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Inotuzumab Ozogamicin (Besponsa)

Section: Injections
Effective Date: December 01, 2019
Revised Date: November 26, 2019

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 (18 years of age or older) when used as single agent therapy for EITHER of the following indications:

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

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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

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

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