NEW YORK – UK's National Institute for Health and Care Excellence has published a draft guidance recommending the National Health Service provide pembrolizumab (Merck's Keytruda) with platinum- and fluoropyrimidine-based chemotherapy as a first-line regimen for certain advanced esophageal and gastro-esophageal junction cancer patients.
Specifically, NICE's proposal would make available the checkpoint inhibitor for advanced esophageal cancer patients whose tumors lack HER2 overexpression but have a PD-L1 expression combined positive score of at least 10. NICE estimated that around 1,000 patients in England would be eligible for this treatment.
Currently, patients with HER2-negative advanced esophageal cancer don't have any treatments that offer the chance for a cure. In making its recommendation, NICE considered data that showed that patients whose tumors are HER2-negative but PD-L1-positive do live longer when pembrolizumab is added to chemotherapy. The treatment also extends the time patients live without disease progression.
"Pembrolizumab meets NICE's criteria to be considered a life-extending treatment at the end of life for this form of esophageal cancer," NICE said in a statement. "The cost-effectiveness estimates are also likely to be within what NICE considers an acceptable use of NHS resources."
The list price for pembrolizumab is £2,630 ($3,629) for a 100 mg vial. Merck has agreed to provide the drug to the NHS at an undisclosed discount.
NICE said in its appraisal document for the treatment that although PD-L1 testing isn't routine for gastrointestinal cancers, it is done readily for patients with other tumor types, such as head and neck cancer. As such, PD-L1 expression analysis could be done using current tests and "adopted easily in the NHS."