EUnetHTA releases draft guidelines on relative effectiveness

The European network for Health Technology Assessment (EUnetHTA) released four draft guidelines covering methods for conducting relative effectiveness assessments (REA) of new drugs, including appropriate comparators and use of composite and surrogate endpoints. According to one guideline, the most appropriate comparator should have "good quality evidence on effect size," and should be approved in the EU. If there is no European-wide agreed upon reference comparator, the guideline says each assessing agency needs to provide evidence showing the chosen comparator is routinely used in clinical practice.

According to EUnetHTA, composite endpoints should only be used for effectiveness assessments when a suitable single endpoint is not available, and each component of the composite endpoint should be reported separately. The group also says surrogate endpoints may be used for an assessment if there is a clear link between the surrogate and a clinical endpoint. Comments on the draft guidelines are due Sept. 10. ...