Krystexxa pegloticase regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Krystexxa pegloticase from Savient to treat severe chronic tophaceous gout in adult patients - its approved indication. NICE said the most plausible incremental cost-effectiveness ratio (ICER) for Krystexxa would be greater than £66,000 ($103,732) per quality-adjusted life year (QALY) gained. NICE usually considers products with ICERs less than or equal to £30,000 per QALY to be cost-effective. Comments are due Feb. 22, with a second appraisal committee meeting scheduled for March 13.

The committee said pegloticase treatment effectively lowers serum uric acid levels for "a significant proportion" of patients with severe chronic tophaceous gout, but said there is "considerable uncertainty" about the drug's long-term efficacy and safety. The committee also said that treatment duration with pegloticase might be "substantially" longer than 6 months. ...