{"title":"Added Therapeutic Benefits of Top-Selling Drugs in Japan: A Cross-Sectional Study Using Health Technology Assessment","authors":"Hayase Hakariya, Akihiko Ozaki, Takanao Hashimoto, Frank Moriarty, Hideki Maeda, Tetsuya Tanimoto","doi":"10.1111/cts.70243","DOIUrl":null,"url":null,"abstract":"<p>It is unclear whether Japanese top-selling drugs have meaningful added therapeutic benefits to justify their high sales. This question is relevant as Japan's healthcare costs are rising consistently, particularly due to increasing drug prices. This cross-sectional study evaluated the added therapeutic benefits of Japan's top-selling drugs in 2021 using ratings from established health technology assessment (HTA) agencies in Canada, France, and Germany. Drug characteristics and benefit ratings were obtained from public databases and HTA agencies, following the established method. Overall, added therapeutic benefit ratings were categorized as binary (high or low). Of 51 identified top-selling drugs in Japan, 43 (86%) had at least one rating from three agencies. Notably, 20 (47%) received low added therapeutic benefit ratings even in our optimistic scenario. Low ratings were more common among small-molecule drugs 15/20 (75%), while high ratings were predominant among biologics 14/23 (61%). Oncology drugs represented the largest category in both high 9/23 (39%) and low 5/20 (25%) groups. Interestingly, 9 drugs (9/16; 56%) approved between 2011 and 2021 received low ratings, compared to 41% (11/27) of those approved before 2011. Additionally, 70% of high-benefit drugs received at least one expedited review, whereas this was 35% for low-benefit drugs. Our findings revealed that many top-selling drugs in Japan had low added therapeutic benefits. Utilizing HTA evaluation frameworks provides valuable insights, particularly in prioritizing drugs based on added therapeutic benefits. While full implementation of such a system in Japan requires further consideration, strengthening HTA processes could help ensure sustainable healthcare costs.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 6","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70243","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cts-Clinical and Translational Science","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/cts.70243","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
It is unclear whether Japanese top-selling drugs have meaningful added therapeutic benefits to justify their high sales. This question is relevant as Japan's healthcare costs are rising consistently, particularly due to increasing drug prices. This cross-sectional study evaluated the added therapeutic benefits of Japan's top-selling drugs in 2021 using ratings from established health technology assessment (HTA) agencies in Canada, France, and Germany. Drug characteristics and benefit ratings were obtained from public databases and HTA agencies, following the established method. Overall, added therapeutic benefit ratings were categorized as binary (high or low). Of 51 identified top-selling drugs in Japan, 43 (86%) had at least one rating from three agencies. Notably, 20 (47%) received low added therapeutic benefit ratings even in our optimistic scenario. Low ratings were more common among small-molecule drugs 15/20 (75%), while high ratings were predominant among biologics 14/23 (61%). Oncology drugs represented the largest category in both high 9/23 (39%) and low 5/20 (25%) groups. Interestingly, 9 drugs (9/16; 56%) approved between 2011 and 2021 received low ratings, compared to 41% (11/27) of those approved before 2011. Additionally, 70% of high-benefit drugs received at least one expedited review, whereas this was 35% for low-benefit drugs. Our findings revealed that many top-selling drugs in Japan had low added therapeutic benefits. Utilizing HTA evaluation frameworks provides valuable insights, particularly in prioritizing drugs based on added therapeutic benefits. While full implementation of such a system in Japan requires further consideration, strengthening HTA processes could help ensure sustainable healthcare costs.
期刊介绍：
Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
