Pfizer’s Xalkori has been turned away by the National Institute for Health and Care Excellence (NICE) to treat ROS1-positive advanced non-small cell lung cancer (NSCLC).

Cost effectiveness estimates for the drug when used in this setting are higher than what would normally be considered value for money for the NHS, being “well over £50,000 per QALY gained and highly uncertain”, the Institute concluded.

However, there may be a reprieve for Xalkori (crizotinib) yet as the company has been asked to submit a proposal for its inclusion in the Cancer Drugs Fund instead, for treatment-naïve patients.

According to NICE, as ROS1-positive advanced NSCLC is a recently discovered subtype not much is known about it or how well existing therapies work.

The main evidence on the effectiveness and safety of Xalkori in this setting is from a small single arm study that included mostly people with previously treated disease that showed the drug can induce durable tumour shrinkage and slow disease progression.

“However, the lack of data comparing crizotinib with ‘standard care’ makes any assessment of relative effectiveness very challenging,” according to appraisal committee papers.

Pfizer also submitted data from two trials on Xalkori for ALK-positive advanced NSCLC (for which the drug is funded by the NHS) as proxy data for the ROS1-positive subet, but “using data from a proxy population is far from ideal, and makes any estimates of cost effectiveness highly uncertain,” NICE notes.

However, the Institute did stress that the Xalkori is a “promising treatment” and has “plausible potential” to be cost effective for untreated ROS1-positive advanced NSCLC, but that more data are needed to establish whether it can be routinely funded.

Therefore, NICE said it would like the company to consider submitting a proposal for including the drug in the CDF.

“This would allow further clinical data to be collected on the demographics of people with ROS1-positive advanced NSCLC, treatment length and the survival benefit (progression-free and overall) with crizotinib,” state consultation documents.

The Institute believes such data would help to address the uncertainty around comparing ROS1-positive and ALK-positive advanced NSCLC populations, as well as the survival benefit of Xalkori in this setting.