10/21/2026

CMS Releases Final Rule for Global Benchmark for Efficient Drug Pricing (GLOBE) Model

On September 30, the Centers for Medicare & Medicaid Services (CMS) released its GLOBE Model final rule, establishing a mandatory international reference pricing model for select Medicare Part B drugs. The final model is substantially narrower in scope, administrative reach, and financial impact, impacting fewer products and manufacturers:

• Key Drug Exclusions: The rule limits the model to single-source drugs in seven therapeutic categories exceeding $100 million in annual Part B charges. It excludes cell and gene therapies, plasma-derived products, certain orphan drugs, and drugs subject to the Medicare Drug Price Negotiation Program.
  
  
• Delayed Timeline: Voluntary manufacturer data collection is postponed to January 1, 2027, with the five-year performance period running from April 1, 2027, through March 31, 2032.
  
  
• Minimal Manufacturer Impact: CMS indicated its intent to waive GLOBE’s mandatory participation requirements for manufacturers participating in the voluntary GENEROUS Medicaid Model to avoid regulatory overlap. CMS estimates only four manufacturers will be subject to mandatory participation in year one. The model retains 19 international reference countries.
  
  
• Drastically Reduced Savings: CMS now estimates $440 million in net savings over seven years, a massive reduction from the originally projected $11.9 billion.

ASCO will continue to monitor the implementation of the GLOBE Model and assess its potential impact on oncology care delivery and drug access.