PRICING STRATEGY SIMULATION UNDER JAPAN’S HEALTH TECHNOLOGY ASSESSMENT SYSTEM: TRADE-OFFS BETWEEN USEFULNESS PREMIUM WITH PRICE MAINTENANCE PROGRAM AND PRICE REDUCTION RISK
Author(s)
Hiroyuki Matsuda, MA, DrPH, Yawen Dai, MA, Mayuko Shinagawa, MSc, You Won Seong, MPP, MIS, Sven Demiya, MBA, MSc, PhD, Katsuya Yamagami, BPharm.
IQVIA Solutions Japan G.K., Tokyo, Japan.
IQVIA Solutions Japan G.K., Tokyo, Japan.
OBJECTIVES: Japan’s health technology assessment (HTA) system will be revised in 2026. A key proposal is to align or reduce prices (up to 15%) for technologies that fail to demonstrate additional clinical benefit versus comparators despite higher costs. Technologies receiving a Usefulness Premium (UP), which increases the likelihood of HTA selection, may benefit from the Patent-period price Maintenance Program for Innovative Drugs (PMP) that protects prices during the patent period. These mechanisms raise strategic trade-offs for market access and long-term revenue. This study aimed to identify factors associated with failure to demonstrate additional clinical benefit and through simulation, assess whether obtaining UP with PMP or avoiding UP (to reduce price adjustment risk) yields greater cumulative revenue.
METHODS: We reviewed 43 drug products (98 subpopulations) with publicly available HTA results from Japan’s HTA organization (C2H) as of May 2026. Additional clinical benefit and underlying reasons were summarized. A simulation assumed a base price of JPY 10,000, incorporating historical average drug price revision rates and time to HTA-based price adjustment. Price reduction rates (0-15%) and UP rates (5-60%) were varied over a 15-year horizon; the base case assumed a 5% UP and a 15% price reduction.
RESULTS: Seventeen products (39.5%) included one subpopulation without additional clinical benefits demonstrated (24/98, 24.5%). Key drivers were indirect comparisons (e.g., network meta-analysis) (50.0%) and no true outcome measure (20.8%). In the base case, UP with PMP yielded higher cumulative revenue for the first three years; from year 4 onward, avoiding UP became superior. With a 5% UP, UP with PMP remained favorable only when price reductions were ≤9%; at ≥10%, avoiding UP was superior.
CONCLUSIONS: Indirect evidence was the primary driver of failure to demonstrate additional clinical benefit. Manufacturers should evaluate pre-launch whether to pursue UP with PMP or avoid UP based on expected price reductions and UP levels.
METHODS: We reviewed 43 drug products (98 subpopulations) with publicly available HTA results from Japan’s HTA organization (C2H) as of May 2026. Additional clinical benefit and underlying reasons were summarized. A simulation assumed a base price of JPY 10,000, incorporating historical average drug price revision rates and time to HTA-based price adjustment. Price reduction rates (0-15%) and UP rates (5-60%) were varied over a 15-year horizon; the base case assumed a 5% UP and a 15% price reduction.
RESULTS: Seventeen products (39.5%) included one subpopulation without additional clinical benefits demonstrated (24/98, 24.5%). Key drivers were indirect comparisons (e.g., network meta-analysis) (50.0%) and no true outcome measure (20.8%). In the base case, UP with PMP yielded higher cumulative revenue for the first three years; from year 4 onward, avoiding UP became superior. With a 5% UP, UP with PMP remained favorable only when price reductions were ≤9%; at ≥10%, avoiding UP was superior.
CONCLUSIONS: Indirect evidence was the primary driver of failure to demonstrate additional clinical benefit. Manufacturers should evaluate pre-launch whether to pursue UP with PMP or avoid UP based on expected price reductions and UP levels.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
MSR29
Topic
Methodological & Statistical Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas