William A. Sarraille
Sidley Austin LLP, USA
Title: Exploring Government Pricing and Reimbursement Policy Challenges Associated with Biosimilars
Biography
Biography: William A. Sarraille
Abstract
The Biologics Price Competition and Innovation Act (BPCIA) was signed into law on March 23, 2010 as part of the Patient Protection and Affordable Care Act (PPACA). BPCIA’s announcement of a new Food and Drug Administration (FDA) regulatory pathway for the approval of biosimilar products has created several government pricing and reimbursement policy challenges. The proposed presentation will discuss the coverage, reimbursement, and related strategy questions from the perspective of both an experienced reimbursement counsel and a reference product manufacturer. Reimbursement issues discussed during this joint presentation will include the impact of Average Sales Price (ASP) and non-ASP reimbursement systems and the crucial distinction between the biosimilar and interchangeability standards. The potential for National Coverage Determinations, Local Coverage Determinations, and innovation reimbursement reforms will also be discussed, as will value-based contracting approaches.
