The National Institute for Health and Care Excellence has issued its first draft guidelines on Ipsen's Cabometyx, recommending against the drug's routine use on the National Health Service as a treatment for pre-treated advanced renal cell carcinoma (RCC).

The drug was cleared by European regulators in September 2016 following an accelerated assessment based on Phase III data showing improvements to overall survival, progression-free survival and objective response rate, and it is currently available to UK patients via a Managed Access Programme.

But NICE's independent appraisal committee concluded that the additional benefits of the drug, when compared with current care, "were highly uncertain as the meta-analysis evidence presented by the company was unreliable," a NICE spokesperson said.

The incremental cost-effectiveness ratios (ICERs) for cabozantinib compared with any comparator were calculated to overshoot the £30,000 per QALY gained, and thus outside the bounds of what is normally considered a cost effective use of NHS resources.

"Cabozantinib was designated as a Promising Innovative Medicine by the UK's Medicines and Healthcare products Regulatory Agency last year, indicating their exceptional commitment to ensuring patients have access to this new therapy in renal cell carcinoma, an area with typically poor prognosis and a limited number of treatment options," noted Ewan McDowall, vice president of Commercial Operations, Ipsen UK & Ireland.

"We understand where we are in the process with NICE and I am sure all parties are committed to working closely during this early consultation period to ensure a favourable outcome in the best interests of UK patients."

Ipsen picked up rights to cabozantinib from Exelixis in March last year under deal worth up to $855 million plus potential royalties.