BioCentury
ARTICLE | Top Story

NICE recommends against Inlyta for RCC

December 7, 2012 2:20 AM UTC

The U.K.'s NICE issued a preliminary appraisal recommending against Inlyta axitinib from Pfizer Inc. (NYSE:PFE) to treat advanced renal cell carcinoma (RCC) in patients who failed treatment with Pfizer's Sutent sunitinib or a cytokine -- its approved indication. The committee noted that the only randomized trial used to support Inlyta compared the drug against Nexavar sorafenib, which is not recommended by the agency, and also did not compare Inlyta to best supportive care. NICE said it was concerned about the "validity and reliability" of Pfizer's "simulated" comparisons of Inlyta and best supportive care in the group that failed Sutent.

Even with an undisclosed discount for Inlyta under a patient access scheme, NICE estimated the incremental cost effectiveness ratio (ICER) for Inlyta in patients who failed treatment with Sutent is about L62,000 ($99,491) per quality-adjusted life year (QALY), but said the figure is "uncertain." The agency said a plausible ICER for patients who failed treatment with cytokines would be more than L50,000 ($80,235) per QALY. The committee said Inlyta met the criteria for a life-extending, end-of-life treatment for patients who failed Sutent, but said Inlyta still could not be considered a good use of NHS resources. Comments are due Jan. 11. NICE has not recommended any drugs for second-line RCC. ...