Advice - do not reimburse teclistamab (Tecvayli®) for the treatment of multiple myeloma
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to not reimburse teclistamab (Tecvayli®) from the basic health care 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’. The National Health Care Institute cannot assess whether the medicinal product is cost-effective.
Teclistamab is intended for certain people with multiple myeloma
Teclistamab is the active substance. The brand name is Tecvayli®. The medicine is administered by subcutaneous injection in the abdominal area or thigh. Subcutaneous means under the skin.
The product can be used in adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Multiple myeloma, also known as Kahler's disease, is a plasma cell cancer. Plasma cells are a type of immune cells of the human body. Myeloma cells is another word for malignant plasma cells. In multiple myeloma, uncontrolled cell division of malignant plasma cells occurs at multiple sites in the bone marrow.
Advice from the National Health Care Institute on the reimbursement of teclistamab
The National Health Care Institute advises the Minister of Health, Welfare and Sport to not reimburse teclistamab (Tecvayli®) from the basic health care package. The National Health Care Institute finds that teclistamab meets the legal criterion of 'established medical science and medical practice' and that there is an added value compared to the physician's choice of treatment. However, the cost-effectiveness analysis provided by the marketing authorisation holder is of insufficient quality. Therefore, its results cannot be used in the decision-making. As a result, the National Health Care Institute is not able to evaluate the cost-effectiveness and to advise on any price negotiations. The National Health Care Institute therefore invites the marketing authorisation holder to modify the pharmaco-economic analysis.
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, excess or whether you should pay a personal contribution, please visit our information page on excess and personal contribution. Or ask your health insurance provider.
How did the advice come about?
The Scientific Advisory Board (WAR) advise the National Health Care Institute about the assessment. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.
Lock procedure for expensive medicinal products
The Minister has placed dostarlimab 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’.