Savient Pharmaceuticals’ gout treatment Krystexxa (pegloticase) has not been recommended by NICE in draft guidance.

NICE’s independent Appraisal Committee decided the evidence supplied as part of the appraisal raised questions around the drug’s long-term benefits and its cost-effectiveness to the NHS.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said that despite Krystexxa demonstrating clinical benefits “there was considerable uncertainty about the long-term efficacy and safety of pegloticase, and a very high cost compared with the known benefit”.

A consultation period on the decision not to recommend the treatment as an option for severe debilitating chronic tophaceous gout in adults has now been opened.

During the appraisal, NICE analysed evidence supplied by Savient which showed how Krystexxa effectively lowers levels of uric acid for a significant proportion of patients with the form of arthritis.

But despite its benefits to patients, NICE’s Committee noted the risk of “serious adverse reactions” and questioned its long-term benefits. The high cost of the treatment was outside the price range for treatments the NHS can afford – usually between £20,000 and £30,000.

US specialist biopharmaceutical company Savient has appointed a former Bristol-Myers Squibb (BMS) executive as President of its European operations.

David Veitch will set up and lead Savient’s European organisation in order to introduce the company’s gout treatment Krystexxa (pegloticase) to this market.

Savient expects Krystexxa to be available in the EU on a named patient basis for treatment of chronic gout by the end of March.

Veitch has 24 years’ experience in the pharmaceutical industry, including 10 years at BMS, where he became Senior VP of European Marketing and Brand Commercialisation. He has also held managerial positions at SmithKline Beecham, now part of GlaxoSmithKline (GSK).

John Johnson, CEO and President of Savient, said of the company’s new executive: “David has spent more than twenty years in critical pharmaceutical leadership positions within the European markets and has a track record of successfully launching specialty products in Europe.”