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 had chemotherapy. NICE was considering evidence submitted by the manufacturer 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 pre-chemotherapy as a result of Janssen, the drug’s manufacturers, not providing adequate data on the benefits of the drug, using a different model than normal to assess its cost-effectiveness and the data presented from the clinical trial being incomplete due to it being unblinded early. If confirmed, today’s 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.
The Scottish Medicines Consortium 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.”
Notes to Editors:
For more information or interviews, please call Prostate Cancer UK press office on 0203 310 7101.
NICE appraised the use of abiraterone for the treatment of metastatic hormone relapsed prostate cancer on the NHS in England and Wales. Today’s (14th May 2014) decision is draft and is now open to consultation until 5th June 2014. The NICE Committee will then meet again to discuss comments made and are expected to make a final decision by August 2014.
This use of the drug was licensed in January 2013 and in February 2013 NICE announced that there would be a delay to the appraisal process to allow the manufacturer more time to conduct analysis of their results.
Abiraterone was approved for use on the NHS for the treatment of metastatic hormone relapsed prostate cancer previously treated with a docetaxel-containing regime in England and Wales in May 2012 and in Scotland in August 2012 after a campaign for access by Prostate Cancer UK.
Abiraterone is currently available for use before chemotherapy in England on the Cancer Drugs Fund. From April 2013 to March 2014 3,023 notifications were recorded for abiraterone before chemotherapy which makes it the second highest of all the drugs available via the fund.
About Prostate Cancer UK:
• Prostate Cancer UK fights to help more men survive prostate cancer and enjoy a better quality of life. We support men and provide vital information. We find answers by funding research into causes and treatments. And we lead change, raising the profile of the disease and improving care. We believe that men deserve better.
About Men United
• Men United v Prostate Cancer is our call for men to join together in a movement against the common enemy of prostate cancer. The aim is to build a united front of men against this disease. We want to get the message out about one of the UK’s biggest man killers, support men affected by it, and intensify the search for more reliable tests and treatments for the future.