Advice - Reimburse lisocabtagene maraleucel (Breyanzi®) for the treatment of lymphoma
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse lisocabtagene maraleucel (Breyanzi®) from the basic health care package after price negotiations. This medicinal product can be used in certain patients with an aggressive form of lymphoma. The reason for this advice was the placing of the product in the so-called ‘lock procedure for expensive medicinal products’.
Lisocabtagene maraleucel is intended for certain people with lymphoma
Lisocabtagene maraleucel is the active substance. This is also called liso-cel. The brand name is Breyanzi®. Liso-cel is a CAR-T cell therapy. This is a treatment in which the immune cells are adjusted to attack the cancer cells.
This medicinal product can be used in adult patients with an aggressive form of lymphoma. The reimbursement is requested for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who have received at least 2 prior systemic treatments. DLBCL, PMBCL and FL3B are forms of lymphoma. Relapsed means that the cancer has come back, after first having disappeared partially or completely. Refractory means that the tumour did not respond to earlier treatment. Diffuse means that the malignant cells are scattered in the tissue. Primary mediastinal means that malignant cells are mainly located between the lungs. Follicular means that there is uninhibited cell division. Systemic means that the treatment works on the whole body.
Advice from the National Health Care Institute on the reimbursement of lisocabtagene maraleucel
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse lisocabtagene maraleucel (Breyanzi®) from the basic health care package after price negotiations. We advise you to include liso-cel, but only if price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of axi-cel or tisa-cel. The Insured Package Advisory Committee has also recommended that the price for a treatment should be reduced when several medicinal products become available for the same indication.
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 about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic health care package.
Lock procedure for expensive medicinal products
The Minister has placed lisocabtagene maraleucel 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’.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.