Scotland backs Cabometyx combo for kidney cancer, amid stalled NICE review

Patients in Scotland with newly-diagnosed advanced kidney cancer can now access a therapy combining Bristol-Myers Squibb's immunotherapy Opdivo with Ipsen's targeted drug Cabometyx, ahead of the rest of the UK and most other countries in the world.

The Scottish Medicines Consortium (SMC) has backed Opdivo (nivolumab) plus Cabometyx (cabozantinib) as a first-line therapy for people with advanced renal cell carcinoma (RCC), a common form of kidney cancer.

The move comes after a review of the regimen by NICE for England and Wales was suspended in April, with no agreement on an access deal. A committee meeting scheduled to review the combination in July was cancelled, although NICE says discussions are continuing.

Ipsen said in a statement that around 230 of the 1,000 or more Scottish patients diagnosed with RCC each year could be eligible for the treatment combination.

The combination of Opdivo with Cabometyx – an oral tyrosine kinase inhibitor which inhibits blood vessel formation in tumours – was approved by the EMA in March.

The green light came on the back of phase 3 results which showed that it reduced the risk of death (34%) by a third compared to Pfizer's Sutent (sunitinib), a standard first-line treatment which is also available as a generic.

The time before disease progression or death was also extended with the two-drug regimen to 17 months from 8.3 months with sunitinib.

Ipsen UK and Ireland's medical director Dr Manjinder Bains hailed what he said was a "pragmatic and innovative approach" taken by the Scottish government and NHS Scotland in its review of the combination.

"Scotland has become the first country in the world to have completed a health technology assessment for the use of cabozantinib in combination with nivolumab in this indication," he added.

The decision comes as RCC cases have been on the rise in Scotland over the last 10 years, particularly in men in whom the incidence has climbed 20%, outstripping other forms of cancer. That is partly a result of the ageing population but may also be linked to lifestyle factors such as obesity.

Five-year survival rates for Scotland are on average 15% lower compared to the European average and the lowest among the devolved nations of the UK, although survival rates are improving, said Ipsen.