ModifiedCentenePolicy CP PHAR.516

Fostemsavir (Rukobia) for HIV-1

Policy governing medical necessity and prior authorization criteria for fostemsavir (Rukobia) for treatment-experienced adults with multidrug-resistant HIV-1 across Centene lines of business.

Policy Summary

PayerCentene

PolicyFostemsavir (Rukobia) for HIV-1

Policy CodePolicy CP PHAR.516

Change TypeRevised indicationsstep therapy updatesremoved discontinued agent requirement

Effective Date

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, resistance data, and viral load) showing the member meets all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Revised FDA approved indication language to align with prescribing information and updated Appendix B with additional generic drug examples.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Removed failure of Fuzeon requirement due to manufacturer discontinuation.

Added disclaimer that medical management techniques, including quantity management, beyond step therapy is not allowed for members in Nevada per SB 439.

600 mgtablet strength (extended-release)

1,200 mg/daymaximum daily dose

>18age requirement

6 moinitial approval

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12 mocontinuation approval

Coverage Criteria for Fostemsavir (Rukobia)

Initial Therapy - HIV-1 Infection

Covered when ALL of the following are met:

Initial approval criteria: 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: step therapy requirements do not apply for Illinois HIM per IL HB 5395 as specified); 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.

Initial approval duration: 6 months

Continuation Therapy - HIV-1 Infection

Covered when ALL of the following are met:

Continuation criteria: 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

Non‑FDA approved (off‑label) uses of fostemsavir (Rukobia) that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (HIM Marketplace), and CP.PMN.53 (Medicaid) for the documentation standards required to support off‑label use.

Coverage determinations for fostemsavir are made in accordance with the member's evidence of coverage and other plan documents. This clinical policy is intended as a guide to medical necessity to assist in making coverage decisions and administering benefits and is not a contract or guarantee of payment. Coverage remains subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements.

Requests for fostemsavir to treat non‑FDA approved indications that lack adequate supporting documentation will be considered not authorized. Such requests must include evidence meeting the Health Plan’s off‑label use documentation requirements; absent that evidence, approval will not be granted. See the off‑label use policies CP.CPA.09, HIM.PA.154, and CP.PMN.53 for the specific documentation needed to substantiate off‑label use.

Coding and Test Thresholds

Codes listedmixed

No procedural, HCPCS, CPT, ICD-10, or NDC codes listed in this segment of the document.

inv-07: HIV RNA viral load

HIV RNA viral load>= 200 copies/mL (within past 30 days)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit a prior authorization request and include complete supporting documentation (e.g., office chart notes, relevant laboratory results, resistance testing, and other clinical information) demonstrating that the member meets all approval criteria for fostemsavir (Rukobia). Prescriptions should be written by or in consultation with an infectious disease or HIV specialist when indicated.

Include office notes and lab results (HIV RNA, resistance assays) with the request
Specialist prescribing or documented consultation required

Denial Risk

Incomplete Documentation May Lead to Denial

Requests lacking documentation that the member meets all approval criteria will be denied. Examples of missing documentation include absence of resistance testing showing resistance to antiretroviral agents from at least three classes, no recent HIV RNA viral load within 30 days, lack of evidence of prior therapy failure or intolerance (including step-therapy failures when applicable), or no documentation of specialist consultation when required.

Background

Fostemsavir (Rukobia) is an HIV‑1 gp120‑directed attachment inhibitor indicated in combination with other antiretroviral agents for heavily treatment‑experienced adults with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety concerns. The product is administered as an extended‑release tablet dosed at 600 mg orally twice daily, with a maximum recommended daily dose of 1,200 mg (2 tablets) when clinically indicated. This background information is provided to support application of the coverage criteria and prior authorization requirements.

Definitions

inv-17: Fostemsavir (Rukobia)

Drug classHIV-1 gp120-directed attachment inhibitor

Dosing600 mg PO twice daily (extended-release tablet)

Maximum daily dose1,200 mg (2 tablets) per day

inv-18: Provider definition

Provider statusProviders are independent contractors who exercise independent judgment and are not agents or employees of the Health Plan.

ResponsibilityProviders are solely responsible for the medical advice and treatment of members.

Control

Policy Summary

PayerCentene

PolicyFostemsavir (Rukobia) for HIV-1

Policy CodePolicy CP PHAR.516

Change TypeRevised indicationsstep therapy updatesremoved discontinued agent requirement

Effective Date

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, resistance data, and viral load) showing the member meets all approval criteria when requesting prior authorization.

SourceLink

On This Page

Missing or incomplete office notes or lab results
No documentation of resistance to ≥1 agent from each of three classes (NRTI, NNRTI, PI) unless clinically contraindicated
No HIV RNA viral load within past 30 days showing ≥200 copies/mL

Documentation Required

Documentation Requirements

Providers must submit documentation supporting that the member meets all clinical criteria. Acceptable documentation includes office chart notes, HIV resistance test reports, HIV ribonucleic acid (viral load) results, prior medication history, and documentation of specialist consultation when required. Follow the Health Plan's coverage documents and applicable administrative rules when preparing requests.

Office chart notes and progress documentation
Recent lab results (HIV RNA viral load within 30 days)
Resistance testing demonstrating required resistance profile
Prior antiretroviral therapy history and rationale for current regimen
Follow applicable Health Plan coverage documents and administrative rules

Step Therapy

Step Therapy Requirement

Step therapy: for CCR5-tropic virus, failure of maraviroc (Selzentry) is required prior to approval of fostemsavir unless maraviroc is contraindicated, causes clinically significant adverse effects, or resistance to maraviroc is documented. For Illinois Health Insurance Marketplace (HIM) requests, the step therapy requirement does not apply as of 01/01/2026 per IL HB 5395.

Failure of Selzentry required for CCR5-tropic virus unless contraindicated, adverse effects, or resistance documented
IL HIM step therapy bypass effective 2026-01-01 per IL HB 5395

Note

Prior Authorization Guidance and Coverage Reference

This clinical policy is intended to guide medical necessity determinations and assist with coverage decisions. Coverage and payment remain subject to the member's contract terms, exclusions, limitations, and applicable state or federal laws. The Health Plan may change or withdraw this clinical policy; providers should consult the plan's coverage documents for final coverage determinations.

Coverage decisions subject to evidence of coverage/certificate of coverage/policy terms
Policy may be amended or withdrawn; effective date determined by the Health Plan

The Health Plan has no control or right of control over referred providers.