ModifiedmhnPolicy CP.PHAR.516

Fostemsavir (Rukobia) coverage

Defines medical necessity and prior authorization criteria for fostemsavir (Rukobia) for treatment-experienced adults with multidrug-resistant HIV-1, and continuation criteria for members covered by the payer's lines of business.

Policy Summary

Payermhn

PolicyFostemsavir (Rukobia) coverage

Policy CodePolicy CP.PHAR.516

Change TypeMaterial clinical and operational revisions

Effective DateMar 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, lab results, resistance testing) demonstrating multidrug-resistant HIV-1 and current viral load.

SourceLink

POLICY UPDATE CHANGES

Initial approval duration extended from 6 months to 12 months for this maintenance medication for a chronic condition.

Added requirement for documentation of resistance to at least 1 antiretroviral agent from each of 3 classes (NRTI, NNRTI, PI).

Medical management techniques, including quantity management beyond step therapy, are not allowed for members in Nevada.

Step therapy bypass for Illinois HIM per IL HB 5395 (no step requirement for IL HIM requests).

12 monthsapproval duration (initial and continued)

≥18minimum age for coverage

≥200required HIV-1 RNA viral load

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Coverage Criteria for Fostemsavir (Rukobia)

Initial Therapy (HIV-1 Infection)

Covered when ALL of the following are met:

Initial approval: 1. Diagnosis of multidrug-resistant HIV-1 infection; 2. Prescribed by or in consultation with an infectious disease or HIV specialist; 3. Age >= 18 years; 4. Documentation of resistance to at least 1 antiretroviral agent from each of 3 classes (NRTI, NNRTI, PI), unless contraindicated or clinically significant adverse effects are experienced; 5. If CCR5 tropic, failure of maraviroc (Selzentry), unless contraindicated, clinically significant adverse effects are experienced, or member is resistant (note: for Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395); 6. Current (within the past 30 days) HIV RNA viral load >= 200 copies/mL; 7. Prescribed concurrently with additional antiretroviral agents to which member is susceptible, if available; 8. Dose does not exceed 1,200 mg (2 tablets) per day.

Approval duration: 12 months

Continued Therapy (HIV-1 Infection)

Covered when ALL of the following are met:

Continuation: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Rukobia for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 1,200 mg (2 tablets) per day.

Approval duration: 12 months

Other diagnoses/indications

If requested use is not listed or policy is outdated:

Other uses: 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, follow the applicable formulary or non-formulary policy for the relevant line of business as listed: formulary/no-coverage criteria (CP.CPA.190, HIM.PA.33, CP.PMN.255) or non-formulary policies (CP.CPA.190, HIM.PA.103, CP.PMN.16); 2. If the requested use is not specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace/ICHRA, CP.PMN.53 for Medicaid).

See referenced policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage statements in this clinical policy, state Medicaid coverage provisions take precedence. Providers and reviewers should consult the applicable state Medicaid manual for any state‑specific coverage rules that supersede this policy.

Requests for use of this drug for non‑FDA approved indications without adequate documentation of efficacy and safety per the applicable off‑label use policies are considered not authorized. Providers must follow the referenced off‑label use policies and submit supporting clinical evidence to justify coverage for off‑label uses.

Product Availability, Dosing, and Coding

Product availability / NDCNDC

NDC	Not listed in this section; product availability listed as 600 mg extended-release tablet.

inv-08: HIV-1 RNA viral load — >= 200 copies/mL

Required current HIV-1 RNA>= 200 copies/mL

Timing of measurementCurrent within the past 30 days

ContextPart of initial approval criteria for HIV-1 infection

inv-09: Maximum daily dose — <= 1,200 mg/day

Maximum daily dose<= 1,200 mg/day (2 tablets)

Prescribed dosing regimen600 mg PO BID (600 mg twice daily) corresponds to 1,200 mg/day maximum

Policy context

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must demonstrate that the member meets ALL initial approval criteria for HIV-1 infection per this clinical policy, including documentation of multidrug-resistant HIV-1 and resistance data. Submit clinical documentation (office/visit notes, lab results, HIV resistance testing) to support that the member meets all criteria. Lack of required documentation (including absence of resistance data showing resistance to at least one agent from each of the three classes: NRTI, NNRTI, PI) may result in denial.

Required documentation: office notes, lab results, resistance testing, consultation notes from infectious disease/HIV specialist.
Coverage decisions subject to Health Plan administrative policies and procedures.

Step Therapy

Step Therapy and CCR5‑Tropic Requirement

Step therapy requirements apply as detailed in this clinical policy and in Health Plan administrative procedures. If the member is CCR5-tropic, provider must demonstrate prior failure of maraviroc (Selzentry®) unless maraviroc is contraindicated, causes clinically significant adverse effects, or the member is documented resistant to maraviroc. For Illinois HIM requests, the step therapy requirement for maraviroc does not apply per IL HB 5395 (effective 1/1/2026).

Background and Clinical Context

Fostemsavir (Rukobia) is a gp120‑directed attachment inhibitor indicated in combination with other antiretrovirals for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who have limited treatment options due to resistance, intolerance, or safety concerns. The agent binds to the viral gp120 protein, preventing attachment of HIV‑1 to host CD4+ cells, and is intended for use as part of a background regimen selected based on susceptibility and resistance testing. This policy requires documentation of multidrug‑resistant HIV‑1 and specialist involvement to guide appropriate selection for patients with limited remaining antiretroviral class options.

Definitions

inv-20: Fostemsavir (Rukobia) — definition and brief drug description.

Drug class / mechanismgp120-directed attachment inhibitor

Brand and genericFostemsavir (Rukobia)

Indication summaryIndicated in combination with other antiretrovirals for heavily treatment-experienced adults with multidrug-resistant HIV-1

inv-21: Multidrug-resistant HIV-1 — definition requiring resistance to at least one agent from NRTI, NNRTI, PI (policy requirement).

DefinitionHIV-1 infection with resistance to multiple antiretroviral classes

Policy requirementDocumentation of resistance to at least 1 agent from each of NRTI, NNRTI, and PI classes unless contraindicated or clinically significant adverse effects are experienced