CMS Guidance on IRA Price Negotiation: Part 1

Healthcare Economist May 9, 2024
Jason Shafrin

CMS released guidance on IRA price negotiation last week. Below are some highlights regarding how drugs will be selected.

Which drugs are eligible for negotiation?

For small molecules, drugs have to be (i) FDA-approved, (ii) be FDA-approved at least 7 years ago, and (iii) have no generic equivalent on the market.
For biologic molecules, drugs have to be (i) FDA-approved, (ii) be FDA-approved at least 11 years ago, and (iii) have no biosimilar equivalent on the market.

Combination medications that are always prescribed together will be considered as if one treatment.

Drugs ranking in the top 15 of Part D spending between November 1, 2023 and October 31, 2024 will be considered negotiation eligible.

How do drugs qualify...