Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An Ispor Medical Devices and Diagnostics Special Interest Group Report

Background: Health Technology Assessment methods have become an important health policy tool. Yet recommendations for what constitutes appropriate and reliable evidence for assessment of medical devices are still debated because methods to evaluate pharmaceuticals are often, and incorrectly, the starting point for assessments. Objectives: The study aims to: (i) propose recommendations on appropriate methodologies to assess the evidence on medical devices (ii) identify assessment methods that can be used to measure device value and (iii) suggest key areas for future work Methods: ISPOR's Medical Devices and Diagnostics Special Interest Group conducted a comprehensive search of databases and gray literature on evidence development and value assessment on medical devices. The literature search was supplemented with hand searching from high impact journals in the related field. The 10-person expert working group obtained written comments through multiple rounds of review from internal and external stakeholders. Recommendations were made to guide future research. Results: Multi-criteria decision analysis was identified as a useful approach to assess the value of treatment. Consideration should be given to resource use measures; valid and reliable functional status questionnaires; and general and disease-specific, health-related, quality-of-life measures in economic evaluations of device use. For future work, best practices for value framework design. Conclusions: Integration of value-based evidence in an evidence-generation and -synthesis process is needed to support market access and adoption. Methodological recommendations for measuring value can be challenging when the selection of domains and assessment of value are not device-specific.