Eisai's Fycompa is a first-of-its-kind seizure drug, a glutamate receptor antagonist and a blockbuster hopeful. The FDA gave the epilepsy drug its approval last year and the Japanese drugmaker is seeking approvals around the world. But Eisai has run into the German pricing agency buzzsaw, and, like its peers, says it is outraged at its treatment.
In fact, "appalled" is how Eisai described its reaction to the German Federal Joint Committee (G-BA) ruling that the additional benefit of Fycompa is unproven compared to current treatments, GlaxoSmithKline's ($GSK) Lamictal and Topamax from Johnson & Johnson ($JNJ), PharmaTimes reports. The company took the agency to task for failing "to adequately interpret the proven patient-relevant benefits substantiated in the submitted benefit dossier and to responsibly recognize the innovative nature of the new drug in a clinical setting with a highly unmet medical need."
Eisai is not the first to be exasperated by Germany's unbending stance on paying higher prices for new treatments. Novartis ($NVS) pulled its blood pressure medication Rasilamlo from the German market three months after introducing it there, and Eli Lilly ($LLY) simply bypassed Germany with its launch of Trajenta, the diabetes drug it's launching in Europe with Boehringer Ingelheim. AstraZeneca ($AZN) late last year blamed Germany's obstinacy for 400 jobs it eliminated in the country.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the German Association of Research-Based Pharmaceutical Companies (VFA) last year warned Germany that its stance on new treatments was going to harm its own citizens. As Eisai pointed out, an estimated 30% of the 400,000 Germans with epilepsy have been unable to control their seizures with the drugs already on the market.
- here's the PharmaTimes story