HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-186-005
Topic:
Ibalizumab-uiyk (Trogarzo)
Section:
Injections
Effective Date:
February 12, 2024
Issued Date:
February 12, 2024
Last Revision Date:
December 2023
Annual Review:
December 2023
 
 

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 naïve 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.

Policy Position

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  one (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) not meeting the criteria as indicated in this policy is considered not medically necessary.

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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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

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 11/28/2022.

  • 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-naïve 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 is not 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) regimen or 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.


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Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Ibalizumab (Trogarzo) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.