The UK Breast Cancer Campaign (BCC) has reacted with dismay to the news that draft guidance has suggested Novartis' Afinitor should not be prescribed for routine use on the NHS.
The charity's chief executive Baroness Delyth Morgan said the news was a major blow to women with secondary breast cancer who "currently have limited treatment options available to them".
The National Institute for Health and Clinical Excellence (NICE) said an appraisal of Afinitor (everolimus) given in combination with exemestane as a treatment for HER2 negative, hormone-receptor-positive advanced breast cancer suggested the drug offered a "step change" in treatment, but that its effects on survival were unclear.
"Using the most appropriate estimates, the committee concluded that everolimus is not a cost-effective treatment option for the NHS," commented NICE chief executive Sir Andrew Dillon. The publication of the draft guidance triggers a consultation period until April 22.
Novartis said it was disappointed by the decision, pointing out that Afinitor is now the sixth treatment that NICE has turned down for patients with advanced breast cancer since 2011.
Others that have failed to meet NICE's cost-effectiveness criteria in advanced breast cancer include Roche's Avastin (bevacizumab), AstraZeneca's Faslodex (fulvestrant), Eisai's Halaven (eribulin) and GlaxoSmithKline's Tyverb (lapatinib).
"Everolimus is the first new licensed therapeutic approach in fifteen years offering substantial impact on hormone responsive advanced breast cancer which affects over 30,000 women in the UK," said Novartis in a statement.
Afinitor is one of the Swiss pharma company's top growth drivers at the moment, growing 85 per cent to reach almost $800m last year in five approved cancer indications, and has been tipped to make sales of $2bn in breast cancer alone at its peak.
Another cancer charity - Breakthrough Breast Cancer (BBC) - said Afinitor can provide women with valuable extra months of life with their families and that NICE's decision is a "big setback for women with the most common form of advanced breast cancer".
"The decision here comes down to cost and we hope that NICE can find a way to meet the manufacturers at a mid-point to find a solution," said Dr Rachel Greig from the charity.