2) About additional benefit assessment conducted by the G-BA
Eisai is confident that the G-BA
will appreciate the significant therapeutic benefits lenvatinib offers to people in Germany.
We are pleased by the positive assessment we received from the G-BA
This assessment by the G-BA
affirms the additional benefit of Halaven, and differs from the preliminary assessment by Germany's IQWiG (Institute for Quality and Efficiency in Health Care)(2) published in February in 2012.
has made an encouraging decision potentially relevant for thousands of women in Germany with advanced breast cancer.
For the scientific monitoring and evaluation of the trials of the G-BA
commissioned a professionally independent scientific institution.
In Europe, with our partner Alcon, we are encouraged by the very positive final guidance from the G-BA
in Germany and NICE in the UK.
With this decision, the G-BA
is denying people with epilepsy for whom no current treatment has been successful, the benefits of medical progress," said Stefan Conrad, President of the German Epilepsy Association.
Since the introduction of the early benefit assessment procedure in Germany in January 2011, G-BA
has assessed more than sixty innovative new drugs.
In line with the G-BA
requirements, additional pooled analyses of data have been specifically performed for the benefit assessment procedure in Germany and reviewed by IQWiG.
We, and our partner Alcon, look forward to working with G-BA
to ensure that the positive benefits shown by JETREA[sup.
The assessment does not include a statement with regard to perampanel's proven clinical efficacy and safety, as demonstrated by the studies submitted to the G-BA
and used for the EU approval of perampanel in September 2012.