NEW YORK – The UK's National Institute for Health and Care Excellence published a final draft guidance on Thursday recommending pembrolizumab (Merck's Keytruda) as a treatment for certain advanced head and neck cancer patients.
NICE said that the National Health Service should make pembrolizumab available as a first-line option for patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) that is unresectable and whose tumors have a PD-L1 combined positive score of at least 1. The agency estimated there are approximately 950 HNSCC patients eligible to receive the treatment within the NHS.
The recommendation is based on data from the KEYNOTE-48 randomized-controlled clinical trial. In the study, metastatic or recurrent HNSCC patients with a PD-L1 combined positive score of at least 1 had median overall survival of 12.3 months on pembrolizumab, compared to 10.3 months for those receiving cetuximab (Eli Lilly's Erbitux) plus chemotherapy.
According to NICE, pembrolizumab monotherapy can be used to treat HNSCC that starts inside or outside the oral cavity. The agency determined that for patients whose cancer starts inside the mouth, pembrolizumab is at least as effective as and has lower overall costs than the combination of cetuximab, platinum chemotherapy, and 5-FU, which is typically the first-line treatment for this type of cancer.
Patients whose cancer starts outside the mouth typically receive platinum chemo and 5-FU. In this setting, there is a need for more treatment options that improve patients' quality of life. NICE determined that pembrolizumab works better than chemotherapy alone, and despite higher overall costs is still cost-effective for NHS patients.
The treatment's list price is £2,630 ($3,440) for a 100 mg vial, though Merck is providing the drug to the NHS at an undisclosed discounted price.