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.
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.
2) About additional benefit assessment conducted by the G-BA
Under this amendment, all eligible new drugs launched on the German market must undergo an additional benefit assessment conducted by the G-BA, with later price negotiations to be based on this assessment and a reimbursement price to be decided within one year from the drug's launch.
Furthermore, when a new drug is launched, the pharmaceutical company must submit to the G-BA a benefit dossier demonstrating the drug's additional benefit over a comparator.
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.
This decision by the G-BA demonstrates support for innovative medicines in the area of oncology, where there are few treatment choices, including breakthrough therapies such as Halaven that prolong the time women with advanced breast cancer can spend with their loved ones,
Mit 101 Absatz 1 Satz 7 SGB V wird der G-BA
verpflichtet, die Bedarfsplanungs-Richtlinie anzupassen, um eine bedarfsgerechte Versorgung sicherzustellen.
For the scientific monitoring and evaluation of the trials of the G-BA commissioned a professionally independent scientific institution.
After Chapter 2 A* 24 of the Rules of Procedure (Rules of Procedure) of the G-BA will establish a project management for the trials.
The invitation to tender and the award of the contract management of the study conduct to an academic institution in accordance with Chapter 2 A* 25 of the Rules of Procedure of the G-BA,