ModifiedMass General Brigham Health PlanPolicy N/A

Mylotarg (gemtuzumab ozogamicin)

Medical-benefit prior authorization policy for Mylotarg (gemtuzumab ozogamicin) for treatment of CD33-positive acute myeloid leukemia (newly diagnosed and relapsed/refractory) in specified age groups; includes prescriber requirements, dosing appropriateness, approval durations, reauthorization limits, and examples of AML regimens.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMylotarg (gemtuzumab ozogamicin)

Policy CodePolicy N/A

Change TypeClinical and operational revisions

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit medical-benefit prior authorization and ensure billing under the medical benefit; include oncologist/hematologist documentation and age confirmation.

SourceLink

POLICY UPDATE CHANGES

For newly diagnosed CD33-positive AML, criteria will require either combination therapy or clinical rationale why combination is not appropriate or if member is ≥60 years of age.

Mylotarg removed from pharmacy benefit and will be managed through medical benefit only.

Policy created and matched to MassHealth UPPL and compliance criteria.

Updated formatting and references as part of annual UM review.

2Covered Indications (newly diagnosed; relapsed/refractory)

2Minimum ages (1 month; 2 years)

3/1Initial approval cycles (newly diagnosed; R/R)

Medical onlyManagement channel

Coverage Summary

Medical-benefit prior authorization policy for Mylotarg (gemtuzumab ozogamicin) for treatment of CD33-positive acute myeloid leukemia (newly diagnosed and relapsed/refractory) in specified age groups. The policy requires prior authorization under the medical benefit (Mylotarg has been removed from the pharmacy benefit and will be managed through the medical benefit only) and provides contact information for medical benefit prior authorization.

Coverage stance: covered_with_criteria. Authorization criteria align with MassHealth requirements and specify prescriber specialty documentation, age thresholds for indications (newly diagnosed: ≥1 month; relapsed/refractory: ≥2 years), appropriate dosing, and regimen requirements for newly diagnosed patients (combination therapy with cytarabine and daunorubicin or fludarabine or documented clinical rationale or age ≥60 years). Examples of common AML induction regimens are included in the policy appendix to inform combination therapy decisions.

Policy quick facts

Covered indications count2 (newly diagnosed; relapsed/refractory)

Minimum ages1 month (newly diagnosed); 2 years (relapsed/refractory)

Initial approval cycles3 cycles (newly diagnosed); 1 cycle (relapsed/refractory)

Management channelMedical benefit only

Effective date2025-07-01

Initial Therapy Criteria — Newly Diagnosed CD33‑positive AML

Authorization criteria — Newly-diagnosed CD33-positive AML (adults and pediatric patients 61 month)

Authorization may be granted when ALL of the following are met:

ALL of the following

ALL of the following
- Indication of newly diagnosed CD33-positive acute myeloid leukemia (AML)
- Prescriber is an oncologist or hematologist or consult notes from an oncologist or hematologist are provided
- Member is ≥1 month of age
- Appropriate dosing

Continuation / Relapsed or Refractory Criteria

Authorization for members new to the plan currently receiving treatment

Authorization may be reviewed on a case by case basis when ALL of the following are met:

ALL of the following

Member is new to the plan and currently receiving treatment with the requested medication
Excludes situations when product is obtained as samples or via manufacturer's patient assistance programs

Provider Actions / Operational Requirements

Prior Authorization

Prior authorization required (Medical Benefit)

Mylotarg is managed under the medical benefit and requires prior authorization; contact numbers for medical and pharmacy benefits are provided in the policy header.

Documentation Required

Prescriber specialty documentation

Prescriber must be an oncologist or hematologist or provide consult notes from an oncologist or hematologist.

Applicable Codes

Benefit / Program and contactmixed

No codes listed

Clinical Evidence & References

Primary manufacturer prescribing information: Mylotarg [prescribing information]. Philadelphia (PA): Wyeth Pharmaceuticals, Inc (Pfizer); 2021 Sep.

Key guideline: National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology Acute Myeloid Leukemia. Version 3.2021.

Background

Mylotarg (gemtuzumab ozogamicin) is a CD33-directed antibody-drug conjugate (ADC) indicated for the treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients one month and older (as combination therapy and as monotherapy) and for relapsed or refractory CD33-positive AML in adults and pediatric patients two years and older (as monotherapy).

The policy aligns with MassHealth criteria and is managed under the medical benefit; Mylotarg has been removed from the pharmacy benefit and will be managed through the medical benefit only. Operational and review history notes the change in benefit channel effective 5/6/24 and a clinical requirement update effective 7/1/25 requiring combination therapy or documented rationale for newly diagnosed patients or age ≥60 years.

The policy appendix includes examples of common AML induction regimens (for patients <60 years and ≥60 years) to inform combination therapy decisions, including schedules that reference a single 3 mg/m2 dose or three fractionated doses of gemtuzumab ozogamicin when used with standard cytarabine/daunorubicin regimens.

Revision History

2025-07-01clinical_requirement_updateLatest

For newly diagnosed CD33-positive AML, criteria will require either combination therapy or clinical rationale why combination is not appropriate or if member is ≥60 years of age. (Updated clinical requirement effective 7/1/25.)

2024-05-06operational_change

Mylotarg removed from pharmacy benefit and will be managed through medical benefit only. (Operational change effective 5/6/24; impacts billing channel.)

2022-08-01initial_creation

Policy Summary

PayerMass General Brigham Health Plan

PolicyMylotarg (gemtuzumab ozogamicin)

Policy CodePolicy N/A

Change TypeClinical and operational revisions

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit medical-benefit prior authorization and ensure billing under the medical benefit; include oncologist/hematologist documentation and age confirmation.

SourceLink

On This Page

Dosing consistent with labeling and examples provided (including single 3 mg/m2 dosing or three fractionated doses as described in regimen examples) and clinical standards.

ONE of the following

Requested agent will be used in combination with cytarabine and daunorubicin or fludarabine
Clinical rationale why combination therapy with cytarabine and daunorubicin or fludarabine is not appropriate
Member is ≥ 60 years of age

Appropriate dosing is defined as dosing consistent with labeling and provided examples, including either a single 3 mg/m2 dose or three fractionated doses as described in regimen examples and clinical standards. Dosing guidance references the product labeling and commonly used regimen examples for AML induction.

Examples noted in the appendix include use of a single 3 mg/m2 dose given on day one (or day two, three, or four) or an alternative schedule of three total doses given on days one, four, and seven when used with standard induction regimens. Decisions about combination therapy should be informed by the appendix examples of common AML induction regimens.

Documentation Required

Age requirement documentation

Document patient's age to confirm eligibility: ≥1 month for newly diagnosed indication and ≥2 years for relapsed/refractory indication.

Billing Rule

Benefit channel change (effective 5/6/24)

Mylotarg has been removed from the pharmacy benefit and will be managed through the medical benefit only (operational: ensure billing under medical benefit).

Denial Risk

Exclusion for assistance/samples

Authorization will not be granted when therapy is obtained as samples or via manufacturer's patient assistance programs.

Policy created and matched to MassHealth UPPL and compliance criteria. (Initial creation effective 8/1/22.)

2025-06-11review

Updated formatting and references as part of annual UM review. (Review dated 06/11/25; non-clinical updates accompanying the clinical change.)