AARDA’s letter to the Centers for Medicare and Medicaid Services (CMS) regarding biosimilars

Autoimmune Association works to advocate for all those who are living with autoimmune diseases. As part of our advocacy efforts, Autoimmune Association submitted a comment letter on September 11, 2017, to the CMS, Centers for Medicare and Medicaid Services about biosimilars payment policy.

Many autoimmune patients also rely on medications that are covered and reimbursed under Medicare Part B, including biologics. From our letter,

“We have significant concerns, however, about CMS’ current policy for the payment of biosimilars under Medicare Part B. We believe that both the statute and a variety of important policies underscore the need for CMS to issue separate Healthcare Common Procedure Coding System (HCPCS) codes for each biologic product—biosimilars as well as reference products. In part, this is necessary to ensure that each biologic product, including each biosimilar, has a separate average sales price (ASP)-based reimbursement, as the statute requires. The policy that we support is also necessary to protect patient safety and to provide appropriate incentives for the biosimilars market, as intended by Congress, and as CMS appropriately identifies as a priority in the Proposed Rule.5 In addition, the policy that we support is consistent with CMS precedent that recognizes and treats biosimilars as single source drugs, not as multiple source drugs.

Importantly, the policy that we support also provides workable solutions for key issues noted by CMS in the Proposed Rule, including, for example, how to address “the innate differences in biological products” and how to reflect such differences in Medicare payment policy, such as instances of “biosimilars that are licensed for fewer than all indications for which the reference product is licensed or situations where different biosimilars may be licensed for different subsets of indications for which the reference product is licensed.”6 These issues underscore the fact that biosimilars—though “similar”—are each distinct products. Accordingly, they should be identified with unique HCPCS codes and reimbursed accordingly under Medicare’s payment policy, as discussed further below.”

You can read the full letter here, and view the comments here.