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Dossier assessment

Tafamidis (transthyretin amyloidosis with cardiomyopathy) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A20-102
Last updated

Report documents

  1. Extract of dossier assessment

    Tafamidis (transthyretin amyloidosis with cardiomyopathy) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 761 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 761 kB, EN, PDF)

  2. Dossier assessment

    Tafamidis (transthyretin amyloidosis with cardiomyopathy) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 864 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 864 kB, DE, PDF)

Dossier assessment

Indication:

Wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) in adult patients

Result of dossier assessment:

Patients with NYHA class I + II cardiac failure: hint of considerable added benefit. Patients with NYHA class III cardiac failure: added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

2021.05.20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A20-102
Commission
Commission awarded on 30.11.2020 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
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

    Tafamidis (transthyretin amyloidosis) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-101
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Tafamidis (wild-type or hereditary transthyretin amyloid cardiomyopathy) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

    Project no.
    G20-03
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Tafamidis - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

    Project no.
    A11-31
    Last updated

    Status: Commission completed

  4. Addendum

    Tafamidis (transthyretin amyloidosis with cardiomyopathy) - Addendum to Commission A20-102

    Project no.
    A21-42
    Last updated

    Status: Commission completed

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