Cobicistat (1) – Tybost®

Adults infected with the human immunodeficiency virus type 1 (HIV-1) and in whom cobicistat (Tybost®) is used as a pharmacological enhancer (booster) of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of a combination therapy

• As the required evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
• Module 4 was not submitted; consequently, no description was provided of the medical benefit and additional medical benefit, nor of the patient groups deriving additional therapeutic benefit.
• Consequently, no assessment has been made as to whether the active ingredient cobicistat has additional benefit, no additional benefit or a minor additional benefit compared with the appropriate comparator therapy.
• In accordance with Section 35a(1), fifth sentence, of SGB V, the additional benefit of cobicistat in relation to the appropriate comparator therapy is deemed not proven.
• If a pharmaceutical manufacturer does not fully provide the evidence required for the benefit assessment of a medicinal product in accordance with Section 35a of the German Social Code, Book V (SGB V), as set out in Chapter 5 Chapter, Section 17(1), sentence 6 of the VerfO, this evidence cannot be submitted at a later stage and taken into account in the ongoing assessment procedure.
• This corresponds to the provision in Section 4(4), first sentence, of the AM-NutzenV, according to which the G-BA must (only) take into account documents submitted within the prescribed time limit.

Courtesy translation only, please refer to the German original.