近年来,我国医保部门持续推动医保药品目录动态调整机制的构建与优化,通过纳入新上市药品、调整药品支付范围、支付标准及续约协议到期药品,同步调出目录内临床价值不高、可替代、撤市或供应保障不足的药品,逐渐优化目录结构。然而,当前目录内药品再评价和动态调整机制仍存在规范化与常态化不足等问题,导致部分临床价值待证实、真实世界疗效与临床试验差异显著等“不确定”药品仍享受政策红利,再评价流程也有待进一步规范。本研究聚焦我国医保目录药品再评价与动态调整机制优化,系统分析了在当前“三医”协同治理体系下,药监、卫健和医保三部门的药品再评价政策框架及现存挑战。通过梳理英国、加拿大、德国、日本和韩国等典型国家在药品再评价与调整机制方面的政策经验,提炼可供借鉴的实践启示。在此基础上,本研究立足我国国情,从触发条件、评价流程、评价标准、调整规则和路径,以及申诉和复核机制等方面,提出我国医保目录药品再评价与动态调整机制的优化建议,并结合我国“真实世界医保综合价值评价”系列工作,以期为相关政策的进一步调整提供理论依据与实践参考。
Abstract
In recent years, China's healthcare security authorities have continuously promoted the construction and optimization of a dynamic adjustment mechanism for the medical insurance drug catalog. By including newly approved drugs, adjusting drug coverage, payment standards, and renewing expired agreements for drugs, while simultaneously removing drugs with low clinical value, replaceable alternatives, market withdrawals, or insufficient supply from the catalog, the structure of the drug catalog has gradually been optimized. However, issues such as insufficient standardization and normalization persist in the current drug re-evaluation and dynamic adjustment mechanisms, leading to some drugs with uncertain clinical value or significant discrepancies between real-world efficacy and clinical trial results still benefiting from policy incentives. The re-evaluation process also requires further standardization. This study focuses on optimizing the drug re-evaluation and dynamic adjustment mechanisms in China's medical insurance catalog, systematically analyzing the policy framework and existing challenges for drug re-evaluation among the three departments—medical products administration, health commission, and healthcare security—under the current governance system of coordinated development and regulation of medical insurance, medical services, and pharmaceuticals. By reviewing policy experiences from typical countries such as the UK, Canada, Germany, Japan, and South Korea in medical insurance drug re-evaluation and adjustment mechanisms, the study extracts practical insights for reference. Building on this, the study proposes optimization suggestions for China's medical insurance drug re-evaluation and dynamic adjustment mechanisms based on the national conditions, covering trigger conditions, evaluation processes, assessment criteria, adjustment rules and pathways, as well as appeal and review mechanisms. Additionally, the study integrates China's "Real-World Comprehensive Value Assessment for Medical Insurance" series of initiatives to provide theoretical and practical references for further policy adjustments.
关键词
真实世界数据 /
药品再评价 /
医保目录 /
动态调整
Key words
real-world data /
re-evaluation of drugs /
medical insurance catalog /
dynamic adjustment
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基金
国家自然科学基金项目“数智化驱动的罕见病多重保障机制设计与实证研究”（7234 2015）
