RW1 A Comparative Analysis of Recommendations for the Post-Reimbursement Collection of Real-World DATA (RWD) in Oncology Appraisals Issued By Six HTA Agencies

As real-world data (RWD) are often used to complement clinical trial evidence, frameworks have been established collect RWD post-reimbursement inform coverage decisions and price negotiations. The extent which collection is integrated within health technology assessments (HTAs) varies internationally by agency. A systematic review was conducted understand current practice in recommendations issued oncology appraisals across six HTA agencies. Single (STAs) published NICE evaluating pharmacologic interventions were searched accordance with PRISMA guidelines identify between January 2016 November 2020. Recommendations on extracted. Twenty STAs selected as case studies, submissions for the same product indication compared five additional agencies: SMC (Scotland), CADTH (Canada), INESSS (Quebec), HAS (France) IQWiG (Germany). Among 284 screened, 145 identified, of 28 (18.6%) a recommendation post-reimbursement. products that received favorable appraisals, varying proportions accepted other (95%), (85%), (65%), (55%) (not reported). most frequently (58% approvals), followed (45%), (38%), (27%). not proposed or appraisals. Of agencies, strongest conditions either mandating safety efficacy studies collecting part managed access agreement. informally using pan-Canadian registry. advocated observational pharmacovigilance representing local population. Post-reimbursement increasingly recommended agencies UK, France, Canada, providing path improved breakthrough treatments through ongoing enhancement evidence base.