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Dossier assessment

Lanadelumab (hereditary angioedema) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-63
Last updated

Report documents

  1. Extract of dossier assessment

    Lanadelumab (hereditary angioedema) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 473 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 473 kB, EN, not accessible)

  2. Dossier assessment

    Lanadelumab (hereditary angioedema) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 554 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 554 kB, DE, not accessible)

Dossier assessment

Indication:

Routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older

Result of dossier assessment:

Added benefit not proven.

Press releases

Routine practice data in manufacturer dossiers: Things are not yet running smoothly

The criteria established by IQWiG in 2020 on routine practice data were positively received by the scientific community. However, there is still a lot of room for improvement in the implementation by the pharmaceutical industry.
Press release

Lanadelumab in hereditary angioedema: added benefit not proven

The drug exceeded the turnover threshold for the simplified orphan drug assessment. There are no comparative studies. The analyses carried out instead are unsuitable for the proof of an added benefit.
Press release

Project details

Project no.
A21-63
Commission
Commission awarded on 12.05.2021 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Immune system and infections
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.

Connected Projects

  1. Dossier assessment

    Lanadelumab - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

    Project no.
    G19-04
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Lanadelumab (hereditary angioedema, 2 to < 12 years) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A23-135
    Last updated

    Status: Commission completed

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press@iqwig.de

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