Dossier assessment

Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A20-36
Last updated

Report documents

  1. Extract of dossier assessment

    Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 533 kB, EN, not accessible
  2. Dossier assessment

    Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible

Dossier assessment

Indication:

Adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease

Result of dossier assessment:

Clear advantages in overall survival and symptomatic progression, disadvantages in some side effects; overall: indication of considerable added benefit.

Project details

Project no.
A20-36
Commission
Commission awarded on 31.03.2020 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
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.

Connected Projects

  1. Dossier assessment

    Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-20
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Apalutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A19-09
    Last updated

    Status: Commission completed

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