A Herceptin-style drug that can offer some women with advanced breast cancer nearly six months of extra life has been turned down for use in the NHS because of its high cost.
In draft guidance now open to consultation, the National Institute for Health and Care Excellence (Nice) blames the manufacturers, Roche, who are asking for more than pounds 90,000 per patient, which is far more than any comparable treatment.
But the decision was slammed by Roche and by some breast cancer charities, who say the drug is needed and that Nice has turned down too many breast cancer drugs already.
The drug, called Kadcyla (generic name trastuzumab emtansine), is already being paid for through the dedicated Cancer Drugs Fund set up by government. A decision was made to fund it so that women with advanced breast cancer could receive it immediately it was available, without waiting for Nice's assessment.
But the Nice verdict raises questions about the future of such expensive cancer drugs once the fund ceases to exist at the end of March 2016. At that point, a new pricing scheme for the NHS is intended to be in place, but Nice will still assess whether a drug is worth the price the manufacturer wants for it.
Kadcyla is a new kind of medicine, according to Roche, combining Herceptin (trastuzumab) with a chemotherapy agent. It is designed for women with HER2+ cancer which has spread to other parts of the body and is inoperable.
It is not a cure, but in trials it extended life by a median of 5.8 months, compared with the current combination of lapatinib plus capecitabine.
Nice says the drug does not work well enough to justify the price tag and called on Roche to rethink during the consultation period.
"We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS," said Nice chief executive Sir Andrew Dillon.
"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."
The cost of Kadcyla is tens of thousands of pounds more than existing second-line treatments for this cancer, said Nice.
Professor Paul Ellis, a consultant oncologist at King's College, London, who worked on the drug trials, said in a statement issued by Roche that it "represents a significant advance in HER2-positive breast cancer, so for Nice to issue negative preliminary guidance is a huge blow.
"The drug tackles the disease in a different way to any other breast cancer medicine and provides women with valuable extra time with their families and loved ones - time that you cannot put a price on. Not only this, Kadcyla is also much better tolerated by women than current standard treatment options, causing much less in the way of traditional chemotherapy associated side effects. As such, the quality of life of women taking Kadcyla is significantly improved."
Jayson Dallas, general manager of Roche Products Limited, said the company was "extremely disappointed that Nice has failed to safeguard the interests of patients with this advanced stage of aggressive disease".
Emma Pennery, clinical director at Breast Cancer Care, said: "It's extremely disappointing news for those living with advanced breast cancer and their families that yet another treatment has not been recommended by Nice."
Around 1,000 women a month die of advanced breast cancer, although not all of them have the HER2+ variety which the drug targets.
A spokesperson for NHS England said: "The Cancer Drugs Fund (CDF) provides an additional pounds 200m each year to enable patients to access drugs that are not routinely funded by the NHS. A number of the drugs available to patients through the CDF have previously been appraised by Nice and are not recommended for routine use. It was for this purpose that the CDF was established.
"A negative Nice appraisal on trastuzumab emtansine will not affect the availability of this drug via the Cancer Drugs Fund."