Regulatory Focus™ > News Articles > NICE Gives Thumbs Down to Novartis Breast Cancer Drug

NICE Gives Thumbs Down to Novartis Breast Cancer Drug

Posted 20 March 2013 | By Louise Zornoza

In draft guidance released on 20 March 2013, the UK's National Institute for Health and Clinical Excellence (NICE) recommends against National Health Service (NHS) reimbursement for Novartis' breast cancer drug Afinitor (everolimus) despite its life extending benefits.

Novartis submitted clinical trial data that established that the median progression-free survival benefit (the time point in the trial at which the 50% of people experience either disease progression or death) for patients using Afinitor combined with exemestane was 4.6 months longer than with the use of exemestane alone. 

According to NICE CEO Sir Andrew Dillon, "For a treatment to be recommended by NICE, it must be shown to be cost-effective." Novartis did not offer a discount on the price of the drug, so cost-rather than therapeutic value-was the key factor in the decision not to recommend reimbursement.

Around 50,000 women and 400 men are diagnosed with breast cancer each year in the UK.  Although there are different types of the disease, most tumors are hormone-receptor-positive (the cancer depends on female hormones like estrogen to grow). Treatment options for this type of breast cancer typically include surgery, chemotherapy, radiotherapy and hormone therapies like aromatase inhibitors and tamoxifen. Around 4 in 5 breast cancers are HER2 negative (which means the targeted treatment trastuzumab - Herceptin - will not work). Novartis estimates that around 1,500 people would be eligible to receive Afinitor, if it were to be recommended.

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