OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) offer new opportunities for the treatment of diseases and address unmet medical need; however, they also present a challenge for regulators. This study aimed to explore attitudes and opinions of experts and public sector executives on the introduction, pricing and reimbursement (P&R) of ATMPs in the Greek pharmaceutical market.

METHODS: two researchers independently conducted personal in-depth interviews, using an interview guide to facilitate discussion. Interview transcripts and notes were content-analysed. The study focused on the perspective of payers; therefore, eligible participants included members of Committees involved in P&R of medicines, executives from public regulatory organisations as well as public hospital executives (hospitals will serve as the point of delivery for ATMPs). Participants were selected via convenience sampling.

RESULTS: Ten interviews were conducted from July to November 2018. Participants had an economic, medical and pharmaceutical background. ATMPs were described as novel and promising health technologies with a potential to address unmet need. Issues of concern regarding their assessment were a) uncertainty regarding long-term effectiveness and safety, b) relative higher prices and c) their significant financial impact on a constrained pharmaceutical budget. Participants considered the Health Technology Assessment process under development as adequate for the appraisal of ATMPs. Pay-for performance (P4P) schemes –- were considered most suitable for reimbursing ATMPs. Participants also made reference to the limited experience with P4P schemes as well as the need for the system as a whole to adjust to the new developments.

CONCLUSIONS: the value potential of ATMPs' is recognized among participants in the present study; however, there are challenges pertaining to their assessment and reimbursement were brought forward. New approaches to value assessment, coverage and funding of ATMPs can meet these challenges.