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Fidaxomicin in Clostridium difficile infection: added benefit not proven
Date:7/2/2013

ot proven - however, this was not claimed by the manufacturer either.

Severe cases and recurrences: advantage of fidaxomicin in global cure

The two approval studies provided usable data on the outcome "global cure" for the two subpopulations "patients with severe course of disease" and "patients with recurrence". According to these studies, patients treated with fidaxomicin have better chances of cure than those treated with vancomycin. Here IQWiG derives a proof.

Data on side effects were not analysed appropriately

Side effects were also recorded in both approval studies. However, the manufacturer did not process these data in an appropriate way: The dossier contained information on severe adverse events only for the total study population, including non-severe cases. The manufacturer failed to analyse the data separately for the subpopulation defined by the G-BA. It cannot be excluded that, in a severe course of disease and recurrences, severe side effects are more frequent under fidaxomicin treatment than under vancomycin treatment.

Overall, the pharmaceutical company did not provide sufficient proof in its dossier that the positive effects (global cure) outweigh the negative effects (side effects). Hence an added benefit of fidaxomicin is not proven also in comparison with vancomycin on the basis of the manufacturer's dossier.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

An overview of the results of IQWiG's benefit assessment is given by a German-language execut
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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