STA: Teduglutide for treating short bowel syndrome
As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) critically reviewed the company’s submission related to the clinical and cost-effectiveness of Teduglutide for treating people aged 1 year and above with short bowel syndrome who are stable following a period of intestinal adaptation after surgery. In terms of clinical effectiveness in adults, the company’s submission focused on evidence from STEPS, a 24-week double-blind phase III randomised controlled trial comparing 24 weeks of treatment with teduglutide with placebo, and its extension studies STEPS2 and STEPS3. The Paediatric case was supported by evidence from the TED-C13-003 phase III open-label study comparing teduglutide with standard care in children between 1 year and 17 years. The economic case was built around a Markov decision model structured around the number of days of parenteral support required per week, informed by the available clinical effectiveness evidence for the adult and paediatric populations.
Outcome and Translation
The Aberdeen HTA group’s involvement in this project is complete but the final appraisal determination of the NICE committee is still to be published. More details will be posted at the Short bowel syndrome - teduglutide section of the NICE website.
External collaborators: Ramsay, C., Brazzelli, M; Cummins, E; Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).
Scotland, G. and Kopasker, D. (2017) Teduglutide for treating short bowel syndrome. Evidence Review Group critique of the new economic evidence submitted by the company in response to the Appraisal Consultation Document, (NICE Technology Appraisal -10048), Aberdeen Health Technology Assessment Group.
Scotland, G., Kopasker, D., Scott, N., Cruickshank, M., Hernández, R., Fraser, C., McLean, M., McKinlay, A. and Brazzelli, M. (2017) Teduglutide for treating short bowel syndrome, (NICE Technology Appraisal -10048), Aberdeen Health Technology Assessment Group.