Presentation (CTI)

OBJECTIVES: In January 2026, the first of three planned US most-favoured-nation (MFN) international reference pricing (IRP) models, GENEROUS (GENErating cost Reductions fOr US Medicaid), was introduced, benchmarking Medicaid prices against eight reference countries. This research examines whether MFN pricing may incentivise manufacturers to delay launch, withdraw products, or seek higher prices in reference markets.
METHODS: A revenue forecast model for a hypothetical product X was developed and calibrated for plausible (PPP adjusted) pricing and market access effects across GENEROUS countries. Scenarios evaluated: (a) US MFN pricing alone; (b) non-launch/withdrawal from European markets; (c) European net price increases. Regulatory and HTA/reimbursement approvals from 2024-2026 were analysed to assess changes in launch activity across MFN reference markets following US MFN policy proposals.
RESULTS: For base case analysis, US Medicaid price was $10/day and accounted for 20% of annual revenue across all nine markets. Under GENEROUS, benchmarking to the UK price ($5/day; Italy lowest at $4/day) reduced total revenue by 9.8%. to $8/day but yielded a larger revenue reduction (-14.5%) due to forgone sales. Where US Medicaid represented >31% of total revenue, non-launch in the UK and Italy slightly reduced revenue losses relative to MFN pricing alone. Launch rate of FDA approved products across all MFN markets fell from 2024 to 2025, with the largest decrease in Switzerland (48% vs 24%), MHRA (58% vs 33%) and EMA (60% vs 46%). Launch rates remained below 30% in Canada and Japan throughout.
CONCLUSIONS: If increases in European net price can be achieved, these are likely to represent a more effective revenue-maintenance strategy than product withdrawal or non-launch in MFN reference markets. However, the threat of market withdrawal, amongst other pressures, may itself create political momentum for higher net prices in European markets.