Teduglutide for treating short bowel syndrome (terminated appraisal) Teduglutide for treating short bowel syndrome (terminated appraisal) | Guidance | NICE 1. Home 2. NICE Guidance 3. Published Guidance Teduglutide for treating short bowel syndrome (terminated appraisal) Technology appraisal [TA690] Published: 21 April 2021 GuidanceThis guidance has been updated and replaced by NICE
Teduglutide for Short Bowel Syndrome Skip to navigationSkip to contentA-Z MedicinesFAQSubscribeSearchSearchSearch medicinePBS MEDICINE SEARCHHomePBS InformationBrowse the PBSFor Health ProfessionalsFor IndustryNewsPublications & DownloadsContactsHome/ Industry/ Listing/ Participants/ Public Release Docs/ 2022 06/ Teduglutide For Short Bowel Syndrome 24 Month Predicted Verus Actual AnalysisTeduglutide for Short Bowel Syndrome: 24 month predicted versus actual analysis, June 2022Page last updated: 21 October 2022Drug utilisation sub-committee (DUSC)June 2022AbstractPurposeTo compare the predicted and actual utilisation of teduglutide for Type III Short Bowel Syndrome with intestinal failure in the first 24 months of PBS listing.Date of listing on the Pharmaceutical Benefits Scheme (PBS
Teduglutide (Revestive) - short bowel syndrome (SBS) 1 Published 10 February 2020 1 SMC2225 teduglutide 5mg vial of powder and solvent for solution for injection (Revestive®) Shire Pharmaceuticals Ltd (part of Takeda Pharmaceuticals Ltd) 10 January 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a resubmission considered under the orphan process teduglutide (Revestive®) is accepted for use within NHSScotland. Indication under review: for the treatment of patients age 1 year and above with short bowel syndrome (SBS). Patients should be stable following a period of intestinal adaptation
Cost-effectiveness of teduglutide in adult patients with short bowel syndrome - a European socioeconomic perspective. The short bowel syndrome with intestinal failure (SBS-IF) is a rare but devastating medical condition. An absolute loss of bowel length forces the patients into parenteral support (PS) dependency and a variety of medical sequalae resulting in increased morbidity and mortality . Interdisciplinary treatment may include therapy with the effective, but expensive intestinotrophic peptide teduglutide. A time-discrete Markov-model was developed to simulate the treatment effect (lifetime-costs, quality-adjusted life-years (QALYs) and life-years (LYs)) of teduglutide plus best supportive care (BSC) compared with BSC alone in SBS-IF patients. The health states of the model were structured around
Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure. Patients with short bowel syndrome-associated intestinal failure (SBS-IF) require long-term parenteral nutrition and/or intravenous fluids (PN/IV) to maintain fluid or nutritional balance. We report the long-term safety, efficacy, and predictors of response in pediatric patients with SBS-IF receiving teduglutide over 96 weeks. This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF. Endpoints included treatment-emergent adverse events (TEAEs) and clinical response (≥20% reduction in PN/IV volume from baseline). A multivariable linear regression identified predictors of teduglutide
Teduglutide improves liver chemistries in short bowel syndrome-associated intestinal failure: Post hoc analysis. Chronic hepatic complications are common in patients with short bowel syndrome-associated intestinal failure (SBS-IF). Teduglutide, a glucagon-like peptide-2 analogue, demonstrated efficacy in reducing parenteral nutrition and/or intravenous fluid dependence among patients with SBS -IF in phase 3 clinical studies. This was a post hoc analysis of pooled data from two separate randomized, double-blind, placebo-controlled, multinational phase 3 clinical studies. Adult patients with SBS-IF with parenteral nutrition and/or intravenous fluid dependence without liver disease at baseline were randomized to treatment with the glucagon-like peptide-2 analogue teduglutide (0.05 or 0.10 mg/kg/day
Efficacy and Safety of Teduglutide in Infants and Children With Short Bowel Syndrome Dependent on Parenteral Support. Our objective was to evaluate the short- and long-term safety and efficacy of teduglutide treatment in infants and children with short bowel syndrome with intestinal failure (SBS-IF). Two open-label phase 3 studies and one extension study investigated the short- and long-term safety and efficacy of teduglutide (0.05 mg/kg/day) in infants and children with SBS-IF: NCT03571516, 24-week study of infants who were randomized to receive teduglutide or standard of care (SoC); NCT02980666, 24-week study of infants and children who all received teduglutide; and NCT03268811, 24-week extension study of patients who completed NCT02980666 (patients could receive up to 48 weeks of total
The Impact of Teduglutide on Real-Life Health Care Costs in Children with Short Bowel Syndrome. To analyze the real-life health care costs of home parenteral nutrition (HPN) in children with short bowel syndrome with intestinal failure (SBS-IF) before and after treatment with teduglutide, and to compare those with costs of children with SBS-IF not treated with teduglutide. All consecutive children with SBS-IF on HPN treated with subcutaneous teduglutide starting from 2018 through 2020 in a tertiary French referral center were retrospectively included. These patients were matched to children with SBS-IF on HPN followed during the same 3-year period who were eligible for the teduglutide but were not treated. HPN direct medical costs included: home-care visits, HPN bags, hospital admissions
Effects of Teduglutide on Diarrhea in Pediatric Patients with Short Bowel Syndrome-Associated Intestinal Failure. This post-hoc analysis evaluated the effect of teduglutide treatment on diarrhea in patients with short bowel syndrome-associated intestinal failure (SBS-IF). Data from 2 open-label, multicenter, phase 3 pediatric SBS-IF clinical trials of teduglutide (NCT01952080 and NCT02682381 ) were pooled where possible. The primary objective was to evaluate the change in stool consistency, frequency, and volume from baseline to weeks 12 and 24 of treatment in patients who received any teduglutide dose from both studies ("total teduglutide"). Safety assessments included gastrointestinal adverse event reporting. Overall, 101 patients were analyzed. Among the total teduglutide group (n = 87
Unexpected upper gastrointestinal polyps in patients with short bowel syndrome treated with teduglutide: need for close monitoring. Teduglutide is a GLP-2 analog indicated for the treatment of short bowel syndrome (SBS) since 2015. Its efficacy in reducing parenteral nutrition (PN) has been shown in patients with SBS. Because teduglutide is a trophic factor, the aim of this study was to assess risk of developing polypoid intestinal lesions during treatment. A retrospective study was conducted in 35 patients with SBS treated with teduglutide for ≥1 y in a home PN expert center. All patients underwent ≥1 follow-up intestinal endoscopy during treatment. In the 35 patients, the small bowel length was 74 cm (IQR: 25-100), and 23 patients (66%) had a colon in continuity. Upper and lower
Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome. Short bowel syndrome (SBS) is the main cause of intestinal failure in children. This single-center study evaluated the safety and efficacy of teduglutide in pediatric patients with SBS-associated intestinal failure (SBS-IF). Children with SBS followed at our center with ≥2 y on parenteral nutrition (PN) and with small bowel length <80 cm who had reached a plateau were consecutively included in the study. At baseline, participants underwent a clinical assessment including a 3-d stool balance analysis, which was repeated at the end of the study. Teduglutide was administered subcutaneously 0.05 mg/kg/d for 48 wk. PN dependence was expressed as the PN dependency index
Teduglutide (Gattex Shire-NPS Pharmaceuticals Inc.) to reduce parenteral support requirements in adults with short bowel syndrome Teduglutide (Gattex; Shire-NPS Pharmaceuticals Inc.) to reduce parenteral support requirements in adults with short bowel syndrome ..
Teduglutide (Revestive) - for the treatment of patients aged 1 year and above with short bowel syndrome Cost-effectiveness of teduglutide (Revestive®) for the treatment of patients aged one year and above with Short Bowel Syndrome. The NCPE has issued a recommendation regarding the cost-effectiveness of teduglutide (Revestive®). Following NCPE assessment of the applicant’s submission, teduglutide (Revestive®) is not considered cost-effective for the treatment of patients aged one year and above with Short Bowel Syndrome and therefore is not recommended for reimbursement. The HSE asked the National Centre for Pharmacoeconomics (NCPE) to carry out an assessment of the applicant’s (Shire) economic dossier on the cost effectiveness
Teduglutide (Revestive) for the treatment of short bowel syndrome Teduglutide (Revestive®) for the treatment of short bowel syndrome | Report | National Health Care Institute Go to content You are here: Home Publications Teduglutide (Revestive®) for the treatment of short bowel syndrome Search within English part of National Health Care Institute Search Teduglutide (Revestive®) for the treatment of short bowel syndromeThe Minister of Health, Welfare and Sport (VWS) has asked the National Health Care Institute to carry out an assessment of teduglutide (Revestive®). This was in response to a request from the marketing authorisation holder to include this drug in the Medicine Reimbursement System (GVS). The National Health Care Institute has carried out the assessment of the medicinal product
Teduglutide (Revestive) - short bowel syndrome Published 9 April 2018 1 teduglutide 5mg and 1.25mg vials of powder and solvent for solution for injection (Revestive®) SMC No 1139/16 Shire Pharmaceuticals Ltd 12 January 2018 (Issued 9 March 2018) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission assessed under the ultra-orphan medicine process teduglutide (Revestive®) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of patients aged one year and above with short bowel syndrome (SBS). Patients should
The Variable Response to Teduglutide in Pediatric Short Bowel Syndrome: A Single Country Real-Life Experience. The glucagon-like peptide-2 analog Teduglutide has been shown to enhance intestinal absorption and decrease parenteral nutrition (PN) requirements in short bowel syndrome (SBS). As data in children is limited, we evaluated nationwide real-life experience and treatment outcome in children with SBS. Longitudinal data of children treated with Teduglutide for ≥3 months was collected. Data included demographic and medical background, anthropometrics, laboratory assessments and PN requirements. Treatment response was defined as >20% reduction in PN requirement. The study included 13 patients [54% males, median (interquartile range {IQR}) age of 6 (4.7-7) years]. The most common SBS
Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study. Enterocutaneous fistula (ECF) is a complication of surgery or inflammatory bowel disease associated with disproportionately high healthcare costs, morbidity, and mortality. We performed this proof-of-concept, feasibility, open-label, pilot randomized, crossover study to assess the efficacy and safety of the use of teduglutide (TED) to treat ECF. Adults (age >18) with low-output (<200 mL/d) ECF were randomized to 2 months of continuing standard-of-care (SOC) followed by crossover to 2 months of SOC + TED or the reverse order. The primary efficacy endpoint was decrease in fistula volume by 20% of baseline 3-day average. Secondary efficacy endpoints were: fistula resolution and health-related
[Teduglutide (short bowel syndrome patients from the age of 1 year) - assessment according to õ 35a (para. 1, sentence 10) Social Code Book V] Teduglutid (für patienten ab dem alter von 1 jahr): bewertung gemäß § 35a abs. 1 satz 10 SGB V; dossierbewertung; auftrag G16-10 [Teduglutide (short bowel syndrome; patients from the age of 1 year) – assessment according to § 35a (para. 1, sentence 10 ] ..
Imaging as predictor of clinical response to teduglutide in adult patients with short bowel syndrome with chronic intestinal failure. Teduglutide (TED) is a glucagon-like peptide 2 analogue approved in patients with short bowel syndrome with chronic intestinal failure. Bowel epithelial hyperplasia has been reported after TED treatment. The aim of this study was to describe small bowel % to +93%), P = 0.061]. All patients with a ≥95% SB wall thickness increase (n = 18) had a clinical response, whereas only 8 of 13 (62%) patients with a <95% SB thickness increase did (P = 0.008). Teduglutide induces a significant SB wall thickness increase that can be depicted by imaging <6 mo after treatment initiation, and the degree of such increase may be associated with clinical response. Bowel