G-BA rebuffs Forxiga, Eylea

Germany's Federal Joint Committee (G-BA) issued negative final benefit assessments for diabetes drug Forxiga dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) and ophthalmic drug Eylea aflibercept from Bayer AG (Xetra:BAYN). Both decisions were in line with March preliminary assessments from the Institute for Quality and Efficiency in Healthcare (IQWiG). Drugs that do not have an additional benefit are added to the reference pricing system, which gives a similar base price to all comparable drugs. If there is no reference, the company will negotiate a price no higher than that of the comparator.

G-BA said Forxiga has "no additional benefit" vs. four sets of requested comparators because the submitted data had "methodological deficiencies." The European Commission approved the sodium-glucose cotransporter 2 (SGLT2) inhibitor to treat Type II diabetes in November. In a joint statement, the partners, which market Forxiga in Germany, said they are evaluating next steps. AstraZeneca said it was too soon to comment on whether Forxiga will remain available to German patients (see BioCentury, March 18). ...