BlueCross BlueShield of Tennessee Medical Policy Manual

Gemtuzumab Ozogamicin


00008-4510-XX Mylotarg 4.5 MG SOLR (PFIZER U.S.)


Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes human CD33 antigen. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.







Acute Myeloid Leukemia

Combination regimen (De Novo AML):

Induction Therapy (1 cycle only):

·         3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine

For patients requiring a second induction cycle, do not administer gemtuzumab ozogamicin during the second induction cycle

Consolidation Therapy (maximum of 2 cycles):

·         3 mg/m2 (up to one 4.5 mg vial) on Day 1 in combination with daunorubicin and Cytarabine

Single-agent regimen:

Induction Therapy (1 cycle only):

·         6 mg/m2 as a single agent on Day 1, and 3 mg/m2 on Day 8

Continuation Therapy (maximum of 8 cycles):

·         2 mg/m2 as a single agent on Day 1 every 4 weeks

Relapsed or Refractory AML (single agent)

·         3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 (1 cycle only)

Acute Promyelocytic Leukemia

Combination regimen:

Induction Therapy (1 cycle only):

·         6-9 mg/m2 on Day 1 in combination with ATRA+ATO

Consolidation Therapy (up to a maximum of 7 cycles):

·         ATRA and ATO are used for consolidation. If ATRA or ATO are discontinued due to toxicity then: Mylotarg, single agent, dosed at 9mg/m2 on Day 1 every 4-5 weeks until 28 weeks from complete remission

 Refrigerate (2-8°C; 36-46°F) and store in the original carton to protect from light. Do not freeze.

 Note: cycle lengths are 28 days




Newly-Diagnosed AML

Relapsed or Refractory AML

Acute Promyelocytic Leukemia

Refer to DOSAGE LIMITS below


BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.


We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.


For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).


Lexicomp Online. (2018, November). AHFS DI. Fluocinolone. Retrieved December 6, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, June). Gemtuzumab ozogamicin. Retrieved December 6, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Gemtuzumab ozogamicin. Retrieved December 6, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, April). Center for Drug Evaluation and Research. MYLOTARG™ (gemtuzumab ozogamicin). Retrieved December 6, 2018 from




Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.




Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 0.1 mg


INDUCTION (1cycle only)



135 billable units on Day 1 & 90 billable units on Day 8 of a 28-day cycle; OR

45 billable units on Days 1, 4, & 7 of a 28-day cycle

45 billable units on Day 1 of a 28-day cycle (up to a maximum of 8 subsequent cycles)


180 billable units on Day 1

180 billable units on Day 1 of a 28-day cycle (up to a maximum of 7 subsequent cycles)