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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 06/01/2018 Title: Mylotarg (gemtuzumab ozogamicin)
Revision Date: 08/01/2022 Document: BI575:00
CPT Code(s): J9203
Public Statement

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.    Mylotarg (gemtuzumab ozogamicin) requires prior authorization.

2.    Mylotarg is used to treat leukemia.

3.    Mylotarg is covered under the medical benefit as a specialty drug.


Medical Statement

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


Reference

1.    Mylotarg Package Insert. Wyeth Pharmaceuticals. August 2021.

2.    Clinical Pharmacology. Accessed online May 23, 2022

3.    NCCN Drugs and Biologics Compendium. Accessed online May 23, 2022.

 

Addendum:

Effective 08/01/2022: Updated AML criteria and added criteria for Acute Promyelocytic Leukemia


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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