The National Institute for Health and Clinical Excellence (NICE) has launched a consultation on new draft guidance in which it does not recommend the use of Sanofi's Jevtana (cabazitaxel) in combination with prednisone or prednisolone as a second-line treatment for prostate cancer.

While NICE appraisal committees normally recommend treatments that cost around £30,000 per quality-adjusted life year (QALY) or less, it has been estimated that the cost per QALY for Jevtana would be more than £89,000, and the appraisal committee therefore concluded that the drug "would not be a cost-effective use of limited NHS resources," says NICE.

Commenting on the Institute's preliminary recommendations, NICE chief executive Sir Andrew Dillon said the manufacturer had provided the committee with one study on the effectiveness of Jevtana, in which the drug was shown to extend life by approximately 10 weeks.

However, despite this evidence of the drug's effectiveness, it is also associated with a number of adverse events, and the committee was particularly concerned about the uncertainty around the effects on patients' renal and cardiac systems, he said.

The panel was also concerned about the validity of the health-related quality of life information provided by the firm, and it did not feel the treatment met the criteria to be considered under NICE's special arrangements for end of life; based on current data, the length of life extension could not be robustly proven to be at least three months, said Sir Andrew.

Once all these factors had been taken into account, it was estimated that the drug's cost per QALY would be more than £89,000, says NICE, which has now put the preliminary recommendations out for public consultation and called for comments by October 21.

"The manufacturer can also consider whether it wishes to reduce the acquisition cost to the NHS of the drug by proposing a patient access scheme, if they wish to do so," NICE suggests.

- In March this year, Jevtana received marketing authorisation from the European Commission for use in combination with prednisone or prednisolone in the treatment of patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing regimen. The decision was applicable in the 27 member states of the European Union (EU), plus Iceland, Lichtenstein and Norway, and follows earlier approvals in the US, Israel, Curacao and Brazil.