Clinical prior authorization and coverage criteria for use of gemtuzumab ozogamicin (Mylotarg) for AML and APL including dosing unit limits and authorization durations; applies to Viva Health members and providers requesting coverage.
No material clinical or coverage changes in this revision.
6 monthsInitial auth duration
Generally NOT allowedRenewal limitation
CD33-positiveBiomarker
3 mg/m2Common per-dose
6-9 mg/m2Induction dose range (APL)
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Covered when ALL of the following universal criteria AND one of the indication-specific criteria are met
Universal criteria: Member is at least 18 years of age (unless otherwise specified); member has not previously received gemtuzumab ozogamicin; baseline ECG obtained in members with history or predisposition for QTc prolongation; member has CD33-positive disease.
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Renewal Therapy
Renewal of prior authorization may be provided when ALL of the following are met
Renewal requirements: Member continues to meet the universal and indication-specific criteria; duration of authorization has not been exceeded; disease stabilization or improvement demonstrated by complete response (morphologic, cytogenetic or molecular CR), complete hematologic response or partial response by CBC, bone marrow cytogenetics, qPCR, or FISH; absence of unacceptable toxicity from the drug (examples include severe infusion reactions, hemorrhage, hepatotoxicity including VOD/SOS, QT prolongation).
Dosing regimens
Covered dosing and administration when following the specified regimens and cycle limits
Combination regimen - Adult (≥18 years): Induction Therapy (1 cycle only): administer 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin or idarubicin and cytarabine. For members requiring a second induction cycle, do not administer gemtuzumab ozogamicin during the second induction cycle.
Consolidation Therapy (maximum of 2 cycles): administer 3 mg/m2 (up to one 4.5 mg vial) on Day 1 in combination with daunorubicin or idarubicin and cytarabine; or administer 3 mg/m2 on Day 1 in combination with high-dose cytarabine.
Combination regimen - Pediatric (1 month to <18 years): Induction Therapy (1 cycle only): administer 3 mg/m2 (BSA ≥ 0.6 m2) or 0.1 mg/kg (BSA < 0.6 m2) on Day 6 in combination with daunorubicin and cytarabine. For members requiring a second induction cycle, do not administer gemtuzumab ozogamicin during the second induction cycle. Consolidation/Intensification Therapy (1 cycle only): administer 3 mg/m2 (BSA ≥ 0.6 m2) or 0.1 mg/kg (BSA < 0.6 m2) on Day 7 in intensification 2.
Single-agent regimen - Adult (≥18 years): Induction Therapy (1 cycle only): administer 6 mg/m2 as a single agent on Day 1 and 3 mg/m2 on Day 8. Continuation Therapy (maximum of 8 cycles): administer 2 mg/m2 as a single agent on Day 1 every 4 weeks; OR administer 6 mg/m2 as a single agent on Day 1 and 3 mg/m2 on Day 8.
Per the policy universal criteria, a member is ineligible for initial authorization if they have previously received gemtuzumab ozogamicin. This is a required element of the universal approval conditions and must be confirmed prior to initial approval.
When gemtuzumab ozogamicin is used as part of a combination induction regimen, it is restricted to a single induction cycle. Specifically, for members who require a second induction cycle, do not administer gemtuzumab ozogamicin during the second induction.
No explicit exclusions are stated in the cited portions of the document. The available text in these chunks does not provide additional exclusion language beyond the universal criteria already noted.
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Renewal of prior authorization is considered not medically necessary when the renewal criteria are not met. Specifically, renewal should not be approved if there is disease progression, lack of response or stabilization, the duration of authorization has been exceeded, or there is the presence of unacceptable drug-related toxicity (examples include severe infusion reactions, hemorrhage, hepatotoxicity such as VOD/SOS, or QT prolongation).
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Billing and Code Limits
Key Values
APL leukocytosis thresholdWBC ≤10 x 10^9/L defines low-risk APL; WBC >10 x 10^9/L defines high-risk APL.
Prior Authorization, Documentation, and Provider Requirements
Note
Key provider actions
Provider actions and requirements related to prior authorization, documentation, and regimen sequencing for gemtuzumab ozogamicin.
Prior authorization validity: Initial prior authorizations are generally provided for 6 months (180 days) unless otherwise specified.
For newly-diagnosed AML in combination regimens (adult and pediatric), and for certain consolidation regimens, initial prior authorization validity is provided for 6 months with the number of cycles specified by indication (e.g., 3 cycles for adult daunorubicin + cytarabine: 1 induction + 2 consolidation; pediatric: 2 cycles: 1 induction + 1 consolidation).
Relapsed/refractory AML: Initial prior authorization validity provided for 6 months (180 days) consisting of 1 cycle (3 doses); renewal is not permitted.
Acute Promyelocytic Leukemia (APL): Initial prior authorization validity generally 6 months (180 days) for induction/consolidation. Renewals for APL induction/consolidation may be allowed every 6 months based on response (refer to renewal criteria). Single-agent APL therapy may have specific shorter validity (e.g., 12 weeks/6 doses) and renewal rules as noted in the clinical criteria.
Renewal rules: Prior authorization validity may NOT be renewed unless otherwise specified. Where renewal is permitted (e.g., certain APL situations or single-agent continuation therapy), renewal is contingent on meeting the renewal criteria (see Renewal Criteria block).
Documentation required for initial and renewal requests: baseline ECG in members with history of or predisposition to QTc prolongation; documentation of response for renewals (morphologic, cytogenetic, or molecular complete response [CR], complete hematologic response, or partial response by CBC, bone marrow cytogenetic analysis, QPCR, or FISH); and documentation of absence of unacceptable toxicity (examples: severe infusion reactions, hemorrhage, hepatotoxicity such as VOD/SOS, QT prolongation).
Drug Background, Definitions, and Context
Gemtuzumab ozogamicin (Mylotarg) is an anti-CD33 antibody–drug conjugate indicated for use in CD33-positive acute myeloid leukemia (AML) and certain acute promyelocytic leukemia (APL) settings. The agent is used in induction, consolidation, and single-agent regimens for relapsed disease; authorization criteria include confirmation of CD33-positive disease, line-of-therapy and indication-specific regimen alignment, and required baseline testing (for example, an ECG in members with history or predisposition for QTc prolongation). Dosing varies by regimen and age group (common combination dose statements include 3 mg/m2, single-agent induction examples include 6 mg/m2 on Day 1 and 3 mg/m2 on Day 8, and continuation dosing such as 2 mg/m2 every 4 weeks are described in the dosing section).
CD33-positive
Biomarker requirementCD33‑positive disease required for eligibility
ScopeRequired for all approvals of gemtuzumab ozogamicin in this policy
Source sectionUniversal Criteria — member must have CD33‑positive disease
Induction Therapy
Permitted Lines of Therapy
multiple
Line-of-therapy options
Biomarker requirement: CD33-positive disease required for approvals.
first-line
Induction: Use in induction as specified: combination regimens (one induction cycle) or single-agent induction dosing per Section V dosing instructions.
second-line
Consolidation/Continuation: Consolidation with combination regimens (up to 2 cycles) and continuation single-agent therapy (up to 8 cycles) per dosing schedules in Section V.
Covered Regimens, Dosing, and Administration
Regimen
Indication / Notes
Coverage
Gemtuzumab ozogamicin in combination with daunorubicin + cytarabine
Newly diagnosed AML (adult) — used in combination with daunorubicin and cytarabine for induction and consolidation; prior auth provided for 6 months covering 3 cycles (1 induction + 2 consolidation).
Single‑agent gemtuzumab ozogamicin
Induction or relapsed/refractory AML as single agent; single‑agent induction (adult) dosing and continuation options described; single‑agent use for relapsed/refractory disease in members ≥2 years.
Combinations with cytarabine + idarubicin
Used for induction or consolidation therapy in AML in combination with cytarabine and idarubicin (adult and pediatric schedules noted).
Combinations with ATRA ± ATO (APL)
Acute promyelocytic leukemia (APL): low‑risk APL (WBC ≤10 x10^9/L) use in combination with tretinoin (ATRA) when arsenic is not available/contraindicated; high‑risk APL (WBC >10 x10^9/L) use in combination with ATRA ± arsenic trioxide for induction/consolidation as specified.
Dose / Schedule
Context / Cycle limits
Coverage
3 mg/m2 on Days 1, 4, and 7
Combination regimens (adult): Induction Therapy (1 cycle only) and consolidation (maximum 2 cycles); per‑dose vial limit up to one 4.5 mg vial noted. Document dosing administered. Prior auth covers specified cycles.
Single‑agent: 6 mg/m2 (Day 1) then 3 mg/m2 (Day 8); continuation 2 mg/m2 every 4 weeks or repeat 6+3 mg/m2 schedule
Adult single‑agent regimen: Induction (1 cycle only) with Day 1 and Day 8 dosing; continuation therapy maximum of 8 cycles (2 mg/m2 Day 1 q4 weeks or repeat 6+3 schedule).
Dose statement
Context / Note
Coverage
Dose = Relapsed or Refractory AML (numeric dose redacted)
Relapsed or refractory AML dosing described in the dosage/administration section; exact numeric value not legible in source fragment. Single‑agent use for relapsed disease referenced.
Dose
When given
Coverage
6–9 mg/m2
Administer on Day 5 as induction therapy (1 cycle only) in combination with ATRA for APL induction.
Dose
Occurrences in document
Coverage
3 mg/m2
Appears repeatedly throughout the dosing/administration section as a standard per‑dose amount (combination and other contexts).
Dose
Setting / Cycle
Coverage
6–9 mg/m2
Administer on Day 5 — induction therapy (1 cycle only) in combination with ATRA for APL induction. Document dosing administered per induction regimen.
Dose
Context
Coverage
6–9 mg/m2
Administer on Day 5 in combination with ATRA — Induction Therapy (1 cycle only). Multiple fragments reiterate this instruction.
Subsection
Detail available
Coverage
Low‑risk disease — Induction subsection
Referenced as 'Low‑Risk Disease: Induction Therapy (1 cycle only)' but numeric doses not fully legible in these fragments; ATRA combination context noted elsewhere.
Heading
Availability of numeric details
Coverage
Regimen heading (APL / other) present
Numeric doses not legible in source fragment; heading indicates APL dosing sections exist but details redacted in excerpt.
APL dosing label
Detail status
Coverage
APL dosing labeled
Section labeled for Acute Promyelocytic Leukemia (APL) dosing but numeric schedule details are partially redacted or missing in these chunks. Other parts of document specify ATRA combinations.
APL / related dosing
Legibility
Coverage
APL dosing referenced (numeric redacted)
Dosing lines in the APL section are present but many numeric details are redacted; other fragments in the document provide specific ATRA combination dosing (e.g., Day 5 6–9 mg/m2).
Dose
Repetition
Coverage
3 mg/m2
Statement 'Administer 3 mg/m2' appears multiple times across dosage/administration fragments (combination and other contexts).
Dose / Schedule
Vial limit / Cycle
Coverage
3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7
One cycle only for this schedule; documented repeatedly as an example administration regimen in the dosing section. Applicable to combination and some single‑agent contexts per other sections.
Dose / Schedule
Context
Coverage
3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7
Repeated dosing example in the document; noted as one cycle only for induction. Also referenced for relapsed/refractory and APL contexts elsewhere.
Dose / Schedule
Context
Coverage
3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7
Documented multiple times as a single‑cycle administration schedule; vial use limited to up to one 4.5 mg vial per dose.
Dose / Schedule
Indications referenced
Coverage
3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7
Appears in APL and relapsed/refractory AML sections as an administration example (one cycle only).
Dose / Agent
Indication
Coverage
Arsenic trioxide 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7
Referenced in the APL and relapsed/refractory AML context as an agent used in combination (ATO) with dosing lines present in the APL section; gemtuzumab ozogamicin combinations with ATO/ATRA are discussed in APL treatment branches.
Dose documentation: For APL (and other indicated regimens where applicable) document dosing administered as 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (one cycle only) when that schedule is used. For other regimens, document the specific regimen dosing given (examples in dosage section include adult single-agent induction: 6 mg/m2 Day 1 and 3 mg/m2 Day 8; continuation dosing: 2 mg/m2 Day 1 every 4 weeks or 6 mg/m2 Day 1 and 3 mg/m2 Day 8; pediatric dosing per body surface area or weight as specified).
APL regimen sequencing considerations: For APL, gemtuzumab ozogamicin is used in combination with tretinoin (ATRA) for induction/consolidation in low- and high-risk disease as specified; arsenic trioxide (ATO) may be used in combination or when available — gemtuzumab is indicated when arsenic is not available or contraindicated, or per relapse/sequencing rules (e.g., use in combination with ATO with or without ATRA depending on prior exposures and timing of relapse). Document concurrent use of ATRA and whether arsenic is unavailable or contraindicated when claiming the APL combination indication.
Authorization duration limits and renewal denial triggers: Renewals may be denied if duration of authorization has been exceeded, the member does not demonstrate disease stabilization or improvement as defined above, or unacceptable toxicity is present. (No additional explicit denial triggers are stated in this section.)
Provider action summary: Ensure prior authorization requests specify the indication, regimen and dosing, number of cycles requested (matching the allowed validity period), relevant baseline testing (e.g., ECG if indicated), prior exposures (e.g., prior ATO), and objective response/toxicity data for renewals.
No explicit denial triggers in this section beyond the renewal criteria and examples provided; No denial triggers stated elsewhere in this section; None stated in this section beyond the renewal criteria; None specified in this segment.
DefinitionInduction Therapy: initial intensive treatment intended to induce remission
Combination use noteWhen gemtuzumab ozogamicin is used in combination regimens, it is recommended for one induction cycle only
Second induction restrictionDo not administer gemtuzumab ozogamicin during a second induction cycle when used in combination regimens
Induction Therapy (Day 5 with ATRA)
One‑cycle administrationInduction Therapy (1 cycle only): agent administered on Day 5 in combination with ATRA
Dose range contextUsed specifically with ATRA for certain APL regimens (Day 5 administration)
ApplicabilityApplies to induction regimens where gemtuzumab ozogamicin is combined with ATRA
Low-Risk Disease
TermLow‑Risk Disease — referenced as a dosing subsection heading in the Dosage/Administration section
Associated noteAppears in context of induction therapy (1 cycle only) dosing entries
Detail availabilitySpecific numeric doses for the low‑risk subsection are not fully legible in the provided excerpt
Acute Promyelocytic Leukemia (APL)
ContextAcute Promyelocytic Leukemia (APL) is listed as an indication in the dosing section
Detail limitationDocument shows APL dosing headings but many numeric specifics are redacted or not legible in the excerpt
Associated regimensAPL entries reference use with ATRA ± ATO and low‑ vs high‑risk stratification
Low-Risk Disease (in context)
Contextual noteLow‑Risk Disease referenced as a dosing context with an 'Induction Therapy (1 cycle only)' note
Dose specificsSpecific numeric doses for this low‑risk context are not present in the readable text of the excerpt
Relation to ATRALow‑risk APL dosing entries appear alongside instructions for combination with ATRA
APL — indication reference
IndicationAPL (Acute Promyelocytic Leukemia) is referenced as an indication for dosing of gemtuzumab ozogamicin
SectionAPL appears under Dosage/Administration headings in multiple chunks
Detail statusMany numeric dosing and schedule details for APL are redacted or missing in the excerpt
Dose (example)
Example dose regimenAdminister 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (1 cycle only)
Vial limitUp to one 4.5 mg vial per dose is specified in the dosing example
Cycle limitSpecified as a single‑cycle administration in the example entries
Specified regimen
Regimen statementDose: 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (1 cycle only)
Use casesThis regimen appears as a single‑cycle administration option in the Dosage/Administration section
Documentation instructionDosing records should document the 3 mg/m2 dose and vial usage on Days 1, 4, and 7 (per provider documentation guidance).
APL (repeated reference)
IndicationAPL (Acute Promyelocytic Leukemia) is repeatedly referenced in the dosing section
Excerpt statusAPL appears across multiple dosing lines though many are partially redacted
Associated dosing exampleSome APL lines are paired with the 3 mg/m2 Days 1, 4, 7 single‑cycle example elsewhere in the section
mixed
Mixed indications: Relapsed or refractory AML; Induction Therapy (1 cycle only) in APL when used with ATRA as specified (e.g., Day 5 dosing range 6-9 mg/m2).
first-line
APL induction with ATRA: Induction Therapy (1 cycle only): administer 6-9 mg/m2 on Day 5 in combination with tretinoin (ATRA) as specified for APL induction.
CD33 — biomarker requirement
BiomarkerCD33 required for approvals
Policy placementListed under Universal Criteria as a required biomarker
ImplicationPresence of CD33‑positive disease is a prerequisite for coverage per this policy