📢 Drug pricing update in the U.S. with two new models: GLOBE and GUARD

 

💡 What´s new? 

Just before Christmas, the Centers for Medicare & Medicaid Services (CMS) in the U.S. released two additional drug pricing models, which are also based on the Most-Favored-Nation (MFN) approach:

GLOBE for Medicare Part B (planned start: October 2026) 

GUARD for Medicare Part D (planned start: January 2027) 

The models apply to U.S. citizens enrolled in Medicare Part B and/or Part D. Beneficiaries may be enrolled in either both programs or in only one of them. 

 

⚖️ Are these models comparable to the GENEROUS model? 

❌ The answer is: No.  

The basket of countries in the new models is broader than in GENEROUS with 19 OECD countries: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. 

Unlike the GENEROUS model, CMS plans to obtain the necessary price information for a price benchmark from the data panels IQVIA MIDAS®, Global Data POLI and Eversana NAVLIN.

 

🧮 How is the relevant reference price determined for the GLOBE and the GUARD program? 

Either the lowest country-specific, purchasing power-adjusted average price from the 19-country basket or a volume-weighted average net price, derived from pharmaceutical company (pC) data. 

 

💰 Unlike the GENEROUS model, which uses the second-lowest net price including confidential discounts from eight countries (Germany, Canada, Denmark, France, Italy, Japan, Switzerland, and the United Kingdom), CMS proposes not to take confidential discount agreements into account when determining the reference price. As a result, the GLOBE and GUARD programs are less restrictive than the GENEROUS model and involve less price intervention for the manufacturers concerned. 

 

💡 Please note: Both models are not finalized yet. They are currently undergoing the regulatory process and may still be subject to change before a final decision is made.