Addressing Unanswered Questions in Medicare Drug Price Negotiations

We invite submissions from researchers and patient communities that could be used by CMS to enable the effective implementation of Medicare drug price negotiation under the Inflation Reduction Act. While the primary audience is CMS, competitive submissions will address implications for Medicare plans as well as other stakeholder perspectives.

Submissions should address one of the following topics related to evidence review in the negotiation of maximum fair price. Competitive submissions will provide a roadmap for CMS to address the selected issue. Example prompts for each topic are provided below.

• Methods for Assessing Clinical Benefit: What approaches should CMS use to evaluate and weigh various sources of evidence in assessing clinical benefit? How can CMS ensure transparency and consistency in the process? How can CMS incorporate meaningful stakeholder perspectives, including patients and clinicians with experience in the condition in question, into the evidence review and decision-making process? How should evidence gaps be addressed?
• Methodological Standards in Comparative Effectiveness: What methodological standards in comparative effectiveness research should CMS adopt in evidentiary review? How can these practices be implemented in accordance with guidance from the IRA regarding specific populations? How should CMS weigh different methods of determining comparative effectiveness? How should evidence gaps be addressed?
• Incorporating Real-World Evidence: How should CMS incorporate RWE into its evaluation? What methodological standards should CMS apply to the review of RWE? How can RWE build upon other evidence types? How can CMS ensure that outcomes most important to patients are incorporated and prioritized?

Winners will be determined jointly by the PhRMA Foundation’s Value Assessment-Health Outcomes Research Scientific Advisory Committee and JMCP editors.

The PhRMA Foundation will present the first author of the top three papers with a $25,000 Challenge Award. Employees of pharmaceutical companies are allowed to submit but are not eligible to receive award money due to restrictions on provision of financial awards by the Foundation.

After completion of the peer-review process, the winning papers will be published in JMCP. Papers are expected to be published online (free to readers with no paywall) in March of 2024 and will also appear in a subsequent print issue of JMCP.

Papers will be submitted through JMCP’s online submission portal: jmcp.msubmit.net.

Submissions must be received by Wednesday, November 1, at midnight Eastern time.

Submissions must be submitted as a “Viewpoint” article (max 2,500 words) and must adhere to JMCP’s author guidelines. Detailed specifications for Viewpoints and author instructions are available at jmcp.org/authorguidelines.