Midazolam Medicine 03 December 2024 Extended indication Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Midazolam Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Epilepsy Extended indication Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults. Current proprietary name Already available biosimilars / generics Proprietary name Buccolam Manufacturer Neuraxpharm0 Portfolio holder Neuraxpharm Mechanism of action Unknown Route of administration Oromucosal Therapeutical formulation Oromucosal gel Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dit betreft de uitbreiding naar volwassenen voor Buccolam: een toediening van midazolam via een spuit voor oromucosaal gebruik. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration November 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2024. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank (1); Expertopinie (2). Additional remarks In 2022 waren er 78.033 gebruikers van midazolam (1). De verwachting is dat deze toedieningsvorm niet vaak ingezet zal worden, omdat er goede alternatieven zijn (2). Expected cost per patient per year Cost References GIPdatabank Additional remarks Buccolam is in Nederland niet verkrijgbaar. Andere vormen van midazolam werden in 2023 voor €133 per patiënt vergoed. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks