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Rilpivirine for HIV: Added benefit for single agent proven
Date:12/7/2012

ders itself compelled to declare the contents of the dossier as "incomplete".

Dossiers are of a widely differing quality

"What is immediately striking in the assessment of rilpivirine, is the widely differing quality of the two dossiers - although the data on which they are based are practically identical", commented Institute Director Jrgen Windeler. "Whereas one manufacturer has used and suitably processed all the available data, the other has completely excluded one relevant study and has also not properly analysed the two other studies". The motives remain obscure.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can 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.

You can also find easily understandable and brief German-language information about rilpivirine and rilpivirine/emtricitabine/tenofovir on the website gesundheitsinformation.de, published by IQWiG.

The G-BA website contains both general English-language information about the procedure of benefit assessment pursuant to 35a Social Code Book V and specific German-language information on the assessment of rilpivirine and of rilpivirine/emtricitabine/tenofovir.


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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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