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NICE changes tack on Sanofi's prostate cancer drug Jevtana

Approves the therapy for NHS use after accepting undisclosed additional discount 

The National Institute for Health and Care Excellence (NICE) has given a green light to Sanofi's Jevtana after negotiating a discount from the company.

The UK cost-effectiveness agency rejected the use of Jevtana (cabazitaxel) by the NHS in England and Wales in 2012, although the drug was made available to around 550 patients via the Cancer Drugs Fund (CDF) until it was de-listed last year.

It was returned to the CDF on appeal by the manufacturer and will remain on the CDF until NICE's announcement is confirmed in four weeks' time.

The agency has published new final guidance backing the use of Sanofi's drug in combination with prednisone or prednisolone to treat metastatic hormone relapsed prostate cancer in people whose disease has progressed during or after docetaxel chemotherapy.

The change of heart comes after Sanofi offered an undisclosed additional discount on Jevtana's list price and also agreed to make the drug available in intravenous bags as well as vials, reducing waste and making administration more efficient.

Previously, NICE said that Sanofi had been unable to demonstrate that Jevtana was cost-effective compared to standard treatments such as Johnson & Johnson's Zytiga (abiraterone), Astellas/Medivation's Xtandi (enzalutamide) or radium-223 dichloride.

Prof Carole Longson, director of the Centre for Health Technology Evaluation at NICE said: "In these times of austerity, it is even more important to ensure that we're getting good value for the NHS.

"This is an excellent example of how pharma companies can work with us to ensure that patients have access to all of their treatment options."

NHS clinical commissioners have three months to ensure the drug is routinely available in their areas.

Medical charity Prostate Cancer UK's Heather Blake said: "It's good news that cabazitaxel is now going to be routinely available to those men who need it.

"This important drug can offer precious extra time to men who are dealing with the latter stages of prostate cancer."

Blake pointed out that NICE also recently reversed its decision on Zytiga and welcomed that NICE has "shown flexibility in its procedures in order to make this decision".

She also welcomed the manufacturer's eventual price cut to get the treatment into clinics, but argued it should have come sooner.

"In future, realistic price negotiations should begin from the outset to avoid leaving men in limbo during lengthy discussions further down the line."

The Scottish Medicines Consortium (SMC) is due to deliver a verdict on Jevtana in the coming weeks, noted Prostate Cancer UK.

Article by
Phil Taylor

25th April 2016

From: Regulatory



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