Package advice for the lock procedure medicinal product ravulizumab (Ultomiris®) for the treatment of adult patients with myasthenia gravis
The National Health Care Institute has assessed whether the medicinal product ravulizumab (Ultomiris®) can be reimbursed from the basic health care package. Ravulizumab can be used to treat certain patients with myasthenia gravis (MG). The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medications’. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to reimburse ravulizumab from the basic health care package for the mentioned condition after price negotiations.
Condition for which reimbursement is requested
Ravulizumab can be used as an additional standard therapy for the treatment of adult patients with generalised MG (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The marketing registration holder now requests the reimbursement for a smaller group of patients. These are patients with refractory gMG who are anti-AChR antibody-positive. Refractory means that the patient has not responded adequately to previous treatment.
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. Their muscles get abnormally fatigued and paralysis can occur. The characteristics and severity of MG vary widely from patient to patient. In gMG, muscle groups in the head, neck, torso or extremities are affected.
Ravulizumab limits the damage to the muscles caused by the immune system.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Ministry of Health, Welfare and Sport to include ravulizumab (Ultomiris®) in the basic health care package for this indication after price negotiations. The price should in any case not exceed the net price of treatment with eculizumab.
Lock procedure for expensive medicinal products
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 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’.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise 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.