|62064-0122-XX TROGARZO 200 MG/1.33 ML (150 MG/ML) SINGLE DOSE VIAL (Theratechnologies)|
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.
Ibalizumab-uiyk for the treatment of human immunodeficiency virus type 1 (HIV-1) infection is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ibalizumab-uiyk for the treatment of other conditions/diseases is considered investigational.
Ibalizumab-uiyk is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of Human Immunodeficiency Virus Type-1 (HIV-1)
Individual has heavily treated multi-drug resistant disease (e.g., NRTI, PI, NNRTI, etc.)
Used in combination with anti-retroviral therapy (ART)
Individual is failing current anti-retroviral regimen
Ibalizumab-uiyk is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease response as indicated by a decrease in viral load
Absence of unacceptable toxicity from the agent, Examples of unacceptable toxicity include immune reconstitution inflammatory syndrome (IRIS), etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Infuse, intravenously, 2000 mg as a one time dose, followed by a maintenance dose of 800 mg every 2 weeks, thereafter. *If a maintenance dose (800mg) is missed by 3 days
or longer beyond the scheduled dosing day, a loading dose (2,000mg) should be administered as early as possible. Resume maintenance dosing (800mg) every 14 days 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.
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).
Lexi-Comp Online. (2019). AHFS DI. Ibalizumab-uiyk. Retrieved March 11, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, November). Ibalizumab-uiyk. Retrieved March 11, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, May). Center for Drug Evaluation and Research. Trogarzo™ (Ibalizumab-uiyk) injection, for intravenous use. Retrieved March 11, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf.
ORIGINAL EFFECTIVE DATE: 4/16/2018
MOST RECENT REVIEW DATE: 7/31/2019
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