Assessing the Value of Post-Approval Research

The US instituted price setting for pharmaceuticals with the Medicare Drug Price Negotiation Program (MDPNP)under the Inflation Reduction Act (IRA) of 2022. Other policies to expand price setting, such as in a most favored nation approach, are under discussion. Intervention in price setting influences investment in drug development by reducing expected revenue for approved medicines. When the IRA was enacted, the Congressional Budget Office (CBO) estimated its effects on new drug development, but not on post-approval drug development for additional uses or indications.