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Dossier assessment

Faricimab (visual impairment due to macular oedema secondary to retinal vein occlusion) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-85
Last updated

Report documents

  1. Extract of dossier assessment

    Faricimab (visual impairment due to macular oedema secondary to retinal vein occlusion) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 284 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-85_en
    Download file : Extract of dossier assessment (PDF document, 284 kB, EN, not accessible)

  2. Dossier assessment

    Faricimab (visual impairment due to macular oedema secondary to retinal vein occlusion) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 479 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-85
    Download file : Dossier assessment (PDF document, 479 kB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with visual impairment due to macular oedema

Result of dossier assessment:
  • Macular oedema secondary to branch retinal vein occlusion: added benefit not proven
  • Macular oedema secondary to central retinal vein occlusion: added benefit not proven

Press releases

Visual impairment due to macular oedema: added benefit of faricimab not proven

The manufacturer fails to set up a study in which the dosing regimen can be individualized as specified in the Summary of Product Characteristics.
Press release

Project details

Project no.
A24-85
Commission
Commission awarded on 27.08.2024 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.

DOI

https://doi.org/10.60584/A24-85_en

Connected Projects

  1. Dossier assessment

    Faricimab (visual impairment due to diabetic macular oedema) – Benefit assessment acc. to § 35a Social Code Book V

    Project no.
    A22-109
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Faricimab (neovascular age-related macular degeneration) – Benefit assessment according to § 35a Social Code Book V

    Project no.
    A22-110
    Last updated

    Status: Commission completed

  3. Addendum

    Faricimab (visual impairment due to macular oedema secondary to retinal vein occlusion) – Addendum to Project A24-85

    Project no.
    G25-03
    Last updated

    Status: Commission completed

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