One promising new HIV prevention strategy is the use of ARVs as pre-exposure prophylaxis (PrEP) among high-risk men who have sex with men (MSM). Several clinical and cost-effectiveness studies demonstrate that PrEP has the potential to reduce HIV infection rates for high-risk MSM in a cost-effective way. However, policymakers continue to face questions regarding how to improve drug adherence, offer services to the most high-risk individuals including African-American and Latino MSM and transgender women, and ensure that adequate financing mechanisms are in place to pay for the many biomedical and behavioral components of PrEP.
Policymakers seeking to increase PrEP access must further contend with the current political reality of constrained financial resources for public health assistance, including for state Medicaid programs and for HIV prevention programs that serve individuals at high-risk of HIV infection. Strategic opportunities for financing and delivery still exist, but numerous public and private sources will need to be mobilized for PrEP to reduce HIV infections in significant numbers.
Key financing and delivery opportunities include Gilead’s application for FDA approval of a prevention label for Truvada; National Institutes of Health (NIH) and Centers for Disease Control (CDC) funding for demonstration projects in San Francisco, Boston, and other U.S. cities; private and public health insurance coverage for PrEP; a Gilead-funded Patient Financing and Delivery Mechanisms to Increase PrEP Access 5 Assistance Program to help low-income patients pay for PrEP; and opening the PrEP drug market to non-Truvada PrEP formulations. Given that new clinical and cost evidence for PrEP is expected to arrive from a variety of studies and projects in the coming years, policymakers will need to adapt their implementation of PrEP accordingly.
The recommendations in this report are designed to help HIV policymakers and advocates like Project Inform improve PrEP access in a manner that is clinically effective, cost-appropriate, and politically feasible in line with existing research and evidence.
Consequently, this report recommends the following:
1.) Support Gilead’s request for FDA approval of a prevention label for Truvada
2.) Encourage the NIH and CDC to finance demonstration projects
3.) Ensure public insurance coverage for PrEP through state Medicaid programs
4.) Ensure private insurance coverage for PrEP
5.) Advocate that Gilead develop a Patient Assistance Program (PAP) for PrEP
6.) Encourage non-Truvada PrEP formulations and promote price breaks for Truvada
7.) Promote PrEP in tandem with other combination approaches to HIV prevention