The implications for the new initiative go far beyond the 10 drugs that CMS will select as their first program participants. The action is expected to significantly impact same-class drugs’ pricing and profitability as well. It is also an ongoing plan for drug price negotiation. The first CMS list of selected drugs will be released on 1 September 2023.
The first guidance document for the price negotiations was released on 15 March 2023. Revised Guidance was issued by CMS on 30 June 2023.