B. Health Technology Assessment

Health technology assessment (HTA) is the systematic evaluation of properties, effects or other impacts of health technology. The main purpose of HTA is to inform policymaking for technology in health care, where policymaking is used in the broad sense to include decisions made at, e.g., the individual or patient level, the level of the health care provider or institution, or at the regional, national and international levels. HTA may address the direct and intended consequences of technologies as well as their indirect and unintended consequences. HTA is conducted by interdisciplinary groups using explicit analytical frameworks, drawing from a variety of methods.

1. Purposes of HTA

HTA can be used in many ways to advise or inform technology-related policies and decisions. Among these are to advise or inform:

• Regulatory agencies about whether to permit the commercial use (e.g., marketing) of a drug, device or other regulated technology
• Payers (health care authorities, health plans, drug formularies, employers, etc.) about technology coverage (whether or not to pay), coding (assigning proper codes to enable reimbursement), and reimbursement (how much to pay)
• Clinicians and patients about the appropriate use of health care interventions for a particular patient’s clinical needs and circumstances
• Health professional associations about the role of a technology in clinical protocols or practice guidelines
• Hospitals, health care networks, group purchasing organizations, and other health care organizations about decisions regarding technology acquisition and management
• Standards-setting organizations for health technology and health care delivery regarding the manufacture, performance, appropriate use, and other aspects of health care technologies
• Government health department officials about undertaking public health programs (e.g., immunization, screening, and environmental protection programs)
• Lawmakers and other political leaders about policies concerning technological innovation, research and development, regulation, payment and delivery of health care
• Health care technology companies about product development and marketing decisions
• Investors and companies concerning venture capital funding, acquisitions and divestitures, and other transactions concerning health care product and service companies
• Research agencies about evidence gaps and unmet health needs

Many of the types of organizations noted above, including government and commercial payers, hospital networks, health professional organizations, and others, have their own HTA units or functions. Many HTA agencies are affiliated with national or regional governments or consortia of multiple organizations. Further, there are independent not-for-profit and for-profit HTA organizations.

HTA contributes in many ways to the knowledge base for improving the quality of health care, especially to support development and updating of a wide spectrum of standards, guidelines, and other health care policies. For example, in the US, the Joint Commission (formerly JCAHO) and the National Committee for Quality Assurance (NCQA) set standards for measuring quality of care and services of hospitals, managed care organizations, long-term care facilities, hospices, ambulatory care centers, and other health care institutions. The National Quality Forum (NQF) endorses national evidence-based consensus standards for measuring and reporting across a broad range of health care interventions.

Health professional associations (e.g., American College of Cardiology, American College of Physicians, American College of Radiology) and special panels (e.g., the US Preventive Services Task Force, the joint Department of Veterans Affairs/Department of Defense Clinical Practice Guidelines program) develop clinical practice guidelines, standards, and other statements regarding the appropriate use of technologies (see, e.g., Institute of Medicine 2011). The Guidelines International Network (G-I-N) of organizations and individual members from more than 40 countries supports evidence-based guideline development, adaptation, dissemination, and implementation toward reducing inappropriate practice variation throughout the world. The National Guideline Clearinghouse (NGC, sponsored by the US Agency for Healthcare Research and Quality), is a searchable database of evidence-based clinical practice guidelines. Among the criteria for a new guideline to be included in NGC effective June 2014 is that it be based on a carefully documented systematic review of the evidence, including a detailed search strategy and description of study selection.

Standards-setting organizations such as the American National Standards Institute (ANSI) and the American Society for Testing and Materials coordinate development of voluntary national consensus standards for the manufacture, use, and reuse of health devices and their materials and components. For example, ANSI has developed standards and specifications for electronic information sharing and interoperability in such areas as laboratory results reporting, medication management, personalized health care, immunizations, and neonatal screening (Kuperman 2010).

As noted above, HTA can be used to support decision making by clinicians and patients. The term evidence-based medicine refers to the use of current best evidence from scientific and medical research, and the application of clinical experience and observation, in making decisions about the care of individual patients (Glasziou 2011; Straus 2011). This prompted the appearance of many useful resources, including:

• Evidence-Based Medicine (Sackett 1997), a guide to the field, recently updated (Straus 2011)
• Evidence-Based Medicine (a joint product of the American College of Physicians and the BMJ Publishing Group), a journal digest of articles selected from international medical journals
• “Users’ guides to the medical literature,” a series of more than 30 articles by the Evidence-Based Medicine Working Group, originally published in the Journal of the American Medical Association, starting in the 1990s and more recently assembled and updated (Guyatt 2008)
• Centre for Evidence-Based Medicine

2. Basic HTA Orientations

The impetus for an HTA is not necessarily a particular technology. Three basic orientations to HTA are as follows.

• Technology-oriented assessments are intended to determine the characteristics or impacts of particular technologies. For example, a government agency may want to determine the clinical, economic, social, professional, or other impacts of cochlear implants, cervical cancer screening, PET scanners, or widespread adoption of electronic health record systems.
• Problem-oriented assessments focus on solutions or strategies for managing a particular disease, condition, or other problem for which alternative or complementary technologies might be used. For example, clinicians and other providers concerned with the problem of diagnosis of dementia may call for HTA to inform the development of clinical practice guidelines involving some combination or sequence of clinical history, neurological examination, and diagnostic imaging using various modalities.
• Project-oriented assessments focus on a local placement or use of a technology in a particular institution, program, or other designated project. For example, this may arise when a hospital must decide whether or not to purchase a PET scanner, considering the facilities, personnel, and other resources needed to install and operate a PET scanner; the hospital’s financial status; local market potential for PET services; competitive factors; etc.

These basic assessment orientations can overlap and complement one another. Certainly, all three types could draw on a common body of scientific evidence and other information. A technology-oriented assessment may address the range of problems for which the technology might be used and how appropriate the technology might be for different types of local settings (e.g., inpatient versus outpatient). A problem-oriented assessment may compare the effectiveness, safety, and other impacts of alternative technologies for a given problem, e.g., alternative treatments for atrial fibrillation (e.g., drug therapy, surgery, or catheter ablation), and may draw on technology-oriented assessments of one or more of those alternatives as well as any direct (“head-to-head”) comparisons of them. A project-oriented assessment would consider the range of impacts of a technology or its alternatives in a given setting, as well as the role or usefulness of that technology for various problems. Although the information used in a project-oriented assessment by a particular hospital may include findings of pertinent technology- and problem-oriented assessments, local data collection and analysis may be required to determine what is appropriate for that hospital. Thus, many HTAs will blend aspects of all three basic orientations.