Magellan Rx Report - Spring 2022 by Prime/Magellan Rx

Magellan Rx Report Spring 2022

Sleep Disorders: Narcolepsy and Idiopathic Hypersomnia

Multiple Sclerosis: New Approvals and Payer Impact

Parkinson’s Disease: Treatment and Management Update

COVID-19 Update: Treatment and Regulatory Update

Magellan Rx Report MEDICAL AND PHARMACY BENEFIT MANAGEMENT Spring 2022

Cervical Cancer:

Therapeutic Update and Looking Ahead magellanrx.com/mrxreport

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M AG E L L A N R X M A N AG E M E N T

SPECIALTY 20

SUMMIT22

CONNECTING YOU

The Magellan Rx Specialty Summit is back in person. Get ready to connect to better ideas, brilliant solutions and the best industry thought leaders at the LIVE event! Registration coming soon.

Let’s Connect Tell us you’re coming to #MRxSummit22

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IN THIS ISSUE | Spring 2022

Managed Care Newsstand

Gout Management:

Sleep Disorders:

COVID-19 Update:

Multiple Sclerosis:

Cervical Cancer:

Parkinson's Disease:

Pipeline

Biosimilars:

Update on Narcolepsy and Idiopathic Hypersomnia

New Approvals and Payer Impact

Treatment and Management Update

Treatment and Management Opportunities

Treatment and Regulatory Update

Therapeutic Update and Looking Ahead

Updates and Pharmacy Management Impact

Published By Magellan Rx Management 4801 E. Washington St., Ste. 100 Phoenix, AZ 85034

Contributors Caroline Carney, M.D., M.Sc., FAPM, CPHQ

Tel: 401-344-1000 Fax: 401-619-5215

SVP, Market General Manager, MRx Specialty

magellanrx.com Editor Lindsay Speicher, J.D.

Project Manager lspeicher@magellanhealth.com 401-344-1105

Advertising, Sales and Distribution Carole Kallas ckallas@magellanhealth.com 401-344-1132

CMO, Magellan Health, Magellan Rx Management

Steve Cutts, Pharm.D.

Haita Makanji, Pharm.D.

VP, Clinical Strategy and Innovation, Specialty

Christine Szurek

Chief Pharmacy O cer P Clinical Analytics, Strategy Innovation, Excellus BlueCross BlueShield

Dennis Bourdette, M.D., FAAN, FANA

Chair and Roy and Eulalia Swank Family Research Professor, Department of eurology, Oregon ealth Science niversity

Yousaf Ali, M.D., FACR

Marketing Manager

Chief, Division of Rheumatology, Mount Sinai West; Professor of Medicine, Icahn School of Medicine at Mount Sinai

Joe Tavares

Steven L. D’Amato, B.S.Pharm.

Carole Kallas

Joseph Mikhael, M.D., M.Ed., FRCPC, FACP

Brian MacDonald, Pharm.D.

Natalie Tate, Pharm.D., MBA, BCPS

SVP, Sales and Business Development, Specialty Project Manager

Director, Specialty Clinical Strategy

Brian Kinsella, Esq.

Senior Legal Counsel

Alina Young

The content of Magellan RxTM Report — including text, graphics, images, and information obtained from third parties, licensors, and other material (“content”) — is for informational purposes only. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Magellan RxTM Report does not verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damages incurred by readers in reliance on such content. Developed by D Custom.

Editorial Advisory Board Mona M. Chitre, Pharm.D., CGP

Associate Legal Counsel

Lilly Ackley

VP, Corporate Communications

Executive Director, New England Cancer Specialists

Chief Medical O cer, nternational Myeloma oundation VP, Pharmacy Management, BlueCross BlueShield of Tennessee

Steve Marciniak, R.Ph.

Director , Medical Benefit Drug Management, BlueCross BlueShield of Michigan

Saira A. Jan, M.S., Pharm.D.

Director of Pharmacy Strategy and Clinical Integration, Horizon BlueCross BlueShield of New Jersey

ISSN: 2159-5372

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A NOTE FROM OUR CMO

Dear Managed Care Colleagues, Welcome to our spring 2022 issue of the Magellan Rx Report! 2022 is o to an e citing start with 7 novel drug approvals so far and many more expected as the year progresses. Millions of Americans are vaccinated against COVID-19 and have received booster doses of the vaccine, while others have benefited from the newly approved CO D-19 treatments. The energy put toward quelling the pandemic through public health e orts and development of preventive and therapeutic drugs is unprecedented. With the pandemic as a backdrop, we must not lose sight of preventing and treating chronic and terminal conditions. Magellan Rx Management is committed to keeping our readers informed and updated across the spectrum of diseases. Our spring issue is full of content focused on trending clinical advances and approvals.

Our article on sleep disorders (page ) focuses specifically on updates in the narcolepsy and idiopathic hypersomnia categories. We touch on new approvals in this space, along with management strategies for payers. Other timely topics in this issue include updates on multiple sclerosis (page 12) and gout management (page 32), a biosimilar update (page 22), and an outline of new treatments and a pipeline for COVID-19 (page 36). As always, the issue is rounded out with our pipeline update (page 46) and managed care newsstand (page 4). To learn more about Magellan Rx Management and our support for payer initiatives of the future, please feel free to contact us at MagellanRxReport@magellanhealth.com. As always, we value any feedback you may have. I hope you enjoy the report! Sincerely,

Approximately 14,000 women will develop invasive cervical cancer in the year ahead. Our cover story (page 41) outlines new treatment options for cervical cancer, which is particularly exciting after a long period without much new development in this category. In another article, we highlight the management of Parkinson’s disease and Parkinson’s disease psychosis. New treatment options and a promising pipeline will create opportunity for better management and outcomes for patients and payers.

Caroline Carney, M.D., M.Sc., FAPM, CPHQ ie edical ffice Magellan Health & Magellan Rx Management

SUBSCRIBE TODAY! Stay on top of managed care trends and become a Magellan Rx Report subscriber. Email us at MagellanRxReport@magellanhealth.com to subscribe today. Magellan Rx Report provides pharmacy and medical management solutions for managed care executives and clinicians. We hope you enjoy the issue; thank you for reading.

Visit us online at magellanrx.com/mrxreport | 3

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MANAGED CARE NEWSSTAND

CMS Wants Rx Discounts Included at the POS On Jan. 12, the Centers for Medicare & Medicaid Services (CMS) proposed to modify the definition of negotiated price to require all pharmacy price concessions in the prescription drug benefit to be included at the point of sale (POS) and remove exceptions for contingency discounts. Successive administrations have considered but repeatedly rejected similar proposals in the past, given the negative impacts on Medicare beneficiaries and the broader Part D program. The proposal would remove the current regulatory provision that excludes contingent discounts from pharmacies that cannot reasonably be determined at the POS from the definition of Part D s negotiated price nder the proposal, the negotiated price would have to reflect the lowest possible reimbursement a network pharmacy or other network dispensing entity will receive for a drug, taking into account price concessions and including all contingent discounts. CMS says additional payments that could be made to a pharmacy as an incentive to encourage e cient drug choices, such as higher generic dispensing, would still be permitted. Those contingent amounts would be excluded from the negotiated price and instead would be reported as negative direct or indirect remuneration (D ) during the Part D reconciliation period CMS further proposes a definition of price concession to mean any form of discount, whether a direct indirect subsidy or rebate received by a Part D sponsor or its intermediary that serves to decrease the costs incurred under the plan by the Part D sponsor

Medicare Prescription Drug Program (Part D) Status Report The Medicare Payment Advisory Commission (MedPAC) met Jan. 13-14 to discuss Medicare payment policies and provide status updates on the program. This session provided an update on the Medicare Part D program and will be included as a chapter in the March 2022 commission s report otable trends in the Part D program included enrollment being split evenly between standalone prescription drug plans and Medicare Advantage prescription drug plans (MA-PDs), as well as Medicare s expected average payment to plan sponsors in 2022 at $5 per member per month. When published, the March 2022 chapter will also include information regarding PDP market segmentation and results from Part D s D analysis

CMS Issues Final Rule Rescinding Most Favored Nation Model CMS issued a final rule in late December rescinding the Most Favored Nation (MFN) Model nterim inal ule with Comment CMS states that it proposed to rescind the model given that the nationwide preliminary injunction precluded implementation of the MFN Model on January 1, 2021, as contemplated, that multiple courts found procedural issues with the November 2020 interim final rule, and that sta eholders expressed concern about the model start date The model would have established a seven-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act)

Rebate Rule Postponed to 2023 The rebate rule was proposed and finali ed during the Trump administration and would

Notable trends in the Part D program included enrollment being spit evenly between standalone prescription drug plans and Medicare Advantage prescription drug plans (MA-PDs), as well as Medicare’s expected average payment to plan sponsors in 2022 at $5 per member per month. remove drug manufacturer rebates paid to Medicare Part D plans, or PBMs under contract with them, from the regulatory discount safe harbor s protections and add a safe harbor for certain POS discounts. n response to litigation brought by the Pharmaceutical Care Management Association challenging the rule, the Biden administration agreed to postpone the e ective date of the provisions of the rule relating to the elimination of the regulatory discount safe harbor for retrospective rebates, from Jan. 1, 2022, to Jan. 1, 2023. The bipartisan infrastructure bill was signed into law Nov. 15, 2021, and delays the rule by three years to 2026.

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FTC Announces RFI on PBMs n ebruary, the ederal Trade Commission (FTC) failed to advance a study on how pharmacy benefit managers a ect drug prices and the businesses of pharmacies. Shortly thereafter, the FTC announced it is soliciting public input on the ways that practices by large, vertically integrated pharmacy benefit managers (PBMs) are a ecting drug a ordability and access The request for information covers a wide range of issues in the PBM mar et, including contract terms, rebates, fees, pricing policies, steering methods, conflicts of interest, and consolidation. The agency seeks information on these practices and their impact on patients, physicians, employers, independent and chain pharmacies, and other businesses across the distribution system. PBMs are companies that manage prescription drug benefits on behalf of private health insurers, Medicare Part D drug plans, large employers, and other payers. The largest PBMs are vertically integrated with health insurance companies and specialty pharmacies, giving them financial incentives to steer patients to use their a liated services Moreover, in response to the commission s request for public input on contracts terms that may harm fair competition, many independent pharmacies commented that PBM contractual terms are confusing, unfair, opaque, and arbitrary. The request for information will enable agency sta to study a wide array of PBM business practices and issues and will help inform the agency s policy and enforcement work. Members of the public can comment on any issues or concerns they believe are relevant or appropriate for the agency s consideration by submitting written data, views, facts, and opinions addressing this subject. The comment period will be open for 60 days, extending through April 25.

CMS Releases Bulletin on Third Party Liability in Medicaid The S Centers for Medicare & Medicaid Services (CMS) released an informational bulletin Aug. 27 to assist states in ensuring that their Medicaid state plans comply with third party liability (TPL) requirements reflected in current laws CMS notes that states should update their Medicaid TPL state plan pages and submit amendments to CMS to reflect the recent changes in law. As states make changes in their TPL programs, they will likely lead to implications for Medicaid-managed care plan contracts.

Proposed National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD) After reviewing more than 250 peerreviewed documents relevant to the CD analysis, as well as reports from other agencies and the nstitute for Clinical and Economic Review, public comments, feedback from two stakeholder meetings, and numerous meetings with stakeholders, CMS has decided that there is insu cient evidence to conclude that the use of monoclonal antibodies directed against amyloid is reasonable and necessary for the treatment of Al heimer s disease As CMS indicates in its discussion of evidence in the proposed decision memo, the assessment focused on the key evidence question of whether the use of monoclonal antibodies directed against amyloid for the treatment of AD improves health outcomes for Medicare beneficiaries Moreover, the standard is not simply, Could this class of drugs be

helpful to patients with AD , but rather an additional determination to be made that it is necessary for them to access these treatments. As a result, CMS proposes to cover DA-approved monoclonal antibodies directed against amyloid for the treatment of AD under Coverage with vidence Development in CMS-approved randomi ed controlled trials that satisfy certain coverage criteria, and in trials supported by the ational nstitutes of ealth All trials must be conducted in a hospital-based outpatient setting.

CMS has decided that there is insufficient evidence to conclude that the use of monoclonal antibodies directed against amyloid is reasonable and necessary for the treatment of Alzheimer’s disease.’

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Sleep Disorders pdate on arcolepsy and diopathic ypersomnia Because individuals with sleep disorders account for high overall healthcare costs, management should aim to improve patient outcomes while containing associated medical utili ation and costs Narcolepsy arcolepsy, which a ects up to 200,000 people in the S , is a chronic neurological disorder that impacts the brain s ability to control sleep-wa e cycles 1 Those with narcolepsy typically first e perience symptoms during childhood or young adulthood; however, it often goes undiagnosed or misdiagnosed as other conditions There is no nown cause of narcolepsy, but research suggests the condition may be a result of low levels of hypocretin ypocretin is a brain hormone that promotes wa efulness and regulates rapid eye movement ( M) sleep and is believed to be decreased by a number of factors, including autoimmune disorders, family history, and or brain in uries 1 Anja Shaughnessey, Pharm.D., PRS, R.Ph. Senior Pharmacy Contract Consultant Point32Health

arcolepsy is characteri ed by symptoms including e cessive daytime sleepiness ( DS), often assessed using the pworth Sleepiness Scale ( SS); cataple y, the sudden loss of muscle tone while awa e, leading to wea ness and loss of voluntary muscle control; sleep paralysis, the temporary inability to move or spea while falling asleep or wa ing up; and hallucinations 1 ndividuals with narcolepsy may also e perience fragmented sleep and insomnia or other behaviors such as temporary sleep episodes, during

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Let’s be

friends?

Listen today! which they fall asleep for seconds at a time during an activity.1 arcolepsy is often classified into two types type 1, previously nown as narcolepsy with cataple y, and type 2, previously nown as narcolepsy without cataplexy.1 Those with type 1 typically either have low levels of hypocretin or report cataple y and have DS, while those with type 2 e perience DS but do not e perience cataplexy and often have less severe symptoms overall with normal levels of hypocretin.1 Proper diagnosis requires a clinical examination and detailed medical history, along with two speciali ed tests that are performed at sleep disorder clinics polysomnogram (PS ) and multiple sleep latency test (MSLT) 1 Diagnostic criteria for narcolepsy requires DS in association with any one of the following cataple y; CS hypocretin deficiency; M sleep latency 15 minutes on nocturnal PS ; or mean sleep latency 8 minutes on MSLT with at least two sleep-onset M-sleep periods 2

Idiopathic Hypersomnia diopathic hypersomnia ( ) is a rare, chronic neurological sleep disorder that can cause individuals to have di culty staying awa e and alert during the day.3 a ects about 0 3 of the population in the S , and symptoms often begin during childhood or young adulthood.4 hile the cause is un nown, in some cases individuals with have family members with or other sleep disorders 3

PHARMACY

FRIENDS

Idiopathic hypersomnia (IH) is a rare, chronic neurological sleep disorder that can cause individuals to ave difficult staying awake and alert during the day.

often presents with symptoms including chronic DS; prolonged periods of sleep without feeling refreshed upon wa ing; nonrefreshing daytime napping; sleep drun enness, or di culty wa ing up and feeling an uncontrollable desire to go bac to sleep after nighttime sleep or naps; brain fog while awa e; and headaches 3 Other less common symptoms associated with include short sleep latency, or ta ing a shorter than normal time to fall asleep; harder time regulating body temperature; aynaud s disease; e cessive sweating; episodes of feeling faint; blood pressure drops upon standing up; sleep paralysis; and sleep-related hallucinations 3

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SLEEP DISORDERS | Continued

Recent data suggests at least two-thirds of patients with newly diagnosed IH slept at least 11 hours per night.3 Individuals with IH have increased prevalence of cardiovascular comorbidities, autonomic nervous system dysfunction, sleep apnea, and psychiatric disorders such as anxiety and depression.5, 6 A claims analysis demonstrated that, when compared to patients without IH, more patients with IH had hyperlipidemia, diabetes, anxiety, depressive disorders, headache or migraine, heart failure, stroke, and history of cardiovascular disease.6, 7 Individuals must meet the following criteria to be diagnosed with IH: symptoms of EDS lasting longer than one year and an ESS score of 10 or higher with daytime napping on most days, no improvement after a trial of increased nighttime sleep, more than two sleep-onset REM periods on MSLT when MSLT was performed, no features to suggest cataplexy, and an apnea or hypopnea index of less than 10.8

Current Narcolepsy Management Symptoms of narcolepsy are often managed with medication and lifestyle changes. According to the American Academy of Sleep Medicine (AASM) clinical practice guidelines, modafinil, pitolisant,

sodium oxybate, and solriamfetol are strongly recommended for the treatment of narcolepsy in adult patients Armodafinil, dextroamphetamine, and methylphenidate are conditionally recommended.9

Recent Approvals XYWAV ® (calcium, magnesium, potassium, and sodium oxybates)10 The U.S. Food and Drug Administration (FDA) approved Jazz Pharmaceutical’s XYWAV® (calcium/magnesium/potassium/ sodium oxybates) in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who are 7 years or older ectiveness was observed in a phase three double-blind, placebo-controlled, randomized-withdrawal, multicenter study of 201 patients. XYWAV® demonstrated statistically significant di erences in the wee ly number of cataple y attac s and ESS scores, compared to the placebo. Dosing options are available for adult and pediatric patients, and prescribers can titrate treatment into unequal doses taken throughout the night. Adverse reactions observed most commonly in adults included

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headache, nausea, dizziness, anxiety, insomnia, decreased appetite, dry mouth, parasomnia, somnolence, diarrhea, hyperhidrosis, fatigue, tremor, and vomiting. XYWAV® has a boxed warning as a central nervous system depressant — and for its potential for abuse and misuse. Because of the risks of CNS depression and abuse and misuse, XYWAV® is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

WAKIX® (pitolisant)11, 12

CLINICAL

Insights PSYCHEDELICS An Emerging Frontier

EXPLORE NOW

In August 2019, the FDA approved WAKIX® (pitolisant, Harmony Biosciences) for the treatment of EDS in adult patients with narcolepsy. This approval was based on two multicenter, randomized, double-blind, placebo-controlled studies, which included a total of 261 patients randomized to receive pitolisant, placebo, or active control. In both studies, patients treated with pitolisant had statistically significant improvement in SS scores Adverse reactions included insomnia, nausea, and anxiety. The FDA approved pitolisant for an additional indication of cataplexy in adult patients with narcolepsy in October 2020. At the time of these approvals, pitolisant was the first and only non-scheduled treatment approved by the FDA for people with EDS or cataplexy in adult patients with narcolepsy. Approval for the treatment of cataplexy was based on results from two randomized, controlled trials. After issuing a complete response letter (CRL) in August 2019, the FDA agreed to review a reanalysis of data and ac nowledged the analyses confirmed a statistically significant reduction in the rate of cataple y in patients treated with pitolisant, compared to placebo. A resubmission following the CRL resulted in FDA approval.

SUNOSITM (solriamfetol)13 The FDA approved SUNOSI™ (solriamfetol, Jazz Pharmaceuticals) in March 2019 for the treatment of EDS associated with narcolepsy or obstructive sleep apnea. Solriamfetol is a once-daily treatment approved in doses of 75 mg and 150 mg for patients with narcolepsy, and it was the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat EDS in adults with narcolepsy. Results from a phase three clinical program consisting of four randomized placebo-controlled studies demonstrating the superiority of solriamfetol relative to the placebo showed that at week 12, 150 mg of solriamfetol demonstrated improvements in wakefulness, compared to the placebo in patients with narcolepsy. Approximately 6874% of patients treated with 75 mg of solriamfetol and 7890% of patients treated with 150 mg of solriamfetol reported

magellanrx.com/clinicalinsights

improvement in clinical condition over the 12-week clinical studies. Common adverse reactions associated with treatment with solriamfetol included headache, nausea, decreased appetite, insomnia, and anxiety.

Lifestyle Changes Because drug therapy does not help all individuals with narcolepsy maintain a typical state of alertness, lifestyle changes are often recommended. Some strategies include taking short naps, maintaining a regular sleep schedule, avoiding ca eine or alcohol before bed, avoiding smoking, exercising daily, avoiding large meals before bedtime, and relaxing before bed.1 It is important for individuals with narcolepsy to take safety precautions with certain activities of daily living, especially driving or wal ing down long flights of stairs 1

Current IH Management XYWAV™ is the only FDA-approved treatment indicated for IH. Prior to its approval, treatment generally involved o -label use of medications approved for narcolepsy, including wakefulnesspromoting agents such as modafinil and traditional psychostimulants, including amphetamines and methylphenidate.3

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SLEEP DISORDERS | Continued

nli e in the management of narcolepsy, behavior modification is not often e ective in individuals with ; for e ample, daytime naps are typically nonrestorative or disruptive for individuals with Daytime activities that could pose a danger, such as driving or operating machinery, should be avoided if DS is not well-controlled 3

XYWAV ® (calcium, magnesium, potassium, and sodium oxybates)14 n August 2021, the DA approved Y A ® as the first and only treatment indicated for in adults n a study of 154 adult patients with , patients randomi ed to switch from Y A ® to the placebo e perienced worsening on measures of sleepiness and symptoms of , when compared to patients randomi ed to continue Y A ® treatment Adverse events included nausea, headache, di iness, an iety, and vomiting Treatment with Y A ® is sub ect to strict safety controls under a MS program; it can only be prescribed by a certified prescriber and dispensed only to an enrolled patient by a certified pharmacy

Individualized clinician-patient treatment choices are best practice recommendations, as these will take into consideration clinical manifestations of the disorder in t e s eci c atient in order to identify the optimal treatment regimen.

Payer Management An analysis published in 2021 estimated that sleep disorders accounted for 94 9 billion in S healthcare costs each year 15 Adult patients with sleep disorders were found to have increased utili ation of o ce visits, emergency department visits, and prescriptions and had higher healthcare e penses, o ce-based e penditures, prescription e penditures, and self-e penditures for prescriptions 15 Proper diagnosis and management in this category may be critical in o setting the higher utili ation and costs associated with these patients Because individuals with sleep disorders account for very high overall healthcare costs, management should have the ob ective of improved patient outcomes while containing associated medical utili ation and costs n narcolepsy, pharmacy costs account for ust 28 of the total healthcare costs; thus, while using lower-cost drugs may result in short-term savings in pharmacy spend, this concept may eopardi e patient outcomes and could potentially results in higher medical utili ation and costs 1 ith sleep disorders such as narcolepsy, treatment plans must be tailored to the specific patient and their symptom

presentation and burden ndividuali ed clinician-patient treatment choices are best practice recommendations, as these will ta e into consideration clinical manifestations of the disorder in the specific patient in order to identify the optimal treatment regimen Proper management policies should include regular follow-up assessments upon treatment initiation to ensure e cacy and improve longer-term outcomes n 2020, the Payer Policy eview Committee of the AASM assessed the alignment between guidelines and private payer policies managing sleep disorders and ultimately developed a scorecard to evaluate how guidelines and payer policies correspond 1 The ob ective of this initiative was to better highlight and communicate discrepancies between medical policies and clinical guidelines to encourage closer alignment and ensure patients with sleep disorders receive high-quality care 17 The publication of the scorecards resulted in ongoing communication between the AASM and payers, which lead to revision of policies to better align with guidelines 17 This ongoing e ort can help achieve consistency in the management of these burdensome disorders

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References 11.

armony Biosciences Announces DA Approval of AK ® (Pitolisant), A irst-in-Class Medication for the Treatment of cessive Daytime Sleepiness in Adult Patients with arcolepsy BioSpace, 15 Aug 2019, https www biospace com article releases harmony-biosciences-announces-fda-approval-ofwa i -pitolisant-a-first-in-class-medication-for-the-treatment-ofe cessive-daytime-sleepiness-in-adult-patients-with-narcolepsy

12.

armony Biosciences eceives DA Approval for panded se of AK ® (pitolisant) for the Treatment of Cataple y in Adult Patients with Narcolepsy.” PRNewswire, 14 Oct. 2020, https://www. prnewswire com news-releases harmony-biosciences-receives-fdaapproval-for-e panded-use-of-wa i -pitolisant-for-the-treatmentof-cataple y-in-adult-patients-with-narcolepsy-301152078 html

Vernet, Cyrille, et al. “Subjective symptoms in idiopathic hypersomnia beyond e cessive sleepiness Journal of Sleep Research, Dec 2010, https pubmed ncbi nlm nih gov 20408941

a Pharmaceuticals Announces S DA Approval of Sunosi (solriamfetol) for cessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea.” PRNewsWire, 20 Mar 2019, https www prnewswire com news-releases a -pharmaceuticals-announces-us-fda-approval-of-sunosisolriamfetol-for-e cessive-daytime-sleepiness-associated-withnarcolepsy-or-obstructive-sleep-apnea-30081 081 html

14.

Miglis, Mitchell, et al requency and severity of autonomic symptoms in idiopathic hypersomnia.” Journal of Clinical Sleep Medicine, 15 May 2020, https pubmed ncbi nlm nih gov 32039754

DA rants irst of its Kind ndication for Chronic Sleep Disorder Treatment U.S. Food & Drug Administration, 12 Aug. 2021, https:// www fda gov news-events press-announcements fda-grants-firstits- ind-indication-chronic-sleep-disorder-treatment

avidia, Matthew Sleep Disorders Cost S 94 9 Billion ach Year, Study Finds.” American Journal of Managed Care, 11 May 2021, https www a mc com view sleep-disorders-cost-us-94-9-billioneach-year-study-finds

“Narcolepsy Fact Sheet.” National Institute of Neurological Disorders and Stroke, https://www.ninds.nih.gov/Disorders/Patient-CaregiverEducation/Fact-Sheets/Narcolepsy-Fact-Sheet.

uo , Chad, et al The CSD-3 and DSM-5 guidelines for diagnosing narcolepsy: clinical relevance and practicality.” Current Medical Research and Opinion, October 2016, https://pubmed.ncbi.nlm.nih. gov 27359185

diopathic hypersomnia Genetic and Rare Diseases Information Center, https rarediseases info nih gov diseases 8737 idiopathichypersomnia.

Ohayon, Maurice rom wa efulness to e cessive sleepiness what we now and still need to now Sleep Medicine Reviews, Apr 2008, https www ncbi nlm nih gov pmc articles PMC23 2500

Saad, R., et al. “Clinical presentation prior to idiopathic hypersomnia diagnosis among U.S. adults: a retrospective, real-world claims analysis poster 497 Presented at: Annual Meeting of the Associated Professional Sleep Societies, 10-13 une, 2021

Anderson, Kirstie, et al dioathic ypersomnia A Study of 77 Cases.” Sleep, 1 Oct. 2007, https://www.ncbi.nlm.nih.gov/pmc/ articles PMC22 27

Mas i, Kiran, et al Treatment of central disorders of hypersomnolence an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.” Journal of Clinical Sleep Medicine, 1 Sept. 2021, https://jcsm.aasm.org/ doi 10 5 4 csm 932

10.

a Pharmaceuticals Announces S DA Approval of ywav (calcium, magnesium, potassium, and sodium o ybates) Oral Solution for Cataple y or cessive Daytime Sleepiness Associated with Narcolepsy.” Jazz Pharmaceuticals, 22 uly, 2020, https investor a pharma com news-releases news-release-details a pharmaceuticals-announces-us-fda-approval- ywavtm-calcium

16. Thorpy, Michael, et al The Medical and conomic Burden of arcolepsy mplications for Managed Care American Health & Drug Benefits, uly 2017, https www ahdbonline com issues 2017 uly-2017-vol-10-no-5 2421-the-medical-andeconomic-burden-of-narcolepsy-implications-for-managed-care 17. Kaplish, Neeraj, et al. “Addressing gaps between payer policies and AASM clinical practice guidelines using scorecards Journal of Clinical Sleep Medicine, 15 May 2020, https csm aasm org doi 10 5 4 csm 8410

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Multiple Sclerosis: New Approvals and Payer Impact As the pipeline promises more new therapies in the MS category, clear guidance and consensus will be even more important to achieve e ective management, improve outcomes, and manage costs

Samir Mistry, Pharm.D. Vice President, Pharmacy Strategy & Services Capital Blue Cross

Multiple sclerosis (MS) is a central nervous system (C S) disease that a ects nearly 1 million people in the U.S.1 Often considered an autoimmune disease, the condition disrupts the communication between the brain and the rest of the body. Initial onset of MS often occurs between the ages of 20 and 40.2 There are four disease courses in MS: clinically isolated syndrome (CIS), relapsingremitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).2 MS is the most common disease course and is characteri ed by clearly defined attac s of new or increasing neurologic symptoms n MS, attac s or relapses are followed by periods of partial or complete recovery, or remissions.2 An estimated 85% of MS patients are initially diagnosed with RRMS. SPMS is secondary to an initial diagnosis of RRMS; some patients with RRMS eventually transition to SPMS, which occurs with progressive worsening of neurologic function over time.2 A minority of MS patients are diagnosed with PPMS, which is characterized by worsening neurologic function from the onset of symptoms without relapses or remissions.2 The first symptom of MS is commonly blurred or double vision, red-green color distortion, or even blindness in one eye Muscle wea ness in the e tremities and di culty with coordination and balance are experienced by most MS patients, and these symptoms can be severe enough to impair wal ing or standing 3 Other common symptoms of MS are paresthesias, transitory abnormal sensory feelings such as numbness, pric ling, or pins and needles sensations; pain; speech impediments; tremors; bladder dysfunction; bowel dysfunction; sexual problems; and dizziness. Around 50% of MS patients su er from cognitive impairments such as di culty with concentration, attention, memory, or poor judgment. In severe cases, patients with MS can develop partial or complete paralysis.3 Proper diagnosis of MS often entails a comprehensive process that may include medical history, neurologic e am, and tests such as an M , spinal fluid analysis, and blood tests to rule out conditions

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with overlapping symptoms.3 The criteria for an MS diagnosis include: evidence of damage in at least two separate areas of the CNS, including the brain, spinal cord, and optic nerves; evidence that damage occurred at di erent points in time; and no other possible diagnosis.4 The revised McDonald Criteria from the nternational Panel on MS Diagnosis has specific guidelines for using M and cerebrospinal fluid analysis in the diagnostic process for MRI; according to these guidelines, MRI can be used to look for a second area of damage in a person who has experienced only one attack (or a relapse or exacerbation) of MSli e symptoms and can also be used to confirm that damage has occurred at two di erent points in time 5

The FDA has approved several disease-modifying therapies for MS that may reduce the number of relapses, delay progression, and limit new disease activity.

Treatment Treatment courses for MS can be used to modify the disease course, treat relapses, and manage symptoms. The U.S. Food and Drug Administration (FDA) has approved several disease-modifying therapies (DMTs) for MS that may reduce the number of relapses, delay progression, and limit new disease activity. DMTs include injections, such as interferon beta-1a and -1b (AVONEX® and BETASERON®), glatiramer acetate (COPAXONE®), and ofatumumab (KESIMPTA®); oral medications, such as teriflunomide (A BA O®), fingolimod ( L YA®), and dimethyl fumarate (Tecfidera®); and infusions, such as alemtu umab (L MT ADA®) and ocrelizumab (OCREVUS®).6 The American Academy of Neurology (AAN) guidelines and other MS guidelines recommend earlier initiation of DMTs, as well as strategies on initiating, switching, and stopping therapy.7

Recent Approvals PONVORY TM (ponesimod)8, 9 n March 2021, PO O Y (ponesimod, ohnson ohnson) received FDA approval for the treatment of adults with relapsing forms of MS, including CIS, RRMS, and active secondary progressive disease. Ponesimod is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator. Results from a two-year, head-to-head phase three clinical trial demonstrated ponesimod s superior e cacy in significantly reducing annual relapses by 30 5 , compared to teriflunomide, in patients with MS n the group treated with ponesimod, 71 had no confirmed relapses, compared to 1 in the teriflunomide group esults indicate ponesimod reduced new gadolinium-enhancing T1 lesions and a number of new or enlarging T2 lesions by 59 , compared to 5 in the teriflunomide group Common adverse events associated

with ponesimod included upper respiratory infection, hepatic transaminase elevation, and hypertension.

KESIMPTA® (ofatumumab)10, 11 The FDA approved KESIMPTA® (ofatumumab, Novartis) in August 2020 as the first and only self-administered, targeted B-cell therapy for patients with relapsing MS. Ofatumumab is a targeted, precisely dosed B-cell therapy used for the treatment of relapsing MS to include CIS, RRMS, and SPMS. Approval was based on phase three ASCL P OS and studies; results showed that ofatumumab demonstrated superiority when compared to teriflunomide in significantly reducing the annuali ed relapse rate (0.11 vs. 0.22, respectively, in trial I, and 0.10 vs. 0 25, respectively, in trial ), three-month confirmed disease progression (10 9 vs 15 05 , respectively), and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions. A post-hoc analysis indicated that ofatumumab may delay new disease activity in relapsing MS patients; the odds of achieving no evidence of disease activity with ofatumumab compared with teriflunomide were more than three times higher in the first 12 months and more than eight times higher in the following 12 months. Observed adverse reactions with ofatumumab included upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.

OCREVUS® (ocrelizumab) Previously approved for the treatment of RRMS as a twiceyearly infusion, OCREVUS® (ocreli umab, enentech) received FDA approval in December 2020 to shorten the infusion time from 3.5 hours to 2 hours, with doses remaining at twice-yearly intervals.12 enentech released data in October 2021 showing that early and ongoing treatment with ocreli umab significantly

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MULTIPLE SCLEROSIS | Continued Pipeline15 Drug

Manufacturer

Route of Administration

Mechanism of Action

Indication

Status

ublituximab (TG-1101)

TG Therapeutics

anti-CD20 antibody

relapsing

pending (3Q 2022)

evobrutinib

Merck KGaA-EMD Serono

oral

Bruton tyrosine kinase inhibitor

relapsing; relapsing-remitting

phase three

fenebrutinib (GDC-0853)

Genentech-Roche

oral

Bruton tyrosine kinase inhibitor

relapsing; primary progressive

phase three

relapsing; primary progressive

phase three

tolebrutinib (SAR442168)

Sanofi-Principia Biopharma

oral

Bruton tyrosine kinase inhibitor

vidofludimus ( M -838)

Immunic Therapeutics

oral

pyrimidine synthesis inhibitor

relapsing-remitting

phase three

delta-9-tetrahydrocannabinol (Sativex)

Pharmaceuticals; a Pharmaceuticals

oral

cannabinoid

spasticity in MS

phase three

Roche

anti-CD20 antibody

relapsing; primary progressive

phase three

natali umab biosimilar (PB00 )

Polpharma BiologicsSando

anti-alpha-4-integrin antibody

relapsing-remitting

phase three

hyaluronidase; ocreli umab (OC S SC)

oche; alo yme Therapeutics; Genentech

anti-CD20 antibody; endoglycosidase

phase three

relapsing

phase three

glatiramer acetate (GA Depot)

Mapi Pharma-Mylan

immunomodulators progressive

phase two

relapsing-remitting

phase two

ocreli umab (OC

S®)

orelabrutinib

nnoCare Pharma-Biogen

oral

Bruton tyrosine kinase inhibitor

Abbreviations: CAR-T = chimeric antigen receptor therapy; IV = intravenous; SC = subcutaneous; MS = multiple sclerosis

reduced the risk of requiring a walking aid in RRMS (35% reduction after seven-and-a-half years vs. when treatment initiated two years later) and disability progression in PPMS (29 reduction in 48-wee confirmed disability after eight years vs. when treatment initiated after the double-blind period in phase three).13 The study also showed the shorter two-hour infusion of ocreli umab was equally well-tolerated in AfricanAmerican, Hispanic, and Latino populations compared with overall study populations.13

TascensoTM ODT (fingolimod lauryl sulfate)14 In December 2021, the FDA approved TascensoTM ODT (fingolimod lauryl sulfate, anda euroscience) 0 25 mg oral disintegrating tablet (ODT) for the treatment of relapsing forms of MS, including C S, MS, and SPMS, in pediatric patients over the age of 10 years.

Payer Management Due to the high cost in this category, MS remains a high priority for payers. As the cost of drugs in categories such as MS continue to rise, specialty drug spend is expected to grow more rapidly than the cost of traditional drugs.16 According to the 2020 Magellan Rx Management Medical Pharmacy Trend eportTM, MS was one of the top four

commercial disease states by per-member-per-month spend in the previous year, with a 48% increase in spending from 2018 to 2019.17 To counteract this rise in spend, payers are implementing strategies such as utili ation management on both pharmacy and medical benefits, site of service, and formulary management 17 In fact, a 2020 analysis from IQVIA suggested that 80% of commercially insured patients receiving a new prescription for MS were sub ect to a utili ation management restriction 18 Step therapy is becoming increasingly popular as a means to manage the MS space for payers. According to the American Academy of eurology (AA ), step therapy programs are encouraged when they are driven by evidence-based clinical data, safety data, and cost-e ectiveness data 19 Factors such as relative e cacies of DMT, mechanisms of action, side e ects, treatment schedule, and routes of administration should be considered in treatment decision on an individuali ed level 19 The AA also noted that neurologists must play a role in containing costs, by making well-educated decisions on the appropriate initiation, use, and discontinuation of DMT, when appropriate.19 The MS category is continuously expanding, with currently 19 brand name products from which payers and providers can choose.18 As the pipeline promises more new therapies in the MS category, clear guidance and consensus will be even more important to achieve e ective management, improve outcomes, and manage costs.

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“Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in educing Annual Relapses and Brain Lesions.” Johnson & Johnson, 19 Mar. 2021, https://www.jnj.com/janssen-announces-u-s-fda-approval-ofponvory-ponesimod-an-oral-treatment-for-adults-with-relapsingmultiple-sclerosis-proven-superior-to-aubagio-teriflunomide-inreducing-annual-relapses-and-brain-lesions.

Kappos, Ludwig, et al Ponesimod Compared with Teriflunomide in Patients with Relapsing Multiple Sclerosis in the ActiveComparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial.” JAMA Neurology, 1 May 2021, https://pubmed.ncbi.nlm.nih. gov/33779698/.

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10. “FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis.” Novartis, 20 Aug. 2020, https:// www.novartis.com/news/media-releases/fda-approves-novartisesimpta-ofatumumab-first-and-only-self-administered-targeted-bcell-therapy-patients-relapsing-multiple-sclerosis. 11.

magellanrx.com/COVID19

auser, Stephen, et al Ofatumumab versus Teriflunomide in Multiple Sclerosis.” New England Journal of Medicine, 6 Aug. 2020, https://pubmed.ncbi.nlm.nih.gov/32757523/.

12. “FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis.” Roche, 14 Dec. 2020, https://www.roche.com/media/releases/medcor-2020-12-14.htm. 13. “New Data up to 8-Years for Genentech’s Ocrevus (ocrelizumab) Show arly and Ongoing Treatment Significantly educed is of Requiring a Walking Aid in Relapsing Multiple Sclerosis and Disability Progression in Primary Progressive Multiple Sclerosis.” Genentech, 12 Oct. 2021, https://www.gene.com/media/pressreleases/14932/2021-10-12/new-data-up-to-8-years-forgenentechs-oc.

References 1.

“MS Prevalence.” National Multiple Sclerosis Society, https://www. nationalmssociety.org/About-the-Society/MS-Prevalence.

“Types of MS.” National Multiple Sclerosis Society, https://www. nationalmssociety.org/What-is-MS/Types-of-MS.

“Multiple Sclerosis Information Page.” National Institute of Neurological Disorders and Stroke, https://www.ninds.nih.gov/ Disorders/All-Disorders/Multiple-Sclerosis-Information-Page.

“How MS is Diagnosed.” National Multiple Sclerosis Society, https:// www.nationalmssociety.org/Symptoms-Diagnosis/Diagnosing-MS.

“Updated McDonald Criteria Expected to Speed the Diagnosis of MS and Reduce Misdiagnosis.” National Multiple Sclerosis Society, 21 Dec. 2017, https://www.nationalmssociety.org/About-the-Society/ News/Updated-McDonald-Criteria-Expected-to-Speed-the-Di.

“Medications.” National Multiple Sclerosis Society, https://www. nationalmssociety.org/Treating-MS/Medications.

“Practice Guideline Recommendations Summary: Disease-Modifying Therapies for Adults with Multiple Sclerosis.” American Academy of Neurology, April 2018, https://www.aan.com/Guidelines/home/ GuidelineDetail/898.

14.

Tascenso ODT (fingolimod) ew formulation approval OptumRx, 2022, https://professionals.optumrx.com/content/dam/ optum3/professional-optumrx/news/rxnews/drug-approvals/ drugapproval_tascensoodt_2022-0104.pdf.

15. IPD Analytics (Citation Coming). 16. “Management of the Multiple Sclerosis Category: An Increasing Focus for Payers.” American Health & Drug Benefits, https://www. ahdbonline.com/web-exclusives/in-the-news/1199-article-1199. 17. “Magellan Rx Management Medical Pharmacy Trend Report, 2020 Eleventh Edition.” Magellan Rx Management, 2020, https://issuu.com/magellanrx/docs/mptr20_050421_ weboptimizedwithlinks?fr=sOGUyMTM2MDc3MDU. 18. Migliara, Gabby. “Payers subject 80% of new RA and MS patients to utilization management restrictions.” PHRMA, 22 July 2020, https:// catalyst.phrma.org/payers-subject-80-of-new-ra-and-ms-patientsto-utilization-management-restrictions. 19. “AAN Position: Availability of Disease Modifying Therapies (DMT) for Treatment of Relapsing Forms of Multiple Sclerosis.” American Academy of Neurology, https://www.aan.com/policy-and-guidelines/ policy/position-statements/availability-of-disease-modifyingtherapies-dmt-for-treatment-of-relapsing-forms-of-multiplesclerosis/.

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Parkinson’s Disease: Treatment and Management Update Properly managing symptoms in this population can decrease emergency department and hospital utilization and can help manage costs. Parkinson’s disease (PD) is a motor system disorder that causes unintended or uncontrollable movements of the body; it is diagnosed in approximately 60,000 U.S. adults each year.1 In the U.S., around 1 million adults are living with PD — a number that is expected to increase to 1.2 million in the next decade.1 The prevalence of PD is greater than the combined number of U.S. individuals with multiple sclerosis, muscular dystrophy, and amyotrophic lateral sclerosis PD a ects men more commonly than women (1 5 times more), and the incidence of PD increases with age.1

Andrea Cole Henry, Pharm.D., MBA, BCPS Specialty, Drug Information Pharmacist Magellan Rx Management

PD has no known cause; however, it may be hereditary in some cases, while a combination of genetics and environmental factors may be the underlying cause in other cases. In individuals with PD, brain cells responsible for producing dopamine are damaged, impacting movement PD is typically defined by four primary symptoms tremor, rigidity or muscle sti ness, dys inesia, and postural instability Additional symptoms associated with PD are di culty swallowing, chewing, or spea ing; emotional changes; urinary problems or constipation; dementia or other cognitive impairments; fatigue; and sleeping problems.2 hile no specific tests are used to diagnose PD, neurologists will use medical history, a review of symptoms, and neurological and physical exams. Lab tests and imaging tests are often utilized as a means to rule out other conditions.2 The severity of PD manifestations can be assessed using di erent scales; one assessment is the Movement Disorder Society-Sponsored nified Par inson s Disease ating Scale (MDS- PD S) which is a comprehensive assessment designed to monitor the burden and extent of PD disease across the longitudinal disease course and provide a clinical end point in therapy trials.3 The MDS-UPDRS assesses activities of daily living, balance, behavior, cognition, communication, coordination, depression, dysarthria, eating, functional mobility, gait, life participation, pain, psychosis, quality of life, sleep, swallowing, and upper extremity function.3

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More than half of PD patients will develop what is known as PD psychosis (PDP) over the course of the disease.2 PDP mostly presents as visual hallucinations, with delusions occurring less commonly. Evidence suggests that factors both intrinsic to the disease and extrinsic to the disease can contribute to the emergence of PDP. Symptoms of PDP have been associated with sleep disturbances, deficits in visual processing attributable to dopamine deficiency, family history of dementia, and the e ects of medications, including those that treat PD.2 While there is a high prevalence of PDP symptoms in patients with PD, this number may be underreported. In a survey of patients with PD, 20% of patients were diagnosed with symptoms of PDP; however, of those undiagnosed, 14 were later identified as having moderate or severe PDP symptoms through chart review.2 Total U.S. costs associated with PD, both direct and indirect, are estimated to be nearly $52 billion per year.1 With the projected number of PD patients at more than 1.6 million by 2037, the total economic burden is projected to surpass 79 billion by the same year These numbers reflect the burden of PD on society, payers, patients, and caregivers.4

Treatment PD is typically treated with medication to manage symptoms, including tremors and movement di culties The most common therapies used to treat PD are levodopa; dopamine agonists, such as pramipexole, apomorphine, and ropinirole; monoamine oxidase-B (MAO-B) inhibitors; and catechol-O-methyltransferase (COMT) inhibitors.5 Amantadine, an antiviral, has been found to reduce symptoms Safinamide, istradefylline, and opicapone have been found to improve symptoms when used as add-on treatments for patients currently taking levodopa/carbidopa and experiencing OFF episodes.5 An OFF episode is a period when a patient’s symptoms increase due to a medication not working well.6 The medication or combination of medications used to treat a patient with PD will vary by the stage and severity of the disease. A comprehensive treatment plan for patients with PD often includes supportive care, such as physiotherapy, to relieve muscle sti ness and oint pain; occupational therapy to identify and resolve areas of di culty in daily living activities; and speech and language therapy Lifestyle modifications, such as diet change, can help improve symptoms.5 In cases where a patient is not responding to treatment, a surgical intervention called deep brain stimulation (DBS) may be appropriate.5 In DBS, electrodes are implanted into the brain and connected to a pulse generator which painlessly stimulates

PD is typically treated with medication to manage symptoms, including tremors and movement difficulties. the brain, blocking signals that cause motor symptoms of PD. DBS does not stop PD from progressing, but it may be valuable for patients with levodopa-responsive PD who are experiencing disabling OFF symptoms despite therapy.5

PDP Treatment There is currently one drug approved to treat PDP; pimavanserin (NUPLAZID®, Acadia Pharmaceuticals) was approved as the first and only drug indicated for PDP in 2016.7 A clinical trial showed that pimavanserin was more e ective than placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms.7 Real world case studies have demonstrated that pimavanserin can be added to PD therapy without compromising its e cacy and tolerability; in some cases, after e ectively managing PDP symptoms with pimavanserin, providers could increase the dose of dopaminergic drugs for better motor control.8,9 Results from a 2018 study of PDP patients with or without cognitive impairment and receiving or not receiving cognitive-enhancing medications showed that pimavanserin has a robust antipsychotic e ect in PD patients with cognitive impairment, which may be enhanced by concomitant cognitive-enhancing medication use.10 The mean change in PD-adapted Scale for Assessment of Positive Symptoms was larger for the cognitively impaired (6.62 vs. -0.91; p=0.002) versus the cognitively unimpaired (-5.50 vs. -3.23; p=0.046), and the comparable change was greater in patients treated concomitantly with cognitive-enhancing medications (-6.04 vs. 2.18; p=0.012) versus those who were not (-5.66 vs. -3.15; p=0.041).10 A multi-year, open-label study that assessed the long-term safety and tolerability of pimavanserin showed that long-term treatment demonstrated a favorable benefit ris profile without unexpected safety concerns and no increased mortality risk.11 In more recent studies, pimavanserin has been shown to be associated with lower mortality in PD patients than other atypical antipsychotics.12

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PARKINSON’S DISEASE | Continued Pipeline22 Drug

Manufacturer

Route of Administration

Mechanism of Action

Status

PD apomorphine (SPN-830)

Supernus Pharmaceuticals; US WorldMeds

dopamine receptor agonist

pending (October 2022)

carbidopa/levodopa (IPX203)

Impax Laboratories; Amneal Pharmaceuticals

oral

aromatic amino acid decarboxylation inhibitor

phase three

foslevodopa/foscarbidopa (ABBV-951)

AbbVie

aromatic amino acid decarboxylation inhibitor

phase three

pramipexole/rasagiline (P2B001)

Pharma Two B

oral

MAOI

phase three

tavapadon

Cerevel Therapeutics-Pfi er

oral

dopamine receptor agonist

phase three

ampreloxetine (TD-9855)

Theravance Biopharma

oral

SNRI

phase three

e aladcigene resoparvovec (VY-AADC)

Voyager Therapeutics

other

gene therapy

phase two

pimavanserin tartrate (NUPLAZID®)

Acadia Pharmaceuticals

oral

atypical antipsychotic

phase three

blarcamesine (ANAVEX2-73)

Anavex Life Sciences

oral

sigma-1 receptor agonist

phase two

dipraglurant (ADX-48621)

Addex Therapeutics; Janssen

oral

metabotropic glutamate receptor

phase three

safinamide ( ADA O®)

Newron Pharmaceuticals-Zambon Pharma

oral

MOA-B inhibitor

phase three

ketamine (PT-001)

PharmaTher

NMDA receptor antagonist

phase two

102)

Theranexus

oral

voltage-gated sodium channel inactivator; CNS stimulant

phase two

carbidopa/levodopa (ND0612)

NeuroDerm

aromatic amino acid decarboxylation inhibitor; dopamine receptor agonist

phase three

e aladcigene resoparvovec (VY-AADC)

Voyager Therapeutics

other

gene therapy

phase two

PD Dementia

PD Dyskinesia

PD Excessive Daytime Sleepiness flecainide modafinil (T PD Motor Deficit

Abbreviations C S central nervous system; serotonin-norepinephrine reuptake inhibitor

intravenous; MAO

monoamine o idase inhibitor; MOA-B

The Movement Disorder Society (MDS) published an update on treatments for non-motor symptoms of PD and concluded that pimavanserin is the only FDA-approved intervention to treat PDP that is e cacious, has acceptable safety ris without speciali ed monitoring, and is clinically useful 13 MDS included the following findings for the other PDP interventions clo apine is e cacious and clinically useful and has acceptable safety ris with speciali ed monitoring; quetiapine has insu cient e cacy evidence, is possibly clinically useful, and has acceptable safety ris ; and olan apine is not e cacious, has unacceptable safety ris , and is not clinically useful 13 According to the American eriatrics Society Beers Criteria® pdate pert Panel from 2019, all antipsychotics are potentially inappropriate for use in patients with PD, with the e ception of pimavanserin, clo apine, and quetiapine, as dopaminereceptor antagonists have the potential to worsen PD symptoms 14 Pimavanserin is currently being investigated for the treatment of dementia-related psychosis, including that associated with PD A

monoamine o idase B; MDA

-methyl-D aspartic acid; SC

subcutaneous; S

post-hoc subgroup analysis was conducted from the A MO Y trial, which assessed pimavanserin in the treatment of hallucinations and delusions associated with dementia-related psychosis 15 The post-hoc subgroup analysis studied patients with dementia and psychosis associated with PD in the A MO Y trial, and findings showed that symptoms of psychosis were reduced during the openlabel treatment and e cacy was maintained 15 owever, A MO Y was not designed to demonstrate the e ects by dementia subgroup and results should be interpreted cautiously 15

Recent Approvals for PD GOCOVRI® (amantadine extended release)16 n ebruary 2021, the DA approved OCO ® (amantadine e tended release ( ), Adamas Pharmaceuticals, nc ) for a second indication as an adjunctive treatment to levodopa/carbidopa in patients with PD e periencing O episodes The drug was

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previously approved by the FDA in 2017 for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The approval was based on results from two pivotal randomized, double-blind, placebo-controlled phase three studies that showed treatment with amantadine significantly reduced both O time and dys inesia A clinically meaningful increase in good O time was observed in patients taking a levodopa-based medication for PD cacy was sustained for at least two years in the phase three, open-label EASE LID-2 study. Adverse reactions observed in patients taking amantadine ER included hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.

KYNMOBI® (apomorphine hydrochloride sublingual) The DA approved KY MOB ® (apomorphine hydrochloride sublingual film, Sunovion Pharmaceuticals) in May 2020 for the acute, intermittent treatment of O episodes in patients with PD 17 The approval was based on a randomized, double-blind, placebocontrolled, parallel-group trial of 109 patients who had at least two hours of total O periods per day, including well-defined morning O episodes, despite being responsive to levodopa treatment 17 Patients were initially given increasing doses of apomorphine hydrochloride until an optimal dose was identified in an initial open-label phase. Patients were then randomly assigned to either apomorphine hydrochloride or the placebo, and treatment was administered for up to five O episodes throughout the day for 12 weeks. The primary outcome was the mean change from pre-dose to 30 minutes post-dose in the MDS- PD S Part in the maintenance phase at the 12-week visit. Patients using apomorphine hydrochloride experienced an 11.1-point reduction in their MDS- PD S scores at wee 12, compared to a 3 5-point reduction for the placebo group with a least-squared mean treatment di erence of -7 (95 C , -11 5 to -3 7; p 0 0002) 17, 18 Clinical improvements were observed as early as 15 minutes after dosing and persisted for up to 90 minutes Of the patients treated with apomorphine hydrochloride, 31 achieved full control of their motor symptoms within 30 minutes at wee 12, compared to 14 of the placebo group.17, 18 Treatment-related side e ects included nausea, sleepiness, and dizziness.17, 18

ONGENTYS® (opicapone)19 n April 2020, the DA approved O TYS® (opicapone, eurocrine Biosciences), a COMT inhibitor, for PD patients e periencing O episodes while on a levodopa carbidopa regimen Opicapone is administered as either 25 mg or 50 mg capsules once a day as ad unctive therapy to levodopa carbidopa t was shown to significantly reduce O periods

Properly managing symptoms in this population can lead to a decrease in ED and hospital utilization and can help manage costs. and e tended the periods of O -time without dys inesia, compared to the placebo in two randomized, double-blind, parallel-group, placebo- and active-controlled or placebocontrolled phase three trials. The approval was based on 38 clinical trials that included more than 1,000 PD patients treated with opicapone. Patients diagnosed at least three years ago, who had been e periencing fluctuations in motor symptoms O time at least 1 5 hours daily while awa e despite being on a stable levodopa carbidopa regimen, were included The B PA K-1 study included 00 patients who were randomly assigned to receive a 5 mg, 25 mg, or 50 mg opicapone dose; entacapone; or placebo Treatment was administered over 14 to 15 wee s while patients were on a continuous levodopa carbidopa regimen. The primary outcome was the mean change from baseline in absolute o -time documented in patient diaries recorded around the cloc (-1 95 vs -0 93 for opicapone and placebo, respectively); the mean di erence was -1 01 (95 C , -1 2 to -0 407; p 0 002) esults from B PA K-1 showed that both 50 mg opicapone and entacapone significantly decreased the duration of daily O periods and increased O time without dys inesia, compared to the placebo Opicapone also led to favorable ratings in both the P -C and C -C scales, unli e entacapone n the B PA K-2 study, 427 patients were randomly assigned either a 25 mg or a 50 mg dose of opicapone or a placebo for 14 to 15 wee s The primary outcome was also mean change from baseline in absolute O -time Patients on opicapone 50 mg dose compared to placebo showed an absolute O -time -1 98 vs -1 07, respectively, with a di erence of -0 9 (C , -1 523 to -0 287; p 0 008) An open-label e tension of both studies showed promising results; the 25 mg dose continued to show reductions in O time and increases in O periods over 12 months of treatment, regardless of whether the patient received opicapone or the placebo in the initial part of the main trials. Common adverse reactions associated with the opicapone treatment included dyskinesia, constipation, an increase in blood creatine kinase, low blood pressure, and weight loss.

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PARKINSON’S DISEASE | Continued

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is here. Gene Therapy According to the American Society of Gene and Cell Therapy, there are 25 ongoing trials for gene therapies treating PD listed in the clinical trials database with the U.S. National Library of Medicine.20 Some phase one clinical trials have shown promising results. In a phase one trial from Genzyme and Voyager Therapeutics, the gene encoding for aromatic amino acid decarboxylase was delivered to the putamen in the brains of patients with PD, and outcomes demonstrated modest improvement in patients who received the therapy.20 While still very much in early development, there is promise on the horizon for innovative treatment approaches for PD in the coming years.21

Managed Care Implications Payer management in this category is key to improving outcomes. Hospitalizations and emergency department (ED) use are substantial among patients with PD — there were more than 272,000 hospitalizations and 416,000 ED visits in 2014.23 Properly managing symptoms in this population can lead to a decrease in

ED and hospital utilization and can help manage costs. Medicare bears the largest share of cost associated with PD; however, employers are negatively impacted by the loss of productivity and absenteeism from patients with PD as well as those who care for them.23 There is a need in the PD space for integration of the evidencebased management from well-controlled studies and the real-world individual treatment. Currently, the evidence from randomized controlled studies has only informed 11.5% of guideline recommendations for PD management.24 It can be challenging to translate the available evidence from studies into clinical care practice as well as payer management, as patients seen in real-world practice often di er in clinical presentation, comorbidities, and age from the carefully selected trial participants.24 Individualized and custom management for patients with PD is key to improved outcomes. As research in precision medicine expands, the ability to tailor the approach to treatment based on individual patient profiles will li ely be enhanced n the meantime, treatment teams are tasked with adjusting evidence-based medicine to determine an e ective treatment plan for each patient

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References 1.

“Statistics.” Parkinson’s Foundation, https://www.parkinson.org/ Understanding-Parkinsons/Statistics.

Hermanowicz, Neal, et al. “Parkinson’s Disease Psychosis: Symptoms, Management, and Economic Burden.” American Journal of Managed Care, 17 Aug. 2015, https://www.ajmc.com/view/a582_aug15_ parkinsons_s199.

Movement Disorder Society-Sponsored nified Par inson s Disease Rating Scale Revision.” Shirley Ryan Ability Lab, https://www.sralab. org/rehabilitation-measures/movement-disorder-society-sponsoredunified-par insons-disease-rating-scale Yang, Wenya, et al. “Current and projected future economic burden of Parkinson’s disease in the U.S.” nature, 9 July 2020, https://www. nature.com/articles/s41531-020-0117-1.

“Parkinson’s Disease Information Page.” National Institute of Neurological Disorders and Stroke, https://www.ninds.nih.gov/Disorders/AllDisorders/Parkinsons-Disease-Information-Page#disorders-r1.

DA approves new add-on drug to treat o episodes in adults with Parkinson’s disease.” U.S. Food & Drug Administration, 27 Aug. 2019, https://www.fda.gov/news-events/press-announcements/fdaapproves-new-add-drug-treat-episodes-adults-parkinsons-disease.

“Adamas Announces FDA Approval for Second Indication for GOCOVRI® as an Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes.” Business Wire, 1 Feb. 2021, https://www.businesswire.com/news/home/20210201005801/ en/Adamas-Announces-FDA-Approval-for-Second-Indication-forGOCOVRI%C2%AE-as-an-Adjunctive-Treatment-to levodopacarbidopain-Parkinson%E2%80%99s-Disease-Patients-Experiencing-OFF-Episodes.

DA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease.” U.S. Food & Drug Administration, 29 Apr 2016, https://www.fda.gov/news-events/pressannouncements fda-approves-first-drug-treat-hallucinationsand-delusions-associated-parkinsons-disease#:~:text=The%20 U.S.%20Food%20and%20Drug,some%20people%20with%20 Parkinson’s%20disease.

Dashtipour Khashayar, et al. “Pimavanserin Treatment for Parkinson’s Disease Psychosis in Clinical Practice.” Hindawi, 4 Jan 2021, https:// www.hindawi.com/journals/pd/2021/2603641/

10. Espay, Alberto, et al. “Pimavanserin for Parkinson’s Disease Psychosis: ects Stratified by Baseline Cognition and se of CognitiveEnhancing Medications.” Movement Disorders, 2 Nov. 2018, https:// pubmed.ncbi.nlm.nih.gov/30387904/. 11. Ballard, Clive, et al. “Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson’s disease psychosis.” Parkinsonism and Related Disorders, 28 June 2020, https://pubmed.ncbi.nlm.nih. gov/32712560/. 12. Mosholder, A., et al. “All-cause mortality in pimavanserin and atypical antipsychotic users with Parkinson’s disease in Medicare.” Movement Disorders, 2020, https://www.mdsabstracts. org/abstract/all-causemortality-in-pimavanserin-and-atypical-antipsychotic-users-withparkinsons-disease-in-medicare/#:~:text=Pimavanserin%20use%20 was%20associated%20with,%2D1.01)%20dementia%20were%20 similar.

13. Seppi, Klaus, et al. “Update on Treatments for Nonmotor Symptoms of Parkinson’s Disease — An Evidence-Based Medicine Review.” Movement Disorders, 2019, https://www.movementdisorders.org/MDSFiles1/Resources/PDFs/Seppi_et_al-2019-Movement_Disorders.pdf. 14. “American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults.” Journal of the American Geriatrics Society, 29 Jan. 2019, https://pubmed.ncbi.nlm. nih.gov/30693946/. 15. Weintraub, Daniel, et al. “Pimavanserin Treatment of Hallucinations and Delusions in Patients with Parkinson’s Disease Dementia: Post Hoc Analysis of the HARMONY Trial.” Clinical Trials on Alzheimer’s Disease Annual Conference, 12 Nov. 2021. 16. “Adamas Announces FDA Approval for Second Indication for GOCOVRI® as an Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes.” Business Wire, 1 Feb. 2021, https://www.businesswire.com/news/home/20210201005801/ en/Adamas-Announces-FDA-Approval-for-Second-Indicationfor-GOCOVRI%C2%AE-as-an-Adjunctive-Treatment-tolevodopacarbidopa-in-Parkinson%E2%80%99s-Disease-PatientsExperiencing-OFF-Episodes. 17. “Sunovion announces U.S. FDA approval of KYNMOBI™ (apomorphine hydrochloride) sublingual film for the treatment of Par inson s disease o episodes Sunovion, 21 May 2020, https://news.sunovion.com/ press-releases/press-releases-details/2020/Sunovion-Announces-USFDA-Approval-of-KYNMOBI-apomorphine-hydrochloride-SublingualFilm-for-the-Treatment-of-Parkinsons-Disease-OFF-Episodes/default. aspx. 18. Martins, n s DA Approves Kynmobi Sublingual ilm to Treat O Episodes in Parkinson’s.” Parkinson’s News Today, 22 May 2020, https://parkinsonsnewstoday.com/2020/05/22/fda-approvesynmobi-sublingual-film-treat-o -episodes-par inson 19. Martins, Inês. “FDA Approves Ongentys as Levodopa Add-on for O Periods Parkinson’s News Today, 27 Apr. 2020, https:// parkinsonsnewstoday.com/2020/04/27/fda-approves-ongentys-addon-therapy-par insons-o -periods-with-levodopa 20. Mulholland, Eoghan. “Parkinson’s Disease: Is Gene Therapy the Answer We Have Been Looking For?” American Society of Gene + Cell Therapy, 13 Apr. 2020, https://asgct.org/research/news/april-2020/parkinsonsdisease-awareness-month. 21. Blits, Bas, et al. “Perspective on the Road toward Gene Therapy for Parkinson’s Disease.” frontiers in Neuroanatomy, 9 Jan. 2017, https:// www.frontiersin.org/articles/10.3389/fnana.2016.00128/full#note1. 22. “Parkinson’s Disease.” IPD Analytics. https://ipdanalytics.com. 23. Ostrovsky, Lilly. “Payers’ Perspective: Incorporating Real-World Evidence in Patient Care.” American Health & Drug Benefits, April 2017, https://www.ahdbonline.com/issues/2017/april-2017-vol-10-no2/2351-payers-perspective-incorporating-real-world-evidence-inpatient-care. 24. Klucken, Jochen, et al. “Management of Parkinson’s Disease 20 Years from Now: Towards Digital Health Pathways.” Journal of Parkinson’s Disease, 18 Dec. 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC6311358/.

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Biosimilars: Updates and Pharmacy Management Impact Biosimilar products covered on the pharmacy benefit will give payers more control as well as the option to drive use of lower-cost options

The biosimilar landscape continues to expand, changing the market across several disease and therapeutic categories There have been 33 biosimilars approved by the S ood and Drug Administration ( DA) and an e pansive pipeline across several indications 1 our new biosimilars were approved in 2021 alone (Table 1) 1 Loo ing forward, 25 biosimilars are e pected to launch in the ne t five years 2 Biosimilars have changed treatment and management across several disease categories Biosimilar competition has been playing a role in containing drug costs; among biologics, most list prices have not increased since the biosimilar launch, and for many, list prices have declined since 2018 3 Erin Ventura, Pharm.D. Manager, Specialty Clinical Programs Magellan Rx Management

ith biosimilars coming to the mar et that will ultimately be covered under the pharmacy benefit, this presents both opportunity and challenges for payers Biosimilar products covered on the pharmacy benefit will give payers more control as well as the option to drive use of lower-cost options 2 Pharmacy benefit managers (PBMs) have strategi ed in innovative ways to manage biosimilars One PBM has used formulary placement preferring biosimilars or reference biologics to drive lowest net costs, while others have implemented drug management strategy programs around the adoption of biosimilars 3 Other PBMs have directly communicated with patients to incentivi e switching to biosimilars when appropriate and coste ective 3 hile biosimilars are not the lowest net cost option in every scenario, interchangeable alternatives and competition create a landscape where costs can be better managed

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Table 1. Recent Biosimilar Approvals1 Drug

Manufacturer

Route of Administration

Mechanism of Action

Indications

YUSIMRY (adalimumab-aqvh)

Coherus BioSciences

TNF blocker

RA; JIA; PsA; AS; CD; UC; PSO

Rezvoglar (insulin glargine-aglr)

Eli Lilly and Company

insulin/insulin analog

control in type 1/type 2 diabetes

BYOOVIZ (ranibizumab-nuna)

Samsung Bioepis

intravitreal

VEGF inhibitor

wAMD

SEMGLEE® (insulin glargine-yfgn)

Mylan

insulin/insulin analog

improve glycemic control in type 1/type 2 diabetes

Abbreviations: AS = ankylosing spondylitis; CD = Crohn’s disease; JIA = juvenile idiopathic arthritis; PsA = psoriatic arthritis; PSO = psoriasis; RA = rheumatoid arthritis; SC = subcutaneaous; TNF = tumor necrosis factor; UC = ulcerative colitis; VEGF = vascular endothelial growth factor; wAMD = wet age-related macular degeneration

A recent survey shows a majority of payers agree that biosimilars provide meaningful cost savings (59% completely agree; 35% somewhat agree), with 94% of payers responding that lower price is a primary influencing factor for designating a preferred product.4 Payers also noted contracting arrangement, therapeutic area, number of indications, physician demand, and length of time on the mar et as secondary influencing factors 4 As the availability of biosimilars has expanded, providers have become more comfortable using these therapies. However, continued provider education alongside patient education will impact uptake, as patient preference may play a role in adoption of many options in the market.

Recent Activity The first M A® biosimilars are expected to launch by 2023, and each has the potential to significantly impact pharmacy spend With high list prices on branded adalimumab, interchangeable biosimilars present a unique opportunity to incentivize payers to adopt lower-cost alternatives and e ectively manage spend 5 A potential eight adalimumab biosimilars are slated to launch in 2023, which may lead discounting and pricing competition.5

According to the U.S. Physicians and Payers Forum report, providers are willing to prescribe biosimilar adalimumab as an alternative to branded adalimumab, and depending on payer strategies around the biosimilars, biosimilar adalimumab may be used as an alternative to etanercept (Enbrel®) when appropriate as well.6 The launch of adalimumab biosimilars will change the market, raising questions around how pricing strategies, discounts, and sequence of launches will impact stakeholders.7 The approval of the first insulin biosimilars in 2021 (S M L ® and Rezvoglar) presents an opportunity for lower-cost treatment options for all stakeholders. Notably, two identical versions of the insulin glargine-yfgn (SEMGLEE®) will launch, including the branded interchangeable product and an authorized interchangeable biosimilar.7 Both of these versions are fully interchangeable with di erent wholesale acquisition cost ( AC) list prices 7 SEMGLEE® was initially launched as a non-interchangeable product, and the WAC was a 65% discount to the reference product, Lantus®.7 Now designated as interchangeable, SEMGLEE® will be relaunched at a WAC amounting to a 5% discount from Lantus®, with the unbranded interchangeable biosimilar at a 65% discount.7 Approximately 8 million Americans use daily insulin injections, and three manufacturers account for more than 95% of the insulin supply.8 These interchangeable biosimilars will impact

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BIOSIMILARS | Continued Table 2. Biosimilar Pipeline Drug

Manufacturer

Route of Administration

Mechanism of Action

Status

Indications

TNF Biosimilars -071 (infli imab biosimilar)

Nichi-Iko-Sagent Pharmaceuticals

in ectable

TNF

phase three

Remsima SC (infli imab biosimilar)

Celltrion Healthcare

TNF

phase three

CD; UC

SB5 C (adalimumab biosimilar)

Samsung BioepisOrganon

in ectable

TNF

pending (August 2022)

RA; JIA

O S-3010 (adalimumab biosimilar)

Ligand Pharmaceuticals

TNF

phase three

plaque psoriasis

MS 11022 (adalimumab biosimilar)

Fresenius Medical Care

TNF

phase three

plaque psoriasis; RA

A T02 (adalimumab biosimilar)

Alvotech-Teva Pharmaceuticals

TNF

pending

plaque psoriasis

ABP 501 C (adalimumab biosimilar)

Amgen

TNF

phase three

plaque psoriasis

YuflymaTM (adalimumab biosimilar)

Celltrion Healthcare

TNF

pending

BAT250 (golimumab biosimilar)

Bio-Thera Solutions

TNF

phase three

PsA

TBD

TNF

pre-clinical

plaque psoriasis; RA

XcimzaneTM (certoli umab pegol biosimilar)

brane Biopharma

P 88 (certoli umab pegol biosimilar)

Pfenex

TNF

developing

AS; CD

YLB113 (etanercept biosimilar)

Lupin

TNF

phase three

12014 (trastu umab biosimilar)

EirGenix-Sandoz

anti-

pending ( 4 2022)

2 breast cancer; gastric cancer

Bmab-100 (bevaci umab biosimilar)

Biocon-Mylan

inhibitor

pending

cervical cancer; glioblastoma multiforme

KB238 (bevaci umab biosimilar)

Centus BiotherapeuticsAstraZeneca

inhibitor

pending

NSCLC

mAb ience-Amneal Pharmaceuticals

inhibitor

pending ( 2 2022)

colorectal cancer

SB8 (bevaci umab biosimilar)

Samsung BioepisOrganon

inhibitor

pending

NSCLC

BAT170 (bevaci umab biosimilar)

Bio-Thera Solutions; Sandoz

inhibitor

pending

NSCLC; glioblastoma multiforme

pending

cancer patients receiving bone marrow or myelosuppression

pending

AML patients receiving induction or consolidation chemotherapy

Oncology Biosimilars

92 (bevaci umab)

2 antibody

CSF Biosimilars

rastofil (filgrastim biosimilar)

ilgrastim Kashiv (filgrastim biosimilar)

APOTEX; Accord Healthcare

Adello Biologics

IV; SC

CSF

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Table 2. Biosimilar Pipeline Drug

Manufacturer

Route of Administration

Mechanism of Action

Status

Indications

T 01 (filgrastim biosimilar)

Tanve BioPharma

in ectable

CSF

pending

severe chronic neutropenia

Lupifil (filgrastim biosimilar)

Lupin

CSF

phase one

severe chronic neutropenia

Biocon; Celgene

IV; SC

CSF

developing

patients undergoing peripheral blood progenitor cell collection and therapy

MSB11455 (pegfilgrastim biosimilar)

resenius Medical Care; Dr eddy s Laboratories

CSF

pending

cancer patients receiving myelosuppressive chemotherapy

TP -120 (pegfilgrastim biosimilar)

Adello Biologics; Amneal Pharmaceuticals

CSF

pending

cancer patients receiving myelosuppressive chemotherapy

Lupifil-P (pegfilgrastim biosimilar)

Lupin

CSF

pending (April 2022)

cancer patients receiving myelosuppressive chemotherapy

Lapelga (pegfilgrastim biosimilar)

APOT ; Accord ealthcare

CSF

pending

cancer patients receiving myelosuppressive chemotherapy

P 529 (pegfilgrastim biosimilar)

Pfenex

CSF

developing

cancer patients receiving myelosuppressive chemotherapy

y neuta (efbemalenograstim biosimilar)

eneron (Shanghai) Corporation

CSF

pending (03 30 2022)

cancer patients receiving myelosuppressive chemotherapy

Basalin (insulin glargine biosimilar)

Gan & Lee PharmaceuticalsSando

insulin insulin analog

phase three