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NICE gives green light to Sanofi's Jevtana for prostate cancer

Undisclosed discount for NHS encourages U-turn to back the chemotherapy drug

Sanofi's taxane chemotherapy drug Jevtana has been backed for routine use on the NHS by the National Institute for Health and Care Excellence (NICE).

The recommendation comes three years after NICE rejected Jevtana (cabazitaxel) for hormone-refractory prostate cancer - and after Sanofi agreed an undisclosed discount on the drug's price in the UK.

The UK cost-effectiveness watchdog said Jevtana can now be used in combination with prednisone or prednisolone as a treatment option for metastatic hormone-relapsed prostate cancer (mHRPC) in England.

The drug has been available via the Cancer Drugs Fund since NICE first rejected it, apart from a period when it was de-listed between December 2014 and May 2015. Sanofi was able to get the drug re-listed on appeal, and it has been administered to around 770 patients under the CDF scheme in the last 18 months.

The Scottish Medicines Consortium (SMC) is due to deliver its own verdict on the drug next month, after first rejecting it in 2011. Meanwhile, NHS Wales and Health and Social Care Northern Ireland are expected to follow NICE's recommendation.

Prostate cancer is currently the most common cancer in men and kills about 10,500 men in the UK every year.

Most prostate cancers become resistant to hormone therapy over time and Jevtana is now the only remaining NICE-approved chemotherapy option for advanced forms of the disease that do not respond to hormone therapies and prior treatment with docetaxel.

In its original ruling, NICE said that while the drug had been shown to increase overall survival by more than three months, this was not enough to justify its £22,200 price tag for six rounds of treatment, given that other chemotherapies approved in this setting - such as mitoxantrone, 5-fluorouracil and carboplatin - were so much cheaper.

The average cost of each cycle in light of Sanofi's discount is "commercial in confidence", says NICE, which said that it had changed its position in light of the new price as well as additional published evidence of the drug's efficacy.

Jevtana was Sanofi's biggest-selling cancer drug in 2015, bringing in €321m in worldwide sales.

Article by
Phil Taylor

27th May 2016

From: Regulatory



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