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) antibody positive, who remain symptomatic.”
Unfavourable opinion for reimbursement in the other situations included in the MA indication.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of ZILBRYSQ (zilucoplan) issubstantial only as an add-on to standard therapy, including first-line immuno-suppressants, for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, who remain symptomatic.
Insufficient
The Committee deems that the clinical benefit of ZILBRYSQ (zilucoplan) is insufficient to justify public funding in the other clinical situations of the MA.
Clinical Added Value
minor
Considering:
evidence of the superiority of zilucoplan compared to placebo:
in terms of the change from baseline to week 12 in MG-ADL score (primary endpoint), with a mean change (SD) of -2.09 (0.58) points (95% CI [-3.24; -0.95]); (p<0.001),
on the clinical ranked secondary endpoints of disease severity assessed at week 12 (QMG and MGC scores and percentage of clinical responders),
in terms of quality of life measured using the specific MG-QOL15r scale, with a difference in mean change of -2.5 points (95% CI [-4.45; -0.54], p=0.013) out of 30 points,
but in view of:
comparative efficacy data limited to the short term (12 weeks),
the safety profile reported in the studies, consistent with that of other C5 complement inhibitors, and with uncertainties in the long term,
the lack of comparison versus rituximab or eculizumab despite the fact that this would have been possible; as well as the absence of comparison versus efgartigimod alfa or ravulizumab due to their concomitant development,
the Committee deems that, like ULTOMIRIS (ravulizumab) and VYVGART (efgartigimod alfa), ZILBRYSQ 40 mg/mL (zilucoplan) solution for injection in pre-filled syringe, as an add-on to standard therapy, including first-line immunosuppressants, provides a minor clinical added value (CAV IV) in the care pathway for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, who remain symptomatic, excluding rituximab and SOLIRIS [eculizumab].
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