Novartis ($NVS) has pinned big hopes on Afinitor's new breast cancer indication. As the FDA approved the indication last year, analysts estimated that breast cancer could add up to $1.5 billion to Afinitor's peak sales. That's a nice chunk of change to help make up for Diovan's patent-cliff losses.
But the U.K.'s cost-effectiveness watchdogs have another idea. The National Institute for Health and Care Excellence (NICE) has rejected Afinitor in breast cancer once again, in spite of Novartis' offer to provide the first month's treatment for free. The drug's sticker price is £2,970 per month, or about $4,420, NICE said.
The agency said that adding Afinitor to treatment with Pfizer's ($PFE) estrogen-blocking drug Aromasin did stave off the cancer's advance for longer than Aromasin could alone. But it's unclear whether Afinitor actually extends patients' lives, NICE said, and comparisons to "relevant chemotherapy regimens" were uncertain.
NICE approval clears the way for use by Britain's National Health Service, but its influence is broader than that. Other countries often take NICE's assessments into account when deciding whether to pay for particular treatments.
"We are disappointed that the evidence for [Afinitor] isn't stronger," NICE chief Sir Andrew Dillon said in a statement, "especially as we acknowledge the drug could represent a new way of treating HER2 negative, hormone-receptor-positive advanced breast cancer by restoring a tumor's sensitivity to hormone therapy."
Novartis can appeal the decision; final guidance is due next month.
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