The impact of the Build Back Better Act (BBBA) on rare disease innovation

Among the Build Back Better Act’s drug pricing reforms are a series of initiatives aimed at addressing out-of-pocket (OOP) expenses in Medicare Part D and the imposition of inflationary caps on price increases of certain Part D drugs. Xcenda worked with the Rare Access Action Project (RAAP) to illustrate the impact of these drug pricing policies on manufacturers of orphan drugs.

To highlight these impacts, Xcenda conducted an analysis of potential manufacturer contributions for various orphan-indicated products, which by definition have a patient population of less than 200,000 in the United States, compared to the current baseline. We found that the total increased liability for manufacturers could be staggering.

Our analysis shows that policymakers need to balance policies to address patient OOP costs within the Medicare Part D design with research and development for orphan diseases. Download the issue brief below.