FROM TOKYO TO WASHINGTON: IMPACT OF JAPAN’S HTA ENVIRONMENT ON U.S. MFN PRICING AND LAUNCH STRATEGY
Author(s)
Heather Wellam, MSc1, Dhanveer S. Sandhu, MSc2, Rohan Chowdhury, PhD Economics2, Clare Foy, Applied Microbiology2;
1Petauri Evidence, Bicester, United Kingdom, 2Petauri, Bicester, United Kingdom
1Petauri Evidence, Bicester, United Kingdom, 2Petauri, Bicester, United Kingdom
OBJECTIVES: We assessed the impact of Japan’s additional health technology assessment (HTA) cost-effectiveness analysis (CEA) step on pricing. We then explored how these findings may inform manufacturer strategies under the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model, a voluntary Centers for Medicare & Medicaid Services (CMS) initiative, applying Most-Favored-Nation (MFN) pricing principles to U.S. Medicaid.
METHODS: We extracted the incremental cost-effectiveness ratio (ICER) threshold and price adjustments (%) from all HTA decisions published by the Center for Outcomes Research and Economic Evaluation for Health (C2H) since the introduction of the CEA step (2019-2023).
Price changes were summarized by ICER intervals, <5 million, 5-7.5 million, 7.5-10 million, >10 million Japanese Yen (JPY)/quality-adjusted life year (QALY). The relationship between ICER and price adjustment was assessed by calculating the correlation coefficient. CMS policy was reviewed to evaluate the implications of price adjustments under the GENEROUS Model.
RESULTS: Amongst 39 completed CEA assessments, 34 reported the ICER value (JPY/QALY) and 25 reported the numeric adjustment in National Health Insurance (NHI) list price, the mean price change was -4.7% (median: -4.1%; range: -0.1 to -24%). By ICER category:• <5 million JPY/QALY (n=9) - mean: -2.9%• 5-7.5 million JPY/QALY (n=10) - mean: -3.8%• 7.5-10 million JPY/QALY (n=3) - mean: -6.1%• >10 million JPY/QALY (n=12) - mean: -6.6%
The relationship between ICER and price adjustment was weak (correlation coefficient: -0.4) and driven by two outliers, yielding no significant association.
CONCLUSIONS: Japan’s CEA step acts as a downward pricing lever. Combined with MFN-style pricing, this is likely to shift U.S. pricing benchmarks, drive revenue erosion, and influence launch sequencing across external reference pricing markets. Manufacturers should integrate the effects of Japan’s HTA approach into their global sequencing strategy, while adopting adaptive pricing and transparency measures to protect price corridors under converging policy pressures.
METHODS: We extracted the incremental cost-effectiveness ratio (ICER) threshold and price adjustments (%) from all HTA decisions published by the Center for Outcomes Research and Economic Evaluation for Health (C2H) since the introduction of the CEA step (2019-2023).
Price changes were summarized by ICER intervals, <5 million, 5-7.5 million, 7.5-10 million, >10 million Japanese Yen (JPY)/quality-adjusted life year (QALY). The relationship between ICER and price adjustment was assessed by calculating the correlation coefficient. CMS policy was reviewed to evaluate the implications of price adjustments under the GENEROUS Model.
RESULTS: Amongst 39 completed CEA assessments, 34 reported the ICER value (JPY/QALY) and 25 reported the numeric adjustment in National Health Insurance (NHI) list price, the mean price change was -4.7% (median: -4.1%; range: -0.1 to -24%). By ICER category:• <5 million JPY/QALY (n=9) - mean: -2.9%• 5-7.5 million JPY/QALY (n=10) - mean: -3.8%• 7.5-10 million JPY/QALY (n=3) - mean: -6.1%• >10 million JPY/QALY (n=12) - mean: -6.6%
The relationship between ICER and price adjustment was weak (correlation coefficient: -0.4) and driven by two outliers, yielding no significant association.
CONCLUSIONS: Japan’s CEA step acts as a downward pricing lever. Combined with MFN-style pricing, this is likely to shift U.S. pricing benchmarks, drive revenue erosion, and influence launch sequencing across external reference pricing markets. Manufacturers should integrate the effects of Japan’s HTA approach into their global sequencing strategy, while adopting adaptive pricing and transparency measures to protect price corridors under converging policy pressures.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA34
Topic
Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas