Health technology assessment in health-care decisions in the United States.

Health technology assessment (HTA) is a form of policy research that examines shortand long-term consequences of the application of a health-care technology. Properties assessed include evidence of safety, efficacy, patient-reported outcomes, real-world effectiveness, cost, and cost-effectiveness as well as social, legal, ethical, and political impacts [1]. At least five distinct activities define a formal health technology assessment process: 1) horizon scanning; 2) topic determination and queuing; 3) collection and assessment of evidence; 4) appraisal; and 5) funding and policy implementation. Horizon scanning involves the early examination and active monitoring of emerging technology to determine, in part, potential evidence requirements, and budgetary implications. Topic determination and queuing activities focus on setting priorities and sequencing of emerging and previously considered technologies for assessment or reassessment. The assessment function entails the process of collecting, evaluating, and systematically reviewing all available evidence for the technology under consideration. Appraisal is the decision-making function and is often distinguished by an external body (e.g., a pharmacy and therapeutics committee in the United States) that considers and weighs the summarized evidence in order to render a recommendation to the payer. Funding and policy implementation are the final steps in the HTA process. The explicit objective of organizations that operate formal HTA programs is to carefully consider a full range of clinical and economic evidence in order to render decisions as to the acceptance, modification, or rejection of technologies on a rational basis [2]. The UK National Health Service National Coordinating Center for HTA suggests that HTA programs directly consider the following attributes of health technology as they undertake their mission: When compared with existing alternatives, does the technology work, in whom does the technology work, and what is the cost impact? [3]. The funding for and use of health technology assessment programs in the United States has a long and storied history, is fragmented and uncoordinated, and includes both public and private sector initiatives. Some readers will be surprised to learn that a number of US HTA programs predate the development of well-known international efforts in Australia (Pharmaceutical Benefits Advisory Committee), Canada (Canadian Agency for Drugs and Technologies in Health), Sweden (Swedish Council on Technology Assessment in Health Care) and the United Kingdom (National Institute for Health and Clinical Excellence [NICE]). Regrettably, a number of these early US initiatives have been discontinued or have been substantially altered in large part because of political, financial and commercial pressures. In this article, we consider the changing landscape for systematic health technology assessment in the United States and what it means for health-care payers. In Section I, we start with a description of the many public and private agencies supplying and using health technology assessment reports to make coverage and reimbursement decisions. In Section II, against a backdrop of escalating costs and few restrictions on the pricing and use of health-care technology, we discuss the factors that are shaping and challenging private and public sector HTA programs. Finally, in Section III, we offer commentary on the potential role that a more formal approach to HTA can play in health care in the United States.