It is looking likely that Novartis’ Afinitor will be ousted from routine use on the National Health Service after cost regulators said it was too expensive to treat patients with renal cell carcinoma.

The National Institute for Health and Clinical Excellence has now published a Final Appraisal Determination rejecting the use of Afinitor (everolimus) as a second-line agent for advanced kidney cancer, sticking with its original position that the drug is simply too expensive for the NHS.

Afinitor gained regulatory clearance in Europe in August last year after Phase III data showed that the drug – currently the only mTOR inhibitor available in oral form for RCC - more than doubled the average time without tumour growth or death in patients with advanced kidney cancer (4.9 versus 1.9 months) and slashed the risk of disease progression by 67%.

But despite reviewing the drug under guidelines for appraising life-extending, end-of-life treatments, Afinitor’s most plausible incremental cost effectiveness ratio compared with best supportive care was calculated by NICE’s Expert Review Group to be £58,300 per QALY, and so well above the cost-effectiveness threshold for NHS use.

A patient access scheme proposed by Novartis, under which the Swiss drugmaker offered to pay for the first treatment pack of Afinitor and charge the NHS £2,822 (a 5% discount) for subsequent packs, nor the fact that there are currently no second-line treatments approved by NICE when patients stop responding to first-line therapy with Pfizer's Sutent (sunitinib), were able to sway the Committee’s decision.

Sir Andrew Dillon, Chief Executive at NICE, said while the Institute is disappointed not to be able to recommend Afinitor in this setting, “we to have ensure that the money available to the NHS is used to best effect, particularly when NHS funds, like the rest of the public sector, is under considerable financial pressure”.