cetuximab (Erbitux)

following a full submission considered under the end of life medicine process

cetuximab (Erbitux®) is accepted for restricted use within NHS Scotland.

Indication under review: Treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:

• in combination with irinotecan-based chemotherapy
• in first-line in combination with FOLFOX;
• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

SMC restriction: for use in patients with RAS wild-type metastatic colorectal cancer, in combination with irinotecan or oxaliplatin-based chemotherapy, in patients who have not previously received chemotherapy for their metastatic disease (first-line treatment).

Efficacy data for the RAS wild-type population come from post hoc subgroup analyses of two studies that compared cetuximab plus chemotherapy with chemotherapy alone.  In the RAS wild-type population, response rates (complete and partial responses) were significantly higher in both studies and overall survival was significantly longer in one study for cetuximab plus chemotherapy than chemotherapy alone.  

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of cetuximab.  It is contingent upon the continuing availability of the Patient Access Scheme 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.