||July 23, 2018
||July 23, 2018
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.
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 circumstances may warrant individual consideration, based on review of applicable medical records.
|Policy Position Coverage is subject to the specific terms of the member’s benefit plan.|
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.
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; 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.
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.
NOTE: Dosage recommendations per the FDA label.
|Professional Statements and Societal Positions|
Department of Health and Human Services (DHHS)
- 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
- 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.
|Place of Service: Outpatient|
Experimental/Investigational (E/I) services are not covered regardless of place of service.
|The policy position applies to all commercial lines of business|
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
|Outpatient HCPCS (C Codes)|
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.
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