As Japan’s healthcare expenditures continue to rise, the value proposition of its most popular pharmaceuticals comes under scrutiny, raising concerns about the efficiency of current drug spending.
Assessment Reveals Majority of Top Drugs Lack High Therapeutic Benefits
A cross-sectional study conducted in 2021 evaluated the added therapeutic benefits of Japan’s top-selling medications by referencing ratings from health technology assessment (HTA) agencies in Canada, France, and Germany. Out of 51 identified leading drugs, 43 secured at least one rating from these international bodies.
Biologics Outperform Small-Molecule Drugs in Therapeutic Ratings
The analysis uncovered that nearly half of the top-selling drugs (20 out of 43) were assigned low added therapeutic benefit ratings. Small-molecule drugs were predominantly represented in this low-benefit category, constituting 75% of low-rated drugs. In contrast, 61% of biologics achieved high benefit ratings. Oncology drugs remained the largest group within both high and low benefit classifications.
• Small-molecule drugs make up the majority of low-benefit ratings.
• Biologics demonstrate a higher likelihood of receiving favorable therapeutic evaluations.
• Oncology medications are significantly represented in both high and low benefit groups.
• Drugs approved between 2011 and 2021 have a higher incidence of low benefit ratings.
• High-benefit drugs are more frequently subjected to expedited review processes.
The study also found that pharmaceuticals approved in the last decade were more likely to be rated as having low therapeutic benefits compared to those approved earlier. Additionally, drugs that received high-benefit ratings were more likely to undergo expedited reviews, indicating a possible prioritization of more beneficial drugs in the approval pipeline.
Integrating HTA evaluation frameworks into Japan’s drug assessment process could offer critical insights for prioritizing medications based on their therapeutic value. This approach may help curb rising healthcare costs by ensuring that high-priced drugs provide meaningful benefits to patients. Strengthening HTA processes is essential for sustainable healthcare management, potentially leading to more informed decisions that balance cost with clinical efficacy.
Enhancing the robustness of HTA evaluations can empower policymakers to better navigate the complexities of drug pricing and therapeutic value, ultimately fostering a more sustainable and effective healthcare system in Japan.

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