基于靶向药物的医保药品谈判实践研究

目的:分析现阶段我国靶向药物的医保谈判实践,提出进一步完善靶向药物谈判工作的建议。方法:收集国家及各省市开展靶向药物谈判的政策及实践资料,对开展靶向药物谈判的地区、药品品种、典型案例进行整理分析。结果:政策引导下,靶向药物谈判被列入药品谈判的重点范围,部分省市积极推进靶向药物的谈判工作。结论:进一步完善靶向药物谈判工作可以建立重大疾病医疗信息数据库,多角度全面评价、筛选靶向药物,逐步扩大谈判范围并开展风险共担谈判。     

国家谈判准入药品在各地的医保管理政策梳理与分析

目的：对两轮国家谈判准入药品在各地的医保管理政策进行梳理和分析，以不断完善相关政策，并为后续国家医保准入谈判药品政策的落地实施提供依据。方法：以“谈判药品”、“抗癌药”、“药品目录”为关键词，检索各地人力资源与社会保障厅（局）和政府官方网站，筛选2017年7月—2019年4月发布的相关文件，从谈判准入药品的特药管理、医保报销、鼓励使用三个方面进行归纳分析。结果：各省已完成将2017年国家谈判准入的36种药品和2018年国家谈判准入的17种抗癌药纳入本地医保药品目录。由于各地医保政策、运行和管理情况存在较大差异，故对于国家谈判准入药品的管理和保障也有较大的地区差异。结论：国家谈判药品的落地实施不仅需要国家层面的宏观指导和监督，也需要各地因地制宜出台具体的管理政策加以保障。     

建立“药品价格谈判机制”初探

建立“药品价格谈判机制”是解决“看病贵”的方法之一。对此,就谈判主体、谈判类型、谈判对象、降价方式等有关？药品价格谈判机制”进行了分析论述,提出建立“药品价格谈判机制”需要对药品集中招标采购进行改革,建立由医保部门主导的药品集中招标采购平台。     

国家谈判药品"双通道"模式实施现状及优化建议——以S市为例

目的:分析国家谈判药品"双通道"运行现状,并提出政策建议.方法:对S市国谈药品"双通道"政策进行梳理,以乳腺癌靶向药物"注射用曲妥珠单抗"为例,研究国谈药品的管理和使用情况.结果:S市国谈药品"双通道"模式实践较早,具有较好的借鉴意义,但在运行中存在一些共性问题.结论:医保部门要根据地方实际,从医院、医药、医保三个方面...     

赫赛汀治疗HER-2阳性乳腺癌的医保预算影响分析

目的:通过对赫赛汀进行预算影响分析,为药品报销目录的遴选决策、药品降价谈判及确立医保支付价格提供科学依据。方法:构建预算影响分析模型,比较国家医保目录内辅助化疗治疗方案,测算赫赛汀在中国上市并进入医保目录对医保支出的预期影响。结果:如果2016年赫赛汀进入医保目录,到2020年HER-2阳性乳腺癌患者医保预算总费用增幅分别为135.30%、141.93%、142.25%、142.27%和143.82%。结论:将赫赛汀纳入城镇医保将较大增加医保预算费用,增幅和各变量呈线性相关,建议进一步发挥国家有关部门集中谈判优势,在"带量降价"基础上,根据各地经济、医保状况,将赫赛汀纳入医保合理报销范围。     

专利药品进入基本药物目录的意义与挑战

本文分析了专利药品进入基本药物目录在提高居民用药层次、保证药品可及性方面的积极意义以及该做法在支付能力和专利时效性方面所面临的挑战。建议在政府财政和医保基金的可承受范围内,通过价格谈判机制和基本药物目录的动态调节机制来降低专利药品价格,并使专利药品进入基本药物目录变为常态,成为我国基本药物目录动态管理的一部分。     

国家谈判药品对综合医院医保管理的影响及对策

利用广西自治区南宁市某三甲医院信息管理系统,提取该医院2017年和2018年统筹区内医保患者数据,分析国家谈判药品使用对医院医保管理的影响。结果显示,国家谈判药品的使用提高了医保住院次均费用、人次人头比、药占比等。对此,应完善对该类药品的管理,提高医院医保管理质量,切实保障患者的医保待遇。     

药品价量协议在医保准入谈判中的应用研究

目前我国医保准入谈判中药品价量协议的应用仅停留在战略层面,在签订协议、履行协议过程中还面临诸多挑战.借鉴典型国家和地区的经验,对药品价量协议在我国医保准入谈判中的应用提出建议:系统研究价量协议的适用条件与实施模式,科学制定操作规程与合同范本,以卫生技术评估作为谈判依据,同时设计有效的价格保密机制,加强医保药品使用监管.     

探索健康公平性之建立药品价格谈判机制的思考

我国对药品价格谈判机制的构建处于探索阶段,药品费用高成为主要的就医难的表现之一,影响公民的健康公平性.本文在可行性分析的基础上,从药品的分类标准、谈判定价模式以及后续保障,探索构建我国医保药品价格谈判机制,以期实现谈判机制可持续运作,优化药品费用的控制.     

降价保供砝码不能都压在基本医保上

正继《我不是药神》掀起举国上下对抗癌药品降价保供的关注后,国家医保局日前发布消息:新一轮抗癌药医保准入谈判工作已确定拟谈判药品范围,预计将于9月底前完成。此前,分别由卫生部门和医保部门主导的两轮国家药品价格谈判,已先后有17种抗癌药实现价格大幅下降,并纳入国家基本医保药品目录。在影片结尾处,价格高昂的药品也是因为进入了基本医保,才使     

韩国和德国专利药价格谈判模式比较研究及启示

为完善我国专利药价格谈判制度,本文从目标、程序及效果三方面,比较分析韩国和德国专利药价格谈判模式的共性与特点,从而为中国提供借鉴。结果发现,韩国和德国专利药价格谈判均以提高国家医保基金使用效率为关键目标,并通过科学的职责分工确保谈判的公平与效率,但技术评估标准的选择因国情差异而存在较大不同。建议我国加强专利药价格谈判与医保报销政策的衔接,建立以专利药创新程度为核心的评估标准体系,同时应制定科学合理的谈判程序与职责分工。     

高值药物支付机制的国际比较及启示

目的:介绍美国、澳大利亚、德国的高值药物支付机制,为完善我国高值药物支付机制提供参考。方法:基于文献,从共付模式、药物遴选标准、谈判定价方式、药物使用管理办法四个方面,探索三国高值药物支付主要内容和特点,并针对我国高值药物支付现状,提出启示及建议。结果:医疗保障制度不同决定了各国共付模式、谈判主体层次的差异,但其药物遴选均与药物经济学评价密切结合,并构建了防止药物滥用的配套管理方法。结论:我国应在大病医疗保险的基础上探索可持续的共付模式,在国家层面探索适宜的药物经济学评价方法,建立相关指标体系,为药物遴选及退出提供科学依据。发挥国家专利高值药集中谈判优势,构建"风险共担"机制降低基金风险,平衡各方利益;探索以明确适应症为主的高值药物使用管理方法。     

Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency

ObjectivesThe aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study.MethodsData were gathered through the information system used by Italian Medicines Agency. The time-frame for this analysis is 2013–2017. Factors influencing the delta price were analyzed through a regression analysis.Results44 orphan drugs and 89 new other molecular entities obtained reimbursement in the last five years. Following the negotiation process, prices were lowered by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than €200 million.DiscussionThe impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger population target), others were more surprising (e.g. a significant price reduction for “innovative” drugs). The implementation of financial-based agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction.     

天津市17种国家谈判抗癌药纳入医保政策对癌症患者影响的调查研究

目的了解天津市17种国家谈判抗癌药纳入医保政策的落实现状及政策实施对患者的影响情况并提出建议,以促进天津市医药政策的落实与完善。方法对天津市多家医院的癌症患者和相关医护人员进行问卷调查。结果 40.94%的患者完全不了解该项政策;66.44%的患者没有享受到该政策;纳入医保的17种国家谈判抗癌药的价格都得到了极大的降低;患者的经济负担和心理负担都有所下降;存在药品审批慢、税负高、医保控费压力大和药品耐药性过快等问题。结论 17种国家谈判抗癌药纳入医保政策对癌症患者来说无疑是一个好消息,但政策的实施情况与患者的期待仍存在一定的差距,多数患者的负担依旧很重,政府应采取措施解决政策实施过程中的问题,进一步减轻癌症患者的负担。     

Medicare Drug Price Negotiation in the United States: Implications and Unanswered Questions

The United States is a relatively free-pricing market for pharmaceutical manufacturers to set list prices at the product launch. Few drug price controls exist, and federal price negotiation as a policy has historically been politically untenable. After decades of debate on whether the federal government, specifically the Medicare program, should more actively manage drug prices, the US Congress passed legislation authorizing Medicare to directly negotiate prices with manufacturers. The purpose of this article is to describe elements and implementation of the price negotiation provisions and then comment on the potential impacts on payers, innovations, and the pharmaceutical industry. While impacting only a few drugs each year in the beginning, price negotiation in the Medicare program will have secondary and long-term effects in the US market and beyond. It is clear that in the United States, the Medicare market for drugs will no longer be a free-pricing environment in the industry.     

Cost-Utility Analysis of Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Genotype 1 and 6 in Vietnam

ObjectiveVery few cost-utility analyses have either evaluated direct-acting antivirals (DAAs) on hepatitis C virus (HCV) genotype 6 patients or undertaken societal perspective. Recently, DAAs have been introduced into the Vietnamese health insurance drug list for chronic hepatitis C (CHC) treatment without empirical cost-effectiveness evidence. This study was conducted to generate these data on DAAs among CHC patients with genotypes 1 and 6 in Vietnam.MethodsA hybrid decision-tree and Markov model was employed to compare costs and quality-adjusted life-years (QALYs) of available DAAs, including (1) sofosbuvir/ledipasvir, (2) sofosbuvir/velpatasvir, and (3) sofosbuvir plus daclatasvir, with pegylated-interferon plus ribavirin (PR). Primary data collection was conducted in Vietnam to identify costs and utility values. Incremental cost-effectiveness ratios were estimated from societal and payer perspectives. Uncertainty and scenario analyses and value of information analyses were performed.ResultsAll DAAs were cost-saving as compared with PR in CHC patients with genotypes 1 and 6 in Vietnam, and sofosbuvir/velpatasvir was the most cost-saving regimen, from both societal and payer perspectives. From the societal perspective, DAAs were associated with the increment of quality-adjusted life-years by 1.33 to 1.35 and decrement of costs by $6519 to $7246. Uncertainty and scenario analyses confirmed the robustness of base-case results, whereas the value of information analyses suggested the need for further research on relative treatment efficacies among DAA regimens.ConclusionsAllocating resources for DAA treatment for HCV genotype 1 and 6 is surely a rewarding public health investment in Vietnam. It is recommended that the government rapidly scale up treatment and enable financial accessibility for HCV patients.     

我国专利药品医疗保险价格谈判的演化博弈研究

利用演化博弈理论,结合我国专利药价格谈判现状,建立专利药品价格谈判博弈的演化模型,并进行仿真模拟分析,探究对演化博弈稳定状态产生影响的因素及其作用路径。结果发现,谈判前后专利药品的销售额、谈判双方的谈判初始意愿和变化方向以及对于社会声誉的考量均能够对演化稳定结果产生影响,最终从上述角度提出谈判双方优化专利药品价格谈判的相关建议。     

The influence of Medicare Part D on the list pricing of brand drugs

Objective

To compare the Medicare Part D market share of brand drugs with their net-to-list price ratio.

Data Sources and Study Setting

SSR Health Brand Net Price Tool and Medical Expenditure Panel Survey, 2007–2019.

Study Design

For each drug, we calculated the ratio of net to list price and the percent of users that were Medicare-eligible. We compared these cross-sectionally in each year and estimated a difference-in-differences model comparing drugs with high or low Medicare market shares (MMS) after following changes to program incentives in 2010.

Data Collection/Extraction Methods

The sample included brand drugs without generic competitors appearing in both datasets.

Principal Findings

Net-to-list price ratios were negatively correlated with MMS in the later years of our sample. In 2019, a 10% increase in MMS was associated with a significant 4.6% [95% CI: 2.1%, 7.1%] decrease in net-to-list ratio. Difference-in-differences showed net-to-list price ratios of drugs with above median MMS fell relative to those with below median MMS. By 2019, we observe an absolute reduction of −0.2 [95% CI: −0.29, −0.11], representing 28% reduction relative to the average ratio in 2010.

Conclusions

Greater exposure to the Medicare Part D market was associated with larger differences between net and list prices of drugs.     

Are Drugs Priced in Accordance With Value? A Comparison of Value-Based and Net Prices Using Institute for Clinical and Economic Review Reports

ObjectivesThe Institute for Clinical and Economic Review (ICER) is an independent organization that reviews drugs and devices with a focus on emerging agents. As part of their evaluation, ICER estimates value-based prices (VBP) at $50 000 to $150 000 per quality-adjusted life-year (QALY) gained thresholds. We compared actual estimated net prices to ICER-estimated VBPs.MethodsWe reviewed ICER final evidence reports from November 2007 to October 2020. List prices were combined with average discounts obtained from SSR Health to estimate net prices. If a drug had been evaluated more than once for the same indication, only the more recent VBP was included.ResultsA total of 34 ICER reports provided unique VBPs for 102 drugs. The net price of 81% of drugs exceeded the $100 000 per QALY VBP and 71% exceeded the $150 000 per QALY VBP. The median change in net price needed to reach the $150 000 per QALY VBP was a 36% reduction. The median decrease in net price needed was highest for drugs targeting rare inherited disorders (n = 15; 62%) and lowest for cardiometabolic disorders (n = 6; 162% price increase). The reduction in net prices needed to reach ICER-estimated VBPs was higher for drugs evaluated for the first approved indication, rare diseases, less competitive markets, and if the drug approval occurred before the ICER report became available.ConclusionNet prices are often above VBPs estimated by ICER. Although gaining awareness among decision makers, the long-term impact of ICER evaluations on pricing and access to new drugs continues to evolve.