Cost regulators for the NHS in England and Wales have ruled that Pfizer's Ibrance is too costly in relation to its benefits as a treatment for breast cancer to be funded by the health service.
The National Institute for Health and Care Excellence has published draft guidelines rejecting the drug's use to treat hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer.
Ibrance (palbociclib) is the first of a new type of drug that increases the effect of aromatase inhibitors, which block the production of the hormone oestrogen, stopping its ability to stimulate some breast cancers to grow.
The committee found that the drug stalled the growth of the cancer for an extra 10 months on average, but concluded that although it was likely that this would result in some improvement in overall survival, this could not be quantified from clinical trials undertaken.
It is estimated around 5,500 people in England would be eligible for treatment with Ibrance, a full course of treatment with which costs £79,650.
"The committee needs more evidence of the drug's impact on overall survival of people with breast cancer. However, even when allowing for these potential benefits, it was still not enough to make palbociclib cost effective at its current price," said Professor Carole Longson MBE, director of the centre for health technology assessment at NICE.
The Institute of Cancer Research, London, said it is disappointed Ibrance will not be made available to patients and is calling for "urgent discussions to reduce the price of the drug".
"Palbociclib is one of the most important advances in treating the most common type of breast cancer in 20 years. Clinical trials show the drug can substantially slow the progression of the disease and help delay chemotherapy, which often has life-limiting side-effects," noted Dr Nicholas Turner, team leader in Molecular Oncology at The ICR and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, also one of the clinical experts on the NICE panel and lead investigator on the PALOMA-3 trial, which assessed a combination of palbociclib and fulvestrant.
"It is very disappointing that palbociclib is not being made available to patients, but cost is the limiting factor. If the manufacturer, NICE and NHS England can find a way of making this treatment available for patients, they will substantially improve the lives of patients with breast cancer."
"Rapid action is needed to ensure that exciting new treatments like palbociclib are priced at a level that allows them to be judged cost-effective," said Professor Paul Workman, chief executive of The ICR, London.
"In the short term that means urgent discussions to get the price of palbociclib down. In the long term it will require large-scale changes to the whole system of creating new cancer treatments, to reduce the cost of drug development and ensure savings are passed on to the NHS".