CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fuzeon (enfuvirtide) — Coverage Criteria for Treatment‑Experienced HIV‑1

Defines coverage and authorization criteria for Fuzeon (enfuvirtide) for treatment‑experienced patients with HIV‑1, including initial and continuation authorization requirements and exclusions. Affects providers prescribing Fuzeon and members seeking coverage.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFuzeon (enfuvirtide) — Coverage Criteria for Treatment‑Experienced HIV‑1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing treatment‑experienced status, viremia despite prior antiretroviral therapy (≥3 months) and resistance or intolerance when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

treatment‑experiencedindicated population

3+ monthsmin prior therapy

Coverage Criteria for Fuzeon (enfuvirtide)

Initial therapy (treatment of HIV-1 infection)

Covered when ALL of the following are met:

FDA-approved indication: Fuzeon used in combination with other antiretroviral agents for treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

Baseline failure criteria: Member has viremia despite 3 or more prior months of therapy with at least one appropriate regimen used to treat HIV, OR member has viremia and documented resistance or intolerance to at least one appropriate regimen used to treat HIV.

Continuation of therapy (reauthorization)

Continuation (reauthorization) covered when ALL of the following are met:

Response to therapy:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFuzeon (enfuvirtide) — Coverage Criteria for Treatment‑Experienced HIV‑1

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization — 12-month approvals

Prior authorization may be granted for a 12-month period when criteria for treatment-experienced HIV-1 with viremia and documented resistance or intolerance are met; reauthorization for an additional 12 months may be granted when there is a positive or stable virologic response to Fuzeon.

Initial or continuation authorizations are for 12 months when policy criteria are satisfied.

Step Therapy

Therapy failure/intolerance prerequisite

Approval requires prior use of at least one appropriate antiretroviral regimen with evidence of viremia despite therapy (persistent HIV-1 replication after ≥3 months of therapy) or viremia with documented resistance or intolerance to at least one appropriate regimen.

Member must have viremia despite 3 or more prior months of therapy with at least one appropriate regimen, or viremia plus documented resistance/intolerance to at least one appropriate regimen.

Documentation Required

Required clinical documentation

Provide clinical documentation demonstrating treatment‑experienced status with HIV-1 and evidence of ongoing viremia despite prior antiretroviral therapy; when applicable include documentation of resistance or intolerance to at least one appropriate regimen. For reauthorization, provide evidence of a positive or stable virologic response to Fuzeon.

Evidence of viremia despite ≥3 months of prior therapy with at least one appropriate regimen, or viremia plus documented resistance or intolerance.
For reauthorization, documentation of positive or stable virologic response to Fuzeon.

Denial Risk

Non‑FDA/compendial indications — denial risk

Use of Fuzeon for indications other than the FDA‑approved indication and compendial uses is considered experimental/investigational and not medically necessary and may be denied.

All non‑FDA and non‑compendial indications are subject to denial as investigational/not medically necessary.

Definitions

treatment-experienced

PopulationPatients with prior antiretroviral therapy exposure who continue to have HIV-1 replication despite treatment (treatment-experienced).

Clinical contextFuzeon (enfuvirtide) is indicated in combination with other antiretroviral agents for this treatment-experienced population.

Coverage scopeCoverage limited to the FDA‑approved indication and compendial uses; all other indications are considered experimental/investigational and not medically necessary.

viremia despite therapy

DefinitionPersistent HIV-1 viral replication despite prior antiretroviral therapy (viremia despite therapy).

Minimum prior therapy duration referencedAt least 3 or more prior months of therapy with at least one appropriate antiretroviral regimen.

Alternate qualifying criterionViremia plus documented resistance or intolerance to at least one appropriate regimen may also meet criteria for authorization.

OpenPayer

Fuzeon (enfuvirtide) — Coverage Criteria for Treatment‑Experienced HIV‑1

Coverage Criteria for Fuzeon (enfuvirtide)

Provider Actions and Prior Authorization Requirements

Background

Definitions