国家医保谈判药品在各省实施政策研究 课 题 报 告 二一九年三月 March 2019 Research on Local Implementation of National Reimbursement Negotiated Drugs in China国家医 保谈判药 品在各省 实施政策 研究 课 题 报 告 国家药 物政策 与医药 产业经 济研究 中心(NDPE) 2019 年 03 月 05 日序 言 2016 年，习近平 总书记在 “ 全国 卫生健康大会 ” 中指出：“健康是促进人 的全面发展的必然要求， 是经济社会发展的基础条件， 是民族昌盛和国家富强的 重要标志，也是广大人民群众的共同追求”。 “健康中 国 2030 ” 规划纲要 作 为新时期国家优先发展的战略部署 规划了包括建立分级诊疗制度、 建立全民医保 制度、以及建立药品供应保障制度等 重点制度建设任务 ，旨在建立高效、优质、 可持续 的医疗服务体系， 满足广大人民群众的医疗服务需求 ， 保障 经济社会的健 康发展。 2017 年， 人社部实施了首次国家医保创新 药谈判，36 种药品通过谈判形成 了医保支付标准，并 要求各地执行谈判结果，将 36 种谈判药纳入 国家医保药 品 目录 乙类报销范围， 且不得调整限定支付范围。 截至 2017 年 12 月底， 所有省 市 已将谈判药品全部纳入乙类目录， 由基本医疗保险基金和参保人员共同支付， 同 时各地严格执行人社部要求的支付范围限制。 然而， 谈判药品的执行在大部分地 区 仍 然存在医保报销、 地方采购、 医院准入和渠道等诸多障碍， 影响了医保准入 谈判 落地执行的效果 。 2018 年， 国家医疗保障局通过谈判 将 17 种抗癌药纳入 国家医保药品目录 乙 类报销范围 ， 并确定了医保支付标准。 各地医保、 人力资源社会保障、 卫生健康 等部门 及时 根据职责对谈判药品执行情况 做 出具体 工作 安排 ， 大大提高了肿瘤患 者对抗癌药品的可及性，减轻 患者的医疗费用负担。 中国外商投资企业协会药品研制和开发行业委员会（RDPAC ） 于 2018 年委 托中国药科大学 国家药物政策与医药产业经济研究中心 （NDPE ）开展了 国 家 医保谈判药品在各省实施政策研究 的课题， 希望通过 政策梳理、 制度比较、 实 证调研等方法对我国谈判药品医保准入的实施情况进行研究， 重点 调研分析执行 谈判结果较差和较好的地区， 总结各地 政策实施 经验 、 分析各省市现存问题， 基 于对经验教训的反思提出相关改进与完善建议， 并 为下一轮谈判厘清地方准入障 碍，提供经验。课题研究 人员 课题负 责人： 邵 蓉 课题研 究人员： 颜建周、 董心月、 黄秋雨、 侯立丽、 葛文霞 、 姚雯、 马旭锋 、 蒋蓉 、 陶田 甜、 谢 金平、 祝 晶京. 1 . 1 . 1 . 1 . 2 . 3 . 3 . 3 . 3 . 5 . 30 . 31 . 42 . 42 . 43 . 43 . 44 . 46 . 47 . 48 . 48 . 48 . 53 . 54 . 54 . 54 . 57 . 57 . 59 . 60 . 62 . 63 . 65 . 67 . 72 . 72 . 72 . 74. 74 . 75 . 75 . 77 . 80 . 87 . 89 . 89 . 89 . 90 . 90 . 91 . 91 . 92 . 95 . 96 . 97 . 99 . 99 . 100 . 1001 2017 7 36 54 36 54 2017 12 312 1 2 33 2015 2016 5 23 7 44 36 44% 2017 7 13 2018 10 10 3 17 56.7% 1 2015 2 ( ) 2015 10 16 11 2016 5 20 2 1 5 3 60% 54 2 3 59% 67% 67% 55% 54% 1 1500 12000 15000 490 5500 7000 1 1 3 ( ) 1500 490 67% ( ) 12000 5500 55% ( ) 15000 7000 54% 3 1 CFDA 2 1 5 2 4 GSK 2016 3 4-5 2016 10 2015 13.4% 2017 2016 42% 2018 28.54% 1 2017 4 14 44 2017 7 19 2 1 2017 44 36 81.8% 2 2 2 6 AMD Celgene a -1b 2 36 44% 70% 3 40% 3 3 / 0.5mg 1709 585 42.02% 105ml:4.2g 4905 2800 42.9% 3ml:18mg 723 410 44.3% 15mg*5 840 495 41.1% 50ml:0.5g 16041 8289.87 48.3% 20ml:440mg 21613 7600 64.8% 4ml:0.1g 5176 1998 61.4% 200mg 23280 12180 47.7% 3 9.html7 1mg*1 4842.5 2344.26 51.6% 3.5mg 12512.4 6116 51.1% 150mg 3220 1365 57.6% 250mg 494 278 43.72% 5ml:250mg 5419.6 2400 55.72% 250mg 36925 17390.4 52.9% Celgene 25mg*21 58787.2 23141.79 60.6% 10mg 46170.5 18186 60.6% 250mg 8300 4900 41% PDB 3 1 4 44 44 68 309 4 2 4 . J. , 2017(08): 16-19.8 4 1 30%-100% 500% 1 5 15 7 2 0 2 4 6 8 10 12 14 16 500% 品种数 谈判准入前后销量增幅9 5 44% 2 2 5 . 17 EB/OL. 2018-10-11/2018-11-14. 6 11 8 4 0 2 4 6 8 10 12 100% 品种数 谈判准入前后销售额增幅10 3 PDB 4 VIIa PDB 2 5411 2017 12 31 / 31 / 4 2017 8 2 36 2017 265 2017 9 1 2017 8 23 2017 2017 100 2017 9 1 2017 11 15 2017 2017 430 2017 12 1 2017 8 21 2017 2017 34 2017 9 1 2017 9 1 2017 2017 74 2017 9 25 2017 2017 221 2017 10 1 2017 9 25 36 2017 32 2017 11 1 2017 10 20 2017 2017 11 22 2017 2017 22 2017 12 2012 2017 8 28 2017 179 2017 9 1 2017 8 28 2017180 2018 3 1 2017 201840 2017 8 23 2017 2017 9 1 2018 5 16 (2018 ) 2018 24 2017 9 1 2017 8 14 36 2017 12 22 36 2017 266 2017 9 1 2018 06 21 2018 ( 2018 29 ) 2017 9 1 2017 11 07 36 2017 2018 1 10 2017 2017 89 2017 9 1 2017 9 6 2017 58 2017 8 10 36 2017 171 2017 9 1 3613 36 2017 856 36 5 36 2017 36 36 36 A 54 36 2017 54 2013 278 2017 2017 3414 36 , 1815 18 -1b 32 , a B 54 2019 12 31 14 20%-50% 16 6 6 2017 8 2 2017 265 2017 9 1 54 6 16 2017 8 23 2017 100 2017 9 1 2017 11 15 2017 430 2017 12 1 2017 54 2017 9 25 2017 221 2017 10 1 2017 8 21 2017 34 2017 9 1 2017 9 25 2017 32 2017 11 1 2017 11 22 2017 22 2017 12 20 2017 8 11 2017 68 2017 9 1 36 20% 2018 1 1 2017 8 31 2017 180 2017 9 1 2017 9 11 2017 9 11 2017 8 16 2017 41 2017 9 1 2017 12 22 2017 266 2017 9 1 2017 7 31 2017 55 2017 9 1 2017 8 10 2017 171 2017 9 1 30% 2017 30% 80% 70% 10% 36 20 a 1 15 20 70% 60% 55% 16 16 10% 20% C 2016 389 2016 390 36 2017 11 1 2017 11 1 2017 2017 22 2017 201718 12 20 2010 2016 143 36 2017 36 2017 12 31 IX 5 7 9 1 12 2017 9 1 50% 2018 1 1 12 20% 2017 9 1 9 1 36 2017 2010 2017 2017 2017 6 36 8 A19 2017 30% 10% 36 2017 11 15 2018 22 / / 7 7 = / 100% 2016-201720 20162017 20162017 3 36 2017 9 1 36 2017 36 2016-2017 36 B 54 36 8 ,21 31 / 31 / 9 11 0 11 0 13 0 5 3 3 2 0 13 6.5 022 13 0 13 0 13 0 100 11 6 13 / / 6.5 13 5 3 2 13 10 31 11 11 13 13 5 3 3 2 13 13 13 13 22 69 61 22 48 35 45 58 77.5 66 87 71 56 69 66 59.523 66 84 92 81 61 76 53 56 62.5 62.5 35 64.5 87 33.5 48 10 8 6 75 4 50-74 3 26-49 2 25 A 2017 8 11 36 20% 2018 7 3 2015 3 39 2018 9 1724 2017 11 2018 11 30 17 a. 11 2017 2017-08-08 36 20% 2016-08-26 3 2017 2017-12-29 36 2018-07-03 : 2018-07-03 : 2018 11 2 17 2018 11 3025 b. 2018 225 2018 19 HER2 / 12 HER2 HER2 HER2 ER/PR / (EGFR) / HER2 2 - TSC-AML) B a.26 13 36 2017 8 36 36 2017 17 36 36 2017 265 2017 2017 251 35 50% 2017 346 : 2017 365 36 2017 265 36 2017 17 2016 7 2016 3 b. 36 2017 2017 251 201727 2017 19 TX10 801 800 HER2 3 PAP 16 17 18 64 21 20 14 14 ( ) -1b -28 ( ) - furthermore, ensure the healthy development of economy and society. In 2017 Ministry of Human Resource and Social Security implemented the first reimbursement negotiation for innovative drugs, and 36 drugs were successfully negotiated with reimbursement payment standard. It was required by MoHRSS that localities should implement negotiation results, hence 36 drugs to be included into B list of reimbursement drug list and no adjustment to be made to reimbursement payment standard. By end of 2017 all the negotiated drugs have been implemented in 31 provinces and cities across the country, which have been included into the PRDL B lists and are paid by the basic medical insurance fund and patients jointly, and in the meantime, the limits of payment scope required by MOHRSS have been strictly enforced. However, in most regions, there have been a lot of obstacles, in terms of medical reimbursement, local procurement, hospital access and channels, etc., which have negatively affected the result of local implementation of national reimbursement negotiation. In 2018 the National Health Security Administration included 17 oncology drugs into B list of reimbursement drug list through negotiation, and reimbursement payment standards of these drugs were set. Local medical security, human resourceand social security, and health authorities made work plans accordingly to ensure local implementation, which has significantly improved patient access to oncology drugs. In 2018 R the drugs with large consumption and high cost shall be included in the intelligent monitoring system of basic medical insurance and medical service for key monitoring and their cost analysis shall be conducted properly; effective measures shall be taken to encourage designated retail pharmacies to provide drugs for the insured, and to play an active role in ensuring the supply of covered by medical insurance. After the release of No. 54 Document, all parts of the country have introduced the corresponding measures to implement the negotiation results. As of the end of December 2017, all the drugs priced through government negotiation have been implemented in 31 provinces and cities across the country, which have been included in the list of Class B drugs and are paid by the basic medical insurance fund and the insured jointly, and in the meantime, the limits of payment scope required by2 MOHRSS have been strictly enforced. Zhejiang, Jiangsu, Beijing, Guangdong, Henan and etc. have better implemented the negotiation results. However, in most regions, there have been a lot of obstacles (in trems of medical reimbursement, local procurement, hospital access and channels, etc.) during the implementation of drugs priced through negotiations, such as too low reimbursement ratio, access of the grassroots limited by the National Essential Medicines List, secondary bargaining of hospitals, drug proportion, blocked opening of retail channels and etc. For example, in Chongqing, Shandong, Guizhou, Henan and other regions, more stricter restrictions have been imposed on medical institutions, qualification of medical practitioners, reimbursement ratio, qualification of patients, disease categories and other aspects of drug use; in this context, the coverage of reimbursement policy for varieties priced through negotiations has been greatly reduced, and drug use and reimbursement of patients as well as the landing and implementation effects of drugs priced through negotiations on medical insurance access have not received good feedback. In this program, the implementation of Chinas drugs priced through negotiations on medical insurance access will be studied by sorting of policies, institution comparison and other empirical research methods, focusing on the research and analysis of the regions with better and worse negotiation implementation results, summarizing the policy implementation experience of various regions, analyzing the existing problems of various provinces and cities, proposing relevant improvement and perfection suggestions based on the reflection to the lessons learned and promoting them in the regions with relatively-poor policy landing effects, so as to help better benefit patients with the drugs priced through negotiations, improve the affordability of drugs, and clarify the local access barriers and provide experience for the next round of negotiations. II. Research Purpose and Significance (1) Research purpose This project studies the access policies, implementation situation and obstacles faced by the negotiation results in various regions by ways of sorting policies,3 literature research and investigation and interview, and, on the basis of field research, draws on the experience of provinces and cities with better implementation effects of landing policies to provide policy suggestions for provinces with poor implementation effects. The goal is to help regions cope with the challenges of implementing the negotiation results of innovative drugs, improve the local access environment of drugs priced through negotiations, and clarify the local access barriers and provide experience for the next round of negotiations. Meanwhile, the following several problems are expected to be solved: How about the overall landing of varieties priced through negotiations in various provinces and cities at present? What are the experiences and lessons learned from the policy implementation of varieties priced through negotiations in typical regions? Is there anything we can learn from and improve? What are the difficulties in the implementation of medical insurance negotiation policies? How to solve them? How to make suggestions to improve the implementation policy of drugs priced through negotiations? (2) Research significance 1 Minimize the expense burden of patients and improve the accessibility of drugs priced through negotiations Based on the policy analysis of drugs priced through negotiations on national medical insurance access and empirical research on the current situation of negotiation landing in various provinces, this research tries to optimize the local access policy of drugs priced through negotiations, establish the new access environment, enable drugs with high clinical value to be implemented rapidly across the country, minimize the medical burden of patients and improve the accessibility of drugs priced through negotiations, so as to optimize the welfare of social medical resources. 2 Promote the optimization and improvement of regulatory policies of drugs priced through negotiations4 By investigating the implementation status and effects of the landing and implementation of drugs priced through negotiations in typical provinces of China, the influences of the current negotiation access policies and measures in various regions on the drug use of patients will be feedback, to improve the regulatory policies of drugs priced through negotiations, which is of great significance to the design and optimization of the macro-level systems. 3 Establish new paths for reform and development of access policies of drugs priced through negotiations Based on the landing and implementation status of the current round of medical insurance access of drugs priced through negotiations in various regions on medical insurance access, the obstacles encountered and the lessons learned are summarized, to improve the medical insurance negotiation mechanism and attempt to put forward new paths for reform and development of access policies of drugs priced through negotiations in the next stage of negotiation5 Chapter II Implementation Effects of National Drug Price Negotiation I. Background of Drug Price Negotiation Since 2015, China has carried out three drug price negotiations. The National Health and Family Planning Commission (NHFPC) was mainly responsible for the first negotiation and issued a notice jointly with 7 departments on May 23, 2016, and announced the negotiation results of the first batch of national drug price negotiations. The main body of the second negotiation was the medical insurance department, 36 of the 44 drug varieties were finally included, and the price was decreased considerably, averaging 44%; MOHRSS issued a notice on July 13, 2017, officially marking the entry into implementation phase of the national medical insurance negotiation results. The last negotiation mainly aimed at the anticancer drugs and, on October 10, 2018, 17 varieties were successfully included in the National Reimbursement Drug List after more than 3 months of negotiation, with an average price decrease of 56.7%. The subjects, mechanisms, price cut and targets of the three negotiations were different, but all the main purposes were to improve the accessibility of high-value and high-price drugs and benefit the majority of patients through government negotiations. II. General Situation of the Three Negotiations (I) First round of drug price negotiation 1 Policy background In February 2015, the General Office of the State Council issued the Guiding Opinions on Improving the Centralized Medicine Procurement for Public Hospitals, which proposed the classified procurement of drugs and established an open, transparent and multi-participatory price negotiation mechanism for part of patented drugs and exclusively produced drugs. For the first time, this document clarifies the national negotiation at the national level. Hereafter, NHFPC drafted the Pilot Work Programme for Establishing Drug Price Negotiation Mechanism (Draft for Comments) (hereinafter referred to as the Programme), in which the specific6 operation process of the negotiations was provided. In October 2015, with the approval of the State Council, 16 ministries and commissions (bureaus) led by NHFPC jointly established a joint inter-ministerial conference system for drug price negotiation, and the first national drug price negotiation was launched in November. On May 20, 2016, the first batch of negotiation results was released to the public after being