The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive (“add-on”) therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether perampanel offers an added benefit over the appropriate comparator therapy. However, such an added benefit cannot be derived from the new dossier either, as the drug manufacturer did not submit any relevant data for this comparison.
Already in the first dossier assessment in December 2012, there was no proof of an added benefit of perampanel because the manufacturer dossier provided no suitable data. The new assessment was conducted upon application of the manufacturer to the Federal Joint Committee (G-BA), which specifies the appropriate comparator therapy.
Appropriate comparator therapy expanded
Fits that affect only a small part of the brain are called “focal” or “partial seizures”. In this type of fit, the muscle twitches and spasms remain limited to isolated parts of the body. However, such seizures may spread across the whole body and are then referred to as “secondary generalization”. Perampanel is approved as add-on therapy for the treatment of partial seizures with or without secondary generalization in people aged 12 years and older.
The G-BA approved the manufacturer’s application for reassessment of the drug according to AMNOG because the appropriate comparator therapy had to be expanded following the change in the AMNOG Regulation for Early Benefit Assessment of New Pharmaceuticals (in §6 (1), Sentence 2, AM-NutzenV): Originally the more economical comparator therapy had to be chosen if several options were available, preferably a treatment with a fixed price. This regulation was dispensed with in 2013. If the G-BA specifies several options as appropriate comparator therapies, the manufacturer is now free to choose a therapy irrespective of the costs.
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