BlueCross BlueShield of Tennessee Medical Policy Manual

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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