Medicare Drug Price negotiation process: How to tailor your approach

CMS recently published guidance on the Medicare Drug Price Negotiation Program (MDRP). But while this provides additional insight into the logistics, evidence requirements, and timeline for the impending price negotiations, several gaps remain. In this article, we highlight the key portions of the MDRP guidance, advise manufacturers on how to prepare for negotiations, and outline key dynamics for the first negotiation cycle.

The negotiation process

On September 1, CMS will announce the drugs eligible for the MDRP negotiation process – a key provision of the Inflation Reduction Act. The process leaves manufacturers with only one month to pull together all of the requested information. While manufacturers have not yet been notified whether their drugs will be eligible, it would be prudent to collate information and develop a strategy well in advance.

Once CMS has the information, they will…