CurrentViva HealthPolicy IC-0355

Ibalizumab (Trogarzo) — Medical Necessity and Coverage Criteria

Medical necessity and coverage criteria for intravenous ibalizumab (Trogarzo) used with antiretroviral therapy in adults with heavily treated, multidrug‑resistant HIV-1; applies to Viva Health members in North Carolina.

Policy Summary

PayerViva Health

PolicyIbalizumab (Trogarzo) — Medical Necessity and Coverage Criteria

Policy CodePolicy IC-0355

Change TypeNo material change

Effective Date

Next Review DateJan 6, 2025

Key ActionSubmit prior authorization for up to 6 months and include resistance testing results, baseline viral load, and diagnosis code B20.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18min age

6 monthsinitial auth

Load 2000 mg; Maint 800 mg q14ddosing

≥200 copies/mLVL threshold

J1746billing code

Coverage Criteria for Ibalizumab (Trogarzo)

Policy Summary

PayerViva Health

PolicyIbalizumab (Trogarzo) — Medical Necessity and Coverage Criteria

Policy CodePolicy IC-0355

Change TypeNo material change

Effective Date

Next Review DateJan 6, 2025

Key ActionSubmit prior authorization for up to 6 months and include resistance testing results, baseline viral load, and diagnosis code B20.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval: Patient is at least 18 years of age; AND used in combination with highly active antiretroviral therapy (HAART) to which the patient's disease is known to be susceptible based on resistance testing; AND patient has heavily treated multidrug‑resistant HIV confirmed by resistance testing to at least one drug in at least three antiretroviral drug classes; AND baseline viral load is ≥ 200 copies/mL; AND patient is failing on their current antiretroviral regimen.≥ 200 copies/mL

Class examples listed in policy: NRTI, NNRTI, PI, Fusion inhibitor, CCR5 antagonist, INSTI.

Continuation Therapy / Renewal

Renewal is allowed when ALL of the following are met:

Renewal: Patient continues to meet the universal and indication‑specific criteria identified for initial approval; AND absence of unacceptable toxicity from ibalizumab (examples include infusion‑related hypersensitivity, anaphylaxis, immune reconstitution inflammatory syndrome [IRIS]); AND disease response as demonstrated by a decrease in viral load from the pretreatment baseline (note: increases from nadir or less than expected reduction should prompt repeat resistance testing and optimization of the background regimen).

Ibalizumab (Trogarzo) is not indicated for patients who do not have documented heavily treated, multidrug‑resistant HIV‑1. Specifically, coverage requires resistance testing confirming resistance to at least one agent in at least three antiretroviral drug classes. In addition, initiation requires a baseline viral load of ≥ 200 copies/mL and evidence that the patient is failing their current antiretroviral regimen.

Ibalizumab must be administered only as part of a combination antiretroviral strategy. The policy requires use in combination with a HAART regimen to which the patient’s virus is shown to be susceptible by resistance testing; use of ibalizumab as monotherapy or without an active, susceptible background regimen is not supported and may be denied.

Coding and Billing

Covered HCPCS 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 CodesICD-10Covered

B20	Human immunodeficiency virus [HIV] disease

inv-08: Baseline viral load — threshold value for initiation

Baseline viral load thresholdBaseline viral load ≥ 200 copies/mL

Context for requirementRequired as part of initial approval for heavily treated multidrug‑resistant HIV‑1 when patient is failing current antiretroviral regimen

Measurement unitsCopies per milliliter (copies/mL)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approval up to 6 months; may be renewed annually when renewal criteria are met.

Prior authorization required
Initial approval: up to 6 months
Renewal: may be renewed annually if renewal criteria met

Note

Use with HAART

Ibalizumab must be used in combination with a highly active antiretroviral therapy (HAART) regimen to which the virus is known to be susceptible based on resistance testing.

Must be used with a HAART regimen confirmed susceptible by resistance testing

Documentation Required

Documentation Requirements

Requests must document the patient has heavily treated multi‑drug resistant HIV (resistance to ≥1 drug in ≥3 classes), baseline viral load, and that the patient is failing current antiretroviral therapy. Documentation must also include patient age.

Document patient age
Document resistance testing showing ≥1 drug resistant in ≥3 classes
Document baseline viral load (≥ 200 copies/mL)
Document current regimen and evidence of treatment failure

Denial Risk

Requests that do not include documented heavily treated multidrug‑resistant HIV (resistance to ≥1 drug in ≥3 classes) will be denied.

Denial risk if no documentation of resistance to ≥1 drug in ≥3 classes

OpenPayer

Ibalizumab (Trogarzo) — Medical Necessity and Coverage Criteria

Coverage Criteria for Ibalizumab (Trogarzo)

Coding and Billing

Provider Actions, Authorization, and Documentation

Background

Definitions