International Comparative Analysis of National Price Negotiation Drugs'Clinical Added Benefit Assessment and New Medicine Classification
Chen Yi
Feng Zhe
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.
Keywords：clinical benefits of innovative druginnovation assessment and gradingpharmacoeconomic evaluationmedical insurance innovationvalue-based purchase
Publication Date：2025-04-05
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：8( 18-25 )