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The rapid diffusion of (often high cost) health technologies challenges decision-makers worldwide. How can one best provide high-quality care according to health needs, while managing health care budgets and safeguarding access, choice and equity? Decision-makers at multiple levels in the health system need to ensure value-for-money and at the same time be accountable. Health technology assessment (HTA) could serve both purposes. This is particularly important in low and middle income countries (LMICs), as many of them are faced with undiscerning procurement processes, severe budget constraints, and demographic and epidemiological transitions. These are situations which severely impact on the burden of disease and consequently on increased health expenditure.[1-2] This creates a vicious cycle in which HTA could play a prominent role.
Health technology assessment: what is it?
A health technology is ‘an intervention developed to prevent, diagnose or treat medical conditions, promote health, provide rehabilitation, or organize healthcare delivery. The intervention can be a test, device, medicine, vaccine, procedure, program or system’.[3]
HTA is a multidisciplinary approach to assess the intended and unintended consequences of using health technology. Most often these include safety, clinical benefit, and economic, ethical, social, cultural and legal aspects.[4] The purpose is to inform health policy and decision-making about the best use of resources to improve health outcomes. HTA is – for example – used for:
- defining emergency kits, disaster planning, (basic) benefit packages, and essential medicines lists;
- medical device and equipment procurement planning;
- setting prices for health technologies;
- rolling-out broad public health programmes;
- formulating clinical guidelines;
- health technology acquisition or adoption, including procurement at the hospital level – i.e. hospital-based (HB-) HTA.[5]
Incorporation of HTA into health systems around the world
HTA had its inception in the United States, where around 1975 the Office for Technology Assessment started collecting available evidence regarding efficacy and cost-effectiveness of health technologies. From 1985 onwards, the focus was on seeking more effective links with policy-makers, particularly in Europe. In the Netherlands, for example, HTA was introduced to address concerns of the Ministry of Health (MoH) about the rapid development of new health technologies, such as heart and lung transplantation and their impact, especially in terms of cost.[6]
Since then, many governments in high-income countries have established formal HTA units or agencies associated with the MoH or its equivalent. For example, in France, the government established the National Health Authority (HAS) which is tasked with improving the quality of care and ensuring equity in the health system. HAS provides recommendations to the National Union of Health Insurance Funds (UNCAM), mainly based on evidence about the therapeutic benefits of health technologies for specific target populations. The UNCAM makes the final recommendation to the MoH for inclusion in the social health insurance benefit package. In the Netherlands, the National Health Care Institute (‘Zorginstituut‘) provides recommendations to the MoH with regard to the inclusion (or exclusion) of various health technologies in the standard benefit package, using severity of disease, effectiveness, cost-effectiveness and feasibility as criteria.
From 2000 onwards, some middle-income countries established formal national HTA agencies, including Brazil, Colombia, Malaysia, Mexico, and Thailand.[7-9] Hospital-based HTA is being implemented in several high-income countries, including Australia, Canada, Denmark, Finland, Italy, Spain, Sweden, the Netherlands, and the USA. Economic development is often associated with increased health care spending and improved access to health technology, which has led to a strong impetus for HTA.[10] It should be noted that in countries without formal agencies, HTA may be labelled as cost-effectiveness analyses or priority setting. The use of cost-effectiveness as the only criterion for allocating scarce resources could lead to flawed decisions as it does not explicitly incorporate considerations of equity.[11]
Political commitment has proven to be of utmost importance for the development of HTA. After a decade of financing several research projects, a formal statement by the European Commission led to the establishment of a network on HTA in Europe (EUnetHTA) in 2004. This network has developed methodological guidance for how to conduct HTA and methods for sharing HTA work and reports between countries.[12] The World Health Organization (WHO) has also emphasized the importance of HTA in several resolutions. In 2014, a resolution on using HTA in support of universal health coverage was approved during the 67th World Health Assembly.[13] This and other resolutions targeting specific regions included a call for strengthening national, sub-regional and regional HTA networks to promote exchange among institutions and countries. In the Americas, countries were encouraged to actively participate in the Health Technology Assessment Network of the Americas (RedETSA).[14] RedETSA was established in 2011, with the (financial) support of the Pan-American Health Organization (PAHO). РАНО explicitly recommends using HTA for the procurement of medical devices and equipment.[1] In the Asia-Pacific Region, three HTA agencies started a collaboration that led to a regional HTA network (HTAsiaLink) in 2011. However, unlike RedETSA, HTAsiaLink does not have a continuous stream of funding, and this poses challenges for its sustainability and the use of HTA in this region.[15]
HTA as a policy tool for low- and middle-income countries
The intent of HTA is to inform health policy and decision-making. This means that HTA is context dependent and as such should reflect what is considered important to society, taking into account the complexity and dynamics of health systems. In countries that formally use HTA, it has shown decision-makers how to best use resources to improve health outcomes. Best practice examples include the establishment of essential medicines lists, the definition of health insurance benefit packages, and the acquisition of health technologies in hospitals (see textbox).
LMICs often do not have a clear framework for integrating HTA results in decision-making processes. In countries that have no established formal HTA mechanisms, decision making is often ad hoc and driven by individual or collective perceptions rather than by evidence. In addition, the majority of LMICs often lack the research infrastructure, capacity and financial resources for conducting HTA, both at the national and local level. To assure appropriate use of HTA in health care decision-making, strong support from policy makers is needed.[10]
Examples of the added value of HTA in LMICS
In Thailand, a semi-autonomous HTA agency (HITAP) was established as part of the MoH in 2007. HTA has informed both the development of the national essential medicines list and the benefit package. Coverage decisions were mainly based on incremental cost-effectiveness, although in some cases additional criteria were used (e.g. for imiglucerase for Gaucher disease type 1 and peritoneal dialysis as initial treatment for patients with end-stage renal disease).[16]
In 2001, HTA was introduced in a public hospital in Buenos Aires (Argentina), targeting a national paediatric facility with its own budget. It aimed to inform hospital administrators and clinicians about the safety, effectiveness and organizational impact of acquiring new health technologies. Since its introduction, HB-HTA has been shown to be a valuable tool for the development of clinical practice guidelines and for optimizing use of the facility’s budget.[17]
How to move forward?
As HTA has shown its potential for informing health policy and decision-making around the globe, it is important to support countries that wish to develop and use HTA. Therefore, the role of international networks, such as HTAi and INAHTA, and regional networks, such as HTAsiaLink and RedETSA, in building capacity – in close collaboration with WHO, PAHO and other partner organizations – continues to be of utmost importance.
References
- Diaconu K, Chen YF, Cummins C et al. Methods for medical device and equipment procurement and prioritization within low- and middle-income countries: findings of a systematic literature review. Global Health 2017;13(1):59.
- Bijlmakers L, Mueller D, Kahveci R et al. INTEGRATE-HTA: a low- and middle-income country perspective. Int J Technol Assess Health Care 2017;33(5):599-604.
- HTA glossary. Available from: http://htaglossary.net/health+technology (Accessed 21 March 2019)
- Oortwijn W, Sampietro-Colom L, Habens F. Developments in value frameworks to inform the allocation of healthcare resources. Int J Technol Assess Health Care 2017;33(2), 323-329.
- World Health Organization. Why use HTA? Website. Available from: https://www.who.int/health-technology-assessment/about/WHY/en (Accessed 21 March 2019)
- Banta D. The development of health technology assessment. Health Policy 2013;63(2):121-132.
- Kahveci R, Oortwijn W, Godman B et al. Role of health technology assessment in pharmaceutical market access in developed countries. In: Koçkaya G, Wertheimer A (Eds). Pharmaceutical market access in developed countries. SEEd, 22 January 2018. https://doi.org/10.7175/747
- Attieh R, Gagnon M. Implementation of local/ hospital-based health technology assessment initiatives in low- and middle-income countries. Int J Technol Assess Health Care 2012;28(4):445-451.
- Mueller D, Tivey D, Croce D. Health technology assessment: Its role in strengthening health systems in developing countries. Strengthen Health Syst 2017;2(1):6-11.
- Oortwijn W, Mathijssen J, Banta D. The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries. Health Policy 2010;95(2-3):174-184.
- Bertram MY, Lauer JA, De Joncheere K et al. Cost-effectiveness thresholds: pros and cons. Bulletin World Health Organ 2016; 94(12):925-30. DOI: 10.2471/BLT.15.164418.
- Available via www.eunethta.eu
- World Health Organization. Resolutions on health technology assessment. Website. Available from: https://www.who.int/medical_devices/assessment/en/ (Accessed 21 March 2019)
- http://redetsa.org/wp/?page_id=209
- Teerawattananon Y, Luz K, Yothasmutra C et al. Historical development of the HTAsiaLink network network and its key determinants of success. Int J Technol Assess Health Care 2018;34(3):260-266.
- Tanvejsilp P, Taychakhoonavudh S, Chaikledkaew U et al. Revisit roles of HTA on drug policy in universal health coverage in Thailand: Where are we? And what is Next? Value in Health Regional Issues 2019;18:78-82.
- Demirdjian G. A 10-year hospital-based health technology assessment program in a public hospital in Argentina. Int J Technol Assess Health Care 2015;31(1-2):103-110.