Why 'the most effective tool for ending the HIV epidemic' is out of reach for some patients

Rising prices for drugs intended to help prevent HIV infection in at-risk individuals as well as insurance changes that have shifted more costs onto patients, are inhibiting public health officials' efforts to increase use of the drugs, Shefali Luthra and Anna Gorman report for Kaiser Health News.

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PrEP's rising prices

CDC says research has shown that pre-exposure prophylaxis (PrEP) is more than 90% effective at preventing HIV infection when the medication is take daily.

According to KHN, the wholesale price for Truvada, a brand-name PrEP drug, has increased by about 45% since FDA approved the drug six years ago. Truvada's list price now is nearly $2,000 for a 30-day supply, and the drug generates billions of dollars in annual revenue for Gilead Sciences, which manufactures Truvada, KHN reports.

Truvada is the only form of PrEP available in the U.S. market. FDA last year approved a generic version of Truvada, manufactured by Teva Pharmaceuticals, but it is not yet available in the United States.

Insurance changes shift more costs onto patients

According to KHN, most health insurers cover PrEP. However, recent changes in the insurance market—such as the move toward high-deductible health plans and insurers restricting the use of copayment coupons provided by drugmakers—has shifted more costs onto patients, making PrEP unaffordable for some.

James Krellenstein, a member of the AIDS advocacy group ACT UP New York, said, "If there is any example of the dysfunction in the American pharmaceutical system, it is this case. We have the most effective tool for ending the HIV epidemic, and one reason we're unable to scale up is because it costs so [much] unnecessarily."

Public health groups also have said PrEP's cost is impeding their ability to help at-risk individuals access the drug. Joey Mattingly, an assistant professor at the University of Maryland School of Pharmacy, said if PrEP cost "only pennies … we would be throwing it around," but "[b]ecause of how costly it is, we have to control it."

Gilead, states, and advocates look to increase use of PrEP

For its part, Gilead spokesperson Ryan McKeel said the company has implemented efforts to help patients mitigate financial barriers to using Truvada. Gilead provides patients with coupons that waive up to $4,800 in out-of-pocket costs for individuals with commercial health insurance, KHN reports. McKeel said Gilead has "designed [its] assistance programs with the intent that people can benefit from their full value, and [the company] cannot control the actions or decisions of health insurers."

Gilead estimates that about 167,000 people are using PrEP. However, CDC has estimated more than one million people are at high risk of becoming infected with HIV and should be using the drug.

According to KHN, a lack of awareness about PrEP among at-risk individuals, as well as some health care providers' hesitation to prescribe the drug, worsen disparities in HIV infection rates and PrEP use. Kristin Keglovitz Baker, chief operating officer of Howard Brown Health, said, "We are not necessarily seeing that those most at risk are the ones starting PrEP."

In an effort to increase awareness about PrEP, Gilead has launched an advertising campaign featuring television and print ads that will run throughout the summer. McKeel said Gilead since 2012 has spent $28 million to support U.S. groups that look to raise awareness about HIV. "We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates, and physicians to better understand and, where possible, help to address these challenges," he said.

In addition, some states, including California and Florida, have created programs intended to help at-risk individuals cover the costs of PrEP, as well as laboratory tests and medical visits associated with obtaining the medication. But the rising costs of PrEP could strain state Medicaid programs, as outreach programs increase use of the drug. According to KHN, California's Medicaid program spent $50 million on PrEP in 2017 and expects those costs to continue rising. Likewise, Massachusetts' Medicaid program spent about $22 million on Truvada in 2017, though that cost does not account for rebates the state received from Gilead.

Elsewhere, some public health departments and patient assistance groups are employing PrEP navigators to help at-risk individuals access the medication. For instance, Michael Kharfen—senior deputy director at the Washington, D.C., health department's HIV/AIDS, Hepatitis, STD, and TB Administration—said the department is giving at-risk individuals no-cost Truvada starter packs in instances when insurance and patient assistance programs cannot cover the costs. According to Kharfen, the District over the past three years has spent nearly $1 million on Truvada, which it gets at a discounted rate under Medicare's 340B drug discount program. However, Kharfen has questioned whether the program will be sustainable, noting that he expects demand for the program to grow (Luthra/Gorman, "Shots," Kaiser Health News/NPR, 6/30; Melendez, ABC 7 News, 7/3).

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