Cost regulators for the NHS in England and Wales have confirmed that patients with advanced breast cancer will not be able to routinely access Novartis' Afinitor.
The National Institute for Health and Care Excellence has now published final guidance which does not recommend funding Afinitor's (everolimus) use by the NHS as it does not offer value for money.
Afinitor was approved for use in Europe in combination with Pfizer's Aromasin (exemestane) back in 2012 to treat patients with oestrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
There was much excitement over the drug because if offered the chance of circumventing a key issue with standard endocrine treatment - i.e. the build up of resistance to therapy - and thereby potentially improve the outlook for this group of patients.
However, after an analysis of data the Institute ruled that, while Novartis's drug could indeed delay the growth and spread of breast cancer by around four months, there were uncertainties relating to how long it could extend life compared with exemestane alone.
Its Independent Committee concluded that the Incremental Cost Effectiveness Ratio (ICER) of £68,000 per QALY gained for Afintor compared with exemestane alone was the most plausible estimate, thereby significantly over what is normally considered value for money for the NHS.
"With limited NHS funds, it's important we make recommendations based on how well a treatment works compared to alternative treatments in the NHS, as well as any associated side effects and the cost that the health service is being asked to pay," said NICE chief executive Andrew Dillon, defending the decision.
The Scottish Medicines Consortium has also rejected the drug's use on NHS Scotland, and Afinitor will continue to be available to patients in England only via the Cancer Drugs, Fund.
Last month Novartis said the decision to reject the drug was "another blow for patients, clinicians and the breast cancer community who have heralded [Afinitor] as a breakthrough treatment representing cutting-edge clinical innovation, which has the potential to change the current treatment pathway".
It insists that "the methodology used to quantify the level of clinical effectiveness, and therefore cost effectiveness, is [not] reasonable".