Jevtana side-effects put NICE off

 NICE has failed to recommend Sanofi’s Jevtana (cabazitaxel) as a second-line treatment in combination with prednisone or prednisolone for prostate cancer in final draft guidance.

Concerns were raised by the Appraisal Committee over the various side-effects of the treatment, especially haematological adverse events and diarrhoea, and the information supplied by Sanofi.

Sir Andrew Dillon, NICE Chief Executive, says the Committee concluded the treatment did not provide “enough health benefit to justify its cost”.

The Committee found that the use of Jevtana resulted in a mean improvement of more than three months in mean overall survival. The drug also met the criteria used be considered under NICE’s end of life considerations.

Each cycle of treatment with Jevtana costs approximately £3,700 and would cost around a median of £22,000 per patient.

However, NICE considered that the additional weight needed to bring the Incremental Cost Effective Ratio (ICER), that is usually considered a cost-effective use of NHS resources, was too high. It calculated that the most plausible ICER would be above £87,500 per QALY gained for the treatment. The highest cost per QALY of a recommended drug has been £50,000.

Alongside the major concerns of the side-effects of haematological adverse events and diarrhoea, NICE also found patients suffered from fatigue, nausea, vomiting, constipation, asthenia, haematuria, back pain, anorexia, pyrexia, dyspnoea, abdominal pain, dysgeusia, cough, arthralgia, and alopecia.

“We need to be sure that new treatments provide sufficient benefits to patients to justify the significant resources the NHS would need to make available,” said Sir Andrew Dillon. “Although cabazitaxel has been shown to be effective in extending life, it is also associated with a number of side effects.”