When Gilead Sciences won Food and Drug Administration approval in October for a second drug to prevent HIV infection, some experts suggested that the drug it already had on the market would be difficult to dethrone. A new notice from the country’s largest private payer to plan members indicates that prediction may come true.
On July 31, Minnetonka, Minnesota-based UnitedHealthcare sent a notice to members – one of which was obtained by MedCity News – stating that starting Sept. 1, its pharmacy benefit plans would stop covering Descovy (emtricitabine and tenofovir alafenamide) for pre-exposure prophylaxis, or PrEP, in favor of Truvada (emtricitabine and tenofovir disoproxil fumarate), which was approved for PrEP in 2012 and will become available as a generic on Sept. 30. Plan members were told that if they were taking Descovy, they would have to speak with their doctors to get prescriptions for branded Truvada before Sept. 1, while the generic would be provided at no out-of-pocket cost once it became available. Meanwhile, further coverage for Descovy as a PrEP medication will be subject to prior authorization, though the insurer said plan members would potentially have to pay a higher cost.
Descovy’s Oct. 4, 2019 approval for PrEP was based on Phase III data showing non-inferiority to Truvada in prevention of HIV, but with a better toxicity profile, in terms of the bone mineral density and kidney function loss that has sometimes been associated with the latter drug. When it was approved, Foster City, California-based Gilead gave it the same same $1,758-per-month list price as Truvada.
Subsequently, sales of Descovy went from $700 million in the first six months of 2019 to $875 million during the same period this year – driven entirely by an increase in U.S. sales following the PrEP approval, while international sales fell. Sales of Descovy for PrEP also helped offset a decrease in overall product sales in the second quarter.
But if other payers are following UnitedHealthcare’s lead, that offset may prove short-lived. A twice-monthly injected PrEP drug from GlaxoSmithKline and ViiV Healthcare, cabotegravir, could present another threat.
In an emailed statement, Gilead noted that it does not comment on ongoing negotiations with payers. But the company said, “Attempts to reverse or interfere with decisions already made by patients and providers may further complicate an individual’s decision to use PrEP and jeopardize ongoing efforts to curb new HIV infections and end the epidemic.”
A spokesperson for UnitedHealthcare acknowledged a request for comment, but did not provide a response by the time of publication.
From a public health perspective, the move could result in a greater use of PrEP.
“I actually believe more people will take more PrEP with zero cost sharing,” said Dr. Mark Fendrick, director of the University of Michigan’s Center for Value-Based Insurance Design, in a phone interview.
“If I had to make a choice, and I had a bucket of money to spend to prevent HIV in the United States, and I’m the New York City health department or New York Medicaid or any other struggling healthcare payer, I think that from a population perspective, offering more people a lower-cost drug at zero cost sharing is a trade-off I’d be willing to make for this change,” Fendrick said. But that comes with the understanding that “there will be some people, because the drugs are not identical, who will not have desired outcomes that they would have achieved on the branded drug.”
Photo: nito100, Getty Images