Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Cetuximab (Erbitux) may be considered medically necessary for the following:
Food and Drug Administration (FDA) Indications
- As treatment of KRAS wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in ANY of the following:
- In combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment; or
- In combination with irinotecan in individuals who are refractory to irinotecan-based chemotherapy; or
- As a single agent in individuals who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan; or
Head and Neck Cancer
- As treatment in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); or
- As treatment in combination with platinum-based therapy with fluorouracil for the first-line treatment of individuals with recurrent locoregional disease or metastatic SCCHN; or
- As a single agent for the treatment of individuals with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
Cetuximab (Erbitux) is considered experimental/investigational for all other indications. Scientific evidence does not support its use for any other indications not listed above.