December 2025 marked a pivotal moment in U.S. drug pricing policy. The Global Benchmark for Efficient Drug Pricing (GLOBE) Model represents a fundamental shift in how Medicare Part B will pay for high-cost biologics and specialty drugs starting late 2026.
What Is the GLOBE Model?
The GLOBE Model is a mandatory payment demonstration under CMS’s Innovation Center authority that ties Medicare Part B drug rebates to international pricing benchmarks. Unlike voluntary programs, like GENEROUS, manufacturers of qualifying drugs must participate.
Here is the straightforward version: If your Part B drug costs more than comparable prices in 19 reference countries (adjusted for purchasing power parity), you will pay additional rebates to Medicare beyond existing inflation rebates. The model is expected to launch in Q4 2026 and run through 2031, with rebate calculations continuing through 2033.
Which Drugs Are In Scope for GLOBE?
The model targets single-source drugs and sole-source biologics with annual Medicare Part B spending exceeding $100 million, focused on seven therapeutic categories: antigout agents, antineoplastics, blood products and modifiers, central nervous system agents, immunological agents, metabolic bone disease agents, and ophthalmic agents.
The GLOBE Model offers manufacturers two calculation pathways:
Method I (Default – CMS-Determined):
CMS uses commercially available data sources to identify the lowest country-level price among 19 reference countries, adjusted for GDP purchasing power parity. This benchmark stays constant throughout the model period and may reflect list prices, invoice prices, or ex-manufacturer prices depending on available data.
Method II (Manufacturer-Submitted):
Manufacturers can voluntarily submit volume-weighted net pricing data from the reference countries. CMS then takes the volume-weighted average net price across those countries.
The reference countries are economically comparable OECD nations: Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
The final price benchmark would be based on the greater of a per unit Method I benchmark (that reflects the lowest country-level price among a set of reference countries) or a per unit Method II benchmark (that reflects the volume-weighted average of the manufacturer’s net pricing within a set of reference countries), after applying an economic adjustment under each method.
Strategic Recommendations for Industry
Conduct Immediate Financial Modeling
Run scenarios under both Method I and Method II before making any reporting decisions. Because CMS selects the higher benchmark, submitting Method II data only works in your favor if your volume-weighted, PPP-adjusted international net prices exceed the Method I benchmark, transparency doesn’t automatically help you.
To stress-test this, map the data sources CMS is likely to use (NAVLIN, MIDAS, POLI) against your actual net prices. The math needs to work before voluntary reporting makes sense.
Review Your International Pricing Architecture
The 19 reference countries likely include markets where you have already made pricing decisions. Those decisions now directly impact your U.S. Medicare liability. Consider:
- How current international launch sequences might amplify or mitigate GLOBE impacts
- Whether GDP-PPP adjustments adequately reflect market differences
- The timing of price increases in reference markets relative to U.S.
Assess Launch Strategy Implications
For pipeline products in the affected therapeutic categories, the GLOBE Model creates a new variable in U.S. commercialization planning. Products launching after model start could face immediate rebate exposure if they exceed the $100M annual threshold quickly. This may influence decisions around indication sequencing, pricing positioning, and market access strategies.
Global Market Access Considerations
For companies operating in both EU and U.S. markets, GLOBE creates a new pricing linkage to manage. European reference pricing systems have long tied countries together; now the U.S. is explicitly joining that web for Medicare Part B.
This has several implications:
- Launch sequencing matters more: The timing of launches in reference countries (especially high-income markets like Germany, France, or UK) could affect U.S. Medicare rebate calculations
- Discount transparency increases: Method II’s voluntary net price submission could reveal pricing strategies you have kept confidential
- Global pricing strategy requires integration: What was once separate regional decision-making now demands coordinated global planning between U.S. and international commercial teams
Stay Informed with Justin Stindt Consultants – Your Market Access Consultancy
At Justin Stindt Consultants, we are actively monitoring CMS policy developments, including the GLOBE Model and related MFN mechanisms, to provide our pharma, biotech, and medical device clients with real-time insights and actionable guidance.
Why Partner With Our Market Access Consulting Experts?
Justin Stindt Consultants is a specialized market access consultancy offering bespoke services to pharma, biotech, and medical device companies. Our team brings deep expertise in both U.S. and EU market access, ensuring our clients are well-prepared to navigate complex and rapidly evolving pricing and reimbursement landscapes. We are the preferred partner for many organizations seeking strategic guidance at the intersection of global pricing, HTA, and payer engagement.
• Proven Expertise: with years of experience in global pricing and reimbursement[EB13.1], our team offers strategic insights and practical solutions built on real-world outcomes.
• Tailored Strategies: we understand that each client, product, and market is unique, and we provide customized approaches to address specific challenges.
• Comprehensive Support: from early strategy development through launch and beyond, we offer end-to-end market access support.
• Regulatory Mastery: our team has deep knowledge of FDA, EMA, and national HTA processes, as well as U.S. and EU payer dynamics, enabling faster, more confident market access decisions.
Get in Touch with Our Market Access Consultancy
Ready to strengthen your U.S. and EU market access strategy in response to the GLOBE Model? Contact Justin Stindt Consultants today to leverage our expertise and navigate this evolving landscape with confidence.
