Patients with advanced breast cancer living in England and Wales will not be allowed routine access to Novartis' Afinitor on the National Health Service, following a decision from the National Institute for Health and Care Excellence that has angered the company and charities.

In final guidance published this week, the cost regulator has not recommended Afinitor (everolimus) as an NHS-funded treatment "because it is not good value for money". 

Afinitor is approved for use in combination with exemestane for the treatment of postmenopausal women with oestrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, that has recurred or progressed following treatment with a non-steroidal aromatase inhibitor.

Endocrine therapy, including non-steroidal aromatase inhibitors, are currently the gold standard of care. However, most patients will eventually develop resistance to treatment allowing the disease to progress, highlighting the need for new approaches.

"New and effective treatment options such as [Afinitor] can make a real difference as they circumvent this resistance, slow down cancer cell growth and ultimately extend and enhance patients’ quality of life," Professor Peter Barrett-Lee, Consultant Clinical Oncologist and Medical Director at the Velindre NHS Trust, Cardiff, has noted.

Indeed, regulatory clearance was based in part on late-stage data showing that Afinitor plus exemestane more than doubled median progression-free survival (PFS) to 11.0 months compared to 4.1 months, and that these improvements were achieved"without compromising health-related quality of life", according to the firm.

However, while NICE's appraisal committee concurred that the Afinitor regimen could delay the growth and spread of breast cancer, the evidence did not allow it to acertain how long everolimus could actually extend a person's life for compared with exemestane alone. 

The Committee concluded that the Incremental Cost Effectiveness Ratio (ICER) of £68,000 per QALY gained for everolimus compared with exemestane alone was the most plausible estimate, thereby significantly overshooting the realm of what is normally considered value for money for the NHS.

However, the decision was slammed by Novartis, which points out that Afinitor is "the sixth treatment that NICE has turned down for patients with advanced breast cancer since 2011".

'Blow for patients'

The drug giant said it is extremely disappointed with the decision given that its drug "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".

"This is 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," Novartis said, and argued that "the methodology used to quantify the level of clinical effectiveness, and therefore cost effectiveness, is [not] reasonable". 

"For the first time we have a new treatment option which is proven to enhance sensitivity to hormone therapy, ultimately delaying the need for chemotherapy in this setting which is an important benefit for many patients. It is frustrating that because of this decision, a drug with this magnitude of clinical benefit will now not be available to all patients who could benefit,” said Professor Stephen Johnston, Professor of Breast Cancer Medicine at The Royal Marsden NHS Foundation Trust, commenting on the decision.

Afinitor will continue to be available to patients in England only via the Cancer Drugs Fund, the future of which post 2014 is still shrouded in uncertainty.