Things are looking bleak for Pierre Fabre's Javlor after cost regulators turned down the drug again as a treatment for advanced or metastatic transitional cell carcinoma of the urothelial tract.

The National Institute for Health and Clinical Excellence has issued final draft guidance in which it does not recommend the use of Javlor (vinflunine) on the National Health Service, after ruling that the cost of the drug is simply too high given uncertainties in the evidence presented.

According to NICE chief executive Andrew Dillon, Pierre Fabre has failed to provide conclusive evidence on how effective Javlor is, "particularly the extent to which it can prolong survival compared with best supportive care".

Added to which, the Institute's Appraisal Committee also has doubts over whether the drug's side effects, including severe constipation, have been fully taken account of in the economic valuation.

The Committee calculated that, based on the evidence provided, Javlor carries an estimated cost per quality adjusted life year gained of more than £120,000, and so well above its cost effective threshold.

Nevertheless, the news will come as a disappointment to many, given that there are currently limited treatment options for the condition and Pierre Fabre claims that its drug is the only one to have shown a 50% improvement in survival in patients compared with best supportive care.

Tarceva ousted

Elsewhere, the Institute has published final draft guidance rejecting Roche's Tarceva (erlotinib) as a maintenance treatment for people with non-small-cell lung cancer, again because of uncertainties in the data supporting its effectiveness in this setting.

While conceding that Tarceva has been shown to have some clinical benefit, with Roche estimating it can potentially extend life by around three months, the Committee felt the evidence was not sufficiently robust to demonstrate this extension to life, NICE said.

The cost watchdog had already approved Eli Lilly's Alimta (pemexetred) as a maintenance therapy for the condition, but while this was shown to offer a potential additional 5.2 months of life to patients, "it is uncertain how much benefit [Tarceva] can offer as a maintenance treatment", Dillon explained.

The Committee's best estimate for the base case incremental cost for Tarceva versus best supportive was "considerably greater than £50,000 per QALY gained", and so the drug could not be recommended as a cost-effective use of NHS resources.