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Sofosbuvir: Indication of added benefit for specific patients
Date:5/2/2014

QWiG therefore recognizes an indication of a benefit for sofosbuvir.

No quantitative conclusion on harm possible

The data on side effects contained in the dossier could only be assessed to a limited extent. The manufacturer presented these data on the basis of the proportions of patients with at least one event. However, this type of analysis is only suitable to a limited extent because the observation period of the patients was different in the two study arms.

Severe adverse events only occurred once in each of the two study arms. A statistically significant difference in the outcome "treatment discontinuation due to adverse events" in favour of sofosbuvir was not robust in the sensitivity analyses performed by IQWiG. With regard to side effects, IQWiG therefore considers the added benefit as not proven.

Overall positive effect remains

For treatment-naive patients with genotype 2 chronic hepatitis C, an overall positive effect of sofosbuvir in comparison with the appropriate comparator therapy remains with regard to serious secondary diseases. The extent of this added benefit which was determined with the surrogate "SVR" is non-quantifiable, however, because it is unclear how often the development of liver cancer can in fact be prevented. With regard to side effects, an assessment was only possible to a limited extent. Greater harm from sofosbuvir is unlikely, however, so that it would not be justified to downgrade the added benefit.

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 assessm
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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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