Health technology assessment is the “multidisciplinary field of policy analysis, studying the medical, economic, social and ethical implications of development, diffusion, and use of health technology” (INAHTA, 2018). It aims to improve access to innovative treatments whilst rewarding producers of new technologies for their research and development efforts. Health technology assessments test the value of new healthcare technology by synthesizing all available evidence including the uncertainty, risks, and benefits of using a new technology.
Many high-income countries implement health technology assessments, and in recent years, middle-income countries joined the process albeit in a more rudimentary and stepwise fashion.
Health technology assessment evaluates new technologies on economic and therapeutic grounds. However, healthcare technology assessments also include broader societal and ethical implications of providing access to new health technologies.
This post reviews select topics and case studies on health technology assessment. We provide examples below of how some countries have built HTA agencies and processes. The post also presents a guide to health technology assessment online resources and key insights with a focus on middle-income countries.
New medicines introduced into the Australian market are all reviewed by the Pharmaceutical Benefits Advisory Committee (PBAC), and the government sometimes calls up for review some currently available products.
A health technology assessment is complete within an 18-week period.
A policy innovation in Australia is the authorization to conduct the HTA in parallel with regulatory approval processes. This means that the government reduces the time taken for new products to reach the market and improves earlier access to innovative technologies for patients.
PBAC does not do an HTA evaluation for medicines funded by state governments. These are medicines used in hospitals and funded by state governments.
In recent years, healthcare technology assessments in Brazil have improved through the establishment of CONITEC. It develops pharmacoeconomic guidelines and implementing decision criteria on cost-effectiveness (cost per QALY) and the budget impact of new technologies.
The Brazilian government manages the unified health system (SUS) which provides universal health coverage to all citizens. The SUS includes a medicine reimbursement schedule, and all new technologies that aim for inclusion on the schedule must undergo a health technology assessment coordinated by CONITEC.
In Brazil, HTA results determine new technology funding by the Brazilian public healthcare system. The Ministry of Health uses the HTA results to negotiate contracts and better pricing with manufacturers.
CONITEC has seen significant improvements over the years, however there are still concerns with the transparency of healthcare technology assessments and integrating CONITEC in the Ministry of Health.
These concerns include which new technologies to prioritize for HTA, methods applied for HTA, and CONITEC’s independence from political influence.
The National Institute for Health and Care Excellence (NICE) conducts HTA and its decisions influence the pricing and reimbursement of new technologies provided through the National Health Service (NHS).
Unlike in Brazil, NICE is an independent unit designated as a non-departmental government body (NDGB) but remains accountable to the Department of Health. This means that NICE maintains independence in its operations, execution of assessments and appraisals, and making recommendations to the Department of Health.
The Department of Health is less likely to influence the technical review of new technologies. They identify in the initial phase new technologies expected to have a significant impact on government health programs and resources. They refer such new technologies to NICE for further analysis based on the use of an incremental cost-effectiveness analysis including a threshold for the cost per quality-adjusted life-year.
The French National Authority for Health (HAS) evaluates all new technologies which are reimbursed by the Social Health Insurance Fund.
The results of the health technology assessments impact new technology pricing. They also influence how the government recommends such technologies for inclusion in benefit entitlements provided under the Social Health Insurance Fund.
Over the years, HAS improved the transparency of the evaluation process and criteria used in assessments. As a result, the public and manufacturers have worked with predictable assessment criteria which have improved the use and dissemination of HTA results.
Although there is a general consensus that HTA is needed and provides value, various barriers to HTA remain; different stakeholders have diverse inherent interests, which HTA may not support.
The following briefly explore some of the barriers to HTA:
Few agencies appear to track the cost of producing assessments suggesting very little oversight by either the Ministry of Health or the Departments responsible for the HTA agency.
The cost of producing assessments is an important indicator of the efficiency of the agency. HTA agencies should provide this level of information to facilitate process improvements and feedback.
Another critical component in the healthcare technology assessment process is the time taken for a thorough assessment. This will impact medicine availability in the market, as the HTA process is a significant determinant of market access.
In some markets, medicine availability is unhampered by HTA processes. They diffuse new technologies through supply chains and networks financed by private health insurance companies or out-of-pocket payments by patients.
However, experience in most HTA-driven markets suggests significant delays for innovative technologies in reaching patients. Policy-makers have overcome these challenges by running HTA processes in parallel with regulatory approval processes. The result is a significant improvement in the timelines for introducing new technologies in a market.
There is a broad consensus that on the grounds of welfare theory, the societal perspective should form the basis for HTA.
The HTA agencies should include a societal perspective and articulate with public decisions on resource allocation and efficiency in the healthcare sector. Excluding indirect costs under the third-party payer perspective will limit the usefulness of health technology assessments. It will also lead to pharmaceutical policies that do not maximize the efficiency and societal benefit of new health technologies.
“Adopting a societal perspective that captures all relevant costs and consequences of the technologies in question, regardless on whom these costs and consequences fall, is considered the most comprehensive approach that can be taken” (Health Information and Quality Authority, 2010).
Patients and non-professional or non-experts (including patient advocates, consumer representatives, family members, non-professional caregivers, citizens, and the public), who have developed expertise about their diseases, disorders conditions and care, are being more recognised in the field of HTA, as they provide perspectives, experiences and different interests, that are not readily available, but are integral to HTA. Patients’ participation may also contribute to openness, transparency, and accountability in HTA systems.
Patient involvement in HTA is still emerging in most countries, with significant variation on how patients are recruited and supported for their involvement, and also what role they have in helping shape HTA findings, or how potential conflicts of interest are addressed.
Patients may also be involved in helping to set research agendas and design clinical trials and other primary data collection (e.g., selecting health outcomes and other endpoints for study that are of particular relevance to patients).
When directly involved in HTA process, patients will share experiences, perspectives, and evidence that complement or even contradict evidence from such traditional clinical sources and may even improve the clinicians understanding and accuracy of patients’ needs and preferences. Patient insight also addresses the burden of a disease or condition on patients, family members, and caregivers, including dimensions of health, pain, quality of life, social and economic burdens.
However, challenges to patients engagement, highlighted in a recent survey of HTA organisations included:
Increased patient involvement and information sharing in HTA are leading to good practices for patient participation as members of boards, committees and working groups, communications with patient groups and the broader public. These emerging good practices focuses on areas as shown below.
Adoption of some of all of these good practices may be impractical for most HTA programs. However, those programs that seek to benefit from greater patient involvement, can adopt more of them as time and resources permit.
In addition, increased patient, and other target population involvement is gradually extending to the development of evidence-based clinical practice guidelines, including to incorporate information about PROs, values, and preferences.
Most evolved HTA systems have established a clear link between the results of an HTA and the eventual impact on the pricing and reimbursement of new technologies.
We also find that HTA results lead to changes in clinical guidelines and prescribing habits of providers under the NHS, for example. However, in most middle-income markets, this linkage is not apparent and requires improved transparency.
Although HTA remains an important tool in many developed healthcare markets, in middle-income countries the budget impact of new technologies remains one of the primary barriers to reimbursement.
Despite the development of pharmacoeconomic guidelines and recommendations on cost-effectiveness criteria for decision-making, affordability criteria still drives decision-making in many middle-income markets.
Available at: https://www.nlm.nih.gov/nichsr/hta101/ ta10103.html
The NICHSR Introduction to Health Technology Assessment document is derived from an evolving set of seminars and other presentations given by the author (Goodman, 2020) on health technology assessment since the mid-1980s. This document introduces fundamental aspects and issues revolving around HTA and draws work from many colleagues and authors who have contributed to the body of knowledge. As HTA is an evolving and dynamic field of inquiry, updates are made to this site. This is the 3rd version since the core material in 1998 was published.
ICER is a non-profit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations and moves that evidence into action to improve the health care system. This guide discussed the purpose of HTA and process. The guide discusses different stakeholders and inputs and expands on the information produced by an HTA.
Available at: https://www.eunethta.eu/
EUnetHTA was established to create an effective and sustainable network for HTA across Europe. It supports collaboration between HTA organizations through facilitation of efficient HTA resource use, creation of a sustainable HTA system of knowledge sharing and promotion of good practice in HTA methods and processes.
Available at: https://www.inahta.org/
INAHTA is a network of 50 HTA agencies that support health system decision making that affects over 1 billion people in 31 countries around the globe. INAHTA focus on general issues, methods, definitions or processes relevant to health technology assessment (HTA) and to HTA agencies.
Available at: http://www.adhophta.eu/
AdHopHTA was an EU funded research project that developed three products for improving the practice of hospital-based HTA. AdHopHTA performed a critical analysis of established hospital-based HTA initiatives and provided an empirically founded set of principles for best practice in hospital-based HTA, making three pragmatic knowledge and implementation tools available: Handbook, Toolkit and Database. The use of AdHopHTA’s products will promote cooperation and coordination between hospital-based HTA initiatives and facilitate their establishment in additional interested hospitals across Europe and the World.
Available at: https://htai.org/
HTAi is a global, non-profit, scientific and professional society for all those who produce, use or encounter health technology assessment (HTA). It is a member-driven organization, representing a variety of stakeholders who have interests in HTA. These stakeholders include researchers, policy makers, industry, academia, health service providers, agencies and patients, who contribute to balanced conversation around HTA across different areas of practice and jurisdictions.
The Australian Government Department of Health uses HTAs to inform the decisions about which health technologies can be sold in Australia, and which ones qualify for Australian Government subsidy. The TGA assesses the safety, quality and efficacy of new health technologies entering the Australian market. Three principal health technology advisory committees assess whether health technologies qualify for Australian Government subsidy: Medical Services Advisory Committee (MSAC), Pharmaceutical Benefits Advisory Committee (PBAC) and Prostheses List Advisory Committee (PLAC).
WHO’s use of HTA is broad and integrated into several programs. The HTA team conducts a global survey of HTA processes in WHO Member States and prepares guidance for its implementation in health systems. This work is conducted through both WHO’s global partnerships and programmes and through the WHO regional offices. The regional offices support the development of HTA capacity in their Member States though advocacy and raising awareness of the use of HTA in policy development, guidance for best practices and the coordination and collaboration between Member States and established partners.
The NHIR was established in 2006 to create a health research system transform research in and for the NHS and helped to shape the health and social care research landscape more broadly. The HTA Programme funds research about the clinical and cost-effectiveness, and broader impact of healthcare treatments and tests, for those who plan, provide or receive care from NHS, and social care services.
As shown above, many high-income countries have implemented health technology assessments agencies and processes. Middle-income countries joined the process with basic healthcare technology assessment systems.
This post reviewed select topics and case studies on health technology assessment, barriers to HTA, and four key insights:
We also provided various online resources on HTA and a shortlist of frequently used terms in HTA.
Our Healthcare Consulting services includes the analysis of Health Technology Assessment systems. We identify best practices in HTA to determine real-world improvements in high- and middle-income countries.
Banta D. (2009) What is technology assessment? Int J Technol Assess Health Care. Jul;25 Suppl 1:7-9. doi: 10.1017/S0266462309090333. Epub 2009 Jun 12. PMID: 19519979.
Carapinha, J. L. (2017). A comparative review of the pharmacoeconomic guidelines in South Africa. Journal of Medical Economics, 20(1), 37–44. Available at: https://doi.org/10.1080/13696998.2016.1223679
Chamova, J. (2017, May). Mapping of HTA national organisations, programmes and processes in EU and Norway. European Commission.
Connelly, P., & Wang, T. (2017, September). HTA Process Maps: Identifying similarities and differences for alignment. R&D Briefing 63. CIRS.
Drummond, M. F., Schwartz, J. S., Jönsson, B., Luce, B. R., Neumann, P. J., Siebert, U., & Sullivan, S. D. (2008). Key principles for the improved conduct of health technology assessments for resource allocation decisions. International Journal of Technology Assessment in Health Care, 24(3), 244–258; discussion 362-368. https://doi.org/10.1017/S0266462308080343
Goodman CS. (2020) HTA 101: Barriers to HTA. Bethesda, MD: National Library of Medicine (US). Available at: https://www.nlm.nih.gov/nichsr/hta101/ta101012.html
Hutton, J., McGrath, C., Frybourg, J.-M., Tremblay, M., Bramley-Harker, E., & Henshall, C. (2006). Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems). International Journal of Technology Assessment in Health Care, 22(1), 10–18.
ICER. (2018) Guide to Understanding Health Technology Assessment (HTA) [Internet]. Institute for Clinical and Economic Review. Available at: https://icer.org/wp-content/uploads/2020/10/ICER-Guide-to-Understanding-Health-Technology-Assessment-6.19.18.pdf
Le Polain, M., Franken, M., Koopmanschap, M., & Cleemput, I. (2010). Drug reimbursement systems: international comparison and policy recommendations. KCE reports 147C. Belgian Health Care Knowledge Centre.Pichler, F., Allen, N., Salek, S., & Liberti, L. (2010, November). Development of systematic process maps to enable comparison between different HTA and decision-making systems: the first step to benchmarking. Poster Presentation presented at the 13th European ISPOR Conference, Prague, Czech Republic.
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