Health technology assessment

Health technology assessment (HTA) is a multidisciplinary process that uses systematic and explicit methods to evaluate the properties and effects of a health technology. Health technology is conceived as any intervention at any point in its lifecycle .The purpose of HTA is to inform "decision-making in order to promote an equitable, efficient, and high-quality health system".  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." 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"

Purpose

Health technology assessment is intended to provide a bridge between the world of research and the world of decision-making. 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. 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.

History

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.

The discipline of HTA was first developed in the U.S. Office of Technology Assessment, which published its first report in 1976. The growth of HTA internationally can be seen in the expanding membership of the International Network of Agencies for Health Technology Assessment (IN A HTA), a non-profit umbrella organization established in 1993. Organizations and individuals involved in the production of HTA publications may also affiliated with international societies such as Health Technology Assessment International (HTAi) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Academic courses, typically in Masters Programs, are also offered in health technology assessment and management.

One of the main criticisms of the health care system in the United States is that it spends too much while achieving too little. Reports consistently indicate that the U.S. spends a greater percentage of its gross domestic product (GDP) on health care and has higher health expenditures per capita than any other industrialized country. However, these high levels of spending have not necessarily produced better health outcomes or improved access to care. Evidence indicates that the U.S. achieves health outcomes similar to those of other industrialized countries that spend far less on health care. Furthermore, for certain outcome indicators, such as the infant mortality rate, the U.S. performs particularly poorly.

One of the contributors to increases in health care expenditures in the U.S. is new technology in the form of new drugs and medical devices. These generally are more costly than previously approved technologies. However, under the current framework of regulation, it is difficult to evaluate whether these new technologies are actually superior to existing treatments. Inability to make these comparisons may lead to unjustified increases in health care expenditures in a technological climate where a “few products will be breakthroughs that improve health outcomes; [and] most will offer little, if any, advantages over existing treatments.”

In recent years, researchers, patient groups, government officials, professional associations, and other stakeholders in the healthcare system have focused on the concepts of health technology assessment (HTA) and comparative effectiveness research (CER) as means of decreasing health care expenditures in the United States. Health technology assessment has been defined as “a form of policy research that examines the short- and long-term consequences of the application of a health-care technology.” Comparative effectiveness research is an activity closely related to HTA, which the Institute of Medicine defined as:

The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist customers, clinicians, purchasers, and policy-makers to make informed decisions that will improve health care at both the individual and population levels.

Health technology assessment and CER have been portrayed as potential avenues by which to obtain information to make informed, evidence-based decisions with the aim of improving health outcomes and containing healthcare costs. The use of such information seems particularly beneficial given that currently, “less than half of medical care in the United States is based on or supported by evidence about its effectiveness, resulting in care that is inappropriate and unnecessary.” In recent years, many stakeholders in the health care system have called on the federal government to establish a sustainable national program of HTA or CER. These efforts culminated in the establishment of the Patient-Centered Outcomes Research Institute (PCORI) in 2010. Its purpose is to fund and oversee CER at the national level.

Although there has been an increased drive for federal support of HTA and CER in the past several years, HTA, in fact, has a long (though fragmented) history of federal funding in the U.S. dating back to the 1970s. Federal agencies that have played a major role in HTA in the past include the Office of Technology Assessment, the National Institutes of Health, and the Agency for Health Care Policy and Research. The Food and Drug Administration (FDA), in contrast, has traditionally played a more limited role in HTA and CER activities. Some commentators, noting that the FDA is the primary federal regulator of drugs and medical devices, have called on the agency to play a more active role in promoting HTA and CER.

This paper explores the history of HTA and CER in the U.S. with a particular emphasis on the role of federal agencies within the executive and legislative branches. Part II gives a brief history and overview of the concepts of HTA and CER. Part III examines the roles that various federal agencies and initiatives have played in generating HTA or CER and applying their results to health care decisions. To illustrate the historical development of HTA and CER, agencies are discussed chronologically, with reference to their involvement with HTA or CER activities. Part IV discusses past challenges that the federal HTA and CER funding faced, as well as the implications of such challenges for current federal CER efforts. Part V highlights potential HTA or CER strategies that the federal government could pursue in the future. Particular focus is given to the potential role of using HTA or CER in the regulation of therapeutic drugs and medical devices.

Impact of HTA implementation

A recent study 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:

·         Improved decision making: HTA aids in making better health financing decisions, including resource allocation and policy formulation.

·         Enhanced transparency and accountability: The most evident benefit of HTA is its role in improving the clarity and responsibility of healthcare decisions.

·         Economic impact: While HTA can generate cost savings in specific areas, its overall impact on the fiscal sustainability of healthcare systems in MICs remains unclear.

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.