The U.K.'s price watchdog, the National Institute for Health and Care Excellence, published draft guidance recommending the use of Pfizer Inc.'s Xalkori to treat adult patients with a type of advanced lung cancer.
NICE said Xalkori, or crizotinib, will be available through the Cancer Drugs Fund to treat ROS-1 positive non-small cell lung cancer, a recently discovered subtype of NSCLC with limited treatment information. CDF is a fund established to make cancer drugs available to patients after being classified by NICE as not cost effective.
The U.K. agency's recommendation is based on the data from a trial involving patients who received prior treatment for the disease, in which the drug was shown to be effective in reducing tumor size and slowing disease progression.
Due to the limited information about Xalkori's clinical and cost effectiveness, the drug cannot be made available for routine use in the National Health Service to treat ROS-1 positive NSCLC. NICE noted that the lack of evidence demonstrating the drug's effectiveness in comparison to other treatments has made the extent of its benefit uncertain.
Pfizer agreed to provide Xalkori at a confidential discounted price while gathering additional data for NICE to evaluate. The data gathering will be done for five years, with annual reviews to be done after two years to check if enough information is already available. The drug will be available via CDF after completing the data gathering process and while NICE assesses the updated data.
Xalkori is approved in the U.S. to treat patients whose NSCLC has spread to other parts of the body and whose tumors are anaplastic lymphoma kinase-positive or ROS1-positive as detected by a test approved by the U.S. Food and Drug Administration.
The drug was also recently granted breakthrough therapy status by the FDA to treat NSCLC with the MET exon 14 gene alteration and anaplastic large cell lymphoma that is ALK-positive.
