| Summary: | Teduglutide (Revestive) is indicated for use in adult and pediatric patients (one year of age and above) with short bowel syndrome (SBS) who are dependent on parenteral support (PS). Teduglutide is available as a 5 mg single-use vial, for subcutaneous injection by a nurse, caregiver, or by self-administration. Optimization and stabilization of intravenous fluid and nutritional support should be performed before initiation of treatment. At the manufacturer's submitted price of $904.00 per vial2 and at a recommended dose of 0.05 mg/kg of body weight once daily as per the Health Canada-approved product monograph,1 the annual cost of teduglutide in patients weighing up to 100 kg is $329,960. Teduglutide was previously reviewed by CADTH in 2016 for the treatment of adult patients with SBS who are dependent on PS. The CADTH Canadian Drug Expert Committee (CDEC) recommended listing teduglutide with clinical criteria as follows: patients greater or equal to the age of 18 whose SBS resulted from major intestinal resection, who have been dependent on parental nutrition (PN) for at least 12 months, who require PN at least three times per week, and who have had a stable PN frequency and volume for at least one month. Treatment should be discontinued if a 20% reduction in PN volume has not been achieved within 24 weeks. The manufacturer's submitted price for teduglutide at the time of this CADTH Common Drug Review (CDR) submission (pediatric population) was identical to the submitted price in the previous submission (adult population), at$904 per vial. The manufacturer is presently requesting reimbursement for the pediatric indication
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