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Dossier assessment

Cipaglucosidase alfa (Pompe disease) – Benefit assessment according to § 35a Social Code Book (SGB) V

Status
Status: Commission completed
Project no.
A23-79
Last updated

Report documents

  1. Extract of dossier assessment

    Cipaglucosidase alfa (Pompe disease) – Benefit assessment according to § 35a Social Code Book (SGB) V

    published on
    Document type
    PDF document, 569 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 569 kB, EN, not accessible)

  2. Dossier assessment

    Cipaglucosidase alfa (Pompe disease) – Benefit assessment according to § 35a Social Code Book (SGB) V

    published on
    Document type
    PDF document, 908 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-79
    Download file : Dossier assessment (PDF document, 908 kB, DE, not accessible)

Dossier assessment

Indication:

Long-term enzyme replacement therapy used in combination with the enzyme stabilizer miglustat for the treatment of adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency)

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2024-02-01 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-79
Commission
Commission awarded on 01.08.2023 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://dx.doi.org/10.60584/A23-79

Connected Projects

  1. Addendum

    Cipaglucosidase alfa (Pompe disease) – Addendum to Project A23-79

    Project no.
    A23-133
    Last updated

    Status: Commission completed

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