Abstract

The Centers for Medicare & Medicaid Services (CMS) published initial¹and revised²guidance describing how the agency will implement the “Drug Price Negotiation Program” (DPNP) (quotation marks around the words “negotiate” and “negotiation” specify that these are terms used by the agency in their publications. Many manufacturers believe the process described by the agency does not provide a genuine opportunity to negotiate, and this is one factual allegation most common among lawsuits filed against the Department of Health and Human Services in response to the Inflation Reduction Act [IRA] implementation) provisions of IRA. Many are concerned about the lack of scientific clarity and rigor in the agency’s process as currently known, as well as the effects of implementation on patient access and the continued development of new treatments, especially in oncology and rare diseases. The agency’s actions and published justification thereof will profoundly affect the timing of new launches, availability of new indications, and role of evidence generation.^3,4 Furthermore, some contend that the DPNP may not even be legal (at the time of writing, at least 8 IRA implementation lawsuits have been filed against the Department of Health and Human Services).