Norvartis’s breast cancer drug Afinitor is not cost-effective for the NHS, the UK’s health-cost regulator has said in a statement.
After examining clinical trial data, the National Institute for Health and Care Excellence (NICE) concluded that it does not recommend Afinitor as an NHS-funded treatment because it is does not provide value for money.
Women already taking the drug should continue to do so, it added.
This decision is draft guidance only. However, if the regulator receives no appeals from the company, health professionals or the public, NICE expects to publish final guidance next month.
The regulator has been assessing the drugs, which is also known as Everolimus, when taken with Exemestane as a treatment for HER2 negative, hormone-receptor-positive advanced breast cancer for a particular group of postmenopausal women.
NICE chief executive Sir Andrew Dillon explained in the statement that when making decisions such as this the regulator weighs up how well a treatment works and compares it to similar treatments in the NHS, while also taking into consideration any associated side effects and the cost that the health service is being asked to pay.
"We are disappointed that the evidence for everolimus isn’t stronger, especially as we acknowledge that the drug could represent a new way of treating HER2 negative, hormone-receptor-positive advanced breast cancer," he added.
Afinitor, which is approved in more than 100 countries, costs £2,970 ($4,420) for a pack of 30 ten-milligram tablets. Patients take one tablet a day for as long as it stops the tumor growth, or until the patient can’t tolerate the side effects, the agency said.
According to Dillon, the evidence suggested the two drugs together could delay the growth and spread of breast cancer by four to five months, but altogether the evidence didn’t allow the committee to establish to what extent everolimus could actually prolong a patient’s life when compared with exemestane alone.
Speaking to Bloomberg, Swiss-based Novartis said, "Novartis is extremely disappointed with today’s announcement given the magnitude of clinical benefit that everolimus can offer patients with advanced breast cancer who have limited treatment options available."
The Scottish Medicines Consortium (SMC) is due to publish its guidance on everolimus for this group of women on 8 July 2013.
Last week, the European Commission granted approval for Novartis’s Lucentis medicine to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia.
Image: Afinitor costs £2,970 ($4,420) for a pack of 30 10-milligram tablets. Photo: courtesy of Andrew