CurrentCommunity Health ChoicePolicy N/A

Trogarzo (ibalizumab-uiyk) Coverage Criteria

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Medical-necessity and prior-authorization criteria for Trogarzo used with an optimized background antiretroviral regimen in members with HIV-1 infection.

Policy Summary

PayerCommunity Health Choice

PolicyTrogarzo (ibalizumab-uiyk) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionDocument HIV-1 RNA greater than 1,000 copies/mL obtained within the past 30 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsContinuation authorization

≥1,000 copies/mLInitial HIV-1 RNA

<200 copies/mLContinuation viral load

2,000 mg / 800 mgTrogarzo dosage

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CurrentCommunity Health ChoicePolicy N/A

Trogarzo (ibalizumab-uiyk) Coverage Criteria

Customize your policy alerts

Sign up for all communityhealthchoice policy alerts

Know when communityhealthchoice releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical-necessity and prior-authorization criteria for Trogarzo used with an optimized background antiretroviral regimen in members with HIV-1 infection.

Policy Summary

PayerCommunity Health Choice

PolicyTrogarzo (ibalizumab-uiyk) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionDocument HIV-1 RNA greater than 1,000 copies/mL obtained within the past 30 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsContinuation authorization

≥1,000 copies/mLInitial HIV-1 RNA

<200 copies/mLContinuation viral load

2,000 mg / 800 mgTrogarzo dosage

Coverage Criteria

Initial Therapy

Trogarzo will be considered medically necessary when ALL of the following initial-authorization criteria are met:

Initial authorization

Age: Patient is at least 8 years of age.≥ 8 years
Diagnosis: Patient has a diagnosis of Human Immunodeficiency Virus (HIV)-1 infection.
Viral load: There is evidence of HIV-1 RNA greater than 1,000 copies/mL within the past 30 days.> 1,000 copies/mL within the past 30 days
Documentation required.
Antiretroviral resistance: Resistance testing demonstrates resistance to at least one antiretroviral medication from each of the following drug classes: Nucleoside/tide Reverse Transcriptase Inhibitor (NRTI), Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), and Protease Inhibitor (PI).At least one medication from each of 3 drug classes
Documentation required.
Prior HAART adherence and treatment failure: The prescriber attests that the member adhered to highly active antiretroviral therapy (HAART) for at least 6 months and that treatment is failing or recently failed.HAART adherence for at least 6 months; treatment failure within the previous 8 weeks
Background regimen: The prescriber attests that the member will continue an optimized background antiretroviral regimen in combination with Trogarzo (ibalizumab-uiyk).

Continuation Therapy

Continuation of therapy is approved for 12 months when ALL of the following criteria are met:

Continuation therapy

Clinical response: Member has experienced a significant clinical response to Trogarzo, evidenced by viral load below 200 copies/mL.< 200 copies/mL
Medication adherence: The prescriber attests that the member has been adherent to prescribed HIV medications.
Background regimen: The prescriber attests that the member will continue an optimized background antiretroviral regimen in combination with Trogarzo (ibalizumab-uiyk).
Tolerability:

For continuation authorization, the member must not have experienced intolerable side effects or drug toxicity from Trogarzo (ibalizumab-uiyk).

Coding and Administration

Applicable Procedure CodeHCPCSCovered

J1746

Injection, ibalizumab-uiyk, 10 mg

Applicable Diagnosis CodesICD-10

B20	Human Immunodeficiency virus (HIV) disease
Z16.33	Resistance to antiviral drug(s)
Z21	Asymptomatic human immunodeficiency virus [HIV] infection status

Loading Dose

MedicationTrogarzo (ibalizumab-uiyk)

Dose typeLoading dose

Amount per administration2,000 mg

Maintenance Dose

MedicationTrogarzo (ibalizumab-uiyk)

Dose typeMaintenance dose

Amount per administration800 mg

Provider Requirements and Authorization Outcomes

Prior Authorization

Diagnosis-Specific Prior Authorization Required

Trogarzo® (ibalizumab-uiyk) requires diagnosis-specific prior authorization. Coverage is considered when all applicable criteria are met: initial authorization is approved for 6 months, and continuation authorization is approved for 12 months.

Member is at least 8 years of age and has a diagnosis of HIV-1 infection.
Initial and continuation requests must satisfy the criteria described below.

Documentation Required

Document a Recent HIV-1 RNA Result

For initial authorization, submit documentation showing HIV-1 RNA greater than 1,000 copies/mL within the past 30 days.

A recent HIV-1 RNA laboratory result is required with the initial request.
The result must be dated within 30 days before the request and exceed 1,000 copies/mL.

Clinical Background

Trogarzo (ibalizumab-uiyk) is used for members with HIV-1 infection and evidence of extensive antiretroviral resistance. Coverage is considered when treatment is provided with an optimized background antiretroviral regimen; initial review considers active viremia, resistance to antiretroviral medications, prior HAART adherence, and recent treatment failure. Continued therapy requires virologic response, adherence, ongoing background therapy, and tolerability.

Definitions and Abbreviations

NRTI

AbbreviationNRTI

Full termNucleoside/tide Reverse Transcriptase Inhibitor

Policy contextAntiretroviral drug class used in resistance testing

NNRTI

AbbreviationNNRTI

Full termNon-Nucleoside Reverse Transcriptase Inhibitor

Policy contextAntiretroviral drug class used in resistance testing

Initial Therapy Criteria

Initial Therapy

Approve for 6 months when all initial authorization criteria are met.

Initial authorization

Age: Patient is at least 8 years of age.≥ 8 years
Diagnosis: Patient has a diagnosis of Human Immunodeficiency Virus (HIV)-1 infection.
Viral load: There is evidence of HIV-1 RNA greater than 1,000 copies/mL within the past 30 days.> 1,000 copies/mL within the past 30 days
Documentation required.

Continuation Criteria

Continuation Therapy

Approve for 12 months when all continuation criteria are met.

Continuation therapy

Clinical response: Member has experienced a significant clinical response to Trogarzo, evidenced by viral load below 200 copies/mL.< 200 copies/mL
Medication adherence: The prescriber attests that the member has been adherent to prescribed HIV medications.
Background regimen: The prescriber attests that the member will continue an optimized background antiretroviral regimen in combination with Trogarzo (ibalizumab-uiyk).

Policy Summary

PayerCommunity Health Choice

PolicyTrogarzo (ibalizumab-uiyk) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionDocument HIV-1 RNA greater than 1,000 copies/mL obtained within the past 30 days.

SourceLink

On This Page

Member has not experienced intolerable side effects or drug toxicity from Trogarzo.

Minimum Age

RequirementMember must be at least 8 years of age

Threshold≥ 8 years

Authorization stageInitial authorization

Initial HIV-1 RNA

TestHIV-1 RNA

Required result> 1,000 copies/mL

Testing timeframeWithin the past 30 days

Prior HAART Adherence

TherapyHighly active antiretroviral therapy (HAART)

Minimum adherence periodAt least 6 months

DocumentationPrescriber attestation of member adherence

Recent Treatment Failure

RequirementTreatment is failing or recently failed

TimeframeWithin the previous 8 weeks

DocumentationPrescriber attestation

Continuation Viral Load

RequirementSignificant clinical response to Trogarzo

Viral-load threshold< 200 copies/mL

Authorization stageContinuation therapy

Documentation Required

Submit Antiretroviral Resistance Testing

For initial authorization, submit resistance-testing documentation demonstrating resistance to at least one antiretroviral medication from each required drug class.

Nucleoside/tide reverse transcriptase inhibitor (NRTI)
Non-nucleoside reverse transcriptase inhibitor (NNRTI)
Protease inhibitor (PI)

Unsupported block type: documentation

Denial Risk

Initial Criteria Must Be Met

An initial authorization request may be denied when the member does not meet all diagnosis-specific initial criteria or the required documentation and attestations are not submitted.

Denial risk applies if the member is younger than 8 years or does not have HIV-1 infection.
Denial risk applies if the required HIV-1 RNA result, resistance-testing documentation, HAART adherence and treatment-failure attestation, or optimized-background-regimen attestation is absent or does not meet the specified requirements.

Denial Risk

Continuation Criteria Must Be Met

A continuation authorization request may be denied when the required clinical response, adherence, regimen, or safety criteria are not met or documented.

Denial risk applies if viral load is not less than 200 copies/mL or significant clinical response is not demonstrated.
Denial risk applies if medication adherence or continuation of an optimized background antiretroviral regimen is not attested.
Denial risk applies if the member has experienced intolerable side effects or drug toxicity from Trogarzo®.

Note

Benefit Plan and Eligibility Govern Coverage

This Guideline does not determine eligibility or benefit coverage. Eligibility, applicable federal or state requirements, and the member’s benefit plan govern coverage independently of this Guideline.

Review eligibility and plan benefit coverage before applying the Guideline.
If the Guideline conflicts with the member’s benefit plan, summary plan description, or contract, the benefit plan, summary plan description, or contract governs.
Other policies and coverage determination guidelines may apply.

AbbreviationPI

Full termProtease Inhibitor

Policy contextAntiretroviral drug class used in resistance testing

HAART

AbbreviationHAART

Full termHighly active antiretroviral therapy

Policy contextPrior therapy for which adherence must be documented

Antiretroviral resistance: Resistance testing demonstrates resistance to at least one antiretroviral medication from each of the NRTI, NNRTI, and PI classes.At least one medication from each of 3 drug classes

Documentation required.

Prior HAART adherence and treatment failure: The prescriber attests that the member adhered to HAART for at least 6 months and that treatment is failing or recently failed.HAART adherence for at least 6 months; treatment failure within the previous 8 weeks

Background regimen: The prescriber attests that the member will continue an optimized background antiretroviral regimen in combination with Trogarzo (ibalizumab-uiyk).

Tolerability: Member has not experienced intolerable side effects or drug toxicity from Trogarzo.