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NICE rejects Sanofi's Jevtana, citing cancer drug's side effects

Final draft guidance also takes issue with prostate cancer treatment's high cost

The UK's National Institute for Health and Clinical Excellence (NICE) has rejected Sanofi's Jevtana as a second-line treatment for prostate cancer despite the fact that it has been shown clinically to prolong life by around three months.

NICE's final draft guidance does not recommend Jevtana (cabazitaxel) in combination with prednisone or prednisolone in prostate cancer that had progressed despite treatment with docetaxel because of the side effect burden with the drug, according to the agency's chief executive Sir Andrew Dillon.

Dillon said the independent committee reviewing the drug for NICE was "concerned about the nature of the health-related quality of life information provided by the manufacturer".

The NICE panel took issue with the risk of haematological adverse events and diarrhoea with Jevtana, and also that in the TROPIC trial - which formed the basis of its approval - more participants on Sanofi's drug died from cardiac and renal complications than in the control group, who were treated with mitoxantrone.

Dillon said: "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant resources the NHS would need to make available.

“Although cabazitaxel has been shown to be effective in extending life, it is also associated with a number of side effects.”

The most common adverse events were related to Jevtana's suppression of bone marrow, with these including a reduction in the number of both red and white blood cells, as well as platelets in the blood.

Gastrointestinal events, such as diarrhoea, also occurred in patients, along with fatigue, nausea and 13 other 'very common' side effects reported by NICE.

NICE appraisal committees generally recommend treatments that cost around £30,000 per quality-adjusted life year (QALY) or less, and the agency estimated the cost per QALY for Jevtana would be more than £89,000, well above that threshold.

Each cycle of treatment with Jevtana costs approximately £3,700 and, as the average number of cycles given to patients in clinical trials was six, treatment would cost a median of £22,200 per patient, NICE said. In contrast, Sanofi's Taxotere brand of docetaxel costs around £8,000 per patient.

The final ruling has been condemned by the Prostate Cancer Charity, which pointed out that Jevtana is one of only two licensed drugs in the UK that have been shown to extend survival in this setting.

"This decision is a huge blow to men living with the very advanced stages of prostate cancer who currently have very limited treatment options open to them," said the charity's chief executive Owen Sharp.

He noted that some men in England may be able to secure access to Jevtana via the Cancer Drugs Fund set up in 2010, but Welsh patients will have to apply for special funding. Around 100 men have already received it via the Fund, according to Sanofi.

Jevtana is Sanofi's follow-up to Taxotere, which is now facing generic competition in the EU and US. In the first nine months of 2011 Jevtana brought in €141m, going some way towards alleviating the 54 per cent drop in Taxotere sales to €772m.

Final guidance is still to be decided, with an appeal period for the appraisal open until January 26, 2012.

13th January 2012

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