teduglutide (Revestive)

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 after surgery.

This submission relates to use in adult patients.

In a phase III randomised study in adults, significantly more patients achieved at least a 20% reduction in parenteral support volume at weeks 20 and 24 when treated with teduglutide compared with placebo.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

SMC has previously accepted teduglutide for restricted use for initiation in paediatric patients (aged 1 to 17 years) (SMC No 1139/16).