WHA

Reblozyl (luspatercept-aamt)

Indications for Prior Authorization

Reblozyl (luspatercept-aamt)
  • For diagnosis of Beta Thalassemia
    Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

    Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

  • For diagnosis of Myelodysplastic Syndromes with Ring Sideroblasts or Myelodysplastic/ Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis Associated Anemia
    Indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

    Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

  • For diagnosis of Myelodysplastic Syndromes Associated Anemia
    Indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

    Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Criteria

Reblozyl

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Beta Thalassemia

  • One of the following:
    • Both of the following:
      • Diagnosis of beta thalassemia major [3]
        • AND
      • Patient requires regular red blood cell (RBC) transfusions
      OR
    • Diagnosis of transfusion-dependent beta thalassemia [3]
    AND
  • Prescribed by or in consultation with one of the following:
    • Hematologist
    • Oncologist
Reblozyl

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Beta Thalassemia

  • Patient demonstrates a positive clinical response to therapy (e.g., reduction in RBC transfusion burden) [1,2]
Reblozyl

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm (MDS-RS, MDS/MPN-RS-T)

  • One of the following diagnoses:
    • Very low-to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS)
      • OR
    • Myelodysplastic or myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)
    AND
  • Patient has failed an erythropoiesis stimulating agent [e.g., Epogen (epoetin alfa), Aranesp (darbepoetin)]
    • AND
  • Patient requires transfusions of 2 or more red blood cell (RBC) units over 8 weeks
    • AND
  • Prescribed by or in consultation with one of the following:
    • Hematologist
    • Oncologist
Reblozyl

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes

  • Diagnosis of very low- to intermediate-risk myelodysplastic syndromes (MDS)
    • AND
  • Patient does not have previous erythropoiesis stimulating agent use (ESA-naïve)
    • AND
  • Patient requires transfusions of 2 or more red blood cell (RBC) units over 8 weeks
    • AND
  • Prescribed by or in consultation with one of the following:
    • Hematologist
    • Oncologist
Reblozyl

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm

  • Patient demonstrates a positive clinical response to therapy (e.g., RBC transfusion independence, improvement in hemoglobin levels) [1,4]

  • Guideline ID
    GL-164005

  • Formulary
    premium

  • Effective date
    Apr 1, 2025

  • P&T approval date
    Mar 1, 2021

P & T Revisions

2025-01-20, 2023-12-12, 2023-09-29, 2023-01-04, 2021-12-08, 2021-09-27, 2021-05-21, 2021-01-05, 2020-06-19, 2020-01-03

  1. Reblozyl Prescribing Information. Celgene Corporation. Summit, NJ. May 2024.
  2. Piga A, Perrotta S, Gamberini M, et al. Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with β-thalassemia. Blood 2019; 133 (12): 1279–1289.
  3. Per clinical consult with oncologist, December 19, 2019.
  4. Fenaux P, Platzbecker U, Ghulam J, et al. Luspatercept in patients with lower-risk myelodysplastic syndromes. N Engl J Med 2020; 382:140-151.
  • 2025-01-20: 2025 annual review. No clinical changes.
  • 2023-12-12: Updated reauth verbiage
  • 2023-09-29: Addition of criteria for new indication of treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve)
  • 2023-01-04: 2023 UM Annual Review. No changes to criteria. Updated references
  • 2021-12-08: 2022 Annual Review - no changes to criteria, updated references
  • 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-01-05: 2021 Annual Review, no changes to criteria.
  • 2020-06-19: Updated with new indication
  • 2020-01-03: Guideline created for new program