Advice

following a second resubmission considered under the ultra-orphan process:

pegvisomant (SomavertĀ®) is accepted for use within NHS Scotland.

Indication under review: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and / or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-1 [insulin-like growth factor 1] concentrations or was not tolerated.

In a phase III study, there were significant reductions in IGF-1 levels and improvements in some of the clinical manifestations of acromegaly with pegvisomant compared with placebo.

SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of pegvisomant and 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 the views from a Patient and Clinician Engagement (PACE) meeting.

Download detailed advice224KB (PDF)

Download

Medicine details

Medicine name:
pegvisomant (Somavert)
SMC ID:
158/05
Indication:
Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize insulin-like growth factor type 1 (IGF-1) concentrations or was not tolerated
Pharmaceutical company
Pfizer Ltd
BNF chapter
Endocrine system
Submission type
Resubmission
Status
Accepted
Date advice published:
13 November 2017