Market Access Policy for New Antimicrobial Drugs:International Experience and Inspiration
10.3870/j.issn.1004-0781.2025.03.014
- VernacularTitle:新型抗菌药物市场准入政策——国际经验与启示
- Author:
Baolong DING
1
;
Qiang LIU
;
Jingxuan WEI
;
Yuyang SUN
;
Wenmin DU
;
Xin LI
Author Information
1. 南京医科大学药学院,南京 211166
- Publication Type:Journal Article
- Keywords:
New antimicrobial drugs;
Access policy;
Antibacterial;
Antifungal;
Value assessment
- From:
Herald of Medicine
2025;44(3):416-421
- CountryChina
- Language:Chinese
-
Abstract:
Objective By reviewing the access policies for new antimicrobial drugs internationally,this study provides a reference for the development of China's antimicrobial drug access policy.Methods The Chinese and English databases,offi-cial websites of health agencies,and health technology assessment agencies of various countries(CNKI,PubMed,NICE in the UK,HAS in France,etc.)were searched to collect and sort out the access policies of new antibacterial drugs.Taking the antibacte-rial drug ceftazidime-avibactam and the antifungal drug esaconazole sulfate as examples,the key evidence points for the evaluation of antibacterial drugs in the market access process of medical insurance were analyzed.Finally,the author put forward suggestions for China's antibacterial drug access policy based on the opinions of experts in related fields of antibacterial drugs in China.Re-sults Access policies for antimicrobial drugs had already established in the UK,US,EU,Sweden Switzerland,and Republic of Korea.These policies included a series of measures such as evaluation approval rewards,patent extensions,additional reimburse-ment,decoupling sales revenue from sales volume,etc.,with the ultimate goal being to encourage research and development of new antibiotics while reducing resistance rates.The review found that besides evaluating the safety,economy,and cost-effectiveness,some evaluation agencies also consider the actual clinical value and social value of drugs when reviewing the evidence of two types of new antibacterial drugs in the medical insurance access link.Conclusion China can draw upon international framework principles while considering unique demands such as national antibiotic management policy or national healthcare negotiation re-quirements to provide certain policy support throughout the market access process for new antimicrobials due to their unique val-ues so that it can encourage research & development while curbing antibiotic resistance.
