Inlyta axitinib regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending against Pfizer's Inlyta axitinib to treat advanced renal cell carcinoma (RCC) in patients who failed treatment with Pfizer's Sutent sunitinib or a cytokine - its approved indication. The decision is in line with December preliminary appraisal (see BioCentury, Dec. 10, 2012). NICE said Pfizer submitted further analysis after the preliminary appraisal supporting the robustness and reliability of the data produced and the effect of the patient access scheme, but the committee still did not conclude that Inlyta was a cost-effective use of NHS resources. Final guidance is expected next month.

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 cytokines would be more than £50,000 ($76,160) per quality-adjusted life year (QALY) gained. NICE estimated the ICER for Inlyta in patients who failed treatment with Sutent would be £33,500-£52,900 ($51,027-$80,577) per QALY gained, but it said the figure was "uncertain" and was thought to be closer to the higher estimate. 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. NICE has not recommended any drugs for second-line RCC. ...