Eylea aflibercept ophthalmic solution regulatory update
Germany's Federal Joint Committee (G-BA) issued a final benefit assessment that said Eylea aflibercept from Bayer has "no additional benefit" vs. Lucentis ranibizumab to treat visual impairment caused by macular edema secondary to central retinal vein occlusion (CRVO). The assessment is in line with a January preliminary assessment from Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) (see BioCentury, Jan. 6). Lucentis is approved for the indication in the EU.
Drugs that do not have an additional benefit are added to the reference pricing system, which gives a similar base price to therapeutically comparable drugs. If there is no reference, companies negotiate a price with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) that is no higher than that of the lowest-cost alternative in the indication. ...