UK's NICE gives initial thumbs down to Pierre Fabre's Javlor for bladder cancer on the NHS

In preliminary draft guidance issued for public consultation yesterday, the UK’s National Institute for Health and Clinical Excellence (NICE) says it has not been able to recommend French independent drugmaker Pierre Fabre’s Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract (bladder cancer) which has progressed following prior treatment with platinum-containing chemotherapy.

Commenting on the latest draft guidance, NICE Chief Executive Sir Andrew Dillon said: "The manufacturer submitted one comparative study for the independent Appraisal Committee to consider. The study compared vinflunine to best supportive care; however it failed to provide the committee with conclusive evidence about the clinical effectiveness of vinflunine, particularly the extent to which it survival is prolonged compared with best supportive care. When we recommend the use of expensive treatments designed to extend life, we need, for the sake of the patients who may wish to use them, to be confident about the nature and the extent of the benefit they bring. Although there is some evidence to indicate that vinflunine can extend life for patients with transitional cell carcinoma, there is considerable uncertainty around the estimates provided by the manufacturer.

Cost well above NICE acceptance levels