G-BA issues three benefit assessments

Germany's Federal Joint Committee (G-BA) issued final assessments for three drugs on Thursday. G-BA said Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) has "significant" additional benefit over docetaxel or pemetrexed-containing chemotherapy in patients with previously treated, advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase ( ALK)-positive -- Xalkori's approved indication. In a February preliminary assessment, the Institute for Quality and Efficiency in Healthcare (IQWiG) said the drug had "no additional benefit" over comparators in the indication, but G-BA said based on data from the Phase III PROFILE 1007 trial, Xalkori leads to a clear improvement in quality of life and a clear reduction in non-serious disease symptoms vs. comparators. Pfizer submitted the data after IQWiG's preliminary assessment. G-BA agreed with IQWiG that Xalkori has "no additional benefit" over best supportive care (BSC) in patients for whom chemotherapy is no longer an option because the company did not submit data for the indication.

G-BA said Type II diabetes drug Komboglyze saxagliptin/metformin from Bristol-Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) provides "marginal" additional benefit over sulfonylurea in combination with metformin. G-BA said Komboglyze led to a reduction in hypoglycemic events vs. the comparator in an additional study that Bristol-Myers and AstraZeneca submitted after IQWiG's preliminary assessment said Komboglyze offered no additional benefit over sulfonylurea. G-BA did agree with IQWiG's assessment that Komboglyze plus insulin has "no additional benefit" over metformin plus human insulin -- the comparator requested by G-BA for Type II diabetics in whom insulin and metformin don't adequately control blood sugar levels. ...