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NICE rejects Pierre Fabre's bladder cancer drug Javlor

Says drug received final draft 'no' because pharma company failed to prove efficacy

NICE (National for Health and Clinical Excellence) 

NICE has handed Pierre Fabre a final draft rejection for its bladder cancer drug Javlor (vinflunine) after deciding the pharma company had failed to prove the drug's efficacy.

Javlor received a negative recommendation for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract which has progressed following prior treatment with platinum-containing chemotherapy.

It's the second time the drug has been through the final appraisal determination (FAD) process after Pierre Fabre previously successfully appealed NICE's first negative FAD.

This forced the NICE's appraisal committee to reconsider its initial draft guidance, taking account of the whole population for whom vinflunine is licensed, using the comparator treatment originally outlined in the appraisal scope (ie best supportive care).

But having done so NICE nevertheless decided Javlor's high cost and 'inconclusive evidence' meant it couldn't back the drug's use.

NICE chief executive Sir Andrew Dillon said: “When we recommend the use of expensive treatments designed to extend life, we need to be confident about the nature and the extent of the benefit they bring.

"In the case of vinflunine, the manufacturer has been unable to provide the appraisal committee with conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care.”

The manufacturer estimated that around 800 to 1,500 patient would be eligible for treatment with Javlor, but NICE decided that although there is some evidence to indicate the drug can extend life for patients with transitional cell carcinoma, there is “considerable uncertainty around the estimates provided by the manufacturer”.

Based on the recommended dosage of Javlor, a course of treatment costs the NHS about £9,817.50 excluding administration costs and, NICE noted, Pierre Fabre did not submit a patient access scheme for consideration.

The committee considered the most plausible incremental cost effectiveness ratio for Javlor compared with best supportive care to be in excess of £120,000 per QALY gained, well above anything that NICE has previously accepted as cost effective.

The final draft guidance is now with consultees, including Pierre Fabre, who have the opportunity to appeal against it before NICE issues final guidance to the NHS, which is expected to come in December.

12th November 2012

From: Sales, Healthcare



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