Advice - reimburse fluorouracil cream (Tolak®) for the treatment of the skin condition actinic keratosis
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse 5-fluorouracil 4% cream (Tolak®) through the basic healthcare package. This medicinal product can be used in certain patients with actinic keratosis. This is an abnormality of the skin that presents as dry, scaly patches; these can later develop into skin cancer. If the minister adopts our advice, the cream will be included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the health insurer’s basic healthcare package.
Fluorouracil cream is intended for certain people with actinic keratosis
5-fluorouracil (5-FU) is the active substance. The brand name is Tolak®. The medicinal product is a cream that you apply to the skin. It contains 4% of the substance 5-fluorouracil.
The medicinal product may be used in adult patients with non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1 and 2) of the face, ears or scalp. Actinic keratosis is a dry, scaly patch on the skin that is the result of damage caused by sunlight. Non-hyperkeratotic means that this patch on the skin is not a callus. Non-hypertrophic means that the patch is not very thick. The result of this is that 5-FU 4% cream cannot be used in patients with Olsen grade 3 actinic keratosis, whereas it can be used in patients with Olsen grade 1 or Olsen grade 2 actinic keratosis. Olsen grade 1 means that the dry, scaly patch can be felt with a gentle touch; grade 2 means that the dry, scaly patch is moderately thick and visible. The dry, scaly patches are generally flesh-coloured to red or brown. There is a risk that these patches can slowly change into skin cancer.
Advice from the National Health Care Institute on the reimbursement of Tolak®
The National Health Care Institute advises the Minister of VWS to reimburse 5-fluorouracil 4% cream (Tolak®) through the basic healthcare package. The recommendation is that the medicinal product should be included on List 1A of the GVS.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of extramural drugs (GVS)’.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.
Explanation about the reimbursement of medicinal products
5-fluorouracil 4% cream is an extramural medicinal product. Extramural means: medicines for home use that can be obtained at the pharmacy with a prescription from a physician. They are only reimbursed from the basic health care package if they are listed in the GVS.