Luspatercept-aamt (Reblozyl®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
A. Treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions
B. Treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions
C. Treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate- risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)
Limitations of Use: Reblozyl is not indicated for use as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
A. Anemia with Beta Thalassemia
Submission of the following information is necessary to initiate the prior authorization review for initial therapy requests:
1. Pretreatment or pretransfusion hemoglobin (Hgb) level
2. Either of the following:
i. Hemoglobin electrophoresis or high-performance liquid chromatography (HPLC) results OR molecular genetic testing results, or
ii. Chart notes or medical record documentation stating diagnosis of beta thalassemia (β-thalassemia) or hemoglobin E/β-thalassemia was previously confirmed
B. Anemia of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm
Submission of the following information is necessary to initiate the prior authorization review for initial therapy requests: Pretreatment or pretransfusion hemoglobin (Hgb) level
III. EXCLUSIONS
Anemia with Beta Thalassemia
Coverage will not be provided for members with hemoglobin S/β-thalassemia or alpha-thalassemia.
IV. CRITERIA FOR INITIAL APPROVAL
A. Anemia with Beta Thalassemia
Authorization of 16 weeks may be granted for treatment of anemia with beta thalassemia in members 18 years of age or older when all of the following criteria are met:
1. The member has symptomatic anemia evidenced by a pretreatment or pretransfusion Hgb level less than or equal to 11 g/dL (grams per deciliter).
2. The member has a diagnosis of beta thalassemia (β-thalassemia) or hemoglobin E/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha globin is allowed) confirmed by one of the following:
i. Hemoglobin electrophoresis or high-performance liquid chromatography (HPLC)
ii. Molecular genetic testing
3. The member required at least 6 red blood cell (RBC) units to be transfused in the previous 24 weeks
Note: If a red blood cell (RBC) transfusion occurred prior to dosing, the pretransfusion hemoglobin (Hgb) level must be considered for dosing purposes.
B. Anemia of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm
Authorization of 24 weeks may be granted for the treatment of anemia of myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm in members 18 years of age or older when all of the following criteria are met:
1. The member has one of the following:
i. Very low- to intermediate-risk myelodysplastic syndrome
ii. Myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)
2. The member has symptomatic anemia evidenced by a pretreatment or pretransfusion Hgb level less than or equal to 11 grams per deciliter
3. The member has been receiving regular red blood cell (RBC) transfusions as defined by greater than or equal to 2 units per 8 weeks
V. CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in members requesting authorization for an indication listed in section IV when both of the following criteria are met:
A. The member has achieved or maintained a reduction in red blood cell transfusion burden
B. The member has not experienced an unacceptable toxicity from Reblozyl
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Reblozyl [package insert]. Summit, NJ: Celgene Corporation, a Bristol-Myers Squibb Company; August 2023.
2. Capellini MD, Viprakasit V, Taher AT, et al. A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia. N Engl J Med 2020;382:1219-31.Benz EJ.
3. Clinical manifestations and diagnosis of the thalassemias. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed October 3, 2023.
4. National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed September 5, 2023.
5. Fenaux P., Platzbecker U, Mufti GJ, et.al. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med 2020;382:140-51.
6. Farmakis D, Porter J, Taher A, Cappellini MD, Angastiniotis M, Eleftheriou A. 2021 Thalassaemia International Federation guidelines for the management of transfusion-dependent thalassemia. Hemasphere. 2022;6(8):e732.
ORIGINAL EFFECTIVE DATE: 1/30/2020
MOST RECENT REVIEW DATE: 5/31/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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