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Insight - Premier Continuum of Care - October 2020

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Premier Continuum of Care | October 2020

C VID-19 Places Nursing Homes in the Policy Spotlight

PLUS • Pharmacists & Technicians: Earn CE credits by completing the program in this issue. Premier Continuum of Care | October 2020

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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

Continuum of Care

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Table of Contents Insight | October 2020

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COVID-19 Places Nursing Homes in the Policy Spotlight

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Biosimilars in the US: Where Are We Now?

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Category Spotlight: Purchased Services

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. Links from this communication to other sites do not constitute an endorsement by Premier. These links are for convenience only. It is the responsibility of the user to evaluate the content and usefulness of information obtained from other sites. Premier has no control over and is not responsible for the information, practices, or content of these or any other sites. The contents of this publication are protected by copyright and are the property of Premier. They may not be reproduced or transmitted in any form without the express written permission of Premier.


COVID-19 Places Nursing Homes in the Policy Spotlight Shara Siegel, MS, Director of Government Affairs, Premier Brad Kile, PhD, President, Dumbarton Group & Associates

Premier Continuum of Care | October 2020

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Policy responses to the COVID-19 public health emergency remain in flux, as more information becomes available on the best approaches for slowing the spread of the SARS-CoV-2 virus. Nursing homes, which account for an estimated 43 percent of all COVID-19 deaths in the U.S.,1 remain a central focus of federal, state, and local officials as they explore a wide range of policy options to protect vulnerable populations. The U.S. Department of Health & Human Services (HHS) has implemented several nursing home policy reforms that largely delegate decision-making to state and local governments. While this approach may be responsive to disease dynamics and geographic variations, fragmented policy guidance and unclear funding pathways have left nursing homes struggling to meet new demands created by the pandemic. This is a look at major policy developments thus far and the policy trends that are likely to ensue.

Early Insights into the COVID-19 Outbreak in Nursing Homes At the onset of the COVID-19 outbreak, nursing homes came to the forefront of the national spotlight due to the significant number of deaths and positive cases that were among the first to be reported in the U.S.2 The virus accelerated at nursing homes because residents are generally vulnerable to its complications and more susceptible in the contained space of a facility.3 Early on, assessing the crisis and the supply chain needs for senior living facilities became a top priority for Premier. Surveys conducted by Premier in March and early April, which included responses from multiple skilled nursing and assisted living providers, in combination and aggregate representing more than 250,000 beds, revealed that 70 percent of respondents were not fully prepared to treat an increasing number of COVID-19 cases.4 About half of survey respondents said they had challenges with staffing and obtaining personal protective equipment (PPE) as a result of COVID-19. Given these findings and the ongoing barriers nursing homes face in finding PPE through traditional distribution channels, Premier channeled 2

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its e-commerce platform, stockd®, to ensure timely access to critical medical supplies during the pandemic.

• adequate staffing;

The Federal Administration’s Response

• social distancing and universal source control for residents and visitors (e.g., face coverings); and

HHS issued a series of temporary policy change and guidance documents aimed at helping states manage the outbreak. In May alone, HHS issued three distinct actions to address COVID-19 in nursing homes – Guidance on Reporting Requirements,5 Best Practices Toolkit to Combat COVID-19,6 and Guidance to States on Safely Reopening Nursing Homes.7

• access to adequate PPE and up-to-date information on local hospital capacity.

The Guidance on Reporting requires nursing homes and long-term care sites to report COVID-19 facility data to the Centers for Disease Control and Prevention (CDC) as well as to residents, their representatives, and their families at least once a week.7 CMS has made this data publicly available on Nursing Home Compare, the long-standing online resource for consumers that contains a series of measures by which consumers may evaluate nursing homes (www. medicare.gov/nursinghomescompare). The Nursing Homes Best Practices Toolkit covers a variety of subjects,6 including infection control, workforce, and staffing levels. In addition to the Toolkit, which serves as a resource directory for states and facilities, HHS has announced 12 Quality Innovation Network-Quality Improvement Organizations that are providing virtual technical assistance to nursing homes with a history of citations for infection control deficiencies. Perhaps the most significant action on the federal level is the CMS guidance document entitled “Recommended Nursing Home Phased Reopening for States.”8 Along with this guidance, CMS released a Frequently Asked Questions9 document that can be used as a framework for public officials to develop policies, with recommendations for states to ensure nursing homes are opening at appropriate times through a three-phase strategy. HHS recommends that decisions on relaxing restrictions be made with careful review of facility-level, community, and state factors that include the status of the following: • COVID-19 cases in the local community; • COVID-19 cases in nursing homes;

• baseline testing for all residents; • weekly testing of all staff;

This guidance allows nursing homes to receive visitors during phase three (when there has been a sustained decrease in COVID-19 cases).10 Testing patients, staff, and outside vendors for COVID-19 remains a fluid issue, with many facilities using their own discretion as to which individuals to test and how frequently to re-test. According to the federal guidance, facilities should have the capacity to give all nursing home staff (including volunteers and vendors who are in the facility on a weekly basis) an initial baseline COVID-19 test, followed by weekly re-testing.11 Most recently, CMS provided updated criteria for facilities to use in determining the frequency of testing staff and residents.11 Much uncertainty also remains about payment responsibility for testing. Federal guidance indicates insurers must cover the cost of COVID-19 testing during the public health emergency declaration – currently set to expire on January 20, 2021 – with Medicare and the federal government providing coverage for individuals not covered by commercial insurance.12 The coverage for repeat testing has yet to be addressed in federal guidance, leaving many facilities and their staff unsure who will ultimately bear the burden of costly re-testing. Advocates have been pressing the federal government to address this issue and eliminate a potential barrier to nursing home safety. Coverage for testing beyond the public health emergency has also not been addressed.

Continued Focus on Infection Prevention: Premier’s Advocacy for Technological Assistance While public officials consider policies to confront nursing homes’ immediate COVID-19 challenges, it is clear that infection prevention and control will be central to policy reforms that address the lasting impact of the virus and future pandemics. The CDC reports that, even


prior to this crisis, a staggering 1 million to 3 million serious infections occur every year in these facilities and as many as 380,000 people die of the infections in nursing homes each year.13 In response, Premier, with the support of its senior living partners, is advocating for federal support to develop the infrastructure needed to help facility-level infection preventionists and clinical pharmacists detect, manage, control, and report conditions related to COVID-19 and beyond. Specifically, Premier is urging Congress to designate funds in an upcoming COVID-19 legislative package to incentivize nursing homes to implement electronic clinical surveillance technology that will provide meaningful assistance with infection control.

Conclusion Several months into the COVID-19 pandemic, with many more to go, officials at the federal, state, and local levels continue to explore policy options to confront the crisis in nursing homes. Although the federal government has intervened with a series of over-arching temporary reforms and recommendations, the lasting impact of COVID-19 on nursing homes is still to be determined. As the virus continues to escalate, swift action will be required to protect lives and establish a safe care environment. For questions or information on how you can engage in our legislative efforts, please contact Shara Siegel, Director of Government Affairs, at shara_siegel@ premierinc.com or 646.484.0905.

REFERENCES 1. Matthew Conlen et al. “More Than 40% of U.S. Coronavirus Deaths Are Linked to Nursing Homes,” The New York Times (accessed June 29, 2020). https://www.nytimes.com/interactive/2020/us/coronavirus-nursing-homes.html. 2. Centers for Medicare & Medicaid Services, “CMS Announces Findings at Kirkland Nursing Home and New Targeted Plan for Healthcare Facility Inspections in Light of COVID-19,” March 23, 2020. https://www.cms. gov/newsroom/press-releases/cms-announces-findings-kirkland-nursing-home-and-new-targeted-planhealthcare-facility-inspections. 3. Centers for Disease Control and Prevention. “Preparing for COVID-19 in Nursing Homes,” accessed July 31, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html. 4. “As COVID-19 Pushes Hospital Patients to Post-Acute Care Settings, Supply and Resource Needs Grow, Per Premier Inc. Survey,” Premier, Inc., April 14, 2020. https://www.premierinc.com/newsroom/press-releases/ as-covid-19-pushes-hospital-patients-to-post-acute-care-settings-supply-and-resource-needs-grow-perpremier-inc-survey. 5. Centers for Medicare & Medicaid Services, “Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes,” May 6, 2020. https:// www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memosstates-and/interim-final-rule-updating-requirements-notification-confirmed-and-suspected-covid-19-casesamong. 6. Centers for Medicare & Medicaid Services, “Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes,” June 2020. https://www.cms.gov/files/document/covid-toolkit-states-mitigate-covid-19nursing-homes.pdf. 7. Centers for Medicare & Medicaid Services, “Nursing Home Reopening Recommendations for State and Local Officials,” May 18, 2020. https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificatio ngeninfopolicy-and-memos-states-and/nursing-home-reopening-recommendations-state-and-local-officials. 8. Centers for Medicare & Medicaid Services, “Recommended Nursing Home Phased Reopening for States,” May 18, 2020. https://www.cms.gov/files/document/qso-20-30-nh.pdf-0. 9. Centers for Medicare & Medicaid Services, “Nursing Home Reopening Recommendations Frequently Asked Questions,” June 23, 2020, https://www.cms.gov/files/document/covid-nursing-home-reopeningrecommendation-faqs.pdf. 10. Centers for Medicare & Medicaid Services, “Recommended Nursing Home Phased Reopening for States,” May 18, 2020. https://www.cms.gov/files/document/qso-20-30-nh.pdf-0. 11. Centers for Medicare & Medicaid Services, “Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID19 Focused Survey Tool,” August 2020, https://www.cms.gov/files/document/qso-20-38-nh.pdf . 12. The Centers for Medicare & Medicaid Services, “FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 42,” April 11, 2020. https://www.cms.gov/files/document/FFCRA-Part-42-FAQs.pdf. 13. Centers for Disease Control and Prevention, “Nursing Homes and Assisted Living (Long-term Care Facilities [LTCFs]),” accessed June 29, 2020. https://www.cdc.gov/longtermcare/index.html#:~:text=1%20to%203%20 million%20serious,infections%20in%20LTCFs%20every%20year. 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 provides 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’s Action on Behalf of Non-acute Members Premier has been raising the profile of the COVID-19 impact on our non-acute members through multiple channels, including a data-driven legislative and administrative strategy. See our resources below (please note: some resources may require PremierConnect® access).

• Premier’s Recommendations to the Coronavirus Commission for Safety and Quality in Nursing Homes • Statement for the Record for the House Ways and Means Health Subcommittee Hearing titled “Examining the COVID-19 Nursing Home Crisis.” • Premier Nexus titled “Leveraging Technology to Minimize COVID-19 Infection Spread in Nursing Homes.” • COVID-19 Regulatory Response Letter- 4.17.2020 • COVID-19 Regulatory Response Letter - 3.24.2020 • Surveys o 6.24.20 - Premier Inc. Survey: Alternate Site Providers Report Increased PPE Needs but Face Challenges with Traditional Distribution Channels o 5.13.20 - Premier Inc. Survey: Clinically Integrated Networks in Alternative Payment Models Expanded Value-Based Care Capabilities to Manage COVID-19 Surge o 5.7.20 - Premier Inc. Survey: Hospitals’ COVID-19 Testing Capacity Must at Least Triple Before Elective Surgeries Can Fully Resume o 4.14.20 - As COVID-19 Pushes Hospital Patients to Post-Acute Care Settings, Supply and Resource Needs Grow, Per Premier Inc. Survey o 3.16.20 - Premier Inc. Survey: More Than Two-Thirds of Senior Living Facilities Say They Can’t Access Personal Protective Equipment Needed for COVID-19 Containment Plans

Premier Continuum of Care | October 2020

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CONTINUING EDUCATION

Biosimilars in the US: Where Are We Now? Liya Davydov, PharmD, BCPS, BCGP, Vice President, Clinical Pharmacy Services, Premier Alternate Site Programs

Premier Continuum of Care | October 2020

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CONTINUING EDUCATION

Biosimilars in the US: Where Are We Now? This CE activity has been produced by Innovatix Institute, an educational program offered by Innovatix, LLC (“Innovatix now operates under Premier Alternate Site Programs”). This activity is accredited for Pharmacists and Pharmacy Technicians.

Goal Statement

The purpose of this activity is to provide the participant with the knowledge needed to understand the place in therapy for biosimilars, and to be able to select and dispense the best agent for a particular patient.

Learning Objectives – Pharmacists

At the completion of this activity, the participant will be able to: 1. Describe current status of biosimilars on the US market 2. Outline recent FDA guidance/regulations/tools pertaining to biosimilars 3. Describe current payer perspectives and formulary considerations for marketed biosimilars 4. Identify current attitudes of providers and patients towards use of biosimilars and list barriers preventing wider adoption of biosimilars among relevant stakeholders

Learning Objectives – Pharmacy Technicians

At the completion of this activity, the participant will be able to: 1. Identify 3 biosimilars currently on the market, and their reference biologics 2. Describe current payer perspectives and formulary considerations for marketed biosimilars 3. Identify current attitudes of providers and patients towards use of biosimilars and list barriers preventing wider adoption of biosimilars among relevant stakeholders

Type of activity Knowledge-based

Cost

This activity is free of charge.

Disclosures

This continuing education activity is managed and accredited by Innovatix. Dr. Davydov and Innovatix have no relevant or apparent financial interests or relationships to disclose. The material presented for this article has been reviewed by the Innovatix Institute CE Committee and has been found to be free of any content influenced or supported by industry. Commercial support was not received for this activity.

Pharmacy Accreditation

Innovatix, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity has been approved for 1 contact hour for pharmacists and pharmacy technicians for Disease State Management/ Drug Therapy. Universal Activity Number: 0409-0000-20-010-H01-P (Pharmacists) and 0409-0000-20-010-H01-T (Technicians).

Target Audience

Pharmacists and technicians involved in the formulary management, dispensing, administration or medical management of patients treated with biosimilar agents.

To receive CE credit, Pharmacists and Technicians must go to www.innovatix.com/evaluations. Click on Insight Magazine and scroll to find the title of this CE article. Complete the evaluation form. A score of 70% or higher is required to receive credit. Statements of Credit will be available from CPE Monitor within eight weeks, upon successful completion and submission of the verification of Continuing Education and Program Evaluation online forms and obtaining a passing score on the test. This lesson will not be valid for CE credit after 8/24/2021.

Legal Disclaimer The materials in this CE activity do not necessarily reflect the views of Premier Healthcare Alliance, L.P., and its affiliates (collectively, “Premier”). A qualified healthcare professional should be consulted before using any therapeutic product referenced as part of the program. Readers should verify all information and data before treating patients or employing any therapies described in the activity materials. As a condition to participating in this program, you acknowledge and agree that Premier is not providing any medical conclusions or advice, but is rather summarizing publicly available clinical information. The activity and corresponding materials may contain statements that may appear to be recommendations or advisory in nature, however, such statements are merely being recounted by Premier from the literature cited and do not constitute the recommendations or advice of Premier. Accordingly, Premier hereby disclaims all warranties, express or implied, as to the accuracy of any of the materials or information contained in the activity, or their fitness for any particular use or purpose. Clinical information and comments contained in the activity are for general guidance only. Mention of specific products in the activity or corresponding materials do not constitute an endorsement or advertisement. The activity provided is intended to provide you with information and is not intended to be used as a substitute for clinical or medical judgment. You agree that Premier shall not be responsible to you or any other third party for any clinical advice rendered by you, including advice related in any way to the activity. You agree to indemnify, defend, and hold Premier and its officers, directors, affiliates, employees, and agents (the “Premier Indemnitees”), harmless from and against any liability, costs, expenses, or damages, including attorneys’ fees and other costs of defense, incurred by any Premier Indemnitee in any action, proceeding, claim, or demand that is caused by, relates to, or arises out of your acts or omissions, or that in any way relate to your use of the information contained in the program or program materials. You agree that the activity and corresponding materials will be used for educational purposes only, and will not otherwise be copied or distributed without the prior written consent of Premier.

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Current Status The United States is experiencing a biosimilar boom. As recently as 2014, there were no biosimilars in the U.S. marketplace, despite their existence in other countries.1 But things have changed dramatically since 2015, when the first biosimilar, filgrastim-sndz (Zarxio), was introduced in the U.S.2 Fast forward to June 2020, and there are currently 27 biosimilars approved for use in the United States, with 17 (63 percent) of those already launched.3,4 Still, at this time, no biosimilar, approved or launched, has the designation of interchangeability.5 That means no biosimilar at this time can be automatically substituted for a reference biologic at the pharmacy level.5 The following tables graphically explain the current state of the U.S. biosimilar market: • Table 1 lists all biosimilar agents approved by the Food and Drug Administration (FDA) as of June 11, 2020. • Table 2 explains which drugs are currently pending (awaiting a decision) with the FDA. • Table 3 shows which biosimilars have been rejected to date. • Table 4 depicts associated drugs’ available unique Healthcare Common Procedure Coding System (HCPCS) codes for biosimilars. All of the launched biosimilars have a unique HCPCS code, with the exception of pegfilgrastim-bmez (Ziextenzo).6,7 For the present, pegfilgrastim-bmez (Ziextenzo) should be billed with a miscellaneous HCPCS code (J3590 – Unclassified Drugs).7

(Considerations in Demonstrating Interchangeability with a Reference Product), originally released Jan. 17, 2017 for comments,8 became final on May 10, 2019.9 This longawaited industry guidance finally provides a comprehensive definition of interchangeability, as well as a clear pathway for development of interchangeable biosimilars.5,9 The very first trial that was designed to study interchangeability was initiated by Boehringer Ingelheim in 2017, and aimed to test interchangeability for its biosimilar adalimumab-adbm (Cyltezo) against the reference biologic adalimumab (Humira).10 While awaiting entrance of interchangeable biosimilars, each state has been challenged with establishing its own guidelines to delineate biosimilar substitution for branded biologic agents at the pharmacy level.11 As of May 3, 2019, bills or resolutions have been filed in 49 states regarding biosimilar substitution, with 45 states and Puerto Rico enacting biosimilar substitution-related laws.11 For up-to-date information on state-specific laws/guidelines/policies regarding biosimilar substitution, go to http://www. ncsl.org/research/health/state-laws-andlegislation-related-to-biologic-medicationsand-substitution-of-biosimilars. aspx#Mandatory.11 Also important to notice: that even if the interchangeability designation is granted for a particular biosimilar, it would primarily affect pharmacy dispensing (as this is the setting where automatic substitution would occur).12 Under the medical benefit, given unique HCPCS codes associated with each biosimilar, a provider selects one for prescription and reimbursement.12

biologic agents that were originally approved as New Drug Applications (NDAs) to become licensed transition biologic agents (i.e., deemed as they have been approved under a Biologic License Application [BLA]).19 Significantly, insulin products were among those biologic agents.19 The importance of this change is that before this transition, while insulins were approved as NDAs, they were still biologic agents, and it wasn’t possible to develop a “true” generic under the traditional regulatory pathway.15,16 As a result, “follow-on” insulins were developed instead, that were approved as branded drugs, and could not be automatically substituted at the pharmacy level, and were priced as individual branded drugs (e.g., insulin glargine injection [Basaglar], insulin lispro injection [Admelog]).15,16,20,21,22 Now that the insulins are reclassified as products approved under BLAs, biosimilar insulins could be developed for these reference biologics.23 If the biosimilar insulins then obtain interchangeability status, they could be automatically substituted for original reference insulins at the pharmacy level.23 This would increase competition for branded insulins and potentially lower insulin cost to patients.23 To provide direction to industry stakeholders regarding development of insulin biosimilars, a draft guidance (Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products) was released on Nov. 25, 2019,24 followed by an FDA statement on Dec. 17, 2019 (Statement on low-cost biosimilar and interchangeable protein products).25

Recent Biosimilar Regulations/Tools

Another draft guidance (Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry) was released on May 21, 2019.13 This guidance provides recommendations for industry regarding how the comparative analytical studies need to be structured and evaluated in order to show that the investigational therapeutic protein agent is biosimilar to the reference biologic.14

The most recent draft guidance, which advises industry stakeholders how to apply for less indications for a biosimilar than that of a reference biologic product or to later apply for additional indications after the initial approval of the biosimilar, was released on Feb. 7, 2020 (Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry).26

The FDA has released several guidance documents regarding biosimilars recently. A draft guidance

A major transition took place on March 23, 2020.15-18 On that day, the FDA allowed re-classification of certain

An original FDA “Purple Book,” launched Sept. 9, 2014,27 was intended to provide a similar directory to

Test Your Knowledge Question 1: What was the name of the first biosimilar that launched in the U.S. market?

Premier Continuum of Care | October 2020

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Figure 1: Listing of biosimilar agents with FDA approval as of June 2020.*2,50-91 Brand Name for the Biosimilar Agent

Generic Name for the Biosimilar Agent

Manufacturer of the Biosimilar

Reference Biologic (Brand/Generic Names)

Manufacturer Date Launch of the Approved Status Reference Biologic

Zarxio

filgrastim-sndz

Sandoz

Neupogen (filgrastim)

Amgen

3/6/15

9/3/15

Inflectra

infliximab-dyyb

Celltrion/ Pfizer

Remicade (infliximab)

Janssen Biotech

4/5/16

Late November 2016

Erelzi

etanercept-szzs

Sandoz

Enbrel (etanercept)

Amgen

8/30/16

Not yet launched

Amjevita

adalimumab-atto

Celltrion/ Pfizer

Remicade (infliximab)

Janssen Biotech

4/5/16

Late November 2016

Renflexis

infliximab-abda

Merck/Samsung Bioepis

Remicade (infliximab)

Janssen Biotech

4/21/17

7/24/17

Cyltezo

adalimumabadbm

Boehringer Ingelheim

Humira (adalimumab)

Abbvie

8/29/17

Not yet launched

Mvasi

bevacizumabawwb

Amgen/ Allergan

Avastin (bevacizumab)

Genentech

9/14/17

7/18/19

Ogivri

trastuzumab-dkst Mylan/Biocon

Herceptin (trastuzumab)

Genentech

12/1/17

12/2/19

Ixifi

infliximab-qbtx

Pfizer

Remicade (infliximab)

Janssen Biotech

12/13/17

No plans to launch yet

Retacrit

epoetin alfa-epbx

Pfizer

Epogen (epoetin alfa) Procrit (epoetin alfa)

Amgen Janssen Products

12/1/17

12/2/19

Fulphila

pegfilgrastimjmdb

Mylan/Biocon

Neulasta (pegfilgrastim)

Amgen

6/4/18

7/26/18

Nivestym

filgrastim-aafi

Pfizer

Neupogen (filgrastim)

Amgen

7/20/18

10/1/18

Hyrimoz

adalimumabadaz

Sandoz

Humira (adalimumab)

Abbvie

10/31/18

Not yet launched

Udenyca

pegfilgrastimcbqv

Coherus BioSciences

Neulasta (pegfilgrastim)

Amgen

11/2/18

1/3/19

Truxima

rituximab-abbs

Celltrion/Teva

Rituxan (rituximab)

Genentech

11/28/18

11/11/19

Herzuma

trastuzumab-pkrb

Celltrion/Teva

Herceptin (trastuzumab)

Genentech

12/14/18

3/16/2020

Ontruzant

trastuzumab-dttb

Samsung Bioepis/ Merck

Herceptin (trastuzumab)

Genentech

1/18/19

4/15/2020

Trazimera

trastuzumab-qyyp

Pfizer

Herceptin (trastuzumab)

Genentech

3/11/19

2/19/2020

Eticovo

etanercept-ykro

Samsung Bioepis

Enbrel (etanercept)

Amgen

4/25/19

Not yet launched

Kanjinti

trastuzumabanns

Amgen/Allergan

Herceptin (trastuzumab)

Genentech

6/13/19

7/18/19

Zirabev

bevacizumabbvzr

Pfizer

Avastin (bevacizumab)

Genentech

6/28/19

1/6/2020

Hadlima

adalimumabbwwd

Samsung Bioepis

Humira (adalimumab)

Abbvie

7/23/19

Not yet launched

Ruxience

rituximabpvvr

Pfizer

Rituxan (rituximab)

Genentech

7/23/19

1/23/2020

Ziextenzo

pegfilgrastimbmez

Sandoz

Neulasta (pegfilgrastim)

Amgen

11/4/19

11/15/19

Abrilada

adalimumab-afzb

Pfizer

Humira (adalimumab)

Abbvie

11/18/19

Not yet launched

Avsola

infliximab-axxq

Amgen

Remicade (infliximab)

Janssen Biotech

12/6/19

Not yet launched

Nyvepria

pegfilgrastimapgf

Pfizer

Neulasta (pegfilgrastim)

Amgen

6/11/2020

Not yet launched

FDA – Food and Drug Administration *Approved biosimilars are listed in the chronological order of when they were first approved; those already launched are highlighted in the table.

8

| Insight


Some plans not only place biosimilars on formularies, they also put them on preferred tiers and exclude the reference biologic from coverage altogether.31-33 A clear example of this trend is Express Scripts 2020 National Formulary, which listed filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) on its “preferred alternatives” tier, while excluding the reference biologic, filgrastim (Neupogen), from coverage.31,32 Similarly, from five marketed biosimilars of trastuzumab (Herceptin), trastuzumab-anns (Kanjinti) and trastuzumab-qyyp (Trazimera) were placed on the preferred alternatives tier, while the reference biologic and its additional biosimilars were excluded.31,32

Figure 2: Listing of the biosimilar agents currently awaiting FDA decision as of June 2020.92-99 Biosimilar Name

Manufacturer of Biosimilar

Reference Biologic

Manufacturer of Reference Biologic

Projected BsUFA Target Date or Launch Date

Lapelga

Apotex

Pegfilgrastim (Neulasta)

Amgen

Unclear – Pending

Grastofil

Apotex

Filgrastim (Neupogen)

Amgen

Unclear – Pending

Filgrastim Kashiv

Adello Biologics

Filgrastim (Neupogen)

Amgen

Unclear – Pending

SB8

Samsung Bioepis/Merck

Bevacizumab (Avastin)

Genentech

September 2020

Bmab-100/ MYL-1402O

Biocon/Mylan

Bevacizumab (Avastin)

Genentech

December 27, 2020

ABP 798

Amgen/Allergan

Rituxan (rituximab)

Genentech

4Q:2020

MSB11455

Fresenius/Dr. Reddy’s

Pegfilgrastim (Neulasta)

Amgen

March 2021

Another payer, CVS, decided to go forward with filgrastim-aafi (Nivestym) as the only preferred formulary option in the filgrastim (Neupogen) category, thus excluding the reference biologic and other biosimilars in that drug class. CVS also elected to include pegfilgrastim (Neulasta) brand and only one biosimilar of pegfilgrastim out of three currently marketed (i.e., pegfilgrastim-cbqv [Udenyca]) on its formulary.31,33

FDA – Food and Drug Administration; BsUFA - Biosimilar User Fee Act

the agency’s “Orange Book”28 for listing biosimilars and reference biologic drugs. 27 It has since been upgraded, and on Feb. 24, 2020, the FDA announced the release of a searchable, publicly available Purple Book: Database of Licensed Biological Products, which allows any interested person to search reference biologics and associated launched biosimilars. It also shows if any of those biosimilars have interchangeability status. 29,30 The upgraded public-facing Purple Book is available at: https://purplebooksearch. fda.gov/?utm_campaign=SBIA%3A%20 FDA%20Releases%20Enhanced%20 Purple%20Book%20Database&utm_ medium=email&utm_source=Eloqua. 30

Test Your Knowledge Question 2: When was the guidance titled “Considerations in Demonstrating Interchangeability with a Reference Product” made final?

Current Payer Perspectives and Formulary Considerations for Marketed Biosimilars As of June 2020, 17 biosimilars are available in the U.S., several of which are marketed for a single reference biologic.3,4 For example, three biosimilars are currently available for pegfilgrastim (Neulasta) and five for trastuzumab (Herceptin).3,4 As a result, payers can select the most cost-effective biosimilar for a given reference biologic for formulary placement. In the past few years more insurers have begun to place biosimilars on their formularies as they recognize the associated cost-benefit of doing so.31

Note that while these biosimilar drugs are covered formulary agents, there are various controls in place to manage their use.33 For example, CVS placed prior authorization utilization controls and limited distribution via a specialty pharmacy only criteria for filgrastimaafi (Nivestym), pegfilgrastim-cbqv (Udenyca) and pegfilgrastim (Neulasta). The company also implemented quantity limits for pegfilgrastim-cbqv (Udenyca), and pegfilgrastim (Neulasta).33 In another show of payer support for biosimilars, America’s Health Insurance Plans (AHIP) specifically provided policy recommendations in a recent comment letter to the FDA

Figure 3: Listing of rejected biosimilars as of June 2020.100-102 Biosimilar Name

Manufacturer of Biosimilar

Reference Biologic

Manufacturer of the Reference Biologic

Date Biosimilar Rejected

GP2013

Sandoz/Novartis

Rituxan (rituximab)

Genentech

CRL on 5/2/18

TX01

Tanvex

Filgrastim (Neupogen)

Amgen

CRL on 9/25/19

CRL – Complete Response Letter

Premier Continuum of Care | October 2020

9


and the Federal Trade Commission (FTC) that called for increased use of biosimilars by all stakeholders.34 One of the recommendations, often echoed by healthcare providers, patients, and other relevant parties, is the increased education about biosimilars (especially the provision of accurate information about them) to facilitate biosimilar adoption across all healthcare settings and appropriate patient groups. Other notable recommendations were to fight anticompetitive behavior in the marketplace and to devote additional resources to

Figure 4: HCPCS codes for launched biosimilars as of June 2020.6 HCPCS Code

Short Description

HCPCS Code Dosage

Q5101

Injection, zarxio

1 MCG

Q5103

Injection, inflectra

10 MG

Q5104

Injection, renflexis

10 MG

Q5105

Inj Retacrit esrd on dialysis

100 UNITS

Q5106

Inj Retacrit nonesrd use

1000 UNITS

Q5107

Inj Mvasi 10 mg

10 MG

Q5108

Injection, fulphila

0.5 MG

Q5110

Nivestym

1 MCG

Q5111

Injection, udenyca 0.5 mg

0.5 MG

Q5112

Inj ontruzant 10 mg

10 MG

Q5113

Inj herzuma 10 mg

10 MG

Q5114

Inj ogivri 10 mg

10 MG

Q5115

Inj truxima 10 mg

10 MG

Q5116

Inj trazimera, 10 mg

10 MG

Q5117

Inj kanjinti, 10 mg

10 MG

Q5118

Inj zirabev, 10 mg

10 MG

Q5119

Inj ruxience, 10 mg

10 MG

HCPCS - Healthcare Common Procedure Coding System There is currently no unique assigned code for pegfilgrastim-bmez (Ziextenzo).7

10 |

Insight

improve stakeholder access to biosimilars, especially to those products that have interchangeability status.34

Test Your Knowledge Question 3: What were some of the recommendations AHIP provided to the FDA and FTC regarding biosimilars?

Current Provider and Patient Attitudes Towards Biosimilars/Barriers to Wider Adoption Providers and patients alike have been slowly warming to the use of biosimilars since their launch in 2015. A recent study, presented at American Society of Clinical Oncology (ASCO) 2020, demonstrated that the use of pegfilgrastim biosimilars, in particular, resulted in significant savings for oncology practices.35,36 Moreover, another study showed that use of filgrastim (Neupogen) biosimilars, such as filgrastim-sndz (Zarxio), proved costeffective in the oncology setting as well.37,38 However, physicians are still apprehensive about widely prescribing these drugs.5 One way to help overcome this hesitancy is to provide more clinical education about biosimilars, especially given the present lack of interchangeable products.5 Additionally, any perception about unfavorable medical reimbursement would create another barrier for physician use of biosimilars.12,39,40 And physicians who must follow a certain protocol as to what drugs are preferred within a medical practice face an additional deterrent if a desired biosimilar is not on the group’s approved list.12,41,42 Patients also continue to have reservations about biosimilars, despite the drugs’ increased availability in the U.S. market and sustained presence in other countries.43 In cases where patient cost-sharing (e.g., percent co-insurance necessary to be paid for a medication) is not a concern, patients are more likely to lean towards a branded reference product over a biosimilar.12,44 Recent surveys indicate that only a certain

percentage of patients feel they know or understand biosimilars.45 Several barriers to wider patient acceptance and use of biosimilars have been noticed. Most frequent ones include: • lack of education about biosimilars; • “nocebo” effect (patients feel worse after receiving a biosimilar agent due to prescriber’s negative attitude/ perception towards the drug in question); and • fear that moving away from the brand biologic to a biosimilar may spur an autoimmune disorder into a flare or cause an increase in side effects.43,45-48 Many patients also voice concerns about biosimilar safety and efficacy.45 Additional education, especially from trusted healthcare providers who are well versed in the biosimilar field, and can project that knowledge in a confident and positive manner to the patients, would help allay patient discomfort with biosimilars, and should facilitate wider adoption of biosimilars among patients.43,45,49

Test Your Knowledge Question 4: What are current prescriber attitudes towards biosimilars?

Conclusion Biosimilars are finally gaining momentum in the United States, with 17 of the approved 27 biosimilars already launched. New draft and final guidance documents from the FDA, as well as updated tools, are likely to pave the way for the anticipated increased adoption of and familiarity with biosimilars. Payers are starting to recognize the cost-benefit of placing biosimilars on formularies. And while prescribers and patients are warming to the use of biosimilars, more education is needed for both of those groups to significantly increase biosimilar use. Biosimilar interchangeability status should further their use by all relevant stakeholders.


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2. Novartis. 2015. “Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States.” News release. September 3. https://www.novartis.com/news/media-

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3. U.S. Food and Drug Administration, “Biosimilar Product Information,” accessed July 6, 2020. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. 4. Generics and Biosimilars Initiative (GaBI), “Approval and launch dates for US biosimilars,” June 19, 2020. http://www.gabionline.net/Reports/Approval-and-launch-datesfor-US-biosimilars.

5. “The FDA Pathway for Interchangeable Biosimilars,” American Journal of Managed Care/The Center for Biosimilars (December 27, 2019). https://www.centerforbiosimilars. com/insights/role-of-biosimilars-in-oncology/the-fda-pathway-for-interchangeable-biosimilars?utm_medium=email&utm_campaign=6-3-20_MYL-19-PB00088_ CFBSS_Role%20of%20Biosimilars%20in%20Oncology_Fulphila&utm_content=6-3-20_MYL-19-PB00088_CFBSS_Role%20of%20Biosimilars%20in%20Oncology_ Fulphila+CID_2e4cf8722a43d14538b892eb4faf4d44&utm_source=CM%20BioSim&utm_term=The%20FDA%20Pathway%20for%20Interchangeable%20Biosimilars.

6. 2020 Healthcare Common Procedure Coding System, HCPCS Q-Codes, accessed July 6, 2020. https://hcpcs.codes/q-codes/. 7. Sandoz Inc., Ziextenzo® (pegfilgrastim-bmez) website, “Sandoz One Source™ Commercial Co-Pay Program Operational Guide For Claim Submission and Payment,” accessed July 6, 2020. https://www.ziextenzo.com/pdf/SOS-Co-Pay-Operational-Guide.pdf.

8. U.S. Food and Drug Administration, draft guidance document, “Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry,” May 2019. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf.

9. Ropes & Gray LLP, “FDA Issues Final Guidance on ‘Considerations in Demonstrating Interchangeability With a Reference Product,’” May 23, 2019. 10. \https://www.ropesgray.com/en/newsroom/alerts/2019/05/FDA-Issues-Final-Guidance-Considerations-Interchangeability-Reference-Product. 11. Academy of Managed Care Pharmacy, Biosimilars Resource Center, “Interchangeability Study for Adalimumab Biosimilar Underway,” August 7, 2017. https://www.biosimilarsresourcecenter.org/interchangeability-study-adalimumab-biosimilar-underway/.

12. National Conference of State Legislatures, “State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars,” updated May 3, 2019. http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx#Mandatory.

13. 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/#b47-ptj4402054.

14. U.S. Food and Drug Administration, draft guidance document, “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other QualityRelated Considerations Guidance for Industry,” May 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeuticprotein-biosimilars-comparative-analytical-assessment-and-other-quality.

15. U.S. Food and Drug Administration, Notice, “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related

Considerations; Draft Guidance for Industry; Availability,” Federal Register 84 (May 22, 2019): 23569. https://www.federalregister.gov/documents/2019/05/22/2019-10667/ development-of-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other.

16. Regina Schaffer, “FDA publishes final guidance to streamline biosimilar insulin development,” Healio.com, February 20, 2020. https://www.healio.com/news/ endocrinology/20200220/fda-publishes-final-guidance-to-streamline-biosimilar-insulin-development#:~:text=Currently%2C%20any%20follow%2Don%20 insulins,drugs%2C%20according%20to%20the%20FDA.

17. Academy of Managed Care Pharmacy, Biosimilars Resource Center, “Is Biosimilar Insulin Available?” accessed July 6, 2020. https://www.biosimilarsresourcecenter.org/ faq/biosimilar-insulin-available/.

18. U.S. Food and Drug Administration, “Information for Patients About Regulatory Changes for Certain Biological Product Medications,” accessed July 6, 2020. 19. \https://www.fda.gov/media/135341/download. 20. Healthline.com, “Why Isn’t There More Affordable, Generic Insulin?” August 14, 2019. https://www.healthline.com/diabetesmine/why-not-more-affordable-genericinsulin#10.

21. U.S. Food and Drug Administration. 2020. “FDA Statement: Insulin Gains New Pathway to Increased Competition.” News release. March 23. https://www.fda.gov/newsevents/press-announcements/insulin-gains-new-pathway-increased-competition.

22. Sandra Levy, “Mylan, Biocon receive FDA nod for ‘follow-on’ insulin glargine Semglee,” Drug Store News (June 12, 2020). https://drugstorenews.com/mylan-biocon-receivefda-nod-follow-insulin-glargine-semglee.

23. “The first follow-on biologic insulin is launched in the US,” Pharmaceutical Technology (January 5, 2017). https://www.pharmaceutical-technology.com/research-reports/

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24. Aydin Harston, “Biosimilar Approvals Stall During COVID-19 Pandemic, But the Pipeline Grows,” Rothwell Figg Biologics and Biosimilars, June 8, 2020. https://www.biosimilarsip.com/2020/06/09/biosimilar-approvals-stall-during-covid-19-pandemic-but-the-pipeline-grows/.

25. U.S. Food and Drug Administration, “FDA In Brief: FDA Approves Insulin Product Providing Patients with an Additional Safe and Effective Treatment Option,” June 11, 2020. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-approves-insulin-product-providing-patients-additional-safe-and-effective-treatment.

26. U.S. Food and Drug Administration, draft guidance document, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products,” November 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-immunogenicity-considerations-biosimilar-and-interchangeable-insulinproducts.

27. U.S. Food and Drug Administration. 2019. “Statement on low-cost biosimilar and interchangeable protein products.” News release. December 17. 28. \ https://www.fda.gov/news-events/press-announcements/statement-low-cost-biosimilar-and-interchangeable-protein-products. 29. U.S. Food and Drug Administration, draft guidance document, “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry,” February 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilarsand-interchangeable-biosimilars-licensure-fewer-all-conditions-use-which-reference.

30. U.S. Food and Drug Administration, “Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” May 11, 2020. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ucm411418.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

31. U.S. Food and Drug Administration, “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book),” accessed July 6, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.

32. U.S. Food and Drug Administration, “FDA In Brief: FDA Enhances Purple Book to Support Transparency in Biosimilars,” February 24, 2020. https://www.fda.gov/newsevents/fda-brief/fda-brief-fda-enhances-purple-book-support-transparency-biosimilars#:~:text=The%20U.S.%20Food%20and%20Drug,products%20and%20their%20 reference%20products.

33. U.S. Food and Drug Administration, “Purple Book: Database of Licensed Biological Products,” accessed July 6, 2020. https://purplebooksearch.fda.gov/?utm_ campaign=SBIA%3A%20FDA%20Releases%20Enhanced%20Purple%20Book%20Database&utm_medium=email&utm_source=Eloqua.

34. “Express Scripts vs. CVS Health: Five Lessons From the 2020 Formulary Exclusions and Some Thoughts on Patient Impact (rerun),” Drug Channels (May 7, 2020). https://www.drugchannels.net/2020/05/express-scripts-vs-cvs-health-five.html.

35. Express Scripts, “2020 National Preferred Formulary Exclusions,” accessed July 6, 2020. https://www.express-scripts.com/art/open_enrollment/ DrugListExclusionsAndAlternatives.pdf.

Premier Continuum of Care | October 2020 11


36. CVS Caremark, “CVS Caremark®Value Formulary – Effective as of 07/01/2020,” accessed July 6, 2020. https://www.caremark.com/portal/asset/Value_Formulary.pdf. 37. America’s Health Insurance Plans, “AHIP Submits Policy Recommendations to FDA and FTC on Supporting a Competitive Biosimilars Marketplace,” April 9, 2020. https://www.ahip.org/ahip-submits-policy-recommendations-to-fda-and-ftc-on-supporting-a-competitive-biosimilars-marketplace/.

38. Tony Hagen, “Biosimilar Pegfilgrasim Cuts OCM Expense, ASCO Study Finds,” American Journal of Managed Care/The Center for Biosimilars (May 28, 2020).

https://www.centerforbiosimilars.com/conferences/asco-2020/biosimilar-pegfilgrasim-cuts-ocm-expense?utm_medium=email&utm_campaign=5-30-20_CFBE_Weekly%20 eNews&utm_content=5-30-20_CFBE_Weekly%20eNews+CID_36f083f5ef763ef1d0092f32df6ab24d&utm_source=CM%20BioSim&utm_term=Biosimilar%20Pegfilgrastim%20 Cuts%20OCM%20Expense%20ASCO%20Study%20Finds.

39. Jennifer Webster et al. “Cost savings of biosimilar pegfilgrastim in a Medicare OCM population” (presentation at ASCO20 Virtual Scientific Program; May 30-31, 2020). Journal of Clinical Oncology 38 (2020; supplement; abstract e19362). https://meetinglibrary.asco.org/record/190722/abstract.

40. Skylar Jeremias, “Filgrastim Agent Is Cost-Effective in NSCLC, According to ASCO Study,” American Journal of Managed Care/The Center for Biosimilars (May 31,

2020). https://www.centerforbiosimilars.com/conferences/asco-2020/filgrastim-agent-is-costeffective-in-nsclc-according-to-asco-study?utm_medium=email&utm_ campaign=6-2-20_CFBE_ASCO%20Conference%20Coverage%20Recap%20eNL&utm_content=6-2-20_CFBE_ASCO%20Conference%20Coverage%20Recap%20 eNL+CID_4957efc55599d095710f2b3273d04cf3&utm_source=CM%20BioSim&utm_term=Filgrastim%20Agent%20Is%20Cost-Effective%20in%20NSCLC%20According%20 to%20ASCO%20Study.

41. Edward C. Li et al. “Cost-effectiveness of filgrastim-sndz as primary prophylaxis (PP) versus secondary prophylaxis (SP) to prevent chemotherapy-induced febrile

neutropenia (FN) in non-small cell lung cancer (NSCLC) patients at intermediate risk” (presentation at ASCO20 Virtual Scientific Program; May 30-31, 2020). Journal of Clinical Oncology 38 (2020; supplement; abstract e19401). https://meetinglibrary.asco.org/record/190652/abstract.

42. Cecile Remuzat et al. “Key drivers for market penetration of biosimilars in Europe,” Journal of Market Access & Health Policy 5 no. 1 (January 30, 2017). DOI: 10.1080/20016689.2016.1272308.

43. Joseph P Fuhr et al. “Product naming, pricing, and market uptake of biosimilars,” Generics and Biosimilars Initiative Journal (GaBI Journal) 4 no. 2 (2015): 64-71. doi: 10.5639/ gabij.2015.0402.015.

44. Stephen Barlas. “Final Rule on ACOs Raises Concerns About Medication Cost-Shifting: Pharmacists to Play a Secondary Role in New Physician–Hospital Organizations,” P & T 36 no. 12 (December 2011): 780.

45. Erwin A. Blackstone et al. “The economics of Medicare accountable care organizations,” American Health & Drug Benefits 9 no. 1 (February 2016): 11–19. 46. HoUng Kim et al. “The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases,” Drugs 80 no. 2 (2020): 99–113. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7007415/.

47. Michael McShea et al. “Biosimilars and Follow-on Biologics: A Pharmacist Opportunity,” Pharmacy Times (November 16, 2016). https://www.pharmacytimes.com/ publications/issue/2016/November2016/biosimilars-and-followon-biologics-a-pharmacist-opportunity.

48. Biologics Prescribers Collaborative, “Patients’ Understanding of Biological Medicines: Survey Findings,” March 2020. https://biologicsprescribers.org/wp-content/ uploads/2020/03/BPC_Survey-Report_March-2020.pdf.

49. Lars Erik Kristensen et al. “Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent,” BioDrugs 32 no. 5 (October 2018): 397–404. doi: 10.1007/s40259-018-0306-1.

50. Piotr Wiland et al. “Biosimilar switching—current state of knowledge,” Reumatologia 56 no. 4 (2018): 234–242. doi: 10.5114/reum.2018.77975. 51. A. Teeple et al. “Patient attitudes about non-medical switching to biosimilars: results from an online patient survey in the United States,” Current Medical Research and Opinion 35 no. 4 (April 2019): 603-609. doi: 10.1080/03007995.2018.1560221.

52. Mourad Rezk et al. “Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect,” Rheumatology and Therapy 4 no. 2 (December 2017): 209–218. doi: 10.1007/ s40744-017-0085-z.

53. Novartis. 2015. “FDA approves first biosimilar Zarxio™ (filgrastim-sndz) from Sandoz.” News release. March 6. http://www.sandoz.com/media_center/press_releases_news/ global_news/2015_03_06_fda_approves_first_biosimilar_zarxio_from_sandoz.shtml.

54. U.S. Food and Drug Administration. 2016. “FDA approves Inflectra, a biosimilar to Remicade.” News release. April 5. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm494227.htm.

55. Pfizer Inc. 2016. “Pfizer announces the U.S. availability of biosimilar Inflectra® (infliximab-dyyb).” News release. October 17. https://www.pfizer.com/news/press-release/ press-release-detail/pfizer_announces_the_u_s_availability_of_biosimilar_inflectra_infliximab_dyyb.

56. U.S. Food and Drug Administration. 2016. “FDA approves Erelzi, a biosimilar to Enbrel.” News release. August 30. https://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm518639.htm.

57. U.S. Food and Drug Administration. 2016. “FDA approves Amjevita, a biosimilar to Humira.” News release. September 23. https://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm522243.htm.

58. Stanton Mehr, “FDA Approves Second Infliximab Biosimilar,” Biosimilars Review & Report (April 24, 2017). https://biosimilarsrr.com/2017/04/24/fda-approves-secondinfliximab-biosimilar/.

59. Merck Sharp & Dohme Corp. 2017. “Merck Announces U.S. Launch of Renflexis™ (infliximab-abda), a Biosimilar of Remicade, for All Eligible Indications.” News release. July

24. https://investors.merck.com/news/press-release-details/2017/Merck-Announces-US-Launch-of-RENFLEXIS-infliximab-abda-a-Biosimilar-of-Remicade-for-All-EligibleIndications/default.aspx.

60. Boehringer Ingelheim Pharmaceuticals, Inc. 2017. “Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for CyltezoTM (adalimumab-adbm), a biosimilar to Humira®, for the treatment of multiple chronic inflammatory diseases.” News release. August 29. https://www.boehringer-ingelheim.us/press-release/boehringeringelheim-pharmaceuticals-inc-receives-fda-approval-cyltezo-adalimumab.

61. U.S. Food and Drug Administration. 2017. “FDA approves first biosimilar for the treatment of cancer.” News release. September 14. https://www.fda.gov/newsevents/ newsroom/pressannouncements/ucm576112.htm.

62. Amgen Inc. 2019. “Amgen And Allergan’s Mvasi™ (bevacizumab-awwb) and Kanjinti™ (trastuzumab-anns) Now Available In The United States.” News release. July 18.

https://www.amgen.com/media/news-releases/2019/07/amgen-and-allergans-mvasi-bevacizumabawwb-and-kanjinti-trastuzumabanns-now-available-in-the-united-states/.

63. U.S. Food and Drug Administration. 2017. “FDA approves first biosimilar for the treatment of certain breast and stomach cancers.” News release. December 1. https://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm.

64. Mylan N.V. 2019. “Mylan and Biocon Launch Trastuzumab Biosimilar, Ogivri™ (trastuzumab-dkst), in the U.S.” News release. December 2. http://newsroom.mylan.com/201912-02-Mylan-and-Biocon-Launch-Trastuzumab-Biosimilar-Ogivri-TM-trastuzumab-dkst-in-the-U-S.

65. Pfizer Inc. 2017. “FDA approves new Pfizer biosimilar.” News release. December 13. https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_new_ pfizer_biosimilar.

66. U.S. Food and Drug Administration. 2018. “FDA approves first epoetin alfa biosimilar for the treatment of anemia.” News release. May 15. https://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm607703.htm.

67. Samantha DiGrande, “Pfizer Launches Epoetin Alfa Biosimilar, Retacrit, at 33.5% Discount to Reference Epogen,” American Journal of Managed Care/The Center for

Biosimilars (November 14, 2018). https://www.centerforbiosimilars.com/news/pfizer-launches-epoetin-alfa-biosimilar-retacrit-at-335-discount-to-reference-epogen.

68. U.S. Food and Drug Administration. 2018. “FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.” News release. June 4. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm.

69. “Biocon: Mylan Has Launched Fulphila™ (pegfilgrastim-jmdb) Biosimilar in the U.S.,” Big Molecule Watch (July 26, 2018). https://www.bigmoleculewatch.com/2018/07/26/ biocon-mylan-has-launched-fulphila-pegfilgrastim-jmdb-biosimilar-in-the-u-s/.

70. Pfizer Inc. 2018. “U.S. FDA approves Pfizer’s biosimilar Nivestym™ (filgrastim-aafi).” News release. July 20. https://www.pfizer.com/news/press-release/press-releasedetail/u_s_fda_approves_pfizer_s_biosimilar_nivestym_filgrastim_aafi-0.

71. Kelly Davio, “Pfizer Launches Biosimilar Filgrastim, Nivestym, at a Substantial Discount,” American Journal of Managed Care/The Center for Biosimilars (October 3, 2018).

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https://www.centerforbiosimilars.com/news/pfizer-launches-biosimilar-filgrastim-nivestym-at-a-substantial-discount.

72. Novartis. 2018. “Sandoz receives US FDA approval for biosimilar Hyrimoz™ (adalimumab-adaz).” News release. October 31. https://www.sandoz.com/news/media-releases/ sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz.

73. Coherus BioSciences, Inc. 2018. “U.S. FDA Approves Udenyca™ (pegfilgrastim-cbqv).” News release. November 2. https://investors.coherus.com/news-releases/news-releasedetails/us-fda-approves-udenycatm-pegfilgrastim-cbqv.

74. Center for Biosimilars Staff, “Coherus Confirms That It Has Launched Its Pegfilgrastim Biosimilar, Udenyca,” American Journal of Managed Care/The Center for Biosimilars (January 4, 2019). https://www.centerforbiosimilars.com/news/coherus-confirms-that-it-has-launched-its-pegfilgrastim-biosimilar-udenyca.

75. U.S. Food and Drug Administration. 2018. “FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma.” News release. November 28. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627009.htm.

76. Kelly Davio, “First Rituximab Biosimilar, Truxima, Launches in the United States,” American Journal of Managed Care/The Center for Biosimilars (November 7, 2019).

https://www.centerforbiosimilars.com/news/first-rituximab-biosimilar-truxima-launches-in-the-united-states#:~:text=Teva%20and%20Celltrion%20have%20 announced,reach%20patients%20on%20November%2011.&text=The%20product%20will%20begin%20to%20reach%20patients%20on%20November%2011.,-Truxima%20 will%20be.

77. U.S. Food and Drug Administration, “FDA approves Herzuma as a biosimilar to Herceptin,” December 18, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm628724.htm.

78. Tony Hagen, “Teva, Celltrion Launch Fourth Trastuzumab Biosimilar,” American Journal of Managed Care/The Center for Biosimilars (March 16, 2020).

https://www.centerforbiosimilars.com/news/teva-celltrion-launch-fourth-trastuzumab-biosimilar#:~:text=Teva%20Pharmaceuticals%20USA%20and%20Celltrion,cost%20 of%20reference%20product%20Herceptin.&text=Three%20months%20after%20its%20FDA,trastuzumab%20biosimilar%20has%20been%20launched.

79. Samantha DiGrande, “FDA Approves Third Trastuzumab Biosimilar, Ontruzant,” American Journal of Managed Care/The Center for Biosimilars (January 18, 2019). https://www.centerforbiosimilars.com/news/fda-approves-third-trastuzumab-biosimilar-ontruzant.

80. Merck & Co., Inc. 2020. “Merck Announces US Launch of Ontruzant® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab).” News release. April 15.

https://investors.merck.com/news/press-release-details/2020/Merck-Announces-US-Launch-of-ONTRUZANT-trastuzumab-dttb-a-Biosimilar-of-Herceptin-trastuzumab/ default.aspx#:~:text=KENILWORTH%2C%20N.J.%2D%2D(BUSINESS%20WIRE,420%20mg%20multiple%2Ddose%20vials.

81. Pfizer Inc. 2019. “U.S. FDA Approves Pfizer’s Oncology Biosimilar Trazimera™ (trastuzumab-qyyp), a Biosimilar to Herceptin®1.” News release. March 11.

https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_oncology_biosimilar_trazimera_trastuzumab_qyyp_a_biosimilar_to_herceptin_1.

82. Center for Biosimilars Staff, “Pfizer Launches Trastuzumab Biosimilar,” American Journal of Managed Care/The Center for Biosimilars (February 20, 2020).

https://www.centerforbiosimilars.com/news/pfizer-launches-trastuzumab-biosimilar#:~:text=Pfizer’s%20trastuzumab%20biosimilar%20to%20Herceptin,gastric%20or%20 gastroesophageal%20junction%20adenocarcinoma.

83. Kelly Davio, “FDA Approves Samsung Bioepis’ Etanercept Biosimilar, Eticovo,” American Journal of Managed Care/The Center for Biosimilars (April 26, 2019). https://www.centerforbiosimilars.com/news/fda-approves-samsung-bioepis-etanercept-biosimilar-eticovo.

84. Amgen Inc. 2019. “FDA Approves Amgen And Allergan’s Kanjinti™ (trastuzumab-anns), A Biosimilar To Herceptin® (trastuzumab).” News release. June 13. https://www.

amgen.com/media/news-releases/2019/06/fda-approves-amgen-and-allergans-kanjinti-trastuzumabanns-a-biosimilar-to-herceptin-trastuzumab/#:~:text=THOUSAND%20 OAKS%2C%20Calif.%20%2C%20June,for%20the%20treatment%20of%20HER2%2D.

85. Pfizer Inc. 2019. “Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, Zirabev™ (bevacizumab-bvzr).” News release. June 28. https://www.pfizer.com/news/ press-release/press-release-detail/pfizer_receives_u_s_fda_approval_for_its_oncology_biosimilar_zirabev_bevacizumab_bvzr#:~:text=(NYSE%3APFE)%20today%20 announced,metastatic%20non%2Dsquamous%20non%2Dsmall.

86. Allison Inserro, “Pfizer Launches Bevacizumab Biosimilar, Zirabev, in the United States,” American Journal of Managed Care/The Center for Biosimilars (January 6, 2020). https://www.centerforbiosimilars.com/news/pfizer-launches-bevacizumab-biosimilar-zirabev-in-the-united-states.

87. Academy of Managed Care Pharmacy, Biosimilars Resource Center, “FDA Approves Hadlima, Fourth Biosimilar to Humira,” July 24, 2019. https://www. biosimilarsresourcecenter.org/fda-approves-hadlima/.

88. Pfizer Inc. 2019. “FDA Approves Pfizer’s Biosimilar, Ruxience™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions.” News release. July 23. https://www. pfizer.com/news/press-release/press-release-detail/fda_approves_pfizer_s_biosimilar_ruxience_rituximab_pvvr_for_certain_cancers_and_autoimmune_conditions.

89. Kelly Davio, “Pfizer Announces Launch Dates for 2 More Anticancer Biosimilars: Ruxience and Trazimera,” American Journal of Managed Care/The Center for

Biosimilars (October 29, 2019). https://www.centerforbiosimilars.com/news/pfizer-announces-launch-dates-for-2-more-anticancer-biosimilars-ruxience-andtrazimera#:~:text=According%20to%20Bourla%2C%20Ruxience%20will,%2C%20on%20December%2031%2C%202019.

90. Kelly Davio, “FDA Approves Sandoz’s Pegfilgrastim Biosimilar, Ziextenzo,” American Journal of Managed Care/The Center for Biosimilars (November 5, 2019). https://www.centerforbiosimilars.com/news/fda-approves-sandozs-pegfilgrastim-biosimilar-ziextenzo.

91. Kelly Davio, “Novartis Confirms It Has Launched Biosimilar Pegfilgrastim, Ziextenzo, in the United States,” American Journal of Managed Care/The Center for Biosimilars (November 15, 2019). https://www.centerforbiosimilars.com/news/novartis-confirms-it-has-launched-biosimilar-pegfilgrastim-ziextenzo-in-the-united-states.

92. Pfizer Inc. 2019. “FDA Approves Pfizer’s Biosimilar, Abrilada™ (adalimumab-afzb) for Multiple Inflammatory Conditions.” News release. November 18. https://www.pfizer. com/news/press-release/press-release-detail/fda_approves_pfizer_s_biosimilar_abrilada_adalimumab_afzb_for_multiple_inflammatory_conditions.

93. Amgen Inc. 2019. “FDA Approves Amgen’s Avsola™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab).” News release. December 6. https://www.amgen. com/media/news-releases/2019/12/fda-approves-amgens-avsola-infliximabaxxq-for-the-same-indications-as-remicade-infliximab/.

94. Pfizer Inc. 2020. “FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, Nyvepria™ (pegfilgrastim-apgf ).” News release. June 11. https://investors.pfizer.com/ investor-news/press-release-details/2020/FDA-Approves-Pfizers-Oncology-Supportive-Care-Biosimilar-NYVEPRIA-pegfilgrastim-apgf/default.aspx.

95. Apotex Inc. 2015. “Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Grastofil™).” News release. February 17. https://www. prnewswire.com/news-releases/apotex-announces-fda-has-accepted-for-filing-its-biosimilar-application-for-filgrastim-grastofil-292257431.html.

96. Apotex Inc. 2014. “Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Pegfilgrastim.” News release. December 17. https://www.prnewswire.com/ news-releases/apotex-announces-fda-has-accepted-for-filing-its-biosimilar-application-for-pegfilgrastim-286092751.html.

97. IPD Analytics Clinical Pipeline, accessed July 6, 2020. www.ipdanalytics.com. 98. Generics and Biosimilars Initiative (GaBI), “FDA accepts application for Adello’s filgrastim biosimilar,” June 10, 2017. http://www.gabionline.net/Biosimilars/News/ FDA-accepts-application-for-Adello-s-filgrastim-biosimilar.

99. Samsung Bioepis Co., Ltd. 2019. “FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate.” News release. November 19. https://www.biospace.com/ article/releases/fda-accepts-samsung-bioepis-bla-for-sb8-bevacizumab-biosimilar-candidate-/.

100. Mylan N.V. 2020. “U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Bevacizumab for Review.” News release. March 9. https://investor.mylan.com/news-releases/news-release-details/us-fda-accepts-biologics-license-application-bla-mylan-and-1.

101. Amgen Inc. 2019. “Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug

Administration.” News release. December 19. https://www.amgen.com/media/news-releases/2019/12/amgen-and-allergan-submit-biologics-license-application-for-abp798-biosimilar-candidate-to-rituxan-rituximab-to-us-food-and-drug-administration/.

102. Fresenius Kabi AG. 2020. “FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim.” News release. May 27. https://www.fresenius-kabi.com/news/regulatory-submission-for-pegfilgrastim-biosimilar-accepted-for-review-by-FDA.

103. Kelly Davio, “FDA Rejects Sandoz’s Proposed Rituximab Biosimilar,” American Journal of Managed Care/The Center for Biosimilars (May 2, 2018). https://www.centerforbiosimilars.com/news/fda-rejects-sandozs-proposed-rituximab-biosimilar.

104. Kelly Davio, “Sandoz Abandons Its US Biosimilar Rituximab Plans,” American Journal of Managed Care/The Center for Biosimilars (November 5, 2018). https://www.centerforbiosimilars.com/news/sandoz-abandons-its-us-biosimilar-rituximab-plans.

105. Kelly Davio, “FDA Rejects Tanvex’s Proposed Filgrastim Biosimilar, TX01,” American Journal of Managed Care/The Center for Biosimilars (October 8, 2019). https://www.centerforbiosimilars.com/news/fda-rejects-tanvexs-proposed-filgrastim-biosimilar-tx01.

Premier Continuum of Care | October 2020 13


Category Spotlight: Purchased Services

With COVID-19 creating an uncertain outlook for the financial health of organizations across the country, adopting a purchased services procurement strategy can help you achieve short-term savings while creating long-term value for your patients. Beyond the savings opportunities in this category, organizations can also unlock operational efficiencies and make improvements to the patient experience. This is critical in today’s environment as the industry reacts to supply shortages and adapts to market changes. Organizations must begin to look beyond traditional negotiated cost savings categories and broaden their scope to effectively manage utilization in a full range of products, including purchased services. Doing so will help provide an economic defense during these challenging times. Premier is here to help. Our industry-leading purchasing portfolio includes a comprehensive set of purchased services supplier contracts that can help restore and expand operations and position your organization strongly for the coming years. To learn more about our purchased services portfolio, please contact your Premier representative or our Customer Care Team at (888) 258-3273.

14 |

Insight


CATEGORY SPOTLIGHT

Purchased Services Contract Listing Contract Number

Contract Title

Contracted Supplier

Contract Expiration Date

PP-SV-200

Advertising & Marketing Services

American Solutions For Business

12/31/21

PP-SV-201

Advertising & Marketing Services

BVK Direct

12/31/21

PP-SV-202

Advertising & Marketing Services

Creative Graphics Management

12/31/21

PP-SV-203

Advertising & Marketing Services

Modern Postcard

12/31/21

PP-SV-204

Advertising & Marketing Services

Netsertive

12/31/21

PP-SV-230

AP Audit Services

Plan2Account

08/31/22

PP-SV-229

AP Audit Services

SpendMend

08/31/22

PP-SV-177

Background Check Services

Accutrace

02/28/21

PP-SV-178

Background Check Services

JD Palatine

02/28/21

PP-SV-179

Background Check Services

MBI Worldwide Background Checks and Drug Screening

02/28/21

PP-SV-180

Background Check Services

PreCheck

02/28/21

PP-SV-181

Background Check Services

Pre-Employ.com

02/28/21

PP-SV-182

Background Check Services

Private Eyes Screening Group

02/28/21

PP-SV-241

Call Center Services

AnswerNet

09/30/22

PP-SV-244

Call Center Services

Voice Products

09/30/22

PP-SV-232

Clinical Equipment Repair & Maintenance Services

Canon Medical Systems

09/30/22

PP-SV-234

Clinical Equipment Repair & Maintenance Services

General Electric Company

09/30/22

PP-SV-235

Clinical Equipment Repair & Maintenance Services

Partssource

09/30/22

PP-SV-236

Clinical Equipment Repair & Maintenance Services

Philips Healthcare

09/30/22

PP-SV-238

Clinical Equipment Repair & Maintenance Services

Siemens Medical Solutions

09/30/22

PP-SV-237

Clinical Equipment Repair & Maintenance Services

Sodexo Operations

09/30/22

PP-SV-292

Collaborative Healthcare Asset Services

Cohealo

03/31/23

PP-SV-274

Courier & Logistic Services

Airspace Technologies

05/31/23

PP-SV-290

Courier & Logistic Services

Neopost

05/31/23

PP-SV-276

Courier & Logistic Services

Reliable Delivery

05/31/23

PP-SV-293

Credit Card Services

Merchant Advocate

08/31/23

PP-SV-185

Credit Card Services

Paymentus Corporation

02/28/23

PP-SV-183

Credit Card Services

Solupay Consulting

02/28/23

PP-SV-184

Credit Card Services

Sun Communications

02/28/23

PP-SV-186

Credit Card Services

USPAY Group

02/28/23

PP-MM-485

Digital Media & Resource Materials

Hilton Publishing

08/31/21

PP-SV-211

Environmental & Facility Management Services

Aramark Uniform and Career Apparel

03/31/22

PP-SV-215

Environmental & Facility Management Services

Compass One Healthcare

03/31/22

PP-SV-212

Environmental & Facility Management Services

FacilitySource

03/31/22

PP-SV-213

Environmental & Facility Management Services

G4S Secure Solutions

03/31/22

PP-SV-216

Environmental & Facility Management Services

Medtegrity Medical Laundry

03/31/22

PP-SV-214

Environmental & Facility Management Services

Sodexo Operations

03/31/22

PP-MM-700

Equipment Leasing & Financial Services

First Financial Healthcare Solutions

03/31/22

PP-SV-218

Equipment Recycling & eWaste Management Services

Cascade Asset Management

04/30/22

PP-SV-219

Equipment Recycling & eWaste Management Services

Centurion Service Group

04/30/22

PP-SV-220

Equipment Recycling & eWaste Management Services

Handle

04/30/22

Premier Continuum of Care | October 2020 15


CATEGORY SPOTLIGHT

Contract Number

Contract Title

Contracted Supplier

Contract Expiration Date

PP-SV-221

Equipment Recycling & eWaste Management Services

Information Systems Resources

04/30/22

PP-SV-222

Equipment Recycling & eWaste Management Services

TekYard Medical

04/30/22

PP-SV-217

Equipment Recycling & eWaste Management Services

Wistron Corporation

04/30/22

PP-SV-252

Executive Recruiting

AMN Healthcare

01/31/23

PP-SV-253

Executive Recruiting

MWIDM

01/31/23

PP-SV-254

Executive Recruiting

Premier Medical Staffing Services

01/31/23

PP-SV-255

Executive Recruiting

Witt/Kieffer

01/31/23

PP-SV-225

Hard Copy Document Shredding & Media Destruction Services

Rapid Shred

07/31/22

PP-SV-224

Hard Copy Document Shredding & Media Destruction Services

Stericycle

07/31/22

PP-SV-266

Healthcare Technology Assessment Resources

ECRI Institute

05/31/23

PP-SV-267

Healthcare Technology Assessment Resources

Inmar Rx Solutions

05/31/23

PP-MM-727

Inbound & Outbound Freight

FedEx

05/31/22

PP-SV-199

Intraoperative Neuromonitoring Services

Nuvasive Clinical Services Monitoring

10/31/21

PP-SV-190

Landscaping & Grounds Maintenance Services

BrightView Landscapes

10/31/21

PP-SV-193

Landscaping & Grounds Maintenance Services

FacilitySource

10/31/21

PP-SV-191

Landscaping & Grounds Maintenance Services

Grounds Control

10/31/21

PP-SV-264

Mailing Services

L5 Express

04/30/23

PP-SV-265

Mailing Services

Neopost

04/30/23

PP-SV-223

Mobile Imaging Services

Shared Imaging

05/31/22

PP-SV-278

Moving Services

Armstrong Relocation

07/31/23

PP-SV-279

Moving Services

Atlas Van Lines

07/31/23

PP-SV-277

Moving Services

Beltmann Integrated Logistics

07/31/23

PP-SV-280

Moving Services

Sirva Worldwide

07/31/23

PP-SV-281

Office Supplies & Business Services

American Office Products Distributors

07/31/23

PP-SV-282

Office Supplies & Business Services

Essendant

07/31/23

PP-SV-283

Office Supplies & Business Services

Guy Brown

07/31/23

PP-SV-284

Office Supplies & Business Services

Office Depot

07/31/23

PP-SV-285

Office Supplies & Business Services

Staples

07/31/23

PP-SV-286

Office Supplies & Business Services

Tech Assurance

07/31/23

PP-SV-245

Off-site Storage Services

Deliverex

01/31/23

PP-SV-246

Off-site Storage Services

National Records Centers

01/31/23

PP-SV-247

Off-site Storage Services

Reliance Information Consulting

01/31/23

PP-SV-251

Outsourced Sterilization Services

STERIS Instrument Management Services

12/31/22

PP-SV-259

Pest Elimination Services

Orkin

02/28/23

PP-SV-261

Pest Elimination Services

Rentokil North America

02/28/23

PP-SV-260

Pest Elimination Services

Terminix International Company

02/28/23

PP-SV-207

Purchasing Cards & Electronic Payables

American Express Company

12/31/21

PP-SV-206

Purchasing Cards & Electronic Payables

CPS Payment Services

12/31/21

PP-SV-208

Purchasing Cards & Electronic Payables

PNC Bank National Association

12/31/21

PP-SV-209

Purchasing Cards & Electronic Payables

Us Bancorp

12/31/21

16 |

Insight


CATEGORY SPOTLIGHT

Contract Number

Contract Title

Contracted Supplier

Contract Expiration Date

PP-SV-239

Reusable Surgical Linen & Gown Reprocessing Services

Novo Health Services

12/31/22

PP-SV-240

Reusable Surgical Linen & Gown Reprocessing Services

Repaul Textiles

12/31/22

PP-SV-226

Ride Sharing Services

Kaizen Health

01/31/21

PP-SV-189

Ride Sharing Services

Lyft

01/31/21

PP-FA-829

Security Systems & Services

Metrasens

06/30/22

PP-MM-738

Service Awards & Promotional Products

American Solutions For Business

08/31/22

PP-MM-739

Service Awards & Promotional Products

Positive Promotions

08/31/22

PP-MM-740

Service Awards & Promotional Products

Staples

08/31/22

PP-MM-764

Service Awards & Promotional Products

Taylor Healthcare

08/31/22

PP-SV-268

Sleep Diagnostic Services

SleepEx LabRetriever

05/31/23

PP-SV-257

Sterile Reprocessing

Medline Industries

01/31/23

PP-SV-256

Sterile Reprocessing

S2S Global

01/31/23

PP-SV-258

Sterile Reprocessing

Stryker Sustainability Solutions

01/31/23

PP-MM-702

Third Party Freight Management

Cardinal Health 200

05/31/22

PP-MM-704

Third Party Freight Management

L5 Express

05/31/22

PP-MM-703

Third Party Freight Management

Triose

05/31/22

PP-SV-195

Transcription Services

Acusis

12/31/21

PP-SV-196

Transcription Services

Chase Transcriptions

12/31/21

PP-SV-197

Transcription Services

MDofficeManager

12/31/21

PP-SV-198

Transcription Services

Mediscribes

12/31/21

PP-SV-270

Translation & Interpretation Services

Globo Language Solutions

06/30/23

PP-SV-271

Translation & Interpretation Services

Language Services Associates

06/30/23

PP-SV-272

Translation & Interpretation Services

Propio Language Services

06/30/23

PP-SV-269

Translation & Interpretation Services

Stratus Video

06/30/23

PP-SV-273

Translation & Interpretation Services

United Language Group

06/30/23

PP-SV-168

Vehicle Rental Services

Hertz Corporation

10/31/23

PP-SV-288

Water Savings Services

UgMO Technologies

04/30/23

PP-SV-174

Workforce Solutions - Human Resources Technology

Medefis

03/31/21

PP-SV-187

Workforce Solutions - Human Resources Technology

Shiftwise

03/31/21

PP-SV-188

Workforce Solutions - Human Resources Technology (Non-VMS)

Job Market Maker

03/31/21

PP-SV-165

Workforce Solutions - Managed Service Providers

AMN Healthcare

03/31/25

PP-SV-289

Workforce Solutions - Managed Service Providers

Randstad Sourceright

03/31/25

PP-SV-173

Workforce Solutions - Recruitment Process Outsourcing

AMN Healthcare

03/31/25

PP-SV-175

Workforce Solutions - Staffing

AMN Healthcare

03/31/25

SD-SV-007

Workforce Solutions - Staffing

Cynet Systems

03/31/21

SD-SV-006

Workforce Solutions - Staffing

Tech Army

03/31/21

SD-SV-005

Workforce Solutions - Staffing

US Tech Solutions

03/31/21

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.

Premier Continuum of Care | October 2020 17


e

National Meeting & Expo October 17 - 20, 2021 Arizona Biltmore Phoenix, AZ

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Insight


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Insight - Premier Continuum of Care - October 2020 by Innovatix - Issuu