Stiripentol (Diacomit®)

Assessment Status Assessment process complete
Drug Stiripentol
Brand Diacomit®
Indication In conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate
Assessment Process
Rapid review commissioned 06/07/2017
Rapid review completed 10/08/2017
Rapid review outcome A Full pharmacoeconomic assessment is recommended
Full pharmacoeconomic assessment commissioned by HSE 04/09/2017
Pre-submission consultation with Applicant 15/01/2018
Full submission received from Applicant 06/07/2018
Preliminary review sent to Applicant 19/12/2018
NCPE assessment re-commenced 21/12/2018
Follow-up to preliminary review sent to Applicant 04/02/2019
NCPE assessment re-commenced 06/02/2019
Factual accuracy sent to Applicant 14/03/2019
NCPE assessment re-commenced 29/03/2019
NCPE assessment completed 03/05/2019
NCPE assessment outcome The NCPE recommends that stiripentol (Diacomit®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.