Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Reblozyl (luspatercept-aamt) requires prior authorization.

2)    Reblozyl is used to treat anemia in adult patients with beta thalassemia.

3)    Reblozyl is a specialty medication.

Reblozyl (luspatercept-aamt) is considered medically necessary for members age 18 or older who meet the following criteria:

A. Transfusion Dependent Beta Thalassemia

1)    Diagnosis  of transfusion dependent thalassemia (TDT) with one of the following genotypes (a or b):

a.    Beta thalassemia

b.    Hemoglobin E/beta thalassemia

2)    Prescribed by or in consultation with a hematologist;

3)    Total volume of transfusions exceeds 6 RBC units within the last 6 months;

4)    Not transfusion-free period >35 days within the last6 months;

5)    Dose does not exceed 1mg/kg every 3 weeks.

B. Myelodysplastic Syndromes (must meet all):

1)    Diagnosis of MDS-RS or MDS/MPN-RS-T that meets one of the following classifications (a, b, or c):

a.    Very low, low, or intermediate risk as classified by IPSS-R;

b.    Low/intermediate-1 risk as classified by IPSS;

c.    Very low, low, or intermediate risk as classified by WPSS;

2)    Prescribed by or in consultation with a hematologist or oncologist;

3)    Member requires ≥ 2 RBC units per 8 weeks documented for at least the last 16 weeks;

4)    Failure of an 8 week trial of an erythropoiesis-stimulating agent (ESA) used in combination with a granulocyte colony stimulating factor (G-CSF), unless one of the following applies (a or b):

a.    Clinically significant adverse effects are experienced or all are contraindicated

b.    Documentation of current serum erythropoietin > 500 mU/mL;

5)    Member has one of the following (a or b):

a.    Ring sideroblast ≥ 15% of erythroid precursors in bone marrow;

b.    Ring sideroblast ≥ 5% if SF3B1 mutation is present;

6)    Member does not have del(5q) cytogenetic abnormality;

7)     Request meets one of the following (a or b):*

a.    Dose does not exceed 1 mg/kg every 3 weeks;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Reauthorization Criteria

Member meets one of the following:

1)    Member is responding positively to therapy as evidenced by at least a 33% reduction in transfusion burden from baseline;

2)    Request is for a dose increase; If request is for a dose increase, new dose does not exceed:

a.    Transfusion Dependent Beta Thalassemia: 1mg/kg every 3 weeks or 1.25mg/kg every 3 weeks, and documentation supports inadequate response to 1mg/kg dosing.

b.    For Myelodysplastic Syndromes:

                                          i.    New dose does not exceed 1 mg/kg every 3 weeks;

                                        ii.    New dose does not exceed 1.33 mg/kg every 3 weeks, and documentation supports lack of transfusion independence after 2 consecutive doses at 1 mg/kg dosing;

                                       iii.    New dose does not exceed 1.75 mg/kg every 3 weeks, and  documentation supports lack of transfusion independence after 2 consecutive doses at 1.33 mg/kg dosing;

                                       iv.    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Codes Used In This BI:

1)    J0896 – Injection, luspatercept-aamt, 0.25mg

1)    Reblozyl Prescribing Information. Cambridge, MA: Acceleron Pharma, Inc. April 2020. Available at: www.reblozyl.com. Accessed October 27, 2020.

2)    Cappellini MD, Vipralasit V, Taher A, et al. The BELIEVE Trial: Resultsof a phase 3, randomized, double-blind, placebo-controlledstudy ofluspatercept inadult beta-thalassemia patients who require regular red blood cell (RBC) transfusions [Oral]. Oral presented at: 60th American Society of Hematology Annual Meeting and Exposition (ASH); December 1-4, 2018; San Diego, CA.

3)    CappelliniMD, Cohen A, Porter J, et al. Guidelines for the management of transfusion dependent thalassemia (TDT) 3rd Edition. Thalassemia International Federation (2014):20.

4)    Fenaux P, Platzbecker U, Mufti GJ, et al. Luspatercept in patients with lower-risk

myelodysplastic syndromes. N Engl J Med. 2020;382:140-151.

5)    National Comprehensive Cancer Network. Myelodysplastic Syndromes Version 1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed October 27, 2020.

6)    Patnaik MM, Tefferi A. Refractory anemia with ring sideroblasts (RARS) and RARS with thrombocytosis (RARS-T) – “2019 Update on Diagnosis, Risk-stratification, and

Management.” Am J Hematol. 2019;94(4): 475–488.

7)    Reblozyl Data on File. Use of Reblozyl (luspatercept-aamt) in patients with

myelodysplastic/myeloproliferative neoplasm with ring siderblasts and  thrombocytosis. Bristol Meyers Squibb. 2020 May.

Addendum:

1)    Effective 07-01-2020: Updated to include J0896.

2)    Effective 06-01-2021: Updated to include myelodysplastic syndromes.