Health Technology Agency insights: informing modification of a qualitative benefit risk framework for Health Technology Reassessment of prescription medications

OBJECTIVES: This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit-Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination. METHODS: A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks. RESULTS: Participant interviews lead to four common themes: "adoption of a qualitative benefit risk framework," "data (either too much or not enough)," "importance of incorporating stakeholder values," and "feasibility of the UMBRA framework." Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants. CONCLUSIONS: Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.