OBJECTIVES : As real-world data (RWD) are often used to complement clinical trial evidence, frameworks have been established to collect RWD post-reimbursement to inform coverage decisions and price negotiations. The extent to which RWD collection is integrated within health technology assessments (HTAs) varies internationally and by agency. A systematic review was conducted to understand current practice in post-reimbursement recommendations issued in oncology appraisals across six HTA agencies.

METHODS : Single technology assessments (STAs) published by NICE evaluating pharmacologic interventions were searched in accordance with PRISMA guidelines to identify oncology appraisals published between January 2016 and November 2020. Recommendations on RWD collection post-reimbursement were extracted. Twenty NICE STAs were selected as case studies, and submissions for the same product and indication were compared across five additional HTA agencies: SMC (Scotland), CADTH (Canada), INESSS (Quebec), HAS (France) and IQWiG (Germany).

RESULTS : Among 284 NICE STAs screened, 145 appraisals in oncology were identified, of which 28 (18.6%) issued a recommendation to collect RWD post-reimbursement. Among the products that received favorable NICE appraisals, varying proportions were accepted across other HTA agencies: HAS (95%), SMC (85%), CADTH (65%), INESSS (55%) and IQWiG (not reported). Recommendations for post-reimbursement RWD collection were most frequently issued by HAS (58% of approvals), followed by NICE (45%), CADTH (38%), and INESSS (27%). RWD collection was not proposed by SMC or IQWiG appraisals. Of the six agencies, HAS and NICE issued the strongest conditions for RWD collection by either mandating safety and efficacy studies or collecting data as part of a managed access agreement. CADTH informally proposed RWD collection using a pan-Canadian registry. INESSS advocated for observational pharmacovigilance studies representing a local population.

CONCLUSIONS : Post-reimbursement RWD collection within oncology is increasingly recommended by HTA agencies within the UK, France, and Canada, providing a path for improved access to breakthrough treatments through ongoing enhancement of the evidence base.