Sugammadex Medicine 03 December 2024 Extended indication Extension of indication to include treatment of paediatric patients from birth to less than 2 years of age for Bridion based on final results from paediatric study PN169 (MK-8616-P169); this is a Phase 4 double-blinded, randomized, active comparator-controlled clinical trial to study the efficacy, safety, and pharmacokinetics of sugammadex (MK-8616) for reversal of neuromuscular blockade in paediatric participants aged birth to <2 years Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Sugammadex Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Muscular diseases other Extended indication Extension of indication to include treatment of paediatric patients from birth to less than 2 years of age for Bridion based on final results from paediatric study PN169 (MK-8616-P169); this is a Phase 4 double-blinded, randomized, active comparator-controlled clinical trial to study the efficacy, safety, and pharmacokinetics of sugammadex (MK-8616) for reversal of neuromuscular blockade in paediatric participants aged birth to <2 years Current proprietary name Already available biosimilars / generics Proprietary name Bridion Manufacturer MSD Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Selective relaxant binding agent; antidotum voor spierverslappers die tijdens operaties kunnen worden ingezet. Dit betreft de indicatieuitbreiding voor 0 tot 2 jaar. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2024 Expected Registration May 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Neostigmine Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Sugammadex wordt in de praktijk al off-label gebruikt bij deze leeftijdsgroep. Er is geen bewijs of farmacologische redenen te bedenken dat sugammadex bij deze leeftijdsgroep anders zou werken dan bij volwassenen. Deze indicatieuitbreiding zal daarom zeker een plaats hebben binnen de behandeling. Duration of treatment Frequency of administration Dosage per administration 2-4 mg/kg References NCT03909165 (MK-8616-P169); Expertopinie Additional remarks Wordt toegediend als eenmalige intraveneuze bolus. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Deze indicatieuitbreiding naar 0 tot 2 jaar zal een gering effect hebben op het patiëntvolume. Het wordt al off-label ingezet. Een Nederlands ziekenhuis ziet niet meer dan 10 toepassingen per jaar van dit middel bij deze leeftijdsgroep. Expected cost per patient per year Cost References Medicijnkosten.nl (1) Additional remarks BRIDION INJVLST 100mg/ml FLACON 2ml: €85,02. Er zijn generieken van sugammadex op de Nederlandse markt (1). 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