Providers, chances are your patients have heard about cabotegravir/rilpivirine (Cabenuva), the first long-acting injectable HIV antiretroviral (ART) regimen, approved in January by the U.S. Food and Drug Administration (FDA). You may have even started conversations with them about switching to the new pill-free treatment option, and perhaps have already administered the first doses. Yet, despite excitement both from people living with HIV (PLWH) and clinicians, the rollout of this new once-monthly regimen has been slow, and in some cases, deliberately so—especially as clinics assess how to deliver these injections effectively while also making sure patients aren’t stuck with the bill.
Judith Currier, M.D., a professor of medicine at UCLA’s Division of Infectious Diseases, expects patients will not make a decision about whether they’ll even want Cabenuva until they know how it will be delivered. “The big thing now is infrastructure, and where and how it will be delivered,” said Currier. We’re still trying to figure this out.”
TheBodyPro spoke with several clinicians in the middle of figuring it out. Each discussed what issues they’re considering to make the rollout of this new regimen easier—on both staff and patients.
Are Payers Covering Cabenuva—and How?
Coverage for Cabenuva may be the biggest hurdle right now, because very few people are able and willing to fork over $4,000 a month, the medication’s list price, which doesn’t include roughly $6,000 for the first dose. In some states, the AIDS Drug Assistance Program (ADAP) has added Cabenuva to its formulary list and budget, which means people with a health plan that covers the medication need only worry about their copay. In other states, that may take a few more weeks. Likewise, your state’s Medicaid program may have added it, but also maybe not. Private insurers are even further behind in covering it, which is not uncommon with new medications.
Jay Gladstein, M.D., chief medical officer and site medical director at APLA Health in Los Angeles, said that after “banging his head against the wall” trying to get his first few patients covered for Cabenuva, he has put plans for a wider rollout on hold to avoid getting his patients’ hopes up.
“Insurance is disorganized, generally,” Gladstein said. “Private insurers are giving several explanations for why they’re denying. Typically, it’s ‘We’re reviewing—not enough info,’ or ‘We want to see that patients have failed on other treatments.’” Gladstein said he expects private insurers will take at least a few more weeks to figure out whether and how they will cover the medication, and that even bigger roadblocks will come from self-insured plans, that is, plans funded by large employers. “[Those plans] are problematic, because they don’t have to abide by the same state health rules,” he added.
If a person in your care has a payer that isn’t covering Cabenuva—or even if it is—it’s worthwhile to check out ViiV’s assistance program, ViiVConnect, to find out how it might help with payment and copays.
How Will Injections Fit Into Your Workflow?
For many people currently on ART, replacing a daily pill regimen with two shots in the butt—one for cabotegravir and the other for rilpivirine—will be a great relief, assuming they can make it to the clinic for the injections once a month. For clinicians, switching people under your care may require some reallocation of resources because you’ll be seeing them once a month, instead of twice a year. For most clinicians, instituting drop-in injection hours would probably prove chaotic, especially considering that staff will need time to administer the injections and to observe the patient for at least 15 minutes afterward for any reactions.
Part of this workflow will include keeping tabs on patients either through a phone call or text message, to make sure they stick to monthly visits—and tracking them down if they miss a visit. Gladstein of APLA Health said his clinic is currently working on such protocols. “You also need to track when [a patient’s] prior authorization expires and reapply for approval,” said Gladstein. “You don’t want them to come in for an appointment on Wednesday and learn the authorization expired Tuesday.”
Other considerations include special handling issues, such transporting the medication to and from the pharmacy or clinic efficiently and bringing the medication to room temperature prior to administering injections (the medication is shipped and stored cold).
Christine Tran, D.N.P., APRN-NP, an infectious-disease nurse practitioner at the University of Nebraska Medical Center, has experience with giving Cabenuva shots because her clinic was the site of industry-sponsored trials ATLAS and FLAIR. But even for early-adopters like Tran, there remains a host of unknowns in terms of switching a potentially significant percentage of the clinic’s patients over to Cabenuva. “If Cabenuva is delivered to the pharmacy, it might make sense to send patients to our outpatient pharmacy for injections,” Tran said. “Our pharmacy already has experience with giving injections for long-acting antipsychotic medication.”
Still, it’s unlikely that clinicians will send patients to their local CVS or Walgreens. Cabenuva is a large-volume injection administered in the buttocks, and currently few neighborhood pharmacies or minute clinics offer a room or space that allows for patients to drop their pants in private.
Who Might Benefit Most From Cabenuva?
While some clinicians are waiting to have the conversation until all payers are on board, others are letting patients bring it up. Still others, like Joseph Garland, M.D., the medical director of the Infectious Diseases and Immunology Center at Brown University, are actively identifying those who might benefit most from switching to Cabenuva and broaching the topic.
According to Garland, certain groups might stand to benefit more from a once-monthly injection than others. “Homeless people with HIV, people who live in shared quarters with others who do not know their HIV status, people who have difficulty swallowing pills, and people who are suffering from pill fatigue are great examples of individuals who might benefit from injectable therapy,” said Garland. Others include those who just might not care to be reminded of their HIV status on a daily basis, added Garland.
Even for groups who fit the high-benefit profile, some may still find it difficult to adhere to monthly visits. “The current monthly challenge has eliminated some patients, but they also say if it’s available every eight weeks, then they’ll do it,” said Tran. “Rural patients have a harder time getting here.”
For those patients, an even longer-acting ART may be just around the corner. In February, drugmaker ViiV Healthcare requested FDA approval of Cabenuva for every-other-month dosing, based on data from the global phase 3b ATLAS-2M study, which showed Cabenuva administered every two months was just as safe and effective as once-monthly administration.