Impact Of Early Health Technology Advice On Clinical Development Programs

Abstract

empanelled with payers, clinicians, policy makers, health economists, and patient representatives. This study sought to identify trends in key advice and actionable information derived from HTAC meetings in North America, Europe, and Asia that influenced the development of pipeline products. Methods: Between 2010 and 2013, 16 HTAC meetings were conducted for 14 Sanofi products in preclinical, Phase I and Phase II research. Six to 12 months after completion of each meeting, Clinical Development Leads completed a 15 question survey to identify the impact of HTAC on their projects. The results were collected and analyzed to determine the overall impact of the HTAC meetings. Results: A total of 14 surveys were completed. Advice and actionable information consisted of suggestions on clinical study design (36%), need of additional Health Economics and Outcomes Research (HEOR) studies (20%), and insights regarding pricing & reimbursement (11%). Feedback from HTAC influenced leadership committee decision-making (14%). Respondents agreed that the HTAC enabled important interactions with global experts early in development; moreover, all suggested that additional time be allowed to prepare for HTAC meetings. All Clinical Development Leads indicated they would return to HTAC and recommend it to a colleague. ConClusions: The most frequent HTAC advice involved suggestions to improve clinical study design. HTAC also recommended performing additional HEOR studies. In many instances, feedback from HTAC influenced leadership committee decision-making, such as licensing agreements.