Towards Market Access of Advanced Therapy Medicinal Products in the Netherlands: Reimbursement Pathways and Past Practices

OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) encompass gene, cell, and tissue therapies and reportedly face challenges in seeking reimbursement in the Netherlands. This research aims to identify reimbursement pathways for ATMPs in the Netherlands and assess past utilisation of these pathways.

METHODS: Reimbursement pathways were identified through a literature and policy review, and validated through expert interviews. A cohort of licensed ATMPs was established (2008-2024), including both centrally authorised ATMPs (CMA-ATMPs) and hospital exemption ATMPs (HE-ATMPs). They were retrospectively traced using reports and other public information of involved assessing authorities.

RESULTS: The review allowed to summarise the reimbursement pathways in ‘reimbursement-roadmaps’, specific to CMA-ATMPs and HE-ATMPs. The cohort showed all CMA-ATMPs were considered inpatient care. Due to their high budget impact, many of their indications were put on a temporary negative list (i.e., ‘the lock’, n = 24/38). These were assessed by the Dutch Healthcare Institute in a formal health technology assessment and subsequently considered for reimbursement by the Minister of Health. Currently, 11 indications are reimbursed, of which 7 through financial arrangements. Indications that are not reimbursed are either of ATMPs that have been retracted (n = 9), or in the process of reimbursement (n = 16). Parallel to the positive reimbursement decision, practical reimbursement was organised by obtaining an add-on declaration title, which was obtained for all reimbursed indications. HE-ATMPs neither appeared on the list of medicinal products assessed in the lock nor on the list of add-on products, illustrating their seemingly different reimbursement pathway.

CONCLUSIONS: The reimbursement-roadmaps provide historical insight in available routes. These may especially guide academic and smaller developers in navigating the reimbursement landscape for ATMPs more effectively. The cohort-analysis showed that most CMA-ATMPs are initially put on a temporary negative list and needed a financial arrangement to be reimbursed. Past utilisation by HE-ATMPs lacks transparency, warranting policy adjustments.