UK's NICE negative on Sanofi's Jevtana, but backs Botox for migraine

Confirming previous negative guidance (The Pharma Letter January 12), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), has today (11 May) published final guidance in which it recommends against the routine National Health Service use of French pharma major Sanofi’s (Euronext: SAN) Jevtana (cabazitaxel) in combination with prednisone or prednisolone as a second line treatment for prostate cancer.

Commenting on the guidance Sir Andrew Dillon, chief executive of the NICE, said: “Although cabazitaxel can extend life for some patients, its price remains well above what the independent Committee appraising this drug considered acceptable, given the benefits it offers. Cabazitaxel is also associated with a number of side effects, and the Committee was concerned about the nature of the health-related quality of life information provided by the manufacturer.”

The Appraisal Committee considered that the most plausible Incremental Cost Effectiveness Ratio (ICER) for cabazitaxel in combination with prednisone or prednisolone would be above £87,500 ($141,391) per QALY gained. The drug did meet the criteria to be considered under the NICE’s end of life considerations. However, the Committee considered that the additional weight needed to bring the ICER into the range considered a cost-effective use of NHS resources was too great. Each cycle of treatment with cabazitaxel costs approximately £3,700. The median number of cycles received in the TROPIC study was 6; therefore cabazitaxel would cost a median of £22,200 per patient. No patient access schemes were submitted by the manufacturer during the course of this appraisal, the NICE noted.