CurrentEmblemHealthPolicy N/A

Mylotarg (gemtuzumab ozogamicin) — Coverage Criteria

Defines accepted indications, dosing limits, contraindications, and prior-authorization expectations for Mylotarg (gemtuzumab ozogamicin) for Evolent-managed members; applies to network ordering providers across applicable EmblemHealth lines of business.

Policy Summary

PayerEmblemHealth

PolicyMylotarg (gemtuzumab ozogamicin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Mylotarg; continuation requests may be exempt if no progression, prior use within last year without >30-day lapse, and no added medications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9203HCPCS code

CD33+ AMLPrimary indication

3/6 mg/m2Adult single‑dose limits

Commercial/MedicaidLines of business

Coverage Criteria for Mylotarg (gemtuzumab ozogamicin)

Indications for Mylotarg

Covered when ALL of the following are met

Primary indication: Member has CD33-positive acute myeloid leukemia (AML)

Applicable for newly diagnosed AML (age >=1 month) as single agent or in combination, and for relapsed/refractory AML (age >=2 years) if they have not received Mylotarg previously.

Age-based indications: Newly diagnosed AML: age 1 month and older; Relapsed/refractory AML: age 2 years and older

Requests for Mylotarg (gemtuzumab ozogamicin) will be excluded when any of the following apply: disease progression on or following Mylotarg or a Mylotarg-containing regimen; dosing that exceeds the listed single-dose limits for adults or pediatrics; or use that is investigational or off‑label without sufficient supporting evidence from CMS‑recognized compendia or acceptable peer‑reviewed literature. The adult single‑dose limits are 3 mg/m2 for combination therapy (maximum 4.5 mg) and 6 mg/m2 when given as a single agent. Pediatric single‑dose limits are 3 mg/m2 for BSA ≥0.6 m2 and 0.1 mg/kg for BSA <0.6 m2.

Policy Summary

PayerEmblemHealth

PolicyMylotarg (gemtuzumab ozogamicin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Mylotarg; continuation requests may be exempt if no progression, prior use within last year without >30-day lapse, and no added medications.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Evolent does not support certain specific regimens containing Mylotarg due to lack of Level 1 evidence showing superior outcomes versus Evolent‑recommended alternatives. Examples explicitly listed in the policy include the induction regimen for patients <60 years of age: fludarabine + HiDAC + idarubicin + G‑CSF + gemtuzumab ozogamicin, and for patients ≥60 years of age the use of single‑agent Mylotarg for induction or consolidation. Use of these regimens is considered not medically necessary when Level 1 evidence is lacking.

Regimens Supported by Policy

Regimen	Indication / Age	Coverage status
Fludarabine + HiDAC + idarubicin + G-CSF + gemtuzumab ozogamicin	Induction therapy in patients < 60 years	Not supported by policy due to lack of Level 1 evidence; not covered

Regimen	Indication / Age	Coverage status
[{"text":"Single-agent gemtuzumab ozogamicin (Mylotarg)","status":""},{"text":"Induction or consolidation therapy in patients 60 years","status":""},{"text":"Not supported by policy due to lack of Level 1 evidence; not covered","status":"not_covered"}]

Billing Codes and Dosing Limits

Covered HCPCS CodesHCPCSCovered

J9203

Injection, gemtuzumab ozogamicin, 0.1 mg

Adult single-dose limits

Combination therapy single-dose limit3 mg/m2 (maximum single-dose 4.5 mg)

Single-agent adult single-dose limitUp to 6 mg/m2

ApplicabilityAdult dosing limits apply to members meeting age and indication criteria per policy

Pediatric single-dose limits

Pediatric BSA >= 0.6 m2Single-dose limit 3 mg/m2

Pediatric BSA < 0.6 m2Single-dose limit 0.1 mg/kg

Age applicabilityPediatric single-dose limits apply to members 1 month and older as specified in policy

Approved Line(s) of Therapy

first-line | salvage

Line of therapy: Newly diagnosed AML (may be used as single agent or in combination) OR relapsed/refractory AML in patients who have not previously received Mylotarg

Age-specific minimums: newly diagnosed >=1 month; relapsed/refractory >=2 years.

Biomarker / Diagnostic Requirements

Biomarker requirement (CD33)

Required biomarkerCD33-positive AML is required for use of Mylotarg

Use settingsAllowed as single agent or in combination for newly diagnosed AML (age >=1 month) and relapsed/refractory AML (age >=2 years) if not previously treated with Mylotarg

DocumentationCD33 status must be documented in the medical record per indication requirements

Provider Actions, Documentation and Denial Risks

Prior Authorization

Prior authorization and continuation request exemptions

Prior authorization is required for initial requests for Mylotarg (gemtuzumab ozogamicin) unless the request meets the continuation-exemption criteria below. Continuation requests are exempt from prior authorization review if all of the following are true: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Continuation exemption conditions: no disease progression on requested medication; prior use within last 12 months with ≤30-day authorization gap; no additional agents added
Prior authorization required for new starts and for continuation requests that do not meet the exemption criteria

Note

Regimen-level exclusions / preferred alternatives

Evolent does not support certain Mylotarg-containing regimens due to lack of Level 1 evidence demonstrating superior outcomes versus recommended alternatives. Specifically unsupported regimens include: induction therapy (<60 years): Fludarabine + HiDAC + idarubicin + G-CSF + gemtuzumab ozogamicin; and induction/consolidation (≥60 years): single-agent Mylotarg. Providers should consider Evolent-recommended alternative regimens (e.g., those listed in Evolent Pathways) when treating AML.

Unsupported regimens: Induction (<60 y): Fludarabine + HiDAC + idarubicin + G-CSF + gemtuzumab ozogamicin; Induction/Consolidation (≥60 y): single-agent Mylotarg
Refer to Evolent Pathways for recommended alternative agents/regimens

Documentation Required

Supporting evidence required

Use of Mylotarg must be supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or peer-reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). Acceptable peer-reviewed evidence should adequately represent the patient and disease characteristics, the regimen administered, and report clinically meaningful outcomes (ASCO-recommended thresholds, e.g., HR < 0.80 and ≥3 months survival benefit for OS/PFS where applicable). Non-randomized trials with substantial subject numbers may be acceptable; case reports alone are generally insufficient.

Acceptable evidence sources: FDA labeling, CMS-approved compendia, NCCN, ASCO, or peer-reviewed literature meeting CMS requirements
Peer-reviewed evidence expectations: representative patient/disease characteristics; regimen represented; clinically meaningful outcomes (ASCO guidance); robust study design or adequate subject numbers
Case reports alone are usually inadequate to support investigational/off-label use

Denial Risk

Exclusion conditions that trigger denial

Requests meeting any exclusion condition listed below are subject to denial. Providers should ensure documentation addresses these conditions before submission.

Disease progression on or following Mylotarg or a Mylotarg-containing regimen
Adult dosing exceeds single-dose limit: >3 mg/m2 per dose when used in combination therapy (absolute max single dose 4.5 mg) or >6 mg/m2 as single agent
Pediatric dosing exceeds single-dose limits: for BSA ≥0.6 m2, >3 mg/m2 per dose; for BSA <0.6 m2, >0.1 mg/kg per dose
Investigational use for off-label indications lacking sufficient evidence (not supported by CMS compendia or acceptable peer-reviewed literature)

Key Definitions and Safety Terms

Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)

Boxed warningHepatotoxicity including severe or fatal hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) has been reported with gemtuzumab ozogamicin

Monitoring requirementMonitor frequently for signs and symptoms of VOD/SOS after treatment with gemtuzumab ozogamicin

Scope of riskRisk reported with single-agent use and as part of combination chemotherapy regimens

Background on Gemtuzumab Ozogamicin (Mylotarg)

Gemtuzumab ozogamicin (Mylotarg) is an anti‑CD33 antibody‑drug conjugate indicated for CD33‑positive acute myeloid leukemia (AML). It may be used as a single agent or in combination with chemotherapy for newly diagnosed AML (age ≥1 month) and for relapsed/refractory AML in patients age ≥2 years who have not previously received Mylotarg. Safety considerations include hepatotoxicity and veno‑occlusive disease (sinusoidal obstruction syndrome), and dosing must adhere to the policy’s specified adult and pediatric single‑dose limits.