MEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 03/07/18 SECTION: DRUGS LAST REVIEW DATE: 02/19/19 LAST CRITERIA REVISION DATE: ARCHIVE DATE:

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1 FUZEON (enfuvirtide) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O959.4.docx Page 1 of 7

2 Description: Fuzeon is an HIV-1 fusion inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment experienced individuals with HIV-1 replication despite ongoing antiretroviral therapy. Definitions: Adult: Age 18 years and older Criteria: See Resources section for FDA-approved dosage. Fuzeon for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment experienced individuals with HIV-1 replication despite ongoing antiretroviral therapy is considered medically necessary with documentation of ALL of the following: 1. Individual is 6 years of age or older 2. Documentation of viral resistance to one agent in each of the following classes (as single agent products or combination products): Non-nucleoside reverse transcriptase inhibitor (NNRTI) [See Resources section] Nucleoside reverse transcriptase inhibitor (NRTI) [See Resources section] Protease inhibitor (PI) [See Resources section] 3. Individual has failed 1 at least 3 months of therapy with antiretroviral therapy regimen consisting of three or more antiretroviral agents 4. Will not be used as monotherapy 5. Absence of hypersensitivity to Fuzeon or any of its components Continuation of Fuzeon is considered medically necessary with documentation of ALL of the following: Achieved and maintains reduced viral load or it is now undetectable CD4 counts have improved O959.4.docx Page 2 of 7

3 Criteria: (cont.) Fuzeon for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Treatment with dosing or frequency outside the FDA-approved dosing and frequency 1 Failure is defined as a confirmed HIV ribonucleic acid (RNA) level of greater than 50 copies/ml while on therapy or intolerance due to drug toxicity O959.4.docx Page 3 of 7

4 Resources: Literature reviewed 03/07/18. We do not include marketing materials, poster boards and nonpublished literature in our review. Fuzeon Package Insert: - FDA-approved indication and dosage: Indication In combination with other antiretroviral agents is indicated for the treatment of HIV- 1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Nursing mothers should not breast-feed infants or children while receiving FUZEON therapy. Recommended Dose Adult: The recommended dose of Fuzeon is 90 mg (1 ml) twice daily injected subcutaneously. Pediatric: In patients 6 years through 16 years of age, the recommended dosage of Fuzeon is 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously. Insufficient data are available to establish a dose recommendation of Fuzeon in patients below the age of 6 years. Table 1 contains dosing guidelines for Fuzeon based on body weight. Weight should be monitored periodically and the Fuzeon dose adjusted accordingly. Table 1: Pediatric Dosing Guidelines for individuals 6 years through 16 years of age. There is insufficient data for the manufacturer to establish dose recommendations for individuals below the age of 6 years. Kilograms (kg) Weight Pounds (lbs) Dose per bid Injection (mg/dose) Injection Volume (90 mg enfuvirtide per ml) 11.0 to to ml 15.6 to 20.0 >34 to ml 20.1 to 24.5 >44 to ml 24.6 to 29.0 >54 to ml 29.1 to 33.5 >64 to ml 33.6 to 38.0 >74 to ml 38.1 to 42.5 >84 to ml > 42.6 > ml O959.4.docx Page 4 of 7

5 Resources: (cont.) Initial Approval Duration: 12 months Renewal Approval Duration: 12 months NNRTI: non-nucleoside reverse transcriptase inhibitors Rescriptor (delavidine, DLV) Sustiva (efavirenz, EFV) Intelence (etravirine, ETR) Edurant (rilpivirine, RPV) Viramune Viramune XR (nevirapine, NVP) NRTI: nucleoside reverse transcriptase inhibitors Ziagen (abacavir, ABC) Epzicom (abacavir + lamivudine) Trizivir (abacavir + lamivudine + zidovudine) Videx (didanosine [ddi]) Emtriva (emtricitabine, FTC) Epivir (lamivudine, 3TC) Combivir (lamivudine+zidovudine) Zerit (stavudine, d4t) Hivid (zalcitabine, ddc) Retrovir (zidovudine, AZT or ZDV) Protease inhibitors Reyataz (atazanavir, ATV) Prezista (darunavir, DRV) Lexiva (fosamprenavir, f-apv) Crixivan (indinavir) Viracept (nelfinavir, NFV) Norvir (ritonavir, RTV) Invirase (saquinavir, SQV) Aptivus (tipranavir, TPV) O959.4.docx Page 5 of 7

6 Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) for Spanish and (877) for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O959.4.docx Page 6 of 7

7 Multi-Language Interpreter Services: (cont.) O959.4.docx Page 7 of 7

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