Zytiga approved in Wales – for now
pharmafile | February 21, 2012 | News story | Sales and Marketing | AWMSG, CDF, Janssen, NICE, Wales, Zytiga
Janssen’s cancer treatment Zytiga has been approved in Wales, in contrast to its rejection by NICE.
The All Wales Medicines Strategy Group (AWMSG) says that Zytiga (abiraterone acetate) can be used in men who have metastatic, castration-resistant prostate cancer.
The All Wales group approved Zytiga using ‘End of Life’ criteria, which places a lesser burden of efficacy on a drug.
But the decision in Wales will only stand until NICE releases its final guidance, which will override the AWMSG decision if Janssen’s drug is rejected.
Money was the problem for NICE, which said earlier this month that the high price of Zytiga (£35,160 per year) did not outweigh its ability to increase survival by more than three months compared to placebo.
A second NICE appraisal hearing will be held at the beginning of March, with final guidance expected in May.
Cancer Research UK, which helped develop the drug, wants Janssen to lower the price and for NICE to use its own End of Life criteria in order to make Zytiga available in England.
“The AWMSG were able to approve the drug because they used the End of Life criteria,” said Professor Peter Johnson, Cancer Research UK’s chief clinician.
“This shows that if NICE use these criteria, they could negotiate a price that makes abiraterone cost effective for the NHS,” he added.
NICE had declined to do so because the number of men who would get the drug after chemotherapy was not a ‘small population’ – a view that Cancer Research disputes.
The pricing watchdog would not approve Zytiga, in combination with steroids prednisone or prednisolone, as a second line treatment for patients in this setting who have failed on Sanofi’s Taxotere.
It currently recommends lower price alternatives: chemotherapy agents mitoxantrone, 5FU, and carboplatin.
Zytiga has been available via the Cancer Drugs Fund in England, and NICE has already indicated that a revised discount from Janssen could help the drug through its approval process.
Around 37,000 men are diagnosed annually with prostate cancer in the UK, with nearly a quarter of these cases affecting men aged between 40 and 65.
Over 10,000 men die of the disease each year, making it the second most common cause of cancer deaths in UK men.
Adam Hill
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