Assessment of outpatient medicines for the benefit of the Medicine Reimbursement System (GVS)
It is the task of the Zorginstituut to advise the Minister of Health, Welfare and Sport (VWS) on the inclusion of outpatient medicines in the Medicine Reimbursement System (GVS). Medicines in the standard health care benefit package are only reimbursed if they have been included in the 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 Zorginstituut's advice
The Zorginstituut assesses the therapeutic value, the budget impact and the cost-effectiveness of medicinal products. The Scientific Advisory Board (WAR) has an advisory role.
The Zorginstituut first assesses the therapeutic value of a medicinal product and draws up a budget impact analysis (BIA), which is linked to the inclusion of the product in the GVS. For new, unique, outpatient medicines (List 1B), the Zorginstituut also provides evidence about the cost-effectiveness together with a pharmacoeconomic analysis.
During this process the Zorginstituut is advised by the WAR. Throughout this process, the marketing authorisation holder and other stakeholders are given an opportunity to comment on the contents of the draft reports. Once the Zorginstituut has confirmed its final assessment, the application for the reimbursement of a medicinal product can go on to the administrative phase. In many cases, the Executive Board of the Zorginstituut bases its definite advice on inclusion of a medicinal product in the GVS on the advice of the WAR and the advice is not discussed by the Executive Board.
The administrative phase is intended for weighing up the societal consequences of the Zorginstituut's substantive assessment. The Insured Package Advisory Committee (ACP) sometimes also has a role to play. During the administrative phase, only procedural and policy issues that relate to the process of weighing up are discussed. The substantive assessment is not open to discussion; this has already been established by the WAR. In specific cases, stakeholders may be given an opportunity to make comments in person during a hearing.
In preparation of the definite reimbursement file, marketing authorisation holders can ask the Zorginstituut to hold a preliminary discussion of the draft file. The Zorginstituut advises which data should be included in the file, based on the marketing authorisation holder's claim. Points for attention are:
- the product's interchangeability with other medicinal products in the GVS;
- the therapeutic value of the medicinal product in comparison with that of other medicinal products or forms of treatment;
- the medicinal product’s cost-effectiveness.
The preliminary discussion can be requested as soon as a positive assessment has been received from the European Medicines Agency (EMA) or the Medicines Evaluation Board (MEB).
Reimbursement of medicinal products in the GVS
Medicinal products in the GVS are reimbursed from the standard health care benefit package. The size of the reimbursement depends on which list they have been placed. Medicinal products that are interchangeable are clustered on List 1A. A reimbursement limit may apply to these. Unique medicinal products are placed on List 1B. No reimbursement limit applies to these. More information can be found on the page 'Reimbursement of outpatient medicines'.