CurrentMass General Brigham Health PlanPolicy N/A

TM Trogarzo (ibalizumab-uiyk) Effective 06/01/2019

Prior authorization policy for Trogarzo (ibalizumab-uiyk) for treatment of HIV-1 in heavily treatment-experienced adults with multidrug resistant HIV-1, including approval criteria, limitations, and reauthorization durations. Applies to pharmacy benefit with quantity/step therapy notes.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTM Trogarzo (ibalizumab-uiyk) Effective 06/01/2019

Policy CodePolicy N/A

Change TypeClarified (administrative separation MH vs Comm/Exch)Reviewed

Effective DateJun 1, 2019

Next Review Date

Key ActionSubmit documentation demonstrating HIV-1 diagnosis, age ≥18, prescriber specialty, current antiretrovirals, exhaustion of available treatments, class-specific resistance, and recent HIV RNA >200 copies/mL after ≥6 months of therapy.

SourceLink

POLICY UPDATE CHANGES

11/16/2022 Reviewed for Nov P&T. Separated out MH vs Comm/Exch: No clinical changes

02/20/2019 Reviewed

1Covered Indication (HIV-1, multidrug-resistant, treatment-experienced adults)

>=18Minimum age

6 moInitial approval duration

12 moReauthorization duration

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Coverage Summary

Coverage stance: Covered with criteria — Trogarzo (ibalizumab-uiyk) is covered when the patient and prescriber meet the specified prior authorization criteria for use in heavily treatment-experienced adults with multidrug-resistant HIV-1 who are failing their current regimen. Scope: prior authorization policy applies to the pharmacy benefit and includes quantity and step therapy program notes. Effective date: 2019-06-01. Last review: 2022-11-16.

Initial Approval Criteria

Trogarzo may be approved if the member meets ALL of the following and documentation is submitted:

ALL of the following

Member is diagnosed with HIV-1 infection
Member is 18 years of age or older>= 18 years
Prescriber is an infectious disease or HIV specialist experienced in the use of this treatment
Member is currently using other antiretrovirals
Documentation that the member has exhausted oral and injectable treatments available for HIV and requires Trogarzo to achieve effective antiretroviral combination therapy, optimized with at least 1 and preferably 2 fully active agents with demonstrated full viral sensitivity/susceptibility
Documented resistance
- Documentation of resistance to at least one antiretroviral medication from each of these antiretroviral medication classes (including combination agents)
- NRTI example agents: Combivir, Viread, Epivir, etc.
- PI example agents: Prezista, Evotaz, Aptivus, etc.
Recent HIV ribonucleic acid (RNA) viral load (within last 8 weeks) of > 200 copies/mL persisting after at least 6 months of antiretroviral therapy> 200 copies/mL (within last 8 weeks) persisting after >= 6 months of antiretroviral therapy

Authorization Duration

ALL of the following

Initial approvals will be for 6 months6 months
Reauthorizations will be for 12 months12 months

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Submit documentation demonstrating HIV-1 diagnosis, age >=18, prescriber specialty (infectious disease/HIV specialist), current use of other antiretrovirals, exhaustion of oral and injectable HIV treatments, resistance evidence across classes, and recent HIV RNA >200 copies/mL after >=6 months of therapy.

Diagnosis of HIV-1 infection
Age ≥ 18 years
Prescriber is an infectious disease or HIV/HIV specialist
Current use of other antiretrovirals
Documentation that oral and injectable HIV treatments have been exhausted
Documentation of resistance across required antiretroviral classes
Recent HIV RNA > 200 copies/mL persisting after ≥ 6 months of therapy

Documentation Required

Applicable Codes

Benefit / Program notesmixed

No codes listed

Clinical Evidence & References

Evidence sources cited in the brief: Trogarzo prescribing information (TaiMed Biologics USA Corp; 2018) and a Phase 3 study (Emu B et al., N Engl J Med 2018). These sources are referenced as the basis for the drug’s efficacy and safety information in the policy.

Background

Background: Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor indicated, in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 failing their current antiretroviral regimen. Policy scope: applies to the pharmacy benefit and includes quantity limits and step therapy notes as part of the prior authorization program.

Key thresholds & quick facts

HIV RNA viral load threshold> 200 copies/mL (test within last 8 weeks) persisting after ≥6 months of antiretroviral therapy

Age>= 18 years

Initial approval duration6 months

Reauthorization duration12 months

Revision History

02/20/2019Reviewed

Initial review date recorded.

11/16/2022Reviewed for Nov P&TLatest

Separated out MassHealth versus Commercial/Exchange administrative distinction without clinical policy changes.