By Deena Beasley
May 5 (Reuters) - Use of Gilead Sciences' Yeztugo, a twice-yearly injection to prevent HIV infection, has climbed since its June launch, but U.S. health providers say not all patients are interested in the new option and those who want to try it can face insurance coverage gaps.
Hurdles include health plans that impose patient cost-sharing for the pricey medication, the appeal of a daily pill over twice-yearly in-office shots, and the potential for small nodules occurring at the injection
site, according to interviews with four providers, a major telehealth firm and two AIDS activists.
"We have close to 75 people who are on Yeztugo right now, which is not as many as we expected or hoped," said Dr. Barry Zingman, medical director of the Montefiore AIDS Center in New York, which has around 700 patients taking pre-exposure prophylaxis, or PrEP, medication.
U.S. regulators approved Yeztugo for at-risk adults and adolescents after it was shown to be nearly 100% effective at preventing HIV infection. Daily pills - Gilead's Descovy and generic versions of older drug Truvada - also block the deadly virus when taken diligently. Viiv Healthcare's Apretude is a PrEP injection given every two months.
Over 9,000 prescriptions were written for Yeztugo injections in the first quarter of this year, compared with around 461,000 for Descovy, 32,000 for Apretude and 4,400 for Truvada, according to prescription data collector IQVIA. The overall number of weekly PrEP prescriptions has not increased.
Analysts estimate Yeztugo sales will rise to over $5 billion a year by 2032, according to LSEG data. Gilead, which has forecast 2026 Yeztugo sales of $800 million, reports first-quarter results on Thursday.
The company said it is "excited by the strong uptake of Yeztugo," pointing to minimal out-of-pocket costs for most insured patients.
REACHING NEW PATIENTS
The Centers for Disease Control and Prevention estimates that about 600,000 of the 2.2 million Americans who could benefit from PrEP are on such a medication.
Reaching those not yet on PrEP and shifting existing patients to the new injection is a sizeable task as a growing number of patients get pills delivered by mail from sites touting "no awkward doctor visits, no needles, no paperwork."
In 2024, around 19% of U.S. PrEP prescriptions were filled by telehealth service MISTR, up from 2% in 2020, according to a study published in JAMA.
MISTR has seven U.S. storefronts where patients could receive Yeztugo, but said it will not offer the drug until a "critical mass" of insurers agree to reimburse for pharmacy administration.
"The last thing we want to do is introduce Yeztugo and then have 9 out of 10 people get rejected for it based on insurance," said MISTR CEO Tristan Schukraft.
Gilead has said more than 90% of insurers cover Yeztugo, but insurers say it is often treated as a medical benefit, which requires the provider to purchase the drug and can be subject to patient co-payments or deductibles.
The twice-yearly shots have a U.S. list price of over $14,000 each. Daily generic pills, the lowest-cost alternative, cost about $350 a year.
INTEREST VERSUS INSURANCE Dr. Rachel Presti, a physician at Washington University's HIV clinic in St. Louis, said the clinic has seen "a lot of interest in Yeztugo," and has an onsite pharmacy experienced at working to secure coverage for the drug.
Still, "if your insurance doesn't cover a pharmacy benefit, we can't give it," she said.
Zingman said most PrEP patients at Montefiore take daily Descovy pills or low-cost generic Truvada, which studies have shown to be effective when used on demand. "Many people just don't want something in their body for weeks or months on end," he said. "For a fair number of people that fits their lifestyle and their risk profile better." Dr. Howard Grossman, medical director at Spectrum Medical Center in Phoenix, in early April said about 200 of their over 1,000 PrEP patients had switched to Yeztugo. He expects those numbers to keep rising.
Spectrum, as a nonprofit, is charged a discounted per-dose price of $10,100, Grossman said. But UnitedHealthcare, the largest U.S. health insurer, is only reimbursing providers $6,000 or $7,000 under some plans. UnitedHealthcare declined to comment.
Eligible patients can get help from Gilead or other programs to bridge those kinds of gaps.
Meanwhile, standardized coverage is on hold. The U.S. panel that decides access to free preventive care in 2023 recommended people at high risk be treated with drugs to prevent HIV, but that has not been updated to include Yeztugo.
As a result, patient costs for Yeztugo are set by individual plans, UnitedHealthcare said via email, adding that its commercial plans cover older HIV prevention drugs at zero cost to patients.
CVS Health, which runs the largest U.S. pharmacy benefit manager, said in an email that its employer and union clients can set plan terms that prioritize use of drugs that are clinically similar to Yeztugo but less expensive.
The insurer said its negotiations with Gilead "have achieved a significant discount on Yeztugo," but the drug's price after discounts is still far higher than other effective options.
Michael Weinstein, president of the AIDS Healthcare Foundation, said Yeztugo "will be a game-changer for individuals who want to be on a drug permanently." But some people simply don't like needles, while others are concerned that the slow-release drug can cause visible nodules under the skin.
"There is a lot of marketing muscle behind it, but it's not a slam dunk," he said.
(Reporting By Deena Beasley; editing by Caroline Humer and Bill Berkrot)
