1.1 Crizotinib is recommended for use within the Cancer Drugs Fund as an option for treating ROS1‑positive advanced non-small-cell lung cancer (NSCLC) in adults, only if the conditions in the managed access agreement are followed.
1.2 This recommendation is not intended to affect treatment with crizotinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
ROS1‑positive advanced NSCLC is a recently discovered type of NSCLC and there are limited data about how well existing treatments work.
Evidence for crizotinib in ROS1‑positive advanced NSCLC comes from a small, single-arm study that included mostly people with previously treated disease. Although the study showed crizotinib to be effective at shrinking tumours and slowing disease progression, the lack of data comparing it with other treatments makes the size of the benefit uncertain.
Because of the limited evidence in ROS1‑positive NSCLC, the company presented data from 2 randomised controlled trials for crizotinib in ALK‑positive NSCLC instead (comparing crizotinib with chemotherapy) as proxy data for ROS1‑positive advanced NSCLC. However, using data from a proxy population is far from ideal, and makes the assessment of clinical and cost effectiveness highly uncertain.
Crizotinib meets NICE's criteria to be considered a life-extending end-of-life treatment, but there are uncertainties in the clinical- and cost-effectiveness estimates. For previously treated disease, the range of cost-effectiveness estimates was broader than for untreated disease and all estimates are higher than what NICE normally considers acceptable for end-of-life treatments. Crizotinib therefore cannot be recommended for routine use in the NHS to treat ROS1‑positive advanced NSCLC.
Crizotinib is innovative but there were no relevant additional benefits that had not been captured in the quality-adjusted life-year calculations. Collecting further data on its use in the Cancer Drugs Fund would help address uncertainties in crizotinib's survival benefit, and the comparability of ROS1‑positive and ALK‑positive advanced NSCLC. Using crizotinib in a managed approach would also encourage standardisation of ROS1 status testing in non-squamous NSCLC. Therefore, crizotinib can be recommended for use within the Cancer Drugs Fund to treat ROS1‑positive NSCLC.