Mylotarg (gemtuzumab oxogamicin) is considered medically necessary for patients
meeting the following:
Acute Myeloid Leukemia
(AML)
1)
Diagnosis of
CD33-positive AML;
2)
Prescribed by or in
consultation with an oncologist or hematologist;
3)
Member meets (a or b):
a.
Age > 1 month with
newly diagnosed disease;
b.
Age > 2 years with
relapsed or refractory disease;
4)
Request meets one of the
following (a, b, c, d, or e):*
a.
Age 1 month to < 18
years: Newly diagnosed disease as combination therapy with standard chemotherapy
(i or ii):
i.
Induction – 1 cycle (1
vial): dose does not exceed 0.1mg/kg (BSA < 0.6m2) or 3mg/m2
(BSA > 0.6m2) given once;
ii.
Intensification – 1 cycle
(1 vial): dose does not exceed 0.1mg/kg (BSA < 0.6m2) or 3mg/m2
(BSA > 0.6m2) given once:
b.
Age > 18 years:
Newly diagnosed disease as combination therapy with daunorubicin and cytarabine
(i and ii):
i.
Induction – 1 cycle (3
vials): dose does not exceed 3mg/m2 on Days 1, 4, and 7;
ii.
Consolidation – 2 cycles
(2 vials): dose does not exceed 3mg/m2 on Day 1 of each cycle;
c.
Age > 18 years:
Newly diagnosed disease as single-agent therapy (i and ii):
i.
Induction – 1 cycle: dose
does not exceed 6mg/m2 on Day 1, and 3mg/m2 on Day 8;
ii.
Continuation therapy – 8
cycles: dose does not exceed 2mg/m2 on Day 1 of each cycle;
d.
Age > 2 years:
Relapsed or refractory disease (single-agent regimen): single course: dose does
not exceed 3mg/m2 o Days 1, 4, and 7 (3 vials);
e.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber
must submit supporting evidence).
*Prescribed regimen must be FDA-approved or
recommended by NCCN.
Approval Duration: 12
months (Up to a total of 10 doses)
Continuation of Therapy
for AML
1)
Member is responding
positively to therapy;
2)
Member has NOT received
the maximum recommended doses as described below (a, b, or c):
a.
As combination therapy
with daunorubicin and cytarabine for newly diagnosed disease: up to 5 doses;
b.
As single-agent therapy
for newly diagnosed disease: up to 10 doses;
c.
As single-agent therapy
for relapsed or refractory disease: up to 3 doses.
3)
Dosing is still
consistent with dose guidelines in initial approval criteria
Acute Promyelocytic
Leukemia (off-label)
1)
Diagnosis of
promyelocytic leukemia;
2)
Prescribed by or in
consultation with an oncologist or hematologist;
3)
Age > 18 years;
4)
Dose is within FDA
maximum limit for any FDA-approved indication or is supported by practice
guidelines or peer-reviewed literature for the relevant off-label use (prescriber
must submit supporting evidence)*
*Prescribed regiment must be FDA-approved or recommended by NCCN.
Approved Duration: 12
months
Codes
Used In This BI:
J9203 – Injection, gemtuzumab ozogamicin, 0.1mg