International Comparative Analysis of National Price Negotiation Drugs'Clinical Added Benefit Assessment and New Medicine Classification
- VernacularTitle:医保谈判药品临床附加价值评估与新药分级的国际实践研究
- Author:
Yi CHEN
1
;
Zhe FENG
1
Author Information
1. 清华大学医院管理研究院 广东 深圳 518055
- Publication Type:Journal Article
- Keywords:
clinical benefits of innovative drug;
innovation assessment and grading;
pharmacoeconomic evaluation;
medical insurance innovation;
value-based purchase
- From:
Chinese Health Economics
2025;44(4):18-25
- CountryChina
- Language:Chinese
-
Abstract:
With a globally fast regulatory approval of new drugs accompanied by limited evidences and uncertain clinical efficacy under conditional approval,challenge arises for the international payers to reimburse drugs with insufficient evidences.Thus,requirement of high quality of clinical outcome data has become an important criterion for assessment of added clinical benefit of new drugs in recent years.Relying on social medical insurance program and price negotiation model,Germany,France and Italy are selected as representative countries,and the negotiation guideline and literature and to explore the common characteristics of these countries in drug clinical added benefit are summarized.All these three countries have established a relatively complete mechanism for evaluating negotiated medicines,by setting up a separate professional organization for clinical value assessment independent of drug pricing,and emphasized the importance of the quality of clinical evidence in the evaluation of the clinical added benefit of medicines,as well as developing the basis for grading negotiated medicines according to their clinical added benefit.It provides international experience for improving China's health technology assessment and drug negotiation mechanism,clarifying the connotation of evaluation indicators for negotiated drugs,introducing the requirements for assessing the quality of clinical evidence,and constructing a grading mechanism for negotiated drugs according to their added value,as well as the idea of differential pricing of drugs.
