Pierre Fabre Drug Fails to Win NICE Backing for Bladder Cancer

Pierre Fabre SA had its medicine Javlor rejected by the U.K.’s health-cost agency to treat bladder cancer in patients who have undergone prior treatment.

The agency does not have enough confidence on the benefits of Javlor, also known as vinflunine, to recommend use of the drug, the National Institute for Health and Clinical Excellence said in an e-mailed statement today. NICE, which advises the U.K.’s state-owned National Health Service on what medicines to pay for, issued the final ruling after dismissing an appeal by Pierre Fabre against a preliminary decision.

Javlor typically costs a patient about 9,818 pounds ($15,600) for a course of treatment for metastatic bladder cancer which progressed after prior administration of platinum-containing chemotherapy, excluding administration costs, according to the regulator.

The drugmaker, based in Boulogne-Billancourt, just outside of Paris, was unable to provide “conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care,” Andrew Dillon, NICE’s chief executive officer, said in the statement.

NICE wasn’t persuaded that an extension of life of at least three months had been proven, the agency said in the statement. Pierre Fabre also didn’t propose a patient access scheme for the medicine, NICE said.

Countries including Austria, the Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Spain and Sweden pay for the drug, Pierre Fabre said in a statement.

``Vinflunine is the only agent registered in its indication,'' the company said. ``It has the highest level of evidence ever reported. Even though NICE does not consider reimbursement in the United Kingdom for this limited population, they acknowledge that there is currently no valuable alternative. Vinflunine significantly prolongs survival in patients eligible for treatment.''

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