The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) not to reimburse axicabtagene ciloleucel (axi-cel, Yescarta®) from the basic healthcare package. This medicinal product can be used in certain patients with a slow-growing form of blood cancer. 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.
Axi-cel is intended for certain people with blood cancer
Axi-cel is the active substance. The brand name is Yescarta®. The medicinal product is an injection.
The medicinal product can be used in patients with recurring or refractory follicular lymphoma. This is a type of blood cancer that grows slowly. 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. Systemic means that the treatment works on the whole body. Axi-cel for follicular lymphoma is a fourth-line treatment. This means that patients cannot be eligible for the use of axi-cel until 3 previous treatments have not worked.
Advice of the National Health Care Institute on the reimbursement of axi-cel
The National Health Care Institute advises the Minister of VWS not to reimburse axi-cel (Yescarta®) from the basic healthcare package. The National Health Care Institute, in its assessment, has determined that the effectiveness of axi-cel for the treatment of the indication mentioned has not been demonstrated. And as such, the medicine does not meet the established medical science and medical practice. This is the legal criterion that healthcare must meet to be reimbursed from the basic healthcare package.
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 axi-cel in the 'lock procedure for expensive medicinal products' for this indication. A medicinal product 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’.