NICE has opened a consultation on a drug for severe gout.
The draft guidance does not recommend pegloticase (Krystexxa), within its marketing authorisation, for treating severe debilitating chronic tophaceous gout in adults.
People currently receiving pegloticase in circumstances where it is not recommended by the draft guidance should be able to continue treatment until they and their clinician consider it appropriate to stop.
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. Gout 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.
Considering the evidence presented, the Committee concluded that pegloticase effectively lowers the level of uric acid in the blood for a significant proportion of patients with severe gout. However the Committee noted the risk of serious adverse reactions, and concluded that there was considerable uncertainty about the long-term efficacy and safety of pegloticase. As the cost per quality-adjusted life-year was considered to be over £66,000, which is above the £20-30K range normally considered cost-effective, the committee's provisional recommendation is that pegloticase 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 recognise that severe debilitating chronic tophaceous gout can be an extremely difficult condition, greatly affecting a person's quality of life. However, the evidence available to the committee showed that there was considerable uncertainty about the long-term efficacy and safety of pegloticase, and a very high cost compared with the known benefit, so the Committee concluded that pegloticase had not been shown to be a cost-effective use of NHS resources as a treatment option for this condition. We welcome comments on these draft recommendations as part of the consultation.'
This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.