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 agencies and processes, 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 key insights in health technology assessment 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 assessments 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 Clinical 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 is 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.
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, p. 19).
Patient organization involvement in the HTA process differs among countries.
Some countries do not include participation from patient organizations, such as France. Over the years, other countries integrated the patient perspective in the health technology assessment process, such as the United Kingdom and Canada.
They involve patient organizations in the decision-making process through formal representation on committees of the HTA agency. In the United Kingdom, the HTA agency includes patient organizations starting from the initial phases of prioritizing which new technologies to assess. They also involve patients in selecting appropriate inputs for studies.
In Brazil, CONITEC has a mechanism to integrate public opinion on prioritizing HTA and provide input to the assessment results.
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.
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. We looked at Australia, Brazil, the United Kingdom, and France. We also presented four key insights:
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.
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