Eisai today announced it is to suspend sales of its epilepsy drug Fycompa in Germany due to unfavourable conditions set by the country’s health regulator.
In a statement, the Japan-based pharma company said it was “unable to accept the assessment” made by the German Federal Joint Committee (G-BA) through the AMNOG system of pricing, which has come under much industry criticism since it was introduced in 2011.
In March this year, the G-BA made its decision not to recommend Fycompa (perampanel) based on an assessment by cost-effectiveness watchdog the German Institute for Quality and Efficiency in Health Care (IQWiG), which determined that the benefits of the drug as an adjunctive treatment of partial-onset seizures in people were unproven based on current evidence.
At the time, Eisai said it was “appalled” by the decision, but the company has now gone a step further by suspending the product, claiming that the comparators used in the assessment were not applicable.
As part of the decision-making process, the G-BA specified that Eisai should present data that compared Fycompa to standard treatment lamotrigine as an add-on therapy 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 Johnson & Johnson’s Topamax (topiramate).
However, Eisai did not include a comparison with topiramate in its data, and the company has now said that it is not suitable to compare new anti-epileptic drugs to single substances in the treatment of people with epilepsy whose seizures are not controlled by medicine, also known as refractory epilepsy.
According to the company, this is a view backed by the German Society for Epileptology (DGfE) and German Society for Neurology (DGN), both of which say additional benefit should be assessed by considering efficacy in patients drug-resistant to standard therapies.
Eisai launched Fycompa in Germany in September 2012, where it has since been used in 3,000 to 4,000 patients with epilepsy.
These patients will continue to receive access to this first-in-class treatment through a continued access programme, according to Gary Hendler, president and CEO, Eisai EMEA.
As for future marketing opportunities, Eisai is hoping the political landscape in Germany will see changes in the country’s medicine laws – a view shared by Boehringer Ingelheim, GW Pharma and other companies that have failed to have treatments pass the strict health technology assessment (HTA) process.
“We are watching closely for any further developments, we are positive we will be able to resolve the situation and re-start commercial distribution of Fycompa in Germany,” said Hendler.
“We intend to submit Fycompa for reassessment at the earliest opportunity.”