Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Luspatercept-aamt (Reblozyl) may be considered medically necessary for individuals who meet
ALL
of the following criteria:
Anemia due to Beta Thalassemia
-
Luspatercept-aamt (Reblozyl) is being prescribed by or in consultation with a hematologist;
and
-
Individual is 18 years of age or older;
and
-
Individual diagnosed with anemia due to beta thalassemia;
and
-
Individual is not diagnosed with hemoglobin S/β-thalassemia or alpha-thalassemia;
and
-
Hemoglobin (Hgb) level is less than or equal to 11 g/dL;
and
-
Individual requires regular red blood cell (RBC) transfusions (i.e. at least six (6) or more RBC units per 24 weeks with no transfusion-free period greater than 35 days during that period);
and
-
Luspatercept-aamt (Reblozyl) is not being used as a substitute for RBC transfusions in individuals who require immediate correction of anemia;
and
-
Individual is not concomitantly being treated with erythropoiesis stimulating agents (ESA), immunosuppressants, or hydroxyurea;
and
-
Individual has not received gene therapy or if individual has received gene therapy the individual meets the above criteria for regular RBC transfusions along with all other criteria;
and
-
Individual is not concomitantly enrolled in a clinical trial for gene therapy for beta thalassemia;
or
Compendia Sources
Luspatercept-aamt (Reblozyl) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
Anemia Failing an Erythropoiesis Stimulating Agent
-
Individual 18 years of age or older;
and
-
Diagnosis of myelodysplastic syndrome;
or
-
Diagnosis of myelodysplastic/myeloproliferative neoplasm;
and
-
Individual has documented lower risk disease as defined as
ONE
of the following:
-
Revised International Prognostic Scoring System (IPSS-R); Very low, low, intermediate (defined as a score of 0 to 4.5);
or
-
IPSS: Low/Intermediate-1 (Score 0 to 1);
or
-
WHO-Based Prognostic Scoring System (WPSS): very low, low, intermediate (Score 0 to 2);
and
-
Hgb less than 10 g/dL;
and
-
Individual requires at least two (2) units of packed red blood cells (pRBCs) in the prior eight (8) weeks;
and
-
Prescriber has ruled out and/or addressed other causes of anemia [e.g., abnormal bleeding (gastrointestinal, uterine, etc.), hemolysis, nutritional deficiency, renal disease];
and
-
Documentation of
ONE
of the following:
-
Ring sideroblasts greater than or equal to 15%;
or
-
Ring sideroblasts greater than or equal to 5% with an SF3B1 mutation;
and
-
Individual with serum erythropoietin greater than 500 mU/mL;
or
- Both
of the following
- Serum erythropoietin less than or equal to 500 mU/mL; and
- Disease is not responsive or patient is intolerant to the combination of an ESA (e.g., epoetin alfa) and granulocyte-colony stimulating factor (G-CSF); or
-
Prescribed by or in consultation with a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of myelodysplastic syndromes;
or
Anemia Without Previous Erythropoiesis Stimulating Agent Use
-
Individual 18 years of age or older;
and
-
Diagnosis of very low to intermediate risk myelodysplastic syndrome;
and
-
Individual has an endogenous serum erythropoietin less than 500 mU/mL;
and
-
Individual requires regular red blood cell transfusions;
and
-
Prescribed by or in consultation with a hematologist, oncologist, or other specialist with expertise in the diagnosis and management of myelodysplastic syndromes;
or
Compendia Sources
Luspatercept-aamt (Reblozyl) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
Reauthorization Criteria
Reauthorization of luspatercept-aamt (Reblozyl) for a period of 12 months may be considered medically necessary for individuals who meet
ALL
of the following criteria:
-
Individual diagnosed with
ANY ONE
of the above diagnoses;
and
-
Prescribed by or in consultation with a hematologist, or other specialist with expertise in the diagnosis and management of myelodysplastic syndromes;
and
-
Previously met the initial authorization criteria;
and
-
Individual experiences a decrease in transfusions;
and
- If individual experiences a response followed by a lack of response or lost response to luspatercept-aamt (Reblozyl), a typical cause was found and resolved or if no typical cause a dose increase resulted in a continued response.
The use of luspatercept-aamt (Reblozyl) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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