ARTICLE | Clinical News

Faslodex fulvestrant regulatory update

December 19, 2011 8:00 AM UTC

The U.K.'s NICE issued final guidance recommending against Faslodex fulvestrant from AstraZeneca as an alternative to aromatase inhibitors to treat estrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women whose cancer has relapsed or progressed. The guidance is in line with a November final appraisal determination (see BioCentury, Nov. 14).

The committee said the most plausible incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained for Faslodex compared with anastrozole, a generic aromatase inhibitor, is £35,000 ($54,513), but that the estimate still had "considerable uncertainty." NICE added that the company did not conclusively show that Faslodex extends life or delays tumor progression any more than aromatase inhibitors. NICE usually considers products with ICERs less than or equal to £30,000 per QALY to be cost-effective. ...