[A22-38] Dolutegravir (HIV) - Benefit assessment according to §35a Social Code Book V

Last updated 01.07.2022

Project no.:
A22-38

Commission:
Commission awarded on 01.04.2022 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 aged 6 to < 18 years who are infected with HIV

Result of dossier assessment:
  • Treatment-naive adolescents aged 12 to < 18 years who are infected with HIV: added benefit not proven
  • Treatment-experienced adolescents aged 12 to < 18 years who are infected with HIV: added benefit not proven
  • Treatment-naive children aged 6 to < 12 year who are infected with HIV-1: added benefit not proven
  • Treatment-experienced children aged 6 to < 12 years who are infected with HIV-1: 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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