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.
Anemia due to Beta Thalassemia
Luspatercept-aamt (Reblozyl) may be considered medically necessary 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 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) may be considered medically necessary for individuals who meet ALL of the following criteria:
- Individual diagnosed with the above diagnosis; and
- Prescribed by or in consultation with a hematologist; 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.
Luspatercept-aamt (Reblozyl) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
