CurrentEmblemHealthPolicy MG.MM.PH.56

Medical Policy: Mylotarg (gemtuzumab ozogamicin) Intravenous

Defines medical necessity criteria, dosing limits, renewal limits, ICD-10 diagnoses, billing codes and NDC for Mylotarg (gemtuzumab ozogamicin) intravenous for treatment of CD33-positive acute myeloid leukemia (AML) in specified age groups.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Mylotarg (gemtuzumab ozogamicin) Intravenous

Policy CodePolicy MG.MM.PH.56

Change TypeAnnual Review (revised)

Effective Date

Next Review Date

Key ActionTreating physician must submit clinical evidence that the member meets the criteria (age, CD33-positive disease, indication) for preauthorization or post-payment review; failure to provide documentation prevents proper review.

SourceLink

POLICY UPDATE CHANGES

Annual Review: Updated dosing limits and ICD-10 codes.

2/1/2024 Annual Review updated dosing limits with no criteria changes.

06/02/2023 Annual Review added multiple ICD-10 codes and removed hyperleukocytosis and single-agent usage criteria.

6/23/2020 Updated age restriction to 1 month of age or older for newly diagnosed AML.

2Covered Indications

8Max continuation cycles

1Relapsed/refractory approval cycles

J9203

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Coverage Summary

Overview: This policy defines EmblemHealth's medical necessity criteria for Mylotarg (gemtuzumab ozogamicin) intravenous. Coverage stance: covered with criteria when the patient meets indication-specific requirements, age limits, and CD33-positivity. Background: Mylotarg is indicated for newly diagnosed CD33-positive AML in patients 1 month of age or older and for relapsed/refractory CD33-positive AML in patients 2 years of age or older, and EmblemHealth based criteria on available clinical literature and regulatory status.

Surface thresholds

Maximum continuation cyclesNo more than 8 cycles

Relapsed/refractory approval duration1 month (1 cycle); may not be renewed

Newly diagnosed initial approval duration6 months; may be renewed once

Medical Necessity Criteria

Medically Necessary - General Eligibility

Mylotarg is considered medically necessary when ALL of the following are met:

ALL of the following

Indication-specific criteria: Patient meets indication-specific criteria (see indication nodes)
Age limits: Patient is within the specified age limits for the indication
Disease marker: Disease is CD33-positive

Indication: Newly diagnosed AML (initial therapy)

Coverage for newly diagnosed acute myeloid leukemia when ALL of the following are met:

ALL of the following

Age: Patient is 1 month of age or older
CD33 positivity: The patient has CD33-positive disease

Indication: Relapsed or refractory AML

Coverage for relapsed or refractory AML when ALL of the following are met:

ALL of the following

Age: Patient is 2 years of age or older
CD33 positivity: The patient has CD33-positive disease

Renewal Criteria (Continuation Therapy)

Coverage may be renewed when ALL of the following are met:

ALL of the following

Response: Documented disease response
Cycle limit: Patient will receive no more than 8 cycles of continuation therapyNo more than 8 cycles
Toxicity: Absence of unacceptable toxicity from the drug (examples include severe infusion related reactions, hemorrhage, hepatotoxicity including hepatic veno-occlusive disease/sinusoidal obstruction syndrome, tumor lysis syndrome, symptomatic QTc prolongation)

Limitations / Exclusions

Authorization durations and renewal limits:

ANY of the following

Relapsed/Refractory duration: For relapsed or refractory AML: Approval will be granted for 1 month (1 cycle) and may not be renewed1 month (1 cycle), may not be renewed
Newly diagnosed duration: For newly diagnosed AML: Approval will be granted for 6 months and may be renewed once6 months, may be renewed once

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required

Requests require review against the policy criteria for indication, age limits, CD33 positivity, dosing limits and renewal criteria; authorization durations differ by indication. Prior authorization is required for claims using HCPCS code J9203. See limitations for specific authorization durations.

Affected code: J9203
See Limitations/Exclusions for authorization durations and renewal rules

Documentation Required

Submit clinical evidence for medical necessity

The treating physician must submit clinical evidence that the member meets the criteria for treatment (including patient age, CD33-positive disease, and the specific indication) for preauthorization or for post-payment review. Failure to provide this documentation will prevent proper review.

Coding

Applicable HCPCS/J-codeHCPCSCovered

J9203

Injection, gemtuzumab ozogamicin, 0.1 mg

Applicable NDCsNDCCovered

00008-4510-01

Mylotarg 4.5mg Solution Reconstituted

Applicable ICD-10 Diagnoses (covered indications)ICD-10Covered

C92.00	Acute myeloblastic leukemia, not having achieved remission
C92.01	Acute myeloblastic leukemia, in remission
C92.02	Acute myeloblastic leukemia, in relapse

Background & Evidence

Background: Mylotarg (gemtuzumab ozogamicin) is a humanized CD33-directed antibody-drug conjugate composed of gemtuzumab linked to a cytotoxic calicheamicin derivative. It is indicated for newly diagnosed CD33-positive acute myeloid leukemia (AML) in patients 1 month of age or older and for relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years of age or older. EmblemHealth based its criteria on a review of available clinical literature, regulatory status, and evidence-based guidelines.

Label	Value
Source - Product information	Mylotarg Product Information (Wyeth), label updates referenced
Guidelines referenced	NCCN Acute Myeloid Leukemia, NCI PDQ

Definitions: Mylotarg (gemtuzumab ozogamicin) — a humanized CD33-directed monoclonal antibody-drug conjugate composed of the IgG4 kappa antibody gemtuzumab linked to a cytotoxic calicheamicin derivative that targets CD33-expressing leukemic cells; indicated for treatment of newly diagnosed CD33-positive AML (patients ≥ 1 month) and relapsed/refractory CD33-positive AML (patients ≥ 2 years).

Revision History

2025-03-17revisionLatest

Annual Review: Updated dosing limits and ICD-10 codes. Initial criteria: removed statements requiring de novo disease and specifying use in combination with daunorubicin and cytarabine or single-agent use; renewal criteria removed 'Patient does NOT have de novo disease'; removed prior limitation granting 3 months (3 cycles) for newly diagnosed de novo AML.

2024-02-01revision

Annual Review: Updated dosing limits with no criteria changes.

2023-06-02