What is the process to apply for reimbursement of a new therapy in the Netherlands?
After EMA or CBG approval, a new medicine must first receive market authorization specifically for the Netherlands, as approval alone does not ensure reimbursement or availability. If the medicine is to be prescribed outside hospitals, the manufacturer must apply for inclusion in the Medicine Reimbursement System (GVS). This application is evaluated by the National Health Care Institute (Zorginstituut Nederland).If the medicine will be used within hospitals, doctors can generally prescribe it immediately, provided it is not placed in the expensive medicines “lock.” For medicines with high but not extreme costs (typically over €1,000 per patient per year), hospitals and insurers may apply for an “add-on” reimbursement. The Committee for Evaluation of Add-On Medicines (CieBAG) evaluates these applications on behalf of Zorgverzekeraars Nederland (ZN), which may also negotiate the price with the manufacturer if necessary.
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Update: The Healthcare Institute published a new assessment procedure for reimbursement which starts February 1st 2025. Nieuwe werkwijze beoordeling van geneesmiddelen | Publicatie | Zorginstituut Nederland
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