Patients with advanced breast cancer in England and Wales will not be allowed routine access to Novartis’ Afinitor on the NHS following a final decision by the National Institute for Health and Care Excellence (NICE).
The agency said that Afinitor (everolimus) had not been shown to be cost-effective as a treatment in combination with exemestane for postmenopausal women with HER2-negative, hormone-receptor-positive advanced breast cancer, in line with a draft appraisal published earlier this year.
The final guidance notes that, while the drug was able to delay the growth and spread of breast cancer by around four months, “there were uncertainties relating to how long it could extend a person’s life compared with the drug exemestane alone,” according to NICE’s chief executive Sir Andrew Dillon.
The Scottish Medicines Consortium (SMC) published guidance last month which also declined to recommend Afinitor in this setting.
The drug costs a little under £3,000 ($4,660) for a 30-tablet pack and – despite Novartis’ efforts to agree a patient access scheme with the Department of Health – NICE’s appraisal committee concluded that the quality adjusted life year (QALY) cost for the drug was £68,000, well above its usual threshold of £30,000.
News of the draft appraisal was met with consternation by patient organisations, including the charity Breakthrough Breast Cancer (BBC), which called the decision “a blow to the nearly 1,500 women who might have benefited from the drug being made routinely available on the NHS”.
Although NICE declined to recommend treating new patients with Afinitor, it said that women already undergoing treatment with the drug should continue until it is “appropriate to stop”.
The decision means that patients in England will now have to seek access via the Cancer Drugs Fund, which provides patients access to drugs not recommended by NICE.
This is a growing list, with Afinitor the latest in a string of advanced breast cancer therapies to be turned down by NICE in the last few years. Others include Roche’s Avastin (bevacizumab), AstraZeneca’s Faslodex (fulvestrant), Eisai’s Halaven (eribulin) and GlaxoSmithKline’s Tyverb (lapatinib).
Novartis said the drug is one of a handful of the new products that will drive growth over the next few years, along with multiple sclerosis treatment Gilenya (fingolimod), Tasigna (nilotinib) for leukaemia, Galvus (vildagliptin) for diabetes and blood cancer therapy Jakavi (ruxolitinib).
First-half sales of Afinitor almost doubled compared to the same period of 2012, coming in at $611m, and the drug has been predicted to reach more than $2bn a year at peak.