Editor’s note: The attached comment letter was submitted to the offices of Representatives DeGette and Bucshon in response to a public request for comment on additional reforms, support mechanisms, or incentives needed to enhance or improve the effectiveness of 21st Century Cures.
This letter responds to your request for input on the progress and future direction of the 21st Century Cures initiative. As experts in the field of patient preference research, we believe we may have a perspective on how you can improve upon the great strides taken through 21st Century Cures. The 21st Century Cures Act has made significant progress in advancing policies that promote patient access to innovative medical technologies. Since the passage of the 21st Century Cures Act, there have been significant advances in the development of scientifically valid qualitative and quantitative methods in assessing patient perspectives through stated preference techniques.
Building on these advancements, a major structural reform that Congress could pursue is to further integrate patient preference information (PPI) into medical product development, regulatory decision-making, and Medicare coverage and payment. Recommendations discussed in the letter to advance the use of PPI in product development and patient access include:
- expanding and codifying the application of PPI in regulatory and reimbursement decision-making;
- developing a coordinated approach between FDA and CMS for evaluating endpoints and outcomes that matter most to patients;
- allocating financial support, potentially through PCORI, for patient organizations to conduct patient preference research;
- utilizing patient preferences to guide CMS policies, such as Coverage with Evidence Development or evaluation of drug value under the IRA drug price negotiation program.
Read the full comment letter here.
Constant Contact Subscribe Form