Ibalizumab-uiyk (Trogarzo)

Policy ID: I-186-003

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 28, 2020

Last Reviewed: November 29, 2022

Applies To: Commercial and Medicaid Expansion

Description

Ibalizumab-uiyk (Trogarzo®) is an intravenous recombinant humanized monoclonal antibody and is the first drug of a new class of antiretrovirals for individuals who have failed most other antiretrovirals and have limited to no treatment options. There are several other antiretroviral options for the treatment of HIV-1 infection and many anti-retroviral regimens recommended for first-line therapy in treatment naive individuals. Ibalizumab (Trogarzo) is the first product specifically approved for use in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing other therapies. Ibalizumab (Trogarzo) blocks HIV-1 from infecting CD4+ T-cells by binding to domain 2 of CD4 and preventing the viral transmission that occurs via cell-to-cell fusion.

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.

The use of ibalizumab (Trogarzo) for the treatment of HIV-1 infection may be considered medically necessary when ALL of the following criteria are met:

Individual is 18 years of age or older; and
Documentation of baseline HIV RNA viral load; and
Has multidrug resistant (MDR) status confirmed via resistance testing to AT LEAST one (1) antiretroviral (ARV) medication from EACH of the following classes:
- Nucleoside Reverse Transcriptase Inhibitors (NRTI); and
- Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI); and
- Protease Inhibitors (PI); and
Failing their current ARV regimen; and
Prescribed by or in consultation with an infectious disease specialist or HIV specialist; and
Individual has current background antiretroviral therapy (ART) containing AT LEAST 1 agent with full susceptibility to HIV infection optimized as defined by treatment guidelines; and
Individual has been receiving background ART therapy for AT LEAST six (6) months; and
Background ART is maintained during course of ibalizumab (Trogarzo) therapy.

Reauthorization Criteria

Continuation of therapy with ibalizumab (Trogarzo) after six (6) months may be considered medically necessary when ALL of the following criteria are met:

Individual has been previously treated with ibalizumab (Trogarzo); and
Medication prescribed by or in consultation with an infectious disease specialist or HIV specialist; and
Clinician attests and confirms BOTH of the following:
- Clinically significant viral response from ibalizumab (Trogarzo) therapy in individual defined as stable or decreased HIV RNA viral load from baseline; and
- Continuation of background ART to be taken in conjunction with ibalizumab (Trogarzo).

The use of ibalizumab (Trogarzo) for any other indication is considered experimental/investigational as the published peer reviewed literature does not support its efficacy or safety for any other indications.

Procedure Codes

J1746

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

B20

Z21

Professional Statements and Societal Positions Guidelines

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Updated December 18, 2019. Accessed 10/9/2020.

On October 17 2017, DHHS updated the treatment guidelines for initiation of antiretroviral therapy (ART). This includes the following:
- ART is recommended for all individuals with HIV, regardless of CD4 T lymphocyte cell count, to reduce the morbidity and mortality associated with HIV infection.
- ART is also recommended for individuals with HIV to prevent HIV transmission.
- Starting therapies for an antiretroviral (ARV) regimen for a treatment-naive patient generally consists of two (2) nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third active ARV drug from one (1) of three (3) classes:
  - An integrase strand inhibitor (INSTI)
  - A non-nucleoside reverse transcriptase inhibitor (NNRTI)
  - Or a protease inhibitor (PI) with a pharmacokinetic (PK) enhancer (booster) such as cobicistat or ritonavir.
- The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) classifies the following regimens as recommended initial regimens for most people with HIV:
  - Dolutegravir/abacavir/lamivudine-only for patients who are HLA-B*5701 negative
  - Dolutegravir plus tenofovir/emtricitabine
  - Elvitegravir/cobicistat/tenofovir/emtricitabine
  - Raltegravir plus tenofovir/emtricitabine
- The fundamental principle of regimen switching is to maintain viral suppression without jeopardizing future treatment options.
- It is critical to review a patient's full ARV history, including virologic responses, past ARV-associated toxicities, and cumulative resistance test results (if available) before selecting a new ART regimen.
- Adverse events, the availability of ARVs with an improved safety profile, or the desire to simplify a regimen may prompt a regimen switch. Within-class and between-class switches can usually maintain viral suppression, provided that there is no viral resistance to the ARV agents in the new regimen.
- Monotherapy with either a boosted protease inhibitor (PI) or an integrase strand transfer inhibitor (INSTI) has been explored in several trials or cohort studies, and has been associated with an unacceptable rate of virologic failure and the development of resistance; therefore, monotherapy as a switching strategy isnot recommended.
- Consultation with an HIV specialist should be considered when planning a regimen switch for a patient with a history of resistance to one or more drug classes.
- More intensive monitoring to assess tolerability, viral suppression, adherence, and laboratory changes is recommended during the first 3 months after a regimen switch.
- Drug-resistance testing should be performed while the patient is taking the failing antiretroviral (ARV) regimenor within 4 weeks of treatment discontinuation. Even if more than 4 weeks have elapsed since ARVs were discontinued, resistance testing can still provide useful information to guide therapy, although it may not detect previously selected resistance mutations.
- A new regimen should include at least two, and preferably three, fully active agents. A fully active agent is one that is expected to have uncompromised activity on the basis of the patient's ART history and his or her current and past drug-resistance testing results. A fully active agent may also have a novel mechanism of action.
- In general, adding a single ARV agent to a virologically failing regimen is not recommended because this may risk the development of resistance to all drugs in the regimen.

For some highly ART-experienced patients with extensive drug resistance, maximal virologic suppression may not be possible. In this case, ART should be continued with regimens designed to minimize toxicity, preserve CD4 cell counts, and delay clinical progression.

Panel on Treatment of Pregnant Women with HIV infection and Prevention of Perinatal Transmission. Department of Health and Human Services. Updated April 14, 2020. Accessed 10/9/2020.

Data are limited regarding use of ibalizumab during pregnancy; therefore, ibalizumab-containing regimens cannot be recommended for use in pregnant women.

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Adopt new policy

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

Internal Medical Policy Committee 11-29-2022 Annual review, no clinical content change

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.

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