Pfenex applauds the Centers for Medicare and Medicaid Services (CMS) for its efforts to create a clear reimbursement framework for biosimilars through the issuance of the 2016 physician payment rule, which provides guidance on reimbursement for biosimilars under Medicare Part B.
However, we are not supportive of the decision to group all biosimilars to a single reference product under the same Healthcare Common Procedure Coding System (HCPCS) code, with the reference product maintaining a separate code. We remain concerned that the current proposal will hinder biosimilar uptake and discourage innovation by not establishing a reimbursement model for biosimilars based on a product’s unique average sales price (ASP).
As defined by the U.S. Food and Drug Administration (FDA), biosimilars are proven to have no clinically meaningful difference in safety, purity, and potency from a reference product. Because biosimilars are comparatively developed to a given reference product, rather than other biosimilars, it is illogical to tie reimbursement to other molecular entities to which the biosimilar was not initially compared. As such, we believe each product should have an individual HCPCS code, which is in accordance with the Biologics Price Competition and Innovation Act (BPCIA). Such a policy will better ensure innovation and drive market entry, ultimately allowing the U.S. to realize the full promise of biosimilars. We encourage lawmakers and regulators to enact policies that ensure the U.S. is an environment conducive to therapeutic innovation and adoption.