PROVINCETOWN — After its approval by the Food and Drug Administration in December 2021, Apretude, an injectable medication for HIV prevention, was expected to be a game-changer for several high-risk populations — including people with substance use disorders or depression and people living in poverty.

There were already HIV prevention pills on the market. Truvada was the first pre-exposure prophylaxis, or PrEP, medication approved in 2012, followed by Discovy in 2019. But those pills must be taken daily to be effective, which can be a problem for people who don’t have a daily routine. Young people who live at home or people who are not out of the closet may avoid the pills for fear they could be discovered by a household member.

Injectable HIV prevention has been seen as a way to better protect vulnerable populations.

Two years after its approval, however, health care providers say that insurance companies have made it difficult to access Apretude, sometimes requiring proof that the patient had already failed to adhere to a pill-based PrEP regimen.

Valerie Al-Hachem, manager of infectious disease clinical services at Cape Cod Healthcare, said that only one patient in that system is currently taking Apretude.

“Initially there was very strong interest, but coming every other month to get an injection isn’t always feasible,” said Al-Hachem. “On top of that, there are still difficulties with insurance coverage.”

Patients taking Apretude begin with two injections one month apart, then bimonthly shots after that. The shots cannot be taken at home and arranging that many medical appointments can be difficult.

“A few of the people we work with who are Boston-based are on Apretude,” said Dan Gates, CEO of the AIDS Support Group of Cape Cod. They receive the injections from their primary care providers in Boston, he said. “Locally, it’s less than one percent of those we serve.”

“Insurance companies have made it very difficult for people to access injectable PrEP,” said Emily Gold, director of medical services at Health Imperatives, which offers HIV and STD screening and treatment at its clinics on Cape Cod and the South Shore.

Insurance companies “put up roadblocks, like requiring prior authorizations and asking for proof of failure on a daily PrEP medication. Others just don’t cover it at all,” Gold said.

“We are seeing a lot of interest, and the insurance companies are making it very difficult,” she added. “It’s discouraging from the patient perspective.”

“There are still barriers being put up by the insurance companies” to injectable PrEP, said Jeff Schaffer, the sexual health program manager at Outer Cape Health Services. “If someone walks in with commercial insurance, there’s no guarantee that it’ll be covered.”

Getting prior authorization from a primary care physician is especially difficult on the Outer Cape, where many doctors are booked months in advance or are not accepting new patients.

“For many people, making a monthly or bimonthly appointment with their medical provider is more of a burden than taking a pill daily,” said Gates.

The Road Ahead

Studies have shown that the injectable drug in Apretude is actually more effective against HIV infection than daily Truvada pills.

Last August, the U.S. Preventive Services task force gave an “A” rating to Truvada, Discovy, and Apretude, which could have the effect of forcing insurers to provide the injections at no cost. A provision of the Affordable Care Act requires most insurance companies, including state Medicaid programs expanded under the ACA, to cover “A” and “B” rated preventive medications with no out-of-pocket charge to patients.

A lawsuit filed in Texas, however, is challenging that part of the law, with the plaintiffs claiming that having to provide PrEP as part of their employer health plans conflicts with their religious convictions against homosexuality and sex out of wedlock. A federal judge found the ACA’s reliance on the Preventive Services Task Force to be unconstitutional in 2022, but that ruling has been stayed while it is appealed.

Even without the lawsuit, “A” ratings from the Task Force don’t always have their intended effect. Truvada received an “A” rating in 2019, which should have made it effectively free from 2021 onward, but Schaffer said that patients can still receive “unexpected bills” for their PrEP pills.

MassHealth has been providing Truvada and Discovy at no cost for years, however, and Schaffer said some MassHealth networks now include Apretude.

“I would say if someone walks in with MassHealth, access to PrEP is going to be extremely easy,” he said.

“Massachusetts is ahead of the curve,” Al-Hachem said. The state’s HIV Drug Assistance Program, which helps residents living with HIV, also has a program that helps people at risk of HIV pay for PrEP. That helps to “remove co-insurance barriers” such as co-pays, Al-Hachem said.