A Guide to Health Technology Assessment

Leadership for Change

Leadership for Change

Introduction

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.

Figure 1: Health Technology Assessments

Select Topics and Case Studies on Health Technology Assessment

Australia

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.

Brazil

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.

United Kingdom

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.

France

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.

Barriers to Health Technology Assessment

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:

  • Technological imperative: In some first world countries, there is a “technological imperative”; the drive to use newer technologies with the expectation that newer is better, even if marginally or even poorly substantiated. Others may argue that the increased potential of technology, only reinforces the necessity to conduct HTA.
  • Limited resources for HTA: Even though some HTA programs and findings are nationally or inter-nationally recognized, many times, even in the wealthy nations, resources for HTA are extraordinarily small compared with national health care spending.
  • Insufficient primary data: Lack of primary studies and other data sources for a particular nation, region, population subgroup or health care facility where a technology may be applicable, limits the evidence base for HTA.
  • Timing misalignment: When the timing of HTA is misaligned with decision-making needs and other events, delays occur. This may include; requesting or allocating funding for an HTA, ongoing adoption and use of technologies while HTA is being conducted, or delays between release of HTA findings and their adoption in policy and practice. In addition, the “moving target problem” in which the relevance of HTA findings is diminished by changes in technologies, their comparators, or how they are used, arises.
  • Prestigious proponents of technology: Opinions from highly regarded “clinical champions” may prevail, even in the absence of credible supporting evidence.
  • Marketing: Influencer marketing of new technologies, often sponsored by healthcare companies to train physicians in using these products, and direct-to-consumer advertising (where this is permitted) can weigh against HTA findings.
  • Financial incentives: The “fee-for-service” payment model has the potential to increase the volume of technology used, even when supporting evidence, related policies and clinical practice guidelines is lacking. Hospitals and physician groups that have invested in major capital equipment and supporting infrastructure such as for diagnostic radiology, radiation oncology, and robotic surgery, have incentives to use these technologies. In addition, patients with little or no exposure to costs tend to seek more health care.
  • Political actions: Lobbying, or pressure groups have the potential to thwart HTA. For example, when laws that mandate (or eliminate) coverage by government or private sector payers for certain technologies are made, in contrast to findings based on available evidence, or in the absence of rigorous evidence.
  • Implementation barriers: There are several barriers to implementing some HTA findings and recommendations. These may include the following:
    • Lack of access to HTA reports, complex and technical formats of HTA reports, questionable data quality, absence of real-world applications, and narrow focus;
    • Difficulty in implementing HTA findings and recommendations due to a reluctance to change long-standing practice routines, inertia of existing payment policies, and rapidly outdated education and training in some instances. A diffidence for scientific inquiry and scepticism in clinical education contributes to this inertia.
    • Implementation of HTA findings also may be limited due to practical external constraints, for example, when the adoption of a new technology requires a particular environment (e.g., special shielded rooms, instrumentation, and related facilities for diagnostic and therapeutic procedures using ionizing radiation), professional training, or other resources that are unavailable in a particular facility.
    • Political forces can circumvent evidence-based processes. In some instances, legislative mandates arise through frustration with slowed or delayed HTA processes. While many payers use HTA findings to inform coverage policies, they are also subject to laws in their respective countries, states, provinces, and other jurisdictions.

Key Insights in Health Technology Assessment

The Cost and Duration of a Health Technology Assessment

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.

Figure 2: Health Technology Assessments

Societal Perspective in Health Technology Assessment

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).

Patient Involvement in Health Technology Assessments

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:

  • Lack of organizational capacity to involve patients;
  • Extensive time requirements;
  • Lack of agreed-upon methods for involving patients in HTA;
  • Lack of clarity about when in the HTA process to involve patients;
  • Lack of funding; and,
  • Concerns regarding the scientific credibility of patient evidence.

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.

Emerging Good Practices for Patient Involvement in HTA

  • Ensure that all HTA processes are appropriately accessible, transparent, fairly applied, documented, and accountable.
  • Gain commitment of HTA organization to patient involvement.
  • Establish, review, and update policies for patient involvement in HTA.
  • Establish a dedicated unit or staff function for patient involvement, with explicit channels of communication and personal points of contact in the HTA organization.
  • Plan and provide for adequate budgets and other resources for patient involvement.
  • Conduct broadly accessible, transparent, and equitable (including relative to other types of participants) recruitment of patients to HTA boards, committees, and working groups.
  • Provide training and education for patient involvement in HTA, including appropriate materials, handbooks, reviewer/evaluation forms, etc.
  • Provide training for HTA staff and other participants on working with patients and groups that represent them.
  • Ensure appropriately equitable rights (e.g., in voting) and responsibilities for patient members of HTA boards, committees, and working groups.
  • Provide adequate notice of meetings, due dates for input, and related scheduling information to patient participants to enable their sufficient preparation and timely participation.
  • Inform the variety of patient groups and other potentially interested groups about planned and ongoing HTA reports and ways to provide input to these reports.
  • Communicate in plain, patient-appropriate language, including in background materials and other documentation to ensure that patients are adequately informed for participation in HTA.
  • Provide patient participants with adequate financial support, including fees commensurate with those for other participants and reimbursement for travel and other out-of-pocket expenses (e.g., for child and other dependent care).
  • Ensure that the context for patient involvement is welcoming and is not intimidating or coercive.
  • Make reasonable accommodations to ensure accessibility to HTA processes for patients and other participants who may have activity limitations (or are otherwise differently-abled).
  • Provide HTA reports (and/or summaries of these) and other outputs in plain, patient-appropriate language and format, including for users with sensory (e.g., visual or hearing) limitations.
  • Provide for active, targeted dissemination of HTA reports and related products to patient groups.
  • Provide links from HTA organization web sites to those of relevant patient groups.
  • Organize special/targeted events, communications, or other activities for engaging individual patients and patient groups.
  • Seek to involve patient groups that are traditionally difficult to reach (e.g., ethnic minorities, underserved populations, stigmatized populations).
  • Document/report patient involvement in HTA, including, e.g., levels of participation, impact on HTA deliberations, findings, and recommendations
  • Provide recognition and feedback to patients regarding their participation.

Sources: European Patients’ Forum (undated); Health Equality Europe 2008; HTAi Patient and Citizen Involvement Interest Sub-Group PIE Good Practice Principles 2012, Good Practice Examples 2013.

A link between Health Technology Assessments and Reimbursement

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.

Health Technology Assessment Online Resources

NICHSR: Introduction to Health Technology Assessment

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: Guide to Understanding Health Technology Assessment (HTA)

Available at: https://icer.org/wp-content/uploads/2020/10/ICER-Guide-to-Understanding-Health-Technology-Assessment-6.19.18.pdf

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.

EUnetHTA

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.

The International Network of Agencies for Health Technology Assessment

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.

AdHopHTA: an European Project on Hospital Based Health Technology Assessment

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.

Health Technology Assessment international (HTAi)

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.

Gov.au: Health Technology Assessments

Available at: https://www.health.gov.au/health-topics/health-technologies-and-digital-health/health-technology-assessments

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 Health Technology Assessment

Available at: https://www.who.int/health-topics/health-technology-assessment#tab=tab_1

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.

NHIR Health Technology Assessment

Available at: https://www.nihr.ac.uk/explore-nihr/funding-programmes/health-technology-assessment.htm

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.

Terminology

  • Budget impact – an estimate of the projected cumulative resource expenditure for a particular intervention in a specific population over a period of time.
  • Clinical effectiveness – The degree of health benefit produced by an intervention.
  • Comparator – an alternative health technology against which an intervention is evaluated.
  • Cost-effectiveness analysis – a type of economic evaluation in which an outcome is measured in incremental costs per incremental health unit, such as life years gained, QALYs, or clinical events avoided.
  • Health technology assessment (HTA) – the systematic evaluation of evidence related to any healthcare intervention that can be used to improve health and prevent and treat disease; HTAs inform policy- and decision-making surrounding the use of such interventions.
  • Horizon scanning – The systematic identification of health technologies that are new, emerging or becoming obsolete and that have the potential to effect health, health services and/or society.
  • Incremental cost-effectiveness ratio (ICER) – The ratio of the difference in costs between two possible interventions, divided by the differences in their effectiveness.
  • Net health benefit – the balance between clinical benefits and risks and/or adverse effects.
  • Quality-adjusted life-year (QALY) – A measure of health benefit that accounts for changes in both quantity (e.g., mortality) and quality of life.

Conclusion

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:

    • The cost and duration of HTA
    • Societal perspective in HTA
    • Patient involvement in HTA
    • A link between HTA and Reimbursement.

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.

Bibliography

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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.