Teduglutide Medicine 07 June 2022 Extended indication Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable folllowing a period of intestinal adaptation after surgery. Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Teduglutide Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable folllowing a period of intestinal adaptation after surgery. Current proprietary name Already available biosimilars / generics Proprietary name Revestive Manufacturer Takeda Portfolio holder Mechanism of action Glucagon analogue Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date February 2022 Expected Registration June 2023 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in april 2023 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op termijn is er mogelijk een plaats voor teduglutide bij een bepaalde groep patiënten met short bowel syndroom. Op dit moment is er geen uitspraak te doen over de therapeutische waarde. Duration of treatment Frequency of administration 1 times a day Dosage per administration 0.05 mg per kg body weight References NCT03571516 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie; Additional remarks Er wordt voorlopig geen groot patiëntvolume verwacht voor deze indicatie. Expected cost per patient per year Cost References https://www.drugs.com/price-guide/gattex Additional remarks Prijs in Nederland is nog niet bekend. De kosten voor Teduglutide subcutane kit 5 mg is ongeveer $1.794, wat ongeveer €1.678,77 is. Over het algemeen liggen de prijzen in de US hoger voor geneesmiddelen dan in Nederland. 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