H. Decentralization of HTA
Although technology assessment originated as a mostly centralized function conducted by government agencies and other national- or regional-level organizations, HTA evolved into a more decentralized function, conducted by a wide variety of organizations in the public and private sectors (Goodman 1998; Rettig 1997). As noted above, an HTA done from a particular perspective may not serve the policymaking needs of other perspectives. Even for the same technology or clinical problem, there can be widely different assessment needs of regulatory agencies, health technology companies, hospitals, payers, physicians, policymakers, and others.
The growth in decentralized HTA activity has arisen less from a reduction in the level of centralized activity than expansion of HTA programs for particular decision-making needs. In the US, for example, there remain multiple government centers with ongoing HTA or other technology evaluation responsibilities to fulfill particular purposes, e.g., FDA regulation of drugs, biologics, and medical devices; CMS coverage policies for the Medicare program; and the Effective Health Care Program, Technology Assessment Program, and US Preventive Services Task Force of AHRQ. There has been considerable expansion in activities elsewhere, particularly in the private sector, as well as greater reliance by centralized sources on HTA inputs from outside sources. Large health care provider institutions and major health care product companies have established groups or units devoted to “technology assessment,” “pharmacoeconomics,” “clinical effectiveness,” and “health economics and outcomes research,” and related areas. More health plans (including various managed care organizations and insurance companies) have established formal programs to assess new pharmaceuticals, procedures, and other technologies in support of payment decisions. The number and magnitude of private firms and university centers involved in HTA and related technology evaluation functions continue to increase. HTA and evidence-based clinical practice guideline committees (with various names) are now common among medical specialty and subspecialty societies. Hospital networks, managed care organizations and other large health care providers in the private sector have HTA programs to support acquisition and management of pharmaceuticals (e.g., P&T committees and formularies), equipment and other technologies, and other technology-related needs throughout their systems (Kaden 2002).
Aside from the growth of HTA in the private sector, even HTA conducted by government agencies is drawing upon more decentralized resources. In the US, the FDA has long relied on advisory panels comprising outside experts to examine clinical trial findings and other evidence to provide recommendations regarding market approval of new drugs, biologicals, and medical devices. CMS has a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) of independent experts that provides findings and recommendations to CMS pertaining to the quality of available evidence to help inform national coverage policies for health technologies, based on the clinical literature, and HTAs and “evidence reports” prepared by selected AHRQ Evidence-based Practice Centers.
AHRQ’s Evidence-based Practice Centers (EPC) program has contracts with 11 EPCs, most of which are affiliated with academic health centers, that generate HTAs and evidence reports in support of clinical practice guidelines, coverage policies, and other practices and policies. Some EPC reports are conducted at the request, via AHRQ, from CMS and other government agencies; other requests are made by other organizations in the private sector, such as health professional organizations. In this manner, AHRQ provides a portal for decentralized HTA, via the EPCs, on behalf of government and non-government organizations. While the AHRQ EPC program is a decentralized model, it also benefits from collaborative efforts to develop and use standardized approaches, such as for evidence appraisal and other aspects of conducting systematic reviews (see, e.g., Methods Guide for Effectiveness 2014). As noted above, AHRQ also administers the US Preventive Services Task Force, an independent panel of experts in primary care and prevention that systematically reviews evidence of effectiveness and develops recommendations for a broad range of clinical preventive services.
The Cochrane Collaboration, another highly decentralized model for evaluating health care, involves 53 workgroups of volunteer experts from more than 100 countries coordinated through 14 centers with additional branches based in about 30 countries that conduct systematic reviews of a diverse variety of health care interventions. As do the AHRQ EPCs, the Cochrane Collaboration develops standardized approaches to conducting systematic reviews and related methods development (Higgins 2011).
Decentralization of HTA and related functions widens the expertise available to HTA and brings broader perspectives to the process and diminishes or balances potential conflicts of interest. Together, these generally add to the credibility of HTA processes and findings, and diminish concerns that assessments reflect narrow or self-serving interests of a particular agency or organization.
Certain changes in the health care market are prompting greater balance between centralized and decentralized HTA. Hospital networks, large managed care systems and other large systems such as the US Department of Veterans Affairs (VA) continually seek to build economies of scale and buying leverage for health care products, ranging from drugs to surgical gloves to hip joint implants. With HTA units that are centralized yet responsive to needs of individual facilities, these large organizations can consolidate their HTA efforts and support system-wide acquisition of health technologies and related services.
As health care providers and payers understand the resource requirements for conducting evaluations of health care technologies, they consider the respective benefits of conducting their own HTAs and subscribing to HTA reports from outside assessment groups. Assessment requirements vary widely depending on the type of technology involved. Acquisition of commodity products such as most types of syringes, surgical gloves, and generic drugs is based largely on price, whereas acquisition of the latest deep-brain stimulator for movement disorders such as Parkinson’s disease requires a more considered evaluation of safety, effectiveness, cost, patient preferences, and other attributes. Nearly all hospitals and health care networks in the US rely on group purchasing organizations (GPOs) that use economies of scale to acquire most of their products. The large GPOs have their own technology evaluation or clinical review committees that examine available evidence on technologies such as implantable cardiac defibrillators and MRI units, whose acquisition depends on factors other than price alone. In turn, many GPOs also subscribe to HTA report services (Lewin Group 2002; Hu 2012).