Financing and Delivery Mechanisms to Increase Pre-Exposure Prophylaxis (PrEP) Access in Populations at High-Risk of HIV Infection

Published: June 1, 2011

Table of Contents
Executive Summary…………………………………………………………………………………………………………………………… 4
Introduction: The Problem ………………………………………………………………………………………………………………. 6
Policy Context of HIV Prevention and PrEP …………………………………………………………………………………… 9
The United States has significant HIV prevention needs …………………………………………………………… 9
PrEP has the potential to improve HIV prevention in the United States ……………………………….12
Definition of pre-exposure prophylaxis (PrEP) ………………………………………………………………………….13
PrEP requires biomedical and behavioral interventions to be effective ………………………………..14
Drug adherence remains a concern for PrEP implementation ………………………………………………… 15
The CDC provides interim guidance on PrEP for MSM ……………………………………………………………….. 16
Health reform presents opportunities and challenges for PrEP coverage …………………………….16
Cost-Effectiveness of PrEP as HIV Prevention ……………………………………………………………………………..19
PrEP Cost Effectiveness in the United States: Targeting the Most High-Risk ………………………… 19
PrEP Cost-Effectiveness outside the United States: A Complement to ARV Treatment ………. 22
Recommendations ……………………………………………………………………………………………………………………………23
Support Gilead’s request for FDA approval of a prevention label for Truvada …………………….23
Encourage the NIH and CDC to finance demonstration projects ……………………………………………24
Ensure public insurance coverage for PrEP through state Medicaid programs …………………..24
Ensure private insurance coverage for PrEP …………………………………………………………………………….25
Advocate that Gilead develop a Patient Assistance Program for PrEP ………………………………….26
Encourage non-Truvada PrEP formulations to promote price breaks for ARVs ………………….27
Promote PrEP in tandem with other combination approaches to HIV prevention ……………… 27
Conclusion………………………………………………………………………………………………………………………………………….28
Appendix ……………………………………………………………………………………………………………………………………………29
References …………………………………………………………………………………………………………………………………………30

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