Reason for request
First listing
Summary of opinion
Favourable opinion for reimbursement 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) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive, who remain symptomatic.”
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
| Substantial |
The clinical benefit of RYSTIGGO (rozanolixizumab) is substantial only as an add-on to standard therapy, including first-line immunosuppressants, for the treatment of generalised myasthenia gravis (gMG) in adultpatients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive, who remain symptomatic.
|
See also
HAS opinions and decisions
03/05/2024
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
hVUW044DKx3mVjxR
