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Dossier assessment

Asciminib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-70
Last updated

Report documents

  1. Extract of dossier assessment

    Asciminib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 364 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-70_en
    Download file : Extract of dossier assessment (PDF document, 364 kB, EN, not accessible)

  2. Dossier assessment

    Asciminib (chronic myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 638 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-70
    Download file : Dossier assessment (PDF document, 638 kB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with ≥ 2 tyrosine kinase inhibitors

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2025-11-2025 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A25-70
Commission
Commission awarded on 28.05.2025 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 (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/A25-70_en

Connected Projects

  1. Dossier assessment

    Asciminib (chronic myeloid leukaemia) - Assessment according to §35a (para. 1, sentence 11) Social Code Book V

    Project no.
    G22-32
    Last updated

    Status: Commission completed

  2. Addendum

    Asciminib (chronic myeloid leukaemia) – Addendum to Project A25-70

    Project no.
    A25-129
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Asciminib (CML, first- and second-line treatment) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-150
    Last updated

    Status: Commission completed

  4. Dossier assessment

    Asciminib (CML, T315I mutation, previously treated) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-53
    Last updated

    Status: Commission completed

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