Eisai disagrees with Germany's IQWiG report on epilepsy drug Fycompa

In the assessment report by the German Institute for Quality and Efficiency in Health Care (IQWiG) on Japanese drug major Eisai’s (TYO: 4523) Fycompa (perampanel), published yesterday on the Federal Joint Committee (G-BA) web site, the institute did not attest an additional benefit for the epilepsy drug.

Comments on the report and its proposed conclusion can be submitted to the G-BA up until January 7, 2013. The G-BA will decide on the additional benefit in March 2013 after reviewing comments and the discussion from an oral hearing of experts end of January. The current IQWiG assessment has no implications on the reimbursement of perampanel or doctors' ability to prescribe this new partial epilepsy treatment. Fycompa was recently approved by the equivalent drugs watchdog in Scotland (The Pharma Letter December 12).

For its part, Eisai expressed its strong disappointment with IQWiG in regards to its assessment of the additional benefit, of the new epilepsy treatment perampanel compared to a treatment defined by the G-BA. It is reported that additional benefit is unproven based on methodological considerations. No statement was made regarding clinical efficacy and safety. Perampanel is the first in an entirely new class of treatment for uncontrolled partial epilepsy with a novel mechanism of action that is different from all other anti-epileptic drugs (AEDs). The company believes that, while discussing at length methodological aspects of analyses, the IQWiG failed to adequately interpret the patient-relevant benefits and responsibly recognise the innovative nature of the new drug in a clinical setting with a high unmet need.