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G-BA issues final assessments for Inlyta, aclidinium bromide

March 22, 2013 12:59 AM UTC

Germany's Federal Joint Committee (G-BA) said Inlyta axitinib from Pfizer Inc. (NYSE:PFE) provides a "marginal" additional benefit over requested comparator Nexavar sorafenib to treat advanced renal cell carcinoma (RCC) in patients who have failed treatment with a cytokine. The committee said Inlyta has no additional benefit over requested comparator Afinitor everolimus to treat advanced RCC in patients who failed prior therapy with Pfizer's Sutent sunitinib. In a January preliminary benefit assessment, Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said Inlyta provided a "significant" benefit in RCC patients who have failed a cytokine, and no benefit in patients who had failed Sutent.

Inlyta is approved to treat RCC in patients who failed treatment with Sutent or a cytokine. Pfizer will now negotiate a price for the inhibitor of VEGF receptors 1, 2 and 3 with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband). Bayer AG (Xetra:BAYN) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) market Nexavar, and Novartis AG (NYSE:NVS; SIX:NOVN) markets Afinitor. ...