Inotuzumab Ozogamicin (Besponsa)

Policy ID: I-185-006

Section: Injections

Effective Date: February 01, 2019

Revised Date: October 31, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Applies To: Commercial and Medicaid Expansion

Description

Inotuzumab ozogamicin (Besponsa™) is a CD22-directed antibody-drug conjugate approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL).

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Inotuzumab ozogamicin (Besponsa) may be considered medically necessary for the treatment of individuals when used as single agent therapy for the following:

Acute Lymphoblastic Leukemia

For relapsed/refractory Philadelphia chromosome (Ph)-positive B-ALL in tyrosine-kinase inhibitor (TKI) intolerant/refractory individuals; or
For relapsed/refractory Ph-negative B-ALL.; or

Compendia Sources

Inotuzumab ozogamicin (Besponsa) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations

The use of inotuzumab ozogamicin (Besponsa) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9229

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for J9229

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-14-2019 Adopted policy

Internal Medical Policy Committee 11-14-2019 Code update

Internal Medical Policy Committee 7-22-2020 Change J9229 to pre-certification drug

Internal Medical Policy Committee 11-19-2020 Added NCCN recommendations

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Internal Medical Policy Committee 11-29-2022

Removed NCCN recommendations; and
Added this statement "Inotuzumab ozogamicin (Besponsa) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations."; and
Updated experimental/investigational statement.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-185-005

Section: Injections

Effective Date: February 01, 2019

Revised Date: November 04, 2020

Revision Effective Date: January 01, 2021

Last Reviewed: November 23, 2021

Archived Date: December 31, 2022

Applies To: Commercial and Medicaid Expansion

Description

Inotuzumab ozogamicin (Besponsa™) is a CD22-directed antibody-drug conjugate approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL).

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Inotuzumab ozogamicin (Besponsa) may be considered medically necessary for the treatment of individuals when used as single agent therapy for the following:

Food and Drug Administration (FDA) Indications

Acute Lymphoblastic Leukemia

For relapsed/refractory Philadelphia chromosome (Ph)-positive B-ALL in tyrosine-kinase inhibitor (TKI) intolerant/refractory individuals; or
For relapsed/refractory Ph-negative B-ALL.; or

National Comprehensive Cancer Network (NCCN) Recommendations

Acute Lymphoblastic Leukemia

As therapy for relapsed/refractory Ph-negative B-ALL or for relapsed/refractory Ph-positive B-ALL in TKI intolerant/refractory individuals as ANY of the following:
- Single-agent therapy; or
- As a component of inotuzumab ozogamicin (Besponsa) in combination with mini-hyper CVD (cyclophosphamide, dexamethasone, vincristine, methotrexate, and cytarabine); or

Pediatric Acute Lymphoblastic Leukemia

As single-agent therapy for ANY of the following:
- Relapsed/refractory Ph-negative B-ALL; or
- Relapsed/refractory Ph-positive TKI intolerant/refractory B-ALL.

Inotuzumab ozogamicin (Besponsa) for any other indication is considered experimental/investigational, as scientific evidence does not support the use of inotuzumab ozogamicin (Besponsa) for any other indication.

Procedure Codes

J9229

Diagnosis Codes

Covered Diagnosis Codes for J9229

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C91.00

C91.01

C91.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-14-2019 Adopt policy

Internal Medical Policy Committee 11-14-2019 Code update

Internal Medical Policy Committee 7-22-2020 Change J9229 to pre-certification drug

Internal Medical Policy Committee 11-19-2020 Add NCCN recommendations

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

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