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NICE rejects Sanofi’s Jevtana

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NICE rejects Sanofi’s Jevtana

Published on 12/01/12 at 09:49am

NICE is not recommending Sanofi’s prostate cancer drug Jevtana due to its high cost and questions over its safety.

In final draft guidance the watchdog has not recommended Sanofi’s Jevtana (cabazitaxel), with steroids prednisone or prednisolone, as a second-line treatment for hormone refractory metastatic prostate cancer.

Sanofi’s older chemotherapy drug docetaxel is currently used as a first line treatment for the disease, and costs around £8,000 per patient.

NICE calculates that Jevtana would cost a median of £22,200 per patient for six rounds of treatment, each costing around £3,700 each.

The chemotherapy agents currently available for treatment in this setting include mitoxantrone, 5FU, and carboplatin, which are all much cheaper than Jevtana.

Sanofi’s drug has been shown to increase overall survival by more than three months, but NICE questions whether this data is accurate.

The watchdog also said the drug came with a high risk of side effects, including anaemia, leukopenia, neutropenia, and thrombocytopenia and gastrointestinal events such as diarrhoea.

Other very common adverse reactions include fatigue, nausea, vomiting, constipation, asthenia, haematuria, back pain, anorexia, pyrexia, dyspnoea, abdominal pain, dysgeusia, cough, arthralgia, and alopecia.

Sir Andrew Dillon, chief executive of NICE, said:“Although cabazitaxel has been shown to be effective in extending life, it is also associated with a number of side effects.”

He added that the committee was ‘concerned about the nature of the health-related quality of life information’ provided by Sanofi.

“Once these factors had been taken into account, the independent committee appraising this drug concluded that it would not provide enough health benefit to justify its cost, which means it would not be a cost effective use of limited NHS resources.”

This could be bad news for Johnson & Johnson’s targeted prostate cancer drug Zytiga (abiraterone), which had its first NICE appraisal meeting on 5 January.

J&J’s drug has a similar European licence to Jevtana, but its drug costs around £25,000 per patient.

Cancer drugs fund

Both drugs will continue to be made available via the £200 million cancer drugs fund, which seeks to make new cancer treatments available to doctors and patients if they are not recommended by NICE.

Zytiga is one of the most approved treatments coming from the fund in the last nine months, with 480 approvals between April and December last year.

According to a Freedom of Information request by the Rarer Cancers Forum, Jevtana was much lower on this list, with just 98 approvals.


by : Anonymousdisease : NA place : NA Number of cases : unknown