Health technology assessment (HTA) is a multidisciplinary process that uses systematic and explicit methods to evaluate the properties and effects of a health technology. [1] Health technology is conceived as any intervention (test, device, medicine, vaccine, procedure, program) at any point in its lifecycle (pre-market, regulatory approval, post-market, disinvestment). [2] The purpose of HTA is to inform "decision-making in order to promote an equitable, efficient, and high-quality health system". [3] It has other definitions including "a method of evidence synthesis that considers evidence regarding clinical effectiveness, safety, cost-effectiveness and, when broadly applied, includes social, ethical, and legal aspects of the use of health technologies. The precise balance of these inputs depends on the purpose of each individual HTA. A major use of HTAs is in informing reimbursement and coverage decisions by insurers and national health systems, in which case HTAs should include benefit-harm assessment and economic evaluation." [4] And "a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method". [5]
Health technology assessment is intended to provide a bridge between the world of research and the world of decision-making. [6] HTA is an active field internationally and has seen continued growth fostered by the need to support management, clinical, and policy decisions. It has also been advanced by the evolution of evaluative methods in the social and applied sciences, including clinical epidemiology and health economics. Health policy decisions are becoming increasingly important as the opportunity costs from making wrong decisions continue to grow. [7] HTA is now also used in assessment of innovative medical technologies like telemedicine e.g. by use of the Model for assessment of telemedicine (MAST).
Health technology can be defined broadly as:
Any intervention that may be used to promote health, to prevent, diagnose or treat disease or for rehabilitation or long-term care. This includes the pharmaceuticals, devices, procedures and organizational systems used in health care. [8]
The discipline of HTA was first developed in the U.S. Office of Technology Assessment, which published its first report in 1976. [9] The growth of HTA internationally can be seen in the expanding membership of the International Network of Agencies for Health Technology Assessment (INAHTA), a non-profit umbrella organization established in 1993.[ citation needed ] Organizations and individuals involved in the production of HTA publications may also affiliated with international societies such as Health Technology Assessment International (HTAi) [10] and International Society for Pharmacoeconomics and Outcomes Research (ISPOR). [11] Academic courses, typically in Masters programs, are also offered in health technology assessment and management. [12] [13]
The United Kingdom's National Institute for Health and Care Research (NIHR) runs several research programmes that may be viewed as falling into the realm of Health Technology Assessment. Of particular note is the NIHR Health Technology Assessment programme, its longest running, which undertakes both conventional HTA in the form of Evidence Synthesis and modelling, and evidence generation with a large portfolio of pragmatic RCTs and cohort studies. [14] The programme's research is regularly published in NIHR's journal Health Technology Assessment. [15]
Also in the UK, the Multidisciplinary Assessment of Technology Centre for Healthcare carries out HTA in collaboration with the health service, the NHS and various industrial partners. MATCH is organised into four themes addressing key HTA topics including Health Economics, Tools for Industry, User Needs and Procurement and Supply chain.
Canada also has a health technology assessment body called the Canadian Agency for Drugs and Technologies in Health (CADTH). [16]
As of today, 11 Italian regions have issued specific regional laws or regulations to manage HTA activities and processes at regional level: Abruzzo, Basilicata, Emilia-Romagna, Lazio, Liguria, Lombardia, Piemonte, Puglia, Sicilia, Toscana, and Veneto. In another four regions (Calabria, Marche, Umbria, and Valle D'Aosta) and in the two autonomous provinces of Bolzano and Trento, HTA is performed at different levels, even if no legislation has yet been produced. [17]
The World Health Organization provides an overview of countries and their corresponding HTA agencies. [18]
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A recent study [19] explored the implementation of HTA in three middle-income countries (MICs) and its influence on health system objectives. The study investigated the impact of HTA globally through a systematic literature review. The study also surveyed stakeholders from the middle-income countries.
The results indicated that the benefits of HTA implementation in these countries largely outweigh the drawbacks. The major advantages identified include enhanced transparency and accountability in healthcare decisions, leading to more informed and equitable healthcare policies.
The study has shown that HTA has a positive impact on several aspects of healthcare systems:
It was also noted that HTA's influence extends to the broader health system goals, such as health gain, equity in health, and responsiveness to patient needs. However, the impact on direct health gains and financial protection of households is less pronounced.
The study emphasizes the gradual adoption of HTA in MICs and the necessity for continuous assessment of its impact.
Cost–utility analysis (CUA) is a form of economic analysis used to guide procurement decisions. The most common and well-known application of this analysis is in pharmacoeconomics, especially health technology assessment (HTA).
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.
The Centre for Reviews and Dissemination (CRD) is a health services research centre based at the University of York, England. CRD was established in January 1994, and aims to provide research-based information for evidence-based medicine. CRD carries out systematic reviews and meta-analyses of healthcare interventions, and disseminates the results of research to decision-makers in the NHS.
Canada's Drug Agency is a pan-Canadian health organization responsible for coordinating and aligning drug policy across provinces and territories. The CDA provides Canada's various healthcare organizations with evidence-based advice, allowing them to make informed choices about drug, health technology, and health system policies, in collaboration with international partners. Its role differs from that of Health Canada in that it can provide data on the comparative effectiveness of drugs and make recommendations that factor in metrics beyond safety and quality, including cost effectiveness.
Health Technology Assessment is a weekly peer-reviewed open access medical journal published by the National Institute for Health and Care Research (NIHR), a research partner of the United Kingdom National Health Service. It publishes research on the evaluations of health technologies, their effectiveness, cost and broader impact. The journal was established in 1997 and the editor-in-chief is John Powell (NIHR). According to the Journal Citation Reports, the journal has a 2015 impact factor of 4.058. The journal, along with four others, is part of the NIHR Journals Library.
Omani nationals have free access to the country's public healthcare, though expatriates typically seek medical care in private sector clinics and hospitals. Generally, the standard of care in the public sector is high for a middle-income country. Oman now has very low rate of once common communicable diseases such as measles and typhoid. Due to rapidly increasing incomes and changing lifestyles and diet, the levels of non-communicable diseases such as cardiovascular disease and diabetes are an increasing problem.
Patient participation is a trend that arose in answer to medical paternalism. Informed consent is a process where patients make decisions informed by the advice of medical professionals.
Medical technology assessment (MTA) is the objective evaluation of a medical technology regarding its safety and performance, its (future) impact on clinical and non-clinical patient outcomes as well as its interactive effects on economical, organizational, social, juridical and ethical aspects of healthcare. Medical technologies are assessed both in absolute terms and in comparison to other (combinations of) medical technologies, procedures, treatments or ‘doing-nothing’.
The National Institute for Health and Care Research (NIHR) is the British government's major funder of clinical, public health, social care and translational research. With a budget of over £1.2 billion in 2020–21, its mission is to "improve the health and wealth of the nation through research". The NIHR was established in 2006 under the government's Best Research for Best Health strategy, and is funded by the Department of Health and Social Care. As a research funder and research partner of the NHS, public health and social care, the NIHR complements the work of the Medical Research Council. NIHR focuses on translational research, clinical research and applied health and social care research.
European Network for Health Technology Assessment (EUnetHTA) is a network, established to create an effective and sustainable structure for health technology assessment (HTA) across Europe that could develop and implement practical tools to provide reliable, timely, transparent and transferable information to contribute to HTAs in Member States.
The Institute for Quality and Efficiency in Healthcare (IQWiG) is a German agency responsible for assessing the quality and efficiency of medical treatments, including drugs, non-drug interventions, diagnostic and screening methods, and treatment and disease management. IQWiG also supplies health information to patients and the general public.
The Egyptian healthcare system is pluralistic, comprising a variety of healthcare providers from the public as well as the private sector. The government ensures basic universal health coverage, although private services are also available for those with the ability to pay. Due to social and economic pressures, Egypt's healthcare system is subject to many challenges. However, several recent efforts have been directed towards enhancing the system.
Model for assessment of telemedicine (MAST) is a framework for assessment of the value of telemedicine.
The Health Intervention and Technology Assessment Program (HITAP) is a semi-autonomous research unit under Thailand’s Ministry of Public Health. It was established in 2007 as a non-profit organization in order to take responsibility for appraising a wide range of health technologies and programs, including pharmaceuticals, medical devices, interventions, individual and community health promotion, and disease prevention as well as social health policy to inform policy decisions in Thailand. HITAP assumes an advisory role to health governmental authorities by providing rigorous scientific evidence through professional assessment of health data in support of public decision-making. These assessments cover a range of topics including system design, selection of technologies for assessment, and the actual assessment of those selected and agreed upon by relevant government agencies. In this effort, HITAP publishes research and studies in the following areas: methodological development, databases and guidelines; knowledge transfer and exchange (KTE) and capacity development; technology assessments on drugs, medical devices, medical procedures, disease prevention and health promotion measures; benefit packages of care – mixing screening and treatments; and other public health policies, e.g. evaluation of Thailand’s government compulsory license policy.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
The Swedish Agency for Health Technology Assessment and Assessment of Social Services previously the Swedish Council on Health Technology Assessment is an independent Swedish governmental agency tasked with assessing and evaluating methods in use in healthcare and social services. SBU is tasked with summarizing and communicating evidence and is a knowledge center for both healthcare and social services in Sweden. The agency performs review by systematically searching the literature, evaluating, assuring quality, and weighing together results. SBU does not carry out any original research beyond meta-analysis, systematic review or health technology assessment (HTA). It is one of the world's oldest HTA agencies that started conducting systematic reviews in 1987.
ISPOR—The Professional Society for Health Economics and Outcomes Research, also known as ISPOR is a global, nonprofit 501(c)(3) public organization for educational and scientific purposes, as defined by the United States Internal Revenue Service.
Kalipso Chalkidou is the Head of Health Finance at The Global Fund to Fight AIDS, Tuberculosis and Malaria and a visiting professor at Imperial College London. Previously she was Director of Global Health Policy at the Center for Global Development and Professor of Practice in Global Health at Imperial College London. Her research considers how local expertise can inform the allocation of scientific and healthcare resources.
Horizon scanning (HS) or horizon scan is a method from futures studies, sometimes regarded as a part of foresight. It is the early detection and assessment of emerging technologies or threats for mainly policy makers in a domain of choice. Such domains include agriculture, environmental studies, health care, biosecurity, and food safety.
The Institute of Global Health Innovation is one of Imperial College London’s global challenge Institutes. Established in 2010, its mission is to improve global health and care through evidence-based innovation. The Institute’s work aims to support the identification, development and implementation of healthcare innovation, with the goal of sustainably reducing inequalities in global health.