December 23, 2025
The Centers for Medicare and Medicaid Services (CMS) announced a proposed five-year model Dec. 19 that would use international benchmarks to adjust Part B drug prices for people on Medicare.
The Global Benchmark for Efficient Drug Pricing (GLOBE) Model would focus on single source drugs and sole source biological products administered in clinical settings with substantial Medicare Part B spending, generally exceeding $100 million annually. Under the proposed model, CMS would require manufacturers to provide rebates if U.S. drug prices exceed those paid in economically comparable countries. The model targets high-cost therapeutic areas such as oncology, autoimmune conditions, arthritis, rheumatology, ophthalmology and endocrinology.
Some blood product modifiers, such as darbepoetin alfa, luspatercept, romiplostim and emicizumab, would fall under the model. Cell and gene therapies and plasma-derived products may be excluded due to supply chain considerations and potential shortages.
CMS plans to launch the GLOBE Model on Oct. 1, with rebate invoicing and reconciliation continuing into 2033. Public comments on the notice of proposed rulemaking are open through Feb. 23.