NICE approves Janssen’s Zytiga for prostate cancer before chemo
pharmafile | March 21, 2016 | News story | Sales and Marketing | Janssen, NICE, Zytiga, prostate cancer
The National Institute for Health and Care Excellence (NICE) has recommended the use of Janssen’s Zytiga (abiraterone acetate) to treat relapsed prostate cancer that has spread prior to chemotherapy.
The news marks a U-turn by the UK cost regulator, which rejected the drug in this indication in draft guidance in December 2015 on the basis of cost, leaving it only available to patients before chemo through applications to the Cancer Drugs Fund.
But Janssen’s negotiations with English health authorities saw the price fall from £3,000 per month for 120 tablets to £2,300, and the drug win NICE’s backing.
In June 2012, NICE approved Zytiga for prostate cancer patients who had already received platinum-based chemotherapy, but the latest green-light opens the drug up to a broader group of NHS patients than ever before.
In its Final Appraisal Determination (FAD), NICE concluded that Zytiga is indeed cost-effective for use before chemotherapy in men with metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer is the most common form of the disease in men. In the UK, some 47,300 people are diagnosed with prostate cancer each year.
Janssen responded by pointing out the lengthy period NICE took to deliberate over the drug’s recommendation in this indication, in contrast to the fact that Zytiga “has been routinely available before chemotherapy for several years in most other European countries – including France and Germany – and that was approved for use on the NHS in Scotland in October last year.”
The company says it proposed a number of different solutions to the Department of Health, NHS England and NICE so that abiraterone could be approved faster for routine use and removed from the Cancer Drugs Fund (CDF), which Janssen says would have “freed up resources for other innovative new medicines.”
Mark Hicken, managing director Janssen UK & Ireland, welcomed the “long overdue decision”, saying: “Patients in England will finally be able to access this innovative cancer medicine routinely on the NHS, putting them on a par with patients in many other European countries who have had access to abiraterone as an option before chemotherapy for some years. We have worked tirelessly for several years to ensure abiraterone, a UK-discovered medicine, which demonstrates long term survival and quality of life benefits for patients, is made widely available for men who cannot have or do not want chemotherapy and are delighted that this is now possible for them.”
Hicken also took aim at the recently-approved changes to the Cancer Drugs Fund, and reiterated calls within the industry to reform to the NICE appraisal system for new cancer drugs.
He says: “Janssen has been successful in making abiraterone before chemotherapy available to men with prostate cancer in 95 countries worldwide, but the length of time taken to gain approval in the UK demonstrates a clear need for reform of the way NICE appraises innovative cancer medicines. We are concerned that the CDF changes recently approved by NICE and NHS England will only exacerbate these problems, resulting in even greater restrictions for cancer patients in England. Janssen will continue to work collaboratively with NICE, NHS England and the Department of Health to create a more flexible system which will support and improve patient access to the best care.”
Joel Levy
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