Novartis AG’s Afinitor drug failed to win the backing of the U.K.’s health-cost regulator, which said clinical trial data failed to show that the medicine is worth the cost for use in treating breast cancer.
Women already receiving the drug, also known as everolimus, should continue to do so, the National Institute for Health and Care Excellence said in draft guidance today. If no appeals are received from the company, health professionals or the public, the agency expects to publish final guidance next month. NICE advises the U.K.’s National Health Service on the cost-effectiveness of treatments.
While Afinitor taken with an estrogen-blocking drug slowed cancer by four to five months in a certain group of post-menopausal women, NICE said it couldn’t establish how long the treatment would work by itself. Novartis had agreed to supply the first month of treatment for free, NICE said.
“We are disappointed that the evidence for everolimus isn’t stronger,” Andrew Dillon, NICE’s chief executive said in the statement. The drug could represent a new way of treating a type of breast cancer by restoring a tumor’s sensitivity to hormone therapy, he said.
Afinitor, which is approved in more than 100 countries, had $797 million in sales globally last year. The drug is used to treat breast, renal cell and pancreatic cancer.
“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 Basel, Switzerland-based company said in an e-mailed statement. The method used by NICE to quantify the level of clinical effectiveness, and therefore cost effectiveness, wasn’t reasonable, the company said.
A pack of 30 10-milligram tablets costs 2,970 pounds ($4,420), NICE said. 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.