0008-0100-XX Besponsa 0.9 MG SOLR (PFIZER U.S.)
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.
Inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia (ALL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Inotuzumab ozogamicin for the treatment of other conditions/diseases is considered investigational.
Inotuzumab ozogamicin is considered medically appropriate if the individual is/ has ALL of the following:
18 years of age or older
Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) that is relapsed or refractory
Disease is CD22 positive
Complete blood count (CBC) to rule out infection, myelosuppression
Baseline Electrocardiogram (ECG)
Inotuzumab ozogamicin is NOT considered medically appropriate for renewal
DOSAGE & ADMINISTRATION
B-cell precursor acute lymphoblastic leukemia (ALL)
1.8 mg/m2 total per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2)Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves CR or CRi, and/or to allow recovery from toxicity
Subsequent Cycles (cycles are 4 weeks in duration):
CR or CRi achieved
1.5 mg/m2 total per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2)
Did not achieve CR or CRi
1.8 mg/m2 total per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2)Those who do not achieve a CR or CRi within 3 cycles should discontinue treatment.
If proceeding to HSCT, Recommended duration of treatment is 2 cyclesA third cycle may be considered for those who do not achieve CR or CRi and MRD negativity after 2 cycles
If not proceeding to HSCT, Additional cycles of treatment, up to a maximum of 6 cycles, may be administered
CR (complete remission); CRi (complete remission with incomplete hematologic recovery); HSCT (hematopoietic stem cell transplant); MRD (minimal residual disease)Refrigerate (2-8°C; 36-46°F) and store in the original carton to protect from light. Do not freeze.
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may not be renewed
Click here to view DOSAGE LIMITS
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.
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.
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).
Lexicomp Online. (2018). AHFS DI. Inotuzumab ozogamicin. Retrieved October 12, 2018 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, September). Inotuzumab ozogamicin. Retrieved October 12, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Inotuzumab ozogamicin. Retrieved October 12, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, August). Center for Drug Evaluation and Research. Besponsa® (inotuzumab ozogamicin) for injection, for intravenous use. Retrieved October 12, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/29/2017
MOST RECENT REVIEW DATE: 11/13/2018
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 0.1 mg