Regulatory Focus™ > News Articles > NICE Declines to Recommend Krystexxa for Severe Gout

NICE Declines to Recommend Krystexxa for Severe Gout

Posted 27 June 2013 | By Louise Zornoza

The UK's National Institute for Health and Clinical Excellence (NICE) has published final guidance  declining to recommend pegloticase (Krystexxa), within its marketing authorization, for treating severe debilitating chronic tophaceous gout in adults.

Gout is a form of arthritis which causes attacks of painful inflammation in the joints. A gout attack can occur when uric acid levels in the blood become too high and small crystals of uric acid form. These crystals can collect in the joints, which then causes irritation to the joint tissue, leading to the inflammation and pain experienced during a gout attack. It is more common in men, and factors that increase the risk of developing gout include obesity, diabetes, high blood pressure and high consumption of beer and spirits.

Although NICE concluded that pegloticase effectively lowers the level of uric acid in the blood for a significant proportion of patients with severe gout, it noted the risk of infusion reactions and anaphylaxis and concluded is that the drug would not represent a cost-effective treatment option for the NHS.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: "We recognize that severe debilitating chronic tophaceous gout can be an extremely difficult condition, greatly affecting a person's quality of life. Given the uncertainties around the assumptions in the manufacturer's analyses, and the risk of adverse reactions, along with the high cost compared with the known benefit, the Committee concluded in this final guidance that pegloticase had not been shown to be a cost-effective use of NHS resources as a treatment option for this condition. The guidance also says that people who are currently receiving pegloticase should be able to continue treatment until they and their clinician consider it appropriate to stop."

NICE: Final Guidance on Krystexxa for Gout

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