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Dossier assessment

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

Status
Status: Commission completed
Project no.
A25-150
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 846 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-150_en
    Download file : Extract of dossier assessment (PDF document, 846 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 3 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-150
    Download file : Dossier assessment (PDF document, 3 MB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

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

    published on
    Document type
    PDF document, 323 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 323 kB, EN, not accessible)

Dossier assessment

Indication:

Adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP)

Result of dossier assessment:
  • Patients undergoing first-line treatment: hint of a minor added benefit
  • Patients who have previously been treated with a tyrosine kinase inhibitor (TKI); second-line treatment: added benefit not proven

Press releases

Problems in the study implementation often affect patient-reported out-comes

Patient-reported outcomes are of great importance in the assessment of new drugs. Nevertheless, these outcomes are repeatedly overlooked in the conduct of studies. This is also evident from the example of asciminib.
Press release

Additional information

Federal Joint Committee (G-BA)

21-05-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-150
Commission
Commission awarded on 01.12.2025 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/A25-150_en

Connected Projects

  1. Dossier assessment

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

    Project no.
    A25-70
    Last updated

    Status: Commission completed

  2. 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

  3. Addendum

    Asciminib (CML, first- and second-line treatment) – Addendum to Project A25-150

    Project no.
    A26-40
    Last updated

    Status: Commission completed

  4. Addendum

    Asciminib (CML, first- and second-line treatment) – Second addendum to Project A25-150

    Project no.
    G26-09
    Last updated

    Status: Commission completed

  5. 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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