CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Trogarzo (ibalizumab-uiyk) coverage

Policy governing medical benefit coverage and authorization criteria for Trogarzo (ibalizumab-uiyk) for adults with multidrug-resistant HIV-1, affecting providers prescribing and billing for infusion therapy and payers adjudicating claims.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrogarzo (ibalizumab-uiyk) coverage

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization documenting age ≥18, confirmed multidrug resistance, baseline viral load >1,000 copies/mL, failing current regimen, and dosing plan with concomitant HAART regimen.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthslength of initial authorization

Load 200; Maint 80 q14dmax billable units

J1746billing J-code

B20covered diagnosis

Coverage and Clinical Criteria

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Initial Approval for Trogarzo: Patient is at least 18 years old; AND patient has heavily treatment‑experienced, multidrug‑resistant HIV‑1 confirmed by resistance testing to at least one drug in at least three antiretroviral classes; AND baseline viral load > 1,000 copies/mL; AND patient is failing on their current antiretroviral regimen; AND Trogarzo will be used in combination with highly active antiretroviral therapy (HAART) for which resistance testing demonstrates susceptibility.

See FDA‑approved indication and definition of antiretroviral classes in policy (NRTI, NNRTI, PI).

inv-02: Renewal

Renewal permitted when ALL of the following are met:

Renewal Criteria: Patient continues to meet the initial approval criteria; AND there is absence of unacceptable toxicity from ibalizumab (examples include immune reconstitution inflammatory syndrome [IRIS]); AND there is evidence of disease response as indicated by a decrease in viral load from the pretreatment baseline; NOTE: increases in viral load from nadir or less than anticipated reduction should prompt resistance testing and optimization of the background regimen.

Renewals align with policy duration of authorization (see policy for length of authorization).

Use of Trogarzo (ibalizumab-uiyk) outside the specified FDA‑approved indication for heavily treatment‑experienced, multidrug‑resistant HIV‑1 is not supported by the evidence summary in this policy. The clinical trial evidence underpinning coverage comes from a single‑arm study in heavily treatment‑experienced adults with multidrug resistance failing current regimens, and efficacy was demonstrated during a defined functional monotherapy period and with continued combination therapy in a subset of patients.

Requests for Trogarzo will be considered not medically necessary when the patient does not meet the policy’s specified resistance and clinical criteria. Examples that would not meet criteria include patients who do not have resistance confirmed to at least one drug in at least three antiretroviral classes, patients who are not failing their current antiretroviral regimen, or patients with a documented baseline viral load of ≤ 1,000 copies/mL. Additionally, Trogarzo must be used in combination with a HAART regimen to which the patient’s virus is known to be susceptible; use as monotherapy or with an inactive background regimen is not consistent with the covered indication.

Billing and Coding

Covered HCPCS/J-codesHCPCSCovered

J1746

Injection, ibalizumab-uiyk, 10 mg; 1 billable unit = 10 mg

NDCNDC

62064-0122-xx

Trogarzo 200 mg/1.33 mL single-dose vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

B20	Human immunodeficiency virus [HIV] disease

inv-08: Baseline viral load — numeric threshold/value

Baseline viral load threshold> 1,000 copies/mL

Role in initial approvalRequired criterion for coverage: patient must have baseline viral load > 1,000 copies/mL

Not medically necessary if below thresholdUse in patients with baseline viral load ≤ 1,000 copies/mL is considered not medically necessary under this policy

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document that the adult patient meets the initial approval criteria for treatment of heavily treatment‑experienced, multi‑drug resistant HIV‑1.

Affected population: adults (≥18 years)
Clinical requirement: Resistance testing confirming resistance to at least one drug in at least three classes (NRTI, NNRTI, PI examples listed in policy)
Baseline viral load requirement: > 1,000 copies/mL
Therapy context: Patient failing current antiretroviral regimen and drug to be used with HAART to which virus is susceptible via resistance testing

Step Therapy

Step Therapy / Policy Intent

Policy intent: ensure use aligns with FDA‑labeled indication and clinical literature, and to promote cost‑effective options and appropriate sequencing of therapies.

Criteria apply to Medicare members only in absence of NCD/LCD
Neighborhood will give individual consideration based on submitted prescriber information

Documentation Required

Required Documentation

Providers must submit documentation showing the patient meets required clinical and laboratory criteria.

Patient age documented as ≥18 years
Resistance testing results confirming heavily treatment‑experienced multi‑drug resistant HIV‑1 (resistance to ≥1 drug in ≥3 classes)
Baseline viral load >1,000 copies/mL prior to initiation
Documentation the patient is failing current antiretroviral regimen
Documentation that the requested drug will be used in combination with HAART for which resistance testing indicates susceptibility
For renewals: evidence of decreased viral load from pretreatment baseline and absence of unacceptable toxicity (e.g., IRIS)

Denial Risk

Denial Risk — Common Triggers

Requests may be denied if clinical criteria are not met or documentation is incomplete.

Denial triggers include: patient not ≥18 years old; lack of resistance testing confirming multi‑drug resistance to ≥1 drug in ≥3 classes; baseline viral load ≤1,000 copies/mL; patient not failing current regimen; requested use not in combination with an appropriate HAART regimen shown susceptible by resistance testing
Renewal denials: lack of evidence of viral load improvement from baseline or presence of unacceptable toxicity

Clinical Background

Ibalizumab (Trogarzo) is a CD4‑directed post‑attachment HIV‑1 inhibitor indicated as adjunctive therapy for adults with heavily treatment‑experienced, multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen. Warnings associated with Trogarzo include hypersensitivity reactions, immune reconstitution inflammatory syndrome (IRIS), and embryofetal toxicity. In the pivotal single‑arm trial of 40 heavily treatment‑experienced subjects, the primary efficacy endpoint measured virologic decline during a defined Functional Monotherapy Period, with 83% of subjects achieving a ≥ 0.5 log10 decrease in viral load during that period and a proportion of patients maintaining viral suppression at later time points.

Key Definitions

inv-14: Heavily treatment‑experienced, multidrug resistant HIV-1 — definition and criteria

DefinitionHIV-1 infection with resistance to at least one drug in at least three antiretroviral classes, confirmed by resistance testing, and associated with virologic failure on the current regimen

Evidence requirementResistance must be confirmed by resistance testing to at least one drug in ≥3 classes (e.g., NRTI, NNRTI, PI)

Clinical contextIndication aligns with FDA‑approved use as adjunctive therapy for heavily treatment‑experienced adults failing current regimens

inv-15: Functional Monotherapy Period — study period definition (Day 7 to Day 13) for virologic decline assessment

Functional Monotherapy Period (study definition)Day 7 to Day 13 — period during which the effect of ibalizumab added to a failing background regimen was assessed for virologic decline compared with the control period (Day 0 to Day 6)

Primary efficacy endpoint during periodProportion of subjects achieving ≥ 0.5 log10 decrease in viral load from beginning to end of Day 7–13 period

Observed results83% of subjects achieved ≥ 0.5 log10 decrease at end of functional monotherapy period (95% CI: 67%, 93%)