CurrentColorado Rocky Mountain Health PlansPolicy N/A

Sunlenca (lenacapavir) — Prior Authorization Coverage Criteria (oral tablets)

Prior authorization requirements and coverage criteria for Sunlenca (lenacapavir) oral tablets for treatment-experienced adults with multidrug-resistant HIV-1; affects prescribers and pharmacy benefit administrators.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySunlenca (lenacapavir) — Prior Authorization Coverage Criteria (oral tablets)

Policy CodePolicy N/A

Change TypeRevised authorization duration

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approval requires diagnosis of multidrug-resistant HIV-1 and use of an optimized background antiretroviral regimen.

SourceLink

POLICY UPDATE CHANGES

Authorization period updated to six months to allow oral bridging for planned missed injections per label.

Program applies specifically to the oral tablet formulation of Sunlenca.

6 monthsauthorization duration

oral tabletformulation covered

treatment-experiencedindicated patient population

prior authprogram type

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Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria

Diagnosis: Patient has been diagnosed with multidrug-resistant HIV-1 infection.
Background regimen: Patient is currently taking or will be prescribed an optimized background antiretroviral regimen.

Initial: Patient has multidrug-resistant HIV-1 AND is taking or will be prescribed an optimized background antiretroviral regimen.

No specific exclusions are detailed in this policy for Sunlenca (lenacapavir) oral tablets. The document does note that supply limits may be in place and that automated approval processes could affect approvals, but it does not list any clinical or population exclusions.

Use of Sunlenca (lenacapavir) outside the labeled and covered population is not supported by the coverage criteria. Approval is limited to patients who meet both elements: (1) a diagnosis of multidrug-resistant HIV-1 infection and (2) the patient is currently taking or will be prescribed an optimized background antiretroviral regimen. Requests that do not meet both conditions may be denied.

Provider Actions, Prior Authorization, and Operational Rules

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Sunlenca oral tablets will be approved when the patient meets program criteria. Authorization is issued for 6 months. State mandates, federal requirements, and the member's specific benefit plan may affect coverage. Other policies and utilization management programs may also apply.

Patient must have multidrug-resistant HIV-1 infection
Patient must be taking or prescribed an optimized background antiretroviral regimen
Authorization duration: 6 months

Step Therapy

No step therapy requirements are specified in this document.

Billing Rule

Automated Approval and Supply Limits

Automated approval and re-approval may be issued based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Use of automated approval processes varies by program and therapeutic class. Supply limits may be applied.

Automated approval/re-approval may occur based on prior claims and diagnosis codes (ICD-10)
Use of automated processes varies by program/therapeutic class
Supply limits may apply

Denial Risk

Coverage Requirements / Denial Risk

Coverage request may be denied if required elements are not met, including documented diagnosis of multidrug-resistant HIV-1 infection and evidence of an optimized background antiretroviral regimen.

Required elements: documented diagnosis and concurrent regimen information

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization rules

Reauthorization: Authorization will be issued for 6 months; reauthorization may be approved based on claim/medication history, diagnosis codes, and claim logic.

Approvals may use automated processes and supply limits may apply.

Step	Requirement
1	No step therapy specified in this program.

Quantity Limits and Supply

Quantity limits — Sunlenca (lenacapavir)

Quantity limit noteSupply limits may be in place for Sunlenca (lenacapavir) oral tablets.

Automated approvals may affect supplyApprovals and re-authorizations can be issued based on previous claim/medication history, diagnosis codes (ICD-10), and claim logic — these processes may enforce program-specific supply limits.

Unit and periodPer the policy brief, limits are applied to the oral tablet formulation (limits expressed per month in internal limits table).

Key Definitions

Optimized background antiretroviral regimen — definition and use

DefinitionAn optimized background antiretroviral regimen is a tailored combination of antiretroviral agents selected based on resistance, prior therapy, tolerability, and safety to provide the most effective regimen for a patient with multidrug-resistant HIV-1.

Role in therapySunlenca must be used in combination with an optimized background antiretroviral regimen for covered use in heavily treatment-experienced adults with multidrug-resistant HIV-1.

Authorization dependencyPrior authorization approval requires that the patient is currently taking or will be prescribed an optimized background antiretroviral regimen.

Background

Lenacapavir (Sunlenca) is an HIV-1 capsid inhibitor indicated, in combination with other antiretroviral(s), for treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are failing current regimens due to resistance, intolerance, or safety concerns. Coverage in this policy is specific to the oral tablet formulation and is intended to be used as part of an optimized background antiretroviral regimen (a tailored combination of antiretroviral agents selected based on resistance, prior therapy, tolerability, and safety).