Germany's cost-effectiveness gatekeepers have delivered another blow to Eisai over the price of Fycompa. And the verdict, just the drugmaker's latest frustration over the epilepsy drug, has left it "speechless" and "dismayed."
Once again, the German Federal Joint Committee (G-BA) has determined Fycompa offers no additional benefit over existing epilepsy drugs--meaning it can only be reimbursed if it's priced at the same level as generics, PMLiVe reports.
"It is deeply regrettable that the G-BA's conclusion did not appropriately assess the clinical value brought about by the innovative properties of Fycompa or the needs of patients," the company said in a statement.
The decision follows up on the G-BA's first negative pricing verdict, which it offered up last year on advice from the German Institute for Quality and Efficiency in Health Care (IQWiG)--a body that hasn't been too popular with pharma lately, thanks to its tightened cost controls. In fact, G-BA's first Fycompa pricing snub roiled the Japanese drugmaker so much that it pulled the drug from the market altogether.
But it got another shot earlier this year, receiving a green light to resubmit the drug for another assessment. Eisai filed data from an observational study, conducted in Germany and Austria, that showed about half of the 281 participants with highly refractory epilepsy experienced at least a 50% reduction in seizure frequency when treated with Fycompa, PMLiVE notes. On top of that, 15% became seizure-free during the observation period.
Now, however, it's back to the drawing board. "We will strive to continue talks with the G-BA to find a solution for the people who depend on new epilepsy treatments" such as Fycompa, Gary Hendler, chief exec of Eisai EMEA, told the publication.
Eisai's Fycompa troubles have hardly been restricted to Germany alone. Last October, it lost a bid to force the Drug Enforcement Agency (DEA) to schedule Fycompa for a U.S. launch a year after its FDA approval.
Special Report: The 25 most influential people in biopharma today - 2013 - Jürgen Windeler - The Institute for Quality and Efficiency in Health Care (Germany)