Abstract
BackgroundThe concept of early health technology assessment, discussed well over a decade, has now been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. Early economic evaluation is essential to assess the value of emerging technologies, but empirical data to inform the current practice of early evaluation is limited. We propose a systematic review of early economic evaluation studies in order to better understand the current practice.Methods/designThis protocol describes a systematic review of economic evaluation studies of regulated health technologies in which the evaluation is conducted prior to regulatory approval and when the technology effectiveness is not well established. Included studies must report an economic evaluation, defined as the comparative analysis of alternatives with respect to their associated costs and health consequences, and must evaluate some regulated health technology such as pharmaceuticals, biologics, high-risk medical devices, or biomarkers. We will conduct the literature search on multiple databases, including MEDLINE, EMBASE, the Centre for Reviews and Dissemination Databases, and EconLit. Additional citations will be identified via scanning reference lists and author searching. We suspect that many early economic evaluation studies are unpublished, especially those conducted for internal use only. Additionally, we use a chain-referral sampling approach to identify authors of unpublished studies who work in technology discovery and development, starting out with our contact lists and authors who published relevant studies. Citation screening and full-text review will be conducted by pairs of reviewers. ed data will include those related to the decision context and decision problem of the early evaluation, evaluation methods (e.g., data sources, methods, and assumptions used to identify, measure, and value the likely effectiveness and the costs and consequences of the new technology, handling of uncertainty), and whether the study results adequately address the main study question or objective. Data will be summarized overall and stratified by publication status.DiscussionThis study is timely to inform early economic evaluation practice, given the international trend in early health technology assessment initiatives.
Highlights
The concept of early health technology assessment, discussed well over a decade, has been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems
Methods/design This protocol describes a systematic review of economic evaluation studies that are conducted to inform the development and planning of early evaluation of emerging health technologies
A study is included if it reports an early economic evaluation of a regulated health technology in order to inform the development of the technology
Summary
Economic evaluation is the comparative analysis of alternative technologies with respect to their costs and consequences [1]. It is often used late in the evaluation of drugs, devices, and other technologies to inform coverage decisions [2]. From an industry's perspective, early evaluation may be used for early market assessment, managing research and development portfolios, and informing pricing and reimbursement scenarios. There is interest from both innovators and payers in early health technology assessment and, early economic evaluation, to inform planning and development decisions by industry and to inform the potential of new technologies that may meet health system needs [8]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.