NICE issues new and positive draft guidance on abiraterone acetate

According to information on the web site of the National Institute for Clinical Excellence (NICE), revised draft guidance has been issued by NICE regarding the routine use of abiraterone acetate.

As we had suggested might be the case, the revision has come after abiraterone’s manufacturer, Janssen, submitted additional information to NICE that included a revised patient access scheme with provision of the drug at a lower cost. Based on this and other related factors, NICE has now stated that the available data “have enabled the committee to revise its preliminary recommendation and now recommend the drug for use on the NHS.”

It would appear that appropriate patients in England (and potentially in other parts of the United Kingdom) should shortly be able to have access to treatment with abiraterone acetate at a price that their nationalized health systems consider affordable.

One Response

  1. This is really good news that NICE have finally approved abiraterone (Zytiga) for use on the NHS in England for the treatment of metastatic prostate cancer. This was the final hurdle in a long haul of regulatory requirements spanning over 20 years of clinical development and trials with each step of the clinical trial process requiring regulatory approval. This drug was invented in 1990 so questions should be asked as to why it takes 22 years of bureaucratic hurdles before a research development that has resulted in a new treatment has to take so long to be available to the people with prostate cancer that need it. People with prostate cancer have been waiting for this drug ever since the news broke out 8 years ago in 2004 of its 80% response rate against the most advanced forms of prostate cancer in phase II clinical trials at the Royal Marsden Hospital. Some of these patients from the various trials are still alive now, several years after the trials started. The drug then had to proceed through phase III trials involving 1,200 patients worldwide before it was approved by the FDA and European regulatory authorities in April 2011. Now NICE have actually recommended abiraterone for use on the NHS, and the people in the UK who need it can at last benefit from this drug. Usually whatever NICE approves is taken up in all four member countries of the UK, so the approval by NICE will eventually mean this drug will be available throughout the UK.

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