The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse berotralstat (Orladeyo®) from the basic healthcare package. This medicinal product can be used in certain patients with hereditary angioedema (HAE). This is a hereditary disease, in which a person experiences attacks of severe swelling of the skin and mucous membranes. If the Minister adopts our advice, berotralstat will be included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the healthcare insurer's basic healthcare package.
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.
Berotralstat is intended to prevent attacks of swelling in certain people
Berotralstat is the active substance. The brand name is Orladeyo®. The medicine is a capsule that you take at the same time each day with a glass of water.
It can be used in people with hereditary angioedema. Hereditary angioedema (HAE) is a hereditary disease in which someone has attacks of swelling that have a rapid onset. This swelling is also called oedema. It can occur in different places in the body, for example in the skin, abdomen, throat or mouth. The cause of the swelling is a leak in the blood vessels due to a gene change.
National Health Care Institute advice on the reimbursement of berotralstat
The National Health Care Institute advises the Minister of VWS to reimburse berotralstat (Orladeyo®) from the basic healthcare package for patients aged 12 years and older. The advice is to include the medicinal product in List 1B of the GVS.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines’.
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 Minister of VWS asks the National Health Care Institute to make an assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Berotralstat is an extramural drug. Extramural means: medicines for home use that can be obtained at the pharmacy with the prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.