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 be stable following a period of intestinal adaptation after surgery.
SMC restriction: initiation in paediatric patients (aged 1 to 17 years).
Results of one phase III randomised study in adults demonstrated that significantly more patients treated with teduglutide compared with placebo achieved at least a 20% reduction in parenteral support at weeks 20 and 24. A 12-week open-label, non-randomised study in paediatric patients also found parenteral support was reduced with teduglutide compared with standard of care.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of teduglutide. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice517KB (PDF)
- Medicine name:
- teduglutide (Revestive)
- SMC ID:
- Treatment of patients aged 1 year and above with short bowel syndrome.
- Pharmaceutical company
- Shire Pharmaceuticals
- BNF chapter
- Gastro-intestinal system
- Submission type
- Date advice published
- 09 April 2018