Market Watch: CMS finalised GLOBE, and cut it

What changed. On 2 October 2026 CMS published the final rule for the Global Benchmark for Efficient Drug Pricing model, putting international reference pricing into Medicare Part B for the first time.¹

It is both real and much smaller than proposed.

The dates moved. Regulations take effect 30 November 2026. The model begins 1 January 2027 with voluntary manufacturer data collection, and the five performance years start 1 April 2027.¹ The proposed rule had suggested 1 October 2026. Anyone still working to that date is six months out.

The scope was cut, and the exclusions are the story. Now outside the model: orphan-only drugs, FDA-listed cellular and gene therapy products, plasma-derived products, and Part B rebatable biosimilar biological products.¹ CMS also dropped its proposed biosimilar reduction for severe supply chain disruption as a consequence.

What remains in scope: single source drugs and sole source biologics in seven USP categories, with HCPCS Level II codes, and more than 100 million dollars in Original Medicare Part B spending over a 12-month lookback.¹

How it works. Mandatory for manufacturers of in-scope drugs, with only the initial data submission voluntary. It applies to Original Medicare beneficiaries in randomly selected ZIP Code Tabulation Areas, covering roughly a quarter of eligible beneficiaries. The benchmark runs two ways: one method estimates the lowest reference country price from commercial international price data, the other uses manufacturer-submitted net prices and an average international price. Nineteen reference countries.¹

Projected net Part B savings are roughly 440 million dollars over the seven-year payment period, about 80 million a year.¹

GUARD has not followed. The Part D companion model remains a proposed rule from 23 December 2025, with CMS's own model page still showing it at announced stage.² Its proposed 1 January 2027 launch is now under three months away with no final rule published. We are not going to predict a slip, but nor should anyone plan around that date as settled.

What to do now. Check your Part B portfolio against the exclusion list first, because that list is now a commercial design parameter rather than a regulatory footnote. An orphan-only designation, a cell or gene therapy classification or rebatable biosimilar status takes a product out of the model entirely.

Then check the 100 million dollar spending threshold, since it determines whether you are in scope at all, and the seven USP categories.

And if your ex-US pricing strategy assumed international reference pricing in Medicare was theoretical, it is not. It is a published final rule with an effective date.