在创新药新上市即将面临医保国谈的背景下,哪些因素可能影响创新药的价格形成和医保准入,成为决策者和社会各界广泛关注的问题。本研究从创新药价格形成的经济学原理、医保谈判的中国实践、医保准入的不同模式、现有研究的主要发现四个方面进行分析。研究发现,从微观上,价值和成本是创新药价格的上下限,临床价值是最重要的价值维度,需要持续评估。从宏观上,国家经济发展水平对支付方和供给侧都会带来复杂和深远的影响。医保基于“战略购买”思路,需要遴选“性价比”更高的药品,药物经济学评价是必要的工具之一,其有助于降低决策风险,促进“有效市场”和“有为政府”更好发挥作用。
Abstract
In the context of the national medical insurance negotiations for the new innovative drugs, what may affect the price formation and medical insurance access of innovative drugs has become a widely concerned issue for decision-makers and various sector. This study analyzes from aspects of the economic principles in the formation of innovative drug prices, the practice of medical insurance negotiations in China, different models of medical insurance access, and the main findings of studies. Research has found that at the micro level, value and cost are the upper and lower limits of innovative drug prices, and clinical value is the most important value dimension that requires continuous evaluation. From a macro perspective, the level of national economic development will have complex and far-reaching impacts on both the payer and the supply side. Based on the "strategic purchasing" approach, medical insurance needs to select drugs with higher cost-effectiveness. Pharmacoeconomic evaluation is one of the necessary tools, which helps to reduce decision-making risks and promote the better performance of "effective markets" and "promising governments".
关键词
创新药 /
价格形成机制 /
医保谈判准入
Key words
innovative drugs /
price formation mechanism /
medical insurance access with negotiation
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参考文献
[1] 韩晟,陶立波,朱大伟,等.新上市药品首发价格形成机制与鼓励高质量创新的经济学理论分析[J].中国医疗保险,2024(03):11-16.
[2] ANNEMANS L J P.Innovative public price mechanisms for market access of innovative medicines: a marriage between cost-effectiveness, medical need, and budget impact[J].Value health, 2023, 26(3): 400-401.
[3] 陶立波.卫生经济学评估中性价比和预算影响分析的作用机制再思考[J].中国医疗保险,2019(03):55-57.
[4] 吴晶.全民医保下的药品价格形成与支付标准思考[J].中国社会保障,2020(03):80-81.
[5] 胡善联.中国医保药品价格谈判回顾和展望[J].卫生经济研究,2024,41(01):9-13.
[6] 孔繁翠.创新药价值评估的国际经验比较及启示[J].中国卫生政策研究,2022,15(06):17-23.
[7] 颜建周,李大双,任晓悦,等.创新药医保准入差异化管理国际经验及启示[J].中国医疗保险,2023(01):5-11.
[8] 吕兰婷,张肇龙,王知,等.英国高值创新药支付保障机制研究与启示[J].中国医疗保险,2023(10):122-128.
[9] 史录文.药品价格形成机制研究[M].北京:北京协和医科大学出版社,2017:41-44.
[10] WIESELER B, MCGAURAN N, KAISER T.New drugs: where did we go wrong and what can we do better?[J].BMJ, 2019 (366): l4340.
[11] HWANG T J, ROSS J S, VOKINGER K N, et al.Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study[J].BMJ, 2020 (371): m3434.
[12] MEYERS D E, JENEI K, CHISAMORE T M, et al.Evaluation of the clinical benefit of cancer drugs submitted for reimbursement recommendation decisions in Canada[J].Jama internal medicine, 2021, 181(5): 499-508.
[13] ZHANG Y, NACI H, WAGNER A K, et al.Overall survival benefits of cancer drugs approved in China from 2005 to 2020[J].Jama network open, 2022, 5(8): e2225973.
[14] PAOLETTI X, LEWSLEY L A, DANIELE G, et al.Assessment of progression-free survival as a surrogate end point of overall survival in first-line treatment of ovarian cancer: a systematic review and meta-analysis[J].Jama network open, 2020, 3(1): e1918939.
[15] KUMAR S, RAJKUMAR S V.Surrogate endpoints in randomised controlled trials: a reality check[J].Lancet, 2019, 394(10195): 281-283.
[16] KOVIC B, JIN X, KENNEDY S A, et al.Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology: a systematic review and quantitative analysis[J].Jama internal medicine, 2018, 178(12):1586-1596.
[17] VOKINGER K N, HWANG T J, DANIORE P, et al.Analysis of launch and postapproval cancer drug pricing, clinical benefit, and policy implications in the US and Europe[J].Jama oncology, 2021, 7(9):e212026.
[18] ZHANG Y, WEI Y, LI H, et al.Prices and clinical benefit of national price-negotiated anticancer medicines in China[J].Pharmaco-economics, 2022, 40(7): 715-724.
[19] ZHOU J, LAN T, LU H, et al.Price negotiation and pricing of anticancer drugs in China: an observational study[J].Plos medicine, 2024, 21(1): e1004332.
[20] VOKINGER K N, HWANG T J, CARL D L, et al.Price changes and within-class competition of cancer drugs in the USA and Europe: a comparative analysis[J].Lancet oncology, 2022, 23(4): 514-520.
[21] PICHON-RIVIERE A, DRUMMOND M, PALACIOS A, et al.Determining the efficiency path to universal health coverage: cost-effectiveness thresholds for 174 countries based on growth in life expectancy and health expenditures[J].Lancet glob health, 2023, 11(6): e833-e842.
基金
国家自然科学基金青年项目“药物经济学评价模型的参数体系构建与本土化研究:以晚期肺癌模型为例”(72104151)