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Germany looks again at Fycompa pricing

Eisai's epilepsy drug could be re-entered onto market

Eisai Fycompa perampanel epilepsyEpilepsy patients in Germany may get access to Eisai's first-in-class drug Fycompa once again following a decision to take another look at its pricing.

Last year, Eisai made headlines after it decided to withdraw Fycompa (perampanel) from the market rather than sell it at the price approved by the Germany's health technology assessment (HTA) agency, the Federal Joint Committee (G-BA). The drug was approved in Europe in 2012 for the treatment of partial-onset seizures in patients aged 12 or over.

The G-BA ruled last June that Fycompa provided no additional benefit over existing treatments for epilepsy and so could only be reimbursed if it was priced at the same level as cheap generic drugs.  In response, Eisai suspended sales of the drug to new patients, and set up an access programme to ensure the 4,000 German patients already taking it could continue to do so at no cost to the national healthcare system.

Other drugmakers electing to suspend sales of new products in Germany because of pricing rulings include AstraZeneca - which withdrew its diabetes drug Forxiga (dapagliflozin) last December - and Pfizer which pulled leukaemia therapy Bosulif (bosutinib) the previous month.

The G-BA has given Eisai an opportunity to resubmit Fycompa for early re-assessment, raising the possibility that an agreement on pricing acceptable to both parties may be reached. In a statement, Eisai said it had three months to resubmit its case and expected the G-BA to take around six months to review it.

Eisai has always maintained that the AMPA receptor antagonist is a valuable second-line treatment for partial-onset seizures, which occur in about 60 per cent of people with epilepsy. Around a third of these patients have seizures that are not controlled by current therapies and need additional treatment options, according to the company.

"Patients are Eisai's first concern and we strongly believe they should be given access to treatment that provides a clear clinical benefit," said Gary Hendler, chief executive of Eisai's EMEA division.

The G-BA's decision to re-open the file on Fycompa was also welcomed by epilepsy specialist Prof Bernhard Steinhoff from Epilepsiezentrum Kork, who said: "Epilepsy affects hundreds of thousands of people in Germany and treatment options such as Fycompa are a welcome addition to our treatment armamentarium."

US launch

Eisai also saw the path to launching Fycompa in the US clear in the US earlier this year after the country's Drug Enforcement Administration (DEA) finally delivered its verdict on the abuse potential of the product in December, designating it schedule III, a category which includes minor stimulant drugs with low potential for misuse.

The drug was approved by the FDA in October 2012 and - after months of delays - Eisai resorted to legal action last summer to try to force the DEA to bring its review of perampanel to a close. The scheduling finally came into effect on January 2, opening the door for a US launch more than nine months after Eisai had expected to start selling the product.

Fycompa is already available in 36 countries and brought in sales of 1.13bn Japanese yen ($11m) in the third-quarter of fiscal 2013. Sales are expected to grow swiftly following its launch in the US, with additional momentum in the offing if it gets approval in Japan and China where it is in phase III trials.

Eisai is also carrying out phase III trials of Fycompa as an adjunctive therapy for the treatment of generalized seizures in patients with epilepsy, as well as mid-stage testing in children with partial-onset seizures.  Analysts have suggested it could achieve peak sales in excess of $1bn a year.

Article by
Phil Taylor

11th February 2014

From: Sales, Regulatory



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