The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse ravulizumab (Ultomiris®) from the basic healthcare package. This medicinal product can be used in certain patients with a rare nervous system disease. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medicinal products’.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advisory report to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Ravulizumab is intended for people with rare nervous system disease
Ravulizumab is the active substance. The brand name is Ultomiris®. The medicinal product is administered by intravenous infusion. It can be used in people with neuromyelitis optica spectrum disorder (NMOSD). This is a rare disorder of the nervous system that mainly affects the optic nerves and spinal cord. NMOSD is an autoimmune disease. This means that the immune system is attacking the patient’s own body. This causes inflammation, especially in the optic nerves and spinal cord. People experience sudden loss of vision, loss of strength or paralysis in arms or legs. They may also suffer from pain or a burning sensation in the back or arms or legs, and problems with urination or bowel movements.
Sometimes the body produces certain antibodies. People with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive have antibodies against AQP4 in their blood. They often have a more severe disease progression, with sudden flare-ups. These are called relapses, where the body re-attacks the nervous system. These relapses can lead to serious symptoms if left untreated. A relapse can damage the nerves. These people are initially treated with the medicinal product rituximab, which suppresses the immune system. If this no longer works sufficiently, people may be eligible for other immune suppressants, such as ravulizumab.
Advice from the National Health Care Institute on the reimbursement of ravulizumab
The National Health Care Institute advises the Minister of VWS to reimburse ravulizumab (Ultomiris®) from the basic healthcare package. The reimbursement applies to patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive and who can no longer be treated with rituximab. Inclusion in the basic healthcare package should not result in additional costs compared to standard treatment with eculizumab, inebilizumab and satralizumab for NMOSD.
The National Health Care Institute also considers it important that ravulizumab is added to the orphan drug arrangement for eculizumab, satralizumab, tocilizumab and inebilizumab. This was determined by health care insurers in 2020 for the treatment of NMOSD.
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 Minister of Health, Welfare and Sport (VWS) asks the National Health Care Institute to carry out an assessment. 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 ravulizumab in the 'package 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’.