新增适应证情形下医保药品价格调整的国际经验及其启示

International experiences and its lessons of medical insurance drug price adjustment in case of indication expansion

新增适应证是我国医保药品目录动态调整时经常面临的一种情形。文章梳理了典型国家在新增适应证情形下药品价格调整的经验,并分析了对我国的启示。典型国家主要采用基于清单价格的分适应证评估准入法、基于价值和使用量的加权定价法、基于量价关系定价法、基于风险共担协议的按适应证定价法以及基于初次准入评估定价法来确定新适应证准入后的药品价格,不同方法在保护医保基金财务风险、激励制药行业研发创新以及保障新适应证患者用药可及性这三个方面的影响是不同的。我国应明确当前阶段医保管理的主要问题与挑战,合理借鉴有益经验,完善新增适应证情形下医保药品价格调整方法。

Indication expansion is a common situation we ofter face in the dynamic adjustment of the national medical insurance drug list in China. This study reviewed the experiences of drug price adjustment in typical countries under the condition of indication expansion and summarized the enlightenment to China. Typical countries took variable measures to determine the drug prices after the expansion of new indications such as access after evaluations by indications based on list prices, weighted pricing method based on value and sales, volume-price drug pricing, indication-based pricing based on risk sharing agreements, and drug pricing based on evaluations in the initial access process. Different approaches have different impacts on protecting the financial risk of the medical insurance funds, encouraging research and development and innovation in the pharmaceutical industry, and ensuring the drug accessibility for the insured patients with new indications. We should clarify the main problems and challenges of medical insurance management in the current stage in China, draw on useful experiences, and improve the price adjustment strategies of medical insurance drugs in the case of indication expansion.