Merck, a leading science and technology company, announced today that the National Institute for Health and Care Excellence (NICE) for England has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux^® (cetuximab) in combination with platinum-based chemotherapy as a first-line therapy for the treatment of patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in the oral cavity.^[1] NICE's decision confirms the positive benefit Erbitux can have on the survival of patients in this setting. Erbitux is already established and reimbursed as an effective therapy for different stages of SCCHN across many countries worldwide.

"This announcement secures continued access to Erbitux for patients in England who have R/M SCCHN with oral cavity tumors -- a positive step forward as the only other available treatment option is platinum-based chemotherapy. Our ultimate goal is to secure access to Erbitux for all patients living with R/M SCCHN," said Maya Martinez-Davis, Global Head of Oncology Franchise for Merck's biopharma business. "Today's recommendation marks another important achievement in our commitment to ensuring that patients worldwide have access to optimal treatments."

For patients with R/M SCCHN, Erbitux has been available in England through the Cancer Drugs Fund (CDF) since 2010. This was in line with the current European Society for Medical Oncology and the US National Comprehensive Cancer Network clinical practice guidelines. Both guidelines recommend Erbitux in combination with platinum-based chemotherapy, followed by Erbitux maintenance monotherapy to disease progression, as the first line standard of care for patients with R/M SCCHN, regardless of tumor location.^[2],[3]

In 2016, a new approach to the appraisal and funding of cancer drugs in England came into place and all drugs previously funded by the CDF had to be reassessed by NICE. The reassessment reviews if the treatments bring sufficient clinical benefit to patients to be a cost-effective use of NHS resources.

Erbitux has obtained marketing authorization in over 90 countries worldwide. To date, more than 259,000 patients with SCCHN have been treated with Erbitux.^[