With the publication of the GLOBE model final rule, CMS outlines exemptions that seem to reduce the value of the program significantly. It also specifies biosimilar impacts of GLOBE.
As published in final rule form, the federal government’s Global Benchmark for Efficient Drug Pricing Model (GLOBE) seems a lot less significant than when it was first proposed in December 2025.
Intended as a method to apply Medicare’s Most Favored Nation (MFN) pricing to Part B biologics, the GLOBE demonstration model has numerous exemptions and exclusions that seemed to render it very limited in scope, according to a simple analysis posted by Brian Reid on LinkedIn. The final rule lists 36 eligible medications for year 1 of the demonstration. This number is quickly whittled down to 4 drugs, because the manufacturers of the other 32 products already have agreed to Medicaid MFN deals, which exempt them from GLOBE. One of those four medications, vedolizumab (Entyvio), will no longer be eligible for GLOBE discounts in January 2028, because Medicare negotiated pricing will take effect.
Five Biosimilars Affected by GLOBE in Year 1
From a biosimilar standpoint, five products—aflibercept, denosumab, golimumab, natalizumab, and tocilizumab—are listed but already have approved and marketed biosimilars (except golimumab, which is not yet marketed). They would be exempt from any MFN agreements. Besides, the biosimilar competition would likely result in lower discounts than can be obtained through MFN or Medicare Fair Price negotiations (MFP).
Endpoints News cited that the savings estimate originally cited at the introduction of the GLOBE project was $11.9 billion; based on the final rule, this figure may be 4% of that original amount or approximately $440 million. That savings amount doesn’t seem worth the effort. Was it nothing but an effort at coercion to force companies to sign Medicaid MFN agreements?
In the GLOBE final rule, CMS specifically states in its response to public comments that it is primarily concerned with lowering existing Medicare costs on these Part B products prior to biosimilar entry and not with effects on future biosimilar development. This is not surprising, as CMS has not expressed concern in the past with MFP or MFN efforts on discouraging biosimilar development on eligible reference biologics.
One other interesting aspect of the GLOBE final rule is the clarification of biosimilar exemptions. This is based on when the biosimilar product is actually marketed. CMS will rely on ASP pricing eligibility for this information plus listing in the FDA’s Purple Book and be identified as “sold or marketed as set forth in 42 CFR 427.20.” This means, “CMS would use marketing data as listed in either the ASP data reported to CMS by a manufacturer or the NDC directory to identify a start marketing date for the biosimilar biological product in the US prior to the applicable calendar quarter when the product meets one of the following criteria: (1) the NDC has units reported for the rebate quarter; (2) the end marketing date is during the rebate quarter; (3) the end marketing date is after the rebate quarter; or (4) the end marketing date is missing.”
Also, the final rule addresses unbranded (reference) biologics or authorized generics: “…authorized generics and unbranded biological products, are directly or indirectly, sponsored by the original pharmaceutical drug manufacturer, [therefore,] we believe that if an authorized generic or unbranded biological product is included in the Medicare Part B Drug Inflation Rebate Program, then, subject to the exclusions described in §513.130(c), it could be included in the GLOBE Model.”