Luspatercept (Reblozyl)

Section: Injections
Effective Date: March 15, 2020
Last Reviewed: March 16, 2020

Description

Luspatercept-aamt (Reblozyl) is a recombinant fusion protein that binds several endogenous TGF-β superfamily ligands, which diminishes Smad2/3 signaling. Luspatercept-aamt (Reblozyl) promotes maturation through differentiation of late-stage erythroid precursors (normoblasts). In a model of β-thalassemia, luspatercept-aamt (Reblozyl) decreased abnormally elevated Smad2/3 signaling and improved hematology parameters associated with ineffective erythropoiesis.

Luspatercept-aamt (Reblozyl) increases risk of thromboembolic events (TEE). Individuals should reduce modifiable risk factors (e.g., smoking, use of oral contraceptives). Thromboprophylaxis should be considered in individuals with beta thalassemia at increased risk of TEEs. Luspatercept-aamt (Reblozyl) may cause an increase in blood pressure.

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 an initial authorization period of six (6) months for individuals who meet ALL of the following criteria:

  • Luspatercept-aamt (Reblozyl) is being prescribed by or in consultation with a hematologist; and
  • Individual is 18 years of age or older; and
  • Individual is not currently pregnant; and
  • Individual does not have uncontrolled hypertension; and
  • Individual does not have major organ damage (i.e., liver disease, heart disease, lung disease, renal insufficiency); and
  • Individual does not have a recent history of deep vein thrombosis (DVT) or stroke; 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.

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 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.

Luspatercept-aamt (Reblozyl) for any other indication is considered experimental/investigational. Scientific evidence does not support luspatercept-aamt (Reblozyl) for any other indication.

Procedure Codes

J3590

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Outpatient HCPCS (C Codes)

C9399

Diagnosis Codes

D56.1 D56.5

Professional Statements and Societal Positions Guidelines

NA

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