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Eisai “appalled” at decision not to recommend Fycompa in Germany

Regulator says pharma company filed inadequate comparison data for its epilepsy drug

Eisai Fycompa Germany

Eisai has said it is “appalled” at the decision by regulators in Germany not to recommend Fycompa for the treatment of epilepsy in the country.

The German Federal Joint Committee (G-BA) gave its recommendation following a review of the drug by the German Institute for Quality and Efficiency in Health Care (IQWiG), which determined that the benefits of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, were unproven based on current evidence.

This was because Eisai had failed to present adequate data that compared Fycompa to already available standard therapies lamotrigine, marketed by GlaxoSmithKline (GSK) under the brand name Lamictal, or topiramate, marketed by Johnson & Johnson (J&J) under the brand name Topamax.

The G-BA had specified that Eisai should present data that compared Fycompa to lamotrigine as an add-on therapy in the indication if the initial first-line therapy did not contain lamotrigine, while if the first-line therapy did contain lamotrigine, data should be presented comparing Fycompa to topiramate.

However, in its assessment, IQWIG said Eisai “deviated from this specification”, and did not include a comparison with topiramate in its data as the company claimed it was “not productive”.

In addition, IQWIQ said the data provided by Eisai comparing Fycompa to lamotrigine was “not adequate” as the company had submitted placebo-controlled studies rather than clinical trials comparing Fycompa directly with the current therapy.

Eisai has disputed the G-BA's decision, claiming the authority “failed to adequately interpret the proven patient-relevant benefits substantiated in the submitted benefit dossier and to responsibly recognise the innovative nature of the new drug in a clinical setting with a highly unmet medical need”.

According to the company, it developed its dossier of evidence based on scientific advice from the G-BA, and provided a “methodologically robust” analysis that compared Fycompa to the “appropriate comparative therapy” lamotrigine.

Nick Burgin, European director of market access, Eisai said: “We believe the G-BA decision failed to take into account the patient need for new innovative treatments. Further they did not acknowledge the patient-value of perampanel that was demonstrated in the comprehensive analyses submitted.”

Eisai did not reference the lack of a comparison with topiramate in its statement.

This is the latest in a series of negative comments from pharma about the drug reimbursement system in Germany, with Boehringer Ingelheim, GSK, Almirall and Cell Therapeutics all receiving knockbacks from IQWIG in the past year.

Germany-based Boehringer has even called for reform of the reimbursement process in its home country, claiming that the comparator therapies in IQWIG's assessment for diabetes medicine Trajenta were inappropriate as the drug was the first of its kind to be ruled upon.

8th March 2013

From: Sales, Regulatory, Healthcare

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