Has the IRA Impacted International Price Differentials? Comparing US and German Drug Prices in the Era of MFP
Author(s)
Loukia Mantzali, MBA, Trisha Srivastava, MBA, Megan O'Brien, NA.
Access Infinity, London, United Kingdom.
Access Infinity, London, United Kingdom.
OBJECTIVES: Under the Inflation Reduction Act (IRA) of 2022, high-spend drugs are subject to price negotiations. Furthermore, the US administration is implementing an externally referenced price policy. We aim to evaluate if rare disease therapies preserve their prices under IRA, and whether it impacts price differences between US and Germany.
METHODS: We conducted a comparative price analysis of US and German (DE) drugs targeted for IRA price negotiations in 2024 (completed), 2025 (ongoing) and 2026 (expected). We leveraged data from Centers for Medicare & Medicaid Services (CMS) and Access Infinity's proprietary platform NURO™ to identify drugs and public list prices which we classified as indicated for rare and non-rare diseases. Criteria applied to the products: 1. Only products with both EMA and FDA approval included 2. Common SKUs in US and DE selected 3. Historical prices over the last 10 years used to capture price differential trends.
RESULTS: 10 drugs qualified for IRA negotiations in 2024, 15 in 2025 and 11 potentially in 2026. Of those, 11 products were approved for rare indications. A consistent price difference was observed between US and DE with some variance between rare and non-rare disease therapies. For non-rare therapies, US prices were 60-90% higher than DE, with this difference widening over the last 10 years by 8-20% points. Rare disease therapies demonstrated a similar initial price differential but a greater widening of this gap, by 10-20% points, over the same period.
CONCLUSIONS: It is anticipated that the international price gap will narrow as drugs selected for maximum fair price (MFP) negotiations are expected to undergo an average list price reduction of >65% for both rare and non-rare therapies. By reducing historically higher US prices, MFP negotiations can eventually limit the impact of list price discrepancies under the “most-favoured nations” policy proposal
METHODS: We conducted a comparative price analysis of US and German (DE) drugs targeted for IRA price negotiations in 2024 (completed), 2025 (ongoing) and 2026 (expected). We leveraged data from Centers for Medicare & Medicaid Services (CMS) and Access Infinity's proprietary platform NURO™ to identify drugs and public list prices which we classified as indicated for rare and non-rare diseases. Criteria applied to the products: 1. Only products with both EMA and FDA approval included 2. Common SKUs in US and DE selected 3. Historical prices over the last 10 years used to capture price differential trends.
RESULTS: 10 drugs qualified for IRA negotiations in 2024, 15 in 2025 and 11 potentially in 2026. Of those, 11 products were approved for rare indications. A consistent price difference was observed between US and DE with some variance between rare and non-rare disease therapies. For non-rare therapies, US prices were 60-90% higher than DE, with this difference widening over the last 10 years by 8-20% points. Rare disease therapies demonstrated a similar initial price differential but a greater widening of this gap, by 10-20% points, over the same period.
CONCLUSIONS: It is anticipated that the international price gap will narrow as drugs selected for maximum fair price (MFP) negotiations are expected to undergo an average list price reduction of >65% for both rare and non-rare therapies. By reducing historically higher US prices, MFP negotiations can eventually limit the impact of list price discrepancies under the “most-favoured nations” policy proposal
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE483
Topic
Economic Evaluation, Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Rare & Orphan Diseases