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Drug - Reblozyl® (luspatercept-aamt) [Celgene]

April 2020

Therapeutic area - Erythropoiesis Stimulating Proteins

Initial approval criteria

  • Patient must be ≥ 18 years AND
  • Patient has a documented diagnosis of beta thalassemia (excludes alpha-thalassemia and hemoglobin S/ß-thalassemia variants) as outlined by the following:
    • Patient diagnosis is confirmed by hemoglobin beta (HBB) sequence gene analysis showing biallelic pathogenic variants OR
    • Patient has severe microcytic/hypochromic anemia, anisopoikilocytosis with nucleated red blood cells on peripheral blood smear, and hemoglobin analysis that reveals decreased amounts or complete absence of hemoglobin A and increased amounts of hemoglobin F AND
  • Patient is red blood cell (RBC) transfusion dependent as defined by requiring 6 to 20 RBC units per 24 weeks AND
  • Patient has NOT had a deep vein thrombosis or a thrombotic stroke which required medical intervention within 6 months prior to therapy AND
  • Patient does NOT have major end organ damage, defined as any of the following:
    • Liver disease with an ALT > 3x the ULN or history of evidence of cirrhosis OR
    • Heart disease, heart failure NYHA classification 3 or higher, or significant arrhythmia requiring treatment, or recent myocardial infarction within 6 months of treatment OR
    • Lung disease, including pulmonary fibrosis or pulmonary hypertension which are clinically significant e.g., ≥ grade 3 OR
    • Creatinine clearance < 60 mL/min AND
  • Patient has a baseline hemoglobin* (Hb) < 11.5 g/dL (if Hb is ≥ 11.5 g/dL, the dose must be delayed until the Hb is ≤ 11 g/dL) AND
  • Other causes of anemia (e.g., hemolysis, bleeding, recent major surgery, vitamin deficiency) have been ruled out AND
  • Females of reproductive potential have a negative pregnancy test prior to start of therapy and will use an effective method of contraception during treatment and for ≥ 3 months after treatment
  • Initial approval is for 15 weeks (6 initial doses)

Renewal criteria

  • Patient must continue to meet the above initial criteria AND
  • Hb* < 11.5 g/dL (if Hb is ≥ 11.5 g/dL, the dose must be delayed until the Hb is ≤ 11 g/dL) AND
    • Patient is experiencing disease response as evidenced by a decrease in the number of RBC transfusions OR
    • For new starts, patient has NOT achieved a reduction in RBC transfusion burden after ≥ 2 consecutive, initial 1 mg/kg doses and requires a dose increase to 1.25 mg/kg OR
    • Patient experienced a response followed by a lack/loss of response and requires a dose increase to 1.25 mg/kg and other causative factors (e.g., a bleeding event) have been ruled out
  • Patient will NOT receive doses < 21 days apart AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., thromboembolic events, severe hypertension)
  • Renewal approval is for 12 months

* If an RBC transfusion occurred prior to dosing, the pretransfusion Hb must be considered for dosing purposes. Lab values are obtained within 7 days of the date of administration.

Note: Discontinue therapy if the patient does NOT experience a decrease in transfusion burden after 15 weeks of treatment (administration of 6 doses) at the maximum dose level or if unacceptable toxicity occurs at any time.

Quantity limits

  • 150 mg every 21 days or 2 vials (25 mg, 75 mg) every 21 days
  • Patient’s most current weight (rounded to the nearest kg) must be provided at time of request

Billing for Reblozyl

Reblozyl must be billed as a medical claim.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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