CurrentCentenePolicy N/A

Clinical Policy: Enfuvirtide (Fuzeon)

Medical necessity and prior authorization criteria for enfuvirtide (Fuzeon) for treatment-experienced patients with HIV-1 infection across Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Enfuvirtide (Fuzeon)

Policy CodePolicy N/A

Change TypeHCPCS code additionreference updatesstate disclaimer added

Effective Date06.01.10

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J1324 (injection, enfuvirtide, 1 mg).

References updated (HIM.PHAR.2I revised to HIM.PA.154) and general references reviewed and updated across multiple annual reviews.

Disclaimer that medical management techniques, including quantity management, beyond therapy is not allowed for members in NV per SB 439.

90 mg SC BIDadult dosing

180 mg/daymax daily dose

≥200 c/mLvirologic failure threshold

6 moinitial approval length

J1324billing code

Policy Summary

PayerCentene

PolicyClinical Policy: Enfuvirtide (Fuzeon)

Policy CodePolicy N/A

Change TypeHCPCS code additionreference updatesstate disclaimer added

Effective Date06.01.10

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial therapy for HIV-1 infection: 1) Diagnosis of HIV-1 infection; 2) Prescribed by or in consultation with an infectious disease or HIV specialist; 3) Age >= 26 years; 4) Failure of >= 12 weeks of antiretroviral therapy that includes 2 nucleoside reverse transcriptase inhibitors and 1 agent from an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a pharmacokinetic-enhanced protease inhibitor (PI); 5) Fuzeon (enfuvirtide) is prescribed concurrently with additional antiretroviral agents to which the member is susceptible; 6) Current (within 30 days) HIV RNA >= 200 copies/mL; 7) Dose does not exceed 180 mg per day.see text

Approval duration Commercial 6 months; Medicaid/HIM 6 months

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy for members already receiving Fuzeon: 1) Currently receiving medication via Centene benefit, or documentation supports member has been receiving Fuzeon 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 180 mg per day.see text

Approval duration Commercial 6 months or to renewal date; Medicaid/HIM 12 months

Requests for indications that are not FDA‑approved and not specifically addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09, HIM.PA.154, or CP.PMN.53) or the member’s evidence of coverage. Prior authorization decisions require submission of clinical documentation that demonstrates the member meets all listed criteria for coverage, including diagnosis, specialist involvement, prior antiretroviral therapy history, virologic status, and dosing limits.

When treating Medicaid members, state Medicaid coverage provisions take precedence over the clinical policy where there is a conflict. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements or exceptions that apply to this clinical policy.

Requests for non‑FDA approved indications that lack adequate supporting documentation as required by the referenced off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or the plan’s evidence of coverage will be considered not authorized. Providers must submit clinical evidence (such as peer‑reviewed literature, clinical trial data, or detailed rationale per the off‑label policy) demonstrating efficacy and safety for the requested off‑label use to be considered for approval.

Coding

HCPCS CodesHCPCSCovered

J1324

Injection, enfuvirtide, 1 mg

HCPCS CodesHCPCS

J1324

Injection, enfuvirtide, 1 mg

inv-08: Virologic failure threshold

Virologic failure thresholdViral load ≥ 200 copies/mL (current within 30 days)

Maximum daily dose related thresholdDose must not exceed 180 mg per day

Therapy failure duration requirementFailure of ≥ 12 weeks of antiretroviral therapy including 2 NRTIs and 1 INSTI/NNRTI/boosted PI

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must obtain prior authorization before initiation of therapy and submit documentation supporting that the member meets all applicable approval criteria (diagnosis, specialist prescribing/consultation, prior therapy, labs, and dosing limits). Failure to obtain prior authorization may result in denial of the request.

Prior authorization required for Fuzeon (enfuvirtide).
Requests must document diagnosis of HIV-1 infection, prescribing or consultation by an infectious disease/HIV specialist, prior antiretroviral therapy failure as specified in policy, current viral load, and that dose does not exceed 180 mg/day.

Documentation Required

Documentation Required — avoid indication mismatches

Providers must submit office chart notes, laboratory results, and any other clinical information that demonstrate the member meets the coverage criteria. Failure to provide adequate supporting documentation or mismatches between the indication submitted and the documentation provided may result in denial of the request.

Background

Enfuvirtide (Fuzeon) is indicated for use in combination with other antiretroviral agents in treatment‑experienced adults with HIV‑1 replication despite ongoing antiretroviral therapy. Assessment prior to use should include adherence evaluation, review of treatment history and tolerability, viral load and CD4 trends, and resistance testing to ensure concurrent antiretroviral agents are those to which the virus remains susceptible.

Definitions

inv-18: Virologic failure definition

Virologic failure (definition)Inability to achieve or maintain suppression of viral replication to an HIV RNA level <200 copies/mL

Clinical assessment elementsAssessment should include adherence, drug interactions, tolerability, HIV RNA and CD4 trends, treatment history, and resistance testing results

Risk notePatients with HIV RNA persistently >200 copies/mL, especially >500 copies/mL, often develop resistance

inv-19: Virologic suppression definition

Virologic suppression (definition)Confirmed HIV RNA level below the lower limit of assay detection (LLOD)

Monitoring recommendationHIV RNA levels should be monitored at least every 3 months to assess need for therapy changes