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Dossier assessment

Fingolimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-87
Last updated

Report documents

  1. Extract of dossier assessment

    Fingolimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 371 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 371 kB, EN, not accessible)

  2. Dossier assessment

    Fingolimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 667 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 667 kB, DE, not accessible)

Dossier assessment

Indication:

Children and adolescents with highly active or rapidly evolving relapsing-remitting multiple sclerosis (RRMS)

Result of dossier assessment:

If RRMS is highly active and switch of basic therapeutic agents is indicated despite a full and adequate course of treatment with at least one disease-modifying therapy: hint of non-quantifiable added benefit. Other patient groups: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2019-06-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-87
Commission
Commission awarded on 19.12.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Head and nerves
Note

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

Connected Projects

  1. Addendum

    Fingolimod (multiple sclerosis in children and adolescents) - Addendum to Commission A18-87

    Project no.
    A19-42
    Last updated

    Status: Commission completed

  2. Dossier assessment

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

    Project no.
    A11-23
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Fingolimod (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A15-48
    Last updated

    Status: Commission completed

  4. Dossier assessment

    Fingolimod (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

    Project no.
    A14-21
    Last updated

    Status: Commission completed

  5. Dossier assessment

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

    Project no.
    A15-12
    Last updated

    Status: Commission completed

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