following a full submission assessed under the ultra-orphan medicine process:
telotristat ethyl (Xermelo®) is accepted for restricted use within NHSScotland.
Indication under review: Treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue therapy in adults inadequately controlled by somatostatin analogue therapy.
SMC restriction: patients with CS diarrhoea who experience an average of four or more bowel motions per day, despite receiving somatostatin analogue therapy.
A phase III double-blind randomised study showed that telotristat ethyl produced a statistically significant greater reduction in the number of daily bowel motions in patients with carcinoid syndrome on stable dose somatostatin analogue therapy compared with placebo.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of telotristat ethyl. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
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