Dossier assessment

Luspatercept (myelodysplastic syndromes) – Benefit assessment according to § 35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-50
Last updated

Report documents

  1. Extract of dossier assessment

    Luspatercept (myelodysplastic syndromes) – Benefit assessment according to § 35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 736 kB, EN, PDF
    DOI-Link
    https://doi.org/10.60584/A24-50_en
  2. Dossier assessment

    Luspatercept (myelodysplastic syndromes) – Benefit assessment according to § 35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 1 MB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A24-50

Dossier assessment

Indication:

Adults with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS)

  • who have not yet received and who are eligible for erythropoiesis-stimulating agent-based therapy
  • without ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoiesis-stimulating agent-based therapy
Result of dossier assessment:

Patients:

  • who have not yet received and who are eligible for erythropoiesis-stimulating agent-based therapy: added benefit not proven
  • without ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoiesis-stimulating agent-based therapy: added benefit not proven

Project details

Project no.
A24-50
Commission
Commission awarded on 30.04.2024 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Haematology
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/A24-50_en

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