Elobixibat Medicine 13 December 2018 Extended indication Chronic idiopathic constipation Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Elobixibat Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Chronic idiopathic constipation Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Albireo Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Remmer van de ileal bile acid transporter (IBAT). Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Goedgekeurd in Japan Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat het geneesmiddel effectief zal zijn, maar het komt in een markt waar al veel alternatieven beschikbaar zijn. Duration of treatment Frequency of administration 1 times a day Dosage per administration 10 mg References NCT01895543 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Mogelijk een beperkt aantal patiënten doordat er veel (betaalbare) alternatieven beschikbaar zijn. Dit middel zal waarschijnlijk worden ingezet wanneer andere geneesmiddelen niet werken. Inschatting is enkele honderden patiënten. Expected cost per patient per year Cost References Additional remarks 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 No Indication extensions References Additional remarks Other information Additional remarks