Medicine pricing & reimbursement in the Netherlands

Pharmaceutical companies submitting dossiers for medicine reimbursement need a good understanding of the processes in the markets they wish to enter. With years of experience, the team at e&a consultants is here to support you every step of the way. Below is a brief guide to medicine pricing and reimbursement in the Netherlands. You can also visit our overviews for the Belgian and Luxembourg markets.

Key stakeholders

Several bodies are involved in the Dutch pricing and reimbursement process, each with a distinct role:

• Zorginstituut Nederland (ZIN) advises the Minister of Health, Welfare and Sport on whether a medicine or treatment should be included in the reimbursed package.
• Farmatec, part of the the executive body of the Ministry of Health, Welfare and Sport, sets the reimbursement limit and determines maximum prices under the Wet Geneesmiddelenprijzen (WGP).
• The Wetenschappelijke Adviesraad (WAR) and the Advies-commissie Pakket (ACP) provide independent scientific and package-related advice during the assessment of new medicines.
• CieBAG, a joint committee of healthcare insurers, evaluates the effectiveness of certain hospital medicines.
• The NZa (Dutch Healthcare Authority) sets add-on tariffs for medicines that fall outside standard hospital financing.
• The Minister of Health, Welfare and Sport takes the final decision on reimbursement.

Pricing system

Prices of medicines are, in principle, set by the manufacturer. Since 1996, however, this has been constrained by the maximum price setting rules of the law for medicine prices: Wet Geneesmiddelenprijzen (WGP), based on international reference pricing.

The maximum price is calculated as the average of the lowest prices for similar products in four reference countries: Belgium, France, the United Kingdom, and Norway. The WGP only applies once a product is marketed in at least 2 of these 4 countries.

On top of this maximum price, health insurers also run their own preference policy: they negotiate pricing agreements directly with manufacturers for the medicines they want to include in their insured package. This can lead to price wars, and means the price of the same medicine can differ between health insurers.

Reimbursement of medicines

A medicine can only be reimbursed once it is included in the basic health insurance package. The government decides on the content of this package based on 4 general principles: necessity, effectiveness, cost-effectiveness, and feasibility.

The procedure differs depending on whether a medicine is used in an outpatient or inpatient setting.

Outpatient medicines

Outpatient reimbursement works through a closed system of package authorisation: once a medicine receives marketing authorisation, it is only reimbursed once it's been placed on the positive list, following a decision of the Minister of Health based on ZIN's advice. This runs through a non-binding 90-day procedure: there is a maximum of 90 days between the submission of the file and the ministerial decision, but no formal consequences if this deadline isn't met.

Reimbursed outpatient medicines are listed under the reimbursement system “Geneesmiddelenvergoedingssysteem” (GVS), which maintains three lists:

• Annex 1A: interchangeable medicines (similar indication, route of administration, and age group), grouped in clusters with a shared reimbursement limit.
• Annex 1B: unique, non-interchangeable medicines, with no reimbursement limit.
• Annex 2: medicines from list 1A or 1B that carry additional reimbursement conditions.

Inpatient medicines: the 'Sluis'/lock procedure

When a new hospital medicine is expected to be particularly costly, it can be placed in the 'Sluis'/lock. Current criteria are:

• total expected expenditure on the drug (two or more indications) exceeds €20 million per year, or
• total expected expenditure on a specific indication exceeds €10 million per year, or where the annual cost per patient is €50,000 or more (in which case only that indication is locked).

The Minister must decide whether to place a drug or indication in the lock within four weeks of marketing authorisation. Around 50 medicines are currently in the lock, with the list available on ZIN's website. While in the lock, a medicine is not reimbursed, though the manufacturer may choose to supply it to patients free of charge in the meantime.

During the lock, ZIN evaluates the dossier, with input from two independent commissions, the WAR and the ACP, and advises the Minister. Depending on the outcome, the Minister either includes the medicine in the package, initiates price negotiations with the manufacturer, or decides against inclusion.

Open access

Hospital medicines that don't meet the 'Sluis' criteria fall under open access: they are automatically part of the base package, provided they meet the current standard of medical science and practice. These medicines are not separately evaluated by ZIN, and the Minister does not take a final decision on them.

• Medicines costing less than €1,000 per patient per year are simply introduced by physicians as part of the Diagnosis treatment combination (DBC).
• Medicines costing €1,000 or more per patient per year are eligible for an add-on title: at least one healthcare provider and one health insurer can request the NZa to determine a separate add-on tariff, based on CieBAG's assessment of the medicine's effectiveness.