Biosimilars Council Statement Regarding The CMS Part B Proposal

The Biosimilars Council is greatly concerned about the recently proposed rule issued by the Centers for Medicare and Medicaid Services (CMS) regarding the reimbursement of biosimilar biologic products under Medicare Part B. The rule, as proposed, would discourage innovation in the biosimilars marketplace and greatly reduce incentives for manufacturers to invest in developing new biosimilar and interchangeable biologics for patients.

CMS has proposed grouping all biosimilars to the same originator biologic product under one biosimilar billing code and payment rate, and by doing so will calculate reimbursement rates under Part B by averaging the sales price of each class of biosimilars together. However, there is no scientific basis for this proposal, and it will likely only serve to discourage the development of a competitive market to create affordable medicines.

Biosimilars are tested and approved based on high similarity to a specific reference biologic. Different biosimilars to the same reference product may not share all of the indications or product presentations as allowed by the Biologics Price Competition and Innovation Act (BPCIA) and Food and Drug Administration (FDA) guidance. They are not compared to one another in any meaningful way, and grouping them together under one billing code would not allow for coverage policies that adequately distinguish between biosimilars, and serve to create confusion in the market.

Developing a consistent and predictable reimbursement scheme for biosimilars is crucial in ensuring the success of the emerging biosimilars market. In order to provide patients with access to a greater array of affordable treatments, the system must provide adequate incentives, while also eliminating confusion within the healthcare community.

The Biosimilars Council urges CMS to work with stakeholders in order to revise its proposal such that all biosimilars for any single reference product are not grouped together into a single J-code and payment rate. The Council stands ready to assist CMS in this effort, and looks forward to submitting further detailed comments to the agency.

About The GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of these more affordable alternatives to costly brand biologic medicines. Areas of focus will include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. For more information, visit www.biosimilarscouncil.org.