Editor’s note: The attached comment letter was submitted to the Centers for Medicare and Medicaid Services (CMS) on April 14, 2023 in response to a public request for information.
As CMS begins building a new program that relies in part on health economic principles to implement the Medicare Drug Price Negotiation Program, Dana Goldman, Charles Phelps and colleagues recommend incorporating several key elements to promote the program’s success. The authors’ recommendations have the goal of building public confidence and stakeholder buy-in through rigor and reliable application to CMS decision-making. As described in greater detail in the letter, the researchers recommend that CMS:
- Establish explicit methodological standards to ensure the rigor of research, evidence reviews, and assessments;
- Describe a methodology for applying evidence to pricing decisions that places the greatest weight on added clinical benefit and contextual factors, such as unmet medical need;
- Create a transparent process to:
- solicit input from patients, physicians, and academic researchers with expertise on issues such as choice of comparators and outcomes;
- describe to stakeholders how they are their input will be considered in proposed decisions.
Read the full comment letter here.
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