Reason for request

Inclusion on list

Summary of opinion

Unfavourable opinion for reimbursement in “the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated”.      


Clinical Benefit

Insufficient

The clinical benefit of FABHALTA 200 mg (iptacopan) hard capsules is insufficient in the MA indication (C3G) to justify public funding +/- in view of the available alternatives.


Clinical Added Value

Not applicable

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Évaluation des médicaments