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Dossier assessment

Patisiran (hereditary transthyretin-mediated amyloidosis with polyneuropathy) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-118
Last updated

Report documents

  1. Extract of dossier assessment

    Patisiran (hereditary transthyretin-mediated amyloidosis with polyneuropathy) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 566 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-118_en
    Download file : Extract of dossier assessment (PDF document, 566 kB, EN, not accessible)

  2. Dossier assessment

    Patisiran (hereditary transthyretin-mediated amyloidosis with polyneuropathy) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 829 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-118
    Download file : Dossier assessment (PDF document, 829 kB, DE, not accessible)

Dossier assessment

Indication:

Adults with hereditary transthyretin-mediated amyloidosis with stage 1 or stage 2 polyneuropathy

Result of dossier assessment:

Hint of lesser benefit

Press releases

Patisiran for hereditary transthyretin amyloidosis: lesser benefit than vutrisiran

In 2023, IQWiG determined an added benefit of vutrisiran over patisiran on the basis of a study. Now the manufacturer cites the same study in the dossier on patisiran, but interprets it completely differently.
Press release

Project details

Project no.
A23-118
Commission
Commission awarded on 30.11.2023 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.

DOI

https://doi.org/10.60584/A23-118_en

Connected Projects

  1. Dossier assessment

    Patisiran (hereditary transthyretin amyloidosis with polyneuropathy) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

    Project no.
    G18-14
    Last updated

    Status: Commission completed

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