Favourable opinion for reimbursement in the “symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of ILARIS (canakinumab) 150 mg/ml solution for injection remains substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
demonstration of the efficacy of ILARIS (canakinumab) compared to triamcinolone acetonide (KENACORT RETARD) on the reduction in pain and the probability of the occurrence of a new gout attack (result to be interpreted with caution in view of the difference in terms of the half-life of these two products);
a safety profile deemed to be acceptable despite the frequent occurrence of adverse events related to infections;
a partially met medical need for the treatment of attacks in patients with gout not responding to treatment with NSAIDs, colchicine and in whom corticosteroids are not appropriate;
but in view of:
the low level of evidence of the available data (post hoc subgroup analysis) in the MA population;
the absence of data enabling its role to be assessed compared to KINERET (anakinra), a clinically relevant comparator;
the results of the PRS concerning a small number of patients (15 patients) and not responding to the Committee’s initial request for access to data on the characteristics of patients treated with ILARIS (canakinumab) in France for gouty arthritis based on a cohort study,
the Committee deems that ILARIS (canakinumab) 150 mg/ml solution for injection provides no clinical added value (CAV V) in the current care pathway, which includes the clinically relevant comparator for ILARIS: KINERET (anakinra), used off-label in attacks of goutyarthritis refractory to first-line treatments.
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