Evidence map›Paper›PMID 40419451›Full record

ArticleClinical and translational science2025

Added Therapeutic Benefits of Top-Selling Drugs in Japan: A Cross-Sectional Study Using Health Technology Assessment.

Hayase Hakariya, Akihiko Ozaki, Takanao Hashimoto, Frank Moriarty, Hideki Maeda, Tetsuya Tanimoto

Abstract read
In one paragraph

Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Hayase HakariyaInterfaculty Institute of Biochemistry, University of Tuebingen, Tuebingen, Germany.ORCID 0000-0002-9121-4551
Akihiko OzakiBreast and Thyroid Center, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan.ORCID 0000-0003-4415-9657
Takanao HashimotoKenkodo Pharmacy, Osaki, Miyagi, Japan.ORCID 0000-0003-2924-3391
Frank MoriartySchool of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.ORCID 0000-0001-9838-3625
Hideki MaedaRegulatory Science, School of Pharmacy, Meiji Pharmaceutical University, Tokyo, Japan.ORCID 0000-0002-0117-3961
Tetsuya TanimotoNavitas Clinic, Tokyo, Japan.ORCID 0000-0002-9818-8587

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Drug CostsTechnology Assessment, BiomedicalCanadaCost-Benefit AnalysisCross-Sectional StudiesHumansJapanadded therapeutic benefithealth technology assessmentJapantop‐selling drugs

Identifiers

PMID40419451
PMCPMC12105913

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.