Dossier assessment

Solriamfetol (obstructive sleep apnoea) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-129
Last updated

Report documents

  1. Extract of dossier assessment

    Solriamfetol (obstructive sleep apnoea) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 398 kB, EN, PDF
  2. Dossier assessment

    Solriamfetol (obstructive sleep apnoea) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 642 kB, DE, PDF

Dossier assessment

Indication:

Improvement of wakefulness and reduction of excessive daytime sleepiness in adult patients with obstructive sleep apnoea (OSA) whose excessive daytime sleepiness has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP)

Result of dossier assessment:

Added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

2022-03-18 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-129
Commission
Commission awarded on 05.10.2021 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Head and nerves
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2022-01-03.

Connected Projects

  1. Addendum

    Solriamfetol (obstructive sleep apnoea) - Addendum to Commission A21-129

    Project no.
    G22-06
    Last updated

    Status: Commission completed

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