Insight | Premier Continuum of Care | June 2020

Premier Continuum of Care | June 2020

Coronavirus Disease 2019 (C VID-19): What We Know

PLUS • Introducing the Premier Continuum of Care Biosimilars Program • Category Spotlight: COVID-19 Recovery Portfolio Premier Continuum of Care | June 2020 1

EDITORIAL STAFF EDITOR IN CHIEF

Gary Feit, MS Vice President, Corporate Communications

CLINICAL EDITOR

Liya Davydov, PharmD, BCPS, BCGP Vice President, Clinical Pharmacy Services

MANAGING EDITOR

Eric Rodriguez Director, Corporate Communications

DESIGNER

Jaclyn Alvarado Creative Director, J2 Design NYC

COPY EDITOR Tina Harlan

PROOFREADER Laura F. Yandell

Table of Contents

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Insight | June 2020

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Coronavirus Disease 2019 (COVID-19): What We Know

Introducing the Premier Continuum of Care Biosimilars Program

Category Spotlight: COVID-19 Recovery Portfolio

555 West 57th St., 12th Floor New York, NY 10019 phone 888.258.3273 fax 646.638.2641 premierinc.com/alternatesites

Insight magazine is published by Premier and is complimentary for Premier members.

For membership information, please call 888.258.3273. To submit ideas for editorial consideration, please contact Eric Rodriguez at 212.901.1242 or eric_rodriguez@premierinc.com.

This publication is intended to provide general information on issues of interest to the members of Premier Healthcare Alliance, L.P., and its affiliates (collectively, “Premier�) and the general public. It does not constitute, nor should it be used as a substitute for any business, legal, or regulatory advice. Premier hereby disclaims all warranties, express or implied, as to the accuracy of any of the information contained herein, whether such information is up-to-date, or its fitness for any particular use or purpose. Nothing contained in it is intended as a treatment recommendation for any particular patient or group of patients. Treating institutions and/ or physicians must make all clinical decisions regarding the use of pharmaceuticals and other products on a case-by-case basis. You should always refer to federal, state, and local laws, rules, and regulations governing the operation of your organization and should consult your own legal counsel. The opinions expressed by the authors of articles included in this issue do not necessarily reflect those of Premier, its affiliates, or its representatives. Furthermore, some of the content contained herein may have been originally prepared by or funded by organizations with financial interests in products or services related to the topics discussed in such article. While every effort was made to ensure the accuracy of information conveyed in this magazine, Premier, its affiliates, and its representatives do not accept responsibility and cannot be held liable for any errors that may exist within the publication. Premier is not responsible for the contents of any Web pages that are referenced by this communication.

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Coronavirus Disease 2019 (C VID-19): What We Know Liya Davydov, PharmD, BCPS, BCGP Vice President, Clinical Pharmacy Services, Premier Alternate Site Programs

[Current as of April 6, 2020]

Premier Continuum of Care | June 2020

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Origin and date first recorded The new coronavirus disease of 2019, abbreviated as COVID-19, was first identified in China, and the World Health Organization (WHO) was notified of the outbreak in late December 2019.1,2 Since that time, the virus has spread globally.1,2 The disease was categorized as a worldwide pandemic by the WHO on March 11, 2020 – the first pandemic caused specifically by a coronavirus.3 As of the first week of April 2020 more than 150 countries/regions have reported confirmed COVID-19 cases.4

Risk factors for severe symptoms or fatal outcomes While there is much to learn about this disease, some patterns have emerged. For instance, certain groups appear to be more affected by the disease and have more severe outcomes, including fatalities. Those at higher risk include people who are older (age 60 and above), long-term care facility residents, or anyone who has underlying conditions (including uncontrolled diabetes, hypertension, obesity with body mass index of at least 40 or higher, chronic lung disease [including moderate/severe asthma], heart disease, kidney failure, liver disease or compromised immunity [due to chemotherapy, smoking, immune deficiencies, etc.]). These populations tend to be more affected by the disease and have more severe outcomes, including fatalities.5,6

Signs and symptoms While this is a novel disease, and not all manifestations are well known yet, there are a number of signs and symptoms that have been identified to date. The apparent hallmark signs/ symptoms include cough, fever and shortness of breath, and if they do develop, it usually takes place within 2-14 days after contact with an infected individual (with a tendency for symptom development around day five).7,8 The disease can present with mild symptoms or may progress to severe sickness culminating in death.7 Some of the severe symptoms, which require urgent 2

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attention, include difficulty breathing/ drawing breath, persistent pain/pressure in the chest region, lips/face turning bluish color and inability to wake up or newly-developed confusion. It’s very important to understand that as more is discovered about the disease, additional signs/symptoms of the disease may become apparent, and as such, the above list of the manifestations is not all-inclusive.7 Once patients get sick, mild disease can linger for about 2 weeks, while severe/critical disease can take up to 6 weeks to clear.9 It is not yet known if it’s possible to be re-infected with COVID-19 after recovering from an original infection with COVID-19, or if a re-infected patient can develop symptoms more than once.10 There are some reports from China, however, indicating that those who tested negative after originally testing positive (meaning they have recovered), are now testing positive again. It is unclear if those patients were asymptomatic carriers or if they were developing a second round of disease. Testing errors are also a possibility.11 Patients who had COVID-19 symptoms and were in self-isolation, if they are not being tested to see if their tests are now negative, are allowed to leave isolation after at least 72 hours have passed since the last fever, and the patient has been afebrile for the past 72 hours without using any anti-pyretic medications. Additionally, at least seven days should have passed since the onset of symptoms.12 New research indicates, however, that in some patients, the virus can still be detected for as long as eight days after the disease clears.13

Prevention Practicing social distancing from others, not touching your hands to your mouth/eyes/nose/face, washing your hands frequently with soap and water for at least 20 seconds (or using alcohol-based sanitizer which should contain at least 60 percent alcohol) are all recommended preventative measures.14 Sneezes or coughs should be contained with a tissue, which should then be expediently disposed of into the trash.14 Additional protection measures, such as the use of masks and gloves, apply in circumstances when a person is already sick with COVID-19,

and should be worn by either the patient (if it’s feasible, because it may exacerbate difficult breathing patients may already experience) or by the caregivers, when the patient is not able to.14,15 Moreover, to protect themselves and others, it is advisable by the Centers for Disease Control and Prevention (CDC) that a covering be placed over nose/mouth when people go to public places (it doesn’t have to be an actual surgical mask, as those are to be reserved for healthcare providers, but something like a scarf, a home-made cloth mask, or a bandana would be advisable, though those coverings have their own associated downfalls).15,16 Patient items such as utensils, toiletries, bed sheets/pillow cases, etc. should not be shared with other members of the household and should be washed (sanitized) separately.15 Furthermore, surfaces that are touched often, and may harbor the virus, should be disinfected every day with an appropriate disinfectant (e.g., bleach solutions, alcohol solutions [containing 70 percent alcohol or higher]).14

Testing A lack of specific approved treatments and difficulty in preventing disease spread have been worldwide dilemmas.

But the U.S. has faced yet another obstacle – the slow ramp-up of testing.17,18 The tests that were initially available were designed to provide results within several days.18,19 As of April 6, 2020, 28 tests had been approved by the Food and Drug Administration (FDA).20 The approval of Abbott’s ID NOW™ COVID-19 test, on March 27, 2020, was a huge step forward.21 This test is able to show positive COVID-19 results in five minutes, with negative results available in less than 15 minutes, and would be immensely useful on front lines for rapid testing, and in any type of healthcare setting (e.g., urgent care entities, health care practitioners’ offices, etc.).21 The company advised that it will be manufacturing about 50,000 units per day, to meet the demand, beginning the week of March 30, 2020.21 Another breakthrough was the April 1, 2020, approval of a test by Cellex, which identifies COVID-19 antibodies in blood. Test results are available in about 20 minutes from an authorized laboratory.22

These tests were moved forward under an Emergency Use Authorization (EUA), which allows the FDA to issue approvals more quickly during a public health emergency. Approvals of this type are valid only for the duration of the specified emergency.20,23 Still eagerly awaited is the introduction of an at-home test for COVID-19 antibodies that would indicate if an individual has ever had COVID-19. This is under development

by Scanwell Health.24 The company has filed an EUA application with the FDA and expects a decision some time in June 2020.24 If approved, this would allow at-home testing and results within a few hours of a simple finger stick.24

Treatment Treatment is primarily supportive at this time. It varies by severity of symptoms and may include use of ventilators, oxygen, etc. (in more extreme cases).25 While there are as yet no approved pharmacological treatments or vaccines specifically for COVID-19, several existing drugs as well as newly developed medications and novel vaccines are undergoing extensive testing.25-28 Table 1 describes drugs that are currently undergoing investigational studies or have already had studies conducted.25-28 Earlier, a small study highlighted the combined use of hydroxychloroquine with azithromycin, which resulted in previously positive patients testing negative for COVID-19 by day five of treatment.29 Recently, the FDA granted (under emergency authorization) healthcare providers permission to use certain antimalarial drugs (i.e., hydroxychloroquine and chloroquine) to treat hospitalized patients with COVID-19.30-32 As per FDA’s EUA for hydroxychloroquine, the suggested dosing regimen in qualifying hospitalized patients who weigh at least 50 kg (110 lbs.) is 800 mg the first day (loading dose), followed by 400 mg/day for four to seven days of total treatment duration.31 The American Society of Health-System Pharmacists (ASHP) has released an evidence-based chart of all current potential treatments under investigation for COVID-19, with applicable proposed dosing regimens.28

Table 1.* Promising treatment modalities under consideration.25,26,28,29,31,32,41-65 Antiviral Drugs

Antimalarial Drugs

Disease-modifying Anti-rheumatic Drugs

Miscellaneous Drugs

Favipiravir (Avigan®, Favilavir)

Chloroquine phosphate

Anakinra

Ascorbic acid

Remdesivir

Hydroxychloroquine sulfate (Plaquenil®)

Sarilumab (Kefzara®)

Azithromycin

Tocilizumab (Actemra®)

Lopinavir-ritonavir (Kaletra®)**

Umifenovir (Arbidol®)

Methylprednisolone (DEPOMedrol®, SOLUMedrol®) Nitric Oxide gas inhalation Sirolimus *Only select treatment modalities with an anticipated potential for treating COVID-19 are listed in the table. **A recent study did not show benefit in severely ill hospitalized patients with COVID-19,41 but another study is currently ongoing to find out if the drug may be useful in patients with milder symptoms.42

This resource is available at www.ashp.org/-/media/assets/pharmacy-practice/ resource-centers/Coronavirus/docs/ASHP-COVID-19-Evidence-Table. ashx?la=en&hash=B414CC64FD64E1AE8CA47AD753BA744EDF4FFB8C.28 The chart also lists drugs that would be best avoided in patients who have tested positive for COVID-19.28 Specifically, there is a theory, which is not confirmed, that use of non-steroidal anti-inflammatory agents (NSAIDs) such as ibuprofen, naproxen, etc. should be avoided in patients with COVID-19, as they worsen the course of the disease.26, 28, 33 The FDA issued an advisory regarding the use of NSAIDs in COVID-19, indicating that patients taking these drugs for reasons other than COVID-19 should continue them.26,34 Further, some have theorized that, given the pathway that the virus uses to replicate, use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensinreceptor blockers (ARBs) may need to be discontinued.26,28,35 However, the American Heart Association (AHA), American College of Cardiology (ACC), the Heart Failure Society of America (HFSA), and the European Society of Cardiology (ESC) continue to recommend that ACEIs and ARBs continue to be taken as prescribed and not discontinued arbitrarily. Stopping these drugs abruptly in select patient populations could lead to negative health outcomes.36-38 In addition to the investigational treatments for the disease, there are over 35 unique vaccines in various stages of development.27 The very first vaccine trial (Moderna mRNA vaccine), funded by the National Institutes of Health, began on March 16, 2020.39 In the absence of an approved vaccine for COVID-19, however, convalescent sera is being investigated as a potential modality to provide passive antibody therapy either to prevent people from getting sick with COVID-19, or even to patients who are experiencing early COVID-19 symptoms.26,40 Premier Continuum of Care | June 2020

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Summary and additional information COVID-19 is an unfolding pandemic, with seemingly daily discoveries about the disease. Multiple treatment regimens are under consideration, without a single FDA-approved modality specifically for COVID-19. Newly approved rapid tests should enhance testing efficiency, help streamline treatment, and slow the spread of the virus.

For additional up-to-date information on COVID-19, please visit the CDC page dedicated to coronavirus at www.cdc.gov/coronavirus/2019-ncov/index.html.

For a snapshot of all medications under consideration as investigational agents, current thoughts on their effectiveness, and an explanation of drugs that should potentially be avoided in patients with COVID-19, please refer to this resource developed by ASHP: www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHPCOVID-19-Evidence-Table.ashx?la=en&hash=B414CC64FD64E1AE8CA47AD753BA744EDF4FFB8C. For current information on vaccine research for COVID-19, please refer to the vaccine tracker at www.raps.org/newsand-articles/news-articles/2020/3/covid-19-vaccine-tracker.

For updated information on testing for COVID-19, visit the FDA’s page, which lists all currently approved diagnostic tests for this disease under EUA: www.fda.gov/medical-devices/emergency-situations-medical-devices/emergencyuse-authorizations#covid19ivd.

For additional resources and to learn more about Premier’s COVID-19 response, visit www.premierinc.com/covid-19-response.

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2. Centers for Disease Control and Prevention, “Coronavirus Disease 2019 (COVID-19): CDC’s Response: Situation Summary,” accessed March 28, 2020. https://www.cdc.gov/ coronavirus/2019-ncov/cases-updates/summary.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fsummary.html.

3. World Health Organization, “WHO Director-General’s opening remarks at the media briefing on COVID-19,” March 11, 2020. https://www.who.int/dg/speeches/detail/ who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.

4. Centers for Disease Control and Prevention, “Coronavirus Disease 2019 (COVID-19): Cases, Data, & Surveillance: World Map,” accessed March 28, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/world-map.html.

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16. Hilary Brueck, “The CDC is recommending that people wear face coverings or cloth masks if they go out in public,” Business Insider (April 3, 2020). https://www.businessinsider.com/cdc-recommending-cloth-masks-face-coverings-in-public-spaces-2020-4?utm_source=notification&utm_medium=referral.

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19. Vanessa Romo, “FDA Approves First Rapid COVID-19 Test.” Coronavirus Live Updates. National Public Radio, March 21, 2020. https://www.npr.org/sections/coronaviruslive-updates/2020/03/21/819629909/fda-approves-first-rapid-covid-19-test?utm_campaign=ida-coronavirus-hay-20200323&cpn=&hmSubId=f8MLi4XMrVs1&hmEmail=M G3dX_GdJR1ji7kYsL_-UPHOvik4NqL8MhkOjt7-LyE1&NID=&email_hash=0e91898ed3cd51f8ba0b3b6b953bb513.

20. U.S. Food and Drug Administration, “Medical Device Safety: Emergency Situations (Medical Devices): Emergency Use Authorizations: In Vitro Diagnostics EUAs,” accessed April 3, 2020. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.

21. “Abbott launches molecular point-of-care test to detect novel coronavirus in as little as five minutes,” Abbott Laboratories, March 27, 2020. https://abbott.mediaroom. com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes.

22. Nicole Wetsman, “FDA authorizes first antibody-based test for COVID-19,” The Verge (April 2, 2020). https://www.theverge.com/2020/4/2/21204478/fda-authorizationcoronavirus-antibody-test-diagnostic-covid-19.

23. U.S. Food and Drug Administration, “Regulatory Information: Search for FDA Guidance Documents: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” accessed March 28, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirusdisease-2019-during-public-health-emergency.

24. Aliza Nadi, “An at-home fingerprick blood test may help detect your exposure to coronavirus.” NBC News, April 4, 2020. https://www.nbcnews.com/health/health-news/ home-fingerprick-blood-test-may-help-detect-your-exposure-coronavirus-n1176086.

25. Centers for Disease Control and Prevention, “Coronavirus Disease 2019 (COVID-19): Healthcare Professionals: Clinical Care: Information for Clinicians on Investigational Therapeutics for Patients with COVID-19,” accessed March 28, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html.

26. “Some Drugs for COVID-19.” The Medical Letter on Drugs and Therapeutics 1595 (April 6, 2020): 49-51.

27. Jeff Craven, “COVID-19 Vaccine Tracker.” Regulatory Focus, accessed March 28, 2020. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccinetracker?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2026%20March%202020.

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28. American Society of Health-System Pharmacists, “Assessment of Evidence for COVID-19-Related Treatments,” accessed April 5, 2020. https://www.ashp.org/-/media/

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55. National Institutes of Health, U.S. National Library of Medicine, “Ascorbic acid/Vitamin C studies,” accessed April 6, 2020. https://clinicaltrials.gov/ct2/ results?cond=COVID19&term=ascorbic+acid&cntry=&state=&city=&dist=.

56. Dawei Wang et al. “Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China,” Journal of The American Medical Association 323, no. 11 (2020): 1061-1069. DOI: 10.1001/jama.2020.1585.

57. “Sobi to initiate a clinical study to evaluate whether anakinra and emapalumab may relieve complications associated with severe COVID-19 disease,” Swedish Orphan Biovitrum AB (publ) (Sobi™), March 18, 2020. https://www.sobi.com/sites/default/files/pr/202003183346-1.pdf.

58. National Institutes of Health, U.S. National Library of Medicine, “Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection,” March 27, 2020. https://clinicaltrials.gov/ct2/show/study/NCT04324021.

59. Chaomin Wu et al. “Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China,” Journal of The American Medical Association Internal Medicine (March 13, 2020). DOI: 10.1001/jamainternmed.2020.0994.

60. Josh Farkas, COVID-19 Internet Book of Critical Care (EMCrit Project, 2020), https://emcrit.org/ibcc/COVID19/.

61. National Institutes of Health, U.S. National Library of Medicine, “Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 (NoCovid),” March 12, 2020. https://clinicaltrials.gov/ct2/show/NCT04305457?cond=NCT04305457&draw=2&rank=1.

62. National Institutes of Health, U.S. National Library of Medicine, “Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19 (NOSARSCOVID),” March 12, 2020. https://clinicaltrials.gov/ct2/show/NCT04306393?cond=NCT04306393&draw=2&rank=1.

63. National Institutes of Health, U.S. National Library of Medicine, “NO Prevention of COVID-19 for Healthcare Providers (NOpreventCOVID),” March 18, 2020. https://clinicaltrials.gov/ct2/show/NCT04312243?cond=NCT04312243&draw=2&rank=1.

64. C.H. Wang et al. “Adjuvant treatment with a mammalian target of rapamycin inhibitor, sirolimus, and steroids improves outcomes in patients with severe H1N1 pneumonia and acute respiratory failure,” Critical Care Medicine 42, no. 2 (2014): 313-321. DOI: 10.1097/CCM.0b013e3182a2727d.

65. Y. Zhou et al. “Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2,” Cell Discovery 6, no. 14 (March 16, 2020): 1-18. DOI: 10.1038/s41421-020-0153-3.

DISCLAIMER: Many personal protective equipment (PPE) are regulated by FDA, NIOSH and other authorities. Government regulations restrict the sale, distribution and donation of PPE without proper authorization. While Premier Healthcare Alliance, L.P., and its affiliates (collectively, “Premier”), are not encouraging the sale or distribution of PPE, etc., individuals or entities that decide to make PPE for personal use or use in clinical or other settings do so at their own risk. Consult local hospital requirements, clinical guidelines for COVID-19 safety or applicable FDA, CDC, NIOSH or other government agency guidelines for additional information or guidance, etc.

Premier is not responsible for any errors or omissions, or for the results obtained from the use of the information provided in this communication (the “Information”). The Information is being provided for informational purposes and any use of the Information is at the user’s own risk. Premier is not a health care provider, regulatory agency or manufacturer, and it and its affiliates do not actively monitor or approve any Information and are not responsible or liable for verifying the accuracy of the Information. Premier provide this Information and these materials on an “as is” basis, with no representations or warranties of any kind, including with respect to accuracy, completeness, quality, non-infringement, or fitness for a particular purpose. No representation is made that the Information is free of the rightful claim of any third person by way of infringement or the like. Any use of the Information in violation of any third-party patent or other intellectual property rights, including without limitation those held by affiliates of Premier, is specifically prohibited. Violation of patent or other intellectual property rights may result in the imposition of substantial money damages or other civil remedies against you, as well as potential criminal penalties. Premier will not be liable for any damages of any kind arising from the use of, or reliance on, any Information made available to you by Premier including but not limited to direct, indirect, incidental, consequential, special or punitive damages. All other rights reserved. By accessing Premier’s websites, including this page, you agree to be bound by the full Terms & Conditions. See the full Terms & Conditions at www.premierinc.com/terms-conditions.

Premier Continuum of Care | June 2020

5

This is an advertisement.

6

| Insight

Introducing the Premier Continuum of Care Biosimilars Program

Giving alternate site healthcare providers the tools needed to thrive in the era of biosimilars Eric Rodriguez, Director, Corporate Communications, Premier Alternate Site Programs

Premier Continuum of Care | June 2020

7

As key biologics continue to lose their patent protections,1 biosimilars are poised to play a vital role in reshaping treatment options for some of the most complex, chronic illnesses. In addition to producing clinically equivalent outcomes to their reference products, biosimilars are also projected to help lower overall healthcare costs.

This paradigm shift is creating new opportunities for alternate site healthcare providers to implement biosimilar strategies and advance efforts to have the products included on formularies. To determine which biosimilars are suitable for inclusion, providers must evaluate both the overall savings opportunity and the specific value proposition offered by each product.

The Current Biosimilars Landscape According to a 2018 report published

by RAND Health Quarterly, biosimilars offer a total savings potential of $54 billion from 2017 to 2026.2 However, realizing these savings will require providers to overcome potential industry-related constraints and adopt biosimilars more readily than in the past.

One of the most significant obstacles to the uptake of biosimilars during the last three years has been reimbursement.3

disparities in reimbursement between biosimilars and their reference products — such as the removal of the biosimilar exclusion from the Medicare Part D coverage gap discount program4 — financial hurdles remain. For instance, many private payers list innovator biologics (i.e. the original, branded drugs) as their preferred agents and require a different prior authorization process for the reimbursement of non-preferred formulary products, creating an additional administrative burden for providers.3 Moreover, some payers will only cover biosimilars if the patient has an intolerance or an ineffective response to the innovator biologic, presenting yet another challenge for providers looking to switch to a specific biosimilar.3 “Although biosimilars are projected to be priced up to 30 percent below their branded counterparts, today’s intricate biosimilar reimbursement landscape has created a situation where biosimilar adoption doesn’t automatically lead to enhanced post-reimbursement value,” says John Klosek, Senior Vice President, Alternate Site Contract and Clinical Services, Premier. “When it comes to biosimilars, providers must keep up-todate on the changing reimbursement policies of each payer in order to continue providing high-quality, low-cost patient care.”

The Biosimilars Calculator

When evaluating the savings potential of a biosimilar, providers must examine the initial acquisition cost, possible conversion opportunities, and payer reimbursement rates. To help alternate site healthcare members through this multifaceted evaluation process, Premier recently launched a biosimilars calculator.

Developed with extensive feedback from members, the online-based tool helps estimate reimbursement for contracted biosimilar products from the Centers for Medicare & Medicaid Services (CMS) and from private payers. Once members input dosage requirements and negotiated reimbursement rates for the biosimilar products in question, the system generates estimated reimbursement for that specific product and dose. The calculations are based on the number of contract units entered (see Figure 1).

Figure 1: Biosimilars Contract Advantage Calculator

“One key benefit of the calculator is that it provides members with an estimation of potential revenue/loss before the drug is bought and administered,” says Liya Davydov, PharmD, BCPS, BCGP, Vice President, Alternate Site Clinical Pharmacy Services, Premier. “By using the tool, members will be able to preserve their existing business model, while ensuring that their patients are being treated in the most cost-effective fashion without sacrificing efficacy of a provided treatment.”

Drug Name

How does the calculator work?

Private Plan Reimbursement Per J-Code Per Billing Units

To view reimbursement estimates, members must: 1. Choose a drug from the drop-down menu.

While policy changes have been proposed or enacted to help ameliorate

Dosage

Medicare Part B Reimbursement Rate

Private Plan Reimbursement Rate

Billing Units

Billing Units

Reimbursement Per Billing Unit Differential Per Billing Unit

Contract Units

Reimbursement Per Billing Unit Differential Per Billing Unit

Contract Units

Reimbursement Per Contract Unit

Reimbursement Per Contract Unit

Differential Per Contract Unit

Differential Per Contract Unit

Differential Per Dosage

Differential Per Dosage

All information contained herein is rounded up to the nearest two decimal points and is subject to change with or without notice.

8

Enter the Premier Continuum of Care (COC) Biosimilars Program

| Insight

2. Enter the amount the commercial payer of the patient pays for one billing unit of the drug (based on the HCPCS code description, provided for the biosimilar next to the entry box).

3. Select the number of contract units needed for the patient.

Once this data is entered, the calculator will then automatically generate two sets of results: reimbursement by CMS (Medicare Part B) and private plan reimbursement (a member’s private negotiated plan rate).

“The generated calculations are based on Premier’s contracted price at the time when

Figure 2: U.S. Biosimilars in the Alternate Site Healthcare Setting

Therapeutic class

Hematopoietic agent

Biosimilars on contract

• Zarxio • Nivestym

• Fulphila • Udenyca • Ziextenzo

Reference biologic/ manufacturer

• Neupogen • Neulasta (filgrastim) (pegfilgrastim) [Amgen] [Amgen]

• Retacrit

• Procrit (Epoetin Alfa) [J&J] • N/A*

(Premier Contracted & Non-Contracted Biologic Products)

Tumor necrosis factor blocker • Inflectra • Renflexis

• Remicade (infliximab) [J&J]

Anti-neoplastic agent • Truxima • Ruxience

• Mvasi • Zirabev

• Kanjinti • Ogivri • Trazimera • Herzuma • Ontruzant

N/A**

N/A***

N/A****

N/A marks the original reference biologics that are NOT on contract with Premier at this time (note: please refer to the corresponding asterisks below for non-contracted original reference biologic product/manufacturer information). The rest of the listed reference biologics in the table above are currently on contract with Premier for various classes of trade. Additonally, the drugs highlighted in red signify biosimilars on contract ONLY for the Physician Practice class of trade (COT). *Epogen (epoetin alfa); Amgen [visit https://www.epogen.com/ for more information]. **Rituxan (rituximab); Genentech [visit https://www.rituxan.com/ for more information]. *** Avastin (bevacizumab); Genentech [visit https://www.avastin.com/ for more information]. **** Herceptin (trastuzumab); Genentech [visit https://www.herceptin.com/hcp.html for more information].

the inquiry is being made,” notes Davydov.

“If a negotiated price isn’t currently available for a particular class of trade, then the calculator will automatically pull in the wholesale acquisition cost (WAC) of the drug and clearly indicate that WAC is being used for the calculations that are generated.”

The Premier COC Biosimilars Portfolio When examining the financial impact that a biosimilar product will have on an organization, it’s vital to understand the setting in which a biosimilar is administered, since reimbursement models and acquisition costs fluctuate based on sites of care. “With a growing number of biosimilars in the pipeline that are used in the alternate site healthcare setting, reimbursement becomes even more complex, and therefore, even more important for organizations to fully understand in terms of the potential cost savings that could be generated,” Klosek explains.

Since 2015, Premier has been working closely with the manufacturers of biosimilars coming to market to successfully gain a contract position for various alternate site classes of trade (see Figure 2 for currently contracted biosimilars). “In a market which was once slow to add new products, there has recently been a flurry of activity that we anticipate will continue throughout the rest of the year,” says Klosek.

“As of June 2020, there are 27 biosimilars approved, yet due to patent litigation, not all have been able to enter the market.”

Continuing Education (CE) Understanding that prescriber and pharmacist confidence in biosimilars

DID YOU KNOW? Premier offers alternate site healthcare members an entire suite of clinical calculators. In addition to biosimilars, we currently provide calculators for contracted IVIG and hemophilia products. To learn more about our suite of clinical calculators, please contact your representative at 888.258.3273 or email AlternateSitePrograms@premierinc.com. is a necessary component of building a successful biosimilar strategy, Premier has developed a number of educational offerings and training resources to help alternate site healthcare members on that front.

“Our biosimilar-specific educational offering is designed to address common misconceptions and highlight information regarding the approval pipeline, efficacy, and safety,” notes Davydov. “As is customary for our valued-added CE-accredited educational programs, information is presented via a number of modalities, including monthly teleconferences, in-person programming, and written educational programs.”

Is Your Organization Prepared for the Era of Biosimilars?

With contending biosimilar versions of game-changing biologics already on the market, the era of biosimilars has officially

taken off. These important new drugs not only offer expanded therapeutic options for chronically ill patients, they also represent an enormous opportunity for alternate site healthcare providers to manage costs and bring additional value to their patients.

Klosek sums it up: “The time is now for providers to establish a biosimilars strategy.

To be successful in this endeavor, alternate site leaders need to proactively take steps to ensure their organization truly understands the market dynamics at play, including pricing strategies, payer and reimbursement influences, and regulatory policies.”

Premier offers alternate site healthcare members comprehensive resources to help support their biosimilar evaluation and strategy development. For more information about our biosimilars program, suite of clinical calculators, or complimentary CE member offerings, contact us today.

REFERENCES 1. Suzanne Elvidge, “Why biosimilars could be market disruptors,” BiopharmaDive.com, January 23, 2017. https:// www.biopharmadive.com/news/why-biosimilars-could-be-market-disruptors/434392/.

2. Andrew W. Mulcahy et al, “Biosimilar Cost Savings in the United States: Initial Experience and Future Potential,” Rand Health Quarterly 7, no. 4: 3 (Epub: March 30, 2018). https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC6075809/.

3. James Smeeding et al, “Biosimilars: Considerations for Payers,” P & T 44, no. 2 (January 2019): 54-63. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355057/.

4. Barbara A. Gabriel, “Medicare Part D Discounts Now Cover Biosimilar Drugs,” AARP.org, February 20, 2018. https://www.aarp.org/health/medicare-insurance/info-2018/biologics-save-money-fd.html.

Premier Continuum of Care | June 2020

9

Category Spotlight: COVID-19 Recovery Portfolio

As parts of the country gradually re-open in the wake of COVID-19, healthcare practices face pressure to quickly adapt to a new reality. Your organization needs a strategy to:

Help ensure the safety of your employees and patients Strive to meet expectations for higher levels of cleanliness throughout your facilities Work to reduce the need for contact to the greatest extent possible

PPE & Medical Supplies (face masks, face shields, gloves, infrared & touchless thermometers)

Sanitizing Products (hand sanitizer, soaps, wipes & disinfectants)

Touchless Products (door entry, faucets & soap dispensers)

Shield Protectors and Barriers

As your group purchasing organization (GPO), we understand

that organizations like yours may need our support more than ever. We value the trust you have placed in us and want you to know that we stand ready to help. Through our purchasing program and stockd®, Premier’s online marketplace, your

Foodservice Disposables (paper goods, food and beverage containers & dispensers)

organization has access to an available supply of items you’ll need to get back in business:*

10 |

Insight

*Access to products are subject to availability from suppliers.

Group Purchasing Contracts/stockd Product Listing Contract Title

Contracted Supplier

Contract Number

Contract Expiration Date

PERSONAL PROTECTIVE EQUIPMENT (PPE) SUPPLIES 3 Ply Disposable Masks Black Nitrile General Purpose Gloves Disposable Non-Sterile Protective Apparel

stockd Marketplace

CLICK HERE >

stockd Marketplace

CLICK HERE >

Amd-Ritmed

PP-NS-1186

11/30/21

Encompass Group

PP-NS-1188

11/30/21

O&M Halyard

PP-NS-1189

11/30/21

S2S Global

PP-NS-1191

11/30/21

Sloan Medical

PP-NS-1192

11/30/21

Tronex International

PP-NS-1193

11/30/21

Welmed

PP-NS-1194

11/30/21

Ansell Healthcare Products

PP-NS-1225

04/30/22

Innovative Healthcare Corporation

PP-NS-1228

04/30/22

Medgluv

PP-NS-1229

04/30/22

O&M Halyard

PP-NS-1227

04/30/22

PlatinumCode

CO-NS-106

10/31/20

S2S Global

PP-NS-1231

04/30/22

Sempermed

PP-NS-1232

04/30/22

Tronex International

PP-NS-1233

04/30/22

stockd Marketplace

CLICK HERE >

stockd Marketplace

CLICK HERE >

stockd Marketplace

CLICK HERE >

stockd Marketplace

CLICK HERE >

Physical Therapy Products & Exercise Equipment

Performance Health Supply

PP-NS-1299

02/28/23

Reusable Textiles & Textile Services

American Dawn

PP-FA-702

11/30/21

Calderon Textiles

PP-FA-703

11/30/21

CareandWear II

PP-FA-704

11/30/21

Encompass Group

PP-FA-705

11/30/21

GoBioMed

CO-FA-102

10/26/20

Hinson & Hale Medical Technologies

PP-FA-706

11/30/21

Phoenix Textile Corporation

PP-FA-708

11/30/21

Standard Textile Co.

PP-FA-709

11/30/21

GM Nameplate

CO-OR-104

10/31/20

GoBioMed

CO-OR-120

10/31/20

Key Surgical

CO-OR-101

10/19/20

Label Source

CO-OR-109

10/31/20

Mobility Exchange

CO-OR-110

10/31/20

O&M Halyard

PP-OR-1691

12/31/22

PlatinumCode

CO-OR-107

10/31/20

Precept Medical Products

PP-OR-1692

12/31/22

Prestige Ameritech

PP-OR-1689

12/31/22

Exam Gloves

Face Shields Goggles Gowns KN95 Masks

Surgical & Isolation Masks

Premier Continuum of Care | June 2020 11

Contract Title

Contracted Supplier

Contract Number

Contract Expiration Date

Surgical & Isolation Masks

Project Graphics

CO-OR-116

10/31/20

(continued)

S2S Global

PP-OR-1688

12/31/22

Surain Industries

CO-OR-113

10/31/20

Thermometry Vinyl General Purpose Gloves

Tidi Products

PP-OR-1690

12/31/22

GoBioMed

CO-NS-123

10/31/20

stockd Marketplace

CLICK HERE >

DISINFECTANT/SANITIZING PRODUCTS Bottled Hand Sanitizer

stockd Marketplace

CLICK HERE >

Electrical & Plumbing Building Materials

Wesco

PP-FA-595

04/30/22

Fire & Life Safety Products & Services

Life Safety Services

PP-FA-741

06/30/22

American Hotel Register Company

PP-FA-798

02/28/23

Betco

PP-FA-635

04/30/21

Diversey

PP-FA-636

04/30/21

Midlab Incorporated

PP-FA-637

04/30/21

Procter & Gamble Distributing

PP-FA-638

04/30/21

Spartan Chemical Co.

PP-FA-639

04/30/21

Hospitality Supplies, Equipment & Distribution Housekeeping Products

Intermediate-Level Disinfectant Wipes

Laundry Products & Maintenance

Maintenance, Repair & Operations Microfiber Products, Mats & Accessories

Non-healthcare Soaps, Lotions & Waterless Rinses

12 |

Insight

Wexford Labs

PP-FA-640

04/30/21

Certol International

PP-NS-1026

04/30/21

Clorox

PP-NS-1345

04/30/23

Diversey

PP-NS-1347

04/30/23

Metrex Research Corporation

PP-NS-1346

04/30/23

Professional Disposables International (PDI)

PP-NS-1344

04/30/23

Betco

PP-FA-719

12/31/21

Diversey

PP-FA-720

12/31/21

Gurtler Industries

PP-FA-721

12/31/21

Procter & Gamble Distributing

PP-FA-722

12/31/21

Spartan Chemical Co.

PP-FA-723

12/31/21

State Industrial Products

PP-FA-724

12/31/21

UNX Incorporated

PP-FA-725

12/31/21

AirSupply Tools

PP-FA-590

04/30/22

WW Grainger

PP-FA-591

04/30/22

American Dawn

PP-FA-654

01/31/21

Aramark Uniform and Career Apparel

PP-FA-690

01/31/21

Cintas Corporation

PP-FA-656

01/31/21

Contec

PP-FA-657

01/31/21

Encompass Group

PP-FA-658

01/31/21

Phoenix Textile Corporation

PP-FA-659

01/31/21

S2S Global

PP-FA-605

01/31/21

Standard Textile Co.

PP-FA-660

01/31/21

Unifirst Corporation

PP-FA-691

01/31/21

Betco

PP-FA-668

04/30/21

Buckeye International

PP-FA-675

04/30/21

Diversey

PP-FA-670

04/30/21

Contract Title

Contracted Supplier

Contract Number

Contract Expiration Date

Non-healthcare Soaps, Lotions & Waterless Rinses

Essity

PP-FA-671

04/30/21

Kimberly-Clark

PP-FA-674

04/30/21

Office Supplies & Business Services

American Office Products Distributors

PP-MM-479

07/31/20

FriendsOffice

PP-MM-476

07/31/20

Guy Brown

PP-MM-477

07/31/20

Office Depot

PP-MM-481

07/31/20

Staples

PP-MM-480

07/31/20

Afflink

PP-FA-606

10/31/20

Network Services Company

PP-FA-607

10/31/20

Office Depot

PP-FA-608

10/31/20

Strategic Market Alliance

PP-FA-609

10/31/20

The Home Depot Pro

PP-FA-610

10/31/20

Triple S

PP-FA-611

10/31/20

American Green Technology

PP-MM-496

01/31/21

Diversey

PP-MM-673

03/31/21

Patho3gen Solutions (fka Green Earth Medical Solutions)

PP-FA-810

03/31/21

Surfacide

PP-MM-501

03/31/21

TMG Health Technologies

PP-FA-816

03/31/21

TOMI Environmental Solutions

PP-MM-502

03/31/21

Tru-D Smart UVC

PP-MM-503

03/31/21

UltraViolet Devices (fka Clorox Sales Company)

PP-MM-497

03/31/21

Xenex Disinfection Services

PP-MM-504

03/31/21

Positive Promotions

PP-MM-739

08/31/22

GoBioMed

CO-NS-105

10/26/20

SC Johnson Professional

PP-NS-1085

09/30/20

Ecolab

PP-DI-1611

04/30/22

(continued)

Paper & Janitorial Supply Distribution

Room Environment Infection Prevention Products

Service Awards & Promotional Products Soaps, Lotions & Waterless Hand Rinses Warewashing Chemicals & Related Products

TOUCHLESS/BARRIER PROTECTION Cubicle Curtains, Tracks & Privacy Screens

Cube Care Company

PP-FA-711

11/30/21

Encompass Group

PP-FA-712

11/30/21

Silentia

PP-FA-716

11/30/21

Custom Solutions

Mobility Exchange

PP-IT-230

06/30/22

Doors, Frames & Hardware

ASSA ABLOY Sales and Marketing Group PP-FA-663

12/31/21

Foodservice Equipment & Supplies Distribution & Kitchen Design Services

Edward Don & Company

PP-DI-1734

05/31/23

Hubert Company

PP-DI-1736

05/31/23

Interior & Exterior Signage

Berry and Homer

PP-FA-787

02/28/23

Low Voltage Systems

Accu-Tech Corporation

CC-IT-007

07/31/22

Paper Towels, Tissues & Dispensers

Carlisle Foodservice Products

PP-FA-771

09/30/22

Essity

PP-FA-768

09/30/22

Georgia-Pacific

PP-FA-769

09/30/22

Kimberly-Clark

PP-FA-770

09/30/22

Premier Continuum of Care | June 2020 13

Contract Title

Contracted Supplier

Contract Number

Contract Expiration Date

FACILITY/LAUNDRY PRODUCTS & SERVICES Air Filtration Products

Can Liners

Environmental & Facility Management Services

AAF International

PP-FA-686

08/31/21

Camfil

PP-FA-687

08/31/21

Koch Filter Corporation

PP-FA-688

08/31/21

Tri-Dim Filter Corp.

PP-FA-689

08/31/21

I.B.S. Solutions Corporation

PP-FA-600

07/31/20

Novolex Holdings

PP-FA-599

07/31/20

Plastics Solutions

PP-FA-601

07/31/20

Aramark Uniform and Career Apparel

PP-SV-211

03/31/22

FacilitySource

PP-SV-212

03/31/22

Medtegrity Medical Laundry

PP-SV-216

03/31/22

Sodexo Operations

PP-SV-214

03/31/22

NeoGenomics Laboratories

PP-LA-485

09/30/23

Quest Diagnostics Incorporated

PP-LA-486

09/30/23

LAB TESTING Clinical Reference Laboratory Testing Services

THERMAL SCANNING SOLUTIONS Custom Solutions

Mobility Exchange (Temperature & environmental monitoring sensors and cameras)

PP-IT-230

06/30/22

Hardware & Software Resellers

PC Connection (Advantech infection prevention solution with video AI integration; Meridian temperature verification kiosk)

PP-IT-164

10/31/20

Low Voltage Systems

Accu-Tech Corporation (Herring technology mobile camera with thermal imaging)

CC-IT-007

07/31/22

Maintenance, Repair & Operations

WW Grainger (Infrared smart phone adapters)

PP-FA-591

04/30/22

Office Supplies & Business Services

Office Depot (Tidel intelligent entry scanner)

PP-MM-481

07/31/20

Staples (Meridian temperature verification kiosk)

PP-MM-480

07/31/20

Paper & Janitorial Supply Distribution

The Home Depot Pro (Meridian temperature verification kiosk; Tauri series temperature-check tablets)

PP-FA-610

10/31/20

Pulse Oximetry & Capnography Devices

Masimo Americas

PP-MM-615

04/30/21

Smiths Medical ASD

PP-MM-612

04/30/21

Anchor Packaging

PP-DI-1633

06/30/22

Cascades

PP-DI-1639

06/30/22

Dart

PP-DI-1629

06/30/22

Eco-Products

PP-DI-1632

06/30/22

Georgia-Pacific

PP-DI-1631

06/30/22

Handgards

PP-DI-1638

06/30/22

Hoffmaster

PP-DI-1636

06/30/22

Pactiv

PP-DI-1630

06/30/22

S2S Global

PP-DI-1637

06/30/22

PULSE OXIMETRY

FOODSERVICE DISPOSABLES Foodservice Disposables

14 |

Insight

Sabert

PP-DI-1635

06/30/22

US Foods

PP-DI-1640

06/30/22

WNA

PP-DI-1634

06/30/22

Contract Title

Contracted Supplier

Contract Number

Contract Expiration Date

REMOTE WORK IT SERVICES/SOLUTIONS Call Center Services

AnswerNet Voice Products

PP-SV-244

09/30/22

Credit Card Services

Sun Communications

PP-SV-184

02/28/23

Hardware & Software Resellers

Insight

PP-IT-166

10/31/20

PC Connection

PP-IT-164

10/31/20

Zones

PP-IT-165

10/31/20

Konica Minolta

PP-IT-222

07/31/22

Managed Print Services, Devices & Accessories

PP-SV-241

09/30/22

REMOTE WORK TRANSPORTATION SERVICES Ride Sharing Services

Kaizen Health

PP-SV-226

01/31/21

Lyft

PP-SV-189

01/31/21

PP-SV-175

03/31/25

STAFFING Workforce Solutions - Staffing

AMN Healthcare

TELEHEALTH SOLUTIONS Television Hardware Software

Telehealth Services

PP-FA-794

02/28/23

Custom Solutions

Mobility Exchange

PP-IT-230

06/30/22

Eligibility is subject to supplier approval. While every reasonable effort has been made to make this listing accurate, information changes rapidly and Premier makes no guarantees of any kind, including guarantees as to the accuracy of this listing. The listing is for informational purposes only and does not create a legal agreement or place any obligations on Premier.

For real-time COVID-19 updates, please visit Premier’s COVID-19 response webpage, our Disaster Response Community on PremierConnect, and the Premier Safety Institute®.

DISCLAIMER:

Many personal protective equipment (PPE) are regulated by FDA, NIOSH and other authorities. Government regulations restrict the sale, distribution and donation of PPE without proper authorization. While Premier Healthcare Alliance, L.P., and its affiliates (collectively, “Premier”), are not encouraging the sale or distribution of PPE, etc., individuals or entities that decide to make PPE for personal use or use in clinical or other settings do so at their own risk.

Consult local hospital requirements, clinical guidelines for COVID-19 safety or applicable FDA, CDC, NIOSH or other government agency guidelines for additional information or guidance, etc.

Premier is not responsible for any errors or omissions, or for the results obtained from the use of the information provided in this communication (the “Information”). The Information is being provided for informational purposes and any use of the Information is at the user’s own risk. Premier is not a health care provider, regulatory agency or manufacturer, and it and its affiliates do not actively monitor or approve any Information and are not responsible or liable for verifying the accuracy of the Information. Premier provide this Information and these materials on an “as is” basis, with no representations or warranties of any kind, including with respect to accuracy, completeness, quality, non-infringement, or fitness for a particular purpose.

No representation is made that the Information is free of the rightful claim of any third person by way of infringement or the like. Any use of the Information in violation of any third-party patent or other intellectual property rights, including without limitation those held by affiliates of Premier, is specifically prohibited. Violation of patent or other intellectual property rights may result in the imposition of substantial money damages or other civil remedies against you, as well as potential criminal penalties. Premier will not be liable for any damages of any kind arising from the use of, or reliance on, any Information made available to you by Premier including but not limited to direct, indirect, incidental, consequential, special or punitive damages. All other rights reserved. By accessing Premier’s websites, including this page, you agree to be bound by the full Terms & Conditions. See the full Terms & Conditions at www.premierinc.com/terms-conditions.

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