Inhibitors of both CYP2C19 and CYP2C9 Clinical Impact

Coadministration of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9 increases the exposure of abrocitinib and its two active metabolites, M1 and M2 which may increase the adverse reactions of CIBINQO.

Intervention Avoid concomitant use of CIBINQO with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9.

Strong CYP2C19 or CYP2C9 Inducers Clinical Impact

Coadministration of CIBINQO with strong CYP2C19 or CYP2C9 inducers decreases the combined exposure of abrocitinib and its two active metabolites, M1 and M2, which may result in loss of or reduced clinical response.

Intervention Avoid concomitant use of CIBINQO with strong CYP2C19 or CYP2C9 inducers.

Effects of CIBINQO on Other Drugs The table below includes clinically significant drug interactions affecting other drugs.

Clinically Significant Interactions Affecting Other Drugs

P-gp Substrate Where Small Concentration Changes May Lead to Serious or Life-threatening Toxicities Clinical Coadministration of CIBINQO with P-gp Impact substrate increases plasma concentrations of P-gp substrates and may result in potential adverse reactions of the P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities (e.g., digoxin).

Intervention Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. Antiplatelet Therapy Drugs Clinical Coadministration of CIBINQO with antiplatelet Impact therapy drugs may increase the risk of bleeding with thrombocytopenia.

Intervention Antiplatelet drugs, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment are contraindicated with CIBINQO.

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USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770 or visit CIBINQOPregnancyRegistry.com.

Risk Summary Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of abrocitinib to pregnant rats and rabbits during organogenesis at exposure 11 or 4 times the maximum recommended human dose (MRHD) based on AUC comparison, respectively, resulted in maternal dystocia and skeletal variations in rats and no adverse effects in rabbits (see Animal Data).

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively.

Animal Data In an embryofetal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, or 60 mg/kg/day during the period of organogenesis. No fetal malformations were observed. Abrocitinib increased the incidence of skeletal variations of short 13th ribs at 30 mg/kg/ day (11 times the MRHD based on AUC comparison).

Increased embryofetal lethality and additional skeletal variations (cervical arches with reduced ventral processes, thickened ribs, and unossified metatarsals) were noted at 60 mg/kg/day (17 times the MRHD based on AUC comparison).

In an embryofetal development study, abrocitinib was administered orally to pregnant rabbits at doses of 10, 30, or 75 mg/kg/day during the period of organogenesis. No abrocitinib-related maternal or developmental toxicity was noted at doses up to 75 mg/kg/day (4 times the MRHD based on AUC comparison).

In a prenatal and postnatal development study, abrocitinib was administered orally to pregnant rats at doses of 10, 30, and 60 mg/kg/day beginning on gestation day 6 and continuing through lactation day 20. Dystocia with prolonged parturition and reduced offspring body weights were noted at 30 mg/kg/ day (11 times the MRHD based on AUC comparison).

Postnatal survival was markedly decreased at 60 mg/kg/day (17 times the MRHD based on AUC comparison). No maternal toxicity was observed at 10 mg/kg/day (2.4 times the MRHD based on AUC comparison). No abrocitinib-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring was noted at doses up to 30 mg/kg/ day (11 times the MRHD based on AUC comparison).

Lactation Risk Summary There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats (see Animal Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose (approximately 5-6 elimination half-lives).

Animal Data Lactating female rats were orally administered a single dose of 10 mg/kg abrocitinib on lactation day 12.

Abrocitinib AUC was approximately 5 times greater in milk than in plasma.

Females and Males of Reproductive Potential Infertility Females Based on the findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration.

Pediatric Use The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older weighing 25 kg or more with atopic dermatitis has been established. In trials Trial-AD-1 and Trial-AD-2, 124 adolescent subjects 12 to less than 18 years old with moderate-to-severe atopic dermatitis were enrolled and randomized to receive either CIBINQO 100 mg (N=51), 200 mg (N=48), or matching placebo (N=25) in monotherapy.

Additional 284 adolescent subjects 12 to less than 18 years of age with moderate-to-severe atopic dermatitis, were enrolled and randomized to receive either CIBINQO 100 mg (N=95) or 200 mg (N=94) or matching placebo (N=95) in combination with topical corticosteroids in Trial-AD-4. Efficacy and adverse reaction profile were consistent between the pediatric patients and adults.

SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age.

Juvenile Animal Toxicity Data In a juvenile animal toxicity study, abrocitinib was administered orally to juvenile rats at doses of 5, 25, and 75 mg/kg/day beginning on postnatal day 10 (approximately equivalent to a human infant) and continuing through postnatal day 63 (approximately equivalent to an adolescent). Abrocitinib caused a reversible, dose-related decrease in the primary spongiosa in the metaphysis of the proximal tibia and distal femur. Abrocitinib produced adverse effects on bone development at all dose levels. Abrocitinib caused irreversible dose-related small or misshapen femoral heads at doses ≥5 mg/kg/day (0.8 times the MRHD based on AUC comparison).

Abrocitinib also irreversibly decreased femur size and caused paw malrotation and limb impairment at doses ≥25 mg/kg/day (7.2 times the MRHD based on AUC comparison). At 75 mg/kg/ day (27 times the MRHD based on AUC comparison), paw fractures generally corresponded to limb impairment, a fractured tibia was noted in a single female. Irreversible bone findings have not been observed in older animals.

Geriatric Use A total of 145 (4.6%) patients 65 years of age and older, while 25 (0.8%) were 75 years of age and older, were enrolled in CIBINQO clinical trials. Clinical trials of CIBINQO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

A higher proportion of patients 65 years of age and older discontinued from clinical trials compared to younger patients.

Among all patients exposed to CIBINQO, including the long-term extension trial, confirmed ALC <500/mm3 occurred only in patients 65 years of age and older. A higher proportion of patients 65 years of age and older had platelet counts <75,000/ mm3. The incidence rate of herpes zoster in patients 65 years of age and older treated with CIBINQO (7.40 per 100 patient-years) was higher than that of patients 18 to less than 65 years of age (3.44 per 100 patient-years).

Renal Impairment In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30-59 mL/min) renal impairment, the combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2, is increased compared to patients with normal renal function (eGFR ≥90 mL/min). This may increase the risk of adverse reactions such as infections.

CIBINQO is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy.

A dosage reduction in patient with moderate renal impairment is recommended. No dosage adjustment is required in patients with mild renal impairment (eGFR 60-89 mL/min).

CIBINQO has not been studied in patients on renal replacement therapy. In Phase 3 clinical trials, CIBINQO was not evaluated in patients with atopic dermatitis with baseline creatinine clearance values less than 40 mL/min.

Hepatic Impairment Avoid use of CIBINQO in patients with severe (Child Pugh C) hepatic impairment.

Dosage adjustment is not required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment based on similar combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2 compared to patients with normal hepatic function. In clinical trials, CIBINQO was not evaluated in patients with severe (Child Pugh C) hepatic impairment.

CYP2C19 Poor Metabolizers In patients who are CYP2C19 poor metabolizers, the AUC of abrocitinib is increased compared to CYP2C19 normal metabolizers due to reduced metabolic clearance. Dosage reduction of CIBINQO is recommended in patients who are known or suspected to be CYP2C19 poor metabolizers based on genotype or previous history/experience with other CYP2C19 substrates.

OVERDOSAGE There is no experience regarding human overdosage with CIBINQO. There is no specific antidote for overdose with CIBINQO. In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.

Rx only This brief summary is based on CIBINQO™ (abrocitinib) Prescribing Information LAB-1424-2.0.

Issued: February 2023.

The product’s label may have been updated. For full Prescribing Information, visit CIBINQOPI.com.

See CIBINQO full Prescribing Information at CIBINQOPI.com.

© 2023 2023 Pfizer Pfizer Inc. All rights reserved.

May 2023.

PP-CIB-USA-0485 February 2023.

PP-CIB-USA-0485

5/21/24 3:28 PM

contents ACCESS DERMATOLOGY

ISSUE 9

FEATU R ES

12 Best Practices EMRs and other helpful technology 20 Unlocking Access Overcoming patient barriers to provider-administered biologic therapies 48 Expert Advice What BCs can learn from field reimbursement managers 52 Navigating the Future Patient access trends and solutions

CO M M U N I TY 9 Founder's Letter Removing access barriers 38 BC Spotlight Recognizing outstanding patient service

L I FESTYL E 30 Skin Smarts The Do's and Don'ts of social media skincare trends for teens 40 Cold Therapy The hot healthcare trend 56 Riveting Reads Must-read new releases ACCESS DERMATOLOGY / ISSUE 9 / 2024

6

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20

12 TOP TIPS FROM FMRS

12 3 48

30 bcofdermatology.com

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ACCESS DERMATOLOGY

A magazine dedicated to supporting patient access with practical information and lifestyle content

ISSUE 9 | 2024

MISSION STATEMENT: Access Dermatology aims to educate and empower the biologic coordinator by keeping them informed of the complex and everchanging drug and patient access landscape. Readers are engaged with editorial and lifestyle content equally suitable for dermatologic patients, so they too may gain a better sense of therapies and the patient services programs that can assist in their therapeutic journey.

EXECUTIVE DIRECTOR Craig Schuette EDITOR Elizabeth Hole CREATIVE DIRECTOR Venera Alexandrova ASSISTANT ART DIRECTOR Lisa Servidio PRODUCTION DIRECTOR Tim Carr

CORRESPONDENCE: Communications regarding original articles as well as editorial suggestions for future issues should be addressed to Craig Schuette at cs@bcofdermatology.com.

Any content forwarded to the publisher assumes no liability for the safety or return of unsolicited art, photographs, or manuscripts.

PRESIDENT Jonathan W. Moffly

DISPLAY ADVERTISING:

VICE PRESIDENT/BUSINESS Elena V. Moffly

Contact Craig Schuette at cs@bcofdermatology.com.

MOFFLY CUSTOM MEDIA 205 Main Street, Westport, CT 06880 telephone: 203-222-0600 email: mail@MofflyCustomMedia.com

Follow the Biologic Coordinators of Dermatology

FACEBOOK LINKEDIN

© 2024 Access Dermatology and Biologic Coordinators of Dermatology. ALL RIGHTS RESERVED. The material in this publication is published by Moffly Custom Media and may not be reproduced or transmitted in any manner, in whole or in part, without the express written permission of Access Dermatology and Moffly Custom Media. NOTICE: The information contained within articles of this magazine represent the views and opinions of the original authors and do not necessarily represent the views and opinions of Access Dermatology or its affiliates. The mere appearance of content in the magazine does not constitute an endorsement by Access Dermatology or its affiliates. The content has been made available for informational and educational purposes only. Editorial advice is not specific, and readers are advised to seek medical, professional, or reimbursement help for individual circumstances. Access Dermatology hereby disclaims all liability to any party for any direct, indirect, implied, punitive, special, incidental, or other consequential damages arising directly or indirectly from any use of the content. CIRCULATION: To be added to the circulation, visit www.bcofdermatolgy.com/ magazine. REPRINTS: For educational, commercial, or promotional reprints, including author off-prints, please email contact@bcofdermatology.com.

ACCESS DERMATOLOGY / ISSUE 9 / 2024

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letter from the founder

Craig Schuette

Removing Access Barriers W

elcome to the summer edition of Access Dermatology from the BCoD community.

Summer symbolizes life's abundance, a season of vitality and rejuvenation. Yet, amid its splendor, many patients face barriers hindering their journey toward wellness.

In this issue, we spotlight the importance of nurturing industry relationships and harnessing technology to enhance patient access.

Together, let's explore pathways that break down barriers and extend the healing reach of healthcare.

As part of our ongoing commitment to our membership Academy, we're excited to announce that the BCoD certificate program is now accessible to all members.

Additionally, this year, we introduce a unique workshop, exclusively available at our October conference. This workshop aims to guide attendees in optimizing office structures for improved efficiency in biologic patient care and collaboration among peers. While such training typically costs more than $1,000 for a

dermatologist's practice, our BC experts are offering it at no charge. Moreover, conference registration fees are waived, further exemplifying our dedication to removing access barriers, even to our conference.

Our national conference—taking place in Orlando from October 27 to 29—serves as a platform for hundreds of biologic coordinators and office access staff to engage in crucial discussions, paving the way for enhanced drug access.

For more information, visit our website at bcofdermatology.com. We eagerly anticipate your presence in Orlando, where patient dedication intersects professional growth and community.

CRAIG SCHUETTE

bcofdermatology.com

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NOW AVAILABLE!

®

DOWN TO AGE 9

Effectively control seborrheic dermatitis and simplify treatment with a steroid-free foam.1 One foam. Once a day. Anywhere.1

SebDone.

DRAMATIC 77% IGA SUCCESS AT WEEK 81,2

Actor portrayal

Trial 203 and STRATUM studies evaluated ZORYVE (n=458) vs vehicle (n=225) once daily for 8 weeks in patients with seborrheic dermatitis. The primary endpoint was IGA Success at Week 8, defined as a score of Clear (0) or Almost Clear (1) and a ≥2-grade improvement from baseline.

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.1 IGA = Investigator Global Assessment

A 2023 Arcutis survey of 93 adults diagnosed with seborrheic dermatitis found that an average of 15 products (including over-the-counter, alternative, and prescription treatments) were reportedly used on a yearly basis. 2

INDICATION ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions (≥1%) include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

See the results at zoryvehcp.com/foam Please see brief summary of full Prescribing Information for ZORYVE foam on the following page.

References: 1. ZORYVE® foam. Prescribing information. Arcutis Biotherapeutics, Inc; 2023.

2. Data on File. Arcutis Biotherapeutics, Inc. © 2024 Arcutis Biotherapeutics, Inc. All rights reserved.

US-COM-154-00125 01/24

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Brief Summary of Prescribing Information for ZORYVE® (roflumilast) foam, 0.3%, for topical use. See package insert for full Prescribing Information.

INDICATIONS AND USAGE ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

DOSAGE AND ADMINISTRATION Shake can prior to each use. Apply a thin layer of ZORYVE foam, 0.3%, once daily to affected areas on skin and/or scalp when they are not wet. Rub in completely.

Wash hands after application.

Avoid fire, flame, and smoking during and immediately following application.

ZORYVE foam, 0.3%, is for topical use only and not for ophthalmic, oral, or intravaginal use.

CONTRAINDICATIONS ZORYVE foam, 0.3%, is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

WARNINGS AND PRECAUTIONS Flammability The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 203 and STRATUM), 683 adult and pediatric subjects 9 years of age or older with seborrheic dermatitis were treated with ZORYVE foam, 0.3%, or vehicle foam once daily for 8 weeks.

The combined trial population was 79% White, 11% Black, and 5% Asian; for ethnicity, 79% identified as non-Hispanic/Latino and 21% identified as Hispanic/Latino.

Fifty percent (50%) were male and 50% were female. The median age was 41 years (range 9 to 87 years). The median body surface area (BSA) affected was 2.5%.

Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE foam, 0.3%.

Table 1: Adverse Reactions Reported in ≥1% of Subjects with Seborrheic Dermatitis Treated with ZORYVE Foam, 0.3%, for 8 Weeks in Trial 203 and Trial STRATUM Adverse Reaction

ZORYVE foam, 0.3% (N=458) n (%)

Vehicle foam (N=225) n (%)

Nasopharyngitis Nausea Headache

7 (1.5) 6 (1.3) 5 (1.1)

1 (0.4) 0 (0) 0 (0)

The following additional adverse reactions were reported in fewer than 1% of subjects treated with ZORYVE foam, 0.3%: diarrhea and insomnia.

In 408 subjects who continued treatment with ZORYVE foam, 0.3%, for up to 24 to 52 weeks in an open-label, long-term trial, the adverse reaction profile was consistent with that observed in vehicle-controlled trials.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are insufficient data available on the use of ZORYVE foam, 0.3%, in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 30 and 26 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 10 times the MRHD. Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 16 and 49 times the MRHD, respectively. Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 49 times the MRHD during pregnancy and lactation periods in mice.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Labor and delivery Avoid using ZORYVE foam, 0.3%, during labor and delivery. There are no human studies that have investigated effects of ZORYVE foam, 0.3%, on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice.

Data Animal data In an embryo-fetal development study, pregnant rats were dosed orally during the period of organogenesis with up to 1.8 mg/kg/day roflumilast (30 times the MRHD on a mg/m2 basis). No evidence of structural abnormalities or effects on survival rates were observed. Roflumilast did not affect embryo-fetal development at a maternal oral dose of 0.2 mg/kg/day (3 times the MRHD on a mg/m2 basis).

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In a fertility and embryo-fetal development study, male rats were dosed orally with up to 1.8 mg/kg/day roflumilast for 10 weeks and females for 2 weeks prior to pairing and throughout the organogenesis period. Roflumilast induced pre- and post-implantation loss at maternal oral doses greater than or equal to 0.6 mg/kg/day (10 times the MRHD on a mg/m2 basis). Roflumilast did not cause fetal structural abnormalities at maternal oral doses up to 1.8 mg/kg/day (29 times the MRHD on a mg/m2 basis).

In an embryo-fetal development study in rabbits, pregnant does were dosed orally with 0.8 mg/kg/day roflumilast during the period of organogenesis. Roflumilast did not cause fetal structural abnormalities at the maternal oral doses of 0.8 mg/kg/day (26 times the MRHD on a mg/m2 basis).

In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day roflumilast during the period of organogenesis and lactation.

Roflumilast induced stillbirth and decreased pup viability at maternal oral doses greater than 2 mg/kg/day and 6 mg/kg/day, respectively (16 and 49 times the MRHD on a mg/m2 basis, respectively). Roflumilast induced delivery retardation in pregnant mice at maternal oral doses greater than 2 mg/kg/day (16 times the MRHD on a mg/m2 basis). Roflumilast decreased pup rearing frequencies at a maternal oral dose of 6 mg/kg/day during pregnancy and lactation (49 times the MRHD on a mg/m2 basis).

Roflumilast also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at a maternal oral dose of 12 mg/kg/day (97 times the MRHD on a mg/m2 basis).

Lactation Risk Summary There are no data on the presence of roflumilast or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.

Roflumilast and/or its metabolites are excreted into the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZORYVE foam, 0.3%, and any potential adverse effects on the breastfed infant from ZORYVE foam, 0.3%, or from the underlying maternal condition.

Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use ZORYVE foam, 0.3%, on the smallest area of skin and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, advise breastfeeding women not to apply ZORYVE foam, 0.3%, directly to the nipple or areola. If applied to the patient’s chest, avoid exposure via direct contact with the infant’s skin.

Data Animal data Roflumilast and/or its metabolite concentrations measured 8 hours after an oral dose of 1 mg/kg given to lactating rats were 0.32 and 0.02 mcg/g in the milk and pup liver, respectively.

Pediatric Use The safety and effectiveness of ZORYVE foam, 0.3%, for the treatment of seborrheic dermatitis have been established in pediatric patients 9 years of age and older. Use of ZORYVE foam, 0.3%, in this age group is supported by data from two 8-week, vehiclecontrolled trials which included 32 pediatric subjects 9 to 17 years of age, of whom 17 received ZORYVE foam, 0.3%, and from open-label trials of up to 52 weeks which included 23 pediatric subjects treated with ZORYVE foam, 0.3%. The adverse reaction profile was consistent with that observed in adults.

The safety and effectiveness of ZORYVE foam, 0.3%, in pediatric patients below the age of 9 years have not been established.

Geriatric Use Of the 683 subjects with seborrheic dermatitis exposed to ZORYVE foam, 0.3%, or vehicle for up to 8 weeks in the controlled clinical trials, 98 (14%) were 65 years of age or older, and 33 (5%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment Oral roflumilast 250 mcg once daily for 14 days was studied in subjects with hepatic impairment. The systemic exposure of roflumilast and roflumilast N-oxide were increased in subjects with moderate (Child-Pugh B) hepatic impairment. ZORYVE foam, 0.3%, is contraindicated in patients with moderate to severe liver impairment (ChildPugh B or C). No dosage adjustment is needed in patients with mild (Child-Pugh A) hepatic impairment.

PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).

Flammability Because the propellants in ZORYVE foam, 0.3%, are flammable, instruct the patient to avoid fire, flame, and smoking during and immediately following application.

Lactation Advise patients to use ZORYVE foam, 0.3%, on the smallest area of skin and for the shortest duration possible while breastfeeding. Instruct patients who are breastfeeding not to apply ZORYVE foam, 0.3%, directly to the nipple or areola to avoid direct infant exposure. Instruct patients to avoid inadvertent contact of treated areas with infant skin. © 2024 Arcutis Biotherapeutics, Inc. All rights reserved.

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Neomi a “Neo” Cuellar

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CCMS, PACS, FRONTIER DERMATOLOGY

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Best Practices F

EMRS AND OTHER HELPFUL TECHNOLOGY

or most practices, working with an Electronic Medical Record (EMR) or A.K.A. Electronic Health Record (EHR) are a daily

part of our lives. There are many options to choose from, and they all have different but similar features. The goal of most EMRs is to keep a patient chart organized, secure and easy to update.

Regardless of what you utilize, there are best practices to keep in mind when it comes to technology.

To use an EMR effectively as a biologic coordinator (BC), there are important elements to determine how your EMR can align and be successful for your needs.

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KEY FACTORS WHEN USING AN EMR 1 Get staff to use and easily get tips and important topics into the patient chart

2 Tracking system

3 Communication with office staff

4 Easy resource accessibility (Manufacturer Enrollment Forms)

5

room and getting the information a BC needs to fight an insurance company. Where it can take a scribe/MA over 10 minutes to complete a specialty drug note, Protocols can complete it after four to five clicks.

To put it in perspective, every specialty drug has its own protocol that over 90% of the staff can use. I know from experience this can be done to facilitate any provider/office load, because I’ve set up practices who have had only a couple providers all the way up to one of the largest groups with more than 100 providers. Even with multiple providers, it’s all in how the protocol is set up. First of all, keep in mind the “the basics.” What details does everyone use in the practice for every patient? Then, what can we set up to be easy for a scribe/MA to personalize?

In most groups, we all use the Plan of Counseling, and in EMA every specialty drug (biologics, PDE, JAK, etc.) has its own medication specific initiation plan, which helps staff answer questions for a BC to use on a PA.

“Some best practices to help staff, both new and senior, get important tips or prompts into a note so they are not forgotten is to use the EMR’s features to assist."

ePA One of the biggest burdens for a biologic coordinator, even some of the most senior BCs, is not getting what they need to fight the insurance company in the note. Maybe it’s because the provider prematurely finalized the visit note before they were able to finish. Alternatively, it could be a more prevalent reason—the staff is new or doesn’t know what needs to go into a specialty drug note. With so much office turnover and high burnout rates, the note may not have all the key points to fight for PA approvals.

Some best practices to help staff, both new and senior, get important tips or prompts into a note so they are not forgotten is to use the EMR’s features to assist. I use EMA by Modernizing Medicine.

EMA’s features that help with this is “Protocols.” Whether I am consulting for practices and setting up their system or managing my own, Protocols helps both intra-office flow for an MA or scribe in the

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WHEN SETTING UP A PROTOCOL, ENSURE IT HAS THE FOLLOWING: An impression of whatever the diagnosis is (Ex: Psoriasis)

Plan of counseling Plan of the medication initiation

(Ex: Skyrizi Initiation) Within this plan, I use the first screen, “Indications,” to add the PA tips that an MA or scribe can simply select on or off, then remember and type from scratch in every note. This is what cuts down on time spent doing a note and gets the information I need as a BC.

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A plan of order tests with the bare minimum that everyone uses

(Ex: QuantiFERON).

I include “Order Tests” because the newer MAs will not forget the patient needs a labs req. Help them remember the basics for your office, as it's always easier to add to something already in the note than to start it from scratch. If the provider wants more labs, simply select “Resume Plan” and add the additional labs per that provider.

When a protocol is in place, as soon as the provider says the drug name, all the MA/scribe has to do (on the iPad) is select the “More” tab at the top right, select “Protocols,” choose the medication protocol they need and select “Save.” Then with literally five clicks, MOST of the note is complete. After that step, they need to add a BSA, Severity and make sure they include tried and failed drugs, or anything personalized to that patient.

While in the room and doing the note, remember to get the medication enrollment form signed. This is sometimes forgotten, or signatures are missed. Each form may or may not have one or more areas a patient has to sign. In addition, we must capture the provider’s signature. Then, at some point during the day, completely fill out each section.

When we have a busy schedule, this is time consuming because the forms aren’t usually kept in the rooms. We have to leave to grab the form and get “wet” signatures.

I know myself and coworkers, in the past,

after we’ve completed our duties of closing rooms down for the day and cleaning up, we can’t just go home. We then have to gather the enrollment forms from the day and finish filling them out and faxing them.

To help intraoffice flow of this enrollment form juggling, some EMRs have a way to integrate forms into the system and collect signatures on the iPads. In addition to not having to leave the room, some also fill out the forms for the staff, allowing us to capture data, get signatures and eFax, all without leaving the visit. In EMA, this feature is found in the “PDF Manager” area of the “More” tab on the iPad. Employees are happy they can just go home at the end of the day, leading to less burnout. The forms do need to be prepared with “SMART Data” and uploaded by an administrative staff member to complete these steps. If you are unsure how to do this, you are lucky to be a BCoD member, because we can help. Just reach out!

Another pitfall could be forgetting to start the PA, since there was not a way to send communication to yourself or others that it is needed. Some staff keep the signed paper enrollment forms, but from personal experience, there are times these get misplaced or lost and we don’t go through with PA because there was not a reminder.

When a provider makes a decision for a specialty drug, we need to find a way to remember it needs to be done. In some EMRs they have a feature to prevent these types of issues.

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Subm Submitting Prescrip

ePresc > Find med

Phon Dial 800.511.5144 >ExD s speak directly to our accountability, and everything is in one place.

There is no clicking in and out to find out what happened, and nothing can be changed or misdated without a time stamp and history of change that was made.

One enhancement that many systems have available now is the ability to actually do a prior authorization in their EMR. Most are known as an “ePA.” This can prompt the user that a PA is needed for the medication and has its own designated area in the EMR to access the scripts needing PAs. The benefit of being able to do a PA from inside the system is that it already has all the information at the tips of the staff’s fingertips: insurance, note, demographics and more. Once a decision is made, you can easily integrate into the patient chart.

Some systems may be more limiting than others; however, they have really evolved over the last decade. I understand you all don’t have EMA as I do, but if you read about ACCESS DERMATOLOGY / ISSUE 9 / 2024

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a feature that you and the staff can benefit from, call your EMR rep. There may be a Fax feature already in your system, and you don’t > Send even know about it yet. If not, whomever you fax t use may be able to take the feature idea and develop it for you and other users across the country in a future update.

Many of us who have been in our position for over a decade have a difficult time adapting our system to an electronic PA process. No one said you have to change Address everything, but knowing how an EMR can work for you and your PAs could allow a better flow, faster decision turnaround, and improved drug to patient timing, so they have a chance to get better sooner.

The only constant in life is change. Start with baby steps in each area if you need and Downloa our referral for remember: BCoD is here for you.Download We have resources and programs in place to help you enhance, elevate, and understand any part of the PA journey.

PHARM PHARMACY ADDRESS Accessi Accessible in Most EMR

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One way to send myself a reminder that a PA is needed, or for staff to let me know without having to physically find me in the office, is to “Create Task” in the EMA system. Other EMRs may have a feature like this, where the staff member opens it up and puts the details of what is needed to be done and it is sent to me or whoever is responsible for the PA. If this isn’t an option, before “Tasks” were available as a feature, I would send myself an intra-mail.

A tracking system is a must, and I know many who still keep a paper log or use Excel. I always think, “What if the paper log gets misplaced or destroyed?” If your EMR system has a tracking platform, find out if it can be used so others can see updates and progress about the PA journey to translate information to patients or help out when needed. In my EMA system, we use the “Task” area for this. You can use “Chart Notes,” but I adore “Tasks” because there is

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CONFERENCE REGISTRATION

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Unlocking Access TOMBAKY - STOCK.ADOBE.COM

OVERCOMING PATIENT BARRIERS TO PROVIDER-ADMINISTERED BIOLOGIC THERAPIES

ACCESS DERMATOLOGY / ISSUE 9 / 2024

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By Jason Zemc ik

VICE PRESIDENT, HEAD OF PRODUCT, POLICY REPORTER

A

midst the ever-changing healthcare landscape, patient access to provideradministered biologic drugs remains a constant challenge. These

groundbreaking therapies offer tremendous promise in treating complex diseases, ranging from autoimmune disorders to cancer. However, their high cost, coupled with administrative hurdles, often creates barriers to patient access that leave patients grappling with their health and financial well-being. Three significant challenges in this area also present opportunities for providers’ staff. Through innovative strategies, both in conjunction with pharmaceutical manufacturers and technology providers,

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providers can reimagine access solutions to better serve patients.

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Healthcare executives cite payer reimbursements across all lines of business as a top challenge their organizations are facing.

A recent study by the American College of Healthcare Executives revealed that 66% of hospital CEOs see managed care and other commercial payments as a top financial concern. Medicaid (51%) and Medicare (51%) followed closely behind.

Revenue Cycle Management as a whole (52%) also made the list of CEOs top financial concerns.

Compounding matters, workforce challenges ranked as the top overall area of concern among survey respondents.

The additional personnel hours required to address payer reimbursement complexities in the form of appeals, resubmissions, and ensuring proper documentation contributes heavily to this.

Claim denials contribute prominently to challenges in both areas. According to a recent national survey conducted

by Premier, Inc., 15% of medical claims submitted to private payers for reimbursement are initially denied.

Additionally, 3.2% of all claims denied included those that were pre-approved via the prior authorization process. On average, providers incur nearly $44 of staff administrative time costs per denial in the form of resolution and resubmission work necessary to pursue a paid claim.

The 2022 Experian Healthcare State of Claims report indicated that 67% of surveyed providers consider claims management more important now than prior to the COVID-19 pandemic due to payer policy changes occurring more frequently.

Providers are actively seeking solutions to aid their efforts in this area. At the 2023 Healthcare Financial Management Association Annual Conference, a roundtable of revenue cycle leaders discussed how their organizations are addressing the impact of payer changes and denials. A common theme was having proactive solutions that educate staff on how to avoid claim issues.

Policy Reporter is assisting provider organizations in this way through our Payer Compliance Dashboard. This tool provides a curated view of key payer requirements, from payers of interest and filterable by geography to line of business and other characteristics. The interface gives staff a streamlined way to remain up to date

on constantly changing requirements, as opposed to scouring the internet and combing through documents for claim submission criteria and documentation requirements.

EVOLVING FINANCIAL SUPPORT PROGRAMS AND MITIGATING THE IMPACT OF DISRUPTION TACTICS

Specialty drugs, specifically biologics, can come with hefty price tags. This places immense financial strain on patients.

Despite advancements in insurance coverage, out-of-pocket costs remain exorbitant for many individuals, leaving them with daunting decisions regarding their treatment. High deductibles, copayments, and coinsurance requirements further exacerbate this issue.

According to the Kaiser Family Foundation 2023 Employer Health Benefits Survey, over the last five years, the percentage of covered workers with a general annual deductible of $2,000 or more for single coverage has grown from 26% to 31%. Such coverage situations force patients to navigate a maze of financial barriers before receiving essential care.

For patients, the financial burden of biologic therapies extends beyond dollars, to impact every aspect of their lives.

Many face the gut-wrenching dilemma of choosing between purchasing life-saving medications or meeting other basic needs, such as housing and food. This financial

“According to a recent national survey conducted

by Premier, Inc., 15% of medical claims submitted to private payers for reimbursement are initially denied."

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OVERCOMING INCREASING DENIALS DUE TO CHANGING PAYER REQUIREMENTS

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“Through innovative strategies, both in conjunction with pharmaceutical manufacturers and technology providers, providers can reimagine access solutions to better serve patients."

strain not only jeopardizes their physical health but also takes a toll on their mental and emotional well-being, leading to heightened stress and anxiety.

To alleviate the financial burden on patients, providers' office staff play a pivotal role in exploring avenues for financial assistance. They can proactively engage with patients to assess their insurance coverage, identify available patient assistance programs such as manufacturer-sponsored copay assistance, Patient Assistance Programs (PAP) or free goods, or charitable foundation assistance, and guide them through the process of applying for and utilizing these resources.

Manufacturer programs are becoming increasingly more generous. A recent study by Mercalis, Policy Reporter’s parent company, which designs and operates patient support services programs on behalf of pharmaceutical manufacturers, found that 56% of manufacturer PAPs reviewed had eligibility criteria at or above 500% of the Federal Poverty Level (FPL).

These programs are not without their challenges, though. Copay accumulators and maximizers are widely known among providers’ staff as being a thorn in the side of patient access and affordability.

However, Alternate Funding Programs, also known as Specialty Carve Outs, are also permeating the space and disrupting patients’ ability to begin therapy in a timely manner and remain adherent.

IDENTIFYING CREATIVE WAYS TO OVERCOME LOGISTICAL BARRIERS TO TREATMENT

There are several solutions to these problems, in the form of alternate patient payment methods and direct reimbursements, as well as letters of eligibility verification to avoid AFP issues.

These are most commonly put in place by the manufacturer sponsoring the program.

A key element of success lies in the providers’ staff maintaining proactive and frequent communication with the pharmaceutical manufacturers’ field teams.

“I text my FRM (field reimbursement manager) multiple times a day. If I ever have an issue, I have them on speed dial,” said one practice financial coordinator. By maintaining this open communication, staff can work to address each unique patient situation and implement alternate financial solutions before the patient’s treatment schedule is disrupted.

Beyond financial and insurance-related challenges, logistical barriers are significant hurdles for patients seeking treatment from provider-administered biologic drugs.

These therapies often require specialized handling, such as refrigeration or intravenous infusion, necessitating concise coordination with healthcare facilities and home healthcare services. Transportation constraints, particularly for patients residing in rural or underserved areas, further complicate access to treatment.

Limitations in physically accessing sites of care inhibit patients’ ability to be adherent to a prescribed treatment regimen.

Logistical barriers impede patients' access by disrupting their treatment schedules and compromising therapeutic outcomes. Missed appointments due to transportation challenges or logistical constraints such as caretaker availability can lead to treatment interruptions, exacerbating disease progression and diminishing efficacy.

Moreover, the added stress of navigating logistical hurdles contributes to patients' overall burden, eroding their confidence in the healthcare system and negatively impacting treatment adherence.

Providers' staff can play a pivotal role in overcoming logistical barriers by implementing proactive strategies to enhance patient accessibility. This

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“Providers' staff can play a pivotal role in overcoming logistical barriers by implementing proactive strategies to enhance patient accessibility."

expand access to care for patients in remote or underserved areas, enabling them to receive timely consultations and monitoring without the need for extensive travel.

While biologic therapies offer a world of possibilities, they also come with a hefty dose of patient access challenges.

By remaining informed on current trends impacting patient access, as well as solutions available, providers’ staff can stay one step ahead of these problems to best ensure patients are able to start and remain adherent to their prescribed therapeutic regimen for the best possible outcomes.

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may involve coordinating transportation services for patients in need, facilitating home healthcare arrangements for those requiring infusion therapies, and optimizing scheduling processes to minimize wait times and logistical challenges.

Manufacturers are more commonly including these services as part of their patient support programs. Once considered largely a financial assistance mechanism, patient services have evolved to include nurse educator support, transportation and lodging assistance, and other ancillary services that contribute to achieving new patient starts and strong adherence to therapy regimens.

Leveraging telehealth technologies can

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Thank you for supporting individuals living with vitiligo and addressing the challenges they experience each day.

Incyte and the Incyte logo are registered trademarks of Incyte. © 2024, Incyte. MAT-DRM-01231 05/24

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A NEW PATIENT SUPPORT PROGRAM Opzelura On Trac™ provides you with resources to help patients get, start, and stay on track with treatment.

Program Features: Enhanced Services Specialty Pharmacy Network Commercial Bridge Program*

Prior Authorization Guidance Patient Support Resources

* For eligible patients.

DESTINATION: ACCESS Scan the QR code or visit opzeluraontrachcp.com.

Please see Important Safety Information on the next page and Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

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INDICATIONS OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include: •

Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

•

Invasive fungal infections, including cryptococcosis and pneumocystosis.

•

Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA. MALIGNANCIES Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.

Thrombocytopenia, Anemia, and Neutropenia Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA. Lipid Elevations Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions In atopic dermatitis, the most common adverse reactions (≥1%) are nasopharyngitis (3%), diarrhea (1%), bronchitis (1%), ear infection (1%), eosinophil count increased (1%), urticaria (1%), folliculitis (1%), tonsillitis (1%), and rhinorrhea (1%).

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-4633463.

Lactation Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination halflives).

Please see Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to

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OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte. © 2024, Incyte. 05/24

MAT-OPZ-02225

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OPZELURA® (ruxolitinib) cream, for topical use Brief Summary of FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE: OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions and Adverse Reactions].

Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

• Invasive fungal infections, including cryptococcosis, and pneumocystosis.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.

The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA [see Warnings and Precautions].

MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions].

MALIGNANCIES Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions].

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke [see Warnings and Precautions].

THROMBOSIS Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately [see Warnings and Precautions].

WARNINGS AND PRECAUTIONS Serious Infections: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral Janus kinase inhibitors. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OPZELURA in patients: with chronic or recurrent infection; with a history of a serious or an opportunistic infection; who have been exposed to tuberculosis; who

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of endemic tuberculosis or with (TRuE-AD1 and TRu have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or withor endemic mycoses; underlying conditions may predispose them patients to infection. patients for w dermatitis underlying conditions that may predispose them to that infection.

Closely monitor for Closely monitoratopic thesymptoms development of signs during and symptoms infection with during and after treatment withof subj group, 62% the development of signs and of infection and afteroftreatment OPZELURA. Interrupt OPZELURA a patient an develops a serious infection, an opportunistic and 4% were Asian OPZELURA. Interrupt OPZELURA if a patient develops a seriousifinfection, opportunistic infection, or sepsis.until Do not until the infection is controlled. and at a greater in infection, or sepsis. Do not resume OPZELURA the resume infectionOPZELURA is controlled.

OPZELURA (N=499) : No cases of active tuberculosis (TB) were reported in clinical trials with Tuberculosis: No cases of active tuberculosis (TB) were reported in clinical trials with adversekinase event (TEAE Cases ofin active wereofreported in clinical OPZELURA. Cases of active TB were reported clinicalTBtrials oral Janus kinase trials of oral Janus (1%) vs 0for (0%), Ea inhibitors used to treat Consider inflammatory conditions.

Consider evaluating 4patients inhibitors used to treat inflammatory conditions. evaluating patients for 4 (1%) vs 0 administration of OPZELURA. DuringUrticaria OPZELURA latent and active TB infection prior to administration of OPZELURA. During OPZELURA 3 (1%) vs 0 (0%), an use, monitor patients for the development of signs and symptoms of TB. Adverse(e.g., reactions Viral reactivation, including cases of herpes virus reactivation Viral Reactivation: Viral reactivation, including: cases of herpes virus reactivation (e.g., OPZELURA group a herpes zoster),trials werewith reported clinicalinhibitors trials with Janus used to herpes zoster), were reported in clinical Janusinkinase used to kinase inhibitors pyrexia, seasonal treatincluding inflammatory conditions OPZELURA. If a patient develops herpes treat inflammatory conditions OPZELURA. If a including patient develops herpes acneiform dermatit consider interrupting OPZELURA treatment until the episode resolves. zoster, consider interruptingzoster, OPZELURA treatment until the episode resolves.

Nonsegmental Vitilig Hepatitis B and C: The impactused of Janus kinase inhibitors used to treat inflammatory Hepatitis B and C: The impact of Janus kinase inhibitors to treat inflammatory 449 adu conditions including on chronic is viral hepatitis reactivation TRuE-V2), is unknown. conditions including OPZELURA on chronic viralOPZELURA hepatitis reactivation unknown. vitiligotrials. were treated PatientsB with history of hepatitis B orfrom C infection Patients with a history of hepatitis or C ainfection were excluded clinical were trials.excluded from clinical of subjects were fe Hepatitis viral load with (HBV-DNA titer)associated increases,elevations with or without associated elevations Hepatitis B viral load (HBV-DNA titer) Bincreases, or without The adverse alanine aminotransferase and aspartate aminotransferase, have beenAsian. reported in in alanine aminotransferaseinand aspartate aminotransferase, have been reported in ≥ 1% and is at notleast 1% patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not OPZELURA initiation period are as follow recommended in patients with active hepatitis B or hepatitis C. any treatment emer In a large, randomized, safety study of an oral JAK inhibitor Mortality: In a large, randomized, postmarketing safety study postmarketing of an oral JAK inhibitor 26 (6%) vs 2 (1%), rheumatoid arthritis patients years of age leastHeadache one in rheumatoid arthritis (RA)in patients 50 years of (RA) age and older50 with at least oneand older with 5at(2%), 1 riskall-cause factor, amortality, higher rate of all-cause sudden cardiovascular risk factor, cardiovascular a higher rate of including suddenmortality, including site erythema 7 (2% death, was observed in patients treated with the JAK inhibitor cardiovascular death, wascardiovascular observed in patients treated with the JAK inhibitor Adverse reactions t Consider benefitspatient and risks for the individual patient compared with TNF blockers. Consider the benefits and risks for thethe individual the OPZELURA gro prior to initiating or continuing therapy with OPZELURA. hypertension, anxie Malignancy and Lymphoproliferative Disorders: Malignancies, including lymphomas, Malignancies, includingdermatitis lymphomas,contac were observed in clinical trials of oral JAK inhibitors used to treat inflammatory inhibitors conditions. used to treat inflammatory conditions. illnes influenza-like Patients who are current or past Patients smokers who are at current additional or past increased smokersrisk. are Malignancies, at additional increased risk. Malignancies, DRUGtoINTERACTI including lymphomas, have including occurred in lymphomas, patients receiving have occurred JAK inhibitors in patients usedreceiving to treat JAK inhibitors used treat Drug interaction s inflammatory conditions. In ainflammatory large, randomized, conditions. postmarketing In a large, safety randomized, study of postmarketing an oral safety study of an oral known to be a su JAK inhibitor in RA patients, aJAK higher inhibitor rate of in malignancies RA patients, a(excluding higher ratenon-melanoma of malignancies skin (excluding non-melanoma skin may increase cancer) was observed in patients cancer) treated waswith observed the JAK in patients inhibitortreated compared withtothe those JAKtreated inhibitor compared to those treated ruxo decrease ruxolitini with TNF blockers. A higher rate withofTNF lymphomas blockers.was A higher observed rate of in lymphomas patients treated was with observed the in patients treated with the Inhibitors JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancersA higher rate of Strong lung cancers inhibitors of CYP3 was observed in current or past smokers treated with the JAK inhibitor compared to those JAK inhibitor compared to those ruxolitinib and cou treated with TNF blockers. treated In this study, with TNF current blockers. or past In smokers this study,had current an additional or past smokers had an additional increased risk of overall malignancies. increased risk Consider of overall the benefits malignancies. and risks Consider for thethe individual benefits and risks for the USEindividual IN SPECIFIC patient prior to initiating or continuing patient prior therapy to initiating with OPZELURA, or continuing particularly therapy with in patients OPZELURA, particularly in patients Pregnancy with a known malignancy (other withthan a known successfully malignancy treated (other non-melanoma than successfully skin cancers), treated non-melanoma skin cancers), Pregnancy Exposu patients who develop a malignancy when on treatment, and patients who are currentand or patients who are current or outcomes in preg past smokers. persons exposed Non-melanoma Skin Cancers: Non-melanoma Non-melanoma Skinskin Cancers: cancersNon-melanoma including basalskin cellcancers and including basal cell and exposure by callin squamous cell carcinoma have squamous occurred cellincarcinoma patients treated have occurred with OPZELURA. in patients Perform treated with OPZELURA. Perform Risk Summary periodic skin examinations periodic during OPZELURA skin examinations treatmentduring and following OPZELURA treatment treatment as and following treatment as to are not sufficient appropriate. Exposure to sunlight appropriate. and UVExposure light should to sunlight be limited andbyUVwearing light should protective be limited by wearing protective other adverse mater clothing and using broad-spectrum sunscreen. of ruxolitinib to pre Major Adverse Cardiovascular Events (MACE): In a large, randomized, postmarketing In a large, randomized, postmarketing adverse developme safety study of an oral JAK inhibitor safetyinstudy RA patients of an oral 50JAK years inhibitor of age inand RAolder patients with50 at least yearsone of age and older with at least one The background cardiovascular risk factor, a cardiovascular higher rate of major risk factor, adverse a higher cardiovascular rate of major events adverse (MACE)cardiovascular events (MACE)are un populations defined as cardiovascular death, defined non-fatal as cardiovascular myocardial infarction death, non-fatal (MI), andmyocardial non-fatal infarction stroke (MI), and non-fatal stroke outc other adverse was observed with the JAK inhibitor was observed compared withtothe those JAKtreated inhibitor with compared TNF blockers. to those Patients treated with TNF blockers. birth Patients defects and m who are current or past smokers are at additional increased risk. Consider the benefits and Consider the benefits and Data risks for the individual patient risks prior fortotheinitiating individual or continuing patient priortherapy to initiating with OPZELURA, or continuing therapy with OPZELURA, particularly in patients whoparticularly are currentin or patients past smokers who are and current patients or past withsmokers other and patientsAnimal with Data: otherRuxolit of organogenesis, a cardiovascular risk factors. Patients cardiovascular should risk be informed factors. Patients about theshould symptoms be informed of serious about the symptoms of serious rabbits.

There were cardiovascular events and thecardiovascular steps to take ifevents they occur. and the Discontinue steps to take OPZELURA if they occur. in patients Discontinue OPZELURA in patients weight of approxim that have experienced a myocardial infarction or stroke.

60 mg/kg/day. This Thrombosis: Thromboembolic events were Thromboembolic observed in clinical events trials were with observed OPZELURA. in clinical trials with OPZELURA. systemic exposure a Thrombosis, including deepThrombosis, vein thrombosis including (DVT), deep pulmonary vein thrombosis embolism(DVT), (PE), pulmonary and embolism (PE), and exposure from ruxo arterial thrombosis have been arterial reported thrombosis in patients have receiving been reported JAK inhibitors in patients used receiving to JAK inhibitors used to affected body surfac treat inflammatory conditions. treatMany inflammatory of these conditions. adverse reactions Many ofwere theseserious adverse andreactions were serious and lower fetal weights some resulted in death. In asome large,resulted randomized, in death. postmarketing In a large, randomized, safety study of postmarketing an oral safety study of an oral highest and matern JAK inhibitor in RA patients JAK 50 years inhibitor of age in RA andpatients older with 50 years at least of one age cardiovascular and older with at least one cardiovascular approximately 70% risk factor, higher rates of overall risk factor, thrombosis, higher DVT, ratesand of overall PE were thrombosis, observed DVT, compared and PE to were observed compared to study in rats, preg those treated with TNF blockers. thoseAvoid treated OPZELURA with TNFinblockers. patients Avoid who may OPZELURA be at increased in patients who may be at increased lactation at doses risk of thrombosis. If symptoms risk of ofthrombosis. thrombosisIf occur, symptoms discontinue of thrombosis OPZELURA occur, anddiscontinue OPZELURA and embryofetal surviva evaluate and treat patients appropriately. function at the highe Thrombocytopenia, Anemia, and Neutropenia: Thrombocytopenia, anemia,Thrombocytopenia, and anemia, and Lactation neutropenia were reported in the clinicalwere trialsreported with OPZELURA. Consider benefits neutropenia in the clinical trialsthe with OPZELURA. Consider the benefits Risk Summary and risks for individual patients and risks who for have individual a knownpatients history who of these haveevents a known priorhistory to of these events prior to the breastfed initiating therapy with OPZELURA. initiatingPerform therapyCBC withmonitoring OPZELURA. asPerform clinicallyCBC indicated. monitoring If as clinicallyon indicated.

If ch of lactating signs and/or symptoms ofsigns clinically and/orsignificant symptomsthrombocytopenia, of clinically significant anemia,thrombocytopenia, and anemia, andrats. W present in human m neutropenia occur, patients should discontinue OPZELURA. serious infections, Lipid Elevations: Treatment with oral ruxolitinib Treatment has been with associated oral ruxolitinib with increases has been associated with increases breastfeed during t in lipid parameters including totalparameters cholesterol,including low-density in lipid total lipoprotein cholesterol, (LDL) low-density lipoprotein last dose(LDL) (approxim cholesterol, and triglycerides.

Data: Lactating ra ADVERSE REACTIONS (30 mg/kg) on pos Clinical Trials Experience: Because clinical trials are conducted Because clinical under widely trials are varying conducted under widely for upvarying to 24 hours. conditions, adverse reaction rates conditions, observed adverse in thereaction clinical trials ratesof observed a drug cannot in the clinical be directly trials of a drug cannot directly plasm thebe maternal compared to rates in the clinical compared trialstoofrates another in the drugclinical and may trialsnot of reflect anotherthe drug rates and may not reflect the of rates several its meta observed in practice. Atopic Dermatitis: In two double-blind, Atopic Dermatitis: vehicle-controlled In two double-blind, clinical trialsvehicle-controlled clinical trials

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ic mycoses; or with (TRuE-AD1 and TRuE-AD2), 499 adult andand pediatric subjects years of pediatric age and older with12 years of age and older with (TRuE-AD1 TRuE-AD2), 49912adult and subjects monitoratopic patients for were treatedatopic dermatitis with dermatitis OPZELURAwere twicetreated daily for 8 weeks.

In the OPZELURA with OPZELURA twice daily for 8 weeks. In the OPZELURA fter treatment withof subjects were group, group, 62% females, andof71% of subjects were White, 23% of were Black,were White, 23% were Black, 62% subjects were females, and 71% subjects on, an opportunistic and 4% were Asian. The adverse byadverse ≥ 1% ofreactions OPZELURA treatedby subjects and reactions 4% were reported Asian. The reported ≥ 1% of OPZELURA treated subjects controlled. and at a greater incidence than in athegreater vehicleincidence arm through are asarm follows for week 8 are as follows for and at than week in the8vehicle through OPZELURA (N=499) vs VehicleOPZELURA (N=250), respectively: Subjects with anyrespectively: treatment emergent (N=499) vs Vehicle (N=250), Subjects with any treatment emergent n clinical trials with adversekinase event (TEAE) 132 (27%) vs 83event (33%),(TEAE) Nasopharyngitis 1383 (3%) vs 2 Nasopharyngitis (1%), Bronchitis 13 (3%) vs 2 (1%), Bronchitis adverse 132 (27%) vs (33%), oral Janus (1%) vs 0for (0%), Ear infection44(1%) (1%)vs vs00(0%), (0%),Ear Eosinophil increased 4 (1%) vs 0 (0%), infectioncount 4 (1%) vs 0 (0%), Eosinophil count increased 4 (1%) vs 0 (0%), uating 4patients 4 (1%) vs 0 (0%), Diarrhea 3 (1%) vs 1vs(<1%), Tonsillitis Urticaria 4 (1%) 0 (0%),Folliculitis Diarrhea 3 (1%) vs 01 (0%), (<1%), Folliculitis 3 (1%) vs 0 (0%), Tonsillitis DuringUrticaria OPZELURA 3 (1%) vs 0 (0%), and Rhinorrhea 3 (1%) 1 (<1%).

3 (1%) vs 0vs (0%), and Rhinorrhea 3 (1%) vs 1 (<1%).

Adverse(e.g., reactions that occurred in TRuE-AD1 in TRuE-AD1 < 1% of subjects in the in < 1% of subjects in the Adverse reactionsand thatTRuE-AD2 occurred in and TRuE-AD2 s reactivation OPZELURA group and none inOPZELURA the vehiclegroup groupand were: neutropenia, allergic none in the vehicle groupconjunctivitis, were: neutropenia, allergic conjunctivitis, inhibitors used to pyrexia, seasonal allergy, herpes otitisallergy, externa,herpes Staphylococcal infection, pyrexia,zoster, seasonal zoster, otitis externa,and Staphylococcal infection, and t develops herpes acneiform dermatitis. acneiform dermatitis. e resolves.

Nonsegmental Vitiligo Nonsegmental Vitiligo: In two double-blind, vehicle-controlled clinical trials (TRuE-V1 and treat inflammatory 449 adult and pediatric TRuE-V2), subjects 449 12 adult years andofpediatric age andsubjects older with 12nonsegmental years of age and older with nonsegmental vation TRuE-V2), is unknown. vitiligotrials. were treated with OPZELURA vitiligo were twicetreated daily forwith 24 weeks.

OPZELURA In thetwice OPZELURA daily forgroup, 24 weeks.

55% In the OPZELURA group, 55% rom clinical of subjects were females, andof81% subjects of subjects were females, were White, and 81% 5% were of subjects Black, and were4% White, were5% were Black, and 4% were sociated elevations The adverse reactions Asian. reported Thebyadverse OPZELURA reactions reported by OPZELURA treated subjects with an incidence of e beenAsian. reported in ≥ 1% and ≥ 1% and at than least in the 1%vehicle greaterarm incidence in the 24-week than in thedouble-blind vehicle arm in the 24-week double-blind URA initiation is at notleast 1% greater incidence period are as follows for OPZELURA period(N=449) are as follows vs Vehicle for OPZELURA (N=224), respectively: (N=449) vs Vehicle Subjects (N=224), with respectively: Subjects with any treatment emergent adverse anyevent treatment (TEAE) emergent 214 (48%) adverse vs 79event (35%),(TEAE) Application 214 (48%) site acne vs 79 (35%), Application site acne n oral JAK inhibitor 26 (6%) vs 2 (1%), Application26site (6%) pruritus vs 2 (1%), 23 (5%) Application vs 6 (3%), siteNasopharyngitis pruritus 23 (5%)19vs(4%) 6 (3%), vs Nasopharyngitis 19 (4%) vs with 5at(2%), leastHeadache one 17 (4%) vs56(2%), (3%),Headache Urinary tract 17 infection (4%) vs 67 (3%), (2%) vs Urinary 1 (<1%), tract Application infection 7 (2%) vs 1 (<1%), Application including sudden site erythema 7 (2%) vs 1 (<1%), site and erythema Pyrexia7 6(2%) (1%)vsvs1 0(<1%), (0%) and Pyrexia 6 (1%) vs 0 (0%). the JAK inhibitor Adverse reactions that occurred Adverse in TRuE-V1 reactions andthat TRuE-V2 occurred in ≥in0.5% TRuE-V1 to < 1% andofTRuE-V2 subjectsinin≥ 0.5% to < 1% of subjects in he individual patient the OPZELURA group and none the OPZELURA in the vehicle group group andwere: none application in the vehicle site group dermatitis, were: application site dermatitis, hypertension, anxiety, application hypertension, site discoloration, anxiety, application applicationsite sitediscoloration, folliculitis, contusion, application site folliculitis, contusion, cludingdermatitis lymphomas,contact, diarrhea, dermatitis ear infection, contact, gastritis, diarrhea, gastroenteritis, ear infection, hordeolum, gastritis, gastroenteritis, hordeolum, mmatory conditions. illness, insomnia, influenza-like influenza-like nasal congestion, illness,and insomnia, vomiting. nasal congestion, and vomiting. risk. Malignancies, DRUGtoINTERACTIONS DRUG INTERACTIONS bitors used treat Drug interaction studies with Drug interaction studies with OPZELURA have not been conducted. Ruxolitinib is ety study of an oral known toskin be a substrate forknown cytochrome to be aP450 substrate 3A4 for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 non-melanoma may increase may increase concentrations ruxolitinib whereas systemic inducers concentrations of whereas inducers of CYP3A4 may ared to those treated ruxolitinib systemic decrease ruxolitinib systemic decrease concentrations. ruxolitinib systemic concentrations. nts treated with the Inhibitors of CYP3A4: Strong Avoid Inhibitors concomitant of CYP3A4: use of Avoid OPZELURA concomitant with strong use of OPZELURA with strong rate of Strong lung cancers inhibitors of CYP3A4 as there inhibitors is a potential of CYP3A4 to increase as there the is asystemic potentialexposure to increase of the systemic exposure of r compared to those ruxolitinib and could increase ruxolitinib the risk of andOPZELURA could increase adverse thereactions. risk of OPZELURA adverse reactions. s had an additional ks for the USEindividual IN SPECIFIC POPULATIONS USE IN SPECIFIC POPULATIONS ticularly in patients Pregnancy Pregnancy noma skin cancers), Pregnancy Exposure Registry Pregnancy Exposure Registry: There is a pregnancy registry that monitors pregnancy who are current or outcomes in pregnant persons outcomes exposed in pregnant to OPZELURA persons during exposed pregnancy. to OPZELURA Pregnantduring pregnancy. Pregnant persons exposed to OPZELURA persons andexposed healthcare to OPZELURA providers should and healthcare report OPZELURA providers should report OPZELURA ding basal cell and exposure by calling 1-855-463-3463. exposure by calling 1-855-463-3463.

PZELURA. Perform Risk Summary Risk Summary: Available data from pregnancies reported in clinical trials with OPZELURA wing treatment as to evaluate aare are not sufficient drug-associated not sufficient torisk evaluate for major a drug-associated birth defects, miscarriage, risk for major or birth defects, miscarriage, or wearing protective other adverse maternal or fetalother outcomes. adverse In maternal animal reproduction or fetal outcomes. studies,Inoral animal administration reproduction studies, oral administration of ruxolitinib to pregnant ratsofand ruxolitinib rabbits to during pregnant the period rats and of organogenesis rabbits during the resulted periodin of organogenesis resulted in ized, postmarketing adverse developmental outcomes adverse at doses developmental associatedoutcomes with maternal at doses toxicity. associated with maternal toxicity. lder with at least one The background risks of major The background birth defects risksandof miscarriage major birth for defects the indicated and miscarriage for the indicated cular events (MACE)are unknown. All populations populations pregnancies are carry unknown. someAll risk pregnancies of birth defects, carry some loss, or risk of birth defects, loss, or and non-fatal stroke outcomes. The other adverse other background adverse outcomes. risk in the U.S. The background general population risk in the of major U.S. general population of major NF blockers.

Patients birth defects and miscarriage birth is 2-4% defects andand 15-20%, miscarriage respectively. is 2-4% and 15-20%, respectively. der the benefits and Data Data py with OPZELURA, Animal Data:orally Ruxolitinib to pregnant was administered rats or rabbits orally during to pregnant the period rats or rabbits during the period patientsAnimal with Data: otherRuxolitinib was administered of organogenesis, at doses of 15, of organogenesis, 30 at doses of 15, 30, or 60 mg/kg/day in rats and 10, 30, or 60 mg/kg/day in ymptoms of serious rabbits.

There were no treatment-related rabbits. Theremalformations were no treatment-related at any dose. Amalformations decrease in fetal at any dose. A decrease in fetal PZELURA in patients weight of approximately 9% was weight noted of approximately in rats at the highest 9% wasand noted maternally in rats attoxic the dose highest of and maternally toxic dose of 60 mg/kg/day. This dose resulted 60 mg/kg/day. in systemicThis exposure dose resulted approximately in systemic 22 times exposure the clinical approximately 22 times the clinical ls with OPZELURA. systemic exposure at the maximum systemic recommended exposure athuman the maximum dose (MRHD; recommended the clinical human systemic dose (MRHD; the clinical systemic mbolism (PE), and exposure from ruxolitinib cream, exposure 1.5% from applied ruxolitinib twice daily cream, to 25-40% 1.5% applied atopictwice dermatitisdaily to 25-40% atopic dermatitisinhibitors used to affected body surface area is used affected body surface area is used for calculation of multiples of human exposure). In rabbits, were serious and lower fetal weights of approximately lower fetal 8% weights and increased of approximately late resorptions 8% and were increased noted atlate theresorptions were noted at the ety study of an oral highest and maternally toxic dose highest of and maternally toxic dose of 60 mg/kg/day. This dose resulted in systemic exposure one cardiovascular approximately 70% the MRHD approximately clinical systemic 70% exposure. the MRHD In aclinical pre-andsystemic post-natal exposure. development In a pre-and post-natal development served compared to study in rats, pregnant animals studywere in rats, dosed pregnant with ruxolitinib animals were from implantation dosed with ruxolitinib through from implantation through may be at increased lactation at doses up to 30 lactation mg/kg/day. at There doses were up to no 30 drug-related mg/kg/day. There adversewere effects no drug-related on adverse effects on ue OPZELURA and embryofetal survival, postnatal embryofetal growth, development survival, postnatal parameters growth, or offspring development reproductive parameters or offspring reproductive function at the highest dose evaluated function (3.1 at the times highest the MRHD dose evaluated clinical systemic (3.1 times exposure). the MRHD clinical systemic exposure). enia, anemia, and Lactation Lactation onsider the benefits Risk Summary Risk Summary: There are no data on the presence of ruxolitinib in human milk, the effects ese events prior to the breastfed on the breastfed on milk production. child, or the Ruxolitinib effects onwas milkpresent production. in theRuxolitinib milk was present in the milk nicallyon indicated.

If child, or the effects of lactating of is lactating presentrats. in animal When milk, a drug it is likely present thatin the animal drugmilk, will be it is likely that the drug will be enia, anemia, andrats. When a drug present in human milk. Because present of theinserious humanadverse milk. Because findingsofinthe adults, serious including adverserisks findings of in adults, including risks of serious infections, thrombocytopenia, serious infections, anemia, and thrombocytopenia, neutropenia, advise anemia, women and neutropenia, not to advise women not to ated with increases breastfeed during treatment breastfeed with OPZELURA during treatment with OPZELURA and for approximately four weeks after the lipoprotein (LDL) last dose (approximately last dose (approximately 5-6 elimination half-lives).

Data: Lactating rats were Data: administered Lactatinga single rats were doseadministered of [14C]-labeled a single ruxolitinib dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day(30 10,mg/kg) after which on postnatal plasma Day and 10, milkafter samples whichwere plasma collected and milk samples were collected nder widely varying for up to 24 hours. The AUCfor forup total to 24 radioactivity hours. TheinAUC milkfor was total approximately radioactivity13 in times milk was approximately 13 times ug cannot be directly the maternal plasma AUC. Additional the maternal analysis plasma showed AUC. Additional the presence analysis of ruxolitinib showedand the presence of ruxolitinib and ot reflect the of rates several its metabolites in several milk, allofatitslevels metabolites higher than in milk, those allinatmaternal levels higher plasma. than those in maternal plasma. ntrolled clinical trials

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Pediatric Use: Atopic Dermatitis: The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from TRuE-AD1 and TRuE-AD2, which included 92 pediatric subjects aged 12 to 17 years with mild-to-moderate atopic dermatitis. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established.

Nonsegmental Vitiligo: The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from TRuE-V1 and TRuE-V2, which included 55 pediatric subjects aged 12 to 17 years with nonsegmental vitiligo. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established.

Juvenile Animal Toxicity Data: Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at systemic exposures that are at least 40% the MRHD clinical systemic exposure.

Geriatric Use: Of the 1249 total subjects with atopic dermatitis in clinical trials with OPZELURA, 115 (9%) were 65 years of age and older. No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

Of the 831 total subjects enrolled with nonsegmental vitiligo in clinical trials with OPZELURA, 65 (8%) were 65 years of age and older. Clinical trials of OPZELURA in subjects with nonsegmental vitiligo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

PATIENT COUNSELING INFORMATION Advise the patient or caregivers to read the FDA-approved patient labeling (Medication Guide).

Infections: Inform patients that they may be at increased risk for developing infections, including serious infections, when taking Janus kinase inhibitors. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection. Advise patients that Janus kinase inhibitors increase the risk of herpes zoster, and some cases can be serious [see Warnings and Precautions].

Malignancies and Lymphoproliferative Disorders: Inform patients that Janus kinase inhibitors may increase the risk for developing lymphomas and other malignancies including skin cancer. Instruct patients to inform their health care provider if they have ever had any type of cancer. Inform patients that periodic skin examinations should be performed while using OPZELURA. Advise patients that exposure to sunlight, and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions].

Major Adverse Cardiovascular Events: Advise patients that events of major adverse cardiovascular events (MACE) including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, have been reported in clinical studies with Janus kinase inhibitors used to treat inflammatory conditions. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions].

Thrombosis: Advise patients that events of DVT and PE have been reported in clinical studies with Janus kinase inhibitors used to treat inflammatory conditions. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions].

Thrombocytopenia, Anemia, and Neutropenia: Advise patients of the risk of thrombocytopenia, anemia, and neutropenia with OPZELURA. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of thrombocytopenia, anemia, or neutropenia [see Warnings and Precautions].

Administration Instructions: Advise patients or caregivers that OPZELURA is for topical use only [see Dosage and Administration].

Advise patients to limit treatment to one 60 gram tube per week or one 100 gram tube per 2 weeks [see Dosage and Administration].

Pregnancy: Inform patients to report their pregnancy to Incyte Corporation at 1-855-463-3463 [see Use in Specific Populations].

Lactation: Advise a patient not to breastfeed during treatment with OPZELURA and for about four weeks after the last dose [see Use in Specific Populations].

Manufactured for: Incyte Corporation 1801 Augustine Cut-off Wilmington, DE 19803 OPZELURA is a registered trademark of Incyte. All rights reserved.

U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 9079912; 9974790; 10639310; 10610530; 10758543; 10869870; 11219624 © 2022-2023 Incyte Corporation. All rights reserved.

Issued: July 2022 PLR-OPZ-00022-JUN23

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Skin Smarts KHORZHEVSKA - STOCK.ADOBE.COM

EXPERT ADVICE ON THE DO'S AND DON'TS OF SOCIAL MEDIA SKINCARE TRENDS FOR TEENS

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MELECIS - STOCK.ADOBE.COM

By Liz Barron

Skincare trends on social media have seemingly taken over the internet and it’s become virtually impossible to scroll through TikTok, YouTube or Instagram without being bombarded with tutorials about elaborate routines promising to make your face glow and radiate youth. And, while wanting to be in the know about the latest and greatest in cosmetics is nothing new, there has been a huge shift in the audience purchasing these products. Stores like Sephora and Ulta Beauty, who once saw middle-aged women as their biggest buyers, now have aisles filled with teens and tweens in search of high-end skincare products. The influence from these social media platforms is very real and children as young as nine or ten are putting things like $60 eye creams and skincare refrigerators on their wish lists.

Aside from the exorbitant cost, product safety is another major factor for parents to consider when deciding whether or not to allow their teens to indulge in this fad.

With a lot of misinformation floating around out there, it can be difficult for even the most discerning of us to understand every ingredient and ensure that buying these products isn’t coming at a cost higher than just our pockets. We sat down with Erin Myers-Albaridi, clinical director, PA-C at New Beauty Wellness (NBW) in New Canaan, CT. Myers-Albaridi helped give us a better understanding of what we should be focused on for optimal skin health by age. bcofdermatology.com

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I am seeing more and more children (and adults for that matter) come into the office with skin conditions, rashes and acne outbreaks made worse by over-the-counter products and cosmeceutical lines. Marketing is very powerful, and the consumer gets sucked into the trends without really understanding what they are using.

It’s important to stress, though, that it's an overall positive that children have a desire to take care of their skin. Skin cancer is the most common cancer in the U.S. Presently about one in five Americans will develop skin cancer in their lifetime and, although skin cancers form later in life, dermatologists know that most of these are caused from excessive sun exposure between the ages of three to 20 years of age.

WHAT PRODUCTS ARE THE MOST CONCERNING TO YOU THAT ARE BEING MISUSED? WHAT NEGATIVE IMPACTS COULD THEY HAVE ON THESE YOUNG TEENS? I would have parents look for and avoid ingredients like vitamin E (tocopherol) as they frequently stimulate acne and can make existing acne worse.

WHAT PRODUCTS, IF ANY, ARE TRULY APPROPRIATE FOR THOSE UNDER 15?

Cleanser, sunscreen and moisturizer. For oily skin, I like Neutrogena Hydro Boost Gel Cleanser. For dry skin, cream- or lotionbased products like CeraVe Hydrating Facial Cleanser work well. And for sensitive skin, Cetaphil Gentle Skin Cleanser is soap free and works well. For acne-prone skin,

I’d recommend trying a cleanser with an ingredient like salicylic acid, glycolic acid or benzoyl peroxide. If your tween has sensitive skin and is acne-prone, avoid these until consulting a dermatologist or dermatological PA/NP as they may be too harsh. Our tweens are listening to the importance of sun protection and many are using it regularly and far earlier than previous generations. Look for ingredients like titanium and zinc in SPF lotion; these completely block the UV rays. Increase the percentage to a 50 if outside and reapply every three hours if in the sun directly.

WHAT HAPPENS WHEN TOO MANY PRODUCTS ARE BEING USED AT ONCE OR OVERUSED?

Outbreaks of acne, rosacea, contact dermatitis, retinoid dermatitis (retinol overuse) and overly dehydrated sensitive skin are just a few of the conditions I see when products are used incorrectly.

Are there any brands that are just not designed for teens? Any product recommended for mature skin should be avoided by teens. Many AHA/BHA products (glycolic acid, salicylic acid) and retinols will increase the risk of sunburn and irritation. Make sure your teens are using a moisturizer and a sunscreen daily if using these products.

ARE THERE ANY BRANDS THAT HAVE PRODUCT LINES THAT TEND TO BE CLEANER/LIGHTER/ MORE APPROPRIATE?

Cetaphil, Neutrogena and Avène all have gentle products. For acne-prone skin, Differin (adapalene) makes a good overthe-counter product and you only need to use a pea-sized amount for the entire face.

It can be drying and irritating, so start three times a week and use a moisturizer either before or after application if your teen is sensitive.

LASER ADVICE

“Recent research and development in regenerative skincare has been advancing by the year. Please make sure you go to someone who understands laser technology indepth. It is a mistake to follow TikTok trends, as many companies are paying consumers and offices to market their machines. It doesn’t mean their device is superior to the competition. Some of the best lasers on the market are those that came out decades ago. Understanding the science is most important and, unfortunately, we are seeing more and more medical spas push devices when they don’t even understand the physics behind the lasers they run.

It’s the musician, not the instrument, that creates results. We have to keep skin type in mind as we run these powerful machines.”

—MYERS-ALBARIDI

TATYANAROW - STOCK.ADOBE.COM; WANGMANDO - STOCK.ADOBE.COM

WHAT ARE YOUR THOUGHTS ABOUT THIS SKINCARE CRAZE THAT SO MANY TEENAGERS ARE ATTRACTED TO?

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40-60S

NBW SKINCARE PRODUCT PICKS BY AGE:

ISDIN

Repair cream for the eye area that helps target fine lines and wrinkles; stimulates the skin’s antioxidant defenses and provides a detox action for a revitalized look.

40-60S

Critical thinking when deciding how to spend money is important when it comes to all things.

40-60S

ALASTIN

Helps combat signs of aging, brightening the complexion and lifting the skin for a more youthful glow.

ALPHARET EXFOLIATING PEEL PADS

TEENS

ENVIRON FOCUS CARE YOUTH+

Triple-acid formula with retinoid exfoliates skin, leaving it smooth and bright.

Toner with a high concentration of glycolic acid; promotes the natural acid mantle of the skin and encourages exfoliation.

TWEEN/ TEEN Recommended

cleanser, moisturizer and SPF Also consider glycolic acid, salicylic acid, benzoyl peroxide wash or retinol for acne-prone skin (make sure to consult a dermatologic provider if the teen’s skin is sensitive or resistant to over-the-counter products).

20-30s

Recommended: cleanser, moisturizer, SPF, retinol and products that help reduce free radical damage to the skin (vitamin C, peptides, alastin, exosomes) Also consider microneedling (with or without radiofrequency) to help with pore size and light resurfacing lasers such as Clear + Brilliant.

s 40-60 Recommended

cleanser, moisturizer, SPF, retinol, antioxidants, peptides

VENERA ALEXANDROVA

20-30S ISDIN PHOTO

Ultralight tinted, fastabsorbing emulsion that helps fight signs of photoaging.

Also consider Alastin’s ALPHARET ($000) Restorative Skin Complex (promotes collagen XXXXXXXand elastin to thicken the skin and helps Cit adigendanti iur? Experistia with elasticity), Skin Better’s cuptam et omnis dolupta doloria AlphaRet Pads with a blend of velitatio. Ga. Et moluptur aspicim patented retinol, lactic acid, quat quate doluptatis eos ullis ipiet glycolic acid and salicyclic iuntemp oreped milit, non reic tem et acid.

Consider adding deeper magnatur? Archili gnimillautem resurfacing lasers, deeper RF microneedling treatments, as well as ultrasound technology for tightening and resurfacing deeper wrinkles.

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NEED ANOTHER REASON TO ATTEND THE BCOD NATIONAL CONFERENCE THIS YEAR? Does your Dermatologist want greater office efficiency, drug approval percentages, and increased patient adherence?

BCoD is offering an immersive workshop designed to set up offices for maximum workflow efficiency.

BCOD MASTERY WORKSHOP: OPTIMIZING OFFICE WORKFLOW FOR BIOLOGIC Participants are provided a BCoD Biologic Binder with the information and resources to guide you for optimal therapy approval and office efficiency.

• • •

Contents include brand-specific approval documents Best practices for prior-approval by brand EMR setup instructions. We work closely with EMA and Epic and will demonstrate how to set up your office using these technologies.

Our resources are designed with years of experience and trial and error to minimize approval hurdles.

A 3-month study on implementing these BCoD practices and resources has demonstrated: • • •

a shortened window to drug vs. a control of offices not using them increased patient satisfaction increased office productivity

This program is commonly offered to Dermatology offices at a premium price. This workshop, its training, and its materials will be provided to you in this conference workshop at NO COST, and conference registration is free.

Join BCoD and attend our national conference for this workshop and many additional empowering workshops and presentations.

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UNLOCK YOUR POTENTIAL WITH BCOD

TOGETHER WE ADVANCE PATIENT ACCESS Join the Biologic Coordinators of Dermatology (BCoD) and discover a world of member benefits designed to elevate your professional journey and enhance patient care.

MEMBER BENEFITS EDUCATIONAL TRAINING

PROFESSIONAL DEVELOPMENT

RESOURCES

IMPROVE PATIENT OUTCOMES

Exclusive invites to educational trainings, webcasts, and meetings.

Office and patient resources for easier approvals and workflow management.

Content designed for personal and professional growth.

Tools and insights that enhance patient outcomes.

COMMUNITY

A platform that connects you with peers nationwide.

Embrace the vibrant community of BCoD, where each member plays a crucial role in advancing patient access.

Learn more at BCOFDERMATOLOGY.COM

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BC SPOTLIGHT

A

RECOGNIZING OUTSTANDING PATIENT SERVICE

t BCoD, we celebrate our members and access managers across the country who ensure a positive patient experience. We applaud these

professionals for their commitment to patients and their efforts to secure the types of therapy needed. This month, we spotlight an outstanding biologic coordinator for her remarkable efforts in advancing patient access.

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LETTER of RECOGNITION BC OD

Katelyn Crane BIOLOGIC COORDINATOR DERMATOLOGY ASSOCIATES, PSC Louisville, KY

“I am writing to nominate Katelyn Crane for special recognition as a biologic coordinator at Dermatology Associates, PSC, in Louisville, KY. Katelyn's exceptional dedication, initiative, and expertise have greatly contributed to the efficiency of our practice and overall care of our patients.

Since joining our team, Katelyn has demonstrated an unparalleled commitment to mastering all aspects of biologics coordination. She swiftly familiarized herself with biologics, prior authorizations, pharmacy logistics, and insurance intricacies, showcasing a remarkable level of diligence and adaptability. One of her initial endeavors was the creation of a comprehensive 'Biologics 101' reference brochure for our clinical staff and physicians, which has proven invaluable in facilitating understanding and efficiency.

Katelyn's initiative shines through her creation of meticulously detailed step-by-step guides for submitting prior authorizations for each biologic medication we utilize. Notably, she crafted 14 distinct guides—each color-coded for clarity and ease of reference, showcasing her dedication to thoroughness and accessibility.

Additionally, Katelyn has developed user guides tailored to our clinical staff, providing crucial information on complex biologics and dosing protocols. Her proactive approach to knowledge dissemination ensures that our office remains wellinformed and capable of delivering optimal patient care.

Katelyn consistently seeks out ways she can help make positive changes, whether that be here in our office or in our government. She goes above and beyond her role, making phone calls or writing letters to hospitals, insurance companies, or lobbying to change laws that negatively impact patients from receiving the medication they need and deserve.

Her commitment to advocating for patients and improving healthcare accessibility sets her apart. She not only excels in her day-to-day responsibilities, but also actively seeks opportunities to make a meaningful difference in the lives of others.

Katelyn's proactive approach and tireless dedication make her an invaluable asset to our team and the community we serve.

Katelyn's dedication to excellence serves as an inspiration to us all, and I am confident that she will continue to excel in anything she puts her mind to.”

— HANNAH GERBER, ASSISTANT PRACTICE MANAGER

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By Georgette Yacoub

take the e g lp un COLD THER

M

APY: THE H

OT HEALTH C

ARE TREND

aybe you know what it feels like to submerge your body into ice-cold water. The involuntary gasp. The initial shock. Your breath becomes

labored and short, in sync with your now-racing heart. Your adrenaline pumps into overdrive as if you were at the first drop of a roller coaster you didn’t really want to ride, when you’re just in a barrel of water in your backyard on a regular Tuesday morning—all in the name of wellness.

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If you aren’t familiar with the feeling, you’ve likely seen others doing it on your social media feeds or heard Joe Rogan talk about it. The question, though, is cold therapy just hot right now or is it worth the hype?

At a high level, scientific studies have shown cold therapy to increase energy, decrease chronic inflammation, reduce muscle soreness, improve sleep quality and strengthen immune function. When you first submerge yourself into cold water, your body goes into fight or flight mode.

Adrenaline jumps by 530% and dopamine (a “feel good” chemical) surges by 250%.

Your veins constrict, pumping blood away from your extremities and to your organs.

Then the magic happens.

Through the process of slowing and regulating your breath, you calm yourself back into your parasympathetic state—your “rest and digest” mode.

That’s where Joshua Church, co-founder of Edge Theory Labs, sees the most benefit.

“Cold therapy builds a sense of resilience.

What happens to the body and the mind once you get in allows you to start to practice the ability to respond to stress by learning to calm yourself down,” he says. “It widens your capacity for stress and builds the confidence that you can do hard things.”

Church played high-school football, and by the age of 19 he had four major surgeries and a body that functioned in chronic pain. After years of suffering, doctors recommended he take Ibuprofen and pick up a non-active sport.

He felt betrayed by his body before he got deep into alternative treatments. In 2019, he decided to go to Iceland for the Wim Hof Method Retreat, where he learned the power of cold-water immersion to regulate the nervous system.

His pain started to dissipate, and he built the capacity to do things he was told he never could—multiple triathlons, mountaineering summits and even a full Ironman. But that wasn’t the only thing that made him start Edge Theory Labs.

“Everyone gets that cold therapy helps you kick out inflammation,” Church says.

“But what fascinated me was what it can teach you about the way you engage with fear and the deeper parts of your subconscious and stress.”

In other words, it’s about “how to take the ice out of the tub.”

Partially because of his desire to share what has changed his life—and partially because he was tired of buying ice— Church called up his cousin to help him build a DIY tub that they eventually made better and better until it was ready to go to market in April 2022.

COLD PLUNGE BEST PRACTICE HOW LONG SHOULD I STAY IN?

Start at two minutes, but you really only need two to three minutes per day.

BEFORE OR AFTER MY WORK OUT?

If you’re focused on muscle growth, it’s best to wait a few hours after your workout before cold plunging (or just pop in for 30 to 60 seconds). Otherwise, do it before, which will lower your muscle temperature and help you have better output.

WHAT TEMPERATURE SHOULD IT BE?

DOES COLD THERAPY HELP WITH WEIGHT LOSS?

Yes, in two ways—shivering and non-shivering thermogenesis.

In other words, we burn calories when we’re cold and shiver, which our body does to warm itself back up. But non-shivering thermogenesis activates and builds brown adipose tissue (brown, healthy fat), which burns white fat (unhealthy, unwanted fat).

Start at 57 degrees Fahrenheit (higher if you need to) and work your way down if you’d like.

WHAT TIME OF DAY?

That totally depends on you.

Some people love to start their day with doing something hard, while others use cold therapy at night to unplug from the day. Most commonly, people do it post-workout to flush out soreness—which works especially well for long runs or endurance workouts.

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More than 75% of commercially insured patient lives have coverage for OPZELURA®1 Covered at any tier. PA and other restrictions may apply.

Coverage is plan specific and subject to change.

For patients 12 years of age and older

CONSIDER OPZELURA

®2

The First and Only FDA-Approved Treatment for Repigmentation in Nonsegmental Vitiligo2* Proven to Promote Skin Repigmentation in Phase III Clinical Trials2 Not an OPZELURA® patient.

F-VASI75 Results at Weeks 24 and 52 Data From Week 24 And an Open-Label Extension Nearly

1 in 3 patients

Nearly 1 in 3 patients achieved F-VASI75† at 24 weeks (primary endpoint; 29.9% vs 7.5% [P<0.0001] and 29.9% vs 12.9% [P<0.01]).2,3

51%

~

About half the patients remaining in the studies who applied OPZELURA® from day 1 achieved F-VASI75 at 52 weeks: ~51% for OPZELURA® and ~28% for vehicle-to-OPZELURA® (Week 24 to Week 52).

Data were reported as observed. No conclusions of safety or efficacy should be made based on these results.2,4

Limitations of an open-label extension: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

OPZELURA® was studied in 2 double-blind, randomized, vehicle-controlled trials of identical design that enrolled 674 adult and adolescent patients with nonsegmental vitiligo ≥12 years of age. Patients had depigmented areas affecting ≥0.5% F-BSA, ≥3% nonfacial BSA, and total body vitiligo area (facial and nonfacial) of up to 10% BSA. Phototherapy was not permitted during the trials. In both trials, patients were randomized 2:1 to treatment with OPZELURA® or vehicle cream BID for 24 weeks followed by a 28-week open-label extension, wherein patients originally assigned to vehicle could switch to OPZELURA®. 2 BID, twice daily; BSA, body surface area; F-BSA, facial body surface area; FDA, Food and Drug Administration: F-VASI, Facial Vitiligo Scoring Index; F-VASI75, ≥75% improvement from baseline in Facial Vitiligo Area Scoring Index. *In patients 12 years of age and older. † F-VASI is a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches.

As assessed, the face did not include surface area of the lips, scalp, eyelids, ears, or neck. 5

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Common Prior Authorization Requirements Patient Age

The patient must be 12 years of age or older.

Indication

OPZELURA® is indicated for nonsegmental vitiligo

Tried and Failed Alternatives

This may include a topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). Be sure to include your patient’s most recent chart notes!

Body Surface Area (BSA)

Indicate the BSA that will be treated: • Nonsegmental vitiligo is up to 10%

Combination Use

Confirm OPZELURA® will not be used with: • Therapeutic biologics • Other JAK inhibitors • Potent immunosuppressants OPZELURA® was studied as a monotherapy treatment. Many plans do not approve combination use.

Turn the page to see the results with OPZELURA® at 52 weeks INDICATION OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

• Invasive fungal infections, including cryptococcosis and pneumocystosis.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA

in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.

Please see Important Safety Information continued on next page and Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

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52-Week Results for a Clinical Trial Participant Whose Repigmentation Met the Primary Endpoint of F-VASI75 at 24 Weeks6‡ PRIMARY ENDPOINT BASELINE

WEEK 24

WEEK 52

Week 0 F -VASI SCORE 1.5

Week 24 F -VASI SCORE 0.3

Week 52 F -VASI SCORE 0.3

80% Improvement From Baseline

80% Improvement From Baseline

‡

Results not typical. Actual patient treated with OPZELURA® in a clinical trial. Individual results may vary.

Not for ophthalmic, oral, or intravaginal use.

See the Possibilities for Your Members With OPZELURA®

IMPORTANT SAFETY INFORMATION (continued) MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

MALIGNANCIES

Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin

42_51_JBCOD_Expert Advice_4 pages Summer_2024.indd 44

cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

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IMPORTANT SAFETY INFORMATION (continued) MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS

Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk.

If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.

Thrombocytopenia, Anemia, and Neutropenia Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated.

If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.

Lipid Elevations

Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy

There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy.

Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

Lactation

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Please see Brief Summary of Full Prescribing Information, including Boxed Warning, on the following pages.

References: 1. VANTAGE Fingertip Formulary, April 2023. 2. OPZELURA® (ruxolitinib) cream. Prescribing Information. Incyte Corporation. 3. Rosmarin D, Pandya AG, Grimes P, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo: 24-week results from 2 randomized, double-blind phase 3 studies. Abstract presented at: 30th European Academy of Dermatology and Venereology (EADV) Congress; September 29-October 2, 2021; virtual. 4. Rosmarin D, Passeron T, Pandya AG, et al. Efficacy and safety of ruxolitinib cream monotherapy for the treatment of vitiligo: results from two 52-week phase 3 studies. Presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Oral Presentation. 5. Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet.

2020;396(suppl):1-121. 6. Data on File. Incyte Corporation.

OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte. © 2023, Incyte Corporation.

MAT-OPZ-01787 07/23

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initiatinginOPZELURA in patients: with chronic infection; or recurrent initiating OPZELURA patients: with chronic or recurrent withinfection; a historywith a history Thrombocy a serious or an opportunistic who have been exposed to tuberculosis; neutropenia of a serious orofan opportunistic infection; whoinfection; have been exposed to tuberculosis; who or have resided traveled in areastuberculosis of endemicor tuberculosis or endemic mycoses; and risks fo who have resided traveled in or areas of endemic endemic mycoses; or withconditions underlyingthat conditions that may them predispose them toClosely infection. Closely initiating th or with underlying may predispose to infection. monitor patients for the development signs andofsymptoms of infection during signs and/ monitor patients for the development of signs and of symptoms infection during and after treatment with Interrupt OPZELURA. InterruptifOPZELURA if a patient and after treatment with OPZELURA. OPZELURA a patient develops a develops a neutropenia OPZELURA® (ruxolitinib) OPZELURA®cream, (ruxolitinib) for topical cream, use for topical use serious an opportunistic infection, DoOPZELURA not resume OPZELURA Lipid Eleva serious infection, an infection, opportunistic infection, or sepsis.

Doornotsepsis. resume until is thecontrolled. infection is controlled. until the infection Brief Summary Brief of FULL Summary PRESCRIBING of FULL PRESCRIBING INFORMATIONINFORMATION in lipid pa cholesterol, Tuberculosis: Tuberculosis: No cases of active No cases tuberculosis of active (TB) tuberculosis were reported (TB) were in clinical reported trials in with clinical trials with INDICATIONSINDICATIONS AND USAGE:AND OPZELURA USAGE:isOPZELURA indicated for is indicated the topical for treatment the topicalof treatment of OPZELURA. Cases OPZELURA. of active Cases TB were of active reported TB were in clinical reported trials in clinical of oral Janus trials ofkinase oral Janus kinase ADVERSE R nonsegmentalnonsegmental vitiligo in adultvitiligo and pediatric in adult patients and pediatric 12 years patients of age 12and years older. of age and older. inhibitors usedinhibitors to treat inflammatory used to treat inflammatory conditions. Consider conditions. evaluating Consider patients evaluating for latent patients for latent Clinical Tria Limitations ofLimitations Use: Use ofofOPZELURA Use: Use of in combination OPZELURA inwith combination therapeutic withbiologics, therapeutic other biologics, other TBand and active infection activeprior TB infection to administration prior to administration of OPZELURA.ofDuring OPZELURA. OPZELURA Duringuse, OPZELURA use, conditions, a JAK inhibitors,JAK or potent inhibitors, immunosuppressants or potent immunosuppressants such as azathioprine such asorazathioprine cyclosporine or iscyclosporine is monitor patients monitor for the patients development for the of development signs and symptoms of signs and of TB. symptoms of TB. compared to not recommended. not recommended.

Viral Reactivation: Viral Reactivation: Viral reactivation, Viral including reactivation, cases including of herpes casesvirus of herpes reactivation virus reactivation in practice. (e.g., herpes zoster), (e.g., herpes were zoster), reportedwere in clinical reported trialsin with clinical Janus trialskinase with Janus inhibitors kinase usedinhibitors used 449 adult an WARNING: SERIOUS INFECTIONS, MALIGNANCY, MAJOR WARNING: SERIOUS INFECTIONS, MORTALITY, MORTALITY, MALIGNANCY, MAJOR to treat inflammatory to treat inflammatory conditions including conditions OPZELURA. including If OPZELURA. a patient develops If a patient herpes develops herpes treated with ADVERSE CARDIOVASCULAR AND THROMBOSIS ADVERSE CARDIOVASCULAR EVENTS, ANDEVENTS, THROMBOSIS were female zoster, consider zoster, interrupting considerOPZELURA interruptingtreatment OPZELURA untiltreatment the episode untilresolves. the episode resolves.

SERIOUS INFECTIONS SERIOUS INFECTIONS adverse reac Hepatitis B and Hepatitis C: The Bimpact and C:ofThe Janus impact kinase of Janus inhibitors kinase usedinhibitors to treat used inflammatory to treat inflammatory least 1% gre Patients treated withkinase oral Janus kinase for inflammatory Patients treated with oral Janus inhibitors forinhibitors inflammatory conditions conditions conditions conditions OPZELURA includingonOPZELURA chronic viral on hepatitis chronic viral reactivation hepatitis isreactivation unknown. is unknown. follows for O at risk forserious developing serious infections may lead to hospitalization or including are at risk forare developing infections that may leadthat to hospitalization or Patients with Patients a history with of hepatitis a historyB of or hepatitis C infection B or were C infection excludedwere fromexcluded clinical trials. from clinical trials. emergent ad death [see andand Precautions and Adverse Reactions]. death [see Warnings andWarnings Precautions Adverse Reactions].

Hepatitis B viral Hepatitis load (HBV-DNA B viral load titer) (HBV-DNA increases, titer) with increases, or withoutwith associated or without elevations associated elevations (1%), Applica Reported infections include: Reported infections include: in alanine in alanine aminotransferase and aspartateand aminotransferase, aspartate aminotransferase, have been reported have been in reported in 17 (4%) vs 6 • Active tuberculosis, maywith present with pulmonary or aminotransferase • Active tuberculosis, which maywhich present pulmonary or patients with chronic patientsHBV withinfections chronic HBV taking infections oral ruxolitinib. taking oral OPZELURA ruxolitinib.initiation OPZELURA is notinitiation is not vs 1 (<1%), a extrapulmonary disease. extrapulmonary disease. recommendedrecommended in patients with in active patients hepatitis with active B or hepatitis BC.or hepatitis C. Adverse rea • Invasive fungal infections, including cryptococcosis, and pneumocystosis.

• Invasive fungal infections, including cryptococcosis, and pneumocystosis.

Mortality: In a Mortality: large, randomized, In a large, postmarketing randomized, postmarketing safety study ofsafety an oral study JAKofinhibitor an oral JAK inhibitor the OPZELU Bacterial, viral, including herpes zoster,infections and otherdue infections due to • Bacterial, •viral, including herpes zoster, and other to in rheumatoidinarthritis rheumatoid (RA) arthritis patients (RA) 50 years patients of age 50 years and older of age with andat older least with one at least one hypertension opportunisticopportunistic pathogens. pathogens. cardiovascular cardiovascular risk factor, a risk higher factor, rate a of higher all-cause rate mortality, of all-cause including mortality, sudden including sudden dermatitis Avoid use ofinOPZELURA in patients with an active, serious infection, including Avoid use of OPZELURA patients with an active, serious infection, including influenza-lik cardiovascular cardiovascular death, was observed death, was in observed patients treated in patients with treated the JAK with inhibitor the JAK inhibitor localizedIf infections.

If a serious infection develops, interruptuntil OPZELURA until localized infections. a serious infection develops, interrupt OPZELURA compared withcompared TNF blockers. with TNF Consider blockers. the benefits Considerand therisks benefits for the andindividual risks for the patient individual patient DRUG INTE infection is controlled. the infectionthe is controlled. prior to initiating priorortocontinuing initiating or therapy continuing with OPZELURA. therapy with OPZELURA. Drug intera Thebenefits risks and benefits ofwith treatment with should OPZELURA should be carefully The risks and of treatment OPZELURA be carefully Malignancy Malignancy and Lymphoproliferative and Lymphoproliferative Disorders: Malignancies, Disorders: Malignancies, including including known to b prior to therapy initiatingin therapy patients withor chronic or considered considered prior to initiating patients inwith chronic lymphomas, lymphomas, were observed were in clinical observed trials in clinical of oral trials JAK inhibitors of oral JAK used inhibitors to treatused to treat may increa recurrent infection. recurrent infection. inflammatory inflammatory conditions.

Patients conditions. who Patients are current who or are past current smokers or past are at smokers additional are at additional decrease ru Patients should monitored be closelyfor monitored for the development Patients should be closely the development of signs andof signs and increased risk. increased Malignancies, risk.

Malignancies, including lymphomas, including lymphomas, have occurred have in patients occurred in patients Strong Inhi infection and afterwith treatment with [see OPZELURA [see symptoms ofsymptoms infection of during and during after treatment OPZELURA receiving JAK receiving inhibitors JAKused inhibitors to treat used inflammatory to treat inflammatory conditions. Inconditions. a large, In a large, inhibitors o and Precautions].

Warnings andWarnings Precautions]. randomized, postmarketing randomized, postmarketing safety study of safety an oral study JAKofinhibitor an oral JAK in RAinhibitor patients, in aRA patients, a ruxolitinib a MORTALITY MORTALITY higher rate ofhigher malignancies rate of malignancies (excluding non-melanoma (excluding non-melanoma skin cancer) was skin observed cancer) was observed USE IN SPE In a large, postmarketing randomized, postmarketing safety study inarthritis rheumatoid (RA) treated In a large, randomized, safety study in rheumatoid (RA) arthritis in patients in patients with treated the JAKwith inhibitor the JAK compared inhibitorto compared those treated to those with treated TNF with TNF Pregnancy patients 50 years of age and at least one cardiovascular patients 50 years of age and older with at older least with one cardiovascular risk factor risk factor blockers. A higher blockers. rateAofhigher lymphomas rate of was lymphomas observedwas in patients observedtreated in patients with the treated with the an oral to JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, comparing ancomparing oral JAK inhibitor tumor necrosis factor (TNF) blocker treatment, Pregnancy JAK inhibitor JAK compared inhibitor to compared those treated to those with TNF treated blockers. with TNF A higher blockers. rateAofhigher lung rate of lung ratemortality, of all-cause mortality, including sudden cardiovascular a higher rate aofhigher all-cause including sudden cardiovascular death, was death, was outcomes i cancers was cancers observed was in current observed or in past current smokers or past treated smokers with treated the JAK with inhibitor the JAK inhibitor with the JAK and Precautions]. observed withobserved the JAK inhibitor [see inhibitor Warnings[see andWarnings Precautions]. persons ex compared to those compared treated to those with TNF treated blockers. with TNF In this blockers. study, current In this study, or past current smokers or past smokers exposure by MALIGNANCIES MALIGNANCIES had an additional had an increased additional riskincreased of overallrisk malignancies. of overall malignancies.

Consider the Consider benefits and the benefits and were reportedtreated in patients with Lymphoma OPZELURA. Lymphoma MalignanciesMalignancies were reported in patients with treated OPZELURA. risks for therisks individual for thepatient individual prior patient to initiating prior to or initiating continuingor therapy continuing withtherapy with Risk Summa and other malignancies have beenin observed patientsJAK receiving JAK and other malignancies have been observed patients in receiving OPZELURA, OPZELURA, particularly in particularly patients in withpatients a known withmalignancy a known (other malignancy than (other than are not suffi inhibitors to treat inflammatory RA patients treatedsuccessfully with an inhibitors used to treat used inflammatory conditions. Inconditions.

RA patientsIntreated with an successfully treated non-melanoma treated non-melanoma skin cancers), skinpatients cancers), whopatients developwho a develop a or other ad administrati oral JAK inhibitor, higher rate of malignancies (excluding non-melanoma oral JAK inhibitor, a higher ratea of malignancies (excluding non-melanoma malignancy when malignancy on treatment, when on and treatment, patients who and patients are current whoorare past current smokers. or past smokers. resulted in a cancer waswhen observed whenwith compared with TNF blockers. skin cancer skin (NMSC)) was(NMSC)) observed compared TNF blockers.

Non-melanoma Non-melanoma Skin Cancers:Skin Non-melanoma Cancers: Non-melanoma skin cancers skin including cancers basal including cell andbasal cell and whoorare current or past are at additional increased risk [see Patients whoPatients are current past smokers are smokers at additional increased risk [see The backgr squamous cellsquamous carcinomacell have carcinoma occurredhave in patients occurred treated in patients with OPZELURA. treated withPerform OPZELURA. Perform and Precautions].

Warnings andWarnings Precautions]. populations periodic skin periodic examinations skin examinations during OPZELURA duringtreatment OPZELURA andtreatment followingand treatment following as treatment as other adver MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) appropriate. Exposure appropriate. to sunlight Exposure andtoUV sunlight light should and UVbelight limited should by wearing be limited protective by wearing protective birth defect In50 RAyears patients 50 years of age and at least one cardiovascular risk In RA patients of age and older with at older least with one cardiovascular risk clothing broad-spectrum and using broad-spectrum sunscreen. sunscreen. factor oral JAK inhibitor, higher of major clothing adverseand using factor treated withtreated an oralwith JAK an inhibitor, a higher ratea of majorrate adverse Data Major Adverse MajorCardiovascular Adverse Cardiovascular Events (MACE): EventsIn (MACE): a large, Inrandomized, a large, randomized, cardiovascular events (MACE) (defined as cardiovascular death, myocardial cardiovascular events (MACE) (defined as cardiovascular death, myocardial Animal Data: postmarketingpostmarketing safety study of safety an oral study JAKofinhibitor an oral JAK in RAinhibitor patientsin50 RAyears patients of age 50 years of age infarction, was observed whenwith compared with TNF blockers. infarction, and stroke), and wasstroke), observed when compared TNF blockers. of organoge who or arepast current or past are atincreased additionalrisk. increased Patients whoPatients are current smokers aresmokers at additional and risk. older withand at least olderone withcardiovascular at least one cardiovascular risk factor, a higher risk factor, rate of a higher major adverse rate of major adverse in rabbits. T in patients who have experienced Discontinue Discontinue OPZELURA inOPZELURA patients who have experienced a myocardiala myocardial cardiovascular cardiovascular events (MACE) events defined (MACE) as defined cardiovascular as cardiovascular death, non-fatal death, non-fatal weight of ap stroke [see and Precautions]. infarction or infarction stroke [seeorWarnings andWarnings Precautions]. myocardial infarction myocardial (MI), infarction and non-fatal (MI), and stroke non-fatal was observed stroke was withobserved the JAK inhibitor with the JAK inhibitor 60 mg/kg/da compared to compared those treated to those with treated TNF blockers. with TNF Patients blockers. whoPatients are current whoorarepast current or past systemic exp THROMBOSISTHROMBOSIS smokers are smokers at additional are at increased additional risk. increased Considerrisk. the Consider benefits and the benefits risks for and the risks for the exposure fro Thromboembolic were observed trials withThrombosis, OPZELURA. Thrombosis, Thromboembolic events were events observed in trials withinOPZELURA. individual priorpatient to initiating prior toor initiating continuingor therapy continuing withtherapy OPZELURA, with OPZELURA, affected bod including pulmonary embolism (PE), thrombosis deep venous(DVT), thrombosis (DVT), andindividual arterial patient including pulmonary embolism (PE), deep venous and arterial patients who in patients are current whoorare past current smokers or past andsmokers patients and withpatients other with other lower fetal w thrombosis have been reported in patients inhibitors to treat inparticularly thrombosis have been reported in patients receiving JAKreceiving inhibitorsJAK used to treat usedparticularly cardiovascular cardiovascular risk factors. risk Patients factors. should Patients be informed should be about informed the symptoms about theofsymptoms of highest and conditions.

Many of these adverse reactions and inflammatoryinflammatory conditions. Many of these adverse reactions were seriouswere and serious serious serious cardiovascular events and the events stepsandto the takesteps if they to occur. take if Discontinue they occur. Discontinue approximate resulted death. In50RAyears patients 50and years of age olderone with at least onecardiovascular some resultedsome in death.

In RAinpatients of age older withand at least cardiovascular risk factor an oral JAK inhibitor, rate of inOPZELURA cardiovascular risk factor treated with treated an oral with JAK inhibitor, a higher rateaofhigherOPZELURA patients that in patients have experienced that have aexperienced myocardial ainfarction myocardial or stroke. infarction or stroke. developmen thrombosis observed when compared with TNF blockers.

Avoid in thrombosis was observedwas when compared with TNF blockers.

Avoid OPZELURA in OPZELURA Thrombosis: Thrombosis: Thromboembolic Thromboembolic events were observed events were in clinical observed trialsinwith clinical OPZELURA. trials with OPZELURA. through lact patients at risk. Ifofsymptoms of occur, thrombosis occur, OPZELURA discontinue OPZELURA patients at risk.

If symptoms thrombosis discontinue Thrombosis, including Thrombosis, deepincluding vein thrombosis deep vein(DVT), thrombosis pulmonary (DVT),embolism pulmonary (PE), embolism and (PE), and on embryofe and treat appropriately and Precautions]. and treat appropriately [see Warnings[see andWarnings Precautions]. arterial thrombosis arterialhave thrombosis been reported have been in patients reportedreceiving in patients JAKreceiving inhibitorsJAK usedinhibitors to used to function at th treat inflammatory treat inflammatory conditions.

Many conditions. of these Many adverse of these reactions adverse were reactions serious were and serious and Lactation WARNINGS AND PRECAUTIONS WARNINGS AND PRECAUTIONS some resultedsome in death. resulted In a in large, death. randomized, In a large,postmarketing randomized, postmarketing safety study ofsafety an oral study of an oral Risk Summa Serious Serious Infections: and fatal sometimes fataldue infections due to bacterial, Serious Infections: and Serious sometimes infections to bacterial, JAK inhibitor inJAK RAinhibitor patientsin50RAyears patients of age 50and years older of age withand at least olderone withcardiovascular at least one cardiovascular on the breas invasive or other opportunistic pathogens mycobacterial,mycobacterial, invasive fungal, viral, fungal, or otherviral, opportunistic pathogens have been have been risk factor, higher risk factor, rates of higher overall rates thrombosis, of overall DVT, thrombosis, and PE were DVT, observed and PE were compared observed to compared to of lactating reported in patients oral Janus kinase inhibitors. lower respiratory reported in patients receiving oralreceiving Janus kinase inhibitors.

Serious lowerSerious respiratory those treated with thoseTNF treated blockers. with TNF Avoidblockers.

OPZELURA Avoid in patients OPZELURA whoin may patients be atwho increased may be at increased present in hu tract infections tract were infections reported were in the reported clinicalindevelopment the clinical development program withprogram topical with topical of thrombosis. risk of Ifthrombosis. symptoms Ifof symptoms thrombosisofoccur, thrombosis discontinue occur, OPZELURA discontinueand OPZELURA and serious infe ruxolitinib. Avoid ruxolitinib. use of Avoid OPZELURA use ofinOPZELURA patients with in patients an active, withserious an active, infection, seriousrisk infection, breastfeed d evaluate and treat evaluate patients and appropriately. treat patients appropriately. including localized including infections. localized Consider infections. the Consider risks and the benefits risks of andtreatment benefits prior of treatment to prior to last dose (ap

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Data: Lactating ratsLactating were administered rats were administered a single dosea ofsingle [14C]-labeled dose of [14C]-labeled ruxolitinib ruxolitinib th a history Thrombocytopenia, Thrombocytopenia, Anemia, andAnemia, Neutropenia: and Neutropenia: Thrombocytopenia, Thrombocytopenia, anemia, and anemia, and Data: (30benefits mg/kg) on(30 postnatal mg/kg)Day on postnatal 10, after which Day 10,plasma after which and milk plasma samples and milk weresamples collectedwere collected uberculosis; neutropenia were neutropenia reportedwere in thereported clinical in trials the with clinical OPZELURA. trials withConsider OPZELURA. the benefits Consider the for prior up to to 24 hours. for upThe to 24 AUC hours. for total The radioactivity AUC for totalinradioactivity milk was approximately in milk was approximately 13 times 13 times c mycoses; and risks for and individual risks for patients individual who patients have a known who have history a known of these history events of these prior toevents the maternal the maternal AUC. Additional plasma AUC. analysis Additional showed analysis the presence showed the of ruxolitinib presence and of ruxolitinib and on. Closely initiating therapy initiating with OPZELURA. therapy withPerform OPZELURA. CBC Perform monitoring CBCasmonitoring clinically indicated. as clinically If indicated.

If plasma severaland of its metabolites several of itsinmetabolites milk, all at levels in milk,higher all at than levelsthose higher in maternal than thoseplasma. in maternal plasma. symptoms and/orofsymptoms clinically significant of clinicallythrombocytopenia, significant thrombocytopenia, anemia, and anemia, ction during signs and/or signs neutropenia patientsoccur, should patients discontinue shouldOPZELURA. discontinue OPZELURA. Pediatric Use:Pediatric Nonsegmental Use: Nonsegmental Vitiligo: The safety Vitiligo: andThe effectiveness safety and effectiveness of OPZELURAofforOPZELURA for develops a neutropenia occur, topical treatment the topical of treatment nonsegmental of nonsegmental vitiligo have been vitiligoestablished have been inestablished pediatric in pediatric OPZELURA Lipid Elevations: LipidTreatment Elevations: with Treatment oral ruxolitinib with oral hasruxolitinib been associated has been with associated increaseswiththe increases patients agedpatients 12 to 17aged years12oftoage.

17 Use yearsofofOPZELURA age. Use ofin OPZELURA this age group in this is supported age group is supported in lipid parameters in lipid including parameterstotal including cholesterol, total low-density cholesterol, lipoprotein low-density (LDL) lipoprotein (LDL) by evidence from by evidence TRuE-V1from and TRuE-V1 TRuE-V2,and which TRuE-V2, included which 55 pediatric includedsubjects 55 pediatric agedsubjects aged cholesterol, triglycerides. and triglycerides. al trials with cholesterol, and 12 to 17 years 12 with to 17nonsegmental years with nonsegmental vitiligo. No clinically vitiligo. meaningful No clinicallydifferences meaningfulindifferences in anus kinase ADVERSE REACTIONS ADVERSE REACTIONS safety or effectiveness safety or effectiveness were observed were between observed adultbetween and pediatric adult and subjects. pediatric Thesubjects. The nts for latent Clinical TrialsClinical Experience: Trials Because Experience: clinical Because trials are clinical conducted trials are under conducted widely varying under widely varying safety and effectiveness safety and effectiveness of OPZELURAofin OPZELURA pediatric patients in pediatric younger patients than younger 12 yearsthan of 12 years of ELURA use, conditions, adverse conditions, reaction adverse rates observed reaction rates in theobserved clinical trials in theofclinical a drugtrials cannot of be a drug directly cannotage be directly with nonsegmental age with nonsegmental vitiligo have not vitiligo beenhave established. not been established. compared to rates compared in the clinical to ratestrials in theofclinical anothertrials drugofand another may not drugreflect and may the rates not reflect observed the rates observed Juvenile Animal Juvenile ToxicityAnimal Data: Oral Toxicity administration Data: Oral administration of ruxolitinib toofjuvenile ruxolitinib ratstoresulted juvenileinrats resulted in practice. double-blind, In two vehicle-controlled double-blind, vehicle-controlled clinical trials (TRuE-V1 clinical trials and (TRuE-V1 TRuE-V2),andeffects TRuE-V2), reactivation in practice. In intwo on growth effects andonbone growth measures. and bone When measures. administered When starting administered at postnatal startingday at postnatal 7 day 7 449 adult and 449 pediatric adult subjects and pediatric 12 years subjects of age 12 and years older of with age and nonsegmental older with nonsegmental vitiligo were vitiligo were ibitors used (the equivalent(the of equivalent a human newborn) of a human at doses newborn) of 1.5 at doses to 75 mg/kg/day, of 1.5 to 75evidence mg/kg/day, of evidence of treated with twice OPZELURA daily for twice 24 weeks. daily In forthe 24OPZELURA weeks. In the group, OPZELURA 55% of group, subjects 55% fractures of subjects lops herpes treated with OPZELURA occurred fractures at doses occurred ≥ 30 at mg/kg/day, doses ≥ 30 and mg/kg/day, effects onand body effects weightonand body other weight boneand other bone were females, were and 81% females, of subjects and 81% were of subjects White, 5% were were White, Black, 5%and were 4%Black, were Asian. and 4%The weremeasures Asian. The[e.g.,measures es. bone mineral [e.g.,content, bone mineral peripheral content, quantitative peripheralcomputed quantitative tomography, computedand tomography, and adverse reactions adverse reported reactions

by OPZELURA reported by treated OPZELURA subjectstreated with an subjects incidence withofan≥ 1% incidence and atof ≥x-ray 1% and at x-ray analysis] occurred analysis] at doses occurred ≥ 5 mg/kg/day. at doses ≥When 5 mg/kg/day. administered Whenstarting administered at postnatal starting at postnatal flammatory least 1% greater least incidence 1% greater than incidence in the vehicle thanarm in the in the vehicle 24-week arm indouble-blind the 24-weekperiod double-blind are as period are as day 21 (the equivalent day 21 (the of aequivalent human 2-3ofyears a human of age) 2-3atyears doses ofof age) 5 toat60 doses mg/kg/day, of 5 to 60 effects mg/kg/day, effects s unknown. follows for OPZELURA follows (N=449) for OPZELURA vs Vehicle (N=449) (N=224), vs Vehicle respectively: (N=224),Subjects respectively: with any Subjects treatment with anyontreatment body weight on and bodybone weight occurred and bone at doses occurred ≥ 15atmg/kg/day, doses ≥ 15which mg/kg/day, were considered which were considered nical trials. emergent adverse emergent event adverse (TEAE) 214 event (48%) (TEAE) vs 79 214(35%), (48%)Application vs 79 (35%), siteApplication acne 26 (6%) site vs acne 2 26adverse (6%) vsat2 60adverse mg/kg/day. at 60Males mg/kg/day. were more Malesseverely were more affected severely than affected females than in all females age in all age (1%), siteApplication pruritus 23site (5%)pruritus vs 6 (3%), 23 (5%) Nasopharyngitis vs 6 (3%), Nasopharyngitis 19 (4%) vs 5 (2%), 19 (4%) Headache vs 5 (2%),groups, Headache d elevations (1%), Application and effects groups, were andgenerally effects were moregenerally severe when moreadministration severe when administration was initiated earlier was initiated earlier 17 (4%) vs 6 (3%), 17 (4%) Urinary vs 6 tract (3%), infection Urinary 7 tract (2%) infection vs 1 (<1%), 7 (2%) Application vs 1 (<1%), site Application erythema 7 site (2%) erythema 7 (2%) reported in in the postnatal in period. the postnatal These period. findingsThese were findings observedwere at systemic observedexposures at systemic thatexposures are at that are at 1 (<1%), 6 (1%) and Pyrexia vs 0 (0%).

6 (1%) vs 0 (0%). iation is not vs 1 (<1%), andvsPyrexia least 40% the least MRHD 40% clinical the MRHD systemic clinical exposure. systemic exposure.

Adverse reactions Adverse that occurred reactionsinthat TRuE-V1 occurred andinTRuE-V2 TRuE-V1inand ≥ 0.5% TRuE-V2 to <in1% ≥ 0.5% of subjects to < 1% in ofGeriatric subjects inUse:Geriatric Of the 831 Use: total Of subjects the 831 total enrolled subjects with nonsegmental enrolled with nonsegmental vitiligo in clinical vitiligo in clinical OPZELURA and none group in the andvehicle none ingroup the vehicle were: application group were: siteapplication dermatitis,site trials dermatitis, AK inhibitor the OPZELURAthegroup with OPZELURA, trials with65OPZELURA, (8%) were6565(8%) years were of age 65 years and older. of ageClinical and older. trials Clinical of trials of hypertension, application anxiety, siteapplication discoloration, site application discoloration, siteapplication folliculitis, site contusion, folliculitis,OPZELURA contusion, in OPZELURA subjects with in subjects nonsegmental with nonsegmental vitiligo did notvitiligo includedid sufficient not include numbers sufficient of numbers of at least one hypertension, anxiety, dermatitis diarrhea, contact,eardiarrhea, infection,eargastritis, infection, gastroenteritis, gastritis, gastroenteritis, hordeolum, hordeolum, subjects 65 years subjects of age 65and years older of age to determine and older whether to determine they respond whether differently they respond from differently from ing sudden dermatitis contact, influenza-like insomnia, illness, nasalinsomnia, congestion, nasal and congestion, vomiting. and vomiting. younger adult younger subjects.adult subjects.

AK inhibitor influenza-like illness, DRUG INTERACTIONS dual patient DRUG INTERACTIONS PATIENT COUNSELING PATIENT COUNSELING INFORMATION INFORMATION Drug interaction Drugstudies interaction with studies OPZELURA withhave OPZELURA not been have conducted. not beenRuxolitinib conducted.is Ruxolitinib is patient Advise the Advise or the caregivers patient or tocaregivers read the toFDA-approved read the FDA-approved patient labeling patient labeling substrate to befor a substrate cytochrome forP450 cytochrome 3A4 (CYP3A4).

P450 3A4 Inhibitors (CYP3A4). of CYP3A4 Inhibitors of CYP3A4 Guide).

(Medication (Medication Guide). , including known to be aknown ruxolitinib increase systemic ruxolitinib concentrations systemic concentrations whereas inducers whereas of CYP3A4 inducersmay of CYP3A4 may ed to treat may increase may Infections: Inform Infections: patientsInform that they patients may that be at they increased may be risk at increased for developing risk for infections, developing infections, decrease systemic ruxolitinib concentrations. systemic concentrations. at additional decrease ruxolitinib including serious including infections, serious when infections, taking Janus whenkinase takinginhibitors.

Janus kinase Instruct inhibitors. patients Instruct to tell their patients to tell their Strong of Inhibitors CYP3A4: Avoid of CYP3A4: concomitant Avoid concomitant use of OPZELURA use of with OPZELURA strong with strongprovider in patients Strong Inhibitors healthcare healthcare if they provider develop any if they signs develop or symptoms any signsoforansymptoms infection. of Advise an infection. patientsAdvise that patients that inhibitorsasofthere CYP3A4 is a as potential there istoaincrease potentialthe to increase systemic the exposure systemic of exposure of inhibitors n a large, inhibitors of CYP3A4 Janus kinase Janus kinase increase inhibitors the risk increase of herpes thezoster, risk of and herpes some zoster, casesand cansome be serious cases can [seebe serious [see could increase and could the risk increase of OPZELURA the risk ofadverse OPZELURA reactions. adverse reactions. Warnings and Precautions].

Warnings and Precautions]. patients, a ruxolitinib andruxolitinib s observed USE IN SPECIFIC USE POPULATIONS IN SPECIFIC POPULATIONS Malignancies Malignancies and Lymphoproliferative and Lymphoproliferative Disorders: Inform Disorders: patients Inform that patients Janus kinase that Janus kinase d with TNF Pregnancy Pregnancy inhibitors mayinhibitors increase may the increase risk for developing the risk forlymphomas developingand lymphomas other malignancies and other malignancies ed with the including skin cancer. includingInstruct skin cancer. patients Instruct to inform patients their to health inform care their provider healthifcare theyprovider have ever if they have ever Pregnancy Exposure Pregnancy Registry: Exposure There Registry: is a pregnancy There isregistry a pregnancy that monitors registry that pregnancy monitors pregnancy rate of lung had any typehad of cancer. any typeInform of cancer. patients Inform that patients periodic that skin periodic examinations skin examinations should be should be outcomes in pregnant outcomes persons in pregnant exposed persons to OPZELURA exposed toduring OPZELURA pregnancy. duringPregnant pregnancy. Pregnant AK inhibitor performed while performed using OPZELURA. while usingAdvise OPZELURA. patientsAdvise that exposure patients to that sunlight, exposure andtoUV sunlight, light and UV light persons exposed persons to OPZELURA exposed toand OPZELURA healthcare andproviders healthcare should providers reportshould OPZELURA report OPZELURA should be limited should by wearing be limited protective by wearing clothing protective and using clothing a broad-spectrum and using a broad-spectrum sunscreen sunscreen ast smokers exposure by calling exposure 1-855-463-3463. by calling 1-855-463-3463. [see Warnings [see and Precautions].

Warnings and Precautions]. enefits and Risk Summary: Risk Available Summary: data Available from pregnancies data fromreported pregnancies in clinical reported trialsinwith clinical OPZELURA trials with OPZELURA erapy with Major AdverseMajor Cardiovascular Adverse Cardiovascular Events: AdviseEvents: patients Advise that patients events ofthat major events adverse of major adverse are to notevaluate sufficient a drug-associated to evaluate a drug-associated risk for major birth risk for defects, major miscarriage, birth defects, miscarriage, other than are not sufficient cardiovascularcardiovascular events (MACE) events including (MACE) non-fatal including myocardial non-fatalinfarction, myocardialnon-fatal infarction, non-fatal or other adverse or other maternal adverse or fetal maternal outcomes. or fetal In outcomes. animal reproduction In animal studies, reproduction oral studies, oral develop a stroke, and cardiovascular stroke, and cardiovascular death, have been death, reported have been in clinical reported studies in clinical with Janus studies with Janus administrationadministration of ruxolitinib toofpregnant ruxolitinib rats toand pregnant rabbitsrats during and the rabbits period during of organogenesis the period of organogenesis kinase inhibitors kinase usedinhibitors to treat inflammatory used to treat inflammatory conditions. Instruct conditions. all patients, Instructespecially all patients, especially mokers. resulted in adverse resulted developmental in adverse developmental outcomes at doses outcomes associated at doses with associated maternal with toxicity. maternal toxicity. current or pastcurrent smokers or past or patients smokers with or patients other cardiovascular with other cardiovascular risk factors, torisk be factors, alert to be alert sal cell and The background The risks background of major risks birthof defects major birth and defects miscarriage and for miscarriage the indicated for theforindicated the development for the of development signs and symptoms of signs and of symptoms cardiovascular of cardiovascular events [see Warnings events [see Warnings RA. Perform populations are populations unknown.are All unknown. pregnancies All carry pregnancies some risk carry of birth somedefects, risk of birth loss,defects, or andloss, or and Precautions].

Precautions]. eatment as other adverseother outcomes. adverse Theoutcomes. background Therisk background in the U.S.risk general in thepopulation U.S. general of population major Thrombosis: of major Advise Thrombosis: patientsAdvise that events patientsofthat DVTevents and PEof have DVT been and PE reported have been in clinical reported in clinical g protective birth defects and birthmiscarriage defects andismiscarriage 2-4% and 15-20%, is 2-4% and respectively.

15-20%, respectively. studies with Janus studies kinase withinhibitors Janus kinase usedinhibitors to treat inflammatory used to treatconditions. inflammatory Instruct conditions. patients Instruct patients to tell their healthcare to tell their provider healthcare if theyprovider developifany theysigns develop or symptoms any signsoforasymptoms DVT or PEof[see a DVT or PE [see Data Data andomized, Warnings and Precautions].

Animal Data: Ruxolitinib Animal Data: wasRuxolitinib administered wasorally administered to pregnant orally ratstoorpregnant rabbits during rats or the rabbits period duringWarnings the periodand Precautions]. ears of age Anemia, andAnemia, Neutropenia: and Neutropenia: Advise patients Advise of the patients risk of of the risk of of organogenesis, of organogenesis, at doses of 15,at30, doses or 60ofmg/kg/day 15, 30, or 60 in rats mg/kg/day and 10, in30,rats or and 60 mg/kg/day 10, 30, or 60 Thrombocytopenia, mg/kg/day Thrombocytopenia, ajor adverse in rabbits. There thrombocytopenia, anemia, and neutropenia anemia, andwith neutropenia OPZELURA. withInstruct OPZELURA. patients Instruct to tellpatients to tell in rabbits. were noThere treatment-related were no treatment-related malformations malformations at any dose. A at decrease any dose. in fetal A decrease in fetal thrombocytopenia, non-fatal weight of approximately theirdose healthcare provider healthcare if theyprovider developif any theysigns develop or symptoms any signs of or thrombocytopenia, symptoms of thrombocytopenia, weight of approximately 9% was noted9% in rats wasatnoted the highest in rats at andthematernally highest and toxicmaternally dose of toxic of their AK inhibitor 60 mg/kg/day.60 or neutropenia anemia, or[see neutropenia Warnings[see and Warnings Precautions]. and Precautions].

This mg/kg/day. dose resulted This in dose systemic resulted exposure in systemic approximately exposure approximately 22 times the clinical 22 timesanemia, the clinical ent or past systemic exposure systemic at theexposure maximum atrecommended the maximum recommended human dose (MRHD; humanthe dose clinical (MRHD; systemic the clinical systemic Administration Administration Instructions: Advise Instructions: patients Advise or caregivers patients that or caregivers OPZELURA that is OPZELURA for topical is for topical sks for the exposure fromexposure ruxolitinibfrom cream, ruxolitinib 1.5% applied cream, twice 1.5% applied daily to twice 25-40% dailyatopic to 25-40% dermatitisatopic use dermatitisonly [see use Dosage onlyand [seeAdministration].

Dosage and Administration].

OPZELURA, affected body surface affectedarea bodyissurface used forarea calculation is used of formultiples calculation of human of multiples exposure). of human In rabbits, exposure).Advise In rabbits, patients Advise to limit patients treatment to limit to one treatment 60 gram to tube one 60 pergram weektube or one per100 week gram or one tube100 gram tube with other lower fetal weights loweroffetal approximately weights of approximately 8% and increased 8% and late increased resorptionslate were resorptions noted at were the noted the [see per 2atweeks per 2Dosage weeksand [seeAdministration].

Dosage and Administration]. ymptoms of highest and maternally highest and toxicmaternally dose of 60toxic mg/kg/day. dose of 60 This mg/kg/day. dose resulted Thisindose systemic resulted exposure in systemic exposure Pregnancy: patients Inform to report patientstheir to pregnancy report theirtopregnancy Incyte Corporation to Incyte at Corporation at Discontinue approximately approximately 70% the MRHD 70%clinical the MRHD systemic clinical exposure. systemic In exposure. a pre-and Inpost-natal a pre-and Pregnancy: post-natal Inform 1-855-463-3463 1-855-463-3463 [see Use in Specific [see Use Populations]. in Specific Populations]. stroke. development study development in rats, pregnant study in rats, animals pregnant were dosed animals with were ruxolitinib dosed with fromruxolitinib implantation from implantation Lactation: Lactation: a patient Advise not toa patient breastfeed not to during breastfeed treatment during withtreatment OPZELURA with and OPZELURA for and for through at doses lactation up to at 30doses mg/kg/day. up to 30 There mg/kg/day. were no There drug-related were noadverse drug-related effectsadverse effectsAdvise OPZELURA. through lactation about four weeks about after fourthe weeks last dose after [see the last Usedose in Specific [see Use Populations]. in Specific Populations]. survival, embryofetal postnatal survival, growth, postnatal development growth,parameters development or offspring parameters reproductive or offspring reproductive m (PE), and on embryofetalon highest dose at theevaluated highest dose (3.1 times evaluated the MRHD (3.1 times clinical the systemic MRHD clinical exposure). systemic exposure).

ManufacturedManufactured for: for: ors used to function at the function Incyte Corporation Incyte Corporation serious and Lactation Lactation 1801 Augustine 1801 Cut-off Augustine Cut-off dy of an oral Risk Summary:Risk There Summary: are no data There onare theno presence data onofthe ruxolitinib presenceinofhuman ruxolitinib milk,inthe human effects milk,Wilmington, the effects DE Wilmington, 19803 DE 19803 rdiovascular on the breastfed onchild, the breastfed or the effects child,on or milk the effects production. on milk Ruxolitinib production. wasRuxolitinib present inwas the milk present in the milk of lactating When a drug rats. isWhen present a drug in animal is present milk,initanimal is likelymilk, thatitthe is likely drug will thatbe the drug will be compared to of lactating rats.

OPZELURA is OPZELURA a registeredistrademark a registered of Incyte. trademark All rights of Incyte. reserved.

All rights reserved. present milk.inBecause human milk. of theBecause serious adverse of the serious findings adverse in adults, findings including in adults, risksincluding of risks of at increased present in human U.S. Patent Nos. U.S.7598257; Patent Nos. 8415362; 7598257; 8722693; 8415362; 8822481; 8722693; 9079912; 8822481; 9079912; serious thrombocytopenia, infections, thrombocytopenia, anemia, and neutropenia, anemia, and advise neutropenia, womenadvise not towomen not to 9974790; 10639310; 9974790; 10610530; 10639310; 10758543; 10610530; 10869870; 10758543; 11219624 10869870; 11219624 ZELURA and serious infections, breastfeed during breastfeed treatment during withtreatment OPZELURA with andOPZELURA for approximately and for approximately four weeks after fourthe weeks after the © 2022-2023©Incyte 2022-2023 Corporation.

IncyteAll Corporation. rights reserved.

All rights reserved.

Issued: July 2022 Issued: PLR-OPZ-00018-JUN23 July 2022 PLR-OPZ-00018-JUN23 last dose (approximately last dose (approximately 5-6 elimination5-6 half-lives). elimination half-lives).

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ACCESS DERMATOLOGY / ISSUE 9 / 2024

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By He ather Sawrey

PRIOR CERTIFICATION COORDINATOR GW MEDICAL FACULTY ASSOCIATES, DEPARTMENT OF DERMATOLOGY

EXPERT ADVICE WHAT BCS CAN LEARN FROM FIELD REIMBURSEMENT MANAGERS

B

iologic coordinators have a specific skill set and extensive knowledge on biologics and oral medications for a dermatology diagnosis. We learn the necessary information to facilitate approvals for patients, we know what to do if the drugs get denied, how to move forward with patient assistance, and any other need that our patients or providers have in regard to the respective drugs. And there are some days that we just don’t know the answers to those questions or how to move forward with the specific process for a certain biologic. When that happens, what do we do and who should we call?

My first call is always to my field reimbursement manager (FRM). Every company has a different name for this amazing, wonderful, smart, connected, efficient individual who is a guiding light in our daily grind. When I started thinking about what I ask FRMs when I call them, it occurred to me that it would be helpful for others to know this too. If FRMs could choose one thing they would say to every BC they come in contact with, what would it be?

This drove me to reach out to several FRM acquaintances, and I asked them this very question. I’m not surprised by their responses; however, it did bring a few things to light I have not thought about in almost 17 years of dermatology. bcofdermatology.com

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TOP TIPS FROM FMRS TRUST US. CALL US.

Besides calling the support center (or hub), FRMs are the only ones who are HIPAA certified and can talk to us about specific patients. We can trust them to tell us the correct information and to troubleshoot when we might not know where to start with an issue. Call your FRM. Let them be your “wingman” and trust them to help you.

12 3

BCS NEED TO OBTAIN SOME TYPE OF SYSTEM TO KEEP UP WITH THEIR BIOLOGICS.

BE OPEN TO SPEAKING TO THE FRM AND BE RESPONSIVE.

The people who hold FRM positions are there to help us in ways that drug reps can’t help, and they know our cases often better than the case managers at the support center. Speaking with the reimbursement managers, they do realize that we are busy and even in some offices, drug reps and FRMs may not be allowed in the clinic. In that event, if they do call, email, or text us, all they ask is that we are responsive to their effort in communicating with us regarding patients. When they do try to get in touch with us, the majority of the time it is to discuss what is happening with a specific patient.

I know a lot of biologic coordinators send the paperwork to the hub or the specialty pharmacy.

Once that is sent, they will send back a benefits verification, and then there is no follow-up after that step. This leaves patients on the other end waiting on medications with their disease quite possibly getting worse and worse. The FRM can still see the patient in their system, and they can see that the movement with the patient gets stopped at a certain point. Then the FRM will be making calls to see if there is a PA ACCESS DERMATOLOGY / ISSUE 9 / 2024 status update.

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DO NOT GET STUCK ON A FAVORITE SPECIALTY PHARMACY—INSTEAD, UTILIZE YOUR FRMS.

4 56

Why would we do this? Utilize the FRMs instead, because they likely know the most efficient pathway for patients to get on the medication that the FRM helps support. They know their covered geography insurance ins and outs in great detail. And if we present them with a question that they do not know the answer to, they have colleagues literally all over the nation they can call for help.

FRMS ARE THERE TO HELP NAVIGATE GETTING AND KEEPING A PATIENT ON THERAPY.

Whatever obstacles we as BCs face to get and keep the patients on therapy, the FRMs are here to help us achieve that.

DO NOT BE AFRAID TO REACH OUT IF YOU HAVE ANY QUESTIONS ABOUT THE ACCESS AND REIMBURSEMENT PROCESS.

Whether a BC is seasoned, has been in the position for a few years, or just starting out, we all need help at some point or another. There is no shame in reaching out, asking questions, and getting educated!

CONCLUSION

Admittedly, when I became a biologic coordinator and got comfortable in my position, I did not think I needed help from FRMs, and I could do my job without them. Little did I know I would be speaking to at least one of my FRMs daily. Every single day, I grow to appreciate the FRM position in our industry and the knowledge they bring to the table. Be open, be teachable, and be accessible to the FRM. They are here to make our jobs a little easier, and they have the same goal as we do—getting medication in the hands of patients in the most efficient and affordable way possible. bcofdermatology.com

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Y: G LO O AT NS RM TIO E D U IN SOL SS D E C AN C A DS T EN REN I T T PA

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G N IT A E G I R V U A T N FU e ht ACCESS DERMATOLOGY / ISSUE 9 / 2024

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G E

By Ben Blake

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STRATEGIC PARTNERSHIPS, PX TECHNOLOGY

A

s the field of dermatology continues to advance, the need for timely patient access to treatments becomes increasingly critical. The processes

of patient enrollments and prior authorizations (PAs) are essential, yet they can often become complex gateways to care. bcofdermatology.com

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OVERCOMING BARRIERS TO PATIENT ACCESS

THE CURRENT STATE OF PATIENT ACCESS IN DERMATOLOGY

THE ROLE OF BIOLOGICAL COORDINATORS IN ENHANCING PATIENT ACCESS Biological Coordinators (BCs) are at the forefront of this transformation, playing a crucial role in managing patient enrollments and PAs. Their efforts are vital in ensuring patients receive the treatments they need without unnecessary delays. Best practices include the adoption of advanced technology solutions and a patient-centric approach aimed at simplifying any hurdles that impact patient care.

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To manage the utilization of such therapies, payors will put stipulations in their formularies.

Utilization management may include PA, step therapy and quantity limitations (QL). Step therapy typically requires use of a clinically recognized first-line drug before approval of a more expensive medication or use of a plan-preferred medication first. QLs may be used to prevent stockpiling, promote adherence to best prescribing practices, or to prevent medication misuse or abuse. Limitations are usually consistent with FDA-approved durations/dosing, or maximum dosing.

There are, broadly, two types of formularies. An open formulary allows for most or all FDA-approved drugs to be covered by the payor, but patients may pay more out-ofpocket for non-preferred products. This results in delays in treatment and increased administrative workloads, which hinder the delivery of timely patient care. Data and case studies have illustrated the necessity for streamlined processes, underscoring the urgency with which the healthcare industry must adapt to meet these evolving demands.

Several barriers stand in the way of efficient patient access in dermatology, including intricate insurance requirements and a general lack of patient awareness regarding the access landscape. Overcoming these obstacles requires a multifaceted approach, leveraging the power of digital tools to automate and expedite the enrollment and PA processes. Educating patients on their rights and the pathways available to them is also essential in this effort.

ACCESS DERMATOLOGY / ISSUE 9 / 2024

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THE PATH FORWARD The future of patient care in dermatology hinges on our ability to adapt and embrace new solutions that promise greater efficiency and effectiveness. By acknowledging the critical role of technology and innovation, BCs and healthcare professionals are encouraged to consider the impact of technological advancements on patient access. While exploring options, it is beneficial to look for tools that provide comprehensive solutions for streamlining patient enrollments and PAs, ensuring expedited and uninterrupted patient care.

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PATIENT ACCESS SOLUTIONS On average, dermatologists receive 420 prior authorization requests each year, leading to 12 percent of their patients receiving delayed care or abandoning treatment all together. PX Technology emerges as a beacon of innovation, offering solutions designed to address these challenges in patient care. By streamlining the enrollment and PA processes, PX Technology aids biologic coordinators in their mission to facilitate access to care. Features such as automated PA submissions and real-time tracking of enrollment status exemplify how technology can be harnessed to enhance operational efficiency and, most importantly, patient outcomes.

bcofdermatology.com

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LONG ISLAND

by Colm Tóibín

1

Compelling and immersive, Long Island is a sequel to Tóibín’s bestseller Brooklyn and picks up 20 years later.

Ellis has been betrayed by her husband and manipulated by his family and returns to Ireland for her mother’s 80th birthday.

This story is poignant and beautifully told, exploring the complex and submerged emotions of Eilis, her friend Nancy and former flame Jim, who are all in midlife. They have experienced loss and loneliness and feel trapped by their circumstances and other people’s expectations.

by Amy Tintera

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by Charlee Dyroff

Debut author Charlee Dyroff has achieved the herculean task of writing a sweet, thoughtful, smart and wickedly precise story of artificial intelligence.

Lee is the overachiever we all know, but when she is hired to teach an AI program on the meaning of loneliness, her life skills are challenged. Dyroff draws an artful and memorable portrait of a woman trying to find her own answers in a world consumed by technology. It gave me enormous hope for the future. Dyroff is a force to be reckoned with!

LISTEN FOR THE LIE

This is a brilliant, twisty dark-comedy-meets-murder mystery. Lucy, a blunt, smart sarcastic anti-heroine, is a complex character you can’t help but root for, even though she may be a cold-blooded murderer.

Lucy claims she cannot remember that fateful night, but most people in her small Texas town think she is lying. And now Lucy is beginning to think that maybe she did kill her best friend. This book promises superb characters, hilarious dialogue, a great plot and a fun, dysfunctional family dynamic. A must-read!

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by Soyoung Park

MUST-READ NEW RELEASES SELECTED BY THE ELM STREET BOOKS TEAM IN NEW CANAAN, CT

This dystopian YA novel is set where the “real world” is a frozen wasteland, and everyone tunes into shows about what happens in the paradise-like Snow Globe, where people are on camera 24/7 (think The Truman Show). Readers are challenged to consider what they’d be willing to do, and who they’d be willing to become, in order to remain in the Snow Globe. Dark and sinister, this book revels in the gray areas of morality and the choices we all must make.

RECOMMENDED

BY BOOKSELLER EVE TABEN

BLANK

by Zibby Owens Zibby Owens makes her fiction debut with Blank.

A wife, mother and frustrated writer faces an impossible deadline for turning her life around in a hilarious novel about family, friendship, success and exhilarating self-(re)discovery.

Pippa’s second novel is due in five days; if she doesn't submit a manuscript, she will forfeit her already spent advance.

When Pippa’s publisher gets involved, it unlocks a series of twists she never saw coming.

This feel-good romp is a page turner. You'll be rooting for Pippa at every turn.

VENERA ALEXANDROVA

RECOMMENDED

BY BOOKSELLER PAT HOEG

Riveting Reads

ACCESS DERMATOLOGY / ISSUE 9 / 2024

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Scan the QR code to learn what else CVS Specialty o�ers. Can’t scan? Go to cvs.co/Derm EHR (Electronic health record) *CVS Health® Enterprise Analytics, April 15, 2020. Actual results may vary depending on bene�t plan design, member demographics, programs implemented by the plan and other factors.

Specialty Expedite is available exclusively for providers who use compatible EHR systems that participate in the Carequality Interoperability Framework or have an eligible EHR with CVS Health-enabled data connections and a fully executed connectivity agreement. All data sharing and usage complies with applicable privacy laws. Some payors have speci�c utilization management requirements related to prior authorization submissions (e.g., review, submission and/or physical signature by prescribers). Specialty Expedite is only used where permissible by payor requirements and applicable law. Patient privacy is important to us. Our employees are trained regarding the appropriate way to handle patients’ private health information. ©2022 CVS Specialty. All rights reserved. 75-1144729A 092622

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