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