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.