14 May 2014

A drug which could delay the need for men with advanced prostate cancer to have chemotherapy has been rejected by the National Institute of Health and Care Excellence (NICE) in a draft decision published today (Wednesday 14 May 2014)

Abiraterone - a simple life extending pill which men can take in the comfort of their own home - has already been approved for men with advanced prostate cancer who have previously had chemotherapy. NICE was considering evidence submitted by the manufacturer, Janssen, to extend its use to those who are yet to have chemotherapy. This would allow thousands of men in England and Wales to enjoy the reduced side effects and improved quality of life that abiraterone can offer earlier, on in their treatment.

In making its draft decision, NICE argues that it has not been able to pass abiraterone for use before chemotherapy as a result of Janssen not providing enough data on the benefits of the drug, using a different model than normal to assess its cost-effectiveness and presenting incomplete data from the clinical trial due to it being 'unblinded' early.

At the moment, abiraterone is only available on the NHS for men who’ve already had both hormone therapy and chemotherapy.

If confirmed, the ruling will mean that chemotherapy will continue to be the first treatment option for men with advanced disease who are no longer responding to hormone therapy. Chemotherapy can cause a number of side effects, such as becoming more at risk of infection fatigue and nausea and it involves a number of hospital visits. So it can have a huge impact on a man’s quality of life.

The Scottish Medicines Consortium, which decides if drugs can be prescribed in Scotland, is due to appraise the use of abiraterone pre-chemotherapy in Summer 2014.

Mikis Euripides, Director of Policy and Strategy at Prostate Cancer UK said:

“This news is a huge blow to those with advanced disease who have long hoped for the chance to delay chemotherapy and the debilitating side effects and incessant hospital visits which come with it. In the sixteen months since it became available on the Cancer Drugs Fund in England, pre-chemotherapy abiraterone has become the fund’s second most requested drug, indicating great confidence from clinicians about its benefits at this stage of the disease and great value from patients who, with input from their clinicians, are opting to delay or avoid having chemotherapy.

“It seems unforgiveable that such a powerful and beneficial treatment should be left tantalisingly out of reach. We implore Janssen and NICE to work together to do everything in their power to make this vital treatment available as soon as possible for all in England and Wales who need it. This decision has been delayed once before and it is more than frustrating that still we seem to be no further forward. Men should not be forced to wait a moment longer.”

What can we do now?

We’re calling for NICE and Janssen to work together to overcome the barriers to recommending this drug – but while Janssen are pulling together the clinical evidence, we think it’s important to tell NICE how this decision will affect real people. We want them to hear your experiences of taking abiraterone before chemotherapy by responding to the NICE consultation. Read more and tell your story.

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