Monthly Case

A 35-year-old male patient suffers from difficult-to-treat focal epilepsy since his 17^th year of life. Presumably, the cause of epilepsy is a former inflammatory brain disorder. First seizures occurred in the acute phase of his CNS inflammation. Currently, the patient suffers from 3-4 complex partial seizures per month, each preceded by an undetermined aura, and rare grand mal seizures. So far, the patient has been treated with more than 10 different antiepileptic drugs, currently his regimen consists of levetiracetam, lamotrigine and primidone, each in high doses. Though a couple of antiepileptic drugs have been introduced in this patient unsuccessfully, at the end of 2016 we decided to make a treatment trial with perampanel, first aiming at a dose of 6 mg per day. The mechanism of action of perampanel differs from all other antiepileptic drugs, the compound is an inhibitor at the excitatory AMPA receptors.

The patient’s expectations towards perampanel were at best ambiguous, as so many other antiepileptic drugs had failed before. However, surprisingly in the first 3 months of treatment, perampanel resulted in a significant reduction in the frequency of complex partial seizures.

However, under the German law (“Arzneimittelmarktneuordnungsgesetz (AMNOG)“) this antiepileptic drug was classified as having no additional benefit in the treatment of epilepsies. This case illustrates the absurdity of this decision, as in individual cases perampanel definitely has the capacity to clearly improve patients’ seizure disorder. However, due to classification of having no benefit, reimbursement of compounds such as perampanel is on the level of generic drugs like lamotrigine. This does not refund the costs for developing new antiepileptic drugs.

Thus, the producing company Eisai took perampanel off the German market, but the substance still can be obtained via international pharmacies. This patient’s health insurance currently checks if they are going to reimburse the costs for perampanel due to individual efficacy in this patient.

Perampanel – likely due to its different mechanism of action – has proved to be a very successful antiepileptic drug in various European countries and in North America. The case of perampanel clearly illustrates that the current methodology used to assess efficacy within the lines of AMNOG is insufficient. This calls for an urgent need for political action.

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