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NICE won't back early use of Zytiga in prostate cancer

Says Janssen drug should not be used prior to chemotherapy

Janssen Zytiga abirateroneJanssen's Zytiga should remain as a second-line therapy after chemotherapy in England and Wales, according to new recommendations from the NHS health guidance watchdog.

The National Institute for Health and Care Excellence's (NICE) new draft guidance does not back the earlier use of Zytiga (abiraterone) in patients with prostate cancer, and NICE says Janssen's economic model meant the drug would not be a cost-effective use of resources in the indication.

Zytiga was backed in 2012 by NICE for use in combination with the steroids prednisone or prednisolone to treat castration-resistant metastatic prostate cancer that has progressed on or after one docetaxel-containing therapy.

The drug has since been approved in Europe for use in patients in whom docetaxel chemotherapy is not yet clinically indicated, allowing men to delay or avoid this more painful and inconvenient treatment course.

However, Janssen has been unable to convince NICE that it is worth recommending Zytiga in this new indication, with the agency citing concerns about the trial used to support the application.

According to NICE, the clinical evidence submitted by Janssen came from one trial, which – despite showing Zytiga delayed disease progression compared to placebo – was stopped early and was unable to prove that the drug improves survival.

NICE also noted that there were a number of issues with the way Janssen calculated estimated cost-effectiveness, claiming the economic model was “particularly complex” and not transparent enough.

In its response, Janssen criticised NICE's decision not to assess the drug under its end-of-life criteria, as per the original Zytiga guidance. This criteria is a special consideration given by NICE to drugs for patients with short life expectancy and means treatments can exceed the standard cost-effectiveness threshold.

Charities also responded to the latest guidance. Prostate Cancer UK implored NICE and Janssen to work together on letting NHS patients gain access to the drug in this new indication and avoid chemotherapy.

The charity's director of policy and strategy Mikis Euripedes 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.”

There is now a consultation process during which time NICE invites comments from Janssen and other stakeholders. Further draft guidance will follow later in the year.

Article by
Thomas Meek

14th May 2014

From: Sales

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