CurrentUnitedHealthcarePolicy N/A

Fuzeon (enfuvirtide) prior authorization

Defines prior authorization requirements for Fuzeon (enfuvirtide) for Medicaid recipients, detailing required documentation, lab evidence, and approval period for initiation and continuation of therapy. Affects prescribers, pharmacies, and Medicaid members in the governed jurisdiction.

Policy Summary

PayerUnitedHealthcare

PolicyFuzeon (enfuvirtide) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with recent viral load and CD4 lab results and genotype/phenotype results (for initiation) to obtain approval for up to six months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 momaximum approval period

6 monthsviral load/CD4 recency

12 monthsgenotype/phenotype dating

>=1000min viral load for testing

Coverage Criteria for Fuzeon (enfuvirtide)

Initial and Continuation Therapy Criteria

Covered when ALL of the following are met:

Initiation of therapy: 1) Documented treatment-experienced HIV-1 infection with evidence of viral replication despite ongoing antiretroviral therapy; 2) Genotype and/or phenotype testing completed with results submitted (for initiation the results should be dated within the past 12 months) unless the recipient is currently on Fuzeon; 3) Viral load lab completed in the past 6 months with a copy of results submitted (only 'Yes' acceptable for approval); 4) CD4 count completed in the past 6 months with a copy of results submitted (only 'Yes' acceptable for approval); 5) Verification of ongoing therapy with other HIV medications and documented compliance with previous therapies; prescriber signature and completed prior authorization form submitted.

Genotyping/phenotyping is not required for recipients currently on Fuzeon; genotyping/phenotyping cannot be effectively performed if viral load < 1000 copies/mL.

Continuation of therapy: 1) Evidence of ongoing compliance with other antiretroviral medications; 2) Recent viral load and CD4 laboratory results (copies of results submitted); 3) Completed prior authorization form with prescriber attestation and any required clinical notes; 4) Documentation supporting clinical benefit or continued need for Fuzeon.

If Fuzeon is effective, CD4 counts should be improved and viral antigen levels may be undetectable.

Policy Summary

PayerUnitedHealthcare

PolicyFuzeon (enfuvirtide) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with recent viral load and CD4 lab results and genotype/phenotype results (for initiation) to obtain approval for up to six months.

SourceLink

On This Page

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Genotyping and phenotyping are not required for recipients who are currently receiving Fuzeon. For initiation of Fuzeon, genotype and phenotype test results must be submitted and should be dated within the past 12 months. Note that genotyping and phenotyping cannot be effectively performed when the viral load is below 1000 copies/mL; this threshold is used to determine whether testing is indicated or feasible.

The policy document does not include an explicit statement labeling any Fuzeon-related service as "not medically necessary." Instead, it specifies conditions under which genotyping/phenotyping are not required (for current Fuzeon recipients or when viral load is 1000 copies/mL) and defines acceptability criteria for lab and documentation submission for authorization decisions.

Laboratory Thresholds and Coding Notes

Viral load threshold for genotyping/phenotyping

Viral load threshold>= 1000 copies/mL

ContextGenotyping/phenotyping cannot be effectively performed if viral load is less than 1000 copies/mL.

Implication for testingIf viral load <1000 copies/mL, genotyping/phenotyping is not required for recipients currently on Fuzeon.

Effective genotyping/phenotyping threshold

Minimum viral load for effective testingGenotyping/phenotyping cannot be effectively done if viral load < 1000 copies/mL.

Practical consequenceDo not rely on genotype/phenotype results when VL is below 1000 copies/mL; testing may be uninformative.

Policy noteGenotyping/phenotyping is not required for recipients currently on Fuzeon when VL is below this threshold.

Prior Authorization, Submission and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are granted for a maximum of six months.

Completed PA form with all fields: recipient Medicaid ID, DOB, recipient name, prescriber name, prescriber NPI, prescriber phone/fax, pharmacy name, pharmacy Medicaid provider #, pharmacy phone/fax, drug name, quantity, length of therapy on prescription, dosage and frequency, indication of initiation or continuation of therapy, prescriber signature and date.
Fax PA form to 1-866-940-7328; Pharmacy PA Call Center: 1-800-310-6826.

Note

Prerequisite Therapy and Compliance

For new (initiation) therapy, verify the patient is currently on concurrent antiretroviral therapy and document compliance with prior therapies. New therapy approvals require labs that demonstrate CD4 counts and viral antigen levels consistent with medication failure. For continuation therapy, verify ongoing compliance with other HIV medications.

New therapy requires verification of: 1) ongoing therapy with other HIV medications; 2) compliance on previous therapies; 3) labs demonstrating CD4 and viral antigen levels consistent with medication failure.
If Fuzeon is effective, CD4 counts should be acceptable and viral antigen levels may be undetectable.

Documentation Required

Required Submission Materials

A completed PA form and supporting documentation are required for review. An incomplete form may be returned and will delay or prevent approval. Providers must retain copies of all documentation for five years.

Include copies of all relevant medical records (diagnostic evaluations, recent chart notes) and the most recent related labs.
Required form fields: Recipient Medicaid ID, Date of Birth, Recipient Full Name, Prescriber's Full Name, Prescriber's NPI, Prescriber Phone/Fax, Pharmacy Name, Pharmacy Medicaid Provider #, Pharmacy Phone/Fax, Drug name, Quantity, Length of Therapy, Dosage and Frequency, Initiation or Continuation selection, Prescriber's Signature and Date.

Documentation Required

Genotype/Phenotype Results

For initiation of therapy, a copy of genotype and/or phenotype test results must be submitted. Genotype/phenotype results should be dated within the past 12 months. Genotyping/phenotyping are not required for recipients currently on Fuzeon therapy or when viral load is <1000 copies/mL (results may be unreliable at low viral loads).

Has the patient had a genotype/phenotype completed? (A copy of test results must be submitted for initial therapy) — Yes/No and Date.
Genotype/phenotype results must be dated within 12 months for initiation of therapy; not required for current Fuzeon recipients or if viral load <1000 copies/mL.

Denial Risk

Missing Required Labs

If required viral load and CD4 labs are not provided, the PA cannot be approved. Only 'Yes' responses to having a viral load and CD4 count within the past 6 months (with copies of lab results) are acceptable for approval. If lab results are missing, the provider should submit the most recent labs or note why testing is not available.

Does the patient have a viral load completed in the past 6 months? A copy of lab results must be submitted — only 'Yes' is acceptable for approval.
Has the patient had a CD4 count completed in the past 6 months? A copy of lab results must be submitted — only 'Yes' is acceptable for approval.

Denial Risk

Incomplete Form May Be Returned

An incomplete PA form may be returned and will delay or prevent approval. Ensure all required fields and supporting documentation are included before faxing.

Fax completed form and supporting documents to 1-866-940-7328.
Providers must retain copies of all documentation for five years.

Indication and Testing Definitions

Approved indication

IndicationTreatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

Combination therapyFuzeon is indicated for use in combination with other antiretroviral agents.

Patient populationSpecifically for treatment-experienced patients (those with prior antiretroviral therapy).

Background on Fuzeon (enfuvirtide)

Fuzeon (enfuvirtide) is used in combination with other antiretroviral agents for treatment-experienced HIV-1 infected patients with ongoing viral replication despite therapy. Initiation requires documentation of prior antiretroviral therapy and compliance, submission of recent viral load and CD4 labs, and genotype/phenotype results when appropriate. Continuation of therapy requires verification of compliance with other HIV medications and submission of recent laboratory results; when Fuzeon is effective, CD4 counts are expected to be improved and viral antigen levels undetectable. Approvals are managed via the PA form and accompanying documentation.