Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
The use of luspatercept-aamt (Reblozyl) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is a, or in consult with, a hematologist or oncologist, or prescriber specializing in the treatment of beta thalassemia or myelodysplastic syndrome/myeloproliferative neoplasm; and
- The individual must have a diagnosis of anemia due to beta thalassemia or myelodysplastic syndrome/myeloproliferative neoplasm with ring sideroblasts; and
- The provider must submit documentation of a pretreatment hemoglobin of less than 11g/dL; and
- Other causes of anemia (e.g., hemolysis, bleeding, recent major surgery, vitamin deficiency, etc.) have been ruled out; and
- The individual must not have any of the following:
- Diagnosis of hemoglobin S/β-thalassemia or alpha-thalassemia; and
- Deep vein thrombosis or stroke within the past 24 weeks; and
- Platelet count greater than 1000 x 109 per liter; and
- For diagnosis for myelodysplastic syndrome/myeloproliferative neoplasm, the provider must submit documentation of the following:
- The individual requires 2 or more RBC units over an 8-week period; and
- One of the following:
- Ring sideroblasts greater than or equal to 15%; or
- Ring sideroblasts greater than or equal to 5% and less than 15% with an SF3B1 mutation; and
- One of the following:
- Serum erythropoietin greater than 500 mU/mL; or
- Serum erythropoietin less than or equal to 500 mU/mL with inadequate response after a 3-month trial with a combination of an ESA (e.g., epoetin alfa) and granulocyte-colony stimulating factor (G-CSF); and
- The individual has very low to intermediate risk disease defined as one of the following:
- Revised International Prognostic Scoring System (IPSS-R); very low, low, or intermediate (Score of 0 to 4.5); or
- IPSS: low/intermediate-1 (Score 0 to 1); or
- WHO-Based Prognostic Scoring System (WPSS): WPSS: very low, low, or intermediate (Score 0 to 2); or
- For diagnosis for anemia due to beta thalassemia, the provider must submit documentation of the following:
- The individual has required at least 6 red blood cell (RBC) transfusions in the previous 24 weeks; and
- The individual has not had a transfusion-free period for ≥ 35 days during the most recent 24 weeks.
Initial Authorization: 6 months
Reauthorization Criteria
Continuation of therapy with luspatercept-aamt (Reblozyl) may be considered medically necessary when ALL of the following are met:
- The individual must have experienced stabilization, slowing of disease progression, or improvement of the condition since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including:
- Reduction in transfusion requirements from pretreatment baseline achieving one of the following:
- At least 2 units packed red blood cells; or
- By one-half; or
- Complete transfusions independence; and
- Dose will be increased to 1.25mg/kg daily; and
- The individual continues to have pretreatment hemoglobin of less than 11g/dL.
Continuation Authorization: 12 months
Luspatercept-aamt (Reblozyl) for any other indication is considered experimental/investigational. Scientific evidence does not support its use for any other indication.
Procedure Codes
