No proof of added benefit of Trobalt (Glaxo Smith Kline) for Epilepsy

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether retigabine, from Glaxo Smith Kline, offers an added benefit compared with the present standard therapy for Epilepsy. It found that no such added benefit can be inferred. The Federal Joint Committee (G-BA) had specified lamotrigine as the appropriate comparator therapy if this drug is used as an add-on. In cases where lamotrigine is used as basic therapy, add-on topiramate is specified as the appropriate comparator therapy. However, Glaxo Smith Kline compared retigabine with lacosamide. From IQWiG's point of view the company did not sufficiently justify this deviation. Neither did it submit studies that would have been relevant to an assessment of retigabine versus the appropriate comparator therapy specified by the G-BA. Therefore no proof of an added benefit can be inferred from the assessment presented in the manufacturer dossier.