On 20th March the GBA has finalized the assessments and published the resolutions on the additional benefit of three active substances.
For Bayer’s Stivarga the GBA acknowledged a minor additional benefit. Stivarga (regorafenib) has been approved for adults with metastatic colorectal cancer in whom previous treatments are no longer effective or for whom these alternatives are not an option. For the assessment GBA determined best supportive care as the appropriate comparator therapy.
The GBA’s resolution on Stivarga can be found here (German only): https://www.g-ba.de/downloads/39-261-1948/2014-03-20_AM-RL-XII_Regorafenib_2013-10-01-D-077.pdf
Genzyme’s (Sanofi) Aubagio, for which the final resolution was issued the same day, received a “no additional benefit” rating by GBA. Aubagio (terfilunomide) has been approved for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). Rebif (interferon beta-1a) was chosen as appropriate comparator therapy.
The GBA’s resolution on Aubagio can be found here (German only): https://www.g-ba.de/downloads/39-261-1949/2014-03-20_AM-RL-XII_Teriflunomid_2013-10-01-D-078.pdf
Bayer’s drug Eylea (aflibercept) also received a “no additional benefit” rating by GBA. Eylea has been approved for the treatment of visual impairment due to macular edema after a central retinal vein occlusion. Appropriate comparator therapy for the assessment of Eylea was Lucentis (ranibizumab).
The GBA’s resolution on Eylea can be found here (German only): https://www.g-ba.de/downloads/39-261-1946/2014-03-20_AM-RL-XII_Aflibercept-nAWG_2013-10-01-D-080_BAnz.pdf