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74 Special Solidarity Fund KCE Reports 133
Figure 13: Drug reimbursement system the Netherlands
Source: KCE, Beleid voor Weesziekten en Weesgeneesmiddelen, KCE reports 112 A, 2009
For EU-registered orphan drugs for which a Market Authorisation exists, but that are
not listed in the GVS - for example because they are still in an experimental stage or
due to a lack of ‘added therapeutic value’ –, the Minister of health developed a specific
subsidy programme for the reimbursement of orphan drugs that are prescribed extra
muros. The aim of the subsidy programme is to ensure that the assessment procedure
to which an orphan drug is imposed, does not impede the reimbursement of the orphan
drug.
Medicines that have been granted Market Authorization somewhere else, but not in the
Netherlands, require a positive reply of the Head Inspector on an import request by a
healthcare provider. In case of a positive advice, reimbursement takes place following
the intra muros or extra muros provisions.
For drugs with no Market Authorisation, one could distinguish different options:
• An insured suffers from a disease with prevalence in the Netherlands not
exceeding 1 in 150.000 inhabitants and the prescription of a nonregistered
drug is considered as ‘rational’: the same reimbursements rules
are applicable, as for drugs with non-Dutch Market Authorization.
• An insured suffers from a disease with prevalence in the Netherlands
exceeding 1 in 150.000 inhabitants:
o The drug is not subjected to clinical research: the same
reimbursements rules could be applicable, as for drugs with a non-
Dutch Market Authorization.
o The drug is subjected to clinical research, in which the insured could
take part. After the clinical trial, pharmaceutical companies often
continue to provide these drugs to the test persons if the drug turned
out to be effective.
o Finally, if the insured does not meet the criteria for participation in
clinical research, he could rely on a ‘compassionate use’ programme in
exceptional cases. Compassionate use is possible if:
o There is a declaration of the healthcare provider (GP, specialist...);
• There is no alternative drug on the market and is waiting a MA.
The following figure illustrates the different reimbursement options for a medicine for
rare diseases.