Defining "Unmet Medical Need"

Patients, people with disabilities, and their caregivers want their experiences and outcomes that matter to them to be considered when the government or other payers make decisions about their treatments. The Inflation Reduction Act (IRA) directs the U.S. Federal government to establish the price for some of the highest selling drugs in the Medicare program based on a number of factors including whether the drug serves an “unmet medical need” relative to other therapeutic options.
 
This report highlights the perspectives of the patient community on “unmet medical needs” based on survey research and public comments from patient advocacy groups and compares those findings to the government’s proposed approach to consider unmet medical needs under the IRA.