The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse ravulizumab (Ultomiris®) from the basic healthcare package under conditions. This medicinal product can be used in certain patients with atypical haemolytic uraemic syndrome (aHUS). This is a rare immune system disorder. 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 the blood disease aHUS
Ravulizumab is the active substance. The brand name is Ultomiris®. The medicinal product is administered by infusion.
It can be used in people with atypical haemolytic uraemic syndrome (aHUS). This is a rare condition in which a part of the immune system attacks a patient’s own body. That part is called the complement system. Because the immune system becomes overactive, the blood vessels are damaged, especially in the kidneys. This causes blood clots in small blood vessels, broken red blood cells and damage to the kidneys. People experience fatigue, anaemia, diarrhoea, nausea, shortness of breath and kidney failure. Without treatment, aHUS can quickly become severe, with permanent kidney damage or even the risk of death. Treatment must ensure that the immune system can relax and does not further damage the body. The treatment consists of plasmapheresis, rinsing the blood to remove harmful substances. If this does not work sufficiently, a treatment with eculizumab is started.
Advice from the National Health Care Institute on the reimbursement of ravulizumab
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include ravulizumab (Ultomiris®), for the treatment of adult and paediatric patients with a body weight of 10 kg or more with aHUS, who have already been continuously treated with eculizumab for 12 months and require long-term treatment (‘chronic treatment indication’), in the basic healthcare package, provided that inclusion in the package does not lead to additional costs.
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 Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
The Minister has placed ravulizumab 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 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’.