CurrentNeighborhood Health Plan of Rhode IslandPolicy 3099-A

Fuzeon (enfuvirtide) — coverage criteria for treatment‑experienced HIV‑1

Policy governing medical necessity and authorization criteria for Fuzeon (enfuvirtide) for treatment‑experienced patients with HIV‑1; affects providers prescribing and requesting prior authorization for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFuzeon (enfuvirtide) — coverage criteria for treatment‑experienced HIV‑1

Policy CodePolicy 3099-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization showing treatment‑experienced HIV‑1 with viremia despite prior therapy or documented resistance/intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period granted for initial or continued therapy

treatment‑experiencedintended patient population

viremia ≥3 monthsbaseline virologic failure criterion

Coverage Criteria for Fuzeon (enfuvirtide)

Initial Therapy (FDA‑approved)

Covered when ALL of the following are met:

Initial therapy criteria: 1) Fuzeon (enfuvirtide) is prescribed in combination with other antiretroviral agents for treatment of HIV-1 in treatment-experienced patients with evidence of ongoing HIV-1 replication; 2) The member has viremia despite ≥3 months of therapy with at least one appropriate regimen OR the member has viremia with documented resistance or intolerance to at least one appropriate regimen used to treat HIV; 3) No exclusions to the prescribed therapy are present.

Authorization of 12 months may be granted when criteria are met.

Continuation Therapy

Covered for reauthorization when ALL of the following are met:

Continuation therapy criteria: Member has had a positive or stable virologic response to Fuzeon during the prior authorization period.

Authorization of 12 months may be granted for continued treatment.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFuzeon (enfuvirtide) — coverage criteria for treatment‑experienced HIV‑1

Policy CodePolicy 3099-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization showing treatment‑experienced HIV‑1 with viremia despite prior therapy or documented resistance/intolerance.

SourceLink

On This Page

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Provider Requirements and Authorization Steps

Prior Authorization

Prior Authorization Required

Prior authorization required for Fuzeon (enfuvirtide).

Affected indication: HIV-1 (treatment‑experienced)

Step Therapy

Step Therapy Prerequisite

Authorization will be granted for up to 12 months when the member meets the step-therapy and documentation requirements below.

Documentation Required

Required Clinical Documentation

Required clinical documentation: documentation of ongoing viremia despite at least 3 months of therapy with at least one appropriate HIV regimen, or documentation of resistance or intolerance to at least one appropriate HIV regimen. For continuation of therapy, documentation of a positive or stable virologic response to Fuzeon is required for reauthorization.

Denial Risk

Non‑approved Indications

Use of Fuzeon for indications other than the FDA‑approved or compendial uses described in this policy is considered experimental/investigational and not medically necessary.

Key Definitions

Treatment‑experienced — definition

DefinitionPatients with prior antiretroviral therapy who have evidence of ongoing HIV-1 replication despite current antiretroviral treatment.

ContextApplies to individuals for whom Fuzeon (enfuvirtide) is indicated in combination with other antiretroviral agents.

Policy implicationMembers meeting this definition may be eligible for prior authorization for Fuzeon when other coverage criteria are satisfied.

Viremia despite therapy — definition

DefinitionPersistent detectable HIV-1 RNA (viremia) despite at least 3 months of therapy with at least one appropriate antiretroviral regimen.

Alternative qualifying criterionViremia with documented resistance or intolerance to at least one appropriate regimen may also meet the requirement for treatment authorization.

Authorization noteWhen this criterion (or the resistance/intolerance alternative) is met, authorization for treatment may be granted for 12 months.

OpenPayer

Fuzeon (enfuvirtide) — coverage criteria for treatment‑experienced HIV‑1

Coverage Criteria for Fuzeon (enfuvirtide)

Provider Requirements and Authorization Steps

Key Definitions

Background