CurrentMass General Brigham Health PlanPolicy N/A

Anti-retroviral agents: Sunlenca (lenacapavir) and Trogarzo (ibalizumab-uiyk)

Prior authorization and medical benefit coverage criteria for Sunlenca and Trogarzo for treatment-experienced adults with multidrug-resistant HIV-1, governing Mass General Brigham Health Plan (MassHealth UPPL) members under the medical benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAnti-retroviral agents: Sunlenca (lenacapavir) and Trogarzo (ibalizumab-uiyk)

Policy CodePolicy N/A

Change TypeMaterial and administrative revisions (drug additions, benefit separation, preferred designation)

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation showing HIV-1 diagnosis, age ≥18, detectable viremia (e.g., >200 copies/mL), documented resistance/intolerance/contraindication, evidence of failing regimen, concurrent antiretroviral therapy, and appropriate dosing.

SourceLink

POLICY UPDATE CHANGES

Sunlenca (lenacapavir) was added to the policy requiring prior authorization through both benefits.

Removed Rx drugs from medical criteria; Rx is available on the MassHealth Drug List (MHDL); Sunlenca and Trogarzo remain on medical criteria.

Yeztugo was added to the medical benefit policy.

Yeztugo was given preferred drug designation and PA will be removed effective 4/1/26.

2drugs in document

12 moapproval duration

≥18min age

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>200viremia threshold

MassHealth UPPLprogram

Coverage Criteria

Sunlenca (lenacapavir) - Initial Therapy

Covered when ALL of the following are met

Sunlenca initial criteria: 1. Member has a diagnosis of HIV-1 infection; 2. Member is >= 18 years of age; 3. Member has ongoing detectable viremia (e.g., >200 copies/mL); 4. Member is antiretroviral experienced with documented historical or baseline resistance, intolerability, and/or contraindication to antiretroviral; 5. Failing current antiretroviral regimen due to resistance, intolerance or safety considerations; 6. Concurrent antiretroviral therapy with at least one other antiretroviral; 7. Appropriate dosing.

*Implies documented history of resistance, adverse reaction, or contraindication to an antiretroviral that is not part of the current regimen. †Implies documented resistance, adverse reaction, or safety concern with current antiretroviral regimen.

Trogarzo (ibalizumab-uiyk) - Initial Therapy

Covered when ALL of the following are met

Trogarzo initial criteria: 1. Diagnosis of HIV-1 infection; 2. Member is >= 18 years of age; 3. Ongoing detectable viremia (e.g., >200 copies/mL); 4. Resistance to ONE antiretroviral medication from each of three classes of antiretroviral medications (including combination agents): NRTI, NNRTI, PI (see Appendix B for examples); 5. Concurrent antiretroviral therapy with at least one other antiretroviral; 6. Appropriate dosing.

Appendix B provides class examples (NRTI, NNRTI, PI).

Continuation of Therapy / Reauthorization

Continuation is allowed when prescriber resubmits indicating positive response

Continuation/reauthorization: Prescriber resubmission/reauthorization request infers a positive response to therapy.12 months

Initial approvals and reauthorizations will be for 12 months.

Requests for members who are not currently receiving the requested medication will not be automatically authorized. Authorization may be granted for members who are currently receiving the medication only when the medication was not obtained as a sample or through a manufacturer patient assistance program; otherwise the member must meet the documented clinical criteria and provide the required supporting documentation for initial coverage consideration.

Coding and Thresholds

Detectable viremia threshold

Detectable viremia threshold>200 copies/mL

ContextExample threshold used in Sunlenca and Trogarzo criteria

UsageRequired to demonstrate ongoing virologic failure when requesting prior authorization

Minimum member age

Minimum member age>= 18 years

ApplicabilityApplies to initial authorization criteria for both Sunlenca and Trogarzo

Documentation

Provider Actions and Prior Authorization

Prior Authorization

Sunlenca (lenacapavir) — Prior Authorization Required

Prior authorization required for Sunlenca (lenacapavir). Submit documentation that all Sunlenca-specific clinical criteria are met; authorization may be granted for members new to the plan who are currently receiving Sunlenca (excludes samples and medications obtained through manufacturer patient assistance programs).

Member has diagnosis of HIV-1 infection
Member is ≥ 18 years of age
Ongoing detectable viremia (e.g., >200 copies/mL)
Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindication to antiretroviral (documentation of prior resistance, adverse reaction, or contraindication required)
Failing current antiretroviral regimen due to resistance, intolerance, or safety considerations (documented)
Concurrent antiretroviral therapy with at least one other antiretroviral
Appropriate dosing

Prior Authorization

Background

Sunlenca (lenacapavir) and Trogarzo (ibalizumab-uiyk) are indicated for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimens and require combination therapy. Coverage under this policy is limited to adults aged ≥ 18 years with ongoing detectable viremia (example threshold: >200 copies/mL) and who meet the agent‑specific criteria for prior authorization (see Sunlenca and Trogarzo initial therapy criteria). Both agents are intended to be used in combination with at least one other antiretroviral and are reserved for patients with documented resistance, intolerance, or contraindication to standard antiretroviral options; continuation approvals will be for 12 months when prescriber resubmission indicates a positive response to therapy.

Definitions

Ongoing detectable viremia

DefinitionPresence of HIV-1 RNA above a detectable threshold (example used in policy: >200 copies/mL)

Role in criteriaDemonstrates failing current antiretroviral regimen and is required for PA consideration

Example value>200 copies/mL as cited for both agents

Antiretroviral experienced with documented resistance/intolerability/contraindication

DefinitionDocumented history of resistance, adverse reaction, or contraindication to antiretroviral agents not part of the current regimen

Sunlenca noteImplies documented historical or baseline resistance, intolerability, and/or contraindication to an antiretroviral

Policy Summary

PayerMass General Brigham Health Plan

PolicyAnti-retroviral agents: Sunlenca (lenacapavir) and Trogarzo (ibalizumab-uiyk)

Policy CodePolicy N/A

Change TypeMaterial and administrative revisions (drug additions, benefit separation, preferred designation)

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Provider must document member age as part of PA submission

Trogarzo (ibalizumab‑uiyk) — Prior Authorization Required

Prior authorization required for Trogarzo (ibalizumab‑uiyk). Submit documentation that all Trogarzo-specific clinical criteria are met; authorization may be granted for members new to the plan who are currently receiving Trogarzo (excludes samples and medications obtained through manufacturer patient assistance programs).

Diagnosis of HIV-1 infection
Member is ≥ 18 years of age
Ongoing detectable viremia (e.g., >200 copies/mL)
Resistance to ONE antiretroviral medication from each of three classes (NRTI, NNRTI, PI) — see Appendix B for examples
Concurrent antiretroviral therapy with at least one other antiretroviral
Appropriate dosing

Denial Risk

New-to-plan continuity / denial risk

New-to-plan continuity: members currently receiving the requested medication may be authorized to continue therapy when documentation shows they are actively treated with the agent at enrollment. Continuity does not apply when the product was obtained only as samples or through a manufacturer's patient assistance program; such cases are not eligible for automatic continuation.

Continuity may be granted for members new to the plan who are currently receiving the requested medication
Excludes coverage when medication was provided only as samples or via manufacturer Patient Assistance Program (PAP)

Trogarzo specificFor Trogarzo, requires resistance to one antiretroviral from each of three classes (NRTI, NNRTI, PI) as detailed in Appendix B