OBJECTIVES: Advanced therapy medicinal products (ATMPs) are cutting-edge therapeutic innovations that could transform patients' health. Yet, their costs and uncertain value claims pose challenges for healthcare payers and Health Technology Assessment (HTA) bodies, ultimately leading to heterogeneous coverage decisions globally. This study aims to explore experiences with Managed Entry Agreements (MEAs) and investigate practices and challenges faced by payers and HTA bodies in negotiating and reimbursing ATMPs in England, the Netherlands, and Spain.

METHODS: We conducted a qualitative study using in-depth semi-structured interviews. A purposive sampling approach was employed to select respondents with practical experience in negotiations, reimbursement, and implementation of MEAs for ATMPs. Experts and former employees from NHS England, the National Institute for Health, and Care Excellence (NICE), Zorginstituut Nederland (ZIN), The Dutch Ministry of Health, Welfare, and Sport, The Spanish Ministry of Health, the Health and Social Consortium of Catalonia (CSC) were interviewed. All interviews were audio-recorded, transcribed verbatim, and entered in NVivo 1.7.1. Subsequently, trends have been identified, and content analysis was performed.

RESULTS: Negotiations in the Netherlands are particularly focused on budget impact. Despite interest in outcome-based agreements (OBAs), simple discounts are preferred. Recently, an OBA for Atidarsagene autotemcel was proposed but not implemented. In Spain, reimbursing CAR-T therapies through OBAs has proven challenging given the time lag between apheresis and infusion. This delay complicates liability management since patients may deteriorate during that period. Similarly, in England, liabilities related to treatment failures or non-treatment-related deaths have been problematic during negotiations. Moreover, the use of registries is challenging given the need to avoid conflicts of interest, especially since companies often fund them.

CONCLUSIONS: The current ATMP oncological pipelines pose additional threats to limited budgets. The dissemination of experiences in negotiating and reimbursing ATMPs is crucial as it provides valuable insights for shaping future practices and exploiting learnings gained elsewhere.