UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Medication Date Approved Date Revised
Notification - Standard Truvada® (emtricitabine/tenofovir disoproxil fumarate) 11/2012 04/2013
1. Background: Truvada® (emtricitabine/tenofovir disoproxil fumarate) is a combination of Emtriva® (emtricitabine) and Viread® (tenofovir disoproxil fumarate), both nucleoside analog HIV-1 reverse transcriptase inhibitors. Truvada is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. Prior to initiating Truvada for PrEP: if clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. While using Truvada for PrEP -HIV-1 screening tests should be repeated at least every 3 months. The use of Truvada as a 2-drug post exposure antiretroviral regimen for the prevention of HIV infection after either an occupational or non-occupational exposure to the HIV virus is supported by guidelines from both the Centers for Disease Control and the World Health Organization2,3. Members who are on combination therapy with another antiretroviral medication for the treatment of HIV infection as documented in the claims history will be allowed to continue to receive coverage for their current therapy. Members who are on Truvada as monotherapy will be required to meet the coverage criteria below. 2.
Coverage Criteria:
A. HIV Infection 1. Truvada will be approved based on the following criterion: a. Patient has a confirmed diagnosis of HIV infection Authorization will be issued for 60 months. B.
Post exposure prophylaxis (PEP) to reduce the risk of HIV infection from either an occupational or non-occupational known or suspected possible exposure to the HIV virus 1.
Truvada will be approved based on both of the following criteria: Confidential and Proprietary, © 2013 United HealthCare Services, Inc. 1
a.
Patient experienced a known or suspected possible exposure to the HIV virus -AND-
b. One of the following: (1) therapy was initiated within 72 hours of exposure (2) therapy will be initiated within 72 hours of exposure Authorization will be issued for 1 month C. Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk 1. Initial Therapy a. Truvada will be approved based on all of the following criteria: (1) Patient has been determined to be at high risk for HIV-1 infection -AND(2) Patient has received counseling on safe sex practices and HIV infection risk reduction. -AND(3) Patient has no clinical symptoms consistent with acute viral infection -AND(4) No recent (< 1 month) HIV exposures are suspected -AND(5) Patient has a confirmed negative HIV-1 status within the past week Authorization will be issued for 6 months. 2. Reauthorization a. Truvada will be approved based on the following criteria: (1) Patient has been determined to be at high risk for HIV-1 infection despite Confidential and Proprietary, Š 2013 United HealthCare Services, Inc. 2
prior counseling on safe sex practices and HIV infection risk reduction. -AND(2) Patient continues to receive counseling on safe sex practices and HIV infection risk reduction. -AND(3) Patient has no clinical symptoms consistent with acute viral infection -AND(4) No recent (< 1 month) HIV exposures are suspected -AND(5) Patient has a confirmed negative HIV-1 status within the past 3 months. Authorization will be issued for 6 months.
3.
Additional Clinical Rules: None
4.
References: 1. TruvadaÂŽ [Package Insert]. Foster City, CA: Gilead Sciences, Inc; July 2012. 2. Centers for Disease Control and Prevention. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for Postexposure Prophylaxis. MMWR 2005;54(No. RR-9): [inclusive page numbers]. 3. Post-exposure prophylaxis to prevent HIV infection: joint WHO/ILO guidelines on post-exposure prophylaxis (PEP) to prevent HIV infection. Accessed February 26, 2013 from http://www.who.int/hiv/pub/guidelines/PEP/en/
Confidential and Proprietary, Š 2013 United HealthCare Services, Inc. 3