GUIDELINES FOR THE USE OF ENFUVIRTIDE (FUZEON) ARIZONA AIDS DRUG ASSISTANCE PROGRAM Adopted June 18, 2003
Enfuvirtide (ENF, Fuzeon) is the first FDA-approved member of the fusion inhibitor class of antiretroviral drugs. The use of this agent in the management of HIV infection will present some unique challenges to patients, health professionals and the heath-care system. The current clinical scientific knowledge of this drug is based on unpublished data from 2 similar controlled trials (TORO-1 [NEJM 203; 348:2175-85] and TORO-2 [NEJM 2003; 348:2186-95]). Since this is the first injectable antiretroviral agent, patients must be eligible to receive syringes and needles as well as be willing and able to reconstitute and inject the drug. Finally, because of the high cost of ENF itself, and the costs of the entire ENF-containing regimen, the use of this drug may strain the limited financial resources of the AIDS Drug Assistance Program (ADAP). Because of these issues, the Arizona ADAP needs to assure that ENF is prescribed for patients most likely to benefit from such therapy, and that the use of ENF does not financially compromise the ability of ADAP to provide medications to all eligible clients.
It is recognized that, based on current scientific knowledge and experience with ENF, that the use of this agent will evolve as more data are made available and as clinicians gain experience. Arizona ADAP understands that the clinical judgment of physicians experienced in the care of patients with HIV/AIDS may wish to prescribe ENF for patients who do not meet these guidelines. The provision of ENF in such patients will be considered on a case-by-case basis as long as there is adequate funding to consider such requests.
1. General indications for ENF a. Previous therapy with at least 1 NRTI, 1 NNRTI and 1 PI, with at least 3 months duration of therapy with each class OR b. History of moderate to severe adverse events/intolerance to at least 1 NRTI, NNRTI and PI OR c. Documented viral resistance to at least one member each of the NRTI, NNRTI and PI class of antiretrovirals AND d. HIV RNA (viral load) >5000 after at least 3 months of combination antiretroviral therapy with evidence of adequate patient adherence. e. Patient is not currently an injection drug user and has not used injection drugs for at least 6 months; patient is not actively abusing alcohol or other substances. f. Patient current CD4 count (>100) is a predictor of virologic response to ENF-containing regimens. Therefore, patients who fit the above criteria and have a current CD4 count >100 and <350 generally should receive preference for ENF given the limited financial resources.
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g. Prescriber should be well-experienced in the care of patients with HIV/AIDS (or be consulting with HIV/AIDS specialist) and have sufficient office/clinic capability to provide patient education and monitoring. 2. Patient and/or Caregiver willingness, ability a. Patient must be willing to administer or have administered ENF by subcutaneous injection twice daily; such willingness must be expressed after the injection site reactions associated with ENF are described by the physician or designee. b. If patient is not willing or able to self-inject but is willing to have injections given by caregiver(s), caregiver(s) must be willing to administer such injections twice daily. c. Patient and/or caregiver(s) must be able to be educated on the reconstitution and administration of ENF and the safe disposal of injection equipment, and be able to demonstrate adequate competency for these procedures. d. Patient must have prior evidence of adherence to therapy and other medical care; physician should have reasonable expectation that adherent behavior will continue after the initiation of ENF therapy. e. Patient’s home should have sufficient heating and cooling to allow ENF storage at proper temperatures (59-86F). 3. Viral resistance testing a. The patient must have recent in vitro (phenotypic or genotypic) viral resistance testing performed (preferably within past 1-2 months) on current antiretroviral regimen prior to prescribing ENF. Such testing is required to choose the “optimized background” regimen of antiretroviral agents to be given with ENF. 4. Optimized background regimen a. Based on in vitro resistance testing, ENF must be administered with at least 2 other active antiretroviral agents in order to maximize the virologic response. Antiretroviral agents that demonstrate in vitro resistance should be discontinued. It should be noted that the TORO trials demonstrated no virologic advantage to administering more than 2 active drugs with ENF vs. 2 active drugs. If there are no currently available (FDA-approved or investigational) active agents for the patient based on in vitro resistance testing, ENF generally should not be prescribed. 5. Virologic response a. Patients should have repeat viral load and CD4 count performed at 12 and 24 weeks after the initiation of the ENF-containing regimen. If the viral load has not decreased by >0.5log by 24 weeks, therapy must be reassessed in the face of virologic failure. Subsequent monitoring should be performed every 12 weeks.
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6. Provision of data to ADAP a. The prescribing physician must provide to ADAP the requested patient information and data (viral load, CD4 count, results of resistance testing, proposed ENF-containing regimen) in order for the patient to receive ENF. Transmission of such data must be done in a fashion to comply with current HIPAA regulations.
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Arizona AIDS Drug Assistance Program (ADAP) Application Process for Patient Access to Fuzeon
The information below outlines the process that clinicians should follow if they have an HIV+ patient that is enrolled in ADAP and that they believe is appropriate and prepared to receive Fuzeon:
1. After reviewing ADAP’s “Guidelines for the Use of Enfuvirtide (Fuzeon)”, the clinician must complete and submit to ADAP the program’s “Arizona AIDS Drug Assistance Program Enfuvirtide (ENF, Fuzeon) Application” form. This form must be completed in its entirety and according to instructions, and the following information/documents must be submitted to ADAP along with the application form: • A copy of the most recent viral load lab report; • A copy of the most recent CD4 lab report; • A copy of the most recent HIV resistance testing lab report; and, • A prescription for the Fuzeon, which will be forwarded to Avella Specialty Pharmacy, if application is approved.
INCOMPLETE APPLICATONS WILL BE RETURNED BY ADAP TO THE SUBMITTING CLINICIAN FOR COMPLETION
2. The clinician’s signature on the ADAP application confirms that the information submitted is accurate and that they understand that Avella Specialty Pharmacy will ship the patient’s supply of Fuzeon to their (the clinician’s) office. The patient has the option of the supply of Fuzeon being mailed directly to their home after the first month, if the clinician feels that is appropriate. Patients should be told not to reuse needles or syringes, and be instructed in safe disposal procedures including the use of the sharps container for disposal of used needles and syringes. Patients must be instructed on the safe disposal of full containers as per local requirements. ADAP highly encourages that patients be instructed to return full sharps containers to the clinician/clinic for proper disposal. 3. The clinician also agrees to monitor the patient’s use of Fuzeon, as well as the other drugs that comprise the medication regimen, on a regular basis. The clinician will assure that the patient understands and can manage the proper administration of this medication, and that the patient understands the importance of and is committed to adhering to their medications in order to optimally benefit from the new regimen. 4. Once the completed application and required attachments are received, ADAP will review the application, and a letter approving or denying the patient’s receipt of Fuzeon under ADAP will be sent to the requesting clinician and patient from ADAP, and the Fuzeon prescription forwarded to Avella Specialty Pharmacy. If you have any questions about the process of applying for a patient or about the
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medical appropriateness/eligibility criteria, please contact ADAP at (602) 364- 3610 or (800) 334-1540 (in-state only).
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ARIZONA AIDS DRUG ASSISTANCE PROGRAM ENFUVIRTIDE (ENF, FUZEON) APPLICATION
Client Name Date of Application
General Indications
Previous therapy with at least 1 NRTI, 1 NNRTI and 1 PI, with at least 3 months duration of therapy with each class? Yes No
Please list prior antiretroviral agents.
History of moderate to severe adverse events/intolerance to at least 1 NRTI, NNRTI and PI? Yes No
Documented viral resistance to at least one member each of the NRTI, NNRTI and PI class of antiretrovirals? Yes No
HIV RNA (viral load) >5000 after at least 3 months of combination antiretroviral therapy with evidence of adequate patient adherence? Yes No
*Most recent viral load Date obtained
*Most recent CD4 count Date obtained
*Please attach or fax most recent viral load and CD4 count lab reports.
Patient is not currently an injection drug user and has not used injection drugs for at least 6 months; patient is not actively abusing alcohol or other substances.
Prescriber is well-experienced in the care of patients with HIV/AIDS (or be consulting with HIV/AIDS specialist) and has sufficient office/clinic capability to provide patient education and monitoring.
Patient/Caregiver
Patient or caregiver is willing to administer or have administered ENF by subcutaneous injection twice daily; such willingness is confirmed after the injection site reactions associated with ENF are described by the prescriber or designee.
Patient has prior evidence of adherence to therapy and other medical care; prescriber has reasonable expectation that adherent behavior will continue after the initiation of ENF therapy.
Patient’s home has sufficient heating and cooling to allow ENF storage at proper temperatures (59- 86F).
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HIV Resistance Testing (Please attach or send copy of most recent lab report)
Date of most recent resistance test Genotypic Phenotypic
Virus susceptible to
Virus resistant to
Proposed ENF-containing antiretroviral regimen
Patient will have repeat HIV RNA and CD4 counts performed 12 and 24 weeks after initiation of ENF-containing regimen to assess effectiveness.
If this patient does not meet current ADAP guidelines for ENF use, please provide information regarding the medical necessity and justification for use.
Physician Signature
Please submit this form to the ADAP office by mail or fax (602-364-3263). If submitting electronically, please save the file as a unique, identifiable file name. If you have any questions, please call (602) 364-3610 or (800) 334-1540 (in-state only)
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