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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
6ZqbY6Kyz9yFepG7