New PrEP Recommendation Likely to Broaden Access to HIV-Protection Drug

Starting in 2021, many insurance plans will be required to offer PrEP, plus all necessary lab work and clinic visits, without deductibles or co-pays.

[Photo: Close-up of Truvada bottles and pills.]
According to the CDC, only a small fraction of the 1.2 million people eligible to take PrEP are doing so. Justin Sullivan / Getty Images

For the first time, an expert panel is recommending doctors offer pre-exposure prophylaxis, a daily medication known as PrEP, to all patients at high risk of HIV infection.

Although PrEP, sold in the United States under the brand name Truvada, has already been endorsed by the Centers for Disease Control and Prevention (CDC) and other medical groups, its new “Grade A” ranking by the U.S. Preventative Services Task Force (USPSTF) is expected to broaden insurance coverage and expand access to the drug.

The USPSTF is not part of the federal government—it’s an independent volunteer group comprising 16 physicians—but its guidelines carry considerable clout among public and private insurance programs.

While the task force’s recommendation is expected to improve insurance coverage of PrEP, doctors and HIV-prevention advocates caution that it may not make a difference for patients without insurance or with inadequate insurance, potentially deepening health disparities that already exist.

PrEP is a key pillar of President Donald Trump’s plan to end the HIV epidemic in the United States by 2030. It’s a daily HIV antiretroviral that can prevent infection when taken by people who are HIV-negative. The CDC has recommended the medication for approximately 1.2 million people in the United States with a substantial risk of contracting HIV, which disproportionately affects gay and bisexual men, African Americans and Latinos, and people living in the Southern states.

Unlike with other viral infections such as polio, hepatitis B, or measles, there is no long-acting vaccination against HIV. For public health officials hoping to inoculate people against HIV, the daily pill is the next-best thing.

“Until we have a vaccination for HIV, PrEP is the only safe and effective way a person can protect themselves from HIV,” said Dr. David Hardy chair of the board of directors of the HIV Medicines Association (HIVMA).

“We really have the tools in place now for ending the epidemic,” said Dr. Rupa Patel, an HIV specialist at Washington University in St. Louis. “In the face of underutilization, [the USPSTF recommendation] is very timely for us, and adds more momentum to the president’s” call to end the HIV epidemic.

However, Patel cautions that PrEP is expensive—as much as $2,000 per month—which has led to spotty insurance coverage and poor usage rates among the people who need it most.

Starting January 2021, most insurance plans will be required to cover the pill, plus all necessary lab work and clinic visits, without deductibles or co-pays, according to NASTAD (the National Alliance of State and Territorial AIDS Directors).

In 2010, the Affordable Care Act (ACA) officially enshrined USPSTF’s impact on insurance providers: Most private insurance plans, as well as states that expanded Medicaid as part of the ACA, are required to cover the full cost of any preventive service given an A or B rating by the task force.

“Because high cost sharing has been a barrier to PrEP, the recommendation’s mandate that most private insurance plans cover PrEP without deductibles or copays means that far more individuals will have affordable access to PrEP through commercial insurance,” NASTAD Acting Executive Director Terrance Moore said in a statement. “Given the disparities in PrEP access, particularly among young, gay Black and Latino men and transgender women, we are hopeful that this recommendation will spur additional action and commitment to increasing access to PrEP for these populations.”

USPSTF’s endorsement “will definitely make a difference” for people with private insurance, said Dr. Latesha Elopre, an infectious disease specialist at the University of Alabama at Birmingham. But because people without insurance still won’t have access, the gap between the insured and uninsured may become more pronounced.

“For those who are in non-Medicaid expansion states, you may see exacerbations, or worsening [of HIV outcomes], between the two groups,” she said.

Since the onset of the HIV epidemic in the United States, the epicenter of infection has shifted from big cities like Los Angeles and New York to rural counties and the Southern states. Unfortunately, said Hardy, states that chose not to broaden Medicaid coverage as part of ACA overlap with the current epicenters of HIV infection.

Across the United States, PrEP has been slow to catch on. According to the CDC, only a small fraction of the 1.2 million people eligible to take it are doing so. But even among the small number of people taking the HIV-protection pill, access is unevenly distributed, with Black and Latino Americans accounting for the smallest portion of PrEP prescriptions.

“There’s a huge disconnect about who needs PrEP in the community and who is getting it,” said Sable Nelson, associate policy and advocacy manager at NMAC, a group that advocates for HIV health equity in communities of color. “White, gay and bisexual men are the ones that receive it the most, and Black/Latinx gay and bisexual men receive it the least—even though they are disproportionately impacted by HIV.”

For Patel, the USPSTF’s endorsement is important but does not address the real barrier to PrEP use: drug costs. Doctors and activists are quick to point out that while PrEP is priced at $1,780 per month in the United States, generic versions can be had for as little as $8 per month in countries like Australia.

“We want to make sure we’re telling policymakers that still, the medication is expensive,” Patel said. “You need to hit the root cause of why this is not accessible.”

The USPSTF’s recommendation, Nelson said, “is definitely a step in the right direction, but it’s just one of the things that needs to happen.” The stigma around taking PrEP also needs to be addressed, she said.

Even though PrEP has been available since 2012, not enough patients are aware there’s a pill that can protect them from HIV infection, Nelson said.

“We need to get the conversation into the pockets of the communities where it’s most needed.”