G-BA says 'no additional benefit' for Stribild

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that HIV drug Stribild from Gilead Sciences Inc. (NASDAQ:GILD) has "no additional benefit" over Atripla emtricitabine/tenofovir/efavirenz, a comparator requested by G-BA, in therapy-naïve patients. In a September preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) had said Stribild was worse than Atripla because it was associated with more AIDS-defining events and serious side effects. G-BA said the overall incidence of AIDS-defining events in the Stribild group was low and that Stribild led to significant improvements in immune deficiency (see BioCentury Extra, Sept. 17).

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 no higher than that of the lowest-cost alternative in the indication. ...