NICE gives green light to Ipsen's Cabometyx

Ipsen has persuaded NICE to back its advanced renal cell cancer treatment Cabometyx (cabozantinib) after offering new evidence and a patient access scheme discount.

The once-daily drug was previously rejected after NICE decided the additional benefits it offered over current care were not sufficient to justify its cost.

Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said: “There are limited treatment options available for people who have advanced kidney cancer, so I am very pleased that the new evidence submitted means we can recommend cabozantinib.”

Cabometyx was approved by European regulators last year to treat advanced renal cell carcinoma in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

The drug has a list price of £5,143 per 30-tab pack to which Ipsen has agreed with the Department of Health to apply a simple discount - the level of which is, as usual, ‘commercial in confidence’.

Ewan McDowall, vice president of commercial operations at Ipsen UK & Ireland, said: “At a time where the NHS is under increasing pressure we have taken our responsibility one step further by implementing an industry first of its kind: a managed access programme throughout the UK that provides cabozantinib free of charge for patients for the duration of their treatment.

“To date nearly 300 patients in the UK have benefited from cabozantinib through this Ipsen initiative, whilst the NICE process took place. We are delighted that now any eligible patient in the UK can benefit from cabozantinib. These patients don’t have time to wait.”

NICE estimates around 1,000 kidney cancer patients will be eligible for Cabometyx treatment after receiving VEGF-targeted therapy, with the data for the drug showing that it may offer patients extended life expectancy.

Nick Turkentine, CEO of charity Kidney Cancer UK, said: “We are absolutely delighted that NICE eventually saw the obvious importance and value of this drug to late stage kidney cancer patients.

“We were very concerned with the initial news that NICE was not recommending the drug. The facts are there in the research, we have also spoken first-hand to patients who have been involved in trials and the benefits of making cabozantinib available through the NHS are very clear.”

Earlier this year NICE performed a similar U-turn on Novartis’ kidney cancer drug Afinitor, following an offer of discount earlier and the provision of new evidence.

Meanwhile, NICE is in the process of assessing Eisai’s Kisplyx (lenvatinib) - approved by European regulators in 2016 as a second-line combination treatment for advanced RCC, guidance from England’s cost-effectiveness watchdog is expected in December.