BIOBRIEF
An analysis of the drug selection criteria under the 2022 Inflation Reduction Act lands as the Centers for Medicare & Medicaid Services readies the next round of Medicare price negotiations.
A consumer advocacy group says a routine administrative decision by the Centers for Medicare & Medicaid Services may have delayed federal price negotiations on a single AbbVie medicine by seven years, potentially keeping the blockbuster at full Medicare pricing for years longer than the Inflation Reduction Act envisioned.
The analysis, reported by STAT+ Pharmalot, lands as CMS prepares its next round of drug-price talks under the IRA, the 2022 law that created the Medicare negotiation program in response to rising prescription drug costs. According to the group, a "little-noticed policy shift" reshaped how the agency selects medicines for negotiation, pushing one costly AbbVie drug far down the queue.
The IRA's small-molecule and biologic selection criteria determine when a drug becomes eligible for negotiation. The advocacy group's argument is that a change to those criteria, rather than the statute itself, lengthened the pre-negotiation window on this product.
Several pieces of the story remain unverified in the material on hand: the specific AbbVie drug is not named, the regulatory text behind the change has not been independently confirmed, and neither AbbVie nor CMS has been heard from in the reporting captured here. The seven-year figure is the advocacy group's estimate, not an official finding.
The IRA's stated goal is to lower what Medicare pays for high-cost drugs. If the analysis holds up, the consequence is a longer run of full Medicare pricing on one blockbuster before any negotiated price takes effect.