Abstract
The implementation of a universal healthcare coverage by the Indian government has forced a relook into the existing systems of healthcare decision-making. Health technology assessment (HTA) is being looked at to provide efficient decision-making and helping in priority setting for the policymakers. The Ministry of Health and Family Welfare has, therefore established a Medical Technology Assessment Board as a way of institutionalising the HTA framework and methodology in India. Despite some challenges, the future looks bright for HTA in India.
Introduction
India for so long a period in its history has been examining the possibility of a universal healthcare coverage (UHC) for its extremely vast population, the majority of which are devoid of basic healthcare. Even though India has witnessed substantial growth in its economy, this has been coupled with rising issues. Chronic diseases, acute and infectious diseases, lifestyle changes along with changes in medical practices, health systems and technological advancements in the field of healthcare are a few concerns. All this has led to a substantial increase in healthcare costs, which sadly has not been mitigated by government, public and private initiatives. The rise in healthcare costs has not been supplemented with rise in GDP allocation towards healthcare. Of the total 5% GDP allocation towards healthcare, India spends only a meagre (1.02%, 2015–2016) of its GDP on healthcare. However, per capita expenditure on health has gone up considerably from ₹621 (2009–2010) to ₹1,112 (2015–2016).
Since healthcare insurance is a growing segment in India, with primarily public players covering 3.4 crore people of a total 4.3 crore Indians under the ambit of healthcare insurance, there was a severe need of UHC from the government (National Health Profile, 2018). UHC and universal healthcare access are also one of the sustainable development goals of the United Nations, and India is slowly but surely aligning itself to this goal. The Government of India as of September 2018 launched the centrally sponsored Ayushman Bharat Yojana or National Healthcare Protection Scheme (NHPS). It aims at making successful interventions in primary, secondary and tertiary healthcare systems—primary via the establishment of healthcare and wellness centres; secondary and tertiary via NHPS. The scale of this initiative is massive as it aims to cover larger population, approximately 50 crore people/beneficiaries, providing insurance coverage up to five lakhs per year per family (Press Information Bureau, Government of India, 2018).
Setting sights on the achievement of sustainable development goals of the UN and, more importantly, providing benefit to the people of the country, the UHC initiative in India needs evidence-backed decisions to chart out a proper path for its implementation. Investment decisions on cost-effective healthcare technologies will prove absolutely critical to improve population health and to provide equity in healthcare across the strata of society. Globally, wherever UHC has been implemented, there has been a movement towards health technology assessment (HTA) as a tool for the effective allocation of resources.
HTA and Its Necessity
The International Society for Pharmacoeconomics and Outcomes Research defines HTA as ‘any process of examining and reporting properties of a medical technology used in healthcare, such as safety, efficacy, feasibility, and indications for use, cost, and cost-effectiveness, as well as social, economic, and ethical consequences, whether intended or unintended’. Its aim is to inform public decision-making by providing an opinion with supporting evidence, taking account of all aspects of the topic concerned (Bingefors et al., 2003). In HTA, a systematic evaluation of properties, effects and/or impacts of health technologies and interventions is done. It covers both the direct, intended consequences of technologies and interventions and their indirect, unintended consequences.
Many healthcare experts over the world have attributed technological changes contributing to increased healthcare costs, so it makes sense to direct efforts towards cost containment on technological front. HTA has expanded from merely technological intervention such as single drugs and devices to an individual or patient level, which include interventions in the clinical aspects, population level. It even includes major public health interventions and policymaking (Hass et al., 2012).
In a developing economy such as India, non-communicable diseases and chronic disorders represent a major public health challenge, so making choices related to the allocation of healthcare resources would be challenging and difficult. As HTA methodology provides an equitable and transparent framework, challenges in resource allocation can be overcome. By effective and efficient means of HTA tools, resources can be allocated fairly in a country like India. There are plenty of potential applications of HTA to offer, to name a few, appropriate public reimbursement of healthcare, pricing strategy for new drugs or drug classes, helps in policymaking to ensure consistency of provisions and evidence-based interventions for maximum efficiency (Hass et al., 2012).
HTA Progress in India
HTA is not even in infancy stage in India as it is not a formal component of healthcare decision-making. However, the discussions around it are now moving from the academic forum to policymaking. This is evident from the ‘12th Five-Year Plan’ and recently approved National Health Policy, which marks a significant change in the decision-making process for allocation of health resources. Earlier at both the national and state levels, healthcare decisions were predominantly made on the basis of the consensus opinion from expert committees. Now, Ministry of Health and Family Welfare (MoHFW) is increasing its efforts to strengthen evidence-based service delivery through various means, one such initiative is the institutionalisation of the National Health Accounts and the establishment of the Medical Technological Assessment Board (MTAB).
To take forward HTA agenda in India and to implement a formal evidence-based process by which health policy decisions are made in the country, the Government of India has designated the task of establishing the MTAB to the Department of Health Research (DHR), a medical research department under the aegis of MoHFW (Downey et al., 2017). However, now the new face of MTAB is HTA in India (HTAIn). A few departments are extensively working not only in assessment but also in capacity building.
Department of Health Research
The Government of India with MoHWF and the Indian Council of Medical Research has established HTAIn under the aegis of DHR. The institute is entrusted with the responsibility of generating evidence through HTA related to the clinical effectiveness, cost-effectiveness and safety of medicines and medical devices. HTAIn provide hands on training on HTA, thereby contributing to capacity building (DHR, 2018). HTAIn will also analyse and safeguard the effective deployment of health technologies, which ensures efficient utilisation of the limited health budget to provide quality healthcare at affordable cost (Prinja et al., 2018).
National Health Systems Resource Centre (NHSRC)
Health technology division at NHSRC was started to assist the MoHFW on policies and strategies for medical devices. It is also being entrusted to come out with action plans for health technologies under the aegis of the National Health Mission. The division contributes in easing the procurement of medical devices by providing technical specifications and minimum standards on equipment to be purchased. It also provides its expertise in maintenance of biomedical equipment. The division ensures a list of tests that are to be provided free of costs under a free diagnostic service initiative. Specifically, the health technology division undertakes assessment of all products referred by the MoHFW.
Department of Community Medicine and School of Public Health
Under the aegis of the Institute of National Importance, Postgraduate Institute and Medical Education and Research, the Department of Community Medicine was established in 1977. Later, it was upgraded to School of Public Health to address the challenges in public health education and research. The faculty of the school is engaged in capacity building of healthcare professionals and equips them with latest developments in Health Economics and Health Policy. A course on HTA was developed in coordination with NHSRC. It even conducts a high-impact policy-relevant economic analysis for healthcare programmes and policies.
Future of HTA in India
The government efforts in establishing HTAIn will help in providing well-formed and legitimate HTA methodologies. The HTA system is essentially required in a country that is burdened by rising healthcare costs and high out-of-pocket expenditure. It may provide a platform from which healthcare payers could engage in more strategic purchasing of health services. HTAIn is also poised to offer a fundamental mechanism for defining evidence-based criteria for the purchase of services through direct procurement, contracting or by health insurance (Mukherjee et al., 2017).
While it is understandable that due to the scale of the country, there are limited resources for carrying out robust economic analysis in India. This is complicated further by the lack of resources dedicated for such studies. Data collection and reporting deficiencies may be anticipated due to lack of trained professionals in HTA in India (Downey et al., 2017). A study by Desai et al. (2011) recommended a standardised set of guidelines for HTA-related studies and stressed upon improving pharmacoeconomic education to produce skilled professionals who can in turn produce high-quality research in this upcoming area.
Successful implementation of HTA mechanisms in India can be challenging due to the complex and highly fragmented Indian healthcare system. There is definitive hindrance to the successful translation of recommendations of HTAIn into practice. Some other challenges are the availability of quality data, health system readiness, information dissemination and high out-of-pocket expenditure. The availability of mechanisms for monitoring and evaluation is also lax. In addition to the above challenges, the relationship between state and central governments in India in the healthcare segment, which has a mixed service delivery, will be a significant hurdle (Chauhan & Agrawal, 2014; Downey et al., 2017; Mukherjee et al. 2017; Prinja et al., 2015).
Furthermore, just policy initiatives would not be enough. Directed and substantial efforts should be made to inculcate the teaching and learning of HTA at the collegiate level in the health sciences disciplines.
Professor David Banda, an expert who developed HTA programmes globally, has summarised the following primacies for the establishment and sustainability of HTA system (Banda, 2007):
Commitment and dedication from regulators/policymakers Earmarking of public money to HTA Support and guidance from all the crucial stakeholders Scientific capability and credibility Expertise to screen the literature available in public domain Involvement of academicians in HTA training programmes Consideration for alternative options An effective health policy structure
Conclusion
In line with the goals and objectives of the UHC, Indian policymakers have begun to feel the necessity of an HTA framework to effectively implement the Ayushman Bharat Yojana. The primary step taken towards this direction was institutionalisation of HTA to make the decisions for the allocation of public funds towards healthcare, evidence-backed and transparent. Setting-up of HTAIn by the MoHFW is aimed at institutionalising the HTA framework. To become successful in its endeavour, HTAIn will require unstinted support from the government, technical capability and expertise from professionals and other stakeholders. Over and above, the assistance from physicians and allied health professionals, for promoting the culture of assessment, is needed. Importantly, there is required an efficient health system that can support implementation of the recommendations from the HTA framework in India. Establishment and effective functioning of HTA will soon be a reality in India if all the stakeholders work in coordination. Finally, cooperation of decision-makers from the medical and paramedical community is required to reap the benefits of HTA.
Footnotes
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The authors received no financial support for the research, authorship and/or publication of this article.
