Advice - do not reimburse nivolumab-relatlimab (Opdualag®) for the treatment of skin cancer
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to not reimburse nivolumab-relatlimab (Opdualag®) from the basic health care package. This medicinal product can be used in certain patients with unresectable and metastatic melanoma. This is a form of skin 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 compared to the standard treatment.
Nivolumab-relatlimab is intended for certain people with skin cancer
Nivolumab-relatlimab is the active substance. The brand name is Opdualag®. The medicinal product is administered by infusion.
The medicinal product can be used for people with melanoma. Melanoma is a very aggressive form of skin cancer. The main cause of skin cancer is a lot of exposure to sunlight or to other forms of UV radiation, such as the use of a tanning bed.
Advice from the National Health Care Institute on reimbursement of nivolumab-relatlimab
The National Health Care Institute advises the Minister of Health, Welfare and Sport to not reimburse nivolumab-relatlimab (Opdualag®) from the basic health care package. The National Health Care Institute concludes that nivolumab-relatlimab has no added value compared to nivolumab alone, the standard treatment. This is because nivolumab-relatlimab does not lead to a longer life or a better quality of life compared to that of patients receiving the standard care. However, more serious adverse effects have been observed. With those results, it therefore does not meet the ‘established medical science and medical practice’.
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, personal expenses or whether you should pay a 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) advises 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 abemaciclib 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’.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.