BioCentury
ARTICLE | Politics, Policy & Law

CMS IRA price-setting process based on therapeutic alternatives

Agency says it is considering softening blow on orphan drugs, seems to exempt CAR T therapies from price-setting

March 16, 2023 1:38 AM UTC

CMS has released a memo outlining how it intends to implement the Inflation Reduction Act’s price-setting provisions and soliciting comments from the public on specific aspects of its plans.

Based on an initial read of the 91-page document, released Wednesday, highlights include CMS’s decisions to: use the relative costs and benefits of therapeutic alternatives as the starting point for price-setting discussions; include all forms and dosages of an active moiety in the price-setting process; and select drugs for the program based on gross prices. If two or more drugs have the same gross price, the drug that has been on the market for the longest period of time will be selected. ...