A DRUG which extends the lives of women who are dying from an aggressive form of breast cancer has been rejected for widespread use on the NHS after health experts ruled it was not worth the money.
Kadcyla has been hailed as the "best drug in a generation" for women with HER-2 positive breast cancer. It has been shown to keep patients alive for an average of six months longer than treatments that are already available, while also improving quality of life.
However, the drug costs £90,000 for a 14-month course and the Scottish Medicines Consortium (SMC) has refused to let doctors prescribe it, saying it did not believe it offered value for money.
Oncologists had called the drug a "significant step forward" in the fight against a particularly aggressive and difficult-to-treat form of the disease, in which cancerous cells divide and grow at a faster rate.
Patients and cancer charities reacted to the ruling with dismay. It comes after the SMC application process was reformed following concerns patients north of the Border were missing out on expensive new drugs available in other parts of the UK.
After the decision there were fresh calls for a Cancer Drugs Fund in Scotland, while the manufacturers of the treatment faced demands to lower their prices.
James Jopling, Breakthrough Breast Cancer's Director for Scotland, described the development as "devastating" for women who were already coming to terms with the fact that secondary breast cancer would kill them, and said it would shorten hundreds of lives throughout the country.
Writing in The Herald today, Mr Jopling added: "Kadcyla is a drug for women with a terminal disease who have pretty much run out of other effective treatment options. These women are facing conversations with family and friends that none of us would want to have. They want, need and deserve the chance for more time."
It is understood that on average, patients using Kadcyla in trials took it for an average of 9.6 months, costing around £56,000 per patient. It works by releasing chemotherapy only into cancer cells, so damage to healthy cells is minimised and side effects are cut.
Lesley Stephen from Edinburgh who was diagnosed with secondary breast cancer six months ago and would have been treated with Kadcyla in future had it been approved, said she was struggling to understand a decision that she saw as putting a price on her life.
Ms Stephen, 48, added: "It has been hard enough to lose the future life that I had taken for granted, having been diagnosed with this particularly aggressive form of the disease, but knowing that I won't be able to receive a drug that could help to extend my life and also give me a good quality of life is doubly hard.
"I'd like to see someone explain this to my four children, and to all those other children out there who will now lose their mothers sooner than they should."
Health Secretary Alex Neil said he hoped that the drug's manufacturer, Roche, would submit a new application for Kadcyla to the SMC "quickly and at a fair price".
Although doctors will not be able to routinely prescribe Kadcyla in Scotland, patients will be able to apply for it on a case-by-case basis through their local health board.
Roche said that it was disappointed with the ruling and said many women north of the Border would now "miss out completely" on Kadcyla. Although the drug has also been rejected by the NHS in England, Wales and Ireland on cost grounds, Roche said it is available to women in England through the Cancer Drugs Fund there.
Scottish Conservative health spokesman Jackson Carlaw said last night: "No matter what the Scottish Government says, the fact remains women in England can access this drug while in Scotland they cannot. That is an unacceptable position. We have been calling for the creation of a Cancer Drugs Fund for years, and had the SNP listened at the time, it could have been in place by now. That would have taken the sting out of decisions like we have seen today."
SMC chairman Professor Jonathan Fox said he was disappointed the body had not felt able to recommend the drug, despite describing it as an effective medicine.
He added: "We have to consider value for money and take account of the needs of all patients who need treatment, not just those affected by the medicine under consideration. NHS Scotland does not have infinite resources.
"This is a devastating condition and we understand that this decision will be very disappointing for patients.
"Most of our committee members are practising clinicians who care for patients daily and the decision to not recommend a life-extending medicine is never taken lightly."
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