Advice

following a full submission assessed under the end of life and orphan equivalent medicine process:

regorafenib (Stivarga®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy.

In two phase III studies, regorafenib was associated with statistically significant benefits in overall survival versus 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.

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Medicine details

Medicine name:
regorafenib (Stivarga)
SMC ID:
SMC2562
Indication:

Adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies

Pharmaceutical company
Bayer Plc
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
09 October 2023