Afinitor everolimus regulatory update

The U.K.'s NICE issued final guidance recommending against Afinitor everolimus from Novartis for second-line treatment of advanced renal cell carcinoma (RCC). The agency said it could not recommend Afinitor as a cost-effective use of NHS resources despite a revised patient access scheme in a November final appraisal determination (FAD) and satisfying the criteria for a life-extending, end-of-life treatment. The guidance is in line with two previous FADs and rejects appeals by Novartis and charity organization Kidney Cancer U.K. of the November FAD (see BioCentury, Dec. 6, 2010 & Jan. 10, 2011).

The committee determined Afinitor's most likely incremental cost-effectiveness ratio (ICER), including the patient access scheme, would be about £51,700 ($84,080) per quality-adjusted life year (QALY). NICE noted the ICER was higher than those considered acceptable for end-of-life treatments to date. It is generally accepted that a technology must have an incremental cost less than or equal to £20,000-£30,000 per QALY for the agency to consider it cost-effective. ...