Vibegron Medicine 10 December 2019 Extended indication Treatment of micturition frequency and/or urgency incontinence as may occur in adult patients with Over Active Bladder (OAB) syndrome. Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Vibegron Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Unknown Extended indication Treatment of micturition frequency and/or urgency incontinence as may occur in adult patients with Over Active Bladder (OAB) syndrome. Current proprietary name Already available biosimilars / generics Proprietary name Obgemsa Manufacturer Urovant Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Beta-3 adrenergic receptor agonist. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration July 2024 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie april 2024 Therapeutic value Current treatment options Urologische spasmolytica, bijvoorbeeld mirabegron. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 75 mg References Farmakotherapeutisch kompas; NCT03492281 (EMPOWUR) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Kenniscentrum Urologie Slingeland Ziekenhuis Additional remarks De overactieve blaas komt bij 10% van de volwassenen voor. Potentieel voor veel patiënten. NCT03492281 (EMPOWUR) Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks De prijs in Nederland is nog niet bekend. Kosten voor bijvoorbeeld mirabegron dat op dit moment voor deze indicatie wordt gebruikt bedragen ongeveer €0,82 per dag. Dit betekent €300 per patiënt per jaar. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Urovant.com Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks