NICE rejects Roche's skin cancer combo

NICE has said Roche's Cotellic (cobimetinib) and Zelboraf (vemurafenib) combination should not receive funding to treat an advanced type of skin cancer.

The cost-effectiveness body does not recommend the combination for people with advanced, metastatic or unresectable BRAF V600 mutation-positive melanoma.

Final draft guidance from the NICE appraisal committee said the combination offers life-extending benefit compared with Zelboraf alone, but compared with alternative treatments it is too expensive. Around 1,000 patients would have been eligible each year.

Earlier this year, NICE recommended Novartis's Mekinist (trametinib) and Tafinlar (dabrafenib) combination in this indication, which extended life by an average of six months in a clinical trial.

Cotellic costs £4,275.67 per 28 days and Zelboraf costs £7,000 per 28 days, excluding VAT. Roche had offered a commercially confidential discount – but this was still not enough to persuade NICE that the drug is cost effective.

Novartis' combination costs £10,080 per 28 days, and the manufacturer has also provided a commercially confidential discount.

Roche is trying to boost sales of Zelboraf, a B-Raf enzyme inhibitor developed by Plexxikon and Roche's Genentech unit.

It is another of the Swiss pharma's more recently launched drugs, but has come under intense competition as standard of care moves from monotherapy to targeted combinations.

Zelboraf generated sales of 214 million Swiss francs, around £164 million last year, down 21%, and Roche hopes to increase this income by combining it with Cotellic, a selective MEK inhibitor developed by Genentech and Exelixis. Cotellic is forecast to generate peak sales of around $790 million.

But NICE's decision means the combination will be unavailable to most UK patients, as it will not be funded by the Cancer Drugs Fund (CDF).

Under the newly-relaunched CDF, the plan is for some drugs to be given up to two years on the market before having to produce more cost-effectiveness data.

But in this case, NICE said that there were “no clinical uncertainties that could be addressed from further data collection.”