在慢病治疗领域,相比于单药联合使用方案,复方制剂具有疗效稳定、副作用少和依从性高等比较优势。近年来,随着健康中国建设步伐加快,我国复方制剂纳入医保目录的需求也快速增长。但由于在准入评估中,无法充分体现复方制剂的比例优势和制剂优势等临床价值,导致准入价格偏低,2021年成功率仅30%。本文结合我国医保目录调整实践和域外HTA先进经验,从参照药物选择、依从性测量、药物经济学模型转归三方面提出优化评估模式,精准体现复方制剂的患者获益的方法学思考。
Abstract
In the field of chronic disease treatment, compared with the single drug combination scheme, compound preparation has the comparative advantages of more stable efficacy, fewer side effects, higher compliance. In recent years, with the accelerated pace of building a healthy China, the demand for compound preparations to be included in the medical insurance catalog has also grown rapidly. However, due to the failure to fully reflect the clinical value such as the proportion advantage, preparation advantage of compound preparations in the access assessment, the access price is low, the success rate in2021is only30%. Based on the practice of medical insurance catalog adjustment in China, the advanced experience of HTA abroad, this paper proposes an optimized evaluation model from three aspects of reference drug selection, compliance measurement, the outcome of pharmacoeconomic model, which accurately reflects the methodological thinking of the benefits of patients with compound preparations
关键词
慢病复方制剂 /
医保准入评估
Key words
chronic disease compound preparation /
evaluation of medical insurance access
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] 中华人民共和国中央人民政府.国务院新闻办就《中国居民营养与慢性病状况报告(2020年)》有关情况举行发布会[EB/OL].[2022-11-01] http://www.gov.cn/xinwen/2020-12/24/content_5572983.htm.
[2] WHO. Noncommunicable diseases: Mortality[EB/OL].[2022-10-11] https://www.who.int/data/gho/data/themes/topics/topic-details/GHO/ncd-mortality.
[3] 王宏宇,丁锦希,李伟,等.联合用药医保准入评估模式研究[J].中国医疗保险,2022(09):5-10.
[4] 国家药品监督管理局.复方制剂与复合制剂有何不同[EB/OL].[2022-04-25].https://www.nmpa.gov.cn/xxgk/kpzhsh/kpzhshyp/20171024171701186.html.
[5] Gautam, C S, & Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. British journal of clinical pharmacology, 65(5), 795-796.
[6] Lakdawalla D N, Doshi J A, Garrison L P Jr, Phelps C E, Basu A, Danzon P M. Defining Elements of Value in Health Care-A Health Economics Approach: An ISPOR Special Task Force Report [3]. Value Health.2018;21(2):131-139. 7.
[7] 段思柳,王侠.浅析老年慢性病人服药依从性现状[J].青年与社会,2019(10):200.
[8] Svensson, E M, Yngman, G, Denti, P, McIlleron, H, Kjellsson, M C, & Karlsson, M O. Evidence-Based Design of Fixed-Dose Combinations: Principles and Application to Pediatric Anti-Tuberculosis Therapy. Clinical pharmacokinetics, 57(5), 591-599.
[9] 新浪科技. 全球首个！诺和诺德“双胰岛素”中国上市管理“中国式血糖变化”[EB/OL]. [2022-07-25] https://tech.sina.com.cn/roll/2019-12-08/doc-iihnzhfz4398225.shtml.
[10] 沙库巴曲缬沙坦在高血压患者临床应用的中国专家建议[J].中华高血压杂志,2021,29(02):108-114.
[11] Gu J, Noe A, Chandra P, et al.Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor-neprilysin inhibitor (ARNi). J Clin Pharmacol. 2010;50(4):401-414.
[12] 丁锦希. 评估准入与调整:全球视角下的创新物HTA评价与医保管理[M].北京:化学工业出版社, 2020: 22-23.
[13] 台湾地区卫生福利主管部门.全民健康保险药物给付项目及支付标准共同拟定会议药品部分第12次(104年2月)会议[EB/OL].[2022-08-05]https://www.nhi.gov.tw/Content_List.aspx?n=77DBE14DAC8390B9&topn=5FE8C9FEAE863B46.
[14] 徐春,阎德文.成人2型糖尿病患者口服降糖药物三联优化方案(二甲双胍+二肽基肽酶4抑制剂+钠-葡萄糖共转运蛋白2抑制剂)中国专家共识[J].中国糖尿病杂志,2021,29(08):561-570.
[15] 王琼. 单片复方制剂在高血压治疗中的优势:从降压到降低心血管事件风险[J].中华高血压杂志,2016,24(01):15-18.
[16] Hiligsmann M, Boonen A, Rabenda V, Reginster J Y. The importance of integrating medication adherence into pharmacoeconomic analyses: the example of osteoporosis. Expert Rev Pharmacoecon Outcomes Res.2012 Apr;12(2):159-66.
[17] WHO. Demonstrating bioequivalence of fixed-dose combination products[EB/OL].[2022-07-16] https://extranet.who.int/pqweb/medicines/bioequivalence.
[18] 丁岩,王艳红,李颖霞.老年慢性病患者心理压力与心理健康的关系:心理弹性的中介作用[J].中国健康心理学杂志,2021,29(01):37-40.
[19] Moreno Guillen S, Losa García J E, Berenguer Berenguer J, et al. Cost-utility analysis of the fixed-dose combination of dolutegravir/abacavir/lamivudine as initial treatment of HIV+ patients in Spain. Análisis de coste-utilidad de la combinación a dosis fijas de dolutegravir/abacavir/lamivudina como tratamiento inicial de pacientes con VIH + en España. Farm Hosp.2017;41(5):601-610. Published 2017 Sep 1.
[20] Cutler R L, Fernandez-Llimos F, Frommer M, Benrimoj C, Garcia-Cardenas V. Economic impact of medication non-adherence by disease groups: a systematic review. BMJ Open.2018 Jan 21;8(1):e016982.
[21] Pednekar, P P, Ágh, T, Malmenäs, M, Raval, et al.A.Methods for Measuring Multiple Medication Adherence: A Systematic Review-Report of the ISPOR Medication Adherence and Persistence Special Interest Group. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 22(2), 139-156.
[22] Yong Y V, Shafie A A. Using a dynamic adherence Markov model to assess the efficiency of Respiratory Medication Therapy Adherence Clinic (RMTAC) on asthma patients in Malaysia. Cost Eff Resour Alloc.2018 Oct 19;16:36.
[23] Delea T E, Stanford R H, Hagiwara M, Stempel D A.Association between adherence with fixed dose combination fluticasone propionate/salmeterol on asthma outcomes and costs. Curr Med Res Opin. 2008;24(12):3435-3442.
[24] 秦文哲,徐凌忠,毕鹏飞.老年慢性病患者用药依从性研究进展[J].中国卫生事业管理,2018,35(05):350-353.
[25] 杨越茗,唐文熙,刘永军.药物经济学评价中患者用药依从性的识别、测量与估值[J].卫生经济研究,2021,38(11):18-21.
[26] Slejko J F, Sullivan P W, Anderson H D, Ho P M, Nair K V, Campbell J D.Dynamic medication adherence modeling in primary prevention of cardiovascular disease: a Markov microsimulation methods application. Value Health. 2014;17(6):725-731.
[27] Tung Y C, Huang Y C, Wu L S, Chang C J, Chu P H. Medication compliance and clinical outcomes of fixed-dose combinations vs free combinations of an angiotensin II receptor blocker and a calcium channel blocker in hypertension treatment. J Clin Hypertens (Greenwich). 2017;19(10):983-989. 5.
基金
国家医疗保障局“药品医保支付标准制定指导规则研究”项目,本文为“医保药品准入”系列第四篇,上三篇己在7月、8月、9月刊发
