Update on Biosimilars
Sarah Nichelson, JD
HOPA’s Health Policy Manager
HOPA’s Issue Brief on Biosimilars: Improving Access and Decreasing Costs for Cancer Patients
In May 2019, the HOPA Board of Directors approved an updated issue brief on biosimilars. HOPA uses issue briefs (two-page documents that summarize a topic or problem) during visits with Congressional leaders and staffers as a way to update them on a topic of importance to HOPA. The biosimilars work group—members Kim Campbell, Chris Campen, Sarah Cimino, and Bhavesh Shah, led by chair Ali McBride—began the task of updating the issue brief in late December 2018.
The first issue brief on biosimilars was developed in 2014 and then revised in 2015. The world of biosimilars has changed since 2014, and the 2019 issue brief reflects the new reality, making the following recommendations—all with the goal of ensuring appropriate and affordable access to, and safe use of, biosimilars:
- Support the elimination of manufacturers’ rebate incentives for payers and pharmacy benefit managers that restrict access to biosimilars. This restricted access inhibits providers’ decision making regarding patients’ access to lower-cost treatments and increases financial toxicity for patients.
- Support parity access to all biosimilars with third-party payers, which would eliminate preference for a particular biosimilar product within a class. This change would eliminate undue administrative, financial, and legal liabilities that arise with increased complexity in inventory management.
- Promote education on the scientific, regulatory, pharmacovigilance, and practice implications of using biosimilars. This information should be provided to all healthcare stakeholders, but especially to providers, payers, and patients.
- Infrastructure should be improved to facilitate provider reporting and monitoring of any unique toxicities that are observed after the biological drugs have been approved.
- Future legislation on biosimilar substitution should be developed with input from state boards of pharmacy, local pharmacy organizations, and healthcare providers. Key parameters in current law regarding generic substitution should be a basis for the legislative discussion.
To learn more, read the issue brief on HOPA’s website at hoparx.org/images/hopa/advocacy/Issue-Briefs.
S. 1681: Advancing Education on Biosimilars Act of 2019
On May 23, 2019, Senators Michael Enzi (R-WY) and Margaret Hassan (D-NH) introduced a bill that would create a website to house educational materials on biosimilars. This bill is important because it acknowledges the need to educate providers, patients, and families on the use of biosimilars. The bill provides direction on the format and type of content for the website in light of the recognition that different audiences will have different educational needs and that the educational material should be tailored to meet those needs. If the bill passes, it is possible that HOPA would have the opportunity to provide expertise and content for the website. In addition, a Merit-Based Incentive Payment System (MIPS)–eligible clinician may be able to earn points toward a MIPS score by completing continuing medical education programs created under this act. HOPA will continue to monitor this bill and provide updates.
In May 2019, the U.S. Food and Drug Administration (FDA) finalized its guidance on biosimilar interchangeability in “Considerations in Demonstrating Interchangeability with a Reference Product: Guidance for Industry.”1 The guidance document presents the FDA’s perspective on how the pharmaceuticals industry can demonstrate interchangeability between a biological product and a reference product. The document defines a biological product as a product that “can be expected to produce the same clinical result as the reference product in any given patient.”2 Although the guidance is nonbinding, it gives a glimpse into the possible direction of future industry plans. Interchangeability offers an opportunity for patients’ out-of-pocket costs for needed medications to be reduced.
As Congress continues to address out-of-pocket medication costs for consumers, we may see additional efforts that target biosimilar availability and interchangeability. Until then, HOPA remains dedicated to ensuring that patients have access to the right medication at the right time.
- U.S. Food and Drug Administration. May 2019. Considerations in Demonstrating Interchangeability with a Reference Product: Guidance for Industry (Docket Number 2019-10001). Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry.
- Public Health Service Act (42 U.S. Code 262(k)).