Evolution of evidence on overall survival benefits of cancer drugs included on the national reimbursement drug list of China, 2005-2022: an observational study.

Abstract

Objective: To assess evidence of overall survival (OS) benefits of cancer drugs listed in China's National Reimbursement Drug List (NRDL), the guiding standard for public insurance coverage of drugs and characterise the evolution of survival evidence after NRDL inclusion.

Design: Retrospective observational study.

Setting: China's NRDL and journal publications.

Participants: Adult cancer drug indications approved in China from 1 January 2005 to 30 June 2022.

Main outcome measures: The primary outcome was the availability of OS benefit evidence at the time of initial NRDL listing, defined as a statistically significant survival gain over the control arm in pivotal clinical trials. The secondary outcome was the availability of evidence on clinical benefits after NRDL inclusion as of 31 December 2023, measured by OS and the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.1. ESMO-MCBS scores A to B in the curative setting or 4 or 5 in the non-curative setting were considered a substantial clinical benefit.

Results: By 30 June 2022, 72.6% (175/241) of cancer indications approved in China were included in the NRDL. The median time interval between marketing authorisation and NRDL inclusion decreased from 9.4 years in 2005-2010 to 4.1 years in 2011-2016, and 1.1 years in 2017-2022. 62 (35.4%) and 4 (2.3%) indications had documented OS benefits at the time of NRDL assessment or after, respectively. The median survival benefit was 3.9 months. Of the 109 indications without documented OS benefits by the end of the observation, 21 (19.3%) had substantial clinical benefits as measured by the ESMO-MCBS.

Conclusions and relevance: The time interval from regulatory approval to NRDL listing in China decreased over time. However, more than half of cancer drug indications listed for public insurance reimbursement did not have confirmed survival gain or substantial clinical benefits at the time of NRDL inclusion or after. Payers should give sufficient consideration to clinical benefit evidence when making reimbursement and disinvestment decisions to avoid wasteful spending of public health insurance funds.