The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse rozanolixizumab (Rystiggo®) from the basic healthcare package. This medicinal product can be used in certain patients with myasthenia gravis (MG). This is a condition where muscle weakness occurs. If the Minister adopts our advice, rozanolixizumab will be included in the Medicines Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the healthcare insurer's basic healthcare package.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Rozanolixizumab is intended for certain people with myasthenia gravis
Rozanolixizumab is the active substance. The brand name is Rystiggo®. The medicinal product is an injection that should be given under the skin (subcutaneously) once a week over 6 weeks.
The medicinal product can be used in certain people with myasthenia gravis (MG). In patients with MG, the immune system targets their own bodies. The immune system works against the substances that transfer stimuli from the nerve to the muscle, thus weakening the muscle. The muscles get abnormally fatigued and paralysis can occur. The characteristics and severity of MG vary widely from patient to patient. Generalised MG (gMG) affects muscles in the head, neck, torso or extremities. The medicine can be used by patients with refractory gMG who test positive for antibodies to the acetylcholine receptor (AChrR) or muscle-specific tyrosine kinase (MuSK). ‘Refractory’ means that it has not proved possible to bring the condition under control with previous treatments.
The National Health Care Institute advice on the reimbursement of rozanolixizumab
The National Health Care Institute advises the Minister of VWS to reimburse rozanolixizumab (Rystiggo®) from the basic healthcare package. The advice is to include the medicinal product in List 1A of the GVS in a newly formed cluster with zilucoplan (Zilbrysq®). The inclusion of the product should not lead to additional costs compared to the cost of treatment with zilucoplan. Specific additional conditions apply for (Rystiggo®), known as the List 2 conditions.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines’.
Conditions for reimbursement of rozanolixizumab
Exclusively for an insured person for whom the medicinal product has been prescribed by an academic centre after approval by the Generalised Myasthenia Gravis (gMG) indication committee.
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 VWS asks the National Health Care Institute to make an assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Rozanolixizumab is an extramural medicine. Extramural means: medicines for home use that can be obtained at the pharmacy with the prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.