The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to not reimburse brexucabtagene autoleucel (Tecartus®) from the basic health care package. This medicinal product can be used in certain patients with acute lymphoblastic leukaemia. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. Missing information from the marketing authorisation holder does not allow us to determine if the medicinal product is worth the asking price.
Brexucabtagene autoleucel is intended for certain people with acute lymphoblastic leukaemia
Brexucabtagene autoleucel (brexu-cel) is the active substance. The brand name is Tecartus®. The medicinal product is a solution for injection to be administered by a specialist physician in a qualified treatment centre.
The medicinal product can be used in certain patients with acute lymphoblastic leukaemia (ALL). ALL is a form of acute leukaemia, another word for blood cancer. Acute leukaemia is a malignant and life-threatening bone marrow disease.
Advice from the National Health Care Institute on the reimbursement of brexucabtagene autoleucel
The National Health Care Institute advises the Minister of Health, Welfare and Sport to not reimburse brexucabtagene autoleucel (Tecartus®) from the basic health care package. The marketing authorisation holder did not provide important information, which was indispensable for the National Health Care Institute to determine whether this very expensive medicinal product is worth the asking price. The National Health Care Institute has also expressly requested this information. The National Health Care Institute again requests the marketing authorisation holder to provide this information.
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) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.
Lock procedure for expensive medicinal products
The Minister has placed brexucabtagene autoleucel for this indication in the lock procedure for expensive medicinal products. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic health care package until:
- there is a positive package advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriateness in place;
- price reductions have been successfully negotiated with the manufacturer.
For more information, see the page ‘Lock procedure for expensive medicinal products’.