A new drug for breast cancer which extends women's lives by almost six months, and was trialled in the North East, is to be blocked from routine NHS access under draft guidance issued by a health watchdog.
Kadcyla, manufactured by Roche, can cost more than £90,000 per patient and is not effective enough to justify the price the NHS is being asked to pay, the National Institute for Health and Care Excellence (Nice) said.
The watchdog, which decides which new medicines are cost effective, said its guidance for Kadcyla, manufactured by Roche, was in draft form and is now up for public consultation.
Meawhile patients will be able to apply to their local NHS and to the Cancer Drugs Fund (CDF) for the drug, a Nice spokeswoman said.
But the decision, if made final later this year, would mean the drug would not be recommended for routine use in England on the NHS and women would have to rely on their doctors' successful application to the Cancer Drugs Fund.
– Sir Andrew Dillon, Nice chief executive
"I hope Roche will act in the best interest of patients and use the consultation period to look again at their evidence and consider if there is more they could do.
"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.
"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."
– Jayson Dallas, general manager, Roche Products Limited
"Roche is extremely disappointed that Nice has failed to safeguard the interests of patients with this advanced stage of aggressive disease.
"The extension to the Cancer Drugs Fund was welcome news for those in England, meaning patients in the UK are some of the first in Europe to be able access medicines like Kadcyla.
"With Nice currently consulting on guidelines for 'value-based assessment', it will be important that they arrive at a sustainable solution that builds upon the success of the CDF, and ensures that patients continue to have rapid access to much needed cancer medicines."
– Professor Paul Ellis, lead triallist for Kadcyla
"Kadcyla 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."
Kadcyla is currently given to breast cancer patients who have failed on conventional treatment with Herceptin and chemotherapy.
The drug is only suitable for patients with the defective Her2 gene and trial results have shown it can extend life by six months compared with treatment with two other drugs, lapatinib (Tyverb) and capecitabine (a type of chemotherapy).
Kadcyla is designed to penetrate cancer cells and destroy them from within and, because its action is so precise, a normally toxic form of chemotherapy can be used.
Clinical trial results have shown that women on Kadcyla survived 30.9 months compared with 25.1 months for patients treated with lapatinib and capecitabine.
The Cancer Drugs Fund (CDF) was set up for patients in England to access drugs approved by doctors but which have not been given the go-ahead for widespread use on the NHS.
The scheme was set to run until March this year but David Cameron announced last September that the funding programme will run for a further two years to March 2016.
Breakthrough Breast Cancer said currently an estimated 1,500 women in Britain could benefit from Kadcyla every year.
A spokeswoman for Roche added that the company would be working closely with Nice as part of the consultation period before final guidance is issued.
She said Kadcyla costs £5,908.16 per month and in the key Phase III study of the drug, patients were treated for an average of 9.6 months at a cost of just under £57,000. But she added that every patient responds differently to treatment.