By Angela Maas
A few recent actions, as well as one expected next year, are expected to help bring down rates of HIV infection. And while the efforts should make it easier for certain populations to gain access to preexposure prophylaxis (PrEP) that helps prevent them from acquiring HIV, some issues are likely to stand in the way of eliminating all infections.
The FDA initially approved Gilead Sciences, Inc.’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in 2004 to treat HIV infection. But in 2012, the agency approved it to reduce the risk of HIV infection in adults, the only therapy indicted for this use.
In its final recommendation, published June 11, the U.S. Preventive Services Task Force (USPSTF) recommended that “clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition,” giving the recommendation an “A” rating. This grade, the highest one possible, means that the USPSTF recommends the service, as “there is high certainty that the net benefit is substantial.”
The grade also means that, per the Affordable Care Act, “a group health plan and a health insurance issuer offering group or individual health insurance coverage” must provide coverage for free of items or services that the USPSTF gives an “A” or “B” ranking.
Payers will still be able to impose “reasonable medical management techniques,” such as prior authorization, notes Elan Rubinstein, Pharm.D., principal, EB Rubinstein Associates.
“Making PrEP available without cost-sharing eliminates a major barrier to this landmark HIV prevention tool,” said Michael Ruppal, executive director of The AIDS Institute. “At a time when out-of-pocket costs are rising for patients as they seek access to medications, this recommendation is a win both for patients and public health.”