The Changing US Reimbursement Landscape and Biosimilars

Abstract

The continued rise of prescription drug spend, in particular specialty drugs has created the need for high-quality, low-cost options for biologics. The passage of the Affordable Care Act (ACA) created an FDA approval pathway for biosimilars, but that is the tip of the iceberg as it pertains to how a biosimilar will actually get to the patient. As a general rule, legislation contains very little detail and requires much regulatory guidance by various government agencies to be developed to facilitate a product coming to market. The Centers for Medicare and Medicaid Services (CMS) is the primary federal agency to provide guidance on the Medicare coverage, coding and payment for biosimilars in the US. CMS will also provide some guidance on the use of biosimilars in state Medicaid programs; however, much of that detail will be determined by the state program. Commercial health plans will also weigh in with their own coverage decisions, but typically follow the coding of biosimilars as set forth by CMS. This chapter will assess the existing reimbursement landscape for biosimilars and will address key considerations and implications around current decisions that will impact biosimilars’ market entry in the US. In many ways, payers, governmental and commercial, will determine the ultimate success of biosimilars in the US by developing benefit designs and provider and patient incentives to drive biosimilar use. This chapter will explore how lessons on biosimilar incentive structures can be gleaned from the European experience and highlight what payer activity we have seen to date with marketed biosimilars in the US.