[A22-134] Bictegravir/ emtricitabine/ tenofovir alafenamide (HIV infections in children and adolescents) – Benefit assessment according to § 35a SGB

Last updated 03.04.2023

Project no.:
A22-134

Commission:
Commission awarded on 20.12.2022 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Immune system and infections

Indication:

Children and adolescents with HIV-1 infection

Result of dossier assessment:
  • Treatment-naive children and adolescents:
    weighing at least 14 kg and aged 2 to < 6 years: added benefit not proven
    weighing at least 14 kg and aged 6 to < 12 years: added benefit not proven
    weighing at least 14 kg and aged 12 to < 18 years: added benefit not proven
  • Pretreated children and adolescents weighing at least 14 kg and aged 2 to < 18 years: added benefit not proven
Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

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