Eisai: Fycompa decision ‘deeply regrettable’
pharmafile | November 11, 2014 | News story | Research and Development, Sales and Marketing | Eisai, Fycompa, Germany, epilepsy, gba, perampanel
Eisai has lashed out at a major German health assessment body, calling its stance on first-in-class epilepsy treatment Fycompa ‘deeply regrettable’.
The Japanese company is objecting to the Federal Joint Committee (G-BA)’s assessment on insurance reimbursement that Fycompa (perampanel) has ‘no additional benefit’ compared to conventional anti-epilepsy drugs.
The German body decides on the benefit of drugs under the Act on the Reform of the Market for Medicinal Products (AMNOG) and is key to pharma’s success in the country.
“This decision is extremely unreasonable and deeply regrettable,” Eisai says in a statement. “It is highly concerning that patients in Germany will not have access to new epilepsy treatments in the future.”
Fycompa was launched in Germany in September 2012, but Eisai temporarily suspended distribution following the previous negative G-BA ruling in March 2013: it has since set up a patient access programme and resubmitted the drug to the G-BA for additional benefit reassessment in May 2014.
The brand was approved in the EU in July 2012 and has been launched in nine European countries as well as in the US.
Eisai insists it will “continue to seek an accurate understanding of the value of Fycompa from the G-BA” and believes that G-BA’s conclusion “does not appropriately assess the clinical value brought about by the innovative properties of Fycompa or the needs of patients”.
Among the company’s main problems are that the G-BA’s conclusion “was based not on the clinical value of Fycompa, but on a methodology that does not accept placebo-controlled study results in its assessment for insurance reimbursement instead”.
But, the firm goes on, placebo-controlled study protocols were accepted for the studies required by US and European regulatory authorities – and Eisai submitted three global pivotal Phase III studies on 1,480 patients with uncontrolled partial-onset seizures, despite their having been treated with other drugs.
These randomized, double-blind, placebo-controlled and dose-escalated studies “showed consistent results in the efficacy and tolerability of Fycompa as an adjunctive therapy in patients with partial-onset seizures”.
A six-month observational study from nine epilepsy centres in Germany and Austria, submitted alongside the Phase III data, showed that approximately half of the 281 people with refractory epilepsy treated with Fycompa experienced at least a 50% reduction in seizure frequency and up to 15% became seizure-free.
Adam Hill
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