Eisai: Antiepileptic Drug Fycompa Regularly Available Again in Germany from December
2017年11月20日 - 03:28PM
JCN Newswire (英)
Eisai Co., Ltd. has announced that its German sales company
Eisai GmbH (Location: Frankfurt) and the National Association of
Statutory Health Insurance Funds (GKV-Spitzenverband) have agreed
on a reimbursement price for Eisai's antiepileptic drug (AED)
Fycompa (perampanel). As of December 1, 2017, Fycompa will
therefore once again be regularly available in Germany.
In the German Federal Joint Committee (G-BA)'s original assessment
of Fycompa after its marketing authorization was granted, the
additional benefit or innovative value (a prerequisite for
insurance reimbursement pricing negotiations) of Fycompa was not,
in Eisai's opinion, appropriately assessed by the G-BA. As a
result, in 2013 Eisai withdrew Fycompa from commercial distribution
in Germany and until March 2016 provided Fycompa free of charge
through a patient access program in order to ensure that eligible
German patients with epilepsy could continue to receive treatment.
From April 2016 the product has been available in Germany through
individual pharmacy importation process.
Fycompa was re-submitted in May 2014 to the G-BA for additional
benefit assessment due to a change in the assessment process, but
in November of the same year the G-BA determined once again that no
additional benefit could be proven. In May 2017, new negotiations
became possible due to a change in the law finally resulting in the
pricing agreement with the GKV-Spitzenverband which is announced
today.
Fycompa is a first-in-class AED discovered at Eisai's Tsukuba
Research Laboratories. It is a highly selective, noncompetitive
AMPA receptor antagonist that reduces neuronal hyperexcitation
associated with seizures by targeting glutamate activity at
postsynaptic AMPA receptors. In July 2012, marketing authorization
was granted in Europe for Fycompa as an adjunctive treatment for
partial onset seizures, with or without secondarily generalized
seizures, in patients with epilepsy aged 12 years and older. In
June 2015, marketing authorization was granted for Fycompa as an
adjunctive treatment for primary generalized tonic-clonic seizures
in adult and adolescent patients from 12 years of age with
idiopathic generalized epilepsy.
Epilepsy is one of the most common neurological conditions in the
world and over half a million people in Germany live with the
condition. As approximately 30% of patients with epilepsy are
unable to control their seizures with currently available AEDs,(1)
this is a disease with significant unmet medical need, and
innovative new medicines with new mechanisms of action are urgently
required.
Through the recommencement of distribution of Fycompa to patients
with epilepsy in Germany who are in urgent need of innovative new
medicines based on the aforementioned agreement, Eisai is delighted
to be able to contribute to many patients.
About Fycompa (perampanel)
Fycompa is a first-in-class AED discovered and developed by Eisai.
With epileptic seizures being mediated by the neurotransmitter
glutamate, the agent is a highly selective, noncompetitive AMPA
receptor antagonist that reduces neuronal hyperexcitation
associated with seizures by targeting glutamate activity at
postsynaptic AMPA receptors. Fycompa is available in tablet form to
be taken once daily orally at bedtime. In addition, a new oral
suspension formulation has been approved and is being marketed in
the United States.
Fycompa is currently approved in more than 55 countries and
territories, including Japan, the United States, in Europe and Asia
as an adjunctive treatment for partial-onset seizures (with or
without secondarily generalized seizures) in patients with epilepsy
12 years of age and older.
In addition, Fycompa has been approved in more than 45 countries,
including Japan, the United States, in Europe and Asia as an
adjunctive therapy for primary generalized tonic-clonic (PGTC)
seizures in patients with epilepsy 12 years of age and older.
Furthermore, Fycompa is now indicated in the United States as a
monotherapy use for the treatment of partial-onset seizures (with
or without secondarily generalized seizures) in patients with
epilepsy aged 12 and older.
Meanwhile, Eisai is conducting respective global Phase III studies
for the agent in pediatric patients with partial-onset seizures or
PGTC seizures and in patients with seizures associated with
Lennox-Gastaut syndrome. Additionally, a Phase III study as
monotherapy for partial-onset seizures is being conducted in
Japan.
About Additional Benefit Assessment Conducted by the German Federal
Joint Committee (G-BA) and Statutory Health Insurance
Reimbursement
In Germany, the enactment of the Act on the Reform of the Market
for Medical Products (AMNOG) came into effect on January 2011.
Under this amendment, all eligible new drugs launched on the German
market must undergo an additional benefit assessment conducted by
the G-BA, with subsequent price negotiations to be based on this
assessment, and a reimbursement price to be agreed upon within one
year from the drug's launch.
The G-BA routinely commissions the country's Institute for Quality
and Efficiency in Health Care (IQWiG) to evaluate the clinical data
demonstrating the drug's additional benefit submitted by the
pharmaceutical company (benefit dossier) to decide whether any
additional benefit exists over a G-BA chosen comparator. The
pharmaceutical company is next given an opportunity to comment on
IQWiG's evaluation, after which the G-BA carries out its final
decision whether or not to attest an additional benefit of the
drug.
If an additional benefit is recognized by the G-BA, the drug
proceeds to the price negotiation stage with the National
Association of Statutory Health Insurance Funds
(GKV-Spitzenverband), and a reimbursement price has to be agreed
upon based on, among other criteria, the assessment of the
additional benefit as decided by the G-BA. On the other hand, if a
drug was deemed to offer no recognized additional benefit or if the
additional benefit could not be proven, the drug is generally
designated either a reference price group, if available, or a
reimbursement price based on the price of the most economical
comparator used during the benefit assessment.
Based on the Act on Strengthening Pharmaceutical Supply in the
Statutory Health Insurance (AM-VSG) that came into effect in May
2017, new negotiations with GKV-Spitzenverband can be initiated for
products for which an additional benefit could not be proven.
(1) "The Epilepsies and Seizures: Hope Through Research. What are
the epilepsies?" National Institute of Neurological Disorders and
Stroke, accessed November 7, 2017,
http://www.ninds.nih.gov/disorders/epilepsy/detail_epilepsy.htm#230253109
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Eisai focuses its efforts in three
therapeutic areas: integrative neuroscience, including neurology
and psychiatric medicines; integrative oncology, which encompasses
oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of
research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide healthcare system. For more information about Eisai Co.,
Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
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