This article was written by Sarita Sah, pursuing the Training program on Using AI for Business Growth Course from Skill Arbitrage, and edited by Koushik Chittella.

This article has been published by Shashwat Kaushik.

Introduction

Health technology assessment (HTA) in modern healthcare is the process that involves the systematic evaluation of health tools such as drugs, devices, and medical procedures. The evaluation of the economic and societal impacts is analysed by the HTA in clinics that basically play the essential role in guiding the decision-making in the sector of health. This paper provides an introduction to HTA: its core values, methodologies, and role in decision-making. The paper addresses the condition of HTA in India today and its upcoming potential to alter the landscape of health policy and health practice in India.

The health sector is constantly changing due to new innovations such as pharmaceuticals, medical devices, and novel, more sophisticated treatments, processes, or methods of delivery. A thorough evaluation of the cost-benefit ratio and the safety of all these aspects is necessary. For the most part, Health Technology Assessment (HTA) is intended to evaluate the features of a health technology with a view to creating information that can be acted upon by decision-makers in health systems.

History

HTA started off in America and Europe during the 1970s and remains a vital consideration for decision-making within the healthcare industry. Policymakers, health providers, and other stakeholders can use HTA as a suitable tool for valuing healthcare technologies and their integration into the wider healthcare system. It has been an important component of evaluation processes because it draws upon resource use and outcomes to inform care. Thus, it is becoming increasingly important in India as there is a growing emphasis on improving health outcomes, making best use of scarce resources when making healthcare decisions, or creating evidence-based debates around policy-making processes, respectively.

Core components

The core components of HTA include:

• Clinical Effectiveness: Clinical effectiveness is the capacity of a health technology to deliver the expected outcome in normal circumstances as a treatment. Clinical effectiveness is one of the elements of HTA, testing whether a technology accomplishes the expected gains in good health compared with those now provided. There are three basic methodological designs to evaluate clinical effectiveness: randomised controlled trials, observational studies, and systematic reviews. 
  For instance, the effectiveness of a new antidiabetic would be determined by proving that it maintains lower sugar levels compared to standard treatment.
• Safety: Safety is the intrinsic component of HTA. It refers to possible risks associated with health technology. For example, the assessment determines adverse events, safety profile in the long term, benefit, and risk comparison. A lot of safety data is often collected through post-marketing surveillance and systems of pharmacovigilance, which monitor how technologies perform once they are already on the market.
  For instance, there was cardiovascular risk monitoring related to some pain medication, which led to the suspension of certain medications from market circulation.
• Cost-Effectiveness: Cost-effectiveness analysis (CEA) involves the measurement of health technology’s economic value by way of comparing the costs of a certain health outcome with the alternative methods that can deliver the same consequences. This part of HTA is most important in a low-resource setting in which the identification of which intervention will lead to better health at the least cost is the focus.
  For instance, some significant categories of metrics suitable to perform a CEA are cost in terms of per quality gained. For instance, a new anti-cancer drug might be estimated for its ability to produce life and its cost-effectiveness in preventing life quality.
• Ethical, Legal, and Social Implications: The HTA process examines the ethical, legal, and social aspects of any health technologies, including, among others, issues with access, equity, and patient agency. For example, genetic tests can raise issues related to privacy, consent, or discrimination due to having genetic information. HTA allows for social considerations when thinking of new technologies.

The introduction of a new health technology brings about changes in not only care but also the organisation of health services. HTA follows the technologies that are applied in the health service in terms of their impact on healthcare systems, which refers to the demand on the infrastructure, the training of HCPs, and the organisation of the clinical workflow. For instance, implementation of telemedicine services means that there should be financial investment in the equipment, training for the healthcare providers, and a change in the flow of patients.

Methodologies

Methodologies of HTA include:

• Systematic Reviews and Meta-Analyses: Systematic reviews and meta-analyses form a very important methodology in HTA because they pool the evidence from multiple studies on a certain technology. A systematic review is a process used in identifying, appraising, and synthesising all relevant research, while a meta-analysis statistically combines the results of such studies to form a more precise effectiveness/safety level of determination for a technology. For example, a systematic review and meta-analysis on the effectiveness of a new vaccine could be performed to pool data from randomised clinical trials.
• Economic Evaluation: Evaluation takes place in cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. In these modes of evaluation, the economic effects of health technologies are assessed, whereby costs are compared with outcomes. For instance, the health technology appraised for cost effectiveness is telemedicine applied in chronic disease to reduce the admissions of patients in hospitals for better patient outcomes.
• Health Outcomes Research: Research on health outcomes helps measure the end results of healthcare interventions, including quality of life, survival rates, and how satisfied patients are. The final results of healthcare or health-related services adjusted to factor in what patients and providers experience can aid in determining how health technologies turn out. For example, experts can evaluate a cancer cure based on whether it helps more patients live longer with a better quality of life. HTA uses decision analysis models like Markov models and decision trees to simulate health technologies for long-term outcomes and costs. These models try to predict how technologies will affect the future based on current evidence. For example, researchers utilised decision models to assess the cost-effectiveness of human papillomavirus vaccination programs by predicting the long-term benefits and costs related to vaccination.
• Real-World Evidence: Real-world evidence (RWE) refers to any information derived from data not collected in the course of a traditional clinical trial—for example, coming from electronic health records, standard-of-care registries, and heterogeneously conducted observational research. These will yield insights on the performance of health technologies under routine clinical practice. For example, RWE is a common approach for establishing oncology drug effectiveness to understand the performance of drugs in affecting patient populations widely.

Role of HTA in healthcare decision-making

The role of HTA in healthcare decision-making includes:

1. Policymakers: HTA is said to play a critical evidence-based role in informing health policy decisions to ensure that health technologies offer proper value. Policymakers should efficiently allocate resources and provide guidance on interventions that benefit the patient population the most. More so, this is of utmost importance as far as this issue is concerned in publicly funded health systems.
2. Healthcare Professionals: To healthcare professionals, HTA provides guidance regarding which effective and efficient technology will be included in clinical practice. When HTA is provided, clinicians are able to select a treatment option that will provide the best outcomes after considering cost and safety. The new surgical procedure with the best results in this example may encourage a clinician to apply it when such outcomes are realised at a reduced cost.
3. Patients: HTA helps patients by giving them clear information about the advantages and disadvantages of different health treatments. This information helps them make better decisions and understand the value of different treatment options. For instance, an HTA report is very useful for patients with long-term health issues because it explains how well these treatments work and what they cost.
4. Industry: HTA is a tool that drug and medical equipment companies use to show the value of their products to government agencies, insurance companies, and doctors. If a positive HTA leads to better chances of selling the product and getting insurance coverage, then that’s why HTA is very important in creating new products. For example, a company that develops a new medicine would use its HTA to show that its product could work better than others that cost the same.
5. Health Insurers: Health insurers rely on HTA to determine which new technologies to cover and under what conditions. Generally, HTA allows balancing the cost of coverage against the benefits that are potentially going to accrue from it toward the health and well-being of the members as well as an effective use of the resources. The insurer, with the help of HTA, will analyse the cost utility and patient outcome in the process of treating a disease, which in turn will give a new treatment coverage plan by an insurer.

Status of HTA in India 

The current status of HTA can be classified into the following:

• Emergence and Growth: In India, HTA is gaining recognition as a valuable approach to improve healthcare outcomes and optimise resource use. To support this goal, a program called Health Technology Assessment in India (HTAIn) has been launched under the Department of Health Research. HTA is ready to help shape policies, thanks to its use of evidence-based health information, especially in the context of diverse, uneven, and low-resource health services.
• Key Stakeholders: Key stakeholders in the Indian HTA landscape include the Ministry of Health and Family Welfare, the National Health Systems Resource Centre, and several state health departments. These bodies engage with international HTA agencies and experts in the development and application of HTA methodologies modified to the Indian setting. For example, the HTAIn works with the International Decision Support Initiative (IDSI) to get the best practices in HTA for its use in India.
• Applications of HTA: HTA has been applied in the evaluation of new drugs, medical devices, and public health interventions in India. To mention one recent example, the cost-effectiveness evaluation of introducing rotavirus vaccination as part of the Indian national vaccination program, which helped in deciding the resource allocation and choice of different vaccination programs to be implemented was undertaken.
• Challenges in Implementing: The increasing significance of HTA in India is accompanied by several challenges. The availability and quality of data present considerable obstacles, as comprehensive and trustworthy data are not readily accessible. Additionally, there is a pressing need for training and capacity building to improve the technical skills necessary for effective HTA. Furthermore, various regulatory and procedural issues hinder the seamless integration of HTA into healthcare decision-making processes. Addressing these challenges is essential for HTA to achieve its full potential in India.

Future of HTA in India

The future of HTA in India could be:

• Expansion of HTA in Policy and Practice: The future of HTA in India lies in its wider application at the state and national levels. As more states set up units dealing with HTA and its effect on integration within the decision-making processes, HTA’s eventual impact on healthcare policy and practice will be felt across the board. This escalation will be driven by the demand for evidence-based policy formulation in a rapidly changing healthcare environment.
• Opportunities for capacity building: Substantial investment in capable capacity, in terms of training healthcare professionals, policymakers, and other stakeholders like researchers, on HTA methodologies and creating an institutional framework that supports HTA activities, is required to back the growing HTA endeavour in India. The relationships with international organisations in the HTA sphere involve knowledge transfer and offer a number of advantages and benefits to India for the development of its own capacity in HTA.
• Integration with Universal Health Coverage (UHC): Being one of the key components towards attaining UHC in India, HTA will deliberately inform the prioritisation of interventions with maximum health gain in the population. Integration of HTA systems into the UHC framework will help the nation focus on interventions that would provide maximum health benefit and move closer to its goal of providing equitable and sustainable healthcare for all segments of the demographic.
• Potential for innovation and collaboration: The use of HTA in India is growing, with new and creative ways being developed. Improvements in digital health technologies, data analysis, and artificial intelligence could make HTA work better and more accurately. Working together with government departments, the private sector, schools, and businesses can help create new methods and uses for HTA.
• Equity and access: One of the major potential future opportunities for HTA in India is that it will address the question of equity and access to healthcare. Systematic evaluation by HTA of the influence of health technologies on different barely reached groups of the population will help to make sure that healthcare interventions are jointly distributed and marginalised in the population that receives the care they deserve.

Conclusion

Being an influential guide for the formulation of health policy by ensuring that new technologies are worthwhile in terms of effectiveness, safety, and value for money, HTA is gaining gradual independence in India as it shapes up the attempt at serving better health outcomes with limitations on resources. Addressing the challenges that HTA faces in India will open up further avenues for deriving the maximum benefit out of the potential of such exercises in transforming policies and practices not only in health but across other domains of the country.

In the humble words of Dr. Atul Gawande, “Better is possible. It does not take genius. It takes diligence. It takes moral clarity. It takes ingenuity. And above all, it takes a willingness to try.” So shall the future of HTA in India be styled, engendering a healthcare model more effective, equitable, and sustainable by design.

References

1. Drummond, M. F., Sculpher, M. J., Claxton, K., Stoddart, G. L., & Torrance, G. W. (2015). Methods for the Economic Evaluation of Health Care Programmes. Oxford University Press.
2. Velasco-Garrido, M., Busse, R., Hisashige, A., & Perleth, M. (2008). Health Technology Assessment and Health Policy-Making in Europe: Current Status, Challenges, and Potential. World Health Organization.
3. Chalkidou, K., Marquez, P., Dhillon, P. K., Teerawattananon, Y., & Anothaisintawee, T. (2020). Health Technology Assessment in India: An Essential Tool for Universal Health Coverage? Value in Health Regional Issues, 21, 60-64.
4. Ministry of Health and Family Welfare, Government of India. (2017). Health Technology Assessment in India (HTAIn). Retrieved from https://hta.gov.in
5. Wilkinson, T., Sculpher, M. J., Claxton, K., Revill, P., Briggs, A., Cairns, J. A., … & Teerawattananon, Y. (2016). The International Decision Support Initiative Reference Case for Economic Evaluation: An Aid to Thought. Value in Health, 19(8), 921-928.
6. Neumann, P. J., Sanders, G. D., Russell, L. B., Siegel, J. E., & Ganiats, T. G. (2016). Cost-Effectiveness in Health and Medicine. Oxford University Press.
7. National Health Systems Resource Centre (NHSRC). (2020). HTA In India: Current Status and the Way Forward. NHSRC.
8. Walker, D. G., Hutubessy, R., & Beutels, P. (2010). WHO Guide for Standardization of Economic Evaluations of Immunization Programmes. Vaccine, 28(11), 2356-2363.
9. Mohara, A., Youngkong, S., Perez Velasco, R., Werayingyong, P., Pachanee, K., Praditsitthikorn, N., … & Tantivess, S. (2012). Using Health Technology Assessment for Universal Health Coverage and Reimbursement Systems in Thailand. Health Research Policy and Systems, 10(1), 1-10.