following a second resubmission considered under the ultra-orphan process:
pegvisomant (Somavert®) 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.
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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