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June 15, 2019 – Treatment Action Group (TAG) strongly supports the final “A” ratings issued on June 11, 2019 by the U.S. Preventive Services Task Force (USPSTF) regarding pre-exposure prophylaxis (PrEP) for individuals highly vulnerable to infection and HIV screening for all Americans between the ages of 15 and 65, including pregnant women. The new rating is a vital boost to efforts to implement PrEP in the U.S. where, as noted by the USPSTF, fewer than 80,000 individuals used the intervention in 2016,i while the U.S. Centers for Disease Control and Prevention (CDC) has estimated that 1.2 million Americans could benefit from PrEP.ii The final recommendation on screening provides crucial support for HIV testing, as an estimated 15% of Americans living with HIV are unaware of their status.iii These ratings send a strong signal to health care providers and policymakers about the importance of  unfettered access to HIV screening and PrEP.

These ratings will require private insurers to provide coverage for PrEP without cost sharing to at-risk individuals, and to continue to do the same for HIV testing. Yet advocates will still need to engage on multiple fronts to ensure access. We need to advocate against the use of stringent prior authorization or risk assessment strategies by insurers that limit access to PrEP. At the same time, the high cost of Truvada (TDF/FTC) continues to strongly disincentivize coverage by insurers. Advocates should continue to press the Department of Health and Human Services to use its leverage over Gilead Sciences to dramatically reduce the cost of both Truvada and Descovy (TAF/FTC), which is anticipated to be approved as a second oral PrEP regimen this year (see TAG’s recent testimony on PrEP pricing to the House Oversight and Reform Committee here). Advocates will need to work with the Center for Consumer Information and Insurance Oversight, as well as their state-level insurance regulators, to issue specific guidance on the new PrEP rating, to dissuade insurers from imposing arbitrary barriers to access.

We are pleased that within its PrEP recommendation, the USPSTF has followed the lead of the World Health Organization (WHO) in recognizing that TDF alone may have substantial benefit in averting HIV infection, when Truvada is not easily accessible.iv Generic TDF and Mylan’s Cimduo (TDF/3TC) are now available in the U.S. The price of Truvada ($1,600 per month)v is substantial, and Gilead’s current monopoly on biomedical primary prevention places a huge burden on the U.S. health care system. Generic competition and cost reduction can play an important role in scaling up PrEP for low-income and uninsured populations, particularly in the southern U.S. and non-Medicaid expansion states.

We welcome the USPSTF final recommendations on PrEP and HIV testing, and are hopeful that these recommendations will quickly translate into increased screening, coverage, access, and uptake for insured individuals. Again, with Truvada continuing to be sold at luxury prices, advocates and stakeholders must monitor and ensure that coverage entities consequently do not institute access barriers. We must continue to fight for universal and affordable access PrEP and HIV prevention for everyone in the U.S., using every advocacy strategy and tool at our disposal.

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About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG works to ensure that all people with HIV, TB, or HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end HIV, TB, and HCV.

i Huang YA, Zhu W, Smith DK, et al. HIV Preexposure prophylaxis, by race and ethnicity – United States, 2014-2016. MMWR Morb Mortal Wkly Rep. 2018;67(41):1147-50.

iiSmith DK, Van Handel M, Wolitski RJ, et al. Vital signs: estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition—United States, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291-5.

iiiDailey AF, Hoots BE, Hall HI, et al. Vital signs: human immunodeficiency virus testing and diagnosis delays – United States. MMWR Morb Mortal Wkly Rep. 2017;66(47):1300-6.

ivWorld Health Organization. WHO Expands Recommendation on Oral Pre-Exposure Prophylaxis of HIV Infection (PrEP). Geneva. November 2015.;jsessionid=91101BFBA3CD2B361854331F50B85EEE?sequence=1

vCenters for Medicare & Medicaid Services. National Drug Acquisition Cost: NADAC as of 2018-05-09. Baltimore, MD.

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