HHS seeks to end HIV epidemic with Ready, Set, PrEP initiative

The U.S. Department of Health and Human Services has made it a goal to end the HIV epidemic by 2030, and on Tuesday it announced a new initiative to help to meet that end: The Ready, Set, PrEP program, which will make pre-exposure prophylaxis (or PrEP) medications available at no cost for qualifying patients.

PrEP medications, such as Truvada and Descovy, are prescription drugs people take daily to reduce their risk of acquiring HIV through sex, and they work by preventing the HIV virus from taking hold and spreading throughout the body.

HHS will initially be covering the costs of dispensing medication, but after March 30, 2020, CVS Health, Walgreens and Rite Aid will be donating their pharmacy dispensing services to the government agency, allowing consumers access to free PrEP medications either in person or via no-cost delivery by mail. Patients will also have access to counseling and steps to promote medication adherence.

HHS Secretary Alez Azar said the program "will come to be seen as one of the major health initiatives of the early 21st Century."

"We have the tools to stop the spread of HIV in its tracks," he said. "Now it's about execution."

Azar pinpointed certain regions of the country as prime initial targets for the program, including several Southern states, Washington D.C. and Puerto Rico, which have higher-than-average prevalences of the HIV virus.

"We've made it a priority to end the stigma around PrEP and HIV," said Azar. "This will make medication more accessible, helping Americans take control of their health, complemented with outreach for patients who need it but find it difficult to access in their communities."

WHAT'S THE IMPACT

Assistant Secretary for Health Brett Giroir, citing figures from the Centers for Disease Control and Prevention, said the number of Americans who are uninsured and need PrEP medication is estimated to be around 200,000, though the actual number may be lower.

To make medications available for that population as quickly as possible, HHS will be using drugmaker Gilead's distribution program, which will cost about $200 per bottle. Once the agreement with CVS, Walgreens and Rite Aid kicks in, HHS would no longer have to pay pharmacy dispensing fees, which at that point will substantially reduce the cost of the program, according to Azar.

"Importantly, in all circumstances, the patient … pays nothing to get the product," Azar said. He added that laboratory and diagnosis costs are not formally part of the program, but that testing and treatment are available at providers throughout the country for individuals with fixed and sliding scale incomes.

Azar, a former pharmaceutical executive, and legislators, have made lowering drug costs a priority.

THE LARGER TREND

The partnership between HHS and Gilead for initial distribution is somewhat curious given that, in November, the Trump Administration filed a lawsuit against Gilead claiming the drugmaker's sales of Truvada and Descovy violated HHS patents.

According to the Advisory Board, HHS filed the lawsuit against Gilead because the latter had allegedly "profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale(s) of Truvada and Descovy."

HHS said Gilead had repeatedly refused to obtain licenses for the use of HHS patents, and cited two unnamed companies that manufacture generic equivalents to those drugs that had agreed to license with HHS. Azar said at the time that Gilead should respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.

Gilead said it would continue to donate PrEP drugs to U.S. residents despite the lawsuit.

WHAT ELSE YOU SHOULD KNOW   

The formal agreement with Gilead continues through 2030, though Azar noted that a generic version of Truvada will become available in 2020, at which point lower-cost options will be available for people who don't necessarily qualify for Ready, Set, PrEP.

To receive PrEP medication through the program, patients must lack prescription drug coverage, test negative for HIV, and have a prescription for a PrEP drug. People can apply at GetYourPrep.com, or by calling 855-447-8410.

Twitter: @JELagasse

Email the writer: jeff.lagasse@himssmedia.com