The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to extend the additional conditions for reimbursement of cannabidiol (Epidyolex®) from the basic healthcare package. This medicinal product can be used in certain patients with Bourneville-Pringle disease. This disease is also known as tuberous sclerosis complex (TSC). “If the Minister adopts our advice, cannabidiol will be reimbursed from the health care insurer's basic healthcare package for this indication.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Cannabidiol is intended for certain people with Bourneville-Pringle disease
Cannabidiol is the active substance. The brand name is Epidyolex®. The medicinal product is a liquid you drink.
The medicinal product can be used in certain people with Bourneville-Pringle disease, also known as TSC. TSC cannot be cured. It is a rare hereditary disorder in which some cells can grow uncontrollably. This causes benign tumours in various areas of the body, such as the kidneys, skin or brain. In the brain, these tumours often lead to seizures, intellectual disabilities and behavioural problems. Treatment varies from patient to patient and depends on the symptoms. For patients with epileptic seizures due to TSC, several medicinal products are available that can prevent epilepsy. They can also receive treatment without medicinal products, such as surgery or a special (ketogenic) diet.
National Health Care Institute advice on the reimbursement of cannabidiol
The National Health Care Institute advises the Ministry of Health, Welfare and Sport to extend the List 1B conditions for cannabidiol (Epidyolex®) and to reimburse cannabidiol from the basic healthcare package for patients with Bourneville-Pringle disease. Cannabidiol was already included in the GVS on List 1B, as treatment for certain patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS).
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines’.
Conditions for reimbursement of cannabidiol
Only for an insured person aged 2 years and older who uses this medicinal product as adjuvant therapy in seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) or in treatment-resistant seizures associated with tuberous sclerosis complex (TSC). Treatment should be discontinued if, after 6 months on a maintenance dose, the seizure frequency has not decreased at least 30% when evaluated according to the guidelines accepted by the relevant professional associations in the Netherlands.
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 on the assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.