Insurers and Medicaid Cover It. So What's Behind the Slow Adoption of Truvada PrEP?

It has been almost two years since the U.S. Food and Drug Administration (FDA) approved the use of Truvada as the first medication for HIV prevention, or PrEP  (pre-exposure prophylaxis) treatment, and one thing is clear to those who advocate for its use: most private insurance companies, and all state Medicaid programs, will cover it.

David Evans, the director of research advocacy at Project Inform, told Healthline, “We are unaware of any private health insurance carrier who is not covering PEP (post-exposure prophylaxis) or PrEP. Some have prior authorization restrictions, but these hurdles can typically be gotten over. All Medicaids are obligated to cover both PEP and PrEP, though some have prior authorization restrictions—usually just confirmation of a negative HIV diagnosis.”

Both PrEP and PEP involve the use of antiretroviral medications by people who do not already have HIV. PEP has been shown to prevent a person exposed to HIV from becoming positive if it is taken within 72 hours of exposure.

Learn More: The Experts Weigh In on Truvada for PrEP »

Manufactured by Gilead Sciences, Truvada PrEP has proven effective at preventing HIV transmission up to 99 percent of the time when used as directed.

Jim Pickett, the director of prevention advocacy and gay men's health at AIDS Foundation of Chicago, told Healthline that “the devil is in the details” when it comes to private insurance coverage for PrEP. He says that cients who come to him for information about PrEP often find that it is more affordable than they'd expected.

Truvada, a commonly used drug for treating people who already have HIV, costs about $1,300 per month. That’s the wholesale acquisition cost, or the cost that large providers pay, that is set by the federal government.

Truvada contains the generic drugs emtricitabine and tenofovir. These are commonly used medications that cost a sliver of the U.S. price in some less developed countries.

Providing Help with Insurance

As of March 2013, less than 1,800 people had filled PrEP prescriptions. Picket said he has heard anecdotally that the number has now surpassed 3,000, but added that he has not seen conclusive data.

The AIDS Foundation of Chicago offers a free service to anyone, regardless of where they live, to help navigate how to pay for PrEP with an individual insurance plan. Gilead, for example, will pay up to $200 per month of a person’s co-payment, regardless of income, Pickett said. Other people may have a high upfront cost because they hit their annual co-pay limit, but will then have to pay very little after that.

While Gilead has given the AIDS Foundation of Chicago grants for training and education, Pickett said the pharmaceutical company is not funding the service to help clients gain access.

He points out that it should be no surprise that public and private insurers are willing to make PrEP available to people at risk for contracting HIV. PrEP is not intended to be taken forever, he said, and it is much cheaper than treating someone who ends up positive and will likely live a long life on costly antiretroviral medications.

“You don’t think they’re doing some great thing out of the goodness of their collective souls, do you?” Pickett said. “If we can keep people negative by paying for PrEP for a while, that’s a much better use of our resources.”

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Despite Unraveling Red Tape, Uptake Is Slow

Meanwhile, red tape that in the past prevented insurers from paying for PrEP has begun to loosen. Organizations dedicated to HIV prevention, particularly those in big cities, have embraced the pill as an effective prevention method and pushed for easier access.

Last month, California’s Medicaid program, known as Medi-Cal, lifted the requirement that doctors complete an authorization request. In a news release, L.A. Gay & Lesbian Center chief of staff Darrel Cummings praised the move. “By making it easier for people at-risk of HIV infection to get access to medicine that has been proven to prevent HIV infection, California has set an important precedent for the rest of the nation. This collaboration between Medi-Cal and community advocates will move California closer to the comprehensive response that is needed to help end the HIV epidemic.”

HIV-prevention advocates argue that the relatively slow uptake of Truvada PrEP can be attributed to a reluctance on the part of doctors to prescribe it. PrEP is for people who do not have HIV, so many go to their primary care provider—not an infectious disease specialist—to request it.

But many doctors who do not provide care to people with HIV have no idea what the pill is, particularly outside of urban centers. Not only are many people at risk for HIV reluctant to talk about sex with their providers, but some providers can’t fathom giving antiretroviral medication to someone not infected with HIV.

“The community at large doesn’t understand that drugs have come a long way,” Pickett said. “Truvada is really, really safe, and well tolerated. There’s still this idea of the HIV drug horror show.”

HIV-prevention specialists in large cities have also reported some stigma associated with people who take PrEP—in the gay community, some people have associated it with promiscuity or expressed fears that it will promote reckless sexual behavior.

Putting PrEP Where It's Needed

Of 50,000 new infections in the U.S. each year, almost two thirds are among men who have sex with men, according to the U.S. Centers for Disease Control and Prevention. The number is trending upward—up 12 percent between 2008 and 2010. Young men and minorities are at even higher risk.

Learn More: Truvada PrEP for Men Who Sleep With Men »

Dr. Jamie Martinez of John H. Stroger Jr. Hospital in Chicago is working with psychologist Sybil Hosek in an effort to reach that population. Hosek is the principal investigator for nationwide trials studying the use of PrEP among people as young as 15 years old. Project PrEPare, funded by Gilead and the NIH, is conducting trials at 13 sites nationwide. The first phase enrolled 100 men ages 18 to 24. The second phase, involving the younger men, has enrolled 50 so far, mostly in Chicago.

Currently, Truvada PrEP is FDA-approved only for adults ages 18 and older. The dosing in the study is the same for adults. Hosek noted that Truvada is already FDA-approved as a medication for children who have been infected with HIV and has proven safe and effective, but study participants still are being closely monitored.

PrEP is intended to be used alongside other prevention measures, including condoms and safer sex education. The upward trend in infections suggests that additional prevention measures are needed, according to Hosek.

Martinez said early indicators show that the young men believe taking PrEP for HIV prevention is acceptable. He said they have reported fewer sexual partners and more consistent condom use. Condoms remain the only prevention method for many sexually transmitted diseases.

“They are interested in telling the nation that PrEP is an important strategy, in addition to condoms,” Martinez said of the study participants.

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