cetuximab (Erbitux)

Following a resubmission

cetuximab (Erbitux) is accepted for restricted use within NHS Scotland for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, Kirsten rat sarcoma (KRAS) wild-type metastatic colorectal cancer in combination with chemotherapy.

Post hoc analyses from one phase III and one phase II study in patients with KRAS wild-type status who had not previously received chemotherapy for metastatic disease, showed an increase in overall response rate and a small, but statistically significant, increase in median progression free survival time, when cetuximab was added to standard first-line combination chemotherapy.

Cetuximab is restricted to use in patients who have not previously received chemotherapy for their metastatic disease, with liver metastases only that are considered non-resectable but in whom potentially curative liver metastasis resection would be undertaken if the lesions became resectable after treatment with chemotherapy and cetuximab.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of cetuximab. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.