A-Rating for PrEP Means Wider Availability
by Larry Buhl
Since it was approved by the FDA in 2012, pre-exposure prophylaxis (PrEP) has been a proven way to prevent exposure to HIV for those who take the once-daily medication as directed. But easy access to PrEP hasn’t been universal, partly due to cost sharing and other insurance roadblocks.
Now most of those barriers should be lifted, as the United States Preventive Services Task Force (USPSTF) issued its final “A” grade for PrEP for the prevention of HIV.
In a news bulletin issued by the USPSTF in early June, officials noted that although HIV acquisition rates have been going down, rates among some groups, most notably among young adults, are still rising.
“Screening for HIV is important so that everyone knows their HIV status, and those with HIV can begin treatment right away,” Task Force member John Epling, MD, noted in the statement. “Today’s treatments help people live long, healthy lives and lower the risk of passing HIV to others.”
In the statement, USPSTF officials noted that people who take PrEP should continue to use condoms and practice other behaviors to reduce their risk of other sexually transmitted infections.
In the same statement USPSTF urged screening for HIV in everyone between the ages fifteen to sixty-five years and all pregnant people.
The A grade for PrEP will widen the availability of this once-daily medication, Truvada, made by Gilead. That’s because the A grade will require most private insurance to cover the drug and do so without patient cost-sharing.
Medicaid beneficiaries in states that have expanded Medicaid will also gain access to PrEP without charge, while people in traditional Medicaid states will gain free access if their state has decided to cover all USPSTF preventive services. To date, at least thirteen states have done so. Medicare will be required to cover PrEP, but in order for beneficiaries to receive it without cost-sharing, a coverage determination will still have to be conducted.
One might ask, what took the Task Force so long to give its blessing to PrEP. The answer, explained Carl Schmid, Deputy Executive Director of The AIDS Institute, is that “it takes time.”
“Researchers have to look at existing research, look at the guidelines, consider the benefits and see if it meets the gold standard of preventative services for certain populations,” Schmid said.
Now, effective for all plans beginning in 2021, PrEP must be covered, and covered without cost sharing. That’s a big deal, said Schmid.
“Many people have very high co-payments,” Schmid said. High enough, he added, that keeps many who could benefit from PrEP from asking for it.
Thanks to the USPSTF, but actually, thanks to the 111th Congress, which, when it passed the Affordable Care Act in 2010, said that all health plans must provide essential health benefits, including preventative care. And if a drug or a test is determined to have significant benefit in preventing a disease in a high risk population—HIV testing qualifies for this, too—then it must be covered.
At the International AIDS Society Conference on HIV Science in 2017, Gilead researchers reported that an estimated 120,000 people had ever started Truvada for PrEP since 2012. But researchers with AIDSvu, who presented their findings at the 2018 Conference on Retroviruses and Opportunistic Infections (CROI) concluded that only five percent of the 1.2 million persons indicated for PrEP are potentially receiving PrEP protection.
Schmid said The AIDS Institute will now work to ensure private insurance plans will be incorporating this new recommendation into their policies without unnecessary roadblocks, such as prior authorizations, that would impede access.
And those who take PrEP know that regular doctor visits and tests for liver and kidney functions. Truvada has been known to affect these organs adversely, though the side effects can be reversible. It is not entirely clear whether all heath plans will waive cost sharing associated with doctor visits and repeated testing, Schmid said.
“We’re working to get clarification on that,” Schmid said.
It is also not clear how soon newer generations of PrEP will get A ratings from USPSTF. Results from a three-year PrEP clinical trial evaluating a new candidate medication for PrEP were revealed at the HIV science conference CROI in March, and were shown to have the same effectiveness as Truvada, but without some of the serious side effects. The PrEP medication tested in the trial was FTC/TAF, sometimes referred to as F/TAF (brand name Descovy) and was approved by the FDA in 2016 as an antiretroviral medication for treatment of HIV.
For now the biggest barrier to getting more people covered with PrEP is education, Schmid said. “Physicians need to understand how it works, and prescribe it, and patients need to know it exists.”
Larry Buhl is a multimedia journalist, screenwriter, and novelist living in Los Angeles. Follow him on Twitter @LarryBuhl.