Glepaglutide Medicine 06 June 2023 Extended indication Short Bowel Syndrome. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Glepaglutide Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Bowel diseases Extended indication Short Bowel Syndrome. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Zealand Portfolio holder Mechanism of action Glucagon analogue Route of administration Subcutaneous Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Glucagon-like peptide 2 stimulants. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion fase 3 studie in juli 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het vergelijkbare geneesmiddel teduglutide wordt nog niet vergoed in Nederland (wel in de meeste andere Europese landen). Glepaglutide gaat concurreren met tedaglutide binnen de groep van glucagon-like peptide-2 analogen bij SBS. De halfwaardetijd van glepaglutide (ca 50u) is vele male langer dan die van teduglutide waardoor een wekelijkse sc injectie mogelijk wordt in plaats van een dagelijkse. Dit is een potentieel voordeel. Duration of treatment Frequency of administration 2 times a week Dosage per administration References NCT03690206 Additional remarks Expected patient volume per year Patient volume < 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie (1); Additional remarks Er wordt verwacht dat er in Nederland enkele honderden patiënten met deze indicatie zijn. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks