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.
Download detailed advice808KB (PDF)
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