IQWiG finds no added proven benefit for Astellas' fidaxomicin in Clostridium difficile infection

In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) says there is currently no proof of an added benefit of Japanese drug major Astellas (TYO: 4503) fidaxomicin (trade name Dificlir in Europe and Dificid in the USA). Dificlir has been approved in Germany since December 2011 for the treatment of adults who have diarrhea caused by Clostridium difficile.

The IQWiG said that Astellas did not submit any studies on non-severe cases. It cited studies on severe courses of disease and recurrences, but did not process the results in a way that would make it possible to draw reliable overall conclusions on benefit and harm of fidaxomicin.

For this benefit assessment, the Federal Joint Committee (G-BA) distinguished between three treatment situations, and hence also specified different drugs as appropriate comparator therapy: in courses of the disease that were not severe, but required treatment, fidaxomicin was to be compared with the antibiotic metronidazole; in severe cases and in patients with recurrence, with vancomycin, another antibiotic.