We appreciate that CMS is planning patient listening sessions and urge steps to ensure they go beyond token engagement. It will be important for patients and people with disabilities to have a central point of contact, or Ombudsman, for bidirectional communication on an ongoing basis. PIPC also urges CMS to host at least one listening session per drug or disease area and take active steps to ensure these sessions are productive by providing resources to be discussed with participants ahead of time and ensuring CMS decision makers are in the room. PIPC encourages CMS to ensure these sessions are only the beginning of an ongoing process, convening follow-up sessions after the first year of the negotiated price being enacted to learn from the community about how negotiation has impacted the affordability and availability of treatments.
Transparency in the negotiation process is a significant priority to the patient and disability communities, including insight about the evidence being considered and the standards set by CMS for high-quality and patient-centered evidence. We were pleased to see CMS acknowledge the current prohibition on the use of the QALY and similar metrics in Medicare. CMS also called on respondents providing evidence to the agency to describe any cost-effectiveness measures included in the research they are submitting, and how they believe the data avoids treating the life extension of an individual who is elderly, disabled, or terminally ill as a lower value than the life extension of an individual who is younger, nondisabled, or not terminally ill.
We urge the data using cost effectiveness measures and the statements related to their potential for discrimination be made publicly available where possible. Additionally, experts representing patients and people with disabilities should have an opportunity to analyze and provide input on the cost effectiveness measures. For example, the patient and disability communities have deep concerns about certain measures, including the evLYG, which is built on the same health utilities as the QALY and fails to value health improvement and quality of life. Patient and disability experts are in an excellent position to help guide CMS to more appropriate data sources. We look forward to working with CMS to set explicit standards for what data the agency will consider high-quality and centered on patients and people with disabilities in the negotiation process.