A cutting-edge cancer drug developed by experts at a West hospital has again been rejected for routine use on the NHS, sparking a major row between patients, the hospital, the drugs company and the Gover nment.
The Government's body that decides what drugs the NHS can afford, the National Institute for Health and Care Excellence - or NICE - has rejected Kadcyla, a life-extending breast cancer drug which is specifically for women with the HER-2 type of breast cancer. Clinical trials at the Royal United Hospital in Bath showed it doubled the length of time women with the HER-2 type of cancer could expect to live, and dismayed doctors there said it was 'hugely disappointing' that the NICE decided its benefits did not outweigh its cost.
But NICE hit back, accusing the drug's manufacturers Roche of charging too much for the drug, and making it impossible to buy cost- effectively.
Roche said that, given Kadcyla is the eighth 'cuttingedge' breast cancer drug to be turned down by NICE in a row, serious questions needed to be asked about the viability of pharmaceutical firms developing new drugs to tackle cancer, if the NHS would not pay for them.
One in five breast cancer sufferers have the HER-2 type, and existing treatments available on the NHS prolong their life expectancy by just over two years, on average, depending on how early the cancer is caught, and how healthy the patient is.
In the trials at RUH, Kadcyla was found to give an average of 30 months extra life, and to give much fewer side-effects, including hair loss and infections. Dr Mark Beresford, the RUH's consultant oncologist, urged both sides of the row to 'do more' to make sure the drug is widely available.
At the moment, it is being prescribed by a special fund that GPs and consultants have to apply for. That only covers England, only runs until 2016 and is only awarded on an individual basis, leaving all patients in Scotland, Wales and Northern Ireland without any access to the treatment, and some English patients denied too.
"Kadcyla represents an important advance in the treatment of a particularly aggressive form of the disease; the decision not to fund it for routine NHS use is hugely disappointing," said Dr Beresford. "Kadcyla uses 'stable linker' technology to join a targeted antibody with a highly potent chemotherapy and has been shown to extend the lives of women while reducing many of the severe side effects commonly associated with chemotherapy - such as hair loss and infections.
"While women in England can access the drug via the Cancer Drugs Fund, more needs to be done to ensure long-term access to drugs like Kadcyla to ensure that those who need them can benefit from them, now and in the future," he added.
Dr Beresford had worked with the drug's creator Roche, and their boss Dr Jayson Dallas, said the decision by NICE was 'an incredible injustice' for those breast cancer patients, and calls into question the entire way decisions about new drugs are funded on the NHS.
"NICE's rejection of Kadcyla demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer," he said.
But Sir Andrew Dillon, NICE chief executive defended the decision not to allow Kadcyla on to the list for routine prescriptions, and hit back at Roche for charging the nation too much for the drug. He said: "We are really disappointed that Roche were not able to demonstrate more flexibility."
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