Prior Auth Protocol

FDA Approved Indications:

In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

Health Net Approved Indications and Usage Guidelines:

AND

Failure of > 2 antiretroviral drug classes as evidenced by genotype and phenotype

OR

Clinically significant adverse effects necessitating Fuzeon (enfuvirtide, T-20) as an option to complete a viable highly active antiretroviral therapy (HAART) regimen which includes a nucleoside analog reverse transcriptase inhibitor (NRTI), and non-nucleoside analog reverse transcriptase inhibitor(NNRTI), and/or protease inhibitor-(PI)

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Per the Department of Health and Human Services (DHHS) Antiretroviral Guidelines:
- Evaluation of virologic failure should include as assessment of adherence, drug-drug or drug-food interactions, drug tolerability, HIV RNA and CD4 T lymphocyte (CD4) cell count trends over time, treatment history, and prior and current drug-resistance testing results.
- Virologic failure is defined as: The inability to achieve or maintain suppression of viral replication (to an HIV RNA level <200 copies/mL).
- Virologic suppression is defined as: A confirmed HIV RNA level below the limit of assay detection (e.g., <48 copies/mL).
- There is no consensus regarding how to manage patients with HIV RNA levels >48 copies/mL and <200 copies/mL. The risk of emerging resistance is believed to be relatively low. HIV RNA levels should be monitored at least every 3 months to assess the need for changes in antiretroviral therapy in the future.
American Hospital Formulary Service (AHFS) classifies Fuzeon as recommended as an alternative agent for use in conjunction with other antiretroviral agents for postexposure prophylaxis of HIV infection in health-care workers and other individuals exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with a risk for transmission of the virus.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Fuzeon	Patients 6 to 16 years old: 2 mg/kg BID up to a maximum of 90 mg SC BID Adult: 90 mg SC BID	Initial authorization for 6 months, continue therapy for length of benefit (For AHCS requests: One Year) with one of the following: 1. Minimum 0.5 log decrease in viral load from baseline 2. Minimum increase of 25% in CD4+ count

Product Availability:

Single Use Vial: 108 mg (90 mg/1 ml)

References:

1. Fuzeon [Prescribing information] South San Francisco, CA: Genentech USA, Inc;October 2013.

2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. May 1, 2014; 1-284. Available at https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/15/virologic-failure-and-suboptimal-immunologic-response. Accessed June 2, 2015.

3. Clinical Pharmacology Web site. Available at http://www.clinicalpharmacology-ip.com. Accessed June2, 2015.

4. Micromedex Healthcare Series [Internet Database]. Greenwood, Colo: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed June 2, 2015.

5. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June2,2015.