The Dutch government has the policy to allow 80% reimbursement upon temporary admission of a drug on the list of high-cost medicines. The criteria for access on this list are that the drug is registered for the indication and (on prognosis bases) the drug will take up more than 0,5% of the average hospital medication budget. At the time of temporary allowance on the list of expensive medicines, a list of effectiveness research questions are formulated. The Dutch Health Care Insurance Board (CVZ) is responsible at the time of temporary admission for the evaluation of the therapeutic value, the cost prognosis and for formulating effectiveness research questions that will need to be addressed in the 3 years of temporary admission on the list of expensive medicines. It is in principle the responsibility of parties directly involved such as the pharmaceutical industry to adequately answer these research questions. These answers will be re-evaluated three years after the temporary allowance in order to determine if the drug should definitively be allowed on the list and the subsequent special reimbursement rule. This decision is made by the Dutch Health Care Authority (NZA) based on the extensive evaluation by CVZ. Orphan drugs have a comparable policy list and procedure for additional funding.
ZonMw has been asked by the Dutch Ministry of Health, Welfare and Sports to set up a subsidy program to allow funding of effectiveness research for drugs on the list of expensive medicines or orphan drugs. The aim of the ZonMw efficiency studies of high-cost medicines programme is to encourage and fund efficiency studies in the context of the high-cost medicines policy guidelines, so that decisions on reimbursement of costs can be substantiated in a valid and reliable way.
In addition ZonMw has been asked to develop a program supporting research leading to the development or optimalisation of Health Technology Assessment (HTA) methodology that can be used as an instrument in efficiency research on drugs. Subsidy will only be granted in case the research leads to results or a methodology that in the end can be used by health policy makers in deciding on the reimbursement of (expensive or orphan) drugs.