{"title":"Draft National Health Policy of India and Determining Cost-effectiveness Threshold","authors":"P. Sakharkar","doi":"10.4103/0976-0105.195078","DOIUrl":null,"url":null,"abstract":"1 The Seventh Asia‐Pacific Conference of the International Society for Pharmacoeconomics and Outcomes Research was held in Singapore this year from September 3, 2016, to September 06, 2016. “Pharmacoeconomics and Outcomes Research in Asia‐Pacific: Challenges, Opportunities, and Future Direction” was the theme of this conference. This occasion presented a perfect opportunity to discuss some of the challenges that are unique to Asian countries in terms of their health‐care and decision‐making processes. This is especially true for a country like India, the world’s third‐largest economy, whose new National Health Policy (NHP) is likely to decide the trajectory of its health‐care system over the next few years. In developed countries, the political debate over economic issues is often seen as a clash between free market principles and government control. Developing regulatory policies in such an environment is an ongoing battle between the public and private sector. Such battles are often seen spilling over in health‐care policy‐making. In India, the fundamental health‐care issues are at the bottom of the list of any political discourse; occasionally they surface to the forefront led by interest groups that have bigger political clout and their own special interest. Issues such as conditions of hospitals, doctors’ compensations, corruption within professional and accreditation bodies draw more public interest and attention than vital questions such as “why do some parts of the country still suffer from diseases like malaria or tuberculosis?” or “why is there a constant shortage of essential drugs in government hospitals?” or “why do drugs and treatment costs vary significantly within the same geographical region?” These kinds of vital questions rarely lead to any public or political discourse. The new government under Prime Minister Modi plans to offer universal health care under its recently released NHP draft.[1] One can sense the intentions of this government from this draft policy as it states, “It is a declaration of the determination of the government to leverage economic growth to achieve health outcomes and an explicit acknowledgement that better health contributes immensely to improved productivity as well as to equity.” While discussing the current situation of health care in India, this NHP draft further acknowledges several challenges that it needs to confront, including inequities in health outcomes, quality of care, growing disease burdens, increasing health‐care costs, inadequate investment and financing of health care, shortage of health‐care professionals, paucity of health services research, and poor regulatory framework.[1] Among all other objectives listed in this draft policy that the government wants to focus on, one of the important objectives – organizing and financing health‐care services – deserves special attention from economists, health outcomes researchers, and health‐care professionals, including pharmacists and policy makers. One cannot downplay the fact that all health services available under national programs in India are free to all its citizens and are universally accessible and moving forward, these services will most likely be expanded as stated in this policy draft, which will add a tax burden to society. Presently in India, the private sector provides 70%–80% of health‐care services, and it does not share any cost burden of providing free care and hardly has any regulations.[2] Implementing this policy as suggested, will require further infusion of approximately $50 billion (Rs. 312,500 crore) to reach the level of health expenditures of 2.5% of gross domestic product (GDP) to fund government’s proposed expansion. According to the government’s own estimates and as stated in its policy draft, over 63 million people are pushed to fall below poverty due to health‐care costs alone every year. Population coverage was expected to grow to about 370 million under the publicly financed health insurance schemes, of which nearly two‐thirds (180 million) of beneficiaries were below the poverty line category in 2014. Based on 2015 estimates, approximately 288 million (28.8 crore) people, less than one‐fifth of India’s population, were covered by health insurance. Among those who had some form of insurance coverage, 67% were covered by public insurance under Central Government Health Scheme, Employees’ State Insurance Scheme, and Rashtriya Swasthya Bima Yojana.[3] In 2014, India spent 1.04% of its GDP, about 4% of its total government expenditure, on health care, which, for a country being touted as the world’s third largest economy, is incomparable to the global standards. This spending, as a percentage of GDP, on health care is one of the lowest among countries of the Southeast Asian region. India’s spending is only a little higher than that of the Myanmar and is the lowest among BRICS (Brazil, Russia, China, and South Africa) countries.[4] Evidence further suggests that countries need to spend at least 5%–6% of their GDP to meet the basic health care needs of its population.[5] The Indian government in this policy draft has indicated its commitment to raise its share of health‐care expenditure to 2.5% of the GDP in next 5–7 years. However, the reality is, one of its major commitments of opening 3000 Jan Aushadhi Stores, aiming to provide generic medicines to people at an affordable cost, only managed to open 310 stores to this day.[6] The pricing of drugs in India is controlled through the National Pharmaceutical Pricing Authority. According to this draft policy, the government would like to include diagnostics and equipment under some form of price control. This draft policy has also suggested creating a regulatory framework modeled on the work of the National Institute for Clinical Excellence (NICE) of the United Kingdom. The NICE produces evidence‐based guidance and advice for health, public health, and social care practitioners, develops quality standards and performance metrics for those providing and commissioning health, public health, and social care services, and provides a range of informational services for commissioners, practitioners, and managers across the spectrum of health and social care. One of the most important roles of NICE is to conduct technology appraisals for assessing the clinical and cost‐effectiveness of the new pharmaceutical and biopharmaceutical products, including procedures, devices, and diagnostic agents, and to ensure that patients using National Health Service (NHS) in the United Kingdom have equitable access to the most clinically and cost‐effective treatments. Recommendations of NICE’s technology appraisals are based on clinical (how well the treatment work) and economic (does it represent the value for money) evidence. To consider technology to be cost effective, NICE has been using an implicit cost‐effectiveness threshold ranging between ₤20,000 and ₤30,000 per quality‐adjusted life year (QALY) gained for many years.[7] This threshold has always been challenged and even subjected to judicial review, instigated by drug companies such as Pfizer and Eisai, and inquiry by the House of Commons Health Select Committee.[8] However, it still remains the threshold for measuring cost‐effectiveness and the basis of resource allocation by the NHS in the United Kingdom. The other cost‐effectiveness thresholds that are currently in use include $50,000 EDITORIAL","PeriodicalId":15046,"journal":{"name":"Journal of Basic and Clinical Pharmacy","volume":"26 1","pages":"1 - 3"},"PeriodicalIF":0.0000,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"9","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Basic and Clinical Pharmacy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/0976-0105.195078","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 9
Abstract
1 The Seventh Asia‐Pacific Conference of the International Society for Pharmacoeconomics and Outcomes Research was held in Singapore this year from September 3, 2016, to September 06, 2016. “Pharmacoeconomics and Outcomes Research in Asia‐Pacific: Challenges, Opportunities, and Future Direction” was the theme of this conference. This occasion presented a perfect opportunity to discuss some of the challenges that are unique to Asian countries in terms of their health‐care and decision‐making processes. This is especially true for a country like India, the world’s third‐largest economy, whose new National Health Policy (NHP) is likely to decide the trajectory of its health‐care system over the next few years. In developed countries, the political debate over economic issues is often seen as a clash between free market principles and government control. Developing regulatory policies in such an environment is an ongoing battle between the public and private sector. Such battles are often seen spilling over in health‐care policy‐making. In India, the fundamental health‐care issues are at the bottom of the list of any political discourse; occasionally they surface to the forefront led by interest groups that have bigger political clout and their own special interest. Issues such as conditions of hospitals, doctors’ compensations, corruption within professional and accreditation bodies draw more public interest and attention than vital questions such as “why do some parts of the country still suffer from diseases like malaria or tuberculosis?” or “why is there a constant shortage of essential drugs in government hospitals?” or “why do drugs and treatment costs vary significantly within the same geographical region?” These kinds of vital questions rarely lead to any public or political discourse. The new government under Prime Minister Modi plans to offer universal health care under its recently released NHP draft.[1] One can sense the intentions of this government from this draft policy as it states, “It is a declaration of the determination of the government to leverage economic growth to achieve health outcomes and an explicit acknowledgement that better health contributes immensely to improved productivity as well as to equity.” While discussing the current situation of health care in India, this NHP draft further acknowledges several challenges that it needs to confront, including inequities in health outcomes, quality of care, growing disease burdens, increasing health‐care costs, inadequate investment and financing of health care, shortage of health‐care professionals, paucity of health services research, and poor regulatory framework.[1] Among all other objectives listed in this draft policy that the government wants to focus on, one of the important objectives – organizing and financing health‐care services – deserves special attention from economists, health outcomes researchers, and health‐care professionals, including pharmacists and policy makers. One cannot downplay the fact that all health services available under national programs in India are free to all its citizens and are universally accessible and moving forward, these services will most likely be expanded as stated in this policy draft, which will add a tax burden to society. Presently in India, the private sector provides 70%–80% of health‐care services, and it does not share any cost burden of providing free care and hardly has any regulations.[2] Implementing this policy as suggested, will require further infusion of approximately $50 billion (Rs. 312,500 crore) to reach the level of health expenditures of 2.5% of gross domestic product (GDP) to fund government’s proposed expansion. According to the government’s own estimates and as stated in its policy draft, over 63 million people are pushed to fall below poverty due to health‐care costs alone every year. Population coverage was expected to grow to about 370 million under the publicly financed health insurance schemes, of which nearly two‐thirds (180 million) of beneficiaries were below the poverty line category in 2014. Based on 2015 estimates, approximately 288 million (28.8 crore) people, less than one‐fifth of India’s population, were covered by health insurance. Among those who had some form of insurance coverage, 67% were covered by public insurance under Central Government Health Scheme, Employees’ State Insurance Scheme, and Rashtriya Swasthya Bima Yojana.[3] In 2014, India spent 1.04% of its GDP, about 4% of its total government expenditure, on health care, which, for a country being touted as the world’s third largest economy, is incomparable to the global standards. This spending, as a percentage of GDP, on health care is one of the lowest among countries of the Southeast Asian region. India’s spending is only a little higher than that of the Myanmar and is the lowest among BRICS (Brazil, Russia, China, and South Africa) countries.[4] Evidence further suggests that countries need to spend at least 5%–6% of their GDP to meet the basic health care needs of its population.[5] The Indian government in this policy draft has indicated its commitment to raise its share of health‐care expenditure to 2.5% of the GDP in next 5–7 years. However, the reality is, one of its major commitments of opening 3000 Jan Aushadhi Stores, aiming to provide generic medicines to people at an affordable cost, only managed to open 310 stores to this day.[6] The pricing of drugs in India is controlled through the National Pharmaceutical Pricing Authority. According to this draft policy, the government would like to include diagnostics and equipment under some form of price control. This draft policy has also suggested creating a regulatory framework modeled on the work of the National Institute for Clinical Excellence (NICE) of the United Kingdom. The NICE produces evidence‐based guidance and advice for health, public health, and social care practitioners, develops quality standards and performance metrics for those providing and commissioning health, public health, and social care services, and provides a range of informational services for commissioners, practitioners, and managers across the spectrum of health and social care. One of the most important roles of NICE is to conduct technology appraisals for assessing the clinical and cost‐effectiveness of the new pharmaceutical and biopharmaceutical products, including procedures, devices, and diagnostic agents, and to ensure that patients using National Health Service (NHS) in the United Kingdom have equitable access to the most clinically and cost‐effective treatments. Recommendations of NICE’s technology appraisals are based on clinical (how well the treatment work) and economic (does it represent the value for money) evidence. To consider technology to be cost effective, NICE has been using an implicit cost‐effectiveness threshold ranging between ₤20,000 and ₤30,000 per quality‐adjusted life year (QALY) gained for many years.[7] This threshold has always been challenged and even subjected to judicial review, instigated by drug companies such as Pfizer and Eisai, and inquiry by the House of Commons Health Select Committee.[8] However, it still remains the threshold for measuring cost‐effectiveness and the basis of resource allocation by the NHS in the United Kingdom. The other cost‐effectiveness thresholds that are currently in use include $50,000 EDITORIAL
国际药物经济学与结果研究学会第七届亚太会议于2016年9月3日至9月6日在新加坡举行。本次会议的主题是“亚太地区的药物经济学和成果研究:挑战、机遇和未来方向”。这一场合为讨论亚洲国家在卫生保健和决策过程中所特有的一些挑战提供了一个绝佳的机会。对于像印度这样的世界第三大经济体来说尤其如此,其新的国家卫生政策(NHP)很可能决定其卫生保健系统在未来几年的发展轨迹。在发达国家,有关经济问题的政治辩论往往被视为自由市场原则与政府控制之间的冲突。在这样的环境下制定监管政策是公共部门和私营部门之间的一场持久战。这样的斗争经常在医疗保健政策制定中蔓延开来。在印度,基本的卫生保健问题在任何政治讨论的清单中都处于最底层;偶尔,它们会在拥有更大政治影响力和自身特殊利益的利益集团的领导下浮出水面。医院条件、医生报酬、专业和认证机构内部腐败等问题比"为什么该国某些地区仍有疟疾或结核病等疾病"等重要问题更能引起公众的兴趣和关注?或者“为什么公立医院的基本药物总是短缺?”或“为什么同一地理区域内的药物和治疗费用差异很大?”这类至关重要的问题很少会引发任何公共或政治讨论。莫迪总理领导下的新政府计划在最近发布的国家健康计划草案中提供全民医疗保健。[1]人们可以从这份政策草案中感受到政府的意图,因为它指出,“这是政府决心利用经济增长来实现健康成果的宣言,并明确承认更好的健康对提高生产力和公平做出了巨大贡献。”在讨论印度卫生保健现状的同时,这份NHP草案进一步承认了印度需要面对的几个挑战,包括卫生结果的不平等、卫生保健质量、疾病负担的增加、卫生保健成本的增加、卫生保健投资和融资不足、卫生保健专业人员的短缺、卫生服务研究的缺乏以及监管框架的薄弱。[1]在这份政策草案中列出的所有其他目标中,政府希望重点关注的一个重要目标——组织和资助卫生保健服务——值得经济学家、健康结果研究人员和卫生保健专业人员(包括药剂师和政策制定者)特别关注。人们不能忽视这样一个事实,即印度国家方案提供的所有卫生服务对所有公民都是免费的,并且普遍可以获得,今后,这些服务很可能会扩大,正如本政策草案所述,这将增加社会的税收负担。目前在印度,私营部门提供70%-80%的医疗保健服务,而且它不分担提供免费医疗的任何成本负担,几乎没有任何法规。[2]按照建议实施这一政策,将需要进一步注入约500亿美元(3125亿卢比),以达到卫生支出占国内生产总值(GDP) 2.5%的水平,为政府拟议的扩张提供资金。根据政府自己的估计和政策草案中所述,每年有超过6300万人因医疗费用而脱离贫困。2014年,公共资助医疗保险计划的人口覆盖率预计将增加到约3.7亿人,其中近三分之二(1.8亿)的受益人生活在贫困线以下。根据2015年的估计,大约2.88亿人(2880亿人)享有医疗保险,不到印度人口的五分之一。在那些有某种形式保险的人中,67%的人参加了中央政府健康计划、雇员国家保险计划和拉什特里亚·斯瓦斯蒂亚·比玛·约加纳的公共保险。[3]2014年,印度在医疗保健方面的支出占GDP的1.04%,约占政府总支出的4%,对于一个被吹捧为世界第三大经济体的国家来说,这是无法与全球标准相比的。我国在卫生保健方面的支出占国内生产总值的百分比是东南亚地区国家中最低的之一。印度的支出仅略高于缅甸,是金砖国家(巴西、俄罗斯、中国和南非)中最低的。 [4]证据进一步表明,各国至少需要花费其国内生产总值的5%-6%来满足其人口的基本卫生保健需求。[5]印度政府在该政策草案中表示,它承诺在未来5-7年内将医疗保健支出占GDP的比例提高到2.5%。然而,现实情况是,它的主要承诺之一是开设3000家Jan Aushadhi商店,旨在以负担得起的价格为人们提供仿制药,但迄今为止只开了310家商店。[6]印度的药品定价是由国家药品定价局控制的。根据这份政策草案,政府希望将诊断和设备纳入某种形式的价格控制之下。该政策草案还建议仿照英国国家临床卓越研究所(NICE)的工作建立一个监管框架。NICE为卫生、公共卫生和社会保健从业人员提供循证指导和建议,为提供和委托卫生、公共卫生和社会保健服务的人员制定质量标准和绩效指标,并为卫生和社会保健领域的专员、从业人员和管理人员提供一系列信息服务。NICE最重要的角色之一是进行技术评估,以评估新药和生物制药产品的临床和成本效益,包括程序、设备和诊断试剂,并确保使用英国国家医疗服务体系(NHS)的患者能够公平地获得最具临床和成本效益的治疗。NICE的技术评估建议是基于临床(治疗效果如何)和经济(是否代表物有所值)证据。为了考虑技术的成本效益,NICE多年来一直使用隐含的成本效益阈值,其范围在每个质量调整生命年(QALY)获得20,000至30,000英镑之间。[7]这一门槛一直受到挑战,甚至受到司法审查,受到辉瑞(Pfizer)和卫材(Eisai)等制药公司的煽动,并受到下议院卫生特别委员会(House of Commons Health Select Committee)的调查。[8]然而,它仍然是衡量成本效益的门槛,也是英国NHS资源分配的基础。目前使用的其他成本效益门槛包括$50,000 EDITORIAL