Dossier assessment

Bosutinib (pretreated chronic myelogenous leukaemia) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-54
Last updated

Report documents

  1. Extract of dossier assessment

    Bosutinib (pretreated chronic myelogenous leukaemia) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 82 kB, EN, not accessible
  2. Dossier assessment

    Bosutinib (pretreated chronic myelogenous leukaemia) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 303 kB, DE, not accessible

Dossier assessment

Indication:

Pretreated adults with Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML) and limited treatment options

Result of dossier assessment:

Due to a lack of suitable study data, added benefit not proven in the chronic phase or in the accelaterated phase and blast crisis

Project details

Project no.
A18-54
Commission
Commission awarded on 30.08.2018 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.

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    Status: Commission completed

  2. Dossier assessment

    Bosutinib - Assessment according to § 35a (para. 1, sentence 10) Social Code Book V (dossier assessment)

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  3. Dossier assessment

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

    Project no.
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    Last updated

    Status: Commission completed

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