Major potential harm in the form of side effects
Overall, the side effect profile of vemurafenib is less favourable than that of dacarbazine, because severe adverse events (according to the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3) and serious adverse events were more frequent in patients who received vemurafenib. The proportion of those who discontinued the treatment due to side effects was comparable in the treatment groups. All in all, IQWiG sees an indication of greater harm from vemurafenib and rates its extent as "major".
Potential for harm reduces the extent of the added benefit
In order to derive proof of benefit from a single study, it must meet special requirements. This particular study does not fulfil them. Therefore no conclusions with the highest probability (proof) are possible - for example, on added benefit; at most indications can be derived from the study.
In summary, there are positive and negative results of the same degree of certainty (indications). On the positive side, the greatest extent - namely "major" - is attained for overall survival. On the negative side, due to side effects, there is an indication of greater harm, and this is also of major extent. For this reason, the Institute downgrades the overall added benefit of vemurafenib relative to the appropriate comparator therapy with dacarbazine from "major" to "considerable".
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
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care