CMS finalizes GLOBE model to link some Part B drug rebates to international prices

CMS finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) model, a mandatory test linking rebates for certain Medicare Part B drugs to prices in economically comparable countries.

The model is scheduled to run from Jan. 1, 2027, through March 31, 2032. Rebates will be calculated using an alternative formula informed by international prices; the program is not a simple across-the-board cap on every Part B drug price.

It will cover beneficiaries in selected geographic areas—about 25% of people with Original Medicare. Reduced coinsurance for affected drugs is planned from April 1, 2027, through March 31, 2032.

The final rule excludes biosimilars and their reference biologics once a biosimilar is available, as well as orphan drugs, plasma-derived products and some cell and gene therapies.

A notable limitation:
manufacturers with separate administration pricing agreements may be exempt. Reuters reported the model could therefore apply to as few as four drugmakers. CMS’s estimated Medicare savings also fell substantially, to about $440 million over the model period, from about $11.9 billion in the proposal.

Manufacturer participation is mandatory for those in scope, and the rule may face legal challenges. CMS says rebate invoicing and reconciliation will continue through March 31, 2034.

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