Evidence map›Paper›PMID 36785854›Full record

ArticleThe Lancet regional health. Western Pacific2023

The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis.

Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Ruijie Tan, Yue Zhou, Zhuangqi Li, Xuecai Xue, Taifeng Li, Kaidi Le and 3 more

Open access · goldAbstract read
In one paragraph

Article in The Lancet regional health. Western Pacific, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% of its field
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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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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

13 authors at 6 institutions in 2 countries.

Xingxian LuoSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Xin DuSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Lin HuangDepartment of Pharmacy, Peking University People's Hospital, Beijing, China.
Qixiang GuoSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Ruijie TanSchool of Pharmacy, Fudan University, Shanghai, China.
Yue ZhouDepartment of Pharmacy, Peking University People's Hospital, Beijing, China.
Zhuangqi LiSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Xuecai XueDepartment of Pharmacy, Peking University People's Hospital, Beijing, China.
Taifeng LiDepartment of Pharmacy, Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Kaidi LeDepartment of Pharmacy, Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Feng QianSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
Shein-Chung ChowBiostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Yue YangSchool of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
National Medical Products Administration · CNPeking University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNDuke University · USFudan University · CNTsinghua University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Affordability to novel anticancer drugs has become a major health issue in China. It is encouraging to note that China initiated its drug regulatory reform and national price negotiation policies since 2015. As a growing number of domestic within-class targeted anticancer drugs are approved in China, it is expected that this may reduce the price of novel anticancer drugs and improve the affordability of anticancer drugs. This study aimed to evaluate the price, efficacy, and safety of the within-class anticancer drugs between domestic and imported drugs approved in China from 2010 to 2022. Methods: The domestic and imported within-class targeted drugs for solid cancers approved in China between 2010 and 2022 were extracted. We classified it as a class of anticancer drugs based on the same indication and similar biological mechanism. The published literature derived from pivotal clinical trials of these domestic and imported drugs was identified based on the review report and the latest labels issued by the China National Medical Products Administration. We evaluated the monthly treatment price at launch and the latest (2022), primary efficacy endpoint and safety between domestic and imported anticancer drugs. Meta-analyses were further employed to evaluate the efficacy and safety of the domestic and imported anticancer drugs, including pooled hazard ratios (HR) for progression-free survival (PFS), overall survival (OS), objective response rates (ORR) for solid cancers, and relative risk for serious adverse events (SAE) and Grade ≥3 adverse events (AEs). Findings: In our cohort study, 12 within-class anticancer drugs with 7 cancer diseases were analyzed, including 18 domestic (21 indications; 21 pivotal trials) and 18 imported (21 indications; 27 pivotal trials) novel anticancer drugs, respectively. The median monthly treatment price of domestic and imported drugs from the years of launch to 2022 had significantly decreased by 71% and 62%, respectively. Moreover, the median monthly treatment price of domestic targeted anticancer drugs on the market at launch ($3786 vs. $5393, Interpretation: The prices of both domestic and imported anticancer drugs significantly decreased after market entry mainly due to the role of national price negotiations. The median monthly treatment price of domestic within-class targeted anticancer drugs was significantly lower than that of imported drugs. Furthermore, the efficacy and safety of domestic anticancer drugs were comparable to that of imported drugs. This evidence implicated that the development of within-class anticancer drugs with national price negotiations in China significantly improved the affordability for patients. Funding: This study was supported by postdoctoral fellowship from Tsinghua-Peking Joint Centers for Life Sciences (CLS).

Indexed as

AffordabilityChinaNational drug price negotiationPivotal trialsTargeted anticancer drugs

Identifiers

PMID36785854
PMCPMC9918802
OpenAlexW4313530771

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.