BlueCross BlueShield of Tennessee Medical Policy Manual

Ibalizumab-uiyk

NDC CODE(S)

62064-0122-XX TROGARZO 200 MG/1.33 ML (150 MG/ML) SINGLE DOSE VIAL (Theratechnologies)

DESCRIPTION

Ibalizumab-uiyk is a CD4-directed post-attachment HIV-1 inhibitor.  Ibalizumab-uiyk, a recombinant humanized monoclonal antibody, blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion.  Ibalizumab-uiyk inhibits the replication of CCR5- and CXCR4-tropic laboratory strains and primary isolates of HIV-1 in phytohemagglutinin stimulated peripheral blood lymphocytes.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
HIV-multidrug resistant Infuse, intravenously, 2000 mg as a one time dose, followed by a maintenance dose of 800 mg every 2 weeks, thereafter.

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed

Refer to DOSAGE LIMITS below

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.

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, the express terms of the health plan will govern.

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).

SOURCE

U. S. Food and Drug Administration. (2018, March). Center for Drug Evaluation and Research. Trogarzo™ (Ibalizumab-uiyk) injection, for intravenous use. Retrieved March 16, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf.

ORIGINAL EFFECTIVE DATE:  4/16/2018

MOST RECENT REVIEW DATE:  4/16/2018

ID_MRxEx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

Heavily treated HIV-1 multidrug resistant

1 billable unit = 1 ml (150 mg/mL)

TBD