New biannual PrEP injectable option rolls out in SF

Patients are already receiving the new PrEP injectable option lenacapavir in the Bay Area, though issues with insurance are complicating the process of getting shots. The new injectable was approved last month by the federal Food and Drug Administration.  

As the Bay Area Reporter recently reported, lenacapavir, made by Gilead Sciences Inc. under the brand name Yeztugo, is the longest-acting HIV prevention method yet. While the other injectable option, Apretude, by ViiV Healthcare, approved in 2021, requires injections every two months, lenacapavir only requires injections twice a year.

But as the B.A.R. also recently reported, at least one San Francisco patient reported difficulty getting Apretude from his primary care provider. Dr. Nas Mohamed, a gay man working with the San Francisco AIDS Foundation to increase access to HIV preventative care in the LGBTQ community, said that there are logistical issues with medicines not commonly used by the general population.

“A lot of insurance plans pick one specific pharmacy they want to work with,” Mohamed told the B.A.R. last month, because “ordering, storing, and dealing with the medication” is more difficult than for oral PrEP. Further, a navigator to remind people to return for HIV tests and appointments for injections is something companies would have to pay for themselves, he said. 

PrEP, or pre-exposure prophylaxis, refers to the use of antiviral drugs to prevent people exposed to HIV from becoming infected. The pill Truvada was first approved for PrEP use in 2012 by the FDA; since then, the agency has also approved the pill Descovy for some groups, Apretude, and Yeztugo.

Mohamed, who runs Osra Medical in San Francisco, provided what are believed to be the first Yeztugo injections in the Bay Area, and among the first in the country. He told the B.A.R. July 14 that as of that time, only nine doses had been administered in the entire U.S. 

Yeztugo has an annual price tag of $28,000 without insurance coverage, leading some advocates to express concern that the cost could limit availability as HIV prevention funding is being slashed in the U.S. and worldwide.

Asked if it is rolling out Yeztugo or deferring to Mohamed’s practice, Stephanie Rivera, the assistant vice president of clinic administration for SFAF’s Magnet clinic at its Strut health center in the Castro, stated that, “SFAF’s Magnet clinic will provide Yeztugo to new and existing PrEP clients. We are currently developing clinic protocols to offer this new injectable PrEP option. The opening of our pharmacy at Strut will also allow us to increase our capacity to offer injectable options for PrEP. We look forward to bringing this game-changing method of PrEP to our community.”

A spokesperson stated she will try to get more specific information about when exactly Yeztugo will be rolled out. SFAF’s pharmacy is expected to open this year.

For now, Osra Medical appears to be the first in the Bay Area to provide the new PrEP.

“Gilead told us we were the first in the Bay Area to give the shot,” Mohamed said.

Patients are pleased
A 30-year-old gay man from Oakland who wishes to remain anonymous because he’s not out to his family was the first of Mohamed’s patients. He said it only took a couple of weeks from when he found out about Yeztugo from news reports to when he got the shot.

The man said he “sometimes flat out” forgot to take daily oral PrEP pills. “So it was that entire side of the equation for me, to ensure I have coverage,” he added.

The man also described the experience of getting the injections.

“You get two injections on each side of the abdomen – little to no pain,” he said in a phone interview. “It feels red for a day or two, but now if I touch the spots I can feel capsules under the skin, so it’s nice not to have to think about it.”

He had been on Apretude in between the transition from oral PrEP to Yeztugo, he said.

“It reduces my number of visits,” he said. “It’s the level of peace and protection one would get with a vaccine. I’m going to see my doctor on a semiannual basis anyway, so if I get it done on that visit, I’m good to go. I love it from that perspective.”

In terms of insurance issues, he was rejected by Aetna, his provider, initially, but Mohamed put in an appeal. 

A spokesperson for Aetna stated to the B.A.R. simply that, “Given the product was recently approved, we are still evaluating our longer-term coverage policies for Yeztugo.”

“I’m pleased with that outcome,” the man concluded. “I don’t know how other insurance companies will handle it. In my case, it went smoothly.”

A 26-year-old gay man from Sacramento, who also wished to remain anonymous, got the injection July 16. He went to Mohamed after his primary care provider – One Community Health – wouldn’t prescribe him Yeztugo.

A spokesperson for One Community Health stated that, “We are fully committed to ensuring equitable access to the most effective and up-to-date care options—including PrEP—for all who need them.

“As with any newly released medication, operational and regulatory steps must be taken before it becomes available at our health center,” the spokesperson continued. “Our clinical and pharmacy teams are actively working with the drug manufacturer and our pharmaceutical distributor to secure access to Yeztugo. Additionally, we are working through insurance and reimbursement channels to ensure patients can access it affordably and safely.” 

The Sacramento man said that, “I did the research before FDA approval. … I contacted my primary care in Sacramento, and they would not provide it, but Dr. Nas [Mohamed] popped up on a Google search. I talked to him and, from there, I got rejected by insurance.”

The man said he paid $200 out of pocket that he was told he might be able to get reimbursed.

Asked why he decided Yeztugo was right for him, he said, “I’ve been on PrEP – Descovy – for four of the last five years. … Taking the pills every single day is a hassle, but I don’t want to take the risk.”

Robert Szulc, a 51-year-old gay man from Oakland, told the B.A.R. July 15 that he is waiting to receive the shots.

“It’s coming within a week,” he said, adding he’d been on Descovy oral PrEP pills for seven years.

“Because of the side effects of the pill, I sometimes feel nauseous or have an upset stomach, sometimes headaches,” he said. “A friend of mine was approved and is getting an injection this week.” 

Twice a health clinic in Oakland rejected Szulc’s request to be given Yeztugo. It was then that he found out about Mohamed’s practice.

Szulc, who has Aetna insurance, said he has “no idea” why they didn’t approve it because “there was no follow up.”

“I hear he [Mohamed] has a better [insurance] approval rate,” said Szulc. 

Insurance issues
Mohamed told the B.A.R. “There are always issues with insurance with a brand new drug. Always.”

In this case, there are often two particular hurdles, he explained. One is that oral PrEP is treated like a medication, so it falls under insurance pharmacy benefits; but an injection is a procedure, “a medical benefit, not covered by the pharmacy,” Mohamed said.

“So, you need to figure out how insurance categorizes the drug, and where to dispense it,” he said. “This is why it’s tough to logistically do it.”

The second is an effect of the drug being new.

“Whenever there’s a new drug, they [insurance companies] clearly use templates to avoid distributing the drug, frankly,” Mohamed said. “For the first patient, the automated template was not applicable at all, because the patient had to fail other options. Well, failing PrEP means getting HIV. I had to go in and tell them that, that’s not applicable, actually.”

Thankfully, Yeztugo does not require refrigeration. Mohamed hopes it will one day be easier to acquire.

“My hope is that all PrEP options become easy to acquire, deliver, and counsel patients on so we can have more people in the population who could benefit from PrEP be on it,” he stated. “They can choose any option that fits their story, their needs and works best for them.”

Mohamed told the B.A.R. that all the clients who’d been approved or had gotten the drug had counseling on all their PrEP options.

“In my view, it’s not that everyone should defer to one drug,” he said. “This drug did extremely well in clinical trials, compared to other medications, and was shown to be extremely effective, and it has a low margin for error because you dose it twice a year compared with six times, or 365 times a year with a pill. People have adherence issues even when they try, and that can be the window to be exposed.”

There are three main reasons why someone may not want to choose Yeztugo, Mohamed said. One is drug interactions with some statins, the class of medications that address cholesterol levels. Another is if they take the over-the-counter herbal supplement St. John’s wort, as it, too, has a strong interaction with the HIV prevention medication. 

Finally, injection-site reactions “can be pretty visible,” especially on people who don’t have as much body fat, Mohamed said.

“The patients who want to do this with me weighed the pros and cons, and for them, this was a winner,” he said.

Asked about rollout and uptake of the new PrEP option, a spokesperson for Gilead Sciences, the San Mateo-based biomedical company that developed Yeztugo, stated, “We are in the initial stages of the rollout following FDA approval. We are pleased and encouraged by the positive response from the community, and broad media coverage, which helps raise awareness of Yeztugo as a PrEP option. 

“In terms of patients having access to Yeztugo, it is important to note that prior to payers reviewing Yeztugo and establishing payer policies, processing a prescription for a newly approved medication takes time,” the spokesperson added. “This is true for any new product.”

Asked if Gilead hopes the product will one day be as prevalent as oral PrEP is now, or if that’s not possible, the spokesperson stated, “Initially, we do expect Yeztugo users to be those already using prevention medication. Beyond the initial launch, we hope to reach more of those who could benefit from PrEP, and then ultimately young adults, women, and anyone with an STI.”

The spokesperson continued that to reach those groups, “our teams have been preparing to support partners, clinics, and community organizations upon the approval of Yeztugo by hiring additional field reimbursement managers (FRMs); ensuring our patient support programs are set up properly to meet the needs of individuals who have been prescribed Yeztugo across the country; and meeting with key stakeholders who are part of the communities most affected by HIV to gain insights.

“We will continue to engage with our partners in these communities to discuss Yeztugo and HIV prevention generally,” the Gilead spokesperson added.