Advice - reimburse ipilimumab (Yervoy®) for the treatment of one particular form of skin cancer
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse ipilimumab (Yervoy®) for certain patients with skin cancer. The reason for this opinion being issued was an efficacy study by the professional group for an off-label use, i.e. using a medicine for an indication that is different from the one for which it is licensed.
Ipilimumab can be used for certain people with skin cancer
Ipilimumab is the active substance, combined with nivolumab; the brand name is Yervoy®. The medicinal product is administered by intravenous infusion. The medicinal product can be used in people with various forms of cancer, including cancers of the skin, kidneys, lungs and intestines.
An academic research group has carried out research into using the medicinal product for people with a particular form of skin cancer, namely patients with operable and macroscopic stage III skin cancer. Macroscopic means that the cancer is visible with the naked eye. The manufacturer of the medicine has not carried out a study on this group of patients. This is called an off-label indication.
Advice from the National Health Care Institute on the reimbursement of ipilimumab
The National Health Care Institute advises the Minister of VWS to reimburse ipilimumab (Yervoy®) in combination with nivolumab through the basic healthcare package for treating people with operable and macroscopic stage III skin cancer. Reimbursement can be made according to what is known as the NADINA scheme of the professional group’s studies. This means that all patients receive treatment with ipilimumab and nivolumab before surgery and only high-risk patients receive treatment after surgery.
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 National Health Care Institute advises the minister on issuing a package recommendation. 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 ipilimumab 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’.