The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse ciltacabtagene autoleucel (cilta-cel; Carvykti®) from the basic healthcare package after price negotiations. This medicinal product can be used in certain patients with multiple myeloma. This is the second time the National Health Care Institute has assessed the medicinal product. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’.
Download: Package advice ciltacabtagene autoleucel (Carvykti®) for the treatment of multiple myeloma
Cilta-cel is intended for the treatment of certain patients with multiple myeloma
Cilta-cel is a CAR-T treatment. Cilta-cel is intended for the treatment of certain patients with multiple myeloma. A CAR-T treatment differs from commonly used treatments for multiple myeloma. During CAR-T treatment, a patient's own immune cells are programmed to turn against the tumour cells. This CAR-T treatment, cilta-cel, has the brand name Carvykti®. The medicinal product is a single-dose gene therapy.
The product can be used in people with multiple myeloma. Multiple myeloma involves an uncontrolled division of malignant plasma cells in the bone marrow. Plasma cells are white blood cells that make antibodies. Bone marrow is tissue in the bones. Multiple myeloma is also called ‘Kahler's disease’. The marketing authorisation holder has requested reimbursement for adult patients with relapsed or refractory multiple myeloma who have undergone at least 3 prior treatments, including a proteasome inhibitor, an immunomodulating agent and an anti-CD38 antibody. Relapsed means that the cancer has come back, after first having disappeared partially or completely. And refractory means that the tumour has not responded to any previous treatment.
Advice from the National Health Care Institute: reimburse cilta-cel after price decrease
The National Health Care Institute advises the Minister of VWS to reimburse cilta-cel (Carvykti®) from the basic healthcare package for the treatment of certain patients with multiple myeloma after price negotiations. Treatment may be reimbursed if the marketing authorisation holder (MAH) lowers the asking price by at least 35%.
Earlier advice on cilta-cel: unclear whether this medicinal product is worth the high asking price
In a previous assessment of cilta-cel in 2022, the National Health Care Institute was obliged to issue a negative reimbursement advice. This was because the MAH did not provide sufficient insight into the relationship between the costs and the benefits of cilta-cel for the patient. In the advisory report, the National Health Care Institute invited the MAH to adapt the pharmaco-economic analysis and to provide better justification for the cost-effectiveness of the medicinal product.
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 cilta-cel 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’.