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