COMPARATOR SELECTION IN JAPAN'S HTA SYSTEM: FROM GUIDELINE PRINCIPLES TO PRACTICE, AND COMPARISON WITH INTERNATIONAL HTA AGENCIES
Author(s)
Kittima Wattanakamolkul, PhD1, Mariko Hirozane, PhD2.
1Value, Evidence and Access department, Johnson & Johnson Innovative Medicine, Tokyo, Japan, 2Policy department, Johnson & Johnson Innovative Medicine, Tokyo, Japan.
1Value, Evidence and Access department, Johnson & Johnson Innovative Medicine, Tokyo, Japan, 2Policy department, Johnson & Johnson Innovative Medicine, Tokyo, Japan.
OBJECTIVES: Comparator is a critical driver of CEA results, which materially influence HTA outcomes. This study examined Japan’s HTA guidance on comparator selection, assessed selected comparator against guideline-recommended principles, and compared the choices with those of international HTA agencies.
METHODS: A targeted literature review of completed HTA evaluations in Japan (April 2019 - March 2026) was conducted using publicly available data. Publicly selected comparators were assessed in relation to HTA guideline‑recommended principles, including: (1) clinical guideline recommendations, (2) comparators used in randomized controlled trials (RCTs), and (3) pricing comparators. Selection of lowest-cost option was also assessed for both public and company selections. For selected case studies, comparator choices were compared with those of major HTA agencies (NICE, HAS, IQWiG, CADTH, PBAC, and ICER).
RESULTS: A total of 41 products (95 analysis populations) were included. Of these, 48.4%, 29.5%, and 22.1% were evaluated under the 2019, 2022, and 2024 guidelines, respectively. Clinical guidelines included multiple treatment options in 67.4% of cases; within these, the lowest-cost option was publicly selected in 56.3%. Misalignment between publicly selected comparators and pricing comparators was observed in 79.7% of applicable cases, and in 30.7% versus RCT comparators. Overall, publicly selected comparators were the lowest-cost option in 41.1%, compared with 15.8% for company-selected comparators. This pattern suggests that publicly selected comparators more frequently correspond to lower-cost alternatives. In selected cases (e.g., clazosentan and molnupiravir), selected comparators in Japan were not aligned with clinical guidelines; for molnupiravir, NICE and PBAC selected similar comparators, while assessments for other agencies and for clazosentan were unavailable.
CONCLUSIONS: Comparator selection in Japan shows deviations from guideline-recommended practice in a subset of cases, with publicly selected comparators more frequently reflecting lower-cost options. These findings highlight differences in stakeholder considerations and underscore the value of enhanced transparency and alignment in comparator selection processes.
METHODS: A targeted literature review of completed HTA evaluations in Japan (April 2019 - March 2026) was conducted using publicly available data. Publicly selected comparators were assessed in relation to HTA guideline‑recommended principles, including: (1) clinical guideline recommendations, (2) comparators used in randomized controlled trials (RCTs), and (3) pricing comparators. Selection of lowest-cost option was also assessed for both public and company selections. For selected case studies, comparator choices were compared with those of major HTA agencies (NICE, HAS, IQWiG, CADTH, PBAC, and ICER).
RESULTS: A total of 41 products (95 analysis populations) were included. Of these, 48.4%, 29.5%, and 22.1% were evaluated under the 2019, 2022, and 2024 guidelines, respectively. Clinical guidelines included multiple treatment options in 67.4% of cases; within these, the lowest-cost option was publicly selected in 56.3%. Misalignment between publicly selected comparators and pricing comparators was observed in 79.7% of applicable cases, and in 30.7% versus RCT comparators. Overall, publicly selected comparators were the lowest-cost option in 41.1%, compared with 15.8% for company-selected comparators. This pattern suggests that publicly selected comparators more frequently correspond to lower-cost alternatives. In selected cases (e.g., clazosentan and molnupiravir), selected comparators in Japan were not aligned with clinical guidelines; for molnupiravir, NICE and PBAC selected similar comparators, while assessments for other agencies and for clazosentan were unavailable.
CONCLUSIONS: Comparator selection in Japan shows deviations from guideline-recommended practice in a subset of cases, with publicly selected comparators more frequently reflecting lower-cost options. These findings highlight differences in stakeholder considerations and underscore the value of enhanced transparency and alignment in comparator selection processes.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA61
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas