Inotuzumab Ozogamicin (Besponsa™)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indication
Besponsa is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
B. Compendial Use
Pediatric acute lymphoblastic leukemia (ALL)
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Testing or analysis confirming CD22 protein on the surface of the B-cell
III. CRITERIA FOR INITIAL APPROVAL
Acute lymphoblastic leukemia (ALL)
A. Authorization of 12 months may be granted for treatment of ALL as frontline (induction) therapy when all of the following criteria are met:
1. Member has B-cell precursor ALL
2. The tumor is CD22-positive as confirmed by testing or analysis to identify the CD22 protein on the surface of the B-cell
3. Member has Philadelphia chromosome-negative disease.
4. The requested drug will be used in combination with cyclophosphamide, dexamethasone, vincristine, methotrexate and cytarabine
5. Member will not receive more than 6 treatment cycles of the requested drug.
B. Authorization of 12 months may be granted for treatment of relapsed or refractory ALL when all of the following criteria are met:
1. Member has B-cell precursor ALL.
2. The tumor is CD22-positive as confirmed by testing or analysis to identify the CD22 protein on the surface of the B-cell.
3. Member meets one of the following:
i. Member has Philadelphia chromosome-positive disease
ii. Member has Philadelphia chromosome-negative disease.
4. The requested drug will be used in one of the following settings:
i. As a single agent
ii. In combination with a tyrosine kinase inhibitor for Philadelphia chromosome-positive disease (e.g., imatinib, dasatinib, nilotinib, bosutinib, ponatinib)
iii. In combination with cyclophosphamide, dexamethasone, vincristine, methotrexate and cytarabine with or without blinatumomab
5. Member will not receive more than 6 treatment cycles of the requested drug.
IV. CONTINUATION OF THERAPY
Authorization of 12 months (up to 6 cycles total) may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen
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.
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).
REFERENCES
1. Besponsa [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals LLC, Inc.; March 2018.
2. Kantarjian Hagop M, DeAngelo Daniel J., Stelljes Matthias, et al. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016; 375: 740-53.
3. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed August 1, 2023.
ORIGINAL EFFECTIVE DATE: 9/29/2017
MOST RECENT REVIEW DATE: 4/30/2024
ID_CHS
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.
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