Out-patient drug policy by clinical assessment rather than financial constraints? The gate-keeping function of the out-patient drug reimbursement system in The Netherlands.

Since 1991, the Dutch Price Reference System (DPRS) has aimed at a growth reduction of out-patient drug costs without loss of medical quality. New drugs are excluded unless they pass legally anchored clinical criteria, i.e. substitutability with accepted drugs (DPRS-list 1a, implies a reimbursement maximum), 'unique and valuable' (DPRS-list 1b, liberal price setting), or lack of value (rejected). We analysed the performance (transparency, judgement stability) of the gate-keeping function during July 1999-July 2002. For drugs applied for DPRS-list 1b status, we relate the satisfaction of existing and implicit criteria to being accepted or rejected. Of 85 DPRS-list 1b applicants, 20 were shifted to DPRS-list 1a, 52 were accepted, and 13 were rejected with different roles of therapeutic value, budget impact, and burden of disease, the latter emerging as a decisive yet non-legal criterion. The gate-keeping function of the DPRS offers a non-opportunistic balance between clinical and economic demands, provided the burden of disease criterion is implemented, and provides influential tools for financial constraints.