Biosimilars: Still Waiting for Promise to Materialize

However, a disconnect exists between what patients see in costs and what manufacturers receive for their medication. Much of that difference derives from pharmacy benefit managers (PBMs; see also “Rheumatologists’ Frustrations with PBMs Aired at Annual Meeting,” The Rheumatologist, January 2017, p. 42). Dr. Huffstutter and other speakers at the ACR/ARHP Annual Meeting noted that PBMs are a disruptive force in the biosimilar marketplace, preventing the competition that could lead to lower costs.

On Nov. 2, 2017, shortly before the ACR/ARHP Annual Meeting started, the Centers for Medicare & Medicaid Services released its Final Policy, Payment, and Quality Provisions in the Medicare Physician Fee Schedule for Calendar Year 2018.² This policy changed a previous proposal that biosimilar products relying on a common reference product’s biologics license application would be grouped into the same payment calculation for determining a single average sales price payment limit. Instead, the new policy will pay for each biosimilar according to its distinct individual average price.

The ACR plans to release a white paper on biosimilars and interchangeability in the near future, reported Angus Worthing, MD, chair of ACR’s Government Affairs Committee. The ACR has also advocated for a national policy on substitution of interchangeable biologics that would require notifying the patient and physician prior to the substitution or within 24 hours. A total of 36 states now have laws in place with similar provisions.

Larry Beresford is a freelance medical journalist in Oakland, Calif.

References

1. U.S. Food & Drug Administration. Considerations in demonstrating interchangeability with a reference product: Draft guidance for industry. 2017 Jan.
2. Centers for Medicare & Medicaid Services. Final policy, payment and quality provisions in the Medicare physician fee schedule for calendar year 2018. 2017 Nov 2.