Luspatercept (Reblozyl) (ARCHIVED)

Policy ID: I-214-008

Section: Injections

Effective Date: March 15, 2020

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-214-008

Section: Injections

Effective Date: March 15, 2020

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

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 Smad 2/3 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.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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 meets the criteria for ANY ONE of the following indications:

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

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.

Procedure Code

J0896

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

NOTE: Luspatercept-aamt (Reblozyl) is not indicated for use as a substitute for RBC transfusions in individuals who require immediate correction of anemia.

Diagnosis Codes

C93.10

C94.40

C94.41

C94.42

C94.6

D46.0

D46.1

D46.20

D46.21

D46.4

D46.9

D46.A

D46.B

D46.Z

D47.1

D47.4

D56.1

D56.5

D75.81

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-16-2020

Adopted policy

Internal Medical Policy Committee 7-22-2020 -Effective July 01, 2020

Removed procedure code C9399; and
Updated J-code to J0896

Internal Medical Policy Committee 9-21-2020

Added new indication, anemia failing an erythropoiesis stimulation agent; and
Added additional diagnosis codes

Internal Medical Policy Committee 9-21-2021 Annual Review

Internal Medical Policy Committee 1-22-2022

Updated other indication statement to read '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.'

Internal Medical Policy Committee 1-26-2023 Annual Review - no clinical content change

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Added Compendia sources statement ' Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.' and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Effective January 01, 2024

Added criteria for Anemia Without Previous Erythropoiesis Stimulating Agent Use

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Added diagnosis codes C94.40; C94.41; C94.42; C94.6; D47.1; D47.4; and D75.81

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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