ArticleTranslational cancer research2026
Clinical value and cost-effectiveness analysis of conditionally approved anticancer drugs in China from 2015 to 2023.
Article in Translational cancer research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: The conditional approval (CA) process in China was established in 2015 to expedite access to urgently-needed drugs, however, the clinical benefits of CA drugs and potential gaps between pre-approval and confirmatory trials remain uncertain. Herein, we aim to compare the clinical values between CA and non-CA anticancer drugs from 2015 to 2023, and to explore the relationship between clinical benefit and average daily cost of treatment of drugs. Methods: This retrospective study analyzed anticancer drugs first approved in China [2015-2023] using data from National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE). Daily treatment costs were derived from Pharmacodia, Yilian Pharmaceutical Procurement Database and provincial centralized pharmaceutical procurement platforms. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and complete remission/complete remission with partial hematological recovery (CR/CRh) were utilized as indicators of clinical benefit. Mann-Whitney U test was conducted to evaluate the differences among approval pathways and Pearson correlation coefficient was calculated to analyse the relationship between clinical benefit and daily cost of treatment. Results: There were 120 new anticancer drugs approved in China from 2015 to 2023, with 48.3% (n=58) granted CA. No significant differences in clinical benefits were observed between CA and non-CA drugs (pooled ORR: 59.3% Conclusions: The CA process has facilitated innovation while addressing clinical needs. However, it is imperative for the policy to strike a balance between the urgency of clinical demands and the requirements for robust evidence. Furthermore, there is a current imbalance between the prices of drugs and their clinical value, necessitating further refinement of the pricing mechanism for innovative drugs.
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