ILARIS

Substantial in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in children aged from 2 years to less than 4 years with body weight of 7.5 kg or above.

Despite the methodological limitations of the available studies, which are due to the small number of children aged from 2 years to less than 4 years that have Cryopyrin-Associated Periodic Syndromes (CAPS), but due to the undeniable value of the place of canakinumab in the management of these patients for whom there is no available alternative treatment or management to date, the Transparency Committee believes that the proprietary medicinal product ILARIS provides a substantial improvement in actual benefit (IAB II) in the management of patients aged from 2 years to less than 4 years with body weight of 7.5 kg or above suffering from CAPS, including Muckle-Wells syndrome, chronic infantile neurological, cutaneous, articular syndrome (CINCA) or neonatal-onset multisystem inflammatory disease (NOMID), severe forms of familial cold autoinflammatory syndrome (FCAS) or familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.