teduglutide (Revestive)

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.