Novartis’ Afinitor fails NICE test
pharmafile | July 8, 2013 | News story | Sales and Marketing | Afinitor, NHS, NICE, Novartis
Novartis’ breast cancer drug Afinitor (everolimus) has been knocked back by NICE as “it is not good value for money”.
The drug pricing watchdog said in draft guidance that it could not recommend the drug, in combination with the Pfizer’s drug Aromasin (exemestane), as a treatment for HER2 negative, hormone-receptor-positive advanced breast cancer for a particular group of postmenopausal women.
NICE said that the evidence for the drug’s efficacy was positive, median progression-free survival (the time point in the trial at which the 50% of people experience either disease progression or death) with Afinitor and Aromasin was 4.6 months longer than with Pfizer’s drug alone.
But the Institute concluded that the clinical trial data ‘generated uncertainty’ relating to the efficacy of the treatment compared with relevant chemotherapy regimens, and how much the treatment could extend overall survival, the golden endpoint in oncology trials.
The price for a pack of 10mg tablets (with 30 tablets per pack) is £2,970, although Novartis has offered a confidential patient access scheme, which cuts the price of the medicine.
But NICE said that this cost, even with a patient access scheme, was still 68,000 per QALY gained, more than double the normal threshold of £30,000 per QALY.
Sir Andrew Dillon, NICE’s chief executive, said: “We are committed to making sure the NHS provides the treatments that can make the greatest difference to people’s lives. This means weighing up how well a treatment works and comparing it to similar treatments in the NHS while also taking into account any associated side effects and the cost that the health service is being asked to pay.”
“Unfortunately, while the evidence presented to the independent Appraisal Committee suggested that everolimus with exemestane could delay the growth and spread of breast cancer by four to five months, the evidence did not allow the Committee to establish how long everolimus could actually extend a person’s life for, compared with exemestane alone. Using the evidence available, the committee concluded that everolimus is not a cost effective treatment option for the NHS.”
In a frank statement, Dillon said that NICE was ‘disappointed’ that the evidence for the drug wasn’t stronger. “Especially as we acknowledge that the drug could represent a new way of treating HER2 negative, hormone-receptor-positive advanced breast cancer by restoring a tumour’s sensitivity to hormone therapy,” he added.
If Novartis or any other stakeholders do not appeal against the decision, NICE said it expects to publish its final guidance on Afinitor next month.
There are different types of breast cancer but hormone-receptor-positive breast cancer is the most common form. Novartis estimates that around 1,500 people would be eligible to receive its drug in England, if it were to be recommended.
Afinitor has a number of European licences, including for pancreatic neuroendocrine tumours and advanced renal-cell carcinoma.
Ben Adams
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