BlueCross BlueShield of Tennessee Medical Policy Manual

Inotuzumab Ozogamicin

NDC CODE(S)

0008-0100-XX Besponsa 0.9 mg (WYETH)

DESCRIPTION

Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC).  It consists of three components:  the IgG4 antibody inotuzumab which is specific for CD22, N-acetyl-gamma-calicheamicin which causes double stranded DNA breaks and an acid-cleavable covalent linker known as dimethylhydrazide. 

Its anticancer activity is likely due to the binding of inotuzumab ozogamicin to CD22-expressing tumor cells followed by the internalization of the ADC-CD22 complex.  Within the cell, the N-acetyl-gamma-calicheamicin is released and activated, inducing double-strand DNA breaks leading to cell cycle arrest and death by apoptosis.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

B-cell precursor acute lymphoblastic leukemia (ALL)

1st cycle 1.8 mg/m2 per cycle – 3 divided doses -3 to 4 weeks

Subsequent cycles – 1.5 mg/m2 – 3 divided doses– 4 weeks OR 1.8 mg/m2 – 3 divided doses – 4 weeks w/o CR or CRi

If proceeding to HSCT, recommend 2 cycles only

If not proceeding to HSCT, maximum of 6 cycles

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, August). Center for Drug Evaluation and Research. Besponsa™ (inotuzumab ozogamicin) for injection, for intravenous use. Retrieved August 17, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/29/2017

MOST RECENT REVIEW DATE:  9/29/2017

ID_MRxEx

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

Inotuzumab Ozogamicin (Besponsa™)

  1. Is this the initial request for the agent?

If yes, go to question #2

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

  1. Is the individual 18 years of age with a diagnosis of CD22 positive B-cell precursor acute lymphoblastic leukemia (ALL) that is relapsed or refractory?

If yes, go to question #3

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

  1. Does the request have results for ALL of the following?

If yes, go to question #4

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

  1. Is the request for the following for an authorization period of 6 months?

INDICATION(S)

DOSAGE & ADMINISTRATION

B-cell precursor acute lymphoblastic leukemia (ALL)

1st cycle 1.8 mg/m2 per cycle – 3 divided doses -3 to 4 weeks

Subsequent cycles – 1.5 mg/m2 – 3 divided doses– 4 weeks OR 1.8 mg/m2 – 3 divided doses – 4 weeks w/o CR or CRi

If proceeding to HSCT, recommend 2 cycles only

If not proceeding to HSCT, maximum of 6 cycles

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.