MFN strategy

MFN refers to several initiatives that link certain U.S. drug prices or manufacturer rebates to international prices. Three key models from the Centers for Medicare & Medicaid Services (CMS) differ in scope and status.

1. GENEROUS | Voluntary Medicaid model: Uses supplemental manufacturer rebates to align Medicaid net prices with international prices, alongside standardized coverage criteria negotiated with CMS. Participation is voluntary for manufacturers and states.

2. GLOBE | Finalized mandatory Medicare Part B model: Uses international pricing benchmarks to calculate manufacturer rebates for certain high-spend drugs and biologics. It applies in geographic areas representing approximately 25% of Original Medicare Part B beneficiaries, with drug exclusions and manufacturer participation waivers.

3. GUARD | Proposed mandatory Medicare Part D model: If approved, this model would use international pricing benchmarks to calculate manufacturer rebates for certain sole-source drugs and biologics. It would apply in geographic areas representing approximately 25% of Part D beneficiaries, subject to final rule-making.

Manufacturer-specific MFN agreements may also shape exposure and overlap with these models. Their implications depend on the products and terms involved.

MFN may affect manufacturer rebates, net revenue, and decisions about pricing, contracting, and launch strategy. The impact will depend on the applicable model or agreement and the products involved.

Evidence and HTA outcomes remain important because they can influence international pricing and reimbursement. Where resulting prices are used in an MFN benchmark, they may also affect U.S. financial exposure.

Implications for coverage, patient costs, and access vary by initiative and should be considered alongside the commercial impact.

Start by assessing portfolio exposure and identifying the products, markets, and pricing arrangements most likely to be affected.

Next, evaluate pricing, contracting, and launch scenarios to understand potential financial implications and market access trade-offs, alongside local evidence needs and HTA readiness.

Then, bring global and local teams together around clear decision-making responsibilities, and revisit the strategy as policies and agreement terms evolve.