HTA in Low Resource Settings

Conducting HTAs in Low and Middle-Income Countries (LMICs)

Challenges in conducting HTAs in resource-limited settings

Health technology assessment (HTA) involves systematically evaluating medical procedures and technologies and is a widely used tool for evidence-based policy advice and policymaking. The HTA landscape is evolving to meet changing health systems contexts and priorities, reflecting that how a given health technology achieves an outcome is frequently complex. While HTAs are routinely used in HICs to support policy-making and payer decisions, adoption in LMICs is more challenging1. Many LMICs conduct HTAs under a different name and often not by a dedicated organisation.

Implementation of HTAs in LMICs has been limited by:

  • Data: A significant benefit of HTAs is the ability to assess a technology within a local context. However, without extensive, granular local data to inform models, HTAs will not offer more accurate decisions than global studies, thus undermining the HTA process.
  • HTAs require expertise, time, and funding, all of which are constrained in many LMICs
  • There is less awareness of HTAs, the benefits and the processes involved in HTA analyses in LMICs by both governments and donors, limiting adoption

Therefore, it is unlikely that HTA processes commonly followed in HICs will transfer directly to LMICs.

The INTEGRATE-HTA project recommends five steps for a comprehensive, integrated assessment of complex technologies and interventions2:

  • Conducting a scoping exercise involving all stakeholders at the beginning of the project to promote stakeholder engagement and ownership
  • Build programme theory collaboratively by making explicit assumptions as to how a given intervention may produce health outcomes, through which mechanisms and what local contextual factors should be addressed
  • Examining a wide range of possible outcomes (not just safety and clinical and cost-effectiveness) that guide the collection of evidence
  • Structuring and, where possible, visualizing the assessment results and considering different scenarios for the intervention depending on the context, potential for implementation, and characteristics of beneficiaries;
  • Being explicit about how the various outcomes of the assessment might be integrated into an overall conclusion regarding the merits and demerits of the healthcare technology or intervention under investigation.

INAHTA (International Network of Agencies in Health Technology Assessment) and HTAi (Health Technology Assessment International) have stated the importance of collaboration and networking for sharing information resources, training, and expertise, which could help to promote HTAs in LMICs. Some studies have attempted to bridge the current gap by offering HTA transfer guidance or modified HTA approaches that could be better suited to LMIC implementation3. For example, the EUnetHTA Adaptation Toolkit contains guidance on transferring and adapting HTAs to local contexts. Although there are examples of HTAs being successfully implemented in LMICs to suit local contexts, there remains further work before HTAs become an institutionalised process commonly seen in HICs. Comparing frameworks from different contexts and building on case studies, a typology of practices covering consumer guidance to assessment approaches to entire reimbursement decision-making has been proposed4 and adapted for digital health applications.

Resources

MedDev Central Academy:

MedDev Central Knowledge Hub:

  1. WHO. Health technology assessment of medical devices. 2011.
  2. Bijlmakers L, Mueller D, Kahveci R, Chen Y, van der Wilt GJ. INTEGRATE-HTA: A LOW- AND MIDDLE-INCOME COUNTRY PERSPECTIVE. Int J Technol Assess Health Care. 2017;33(5):599-604.
  3. Heupink LF, Peacocke EF, Sæterdal I, Chola L, Frønsdal K. Considerations for transferability of health technology assessments: a scoping review of tools, methods, and practices. Int J Technol Assess Health Care. 2022;38(1):e78.
  4. Degelsegger-Márquez A, Panteli D. Towards reimbursement of mobile digital health applications? An international comparison of practices. European Journal of Public Health. 2020;30(Supplement_5):ckaa165. 1327.

Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.

Clinical Guideline: A systematically developed statement to assist healthcare practitioners and patients in making decisions about appropriate healthcare for specific clinical circumstances.

Economic Evaluation: The evaluation and analysis of the costs and consequences of using a medical device or intervention, often comparing different options to inform decision-making. This may also be called an Economic Assessment.

Health System: The organised network of institutions, resources, and people that deliver healthcare services to meet the health needs of a specific population.

Health Technology: The application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives (WHO definition).

Health Technology Assessment (HTA): A systematic evaluation of the properties, effects, and impacts of health technology, such as medical interventions, pharmaceuticals or medical devices, to inform healthcare decision-making.

High-Income Country (HIC): Countries defined based on their Gross National Income (GNI) per capita, where high-income countries have a GNI per capita above a specified threshold.

Low and Middle-Income Countries (LMICs): Countries defined based on their Gross National Income (GNI) per capita, where low-income countries have a GNI per capita below a specified threshold, and middle-income countries fall above that threshold but below the threshold for high-income countries.

Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.

Stakeholder: Any individual or group with an interest or influence in the delivery, outcomes, or policies of healthcare services.