[A24-50] Luspatercept (myelodysplastic syndromes) – Benefit assessment according to § 35a Social Code Book V

Last updated 01.08.2024

Project no.:
A24-50

Commission:
Commission awarded on 30.04.2024 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Haematology

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
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.

DOI:

https://doi.org/10.60584/A24-50_en

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