Advice - reimburse efgartigimod alfa (Vyvgart®) for the treatment of myasthenia gravis
The National Health Care Institute has advised the Minister for Medical Care to reimburse efgartigimod alfa (Vyvgart®) from the basic healthcare package, after price negotiations. This medicinal product can be used in 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 medicinal products'.
Efgartigimod alfa is intended for certain people with myasthenia gravis
Efgartigimod alfa is the active substance; the brand name is Vyvgart®. The medicine limits the muscular weakness caused by the immune system.
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 generalised myasthenia gravis (gMG), muscle groups in the head, neck, torso or extremities are affected.
The medicine can be used for treating adult patients with refractory generalised myasthenia gravis (gMG) who are positive for the anti-acetylcholine receptor (AChR) antibody. Refractory means that the patient has not responded adequately to previous treatments.
Advice from the National Health Care Institute on the reimbursement of efgartigimod alfa
The National Health Care Institute is advising the Minister for Medical Care to reimburse efgartigimod alfa (Vyvgart®) from the basic healthcare package, after price negotiations. Our advice in this regard is that the net price should not exceed the net price of eculizumab or ravulizumab.
The physician’s association has indicated that it will prescribe efgartigimod alfa through an indication committee, as is done for eculizumab and ravulizumab. Start and stop criteria will be applied that ensure that treatment will only take place if clinically relevant results are achieved.
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 advises the National Health Care Institute about the assessment. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.
Lock procedure for expensive medicinal products
The Minister has placed efgartigimod alfa 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’.