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New HTA Decisions in France
December 2019
Drug name
INOVELON® (rufinamide)
Company
Eisai SAS
Decision date
06/11/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Epilepsy
Official notice date
25/11/2019
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
INOVELON® is indicated for the adjuvant treatment of epilepsy seizures associated with Lennox-Gastaut syndrome in patients aged 1 year to less than 4 years.
Decision Type
Extension of indication.
Summary
The committee considered the actual benefit of INOVELON® to be 'important' in the extension of indication in children from 1 year to less than 4 years old. Considering: - pharmacokinetic data for INOVELON® in children aged 1 to less than 4 years comparable to the population of patients aged 4 years and over, for which the efficacy of rufinamide has been demonstrated versus placebo in terms of reduction of the total frequency of seizures, reduction of the frequency of tonic-atonic seizures and reduction of seizure severity; - the lack of demonstrated superiority versus other antiepileptic treatments on a behavioral score (primary endpoint), in the randomized, comparative, open-label, phase III study that included a small number of patients aged 1 year to less than 4 years; - the absence of good-quality data on the quality of life of patients or caregivers; it was concluded that INOVELON® does not provide any improvement in the medical service rendered (ASMR V) in the care provided. The committee proposed 65% reimbursement.