Recent Health Technology Assessment Developments in Japan
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES: In Japan, cost‑effectiveness assessments (CEAs) are a centralized health technology assessment (HTA) system. The CEAs are primarily conducted by the Central Social Insurance Medical Council (Chuikyo). After the completion of a successful CEA trial run, the CEA system of reviewing drugs began in earnest in April 2019 with a limited scope. The objective of this research is to assess the latest HTA developments in Japan. METHODS: CEAs from 2021 were assessed. RESULTS: As of April 14, 2021, 16 products have been assessed. With the CEA system, drugs are categorized as H1 (new drugs with ¥ 10 billion or more in peak sales), H2 (new drugs with ¥ 5 billion to ¥ 10 billion in peak sales), H3 (new drugs selected by Chuikyo based on their significantly high prices), H4 (already listed drugs with ¥ 100 billion or more in peak sales or selected based on their significantly high prices), or H5 (similar products that reference the prices of drugs in the H1 to H4 categories). Fifty percent of the drugs were in the H1 category, 6% were in H2, 13% were in H3, and 31% were in H5. The committee assessed two H3 orphan drugs (tisagenlecleucel and onasemnogene abeparvovec). Tisagenlecleucel’s cost was reduced by 4.3% after price adjustment. Products with high peak sales and significantly high cost are prioritized. CONCLUSIONS: The HTA landscape in Japan is evolving. Chuikyo is focused on improving the system by setting appropriate prices. The agency will continue to consider comprehensive evaluation and price adjustments while referring to the efforts in other countries. Understanding the requirements and decision-making process may result in faster market access to innovative treatments in Japan.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSB274
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy, Systems & Structure, Value Frameworks & Dossier Format
Disease
Drugs, Multiple Diseases, Oncology, Rare and Orphan Diseases