The National Health Care Institute has advised the Minister of Health, Welfare and Sport (hereinafter also “VWS”) not to reimburse idecabtagene vicleucel (Abecma®) from the basic healthcare package. This medicinal product can be used in certain patients with multiple myeloma. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’. It has not been demonstrated that this medicinal product has an added value for patients.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this 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 healthcare package.
Idecabtagene vicleucel is intended for certain people with multiple myeloma
Idecabtagene vicleucel (ide-cel) is the active substance; the brand name is Abecma®. The medicine is a CAR T-cell therapy. CAR-T treatment is different from the usual treatments for multiple myeloma. During CAR-T treatment, immune cells in the patient’s own body are programmed to turn against tumour cells. The medicinal product is a single injection.
The product can be used in people with multiple myeloma. Multiple myeloma, also known as Kahler's disease, is a plasma cell cancer. Plasma cells are one type of immune cell in the human body. Myeloma cells is another name for malignant plasma cells. In multiple myeloma, uncontrolled cell division of malignant plasma cells occurs at multiple sites in the bone marrow. The treatment is specifically for adult patients with:
- recurring and refractory multiple myeloma;
- who have received at least two previous treatments, including an immunomodulatory agent, a proteasome inhibitor and a monoclonal anti-CD38 antibody; and
- who showed disease progression during the last treatment.
Relapsing 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.
Advice from the National Health Care Institute on reimbursing ide-cel
The National Health Care Institute advises the Minister of Health, Welfare and Sport not to reimburse idecabtagene vicleucel (Abecma®) from the basic healthcare package. The National Health Care Institute has determined that ide-cel does not meet the legal criterion of ‘established medical science and medical practice’ for the indication stated. This means that it has not been demonstrated that this medicinal product has added value for patients.
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 when issuing a package advice. The final decision as to whether or not reimbursement from the basic healthcare package will take place lies with the Minister.
Explanation of the package lock procedure for expensive medicinal products
The Minister has placed ide-cel for this indication in the lock procedure for expensive medicinal products. A medicine in this lock procedure will not be eligible for reimbursement from the basic healthcare 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 marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.