Eisai Rips German Regulators

Eisai Rips German Regulators

March 8th, 2013 // 7:09 pm @

A Classic FDA Inspector Trick

Drugmakers are known to chafe at regulatory decisions over approvals and, in Europe, coverage matters, but Eisai is now the latest to lash out at German regulators over reimbursement. The German Federal Joint Committee, which is the reimbursement agency, yesterday decided that Fycompa, a first-in-class treatment for uncontrolled partial epilepsy, was unproven compared with Lamicta, which is sold by GlaxoSmithKline, and Johnson & Johnson’s Topamax.

And so, the Eisai team wasted no time in letting German regulators know how they feel. The drugmaker, which is headquartered in Japan, issued a scathing press release to say it is “appalled by the ruling.” Eisai also bitterly noted that the German Institute for Quality and Efficiency in Health Care three months ago came to the same conclusion on methodological grounds.

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“The company believes that the G-BA (the German Federal Joint Committee) failed 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 laments in its press release.

“Eisai diligently developed the benefit dossier following scientific advice from the G-BA. In addition, Eisai provided further evidence in a written statement preceding the G-BA Oral Hearing on 29 January 2013, and reiterated the additional benefit perampanel provides to patients, especially to patients who require new options to help manage their seizures,” the drugmaker continues (here is the statement).

For the record, the German Institute for Quality and Efficiency in Health Care, or IQWIG, noted that Eisai had failed to present data that was productive or adequate to make comparisons with the other drugs (here is the IQWIG statement from December).

In openly expressing its disgust, Eisai joins Glaxo (GSK) and Boehringer Ingelheim, which have similarly chided and criticized German authorities for their recent reimbursement decisions. Last year, for instance, Glaxo called a rejection of a lupus drug “completely inexplicable from a medical point of view and disregards genuine progress in therapy,” and added the move may have “dire consequences” for medical innovations” (read here).

So what happens from here? “Drugs that do not have an additional benefit are added to the reference pricing system, which gives a similar base price to all comparable drugs,” BioCentury notes. “If there is no reference price, Eisai will negotiate with Germany’s Statutory Health Insurance Funds Association a price (that is) no higher than that of the comparator” drugs.

Fycompra, by the way, was approved by the European Commission last July and by the FDA in October. The Eisai drug is currently available in the UK, Denmark, Germany, Austria, Sweden, Norway and Switzerland.

H/T: Pharmalot


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