Latest developments and scope of Health Technology Assessment in India: Tapping into the future

Resources for the review

A literature search was undertaken in PubMed and Google Scholar to identify articles related to HTA in India. Additionally, a search was conducted for grey literature on government websites of the “Ministry of Health and Family Welfare”, “Health Technology Assessment in India” (HTAIn), “Department of Health Research” (DHR) and the “International Decision Support Initiative” (IDSi). The search was conducted in August 2019 and updated in March 2021. Reviews or reports describing the status and process of HTA in India were included.

Indian healthcare system and importance of HTA in India

India has a complex healthcare system that includes public and the dominant private sector. Information on the healthcare system and healthcare expenditure in India can be found in the extended data.¹³ With only 1.2% of “Gross Domestic Product” (GDP) spent on the public health infrastructure, the provision of UHC is an ambitious feat, especially at a time of rising burden of non-communicable diseases in India in addition to infectious diseases (including COVID-19) and malnourishment.¹⁴ Government health spending as GDP (%) in India is similar to Indonesia (1.1% of GDP)¹⁵ but, lower than other low- and middle-income countries such as Bhutan (2.5% of GDP)¹⁶ and contrastingly different than that of 7.3% of the GDP in the UK.¹⁷ Therefore, prioritising resources based on evidence becomes important for improving efficiency and to get the maximum value for money.¹⁸ To address problems of inequitable and unaffordable healthcare and to move towards more effective allocation of resources, the government of India has shifted its focus towards the concept of HTA. Discussions about HTA have been incorporated in the government policies, viz. the 12^th five-year plan and the National Health Policy.^2,19

In India, it was stated that HTA, via a viable HTA system, would help in the decision-making process for allocation and proper utilisation of resources. It will provide more transparency related to treatment options for different patients with the same disease.⁸ HTA provides evidence about the effectiveness and affordability of newer drugs and technologies by comparison of the risks and costs, therefore, providing information about the indications of use for a newly introduced health technology to medical practitioners.²⁰ The other applications for HTA in India include supporting development of a pricing strategy for newer drugs and technology for the entire nation or state; thereby helping in providing value-based pricing for the drugs and technology.^1,18 Additionally, it will support in preparation of clinical practice guidelines for maximum efficiency of interventions.¹⁸ HTA assists the government in priority decision-making, and during purchase of health services from the private health sector. It is beneficial for providing evidence related to equity and social justice, which are important areas to focus on while making decisions regarding priority-setting for allocation of resources.¹ The users and producers of HTA evidence in India are given in Figure 1.^1,21

Figure 1. Users and producers of HTA in India.

Administrative structure of HTAIn

For institutionalising HTA and to support transparent evidence informed decision-making process, the DHR, India, established HTAIn in January 2017, which was formerly known as the “Medical Technology Assessment Board” (DHR HTAIn). HTAIn conducts full HTAs (various methodologies) upon receiving requests from the different central and state departments. HTAIn aids these departments with scientific evidence for proper resource allocation and priority-setting.

HTAIn consists of three core bodies, the “HTAin Secretariat”, the “HTAIn Technical Appraisal Committee” or “HTAIn Technical Advisory Committee”, and the “HTAIn Board”. “Regional Resource Hubs” (RRH) and “Technical Partners” (TPs) are academic and research institutions, usually under the government (Central or State), which have capacity, expertise and experience in HTA. RRH and TPs are explained in detail under the section HTA networks in India.¹³ The user departments are the central and state health ministries, or any government healthcare provider or agency that are directly or indirectly involved in the health sector in India. The structure of the HTAIn is depicted in Figure 2.²¹ The detailed information about the HTAIn core bodies is given in the extended data.¹³

Figure 2. Health Technology Assessment structure in India.

Methods used for conducting HTAs in India

HTA must be rooted firmly in research and scientific method. It employs principles of benefit-harm assessment and economic evaluation to identify beneficial and safe health technologies and allows assessing their incremental cost-effectiveness ratios. The various steps of HTA that are followed by HTAIn are listed in Figure 3²¹; viz. the research proposal must be explicit, relevant and transparent. It must incorporate appropriate methods to assess benefits, harms and costs, safety and address the issues of generalisability and transferability. Table 1 lists the key data sources for HTA in India that are used for conducting HTA analysis.²² All key stakeholder groups should be included in the HTA process. Currently, an HTA undertaken by HTAIn, RRHs or TPs typically takes six months to one year or more for completion, followed by report publication and policy brief. More information on the steps is given in the extended data.¹³

Figure 3. Process of conducting an HTA study in India via HTAIn.

HTA analysis studies conducted by HTAIn

Since 2017, HTAIn has published six policy documents. Priority topics have been researched and the reports are available in the public domain (HTAIn Policy Documents).²³ Other examples of HTA conducted in India are: a) HTA conducted by the “National Health System Resource Centre” in 2017 successfully demonstrated a reduction in the average cost of drug eluting cardiac stents from INR 121,000 (Approx. USD 1,650) to INR 29,600 (Approx. USD 405).²³ b) To guide policy decisions for health innovations in India, HTA was conducted for one of the health innovations from India i.e. “FnCas9 Editor Linked Uniform Detection Assay” (FELUDA), to test its addition in the COVID testing policy. It was concluded that the FELUDA test was less costly and equally effective as an RT-PCR (“Reverse Transcriptase-Polymerase Chain Reaction”) test for COVID-19 diagnosis. Future HTAs, using field level effectiveness data were recommended for the FELUDA test, also, it was recommended that the scale up of this test would be more sustainable for the health system.²⁴

HTA capacity building in India

The government of India is committed to institutionalising HTA as a part of the priority-setting exercise in the “12^th five-year plan”, by the “National Institution for Transforming India (NITI) Aayog”. To achieve this, a “national program for capacity building in HTA” was initiated by the government.²⁵ This was a locally tailored capacity building approach supported by the iDSI, active from June 2015 to 2019. Important components of this capacity building program were 1) Developing a framework for capacity building; 2) Mapping and engaging relevant stakeholders; 3) Assessing need, assets and gaps for capacity building in HTA; 4) Developing a capacity development response; 5) Implementing the capacity development response which was done by environment capacity development i.e., recognition of the political economy of HTA, building HTA capacity building and resource networks in India, developing a central nodal point for HTA in the country (the HTAIn), and individual HTA capacity building training; 6) Evaluating capacity development via a Monitoring Evaluating and Learning Framework; and 7) Measuring the impact of the capacity development program.²⁵ Furthermore, workshops were held for discussing the need of HTA and sensitisation of clinician/stakeholders on evidence-based medicine.^7,8

There is an apparent gap in the HTA curriculum in India with few institutions offering HTA as a component in regular undergraduate or higher educational courses. These courses are pertaining to the fields of medical technology, biostatistics, and health economics.²⁶ HTA as an independent curriculum is not offered by any of the institutions across India; however, two medical institutions (“School of Public Health, Postgraduate Institute of Medical Education and Research”, Chandigarh and “Amrita Institute of Medical Science”, Kerala jointly with Ruskin University, UK) offer HTA certificate courses through a virtual platform.²⁶

Strengths and limitations

The strength of this review is that it collates latest developments of HTA in India including comprehensive information about HTAIn. The consolidated information provided, can be utilised by researchers and stakeholders working in HTA. However, this review has limitations. First, our literature search was restricted to selected databases, and to English language publications, which may lead to a substantial selection bias. Second, several important documents may not be published through journals or websites, leading to a potential publication bias. We tried to limit this risk by including grey literature in our review. We may have missed aspects that are important today or in the future. Fourth, the included studies had their own weaknesses limiting the information in our review. For example, the information within the reports and studies were heavily focused on the expert opinion and there is possibility that the experts might have been chosen through personal contacts.

Underlying data

No data are associated with this article.

Extended data

Figshare: Extended data for ‘Latest developments and scope of Health Technology Assessment in India: Tapping into the future’, https://doi.org/10.6084/m9.figshare.19203245.v1.¹³

This project contains the following extended data:

Data are available under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0)