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VYVGART (efgartigimod alfa) - Myasthenia
Reason for request
Summary of opinion
Favourable opinion for reimbursement only as an add-on to standard therapy, including first-line immunosuppressants, for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, who remain symptomatic.
Unfavourable opinion for reimbursement in the other clinical situations covered by the MA indication.
No clinical added value of the new pre-filled syringe forms compared to the forms already available.
Clinical Benefit
| Substantial |
The clinical benefit of VYVGART (efgartigimod alfa) 1,000 mg solution for injection in pre-filled syringe for subcutaneous administration issubstantial only as an add-on to standard therapy, including first-line immunosuppressants, for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, who remain symptomatic,
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| Insufficient |
The clinical benefit of VYVGART (efgartigimod alfa) 1,000 mg solution for injection in pre-filled syringe for subcutaneous administration is insufficient to justify public funding in view of the available alternatives in the other clinical situations of the MA. |
Clinical Added Value
| no clinical added value |
Ces spécialités sont un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport à aux présentations déjà inscrites. |
