Cost regulators for the NHS in England and Wales have published draft guidelines barring adults with gout from routine access to Gruenenthal’s Zurampic-based therapy for treating hyperuricaemia.

The National Institute for Health and Care Excellence has published an appraisal consultation document turning down the drug’s use within its marketing authorisation, that is, for treating hyperuricaemia in patients whose serum uric acid is above the target level despite an adequate dose of a xanthine oxidase inhibitor (XOI) alone.

Evidence from two randomised controlled trials showed that a target serum uric acid level is reached in more people having Zurampic (lesinurad) plus the XOI allopurinol than in those taking the latter the drug alone.

“However, the evidence did not show that lesinurad plus allopurinol reduces flares, improves healing of tophi, or lengthens life compared with allopurinol alone, which are more important for patients,” the Institute noted.

The most plausible incremental cost-effectiveness ratio (ICER) for Zurampic/allopurinol compared with allopurinol alone was at least £72,191 per quality-adjusted life year gained, but even this result - which is far above what is normally considered a cost-effective use of NHS resources - is based on the assumption that the treatment prolongs life, for which no robust evidence was submitted, NICE said, further explaining the decision.

A third committee meeting on the appraisal is due to be held on July 19.

The drug won European clearance in February last year. As part of the approval, a Non-Interventional Post-Authorisation Safety Study (PASS) is being conducted to assess the drug’s cardiovascular safety profile, mainly in patients with history of cardiovascular disorder, as well as an EU renal study.

In June 2016, AstraZeneca sold exclusive rights to Zurampic (lesinurad) in Europe and Latin America to Gruenenthal for $320 million plus milestones and royalties.