Is There Room for Patient-Centered Value Assessment in Medicare Negotiation and State Prescription Drug Affordability Board Processes?

PURPOSE: In 2023, the federal government and state governments will begin assessing product affordability and value to regulate drug costs. Medicare will begin negotiating drug prices, and Prescription Drug Affordability Boards (PDABs) in states such as Colorado and Maryland will begin the process of setting upper payment limits. However, these processes have not been fully defined, and it is unclear the extent to which product value and patient perspectives will be reflected. The laws and regulations establishing these programs include constraints in process (e.g., short timeframes) and methodology (e.g., QALY bans) that may prevent comprehensive, patient-centered value assessments. This session will utilize real-world examples to discuss how these processes can best reflect value from the patient perspective given the policy constraints, and the risks of getting it wrong.

DESCRIPTION: Workshop attendees will obtain a working knowledge of the opportunities, tools, and constraints CMS and state governments have in assessing value and engaging patients. Dr. McQueen will provide this overview, reflecting his experience advising the Colorado PDAB, conducting ICER assessments, and piloting Multi Criteria Decision Analysis. Dr. Mattingly will present his experience engaging patients in value assessment and his work as an advisor to the Maryland PDAB. Deanna Darlington has worked with multiple patient groups responding to ICER reviews. She will highlight her work engaging patients on the value of HIV treatment and discuss the challenges patients face when contributing to value assessments. Dr. Montgomery will discuss why these new drug price regulation programs run the risk of establishing precedents for US value assessment that do not align with best practices. Workshop attendees will be presented with scenarios for how patient-centered value assessment could be implemented in these programs, asked to weigh tradeoffs between best practices and feasibility, and vote for implementation scenarios they believe best reflect patient-centered value.