Unbiased Analysis of Today's Healthcare Issues
In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites,…
When we think of utilization management (e.g., prior authorizations, step edits), we often think payers only use these for higher cost branded products including biologics. Generic drugs should have low cost sharing and limited utilization management. One question, however, is whether payers’ utilization management practices for biosimilars mirror those of biologic products, or small-molecule generics,…
From Cahan, Kocher, and Bohn in the Health Affairs blog: Since passage of the 2010 “Biosimilars” Act aimed at stimulating non-inferior innovation and competition in therapeutics markets, only 17 agents have been approved, and only seven have made it to market. Why haven’t biosimilars been more attractive? Blackstone et al. (2013) cites 3 key issues:…