Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that HIV drug Stribild from Gilead 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, Sept. 23). G-BA noted that there was no statistically significant difference in virologic response and that while Stribild did not demonstrate an overall additional benefit, it was not worse than the comparator. G-BA had requested efavirenz in combination with two nucleoside or nucleotide analogs as comparator therapy.

G-BA also said Stribild has "no additional benefit" over individualized therapy in treatment-experienced patients without mutations associated with resistance to the antiviral agents in the product. The decision was in line with IQWiG's assessment. 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. ...