1.1 Lesinurad is not recommended within its marketing authorisation, that is, with a xanthine oxidase inhibitor for treating hyperuricaemia in adults with gout whose serum uric acid is above the target level despite an adequate dose of a xanthine oxidase inhibitor alone.
1.2 This recommendation is not intended to affect treatment with lesinurad that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made this recommendation
Drug treatments for gout include 2 xanthine oxidase inhibitors, allopurinol or, if that is not tolerated, febuxostat. Evidence from 2 randomised controlled trials shows that more people on lesinurad plus allopurinol reach a target serum uric acid level than people on allopurinol alone. This outcome is seen as clinically relevant when treating gout, but the number of flares and tophi healing are more important outcomes for patients. It is plausible that lowering serum uric acid levels reduces the number of flares and improves healing of tophi, but the clinical evidence does not show that lesinurad plus allopurinol improves these outcomes compared with allopurinol alone.
The main factors affecting the cost effectiveness of lesinurad are the assumptions that lowering serum uric acid levels in people with gout improves quality of life and that it prolongs life. Results from observational studies suggest that people with chronic gout have a shorter life expectancy than people without gout. However, there is no robust evidence from randomised trials to show that lowering serum uric acid levels extends life.
The preferred cost-effectiveness estimate for lesinurad plus allopurinol compared with allopurinol alone is £62,298 per quality-adjusted life year gained. However, this estimate is not based on comparing lesinurad plus allopurinol with the highest possible dose of allopurinol, so the most plausible cost-effectiveness estimate could be even higher. Because this is substantially above the range normally considered by NICE to be a cost-effective use of NHS resources, lesinurad cannot be recommended.