Assessment of outpatient medicines for the benefit of the Medicine Reimbursement System (GVS)

Registration and reimbursement

There are 2 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 healthcare 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 healthcare 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 the National Health Care Institute for advice. In forming its advice, the National Health Care Institute 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 National Health Care Institute's advice

The National Health Care Institute assesses the therapeutic value, the budget impact and the cost-effectiveness of medicinal products. The Scientific Advisory Board (WAR) has an advisory role.

Therapeutic value

The National Health Care Institute 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 National Health Care Institute also provides evidence about the cost-effectiveness together with a pharmacoeconomic analysis.

During this process the National Health Care Institute 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 National Health Care Institute 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 National Health Care Institute 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.

Administrative phase

The administrative phase is intended for weighing up the societal consequences of the National Health Care Institute'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.

Preliminary discussion

In preparation of the definite reimbursement file, marketing authorisation holders can ask the National Health Care Institute to hold a preliminary discussion of the draft file. The National Health Care Institute 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 healthcare 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'.