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ASPAVELI (pegcetacoplan) - Paroxysmal nocturnal haemoglobinuria (PNH)
Opinions on drugs -
Posted on
Nov 27 2024
Reason for request
Indication extension
Summary of opinion
Unfavourable opinion for reimbursement in the indication extension “ASPAVELI is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia and have not had previous treatment with a complement inhibitor.”
Clinical Benefit
| Insufficient |
The Committee deems that the clinical benefit of ASPAVELI 1,080 mg (pegcetacoplan) solution for infusion is insufficient in the indication extension “treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia and have not had previous treatment with a complement inhibitor” to justify public funding in view of the available alternatives. |
Clinical Added Value
| Not applicable |
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