Advice - extending the reimbursement of axicabtagene ciloleucel (Yescarta®) for the treatment of lymphoma
The National Health Care Institute has advised the Minister for Medical Care to extend the reimbursement of axicabtagene ciloleucel (Yescarta®; axi-cel), 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 medicinal product in the so-called ‘lock procedure for expensive medicinal products'.
Axi-cel is intended for certain people with lymphoma
Axi-cel is the active substance; the brand name is Yescarta®. The medicine is administered by injection.
The drug can be used in fit adult patients with diffuse large-cell B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. This is a second line of treatment: if previous treatment with another medicinal product has not worked well, these patients may be eligible to use axi-cel. 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 the reimbursement of axi-cel
The National Health Care Institute advises the Minister for Medical Care to extend the reimbursement of axi-cel (Yescarta®), after price negotiations. This applies to fit adults with R/R DLBCL or HGBL who are eligible for autologous stem cell transplantation as a second line of treatment. The National Health Care Institute concludes that the medicinal product has added value compared to the standard treatment, including autologous stem cell transplants.
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 and the Insured Package Advisory Committee advise the National Health Care Institute about the assessment. 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 axicabtagene ciloleucel 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’.