G-BA rejects GSK's Tafinlar

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has "no additional benefit" vs. Zelboraf vemurafenib from Roche (SIX:ROG; OTCQX:RHHBY) to treat unresectable or metastatic melanoma with a BRAF V600 mutation. The European Commission approved the oral BRAF protein kinase inhibitor in September.

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. ...