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.
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See also
HAS opinions and decisions
03/05/2024
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