CMS finalizes new drug pricing model: 7 notes

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CMS has finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a mandatory payment model that will tie Medicare Part B drug rebates to prices paid in 19 reference countries, according to a Sept. 30 CMS news release.

Here are seven things to know:

  1. The model uses an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable drugs and biologics, typically medications administered by clinicians in healthcare settings. The regulation takes effect Nov. 30.
  1. CMS will benchmark prices against Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland and the United Kingdom, citing research showing U.S. brand-name drug prices exceed the non-U.S. OECD average by more than 400%.
  1. The final version is considerably narrower than what CMS proposed. GLOBE now excludes orphan-only drugs, biosimilars and their reference biologics once a biosimilar enters the U.S. market, plasma-derived products and certain cell and gene therapies, changes CMS made in response to public comments.
  1. As a result, CMS’s estimated savings fell substantially: The proposed rule projected $8.4 billion in Original Medicare Part B net spending savings, plus billions more for Medicare Advantage and Medicaid, while the final rule projects $440 million in overall Medicare Part B net spending savings over the seven-year payment period. The final estimate includes $298 million in Original Medicare Part B benefit savings and $288 million in Medicare Advantage payment savings, offset in part by $147 million in premium impacts.
  1. GLOBE will begin Jan. 1, 2027, with voluntary manufacturer submission of international drug pricing data. Its five-year performance period will run from April 1, 2027, through March 31, 2032, while the seven-year payment period for rebate calculations, invoicing, collection and reconciliation will continue through March 31, 2034.
  1. It applies to a randomly selected group of ZIP Code Tabulation Areas covering about 25% of beneficiaries with Original Medicare Part B as their primary coverage. Those affected by the model may begin seeing reduced out-of-pocket costs April 1, 2027.
  1. GLOBE was first proposed in December 2025 alongside a companion model, GUARD, that applies a similar international-reference-pricing approach to Medicare Part D drugs. It follows CMS’s Medicaid-focused GENEROUS model, in which 40 states and Puerto Rico have signed agreements to apply similar international benchmarking to Medicaid drug pricing.

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