Novartis will no doubt be disappointed by the National Institute for Health and Clinical Excellence’s decisions to reject two of its cancer drugs - Afinitor and high dose Glivec - for use on the National Health Service in England and Wales.

The cost regulator has republished draft guidance turning down Afinitor (everolimus) as a second-line option for the treatment of advanced renal cell carcinoma, sticking with its earlier position that the drug “does not provide enough benefit to patients to justify its high cost”.

The decision comes despite Novartis’ attempts to sweeten the deal with an amended patient access scheme following initial draft guidance issued back in July. Initially the Swiss drugmaker said it would provide the first treatment pack of Afinitor free to the NHS and subsequent treatment packs at a cost of £2,822 (a 5% acquisition cost discount), but the firm has kept details of the updated scheme under wraps.

As well as the modified PAS Novartis also submitted and additional cost-effectiveness analysis during the consultation period, but the Appraisal Committee felt there was still too much uncertainty surrounding the drug’s potential incremental cost, and so could not recommend it for use on the NHS.

Afinitor was approved in Europe in August last year on the back of Phase III data which 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%.

High dose Glivec

Meanwhile, in another blow for Novartis, the Institute said it is unable to recommend Glivec (imatinib) at increased doses to treat gastrointestinal stromal tumours (GISTs), when standard doses have stopped working, “due to insufficient new evidence”.

NICE already currently recommends Glivec at a dose of 400mg/day to treat GISTs that cannot be removed by surgery, but in the absence of any new good quality clinical and cost effectiveness data on the 600 or 800mg/day strengths since original guidance was published in 2004, the Committee was unable to justify their use, it said.

Despite evidence to suggest that Glivec could delay the disease recurring in certain people who have had their tumours removed, “it is not clear that it increases survival or that it improves patients’ quality of life”, the Institute’s chief executive Andrew Dillon previously explained.