National School of Development, Peking University, Beijing, China; Institute for Global Health and Development, Peking University, Beijing, China.
School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China; Center for Social Science Survey and Data, Tianjin University, Tianjin, China.
Value Health Reg Issues. 2022 Jul;30:59-66. doi: 10.1016/j.vhri.2021.12.003. Epub 2022 Feb 27.
In China, efforts to qualify innovative medical products for reimbursement used to be subject to substantial delays after regulatory approval due to fiscal and bureaucratic barriers. In this review, we surveyed the Chinese government's most recent initiatives to improve access to innovative medicines from both the regulatory and the reimbursement aspects, which not only accelerated the launching of drugs in the Chinese market but also expanded the reimbursement coverage of such products. We also provided a discussion of the current challenges.
We provided a comprehensive review of the updates in China's national reimbursement listing policies of medicines.
As the most recognized regulatory shortcuts, priority and conditional approvals have expedited the authorization of many innovative medicines. In addition, the national negotiation process was institutionalized to enable timely access to innovative medicines through the National Reimbursement Drug List, leading examples of which were new anticancer drugs. Other impactful reimbursement policies in recent years included dynamic updates of the National Reimbursement Drug List, manufacturer-initiated reimbursement coverage applications, and parallel fund robustness tests and pharmacoeconomic analyses for price estimation. Recent administrative efforts have substantially improved the access to and affordability of innovative medicines in China. Nevertheless, standardized and transparent evidence appraisal processes need to be established for informed decision making in the future.
在中国，由于财政和官僚障碍，创新型医疗产品在获得监管批准后，其报销资格的认定通常会有很长的延迟。在本次综述中，我们调查了中国政府最近在监管和报销方面为改善创新药物的可及性而采取的措施，这些措施不仅加速了药品在中国市场的推出，还扩大了这些产品的报销范围。我们还讨论了当前面临的挑战。
我们对中国药品国家报销目录政策的最新调整进行了全面综述。
作为最受认可的监管捷径，优先审批和有条件审批加速了许多创新药物的授权。此外，国家谈判程序已经制度化，通过国家医保药品目录使创新药物能够及时获得准入，其中新的抗癌药物是典型代表。近年来，其他有影响力的报销政策还包括国家医保药品目录的动态更新、制药企业发起的报销覆盖申请，以及仿制药质量和疗效一致性评价的平行基金稳健性测试和药物经济学分析用于定价估算。最近的行政努力大大提高了中国创新药物的可及性和可负担性。然而，未来需要建立标准化和透明的证据评估流程，以做出明智的决策。
