孙权,黄哲,董丽,张方
SUN Quan,HUANG Zhe,DONG Li,ZHANG Fang

• 1:沈阳药科大学工商管理学院
• 2:中兴公益卫生技术评估中心

摘要(Abstract)：

目的 梳理各国新型抗菌药物的创新支付方式，为优化我国新型抗菌药物的支付标准提供政策参考。方法 对国外适用于新型抗菌药物创新支付方式的国家/地区的相关政策法规进行收集、整理和分析，并探讨为我国所借鉴的可行性。结果 美国、英国、法国、德国和瑞典的创新药物支付制度较完善，且均有适用于新型抗菌药物报销的相关政策。结论 部分医疗体系发达国家的新型抗菌药物支付方式能够更好地体现新型抗菌药的综合价值，并有效地调动制药企业研发新型抗菌药物的积极性。我国应基于国情，结合国外先进的支付方式，优化我国新型抗菌药物医保支付制度，改进新型抗菌药物医保支付标准，激励更多新药更早的应用于临床。
Objective To investigate the innovative payment methods of new antibacterial drugs in various countries/regions, and to provide policy reference for optimizing the reimbursement system of new antibacterial drugs in China.Methods To search, sort out and analyze, the relevant policies and regulations on the payment methods of new antibacterial drugs in foreign countries/regions were collected and analyzed.Then, the feasibility for using them for reference in China was discussed.Results The payment systems of new drugs in the United States, Britain, France, Germany and Sweden are relatively mature, and all of them have relevant reimbursement policies applicable to new antibacterial drugs.Conclusion The payment methods of new antibacterial drugs in some countries with sound medical systems can better reflect the comprehensive value of new antibacterial drugs and effectively mobilize the enthusiasm of pharmaceutical enterprises to develop new antibacterial drugs.Based on Chinese national conditions and combined with foreign advanced payment methods, we should optimize the medical insurance payment system of new antibacterial drugs, improve the medicare reimbursement standards of new drugs, and encourage more new drugs to be used in clinic earlier.

关键词(KeyWords)： 新型抗菌药物;医疗保险;支付方式;报销;抗击微生物耐药性
new antibacterial drugs;medical insurance;payment method;reimbursement;AMR

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 孙权,黄哲,董丽,张方
SUN Quan,HUANG Zhe,DONG Li,ZHANG Fang

DOI: 10.14066/j.cnki.cn21-1349/r.2021.1014

参考文献(References)：

• [1] World Health Organisation.Global action plan on antimicrobial resistance [EB/OL].(2016-01-01)[2021-08-03].https://apps.who.int/iris/rest/bitstreams/864486/retrieve.
• [2] Driving Reinvestment in Research and Development and Responsible Antibiotic Use Revitalizing the antibiotic pipeline:Stimulating innovation while driving sustainable use and global access [EB/OL].(2017-09-17)[2021-08-03].http://drive-ab.eu/wp-content/uploads/2018/01/DRIVE-AB-Final-Report-Jan2018.pdf.
• [3] O′NEILL J.Tackling drug-resistant infections globally:Final report and recommendations:The review on antimicrobial resistance[R].(2016-05-19)[2021-08-22].https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf.
• [4] DEAK D,OUTTERSON K,POWERS J H,et al.Progress in the fight against multidrug-resistant bacteria?A review of U.S.Food and Drug Administration–approved antibiotics,2010-2015[J].Ann Intern Med,2016,165(5):363-372.
• [5] OUTTERSON K.A shot in the arm for new antibiotic[J].Nat Biotechnol,2019,37(10):1110-1112.
• [6] BENNET M.The pioneering anti-microbial subscriptions to end up surging resistance act of 2020[EB/OL].(2020-11-11)[2021-06-27].https://cobioscience.com/wp-content/uploads/2020/05/PASTEUR-Act-Text-05042020.pdf.
• [7] MOON S,ERICKSON E.Universal medicine access through lump-sum remuneration — Australia′s approach to hepatitis C[J].N Engl J Med,2019,380(7):607-610.
• [8] ALAN J,DIANE A O,ELIZABETH B.Antibiotic stewardship initiatives as part of the UK 5-year antimicrobial resistance strategy[J].Antibiotics,2015,4(4):467-479.
• [9] Department of Health and Social Care,National Institute for Health and Care Excellence,Service NH.Developing and testing innovative models for the evaluation and purchase of antimicrobials:subscription-based payment model[EB/OL].(2020-03-05)[2021-08-02].https://amr.solutions/wp-content/ uploads/2020/03/
• 2020-03-25-NHS-AMR-Market-Engagement-Briefing-Final.pdf.
• [10] Access to Medicine foundation.2020 antimicrobial resistance benchmark [EB/OL].(2020-01-21)[2021-08-02].https://accesstomedicinefoundation.org/publications/2020-antimicrobial-resistance-benchmark.
• [11] National institute for health and care excellence,National health service.Antimicrobial Resistance:Developing and testing innovative models for the evaluation and purchase of antimicrobials[M].Manchester:National institute for health and care excellence,2019.
• [12] ROTHERY C,WOODS B,SCHMITT L,et al.Framework For value assessment of new antimicrobials:implications of alternative funding arrangements for NICE appraisal[R].2018.http://www.eepru.org.uk/wp-content/uploads/2017/11/eepru-report-amr-oct-2018-059.pdf.
• [13] Conseil National de l′industrie.Contrat stratégique de filière industries et technologies de santé[R].https://www.conseil-national-industrie.gouv.fr/sites/www.conseil-national-industrie.gouv.fr/files/files/csf/sante/contrat-de-la-filiere-sante-signe-fev-2019.pdf.
• [14] Agence Technique de L′information sur L′hospitalisation.Unités communes de dispensation prises en charge en sus [EB/OL].(2021-01-05)[2021-08-02].https://www.atih.sante.fr/unites-communes-de-dispensation-prises-en-charge-en-sus.
• [15] Comité économique des Produits de Santé.Accord cadre du entre le Comité économique des produits de santé et les entreprises du médicament[EB/OL].(2015-12-31)[2021-08-02],https://solidarites-sante.gouv.fr/IMG/pdf/accord_cadre_version_definitive_20151231-2.pdf.
• [16] Légifrance-le service public de la diffusion du droit en France Section 2:Contribution à la charge des entreprises assurant l′exploitation d′une ou de plusieurs spécialités pharmaceutiques[EB/OL].(2019-01-01)[2021-08-02].https://www.legifrance.gouv.fr/affichCode.do?idSectionTA=LEGISCTA000029961752&cidTexte=LEGITEXT000006073189&dateTexte=20190101.
• [17] Public health agency of Sweden.Availability of antibiotics:Reporting of Government commission.2017[EB/OL].(2018-01-10)[2021-08-02].https://www.folkhalsomyndigheten.se/contentassets/ab790 66a80c7477ca5611ccfb211828e/availability-antibiotics-01229-2017-1.pdf.
• [18] World Health Organization.Model list of essential medicines,21st list[EB/OL].(2019-07-23)[2021-08-15].https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?ua=1.
• [19] HELLMAN J.Reimbursement model to ensure access to new critical antibiotics in Sweden[M]//WASHINGTON D C.2019.
• [20] Folkh?lsomyndigheten.Bilaga 2.Definiera och v?rdera antibiotika med tillg?nglighetsproblemDelrapport 1 i regeringsuppdrag om Tillg?nglighet till antibiotika.2017[EB/OL].(2017-11-30)[2021-08-02].https://www.folkhalsomyndigheten.se/contentassets/49287008bc79445e846880f2cd9457fb/xdelrapport-1-identifiera-01229-2017-1.pdf.
• [21] Organisation for Economic Co-operation and Development.Pharmaceutical reimbursement and pricing in Germany[EB/OL].(2018-06-01)[2021-08-02].http://www.oecd.org/els/health-systems/Pharmaceutical-Reimbursement-and-Pricing-in-Germany.pdf.
• [22] Bundesministerium der justiz und für verbraucherschutz.Verordnung über die Nutzenbewertung von Arzneimitteln nach § 35a Absatz 1 SGB V für Erstattungsvereinbarungen nach § 130b SGB V (Arzneimittel-Nutzenbewertungsverordnung - AM-NutzenV) § 5 Zusatznutzen[EB/OL].(2021-01-01)[2021-08-02].https://www.gesetze-im-internet.de/am-nutzenv/__5.html.
• [23] Bundesministerium für gesundheit.Gesetz für einen fairen kassenwettbewerb in der gesetzlichen krankenversicherung.Artikel 5.22 Mar 2020[EB/OL].(2020-03-22)[2021-08-02].https://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl&start=%2F%2F%2A%5B%40attr_id=%27bgbl120s0604.pdf%27%5D#__bgbl__%2F%2F*%5B%40attr_id%3D%27bgbl120s0604.pdf%27%5D__1588265847524.
• [24] KIRCHMANN T,KIELHORN-SCH?NERMARK H,SCH?NERMARK M P.White paper:orphan drugs in Germany–lessons learned from AMNOG,best and worst practices and strategic implications [EB/OL].(2017-03-10)[2021-08-02].https://skc-beratung.de/wp-content/uploads/2017/03/White_Paper_SKC.pdf.
• [25] CLANCY C J,POTOSKI B A,DEANNA B,et al.Estimating the treatment of carbapenem-resistant enterobacteriaceae infections in the United States using antibiotic prescription data[J].Open Forum Infect Dis,2019,6(8):8.
• [26] European Centre for Disease Prevention and Control.Surveillance of antimicrobial resistance in Europe 2018[M] Stockholm:European Centre for Disease Prevention and Control,2019.