Reimbursement of outpatient medicines
Medicinal products are used, by physicians or nurses, as a part of treatment in a hospital, or in an outpatient setting, by direct delivery to an insured person (by a public pharmacist, a dispensing GP or a pharmacist working in an outpatient setting). Outpatient medicines are eligible for reimbursement as soon as they have been included in the Medicine Reimbursement System (GVS).
Registration and reimbursement
There are two important assessment procedures for outpatient medicines:
- Procedures to allow entry onto the Dutch market. These procedures take place via the Medicines Evaluation Board (MEB). More information can be found on the MEB's website;
- Procedures to become eligible for reimbursement within the framework of the insured standard health care benefit package (in accordance with the regulations of the Health Insurance Act).
These are separate procedures that each have their own assessment criteria.
Reimbursement via the standard health care benefit package
Whether a medicinal product is eligible for reimbursement is largely determined by its therapeutic value in comparison with the standard treatment used in the Netherlands and by evidence of its effectiveness. The decision on inclusion is made by the Minister of Health, Welfare and Sport (VWS), who can ask Zorginstituut Nederland for advice. In forming its advice, the Zorginstituut takes into account the opinion of the Scientific Advisory Board (WAR). This advisory board is comprised of, at most, 50 external, independent experts. The Medicinal Products Committee (CG), with about 20 members, is a part of the WAR. In order to be included in the GVS, a medicinal product must go through a statutory procedure.
The Medicine Reimbursement System (GVS)
A medicinal product is eligible for reimbursement as soon as it has been included in the Medicine Reimbursement System (GVS). The GVS is a part of the Health Insurance Decree. The GVS maintains lists of medicinal products that are insured provisions within the framework of the Health Insurance Act (Zvw). Medicinal products that have been included in the GVS are clustered on List 1A of the Health Insurance Decree or are listed separately on List 1B.
On List 1A are groups of medicinal products that are interchangeable.
Medicinal products are regarded as interchangeable if they:
- can be used for a similar area of indications,
- are administered via a similar route of administration, and
- in general, are intended for the same age group.
Medicinal products on this list are subject to a reimbursement limit. An insured person will have to pay the excess when the price of a medicinal product exceeds this limit.
On List 1B are medicinal products included in the GVS but which are not interchangeable. There is no reimbursement limit for medicinal products on this list.
Medicinal products that are on Lists 1A and 1B can also be placed on List 2. This implies that their reimbursement is subject to extra conditions. For instance, if only specific patients, and not the entire group of patients, are eligible for reimbursement of the medicinal product for the registered indication.