In the rule, CMS said that it would lower the maximum co-pay amount for low-income subsidy (LIS) beneficiaries for biosimilar and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs.
CMS has released its final rule for the Medicare program for the contract year 2019, and it includes a key change to its approach to biosimilars.
In the rule, CMS said that it would lower the maximum co-payment amount for low-income subsidy (LIS) beneficiaries for biosimilar and interchangeable biosimilars to match the lower co-pay amount required for generic and preferred multiple-source drugs.
This rule represents a change from CMS’ previous proposal to include biosimilars and interchangeable biosimilars under a revised definition of “generic drugs” for the purposes LIS beneficiaries’ cost sharing. The rule indicates that CMS was concerned that misinterpretations of a revised definition of generics could create confusion about the broader treatment of biosimilar products and interchangeable biosimilars. Under the final rule, “CMS achieves the same goal intended by our original proposal, but now does so without the confusion that would result from defining biosimilar and interchangeable biological products as generic drugs for this limited purpose,” reads the rule.
CMS was careful to point out that its change of approach only applies to cost sharing, and “This policy does not change or supersede our existing formulary requirements for biosimilar biological products.”
However, CMS noted that it “does not have the flexibility” to establish a lower co-pay amount for biosimilars and interchangeable biosimilars for non-LIS enrollees who are in the catastrophic phase of the Medicare Part D benefit, however, and “given the high cost of biological products in general, the non-LIS catastrophic cost sharing will almost certainly be [5%].”
According to CMS, this new policy will reduce spending by approximately $10 million (and that the overall provisions of the final rule will save $123.6 million). It also noted that its approach to biosimilars will “reduce confusion in the marketplace surrounding this issue, [and] will improve enrollee protections while also improving enrollee incentives to choose biosimilar and interchangeable biological products over reference biological products.”
Finally, in response to comments urging CMS to revisit treatment of biosimilars and interchangeable biologics for the purpose of mid-year formulary changes, CMS clarified the fact that, as yet, there are no interchangeable biosimilars approved in the United States, and that, when “interchangeable biological products become available, we would consider whether additional regulatory changes would be warranted.”
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.