{"title":"Does price negotiation in China bring high-value novel drugs to the national medical insurance beneficiaries?","authors":"Xingyue Zhu , Yang Chen","doi":"10.1016/j.hlpt.2024.100963","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>China has initiated the drug price negotiation since 2017 to incorporate in-patent drugs into the reimbursement list of the Basic Medical Insurance (BMI). From 2020 onwards, the annual price negotiation accepts unsolicited applications from drug companies. However, it's unknown whether the negotiations attract new drugs with higher clinical benefits to improve the allocative efficiency of the BMI.</div></div><div><h3>Method</h3><div>We collected the new oncology indications approved in China between Jan 1, 2015 and June 30, 2023, and checked their reimbursement status in the recent four negotiations (2020–2023). The clinical benefits were defined as the treatment effects on the primary outcome in the pivotal trial supporting the indication approval. The outcomes were classified as response rate, time-to-event, and overall survival. An instrument variables (IV) strategy was established to explore the association between the reimbursement status and the magnitude of clinical benefits for each outcome type.</div></div><div><h3>Results</h3><div>A total of 222 oncology indications were gathered, among which 60.4 % obtained the reimbursement eligibility through the price negotiations. The IV regressions found that, the reimbursed indications had a 20 % higher response rate and a 0.26 lower hazard ratio of incurring a specific event than the non-reimbursed; but the survival benefits didn't differ between the two groups.</div></div><div><h3>Conclusion</h3><div>The price negotiations in China have brought new drugs with higher surrogate benefits into the BMI, yet have not attracted those with superior survival benefits. Regulatory innovations are needed to prioritize drugs validating therapeutic value in the reimbursement decision-making process to refine drug access.</div></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 1","pages":"Article 100963"},"PeriodicalIF":3.4000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health Policy and Technology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2211883724001266","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Objective
China has initiated the drug price negotiation since 2017 to incorporate in-patent drugs into the reimbursement list of the Basic Medical Insurance (BMI). From 2020 onwards, the annual price negotiation accepts unsolicited applications from drug companies. However, it's unknown whether the negotiations attract new drugs with higher clinical benefits to improve the allocative efficiency of the BMI.
Method
We collected the new oncology indications approved in China between Jan 1, 2015 and June 30, 2023, and checked their reimbursement status in the recent four negotiations (2020–2023). The clinical benefits were defined as the treatment effects on the primary outcome in the pivotal trial supporting the indication approval. The outcomes were classified as response rate, time-to-event, and overall survival. An instrument variables (IV) strategy was established to explore the association between the reimbursement status and the magnitude of clinical benefits for each outcome type.
Results
A total of 222 oncology indications were gathered, among which 60.4 % obtained the reimbursement eligibility through the price negotiations. The IV regressions found that, the reimbursed indications had a 20 % higher response rate and a 0.26 lower hazard ratio of incurring a specific event than the non-reimbursed; but the survival benefits didn't differ between the two groups.
Conclusion
The price negotiations in China have brought new drugs with higher surrogate benefits into the BMI, yet have not attracted those with superior survival benefits. Regulatory innovations are needed to prioritize drugs validating therapeutic value in the reimbursement decision-making process to refine drug access.
期刊介绍:
Health Policy and Technology (HPT), is the official journal of the Fellowship of Postgraduate Medicine (FPM), a cross-disciplinary journal, which focuses on past, present and future health policy and the role of technology in clinical and non-clinical national and international health environments.
HPT provides a further excellent way for the FPM to continue to make important national and international contributions to development of policy and practice within medicine and related disciplines. The aim of HPT is to publish relevant, timely and accessible articles and commentaries to support policy-makers, health professionals, health technology providers, patient groups and academia interested in health policy and technology.
Topics covered by HPT will include:
- Health technology, including drug discovery, diagnostics, medicines, devices, therapeutic delivery and eHealth systems
- Cross-national comparisons on health policy using evidence-based approaches
- National studies on health policy to determine the outcomes of technology-driven initiatives
- Cross-border eHealth including health tourism
- The digital divide in mobility, access and affordability of healthcare
- Health technology assessment (HTA) methods and tools for evaluating the effectiveness of clinical and non-clinical health technologies
- Health and eHealth indicators and benchmarks (measure/metrics) for understanding the adoption and diffusion of health technologies
- Health and eHealth models and frameworks to support policy-makers and other stakeholders in decision-making
- Stakeholder engagement with health technologies (clinical and patient/citizen buy-in)
- Regulation and health economics