CurrentAetnaPolicy 0671

Enfuvirtide (Fuzeon)

Defines Aetna's medical necessity criteria, dosing notes, experimental uses, and coding guidance for enfuvirtide (Fuzeon) injections for treatment-experienced patients with HIV-1; applies to Aetna benefit administration.

Policy Summary

PayerAetna

PolicyEnfuvirtide (Fuzeon)

Policy CodePolicy 0671

Change TypeNo material change

Effective DateSep 5, 2003

Next Review DateJan 25, 2024

Key ActionObtain prior authorization documenting treatment-experienced status with viremia or documented resistance/intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 mg BIDrecommended adult dose

108 mgvial strength

98%injection site reactions

3 momin prior therapy

J1324HCPCS

Coverage Criteria for Enfuvirtide (Fuzeon)

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inv-01: Initial Approval — ANY of the following are met

Aetna considers enfuvirtide medically necessary when ANY of the following are met:

ANY of the following: The member has viremia despite 3 or more prior months of therapy with at least one appropriate regimen used to treat HIV>= 3 months prior therapy

From policy criteria

ANY of the following: The member has viremia and documented resistance or intolerance to at least one appropriate regimen used to treat HIVdocumented resistance or intolerance

From policy criteria

inv-02: Continuation of Therapy — ALL of the following are met

Continuation of therapy is considered medically necessary when ALL of the following are met:

ALL of the following: Member has had a positive or stable virologic response to enfuvirtidepositive or stable virologic response

From policy continuation section

Use of enfuvirtide (Fuzeon) for treatment‑naive HIV‑infected persons and for treatment of COVID‑19 is considered experimental and investigational (not covered). Aetna’s determination reflects that effectiveness for these indications has not been established.

This Clinical Policy Bulletin is provided to assist in administering plan benefits and contains only a partial, general description of plan or program benefits; it does not constitute a contract or an offer of coverage. Treating providers remain responsible for medical advice and treatment. The bulletin may be updated and is subject to change.

Indications for enfuvirtide outside the specified treatment‑experienced HIV‑1 population — for example, use in treatment‑naive persons or for management of COVID‑19 — are considered experimental/investigational and not medically necessary under this policy. Requests for such indications are at risk for denial; when coverage is being considered for HIV‑1, ensure the member meets the treatment‑experienced criteria and document the appropriate diagnosis code (B20) and supporting clinical information.

Coding Guidance

Covered HCPCS Codes if selection criteria are metHCPCSCovered

J1324

Injection, enfuvirtide, 1 mg

Covered ICD-10 Codes if selection criteria are metICD-10Covered

B20	Human immunodeficiency virus [HIV] disease

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive)ICD-10Not Covered

U07.1

COVID-19

Pediatric dosing threshold and administration notes

Pediatric weight threshold>= 11 kg for patients >= 6 years; dose 2 mg/kg twice daily up to a maximum of 90 mg twice daily (subcutaneous)

Age minimum6 years of age and older

Maximum pediatric dose90 mg twice daily (same as adult maximum)

Administration routeSubcutaneous injection into upper arm, anterior thigh, or abdomen

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests must document that the member is treatment‑experienced with viremia despite prior therapy (≥3 months on at least one appropriate HIV regimen) or has viremia with documented resistance or intolerance to at least one appropriate HIV regimen. Include applicable billing code J1324 when submitting claims.

Prior authorization required showing treatment‑experienced status or documented resistance/intolerance
Billing code: J1324 (Injection, enfuvirtide, 1 mg)

Note

Prior Authorization: administrative details not specified

The policy text does not specify additional prior authorization administrative details (such as submission portal, forms, or phone numbers). Consult the payer's provider resources or the Clinical Policy Bulletin Notes for administrative instructions.

Note

No specific authorization/denial workflow provided

No specific authorization or denial algorithm beyond the clinical criteria is provided in the referenced policy sections. Administrative review and usual medical‑necessity adjudication apply; requests not meeting the listed clinical criteria may be denied.

Requests not meeting the initial approval criteria (viremia despite ≥3 months therapy or documented resistance/intolerance) are subject to denial

Documentation Required

Required Supporting Clinical and Coding Documentation

Supporting clinical documentation must demonstrate treatment‑experienced status or documented resistance/intolerance and current viremia (laboratory results, prior regimen history, resistance testing or documented intolerance). Include ICD‑10 code B20 when criteria are met; do not use U07.1 (COVID‑19) for coverage.

Clinical: viral load results showing viremia; prior antiretroviral treatment history (≥3 months on ≥1 appropriate regimen) or resistance test results; documentation of intolerance if applicable
Coding: ICD‑10 B20 for HIV disease when criteria met; J1324 for enfuvirtide; U07.1 (COVID‑19) is a not‑covered indication per policy

Step Therapy

Step therapy: not specified

Step therapy is not specified in the provided policy text beyond the requirement that the member be treatment‑experienced or have documented resistance/intolerance. No sequential step‑therapy regimen or required trials are listed.

Note

No step therapy requirements or sequence specified

There are no step‑therapy sequences or trials defined in the policy sections provided; the clinical criteria focus on treatment‑experienced status or documented resistance/intolerance rather than stepwise agent trials.

Definitions

Treatment‑experienced — definition and relation to FDA‑approved population

Definition (treatment-experienced)Patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy (population for which Fuzeon is FDA‑approved)

Clinical contextFuzeon is indicated in combination with other antiretroviral agents for treatment-experienced patients with ongoing viral replication despite therapy

Implication for coveragePolicy applies to the FDA‑approved treatment‑experienced population; requests outside this population (e.g., treatment‑naive) are considered experimental/investigational

Supporting evidenceRandomized studies (TORO‑1, TORO‑2) showed clinical benefit in treatment‑experienced patients

Clinical Policy Bulletin — definition and disclaimer

Definition (Clinical Policy Bulletin)An Aetna‑developed bulletin to assist in administering plan benefits; it is not an offer of coverage or medical advice

ScopeProvides a partial, general description of plan or program benefits and may be updated; specific contract language and coverage determinations are governed by member documents

Provider responsibilityTreating providers remain responsible for medical advice and treatment decisions; the bulletin is an administrative reference

OpenPayer

Enfuvirtide (Fuzeon)

Coverage Criteria for Enfuvirtide (Fuzeon)

Coding Guidance

Provider Actions, Prior Authorization and Documentation

Background

Definitions