- Email: [email protected]
Role of Culture, Values, and Politics in the Implementation of Health Technology Assessment in India: A Commentary
-
Contents lists available at sciencedirect.com Journal homepage: www.elsevier.com/locate/jval
VALUE HEALTH. 2019; -(-):-–-
Role of Culture, Values, and Politics in the Implementation of Health Technology Assessment in India: A Commentary Shilpi Swami, MSc1,2 Tushar Srivastava, MSc3,* 1 Department of Health Sciences (DoHS), University of York, York, England, UK; 2Evidera, London, England, UK; 3School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
A B S T R A C T India is a diverse land with different cultures, social norms, castes, religions, faiths, languages, politics, and a complex healthcare system. As a step to enhance healthcare, the government of India announced a move toward universal health coverage to increase accessibility and affordability of health-related services. Recently, there has been an introduction of health technology assessment (HTA) in India to help inform evidence-based decision making in cases of limited resources and budgets. Nevertheless, there are challenges related to biased decision making, an unregulated healthcare framework, and the lack of data and capacity that will (directly or indirectly) affect the use of HTA in India. For HTA to be successful in India and in similar low- and middle-income countries, it is important that the decision makers acknowledge these challenges and embrace differences in ideologies, cultures, and politics instead of ignoring them. Drawing lessons from countries with welldeveloped HTA bodies may help, but these need to be modified for the country-specific context. Ensuring quality and transparency is key to building trust in medical decision making. Improved coordination at all levels of healthcare is vital to ensure the long-term success of HTA in India. This is challenging but achievable by spreading awareness among stakeholders and achieving moderate health-sector regulation that can combat corruption. HTA will prosper in India if it incorporates cultural and institutional diversity, alongside tackling socioeconomic inequalities. Keywords: culture, economic evaluation, healthcare, health policy, health technology assessment, HTA, HTAIn, India, universal health coverage. VALUE HEALTH. 2019; -(-):-–-
Overview of Healthcare in India Culturally and historically, India has been a land of diverse healthcare practices with a significant inclusion of traditional and alternative medicine, such as Ayurveda, homeopathy, Unani, yoga, and Siddha, along with the use of allopathic medicines. In most parts of the country, home remedies are often used as an effective mode of treatment because of their low costs, rather than consulting trained medical practitioners. In the Indian context, family and elders play a significant role in decision making, including personal choices, such as healthcare. Sometimes, myths and misconceptions govern the adoption of a healthcare provision. An example is the long-prevailing antivaccine movement in which parents are strongly against or hesitant toward their child’s vaccination.1 In a country with dire healthcare needs and divisive inequality, delivering affordable and equitable healthcare is both a challenge and an opportunity. Poor funding and health insurance coverage
characterize the current landscape of medical practice in India. In 2015, India spent only 3.9% of its gross domestic product on healthcare.2 Just under 35% of Indians are covered under any health insurance scheme, as per a survey conducted in 2016 to 2017.3 The private sector provides most healthcare services, comprising 79% and 72% of total outpatient services and 68% and 58% of inpatient services in urban and rural India, respectively (2014 figures).4 There has also been a rapid upsurge in small private hospitals, which inflict high out-of-pocket expenditures on patients.5 In 2015, about 65% of health expenditure was out-ofpocket, compared with the world average of 19%.6 The public healthcare system provides free (or low cost) treatment and essential drugs to all, but its quality is perceived as low.7 Although it is managed by both the central and the state governments, they have distinct roles. The central government deals with broad health-related aspects such as prevention of major infectious diseases, general family welfare, and creation of guidelines and standards, which state-level governments can use.8
* Address correspondence to: Tushar Srivastava, MSc, Health Economics and Decision Science (HEDS), School of Health and Related Research (ScHARR), The University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, England, United Kingdom. Email: t.srivastava@sheffield.ac.uk 1098-3015/$36.00 - see front matter Copyright ª 2019, ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. https://doi.org/10.1016/j.jval.2019.10.002
2
- 2019
VALUE IN HEALTH
Nevertheless, health is much of a “state” subject in India, as the state government addresses issues such as local hospitals, public health, sanitation, and so forth. There is some level of interaction between the state and central governments for issues concerning the entire nation, such as medical education, population control, and control of the quality of medicines manufactured.
Introduction and Current Scenario of Health Technology Assessment in India The Indian government had already disclosed on a global level to provide universal health coverage to its citizens. Recently, in 2018, it announced the Ayushman Bharat Scheme to foster the implementation of universal health coverage. The Ayushman Bharat Scheme has 2 components: establishing 150 000 health and wellness centers by the year 2020 to enhance primary healthcare and to provide financial protection for hospitalizations at secondary and tertiary levels (as part of the National Health Protection Scheme).9 The National Health Protection Scheme will cover up to INR 500 000 (about US $7000) per annum for vulnerable families (about 40% of the Indian population), and benefits will cover services from enrolled private and public sectors across the country.9 The establishment of a health technology assessment (HTA) agency in India is crucial to achieve the goal of universal health coverage and to rationalize healthcare spending within constrained budgets or limited resources. HTAs are widely used in some countries to prioritize and manage resources in the presence of competing treatment options to get the maximum value for the money spent.10 It is an evidence- and research-based multidisciplinary process that evaluates or compares treatment and diagnostic interventions in terms of their cost-effectiveness, along with considerations of clinical effectiveness and ethical and equity issues. The Department of Health Research (under the Ministry of Health & Family Welfare; MoHFW) in India has set up an HTA body for systematically assessing evidence to aid healthcare policy.11 The aim of HTA in India (HTAIn) is to combat the healthcare challenges by maximizing health and reducing out-of-pocket expenditures and inequity among the Indian population. Like the country’s politics, the structure of HTAIn is complex, and it mainly
consists of a Department of Health Research in-house secretariat, technical appraisal committee, technical partners, and regional resource hubs (Fig. 1).12,13
Challenges for Implementation of HTAIn There will be many challenges in enforcing the implementation of HTAIn. Cultural values and politics will affect this implementation both directly and indirectly. Nevertheless, there are 4 major challenges related to (1) decision making, (2) the regulatory framework, (3) data, and (4) capacity. The challenge of decision making mainly relates to political values and the position of policy makers. In India, the political ideologies greatly influence health policies by affecting decisions related to technologies, allocation of resources, and extent of healthcare accessibility to the citizens. Unfortunately, these political ideologies are also tied to caste- and religion-based needs. As India already faces the challenge of combating corruption and a lack of regulation at all levels of governance, it is important to conduct evidence-based research transparently. In India, like in typical Asian cultures, there is a great deal of respect for expert (or senior) authorities or opinions.14 There is a possibility that the expert (or senior) opinion may become superior to evidencebased research, leading to a lack of transparent and good-quality research and thus affecting policy decisions.14 Also, there is a fear that policy makers in India can resist the use of economic evaluation if they feel that their power is threatened and their authority to make coverage decisions is transferred to the researchers, as experienced in Thailand, a neighboring Asian country.15 The second issue is that of the regulatory framework, which is affected by the unregulated, uncoordinated, and diverse healthcare market in India. There is wide availability of low-cost alternative treatments (homeopathy and Ayurveda) and locally manufactured drugs and devices, alongside imported treatments. Nevertheless, there is minimal clinical and economic evidence available on these generic medicines and alternative treatments. Because HTAIn is a centralized framework and health financing lies with the states, much of the demand for assessments should come from the latter. Many states have their own health insurance schemes. Nevertheless, there are existing wealth inequalities
Figure 1. Structure of HTA in India.
TAC
Producers of HTA evidence
Users of HTA evidence
Central or state health programmes
Resource hubs
Secretariat DHR Payers or regulatory agencies
Technical partners
Government or private financial protec on schemes
Stakeholders
DHR indicates Department of Health Research; HTA, health technology assessment; TAC, technical appraisal committee.
--
among states in their healthcare budgets, and most of these schemes are restricted to a prescribed list of tertiary-level treatments and do not cover preventive interventions. For instance, implemented in 2009, Tamil Nadu was among the first states to have its own healthcare insurance scheme called “Kalaingner kapittu thittam,” which covered families under the poverty line. Some states, for example, Chhattisgarh, Odisha, Telangana, and West Bengal, have shown cold shoulders to the roll out of the Ayushman Bharat Scheme.16 Thus, because of states’ preexisting insurance schemes or political issues, there is a hidden centerand-state conflict that could add friction to HTA implementation. Third, like any other low- and middle-income country, India faces a lack of data on costs and quality-of-life related to health. The main reason is that healthcare data are often not recorded and are rarely digitalized. One of the solutions is to digitize the recordings and make a collective data repository. In fact, the MoHFW is aiming to set up a National eHealth Authority to enable, organize, manage, and store electronic health records of patients and has introduced a draft bill titled the “Digital Information Security in Healthcare Act” (DISHA) in 2018 in this direction.17 It is important, however, that the digitized innovation take into account data policies and patients’ rights. Other ongoing works include the development of a reference case for HTAIn, a national costing database, a repository of HTAs, and Indian tariff values for EQ5D health states.18,19 The final major challenge is the lack of existing human resource capacity to undertake HTA analyses.19 To overcome that, online resources, in-house training by companies, and short-term government training programs are being built and run in collaboration with national and international partners. The growth of HTAIn will put further pressure on the educational system to meet the capacity demand, and there will be need for more postgraduate courses to teach concepts of health economics.
Suggestions for Future Growth of HTAIn HTAIn can draw lessons from culturally similar countries, as merely mimicking the developed world, which has different sociocultural and economic issues, will not help. Thailand’s Health Intervention and Technology Assessment Program (HITAP) and its lessons in implementation provides a useful model that could somewhat align with the demands of HTAIn. HITAP is already helping HTAIn by providing training and workshops for capacity building and HTA topic selection. Nevertheless, India’s population base and religion diversity are greater than Thailand, so caution is needed to prevent blind adoption of their methods. Because HTA is not independent of the healthcare system, the regulation of the former in India will be directly related to the regulation of the latter. For HTAIn to flourish transparently, the political pressures should fade. Physicians should be made more aware of methods of HTA to help them make evidence-based rational decisions. There should be close ties with the National Technical Advisory Group on Immunisation in India (which informs decisions regarding new vaccines and national immunizations programs), donor agencies, and the HTA agencies.20 This will ensure sharing of expertise, rapid assessment, and publication of long-term (direct and indirect) benefits vis-à-vis costs of vaccines to inform decisions and educate masses (especially those against vaccines) about regional and national vaccination programs. HTAIn should also work with the Central Drugs Standard Control Organization (equivalent to the Food and Drug Administration in the United States) to ensure that vital medicines are delivered to patients promptly, without excessive holdups at the higher level.
3
These vital medicines, which are required to be available at all times in adequate quantities, appropriate doses, and an affordable cost to serve the priority health needs of the public, are mentioned in the existing National List of Essential Medicines.21 Then, although not a regulatory document but serving as a guidance, there is a National Formulary of India, which contains some other drugs alongside the drugs listed in the National List of Essential Medicines.22 Therefore, a lot of coordination is required at all related levels of healthcare, which is currently lacking. To reduce variability in clinical practice, poor diagnosis, irrational use of medicines, and substandard treatments, clear standardized guidelines are also important. Many countries with highly regulated health systems have a dedicated agency to provide evidence-based national guidelines (eg, the National Institute of Clinical Excellence supports the National Health Service in the United Kingdom). Also, some low- and middle-income countries have general practice- and disease-specific centralized treatment guidelines (eg, South Africa and Kenya).23,24 For India, culturally, the concept of treatment guidelines has existed since the old times, when traditional healers had their own standard set of cures. These cure methods were eventually adapted and circulated by word of mouth (or writings) from generation to generation.25 In the current scenario, multiple agencies at the state and national level have developed numerous scientific clinical guidelines for different diseases.25-27 Nevertheless, in 2014, the MoHFW, realizing the importance of regulated guidelines, assembled a task force to develop a way ahead for standardizing the clinical management practice of diseases in India.28 To date, the MoHFW has published 12 standard treatment guidelines for different disease areas. The guidelines currently do not include cost-effectiveness analysis, and thus, integrating that feature will be another step toward regulated HTA. Although there is a need to use the existing resources in a manner that maximizes health per every dollar (or rupee) spent, evidence-based decision making in a pluralistic society such as India is a challenge and requires a structure that incorporates and embraces diversity. Thus, HTAIn could foster this type of decision making if it acknowledges diversity related to religions, cultures, and politics and works toward reducing inequalities, along with focusing on socioeconomically disadvantaged groups.
Acknowledgments We would like to thank Dr Radha Shukla, MBBS, for review of this article. We also thank Dr Sumit Mazumdar, PhD and the anonymous reviewers for providing valuable suggestions and feedback. The authors have no other financial relationships to disclose.
REFERENCES 1.
2.
3.
4.
5.
6.
Dubé E, Vivion M, MacDonald NE. Vaccine hesitancy, vaccine refusal and the anti-vaccine movement: influence, impact and implications. Expert Rev Vaccines. 2015;14(1):99–117. World Bank. World development indicators (2015)—current health expenditure. https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS?locations=IN. Accessed November 12, 2018. Central Bureau of Health Intelligence. National Health Profile (NHP) of India— 2018. http://www.cbhidghs.nic.in/WriteReadData/l892s/Chapter%204.pdf. Accessed November 12, 2018. National Sample Survey Office. 71st Round Survey (Ministry of Statistics and Program Implementation, Govt. of India). Key indicators of social consumption in India: health. http://mospi.nic.in/sites/default/files/national_data_ bank/ndb-rpts-71.htm. Accessed November 13, 2018. Kate A. Future of small hospitals in India. In: Association of Physicians of India. Medicine Update. Vol 23, Ch 155. http://www.apiindia.org/medicine_ update_2013/chap155.pdf. Accessed May 22, 2019. World Bank. World development indicators (2015)—out-of-pocket expenditure. https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS? locations=IN. Accessed November 12, 2018.
4
7. 8. 9. 10.
11. 12.
13. 14.
15.
16.
17.
18.
- 2019
VALUE IN HEALTH Kasthuri A. Challenges to healthcare in India—the five A’s. Indian J Community Med. 2018;43(3):141–143. Chokshi M, Patil B, Khanna R, et al. Health systems in India. J Perinatol. 2016;36(s3):S9–S12. Lahariya C. Ayushman Bharat’ program and universal health coverage in India. Indian Pediatr. 2018;55(6):495–506. World Health Organization. 2015 global survey on health technology assessment by national authorities. http://www.who.int/health-technologyassessment/MD_HTA_oct2015_final_web2.pdf. Accessed November 14, 2018. Department of Health Research (Government of India). About HTA in India. https://dhr.gov.in/about-mtab. Accessed November 14, 2018. Department of Health Research (Government of India). HTAIn: newsletter. https://dhr.gov.in/sites/default/files/eNewsletter/HTAIn-NewsLetter.html. Accessed November 14, 2018. Rao NV, Downey L, Jain N, Baru R, Cluzeau F. Priority-setting, the Indian way. J Glob Health. 2018;8(2):020311. World Health Organization, Regional Office for the Western Pacific. Factors conducive to the development of health technology assessment in Asia: impacts and policy options. http://iris.wpro.who.int/handle/10665.1/12588. Accessed November 13, 2018. Teerawattananon Y, Russell S. A difficult balancing act: policy actors’ perspectives on using economic evaluation to inform health-care coverage decisions under the universal health insurance coverage scheme in Thailand. Value Health. 2008;11:52–60. Sharma N. Chhattisgarh govt to pull out of Ayushman Bharat. Economic Times (Healthcare). https://economictimes.indiatimes.com/industry/healthcare/ biotech/healthcare/chhattisgarh-govt-to-pull-out-of-ayushman-bharat/articl eshow/67550227.cms. Published January 16, 2019. Accessed May 22, 2019. Ministry of Health and Family Welfare (Government of India). Digital Information Security in Health Care Act (DISHA). https://mohfw.gov.in/ newshighlights/comments-draft-digital-information-security-health-careactdisha. Accessed November 14, 2018. Jain S, Rajshekar K, Sohail A, Gauba VK. Department of Health ResearchHealth Technology Assessment (DHR-HTA) database: national prospective register of studies under HTAIn. Indian J Med Res. 2018;148(3):258–261.
19.
20. 21.
22.
23.
24.
25.
26.
27.
28.
Prinja S, Downey LE, Gauba VK, Swaminathan S. Health technology assessment for policy making in India: current scenario and way forward. Pharmacoecon Open. 2018;2(1):1–3. John TJ. India’s national technical advisory group on immunisation. Vaccine. 2010;28:A88–A90. The Gazette of India, Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), Government of India. Extraordinary—part 1, section 1. National pharmaceutical pricing policy, 2012. http://pharmaceuticals.gov.in/ sites/default/files/National%20Pharmaceutical%20Pricing%20Policy%202 012_1.pdf. Published 2012. Accessed May 22, 2019. Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India. National Formulary of India 2011. 4th ed. https://apps. who.int/medicinedocs/documents/s23089en/s23089en.pdf. Published 2011. Accessed May 22, 2019. English M, Irimu G, Nyamai R, Were F, Garner P, Opiyo N. Developing guidelines in low-income and middle-income countries: lessons from Kenya. Arch Dis Child. 2017;102(9):846–851. Department of Health. Republic of South Africa. Standard Treatment Guidelines and Essential Medicines List for South Africa. 4th ed. https://www. idealhealthfacility.org.za/docs/guidelines/Standard%20Treatment%20 Guidelines%20and%20Essential%20Medicines%20List%20for%20Hospit al%20Level%20Paediatrics%202017.pdf. Published 2017. Accessed August 12, 2019. Gopalakrishnan S, Udayshankar PM, Rama R. Standard treatment guidelines in primary healthcare practice. J Family Med Prim Care. 2014;3(4):424–429. Ministry of Health and Family Welfare, Government of India. Standard Treatment Guidelines—Methods Book. http://qi.nhsrcindia.org/sites/default/ files/Methods%20Book.pdf. Published 2017. Accessed May 22, 2019. Ministry of Health and Family Welfare, Government of India. India: The Clinical Establishments (Registration and Regulation) Act, 2010. http:// clinicalestablishments.gov.in/En/1068-standard-treatment-guidelines.aspx. Accessed May 22, 2019. Mehndiratta A, Sharma S, Gupta NP, Sankar MJ, Cluzeau F. Adapting clinical guidelines in India-a pragmatic approach. BMJ. 2017;359:j5147.
Contents lists available at sciencedirect.com Journal homepage: www.elsevier.com/locate/jval
VALUE HEALTH. 2019; -(-):-–-
Role of Culture, Values, and Politics in the Implementation of Health Technology Assessment in India: A Commentary Shilpi Swami, MSc1,2 Tushar Srivastava, MSc3,* 1 Department of Health Sciences (DoHS), University of York, York, England, UK; 2Evidera, London, England, UK; 3School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, England, UK
A B S T R A C T India is a diverse land with different cultures, social norms, castes, religions, faiths, languages, politics, and a complex healthcare system. As a step to enhance healthcare, the government of India announced a move toward universal health coverage to increase accessibility and affordability of health-related services. Recently, there has been an introduction of health technology assessment (HTA) in India to help inform evidence-based decision making in cases of limited resources and budgets. Nevertheless, there are challenges related to biased decision making, an unregulated healthcare framework, and the lack of data and capacity that will (directly or indirectly) affect the use of HTA in India. For HTA to be successful in India and in similar low- and middle-income countries, it is important that the decision makers acknowledge these challenges and embrace differences in ideologies, cultures, and politics instead of ignoring them. Drawing lessons from countries with welldeveloped HTA bodies may help, but these need to be modified for the country-specific context. Ensuring quality and transparency is key to building trust in medical decision making. Improved coordination at all levels of healthcare is vital to ensure the long-term success of HTA in India. This is challenging but achievable by spreading awareness among stakeholders and achieving moderate health-sector regulation that can combat corruption. HTA will prosper in India if it incorporates cultural and institutional diversity, alongside tackling socioeconomic inequalities. Keywords: culture, economic evaluation, healthcare, health policy, health technology assessment, HTA, HTAIn, India, universal health coverage. VALUE HEALTH. 2019; -(-):-–-
Overview of Healthcare in India Culturally and historically, India has been a land of diverse healthcare practices with a significant inclusion of traditional and alternative medicine, such as Ayurveda, homeopathy, Unani, yoga, and Siddha, along with the use of allopathic medicines. In most parts of the country, home remedies are often used as an effective mode of treatment because of their low costs, rather than consulting trained medical practitioners. In the Indian context, family and elders play a significant role in decision making, including personal choices, such as healthcare. Sometimes, myths and misconceptions govern the adoption of a healthcare provision. An example is the long-prevailing antivaccine movement in which parents are strongly against or hesitant toward their child’s vaccination.1 In a country with dire healthcare needs and divisive inequality, delivering affordable and equitable healthcare is both a challenge and an opportunity. Poor funding and health insurance coverage
characterize the current landscape of medical practice in India. In 2015, India spent only 3.9% of its gross domestic product on healthcare.2 Just under 35% of Indians are covered under any health insurance scheme, as per a survey conducted in 2016 to 2017.3 The private sector provides most healthcare services, comprising 79% and 72% of total outpatient services and 68% and 58% of inpatient services in urban and rural India, respectively (2014 figures).4 There has also been a rapid upsurge in small private hospitals, which inflict high out-of-pocket expenditures on patients.5 In 2015, about 65% of health expenditure was out-ofpocket, compared with the world average of 19%.6 The public healthcare system provides free (or low cost) treatment and essential drugs to all, but its quality is perceived as low.7 Although it is managed by both the central and the state governments, they have distinct roles. The central government deals with broad health-related aspects such as prevention of major infectious diseases, general family welfare, and creation of guidelines and standards, which state-level governments can use.8
* Address correspondence to: Tushar Srivastava, MSc, Health Economics and Decision Science (HEDS), School of Health and Related Research (ScHARR), The University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, England, United Kingdom. Email: t.srivastava@sheffield.ac.uk 1098-3015/$36.00 - see front matter Copyright ª 2019, ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. https://doi.org/10.1016/j.jval.2019.10.002
2
- 2019
VALUE IN HEALTH
Nevertheless, health is much of a “state” subject in India, as the state government addresses issues such as local hospitals, public health, sanitation, and so forth. There is some level of interaction between the state and central governments for issues concerning the entire nation, such as medical education, population control, and control of the quality of medicines manufactured.
Introduction and Current Scenario of Health Technology Assessment in India The Indian government had already disclosed on a global level to provide universal health coverage to its citizens. Recently, in 2018, it announced the Ayushman Bharat Scheme to foster the implementation of universal health coverage. The Ayushman Bharat Scheme has 2 components: establishing 150 000 health and wellness centers by the year 2020 to enhance primary healthcare and to provide financial protection for hospitalizations at secondary and tertiary levels (as part of the National Health Protection Scheme).9 The National Health Protection Scheme will cover up to INR 500 000 (about US $7000) per annum for vulnerable families (about 40% of the Indian population), and benefits will cover services from enrolled private and public sectors across the country.9 The establishment of a health technology assessment (HTA) agency in India is crucial to achieve the goal of universal health coverage and to rationalize healthcare spending within constrained budgets or limited resources. HTAs are widely used in some countries to prioritize and manage resources in the presence of competing treatment options to get the maximum value for the money spent.10 It is an evidence- and research-based multidisciplinary process that evaluates or compares treatment and diagnostic interventions in terms of their cost-effectiveness, along with considerations of clinical effectiveness and ethical and equity issues. The Department of Health Research (under the Ministry of Health & Family Welfare; MoHFW) in India has set up an HTA body for systematically assessing evidence to aid healthcare policy.11 The aim of HTA in India (HTAIn) is to combat the healthcare challenges by maximizing health and reducing out-of-pocket expenditures and inequity among the Indian population. Like the country’s politics, the structure of HTAIn is complex, and it mainly
consists of a Department of Health Research in-house secretariat, technical appraisal committee, technical partners, and regional resource hubs (Fig. 1).12,13
Challenges for Implementation of HTAIn There will be many challenges in enforcing the implementation of HTAIn. Cultural values and politics will affect this implementation both directly and indirectly. Nevertheless, there are 4 major challenges related to (1) decision making, (2) the regulatory framework, (3) data, and (4) capacity. The challenge of decision making mainly relates to political values and the position of policy makers. In India, the political ideologies greatly influence health policies by affecting decisions related to technologies, allocation of resources, and extent of healthcare accessibility to the citizens. Unfortunately, these political ideologies are also tied to caste- and religion-based needs. As India already faces the challenge of combating corruption and a lack of regulation at all levels of governance, it is important to conduct evidence-based research transparently. In India, like in typical Asian cultures, there is a great deal of respect for expert (or senior) authorities or opinions.14 There is a possibility that the expert (or senior) opinion may become superior to evidencebased research, leading to a lack of transparent and good-quality research and thus affecting policy decisions.14 Also, there is a fear that policy makers in India can resist the use of economic evaluation if they feel that their power is threatened and their authority to make coverage decisions is transferred to the researchers, as experienced in Thailand, a neighboring Asian country.15 The second issue is that of the regulatory framework, which is affected by the unregulated, uncoordinated, and diverse healthcare market in India. There is wide availability of low-cost alternative treatments (homeopathy and Ayurveda) and locally manufactured drugs and devices, alongside imported treatments. Nevertheless, there is minimal clinical and economic evidence available on these generic medicines and alternative treatments. Because HTAIn is a centralized framework and health financing lies with the states, much of the demand for assessments should come from the latter. Many states have their own health insurance schemes. Nevertheless, there are existing wealth inequalities
Figure 1. Structure of HTA in India.
TAC
Producers of HTA evidence
Users of HTA evidence
Central or state health programmes
Resource hubs
Secretariat DHR Payers or regulatory agencies
Technical partners
Government or private financial protec on schemes
Stakeholders
DHR indicates Department of Health Research; HTA, health technology assessment; TAC, technical appraisal committee.
--
among states in their healthcare budgets, and most of these schemes are restricted to a prescribed list of tertiary-level treatments and do not cover preventive interventions. For instance, implemented in 2009, Tamil Nadu was among the first states to have its own healthcare insurance scheme called “Kalaingner kapittu thittam,” which covered families under the poverty line. Some states, for example, Chhattisgarh, Odisha, Telangana, and West Bengal, have shown cold shoulders to the roll out of the Ayushman Bharat Scheme.16 Thus, because of states’ preexisting insurance schemes or political issues, there is a hidden centerand-state conflict that could add friction to HTA implementation. Third, like any other low- and middle-income country, India faces a lack of data on costs and quality-of-life related to health. The main reason is that healthcare data are often not recorded and are rarely digitalized. One of the solutions is to digitize the recordings and make a collective data repository. In fact, the MoHFW is aiming to set up a National eHealth Authority to enable, organize, manage, and store electronic health records of patients and has introduced a draft bill titled the “Digital Information Security in Healthcare Act” (DISHA) in 2018 in this direction.17 It is important, however, that the digitized innovation take into account data policies and patients’ rights. Other ongoing works include the development of a reference case for HTAIn, a national costing database, a repository of HTAs, and Indian tariff values for EQ5D health states.18,19 The final major challenge is the lack of existing human resource capacity to undertake HTA analyses.19 To overcome that, online resources, in-house training by companies, and short-term government training programs are being built and run in collaboration with national and international partners. The growth of HTAIn will put further pressure on the educational system to meet the capacity demand, and there will be need for more postgraduate courses to teach concepts of health economics.
Suggestions for Future Growth of HTAIn HTAIn can draw lessons from culturally similar countries, as merely mimicking the developed world, which has different sociocultural and economic issues, will not help. Thailand’s Health Intervention and Technology Assessment Program (HITAP) and its lessons in implementation provides a useful model that could somewhat align with the demands of HTAIn. HITAP is already helping HTAIn by providing training and workshops for capacity building and HTA topic selection. Nevertheless, India’s population base and religion diversity are greater than Thailand, so caution is needed to prevent blind adoption of their methods. Because HTA is not independent of the healthcare system, the regulation of the former in India will be directly related to the regulation of the latter. For HTAIn to flourish transparently, the political pressures should fade. Physicians should be made more aware of methods of HTA to help them make evidence-based rational decisions. There should be close ties with the National Technical Advisory Group on Immunisation in India (which informs decisions regarding new vaccines and national immunizations programs), donor agencies, and the HTA agencies.20 This will ensure sharing of expertise, rapid assessment, and publication of long-term (direct and indirect) benefits vis-à-vis costs of vaccines to inform decisions and educate masses (especially those against vaccines) about regional and national vaccination programs. HTAIn should also work with the Central Drugs Standard Control Organization (equivalent to the Food and Drug Administration in the United States) to ensure that vital medicines are delivered to patients promptly, without excessive holdups at the higher level.
3
These vital medicines, which are required to be available at all times in adequate quantities, appropriate doses, and an affordable cost to serve the priority health needs of the public, are mentioned in the existing National List of Essential Medicines.21 Then, although not a regulatory document but serving as a guidance, there is a National Formulary of India, which contains some other drugs alongside the drugs listed in the National List of Essential Medicines.22 Therefore, a lot of coordination is required at all related levels of healthcare, which is currently lacking. To reduce variability in clinical practice, poor diagnosis, irrational use of medicines, and substandard treatments, clear standardized guidelines are also important. Many countries with highly regulated health systems have a dedicated agency to provide evidence-based national guidelines (eg, the National Institute of Clinical Excellence supports the National Health Service in the United Kingdom). Also, some low- and middle-income countries have general practice- and disease-specific centralized treatment guidelines (eg, South Africa and Kenya).23,24 For India, culturally, the concept of treatment guidelines has existed since the old times, when traditional healers had their own standard set of cures. These cure methods were eventually adapted and circulated by word of mouth (or writings) from generation to generation.25 In the current scenario, multiple agencies at the state and national level have developed numerous scientific clinical guidelines for different diseases.25-27 Nevertheless, in 2014, the MoHFW, realizing the importance of regulated guidelines, assembled a task force to develop a way ahead for standardizing the clinical management practice of diseases in India.28 To date, the MoHFW has published 12 standard treatment guidelines for different disease areas. The guidelines currently do not include cost-effectiveness analysis, and thus, integrating that feature will be another step toward regulated HTA. Although there is a need to use the existing resources in a manner that maximizes health per every dollar (or rupee) spent, evidence-based decision making in a pluralistic society such as India is a challenge and requires a structure that incorporates and embraces diversity. Thus, HTAIn could foster this type of decision making if it acknowledges diversity related to religions, cultures, and politics and works toward reducing inequalities, along with focusing on socioeconomically disadvantaged groups.
Acknowledgments We would like to thank Dr Radha Shukla, MBBS, for review of this article. We also thank Dr Sumit Mazumdar, PhD and the anonymous reviewers for providing valuable suggestions and feedback. The authors have no other financial relationships to disclose.
REFERENCES 1.
2.
3.
4.
5.
6.
Dubé E, Vivion M, MacDonald NE. Vaccine hesitancy, vaccine refusal and the anti-vaccine movement: influence, impact and implications. Expert Rev Vaccines. 2015;14(1):99–117. World Bank. World development indicators (2015)—current health expenditure. https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS?locations=IN. Accessed November 12, 2018. Central Bureau of Health Intelligence. National Health Profile (NHP) of India— 2018. http://www.cbhidghs.nic.in/WriteReadData/l892s/Chapter%204.pdf. Accessed November 12, 2018. National Sample Survey Office. 71st Round Survey (Ministry of Statistics and Program Implementation, Govt. of India). Key indicators of social consumption in India: health. http://mospi.nic.in/sites/default/files/national_data_ bank/ndb-rpts-71.htm. Accessed November 13, 2018. Kate A. Future of small hospitals in India. In: Association of Physicians of India. Medicine Update. Vol 23, Ch 155. http://www.apiindia.org/medicine_ update_2013/chap155.pdf. Accessed May 22, 2019. World Bank. World development indicators (2015)—out-of-pocket expenditure. https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS? locations=IN. Accessed November 12, 2018.
4
7. 8. 9. 10.
11. 12.
13. 14.
15.
16.
17.
18.
- 2019
VALUE IN HEALTH Kasthuri A. Challenges to healthcare in India—the five A’s. Indian J Community Med. 2018;43(3):141–143. Chokshi M, Patil B, Khanna R, et al. Health systems in India. J Perinatol. 2016;36(s3):S9–S12. Lahariya C. Ayushman Bharat’ program and universal health coverage in India. Indian Pediatr. 2018;55(6):495–506. World Health Organization. 2015 global survey on health technology assessment by national authorities. http://www.who.int/health-technologyassessment/MD_HTA_oct2015_final_web2.pdf. Accessed November 14, 2018. Department of Health Research (Government of India). About HTA in India. https://dhr.gov.in/about-mtab. Accessed November 14, 2018. Department of Health Research (Government of India). HTAIn: newsletter. https://dhr.gov.in/sites/default/files/eNewsletter/HTAIn-NewsLetter.html. Accessed November 14, 2018. Rao NV, Downey L, Jain N, Baru R, Cluzeau F. Priority-setting, the Indian way. J Glob Health. 2018;8(2):020311. World Health Organization, Regional Office for the Western Pacific. Factors conducive to the development of health technology assessment in Asia: impacts and policy options. http://iris.wpro.who.int/handle/10665.1/12588. Accessed November 13, 2018. Teerawattananon Y, Russell S. A difficult balancing act: policy actors’ perspectives on using economic evaluation to inform health-care coverage decisions under the universal health insurance coverage scheme in Thailand. Value Health. 2008;11:52–60. Sharma N. Chhattisgarh govt to pull out of Ayushman Bharat. Economic Times (Healthcare). https://economictimes.indiatimes.com/industry/healthcare/ biotech/healthcare/chhattisgarh-govt-to-pull-out-of-ayushman-bharat/articl eshow/67550227.cms. Published January 16, 2019. Accessed May 22, 2019. Ministry of Health and Family Welfare (Government of India). Digital Information Security in Health Care Act (DISHA). https://mohfw.gov.in/ newshighlights/comments-draft-digital-information-security-health-careactdisha. Accessed November 14, 2018. Jain S, Rajshekar K, Sohail A, Gauba VK. Department of Health ResearchHealth Technology Assessment (DHR-HTA) database: national prospective register of studies under HTAIn. Indian J Med Res. 2018;148(3):258–261.
19.
20. 21.
22.
23.
24.
25.
26.
27.
28.
Prinja S, Downey LE, Gauba VK, Swaminathan S. Health technology assessment for policy making in India: current scenario and way forward. Pharmacoecon Open. 2018;2(1):1–3. John TJ. India’s national technical advisory group on immunisation. Vaccine. 2010;28:A88–A90. The Gazette of India, Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), Government of India. Extraordinary—part 1, section 1. National pharmaceutical pricing policy, 2012. http://pharmaceuticals.gov.in/ sites/default/files/National%20Pharmaceutical%20Pricing%20Policy%202 012_1.pdf. Published 2012. Accessed May 22, 2019. Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India. National Formulary of India 2011. 4th ed. https://apps. who.int/medicinedocs/documents/s23089en/s23089en.pdf. Published 2011. Accessed May 22, 2019. English M, Irimu G, Nyamai R, Were F, Garner P, Opiyo N. Developing guidelines in low-income and middle-income countries: lessons from Kenya. Arch Dis Child. 2017;102(9):846–851. Department of Health. Republic of South Africa. Standard Treatment Guidelines and Essential Medicines List for South Africa. 4th ed. https://www. idealhealthfacility.org.za/docs/guidelines/Standard%20Treatment%20 Guidelines%20and%20Essential%20Medicines%20List%20for%20Hospit al%20Level%20Paediatrics%202017.pdf. Published 2017. Accessed August 12, 2019. Gopalakrishnan S, Udayshankar PM, Rama R. Standard treatment guidelines in primary healthcare practice. J Family Med Prim Care. 2014;3(4):424–429. Ministry of Health and Family Welfare, Government of India. Standard Treatment Guidelines—Methods Book. http://qi.nhsrcindia.org/sites/default/ files/Methods%20Book.pdf. Published 2017. Accessed May 22, 2019. Ministry of Health and Family Welfare, Government of India. India: The Clinical Establishments (Registration and Regulation) Act, 2010. http:// clinicalestablishments.gov.in/En/1068-standard-treatment-guidelines.aspx. Accessed May 22, 2019. Mehndiratta A, Sharma S, Gupta NP, Sankar MJ, Cluzeau F. Adapting clinical guidelines in India-a pragmatic approach. BMJ. 2017;359:j5147.