BlueCross BlueShield of Tennessee Medical Policy Manual

Gemtuzumab Ozogamicin

NDC CODE(S)

0008-4510-xx Mylotarg 4.5 mg SOLR (WYETH / PFIZER)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Acute Myeloid Leukemia

  • Newly-diagnosed AML (combination regimen)

    • Induction (1 cycle only): 3mg/m2 (up to one 4.5 mg vial) on Days 1, 4 and 7 in combination with daunorubicin and cytarabine

    • Consolidation (maximum of 2 cycles): 3mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine

  • Newly-diagnosed AML (single-agent regimen)

    • Induction (1 cycle only): 6mg/m2 on Day 1 and 3mg/m2 on Day 8

    • Continuation (maximum of 8 cycles): For individuals without evidence of disease progression following induction, up to 8 continuation courses 2mg/m2 on Day 1 every 4 weeks

  • Relapsed or refractory AML (single-agent regimen)

    • 3mg/m2 on Days 1, 4 and 7 (1 cycle only)

NOTE:  Cycle length is 28 days

 

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION  

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).

SOURCE

U. S. Food and Drug Administration. (2017, September). Center for Drug Evaluation and Research. MYLOTARG™ (gemtuzumab ozogamicin). Retrieved September 5, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf.

ORIGINAL EFFECTIVE DATE:  10/23/2017

MOST RECENT REVIEW DATE:  10/23/2017

ID_MRx

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.

Pharmaceutical Decision Support Tree

Gemtuzumab Ozogamicin (Mylotarg™)

  1. Is this the initial request for gemtuzumab ozogamicin?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of CD33-positive acute myeloid leukemia (AML)?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria 

  1. Does the individual have a history of, or predisposition for, QTc prolongation?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria 

  1. Does the individual have a baseline electrocardiogram (ECG)?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria 

  1. Does the individual have hyperleukocytosis (leukocyte count equal to or greater than 30 x 109/L)?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria 

  1. Has the individual had cytoreduction?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria 

  1. Does the individual have newly diagnosed CD33 positive AML?

If yes, go to question #8

If no, go to question #9 

  1. Is the individual 18 years of age or older and use of the agent meets ANY ONE of the following?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have relapsed or refractory CD33 positive AML?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria 

  1. Is the individual 2 years of age or older and the agent is intended only for single agent use?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 4.5 mg vials (5 vials per initial 28 days; 1 vial per 28 thereafter up to a maximum of 8 cycles [28 days per cycle]) billable units for ANY ONE of the following for an authorization?

INDICATION(S)

DOSAGE & ADMINISTRATION

Acute Myeloid Leukemia

  • Newly-diagnosed AML (combination regimen)

    • Induction (1 cycle only): 3mg/m2 (up to one 4.5 mg vial) on Days 1, 4 and 7 in combination with daunorubicin and cytarabine

    • Consolidation (maximum of 2 cycles): 3mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine

  • Newly-diagnosed AML (single-agent regimen)

    • Induction (1 cycle only): 6mg/m2 on Day 1 and 3mg/m2 on Day 8

    • Continuation (maximum of 8 cycles): For individuals without evidence of disease progression following induction, up to 8 continuation courses 2mg/m2 on Day 1 every 4 weeks

  • Relapsed or refractory AML (single-agent regimen)

    • 3mg/m2 on Days 1, 4 and 7 (1 cycle only)

NOTE:  Cycle length is 28 days

 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.