Ipsen in talks with NICE over Cabometyx rejection

Ipsen says discussions with the National Institute for Health and Care Excellence are ongoing following a second rejection of Cabometyx for 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 in draft guidelines earlier this year NICE's independent appraisal committee concluded that the additional benefits of Cabometyx (cabozantinib), when compared with current care, "were highly uncertain as the meta-analysis evidence presented by the company was unreliable," a NICE spokesperson said.

Now, a second Appraisal Consultation Document (ACD) published by the Institute following a further analysis of cost-effectiveness information has also rejected routine prescribing of the drug after vascular endothelial growth factor (VEGF) targeted therapy on the NHS in the RCC setting.

The committee noted that, in all the analyses, the incremental analysis showed that Cabometyx was associated with an incremental cost effectiveness ratio of more than £60,000 per QALY gained compared with Novartis’ Afinitor (everolimus), and thus well outside the bounds of what is normally considered value for money for the NHS.

Ipsen said it is working with NICE and discussions continue, and also noted that, until final guidance is published, eligible patients will continue to receive access to Cabometyx via the Ipsen Managed Access Programme, under which 186 patients are currently receiving the drug free of charge in England.

"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. We are convinced that all parties are committed to working closely during this period to ensure a favourable outcome in the best interests of UK patients," said Ewan McDowall, vice president of Commercial Operations, Ipsen UK & Ireland.

RCC is the most common type of kidney cancer, responsible for around 12,000 new cases every year in the UK, or around 33 per day. Despite rates increasing each year, only 12 percent of patients with metastatic RCC will survive for longer than five years after diagnosis, highlighting the urgent need for new treatment options.

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