In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) says it does not recommend Sanofi's Jevtana (cabazitaxel), in combination with prednisone or prednisolone, as a second-line treatment for prostate cancer.

Although the drug has been shown to be effective in extending life, it is also associated with number of side effects, and NICE's independent appraisal committee was also concerned about the nature of the health-related quality of life information provided by the manufacturer, said NICE chief executive Sir Andrew Dillon.

The most commonly-occurring adverse reactions with Jevtana relate to bone marrow suppression and include anaemia, leukopenia, neutropenia and thrombocytopenia, and gastrointestinal events such as diarrhoea. For the committee, haematological adverse events and diarrhoea were major concerns, says NICE.

The panel was also concerned that in the TROPIC multinational Phase III trial - of cabazitaxel or mitoxantrone (Serono's Novantrone) with predisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (Pfizer's Taxotere and generics) - more patients in the cabazitaxel arm died from cardiac and renal complications than in the mitoxantrone arm.

Committee members concluded that treatment with Jevtana resulted in a mean improvement of greater than three months in mean overall survival, thus meeting the criteria to be considered under NICE's supplementary advice for end-of-life treatments, and this means that a higher cost per Quality-Adjusted Life Year (QALY) may be accepted. While there is no set threshold cost per QALY for such drugs, since the supplementary advice was introduced the highest cost per QALY of a recommended drug has been £50,000 - for first-line use of Pfizer's Sutent (sunitinib) in renal cell carcinoma.

However, NICE's committee considered that the most plausible Incremental Cost-Effectiveness Ratio (ICER) for Jevtana would be above £87,500 per QALY gained and that therefore 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 the drug costs around £3,700, and as the median number of cycles received in the TROPIC study was six, treatment would cost a median of £22,200 per patient, the panel concluded.

"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," said Sir Andrew.

The draft guidance on Jevtana is now with consultees, who have the opportunity to appeal against it, says NICE, which also points out that the Scottish Medicines Consortium (SMC) does not recommend the drug for this condition.

- Owen Sharp, chief executive of the Prostate Cancer Charity, described NICE's decision as "a huge blow to men living with the very advanced stages of prostate cancer," and added: "we are very concerned that this will lead to a postcode lottery and mean some men will not be able to get cabazitaxel in time for it to benefit them."