NICE refuses to back Sanofi’s Jevtana
pharmafile | September 30, 2011 | News story | Sales and Marketing | Jevtana, NICE
NICE has not recommended Sanofi’s prostate cancer drug Jevtana due to its high cost and concerns over its safety data.
The second-generation chemotherapy drug is being appraised for use after the failure of Sanofi’s established drug Taxotere (docetaxel) in men with hormone-refractory metastatic prostate cancer.
The watchdog said in new draft guidance that it could not approve Jevtana (cabazitaxel) because of the drug’s high cost and limited clinical data.
Sir Andrew Dillon, chief executive of NICE, said: “Appraisal committees will normally recommend treatments that cost around £30,000 per QALY or less.
“The manufacturer of cabazitaxel provided one study on the effectiveness of the drug; in this study cabazitaxel was shown to extend life by approximately 10 weeks.
“Although cabazitaxel has been shown to be effective, it is also associated with a number of adverse events – the committee was particularly concerned about the uncertainty around the effect on patients’ renal and cardiac systems.”
Dillon said that the committee was also concerned about the validity of the health-related quality of life information provided by Sanofi.
He added that the drug did not meet the watchdog’s end of life criteria, as Sanofi’s current data could not prove Jevtana could extend life by over three months.
“Once all these factors had been taken into account, it was estimated that the cost per QALY would be more than £89,000,” Dillon said, adding that all this meant NICE did not believe the drug would be a cost effective use of NHS resources.
Each cycle of treatment with Jevtana currently costs around £22,200 per patient for six rounds of treatment.
NICE said that the guidance would now be sent out for comments, adding that Sanofi could consider offering a patient access scheme for the drug, which could lower its overall price.
Ben Adams
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