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Alliance Statement on Medicare Drug Price Negotiation Program Revised Guidance

Published June 30, 2023

Paper $20 bills wrapped up in a blue stethoscope and inside an orange pill bottle.

This morning, the Centers for Medicare and Medicaid Services (CMS) released updated guidance on the Medicare Drug Price Negotiation Program. Michael Ward, MS, Vice President of Public Policy and Government Affairs at the Alliance for Aging Research, issued the following statement in response:

The Alliance for Aging Research has consistently opposed the direct negotiation provision of the Inflation Reduction Act (IRA)  due to concerns about use of prominent metrics that have been shown to limit access to breakthrough treatments and discriminate against older adults and people with disabilities. Despite efforts by CMS to avoid well-known harmful metrics like the Quality Adjusted Life Year (QALY), the recently revised guidance indicates CMS plans to rely on similar assessments, such as the equal value of life years gained (evLYG) metric.

An international health economics journal reports that both QALYs and evLYGs consider treatments that cure disease or extend life as more cost-effective than treatments that primarily improve quality of life. The National Council on Disability — an independent federal agency — found that the evLYG measure does not fix the inherent biases of the QALY or help improve patient access to new therapies. In short, it does not represent real reform. In addition, the Alliance maintains that use of the evLYG is statutorily prohibited in the Medicare program.

On the positive side, we were pleased to see CMS adopt several recommendations advanced by the Alliance:

  • Expanding the definition of “unmet need” to align more closely with the U.S. Food and Drug Administration’s definition,
  • Holding public patient-focused listening sessions in the Fall of 2023, and
  • Monitoring impacts changes have on beneficiary access.

These are meaningful steps to ensure patients’ perspectives are part of the conversation. The patient voice must be central in the implementation of the IRA’s healthcare provisions. There is more work to do, and the Alliance will continue to monitor and communicate with CMS to not only address older adults’ health and economic well-being, but to ensure all Medicare beneficiaries are treated equitably.

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