THE NETHERLANDS - REIMBURSEMENT PROCESS
(Updated December 2007)
Description of Health Care System
In The Netherlands, the main response to rising costs has been the introduction of an impressive number of cost containment policies over the last decade, which resulted in the Drug Reimbursement System, which is based on the classification of drugs into groups of interchangeable drugs (GVS). There is a fixed refund price being based on the average list price for “therapeutically interchangeable drugs” belonging to the same group (cluster). Any new drug, which cannot be clustered, is not reimbursed, unless there is a clinical benefit compared to standard therapy (“therapeutische waarde”) and the new drug is cost-effective. The use of cost-effectiveness data has been officially implemented since January 2005, leading to official requirements for submission of health economic data comparable with the UK, Australia and Canada.
Reimbursement and Pricing Approval Process
Besides the cost-effectiveness of a new drug, reimbursement will also be based on the budgetary impact of a new drug on JOZ (Jaaroverzicht Zorg: Annual National Health Care Budget), especially the impact of a new drug on the drug budget. Therefore, the authorities require an assessment of the impact of a new drug on the annual health care budget, and especially the drug budget. For the financial analysis, data on the following subjects will be required: descriptive epidemiology (data on incidence and prevalence); the patient group that is indicated for the drug and the anticipated substitution effects (i.e. the extent to which the existing treatment will be replaced); the use of the drug (posology, length of the treatment, etc.), the price of the drug, off-label use, plus the variables that would facilitate or slow down the drug sales and the total treatment costs.
Another cost containment policy has been the development of prescription restrictions, which have been used since 1996, nearly 10 years before the implementation of official requirements for cost-effectiveness data in 2005. Pharmaceuticals, which are approved for reimbursement based on prescription restrictions, are placed on the so-called “List 2”. Most new innovative drugs, which cannot be clustered and are reimbursed based on prescription restrictions, are placed on List 2 B. New drugs with prescription restrictions, which can be clustered in an existing category, are placed on List 2A. On 1 July 2005, 47 drugs (or groups of drugs) were reimbursed based on prescription restrictions. As prescription restrictions have been implemented before the requirements for cost-effectiveness data, initially the reimbursement decision for an innovative drug was based mainly on the clinical benefit compared to standard therapy and its budgetary impact. It is obvious that a drug without an additional clinical benefit is not approved according to this system, regardless of its budgetary impact. A drug with an additional clinical benefit and affordable budget would usually be reimbursed. The question mark relates to a drug with an additional clinical benefit, which is not affordable. According to the strict use of the criteria, is would not be approved, because of its unacceptable budgetary implications. But the consequence is that the drug would not be reimbursed and therefore not available for most of the Dutch patients. (Note: if a non-reimbursed drug is registered, the drug can be prescribed, but the patients have to pay the drug by themselves, which is uncommon in The Netherlands). The rational of a prescription restriction is to limit the use of the drug to a specific subpopulation in order limit the budgetary impact.
Reimbursement Organizations/HTA Organizations
- ÖBIG (2006). Surveying, Assessing and Analyzing the Pharmaceutical Sector in the 25 EU Member States. Available at: http://ec.europa.eu/comm/competition/mergers/studies_reports/oebig.pdf
- Stolk EA, Poley MJ. Criteria for determining a basic health services package. Recent developments in The Netherlands. Eur J Health Econ. 2005 Mar;6(1):2-7.
- Exter A, Hermans H, Dosljak M, Busse R. Health care systems in transition: Netherlands. Copenhagen, WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies, 2004. Available at: http://www.euro.who.int/document/e84949.pdf
- Drummond MF, et al. Current Trends in the Use of Pharmacoeconomics and Outcomes Research in Europe. Value in Health 1999. 2(5):323-32