Dossier assessment

Vosoritide (achondroplasia, ≥ 2 years) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-92
Last updated

Report documents

  1. Extract of dossier assessment

    Vosoritide (achondroplasia, ≥ 2 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 684 kB, EN, not accessible
  2. Dossier assessment

    Vosoritide (achondroplasia, ≥ 2 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-92

Dossier assessment

Indication:

Patients with achondroplasia 2 years of age and older whose epiphyses are not closed

Result of dossier assessment:

Indication of non-quantifiable added benefit

Press releases

Vosoritide for achondroplasia: indication of added benefit for children aged two years and older

Two small RCTs with children of different ages allow a joint conclusion: The new drug promotes length growth.

Additional information

Federal Joint Committee (G-BA)

2024-02-15 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-92
Commission
Commission awarded on 01.09.2023 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Muscles, bones and joints
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/A23-92

Connected Projects

  1. Dossier assessment

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

    Project no.
    G21-29
    Last updated

    Status: Commission completed

  2. Addendum

    Vosoritide (achondroplasia, ≥ 2 years) – Addendum to Project A23-92

    Project no.
    A24-08
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Vosoritide (achondroplasia, ≥ 4 months) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A23-116
    Last updated

    Status: Commission completed

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