A new cancer drug which targets secondary breast cancer has been rejected by the National Institute of Clinical Excellence (NICE) due to its high cost.
The treatment, Kadcyla, does not work well enough to justify its cost of £90,000 per patient, the clinical watchdog said.
The drug, which is available under the Cancer Drugs Fund, is manufactured by pharmaceutical giants Roche Products Ltd.
It treats people with HER2-positive breast cancer that has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.
Every month in the UK, 1,000 women die from metastatic, or secondary, breast cancer, according to research from Breast Cancer Breakthrough.
Draft guidance by NICE, published for a consultation into the drug, says that despite some evidence of clinical efficacy, it does not work well enough to justify its cost and should not be recommended for routine NHS use.
Sir Andrew Dillon, chief executive of NICE said he had hoped Roche would have reduced the cost of the drug to the NHS given the challenges the NHS faces in adopting expensive new treatments.
Dillon added: "This drug is already being funded through the special Cancer Drugs Fund. Our job is to recommend whether it should transfer into the NHS budget. We are very aware of the importance that people place on life-extending cancer drugs and a decision not to recommend a cancer treatment for routine NHS funding is never taken lightly.
"We apply as much flexibility as we can in approving new treatments, but the reality is that given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer."
Third rejection
The independent Appraisal Committee, which develops recommendations on behalf of NICE, considered evidence from the manufacturer, doctors and patient experts.
It heard that the drug is most likely to be given as a ‘second-line' treatment and could potentially help to extend life by nearly 6 months compared with other drugs available on the market.
However, considering its high costs, the committee concluded that it could not recommend it as a cost-effective use of NHS money.
It will be the third breast cancer drug made by Roche and rejected by NICE based on cost.
NICE's Dillon continued: "We hope the manufacturer will act in the best interests of patients and use this consultation period to look again at their evidence and consider if there is more they can do."
Jayson Dallas, general manager at Roche Products, told the BBC: "Roche is extremely disappointed that NICE has failed to safeguard the interests of patients with this advanced stage of aggressive disease."
Process 'must change'
Meanwhile, Breast Cancer Breakthrough senior policy manager Dr Caitlin Palframan said the drug appraisal process in England and the high cost of drugs must change.
She said: "Drug development and research is moving at a pace that the system can't seem to keep up with. Kadcyla is a very impressive drug that has been shown to extend life by up to six months in HER2-positive secondary breast cancer patients, and with more manageable side effects than alternative drugs.
"We are now looking to the Department of Health and the pharmaceutical industry to find a way to work together to bring the cost of expensive drugs down and put a sustainable system in place by which new treatments can be made available on the NHS on a routine basis.
"Until then it appears NICE will be forced to reject these cutting-edge treatments, some of which are capable of providing women facing terminal breast cancer diagnoses with extra time with their loved ones, which is the very least they deserve."
The draft consultation is open on NICE's website until Monday 19th May 2014.
