Reimbursement routes and past practices for advanced therapy medicinal products in the Netherlands.

Abstract

Aim: Achieving market access for advanced therapy medicinal products (ATMPs) requires navigating national reimbursement routes. This is said to be particularly challenging for academic developers and small- and medium-sized enterprises, increasingly involved in ATMP development. We aimed to identify reimbursement routes for ATMPs in the Netherlands and assess how ATMPs obtained reimbursement.

Methods: We conducted a scoping review of legal and policy documents and identified ATMPs, granted EU-wide marketing authorization (MA) or national hospital exemption (HE) between January 2008 and March 2024, and assessed how these obtained reimbursement.

Results: The Dutch reimbursement process involves two steps: (i) obtaining entitlement and (ii) obtaining funding. Of the 27 ATMPs, since 2018, 82% (n = 14/17) of MA-ATMPs were temporarily excluded from reimbursement as they were placed in 'the lock,' requiring health technology assessments and often negotiations to obtain entitlement. All MA-ATMPs that obtained entitlement obtained funding through an additional code for funding ('add-on'). In contrast, HE-ATMPs cannot be placed in the lock and, although possible, the identified HE-ATMP was reimbursed without an add-on.

Conclusion: We constructed a roadmap of current reimbursement routes for ATMPs in the Netherlands and found that the MA-ATMPs followed a standard reimbursement route similar to non-ATMPs, whereas HE-ATMPs did not.