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

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.

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.

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.

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.