Ryan Bitton, PharmD, MBA

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I think that long-acting injectable PrEP [pre-exposure prophylaxis], which will hopefully be available in 2022, is something that could be used for virtually anyone. I think if someone is doing well on oral PrEP, and they want to switch to injectable PrEP, I think that’s absolutely something that people should have the option to do. In terms of the greatest benefit for improving population health and meeting national goals, we need to think about injectable PrEP as a way to not only keep people who are using oral PrEP and using it with adherence and persistence, engaged in PrEP, but how do we get new people and new populations engaged?

If people have marginalized housing, if they have issues with psychosocial challenges like depression, anxiety, PTSD [post-traumatic stress disorder], substance use disorders, all the things that make it challenging to adhere to daily pill-taking, these are populations where I think first and foremost, we want to see if there are ways to integrate the injectable PrEP option into people’s lives in a way that oral PrEP maybe couldn’t. I don’t think there’s ever going to be a one-size-fits-all, so we need to discuss all these options with all the individuals and populations who may be accessing PrEP. We shouldn’t think that we know the right answer for any specific individual and keep an open mind.

I do think that being intentional about engaging new communities in long-acting injectable PrEP could improve what people have termed as the mosaic effectiveness of PrEP, which is not just keeping people who are already on PrEP on PrEP, which they may do with things like oral tenofovir and emtricitabine, which are already in existence and are available in generic forms so it can be a very cost-effective long-term option. But can we get new people onto PrEP? I’m optimistic that there’s a lot of excitement.

There have been studies showing that hypothetical acceptability for long-term injectable PrEP is high in some of the populations that have underused oral PrEP thus far. Maybe this will be a chance to right some of those inequities. People who were in the injectable PrEP studies also gave very high marks to using injectable PrEP, and the vast majority wanted to continue using injectable PrEP. All the avenues point toward going here for engaging new populations. I think we have to be careful because of some of the lessons learned from other long-acting injectable options in terms of HIV treatment, which has also been available for the past year.

I think usage has been slow in my own practice. I talk to dozens of people about long-acting injectable antiretroviral therapy for people who are HIV positive. For the vast majority of them, they’d rather take a pill a day and see me on an annual basis and get laboratory tests done twice a year than come see the nurse in our clinic every 4 weeks. As long-acting injectable agents become less burdensome in terms of the care and the frequency of visits, I think it will expand the options even further. I know that’s still in the pipeline, but there are some agents that are being looked at that maybe could have an every 6-month injection. The future has a lot of different paths that can be taken. As long as we’re thinking about offering long-acting injectable PrEP as an important new option to as many people as possible, I think we’ll see the biggest population health benefits.

As a payor, how would we look to find patients who are eligible or probably should be on a long-acting medication if they’re on short-acting medication? That’s a good question. I think there are a lot of specifics that we’re not going to be able to get at, as far as who the patient is, preferences, etc. We don’t really see that, but we have the ability to look at claims, and so we can say, “You’re on a short-acting, but you fill a monthly prescription every 3 months. You’re not compliant.” That’s an obvious opportunity.

I think you could also look and say if we marry medical benefit data up with pharmacy data, and we say this patient, maybe they’re in an outlying town where there’s no opportunity to get into the clinic more often. We can look at those types of things, but it’s going to be difficult aside from looking at how they’re taking the short-acting. Really, it’s fill rates and how often they’ve got therapy at home to take versus when they don’t, and would a monthly therapy or a monthly administration or some long-acting agent be better for them? We would look at pharmacy claims data, which I think is the best way that we have to figure that out.

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Types of patients who will likely benefit from long-acting injectable PrEP therapies in the HIV treatment pipeline.

Long-Acting Injectable PrEP Therapy for HIV

I’m involved in clinical research, and it’s always fascinating and exciting to be involved in projects that you won’t hear about for another year to 2 years from now, but we are moving quite rapidly into the PrEP [pre-exposure prophylaxis] world. Prior to this conversation, we have Truvada, we have Descovy, and we’ll have an injectable PrEP pretty soon. This will be an injection every 2 months for PrEP. Apart from that, what’s also in the pipeline? We’ll have probably weekly pills, monthly pills, 6-monthly injections of PrEP, PrEP implants. And then for women, there are also going to be intravaginal rings for PrEP.

There are a lot of these agents, so to speak, or new modules of treatment or new medications involving treatment that will be rolling out soon. I think this is going to be good because a lot of time people will start PrEP, stop PrEP. If you have an injectable PrEP that stays in your system up to 2 months, you get a shot today, 2 months there or even longer, and you have a 6-month PrEP, I really do believe these new agents will be game changers. It’s not about taking a pill every day anymore. It’s about knowing full well that you’re protected against HIV by having an injectable agent in your system. That’s going to protect you for several months at a time.

Once we get there, I really truly believe once the access issues have been addressed, once we recognize—of course, you’re going to hear, “Well, you’re implanting some slow-release product.” That could be a challenge because we’ve seen the challenge with COVID-19 vaccines, or even if you give an injection. But I do believe that the patients involved in HIV care, what I’ve seen is that they’re more in tune with understanding medical care and what’s developing. They’re looking forward to these new strategies. And again, just to remind you what these strategies are, long-acting pills once a week, or probably once a month, long-acting injections every 2 months, probably every 6 months, vaginal rings, and implants that can stay in your system for quite a while.

As far as the long-acting agents in the pipeline and the potential barriers and logistical concerns surrounding those products, I’m not sure that there’s a huge worry as far as logistical concerns. When you have medical benefit provider–administered products, that does introduce logistical issues because those products need to be shipped to the provider’s office versus being picked up from the pharmacy or being shipped to the member’s home. There are some considerations there, but I think as a health care system, we’ve ironed that out. But it is more complicated than taking a prescription to the pharmacy. With the long-acting agents that may be self-administered, I think there are fewer logistical issues. The worry then is, it’s not a daily administration, potentially, therefore adherence becomes more of an issue because if you miss your dose, whether weekly or monthly, it becomes a bigger issue than if you miss just 1 day. I think those are the logistical concerns, but I don’t think either of those are insurmountable. I think having options that are long-acting that provide better options for adherence are going to be a boon for the patients and for the HIV PrEP community.

For how we overcome the challenges with the medical benefit, the logistical concerns from a provider perspective, I think over time, the introduction of specialty pharmacies into this buy-and-bill medical adjudication, distribution perspective has helped. It used to be that if providers were going to administer something, it had to be buy-and-bill. Sometimes providers don’t want to get involved in having overhead and the complicated aspects there, but now with specialty pharmacies being able to be involved, bill medically, and then ship the product to the provider office, I think that has helped. The PrEP therapy would come from the specialty pharmacy with the patient’s name on it, and it says, OK, this is here for patient A when patient A comes in to get their administration. I think that prevents them from having the overhead of stocking these things. That’s been one helpful tool, because that was one of the big barriers, that not every provider wanted to go through that.

An overview of HIV PrEP therapies in the pipeline and their potential roles as they are introduced into the community for use among high-risk populations.

Developments in HIV Prophylaxis: New PrEP Options

The USPSTF [US Preventive Services Task Force] recommendations have changed our strategies around PrEP [pre-exposure prophylaxis] because now it’s officially recommended, and we have preventive guidelines within our health plan to ensure that those recommendations are followed and accepted within the benefit design. What changed is now PrEP therapy is eligible for $0 co-pay, and so we made a path to ensure that we have a therapy at a $0 co-pay. That was the main thing. We didn’t have utilization management [UM], PA [prior authorization], on generic Truvada, but this paved the way for that to be $0. That was the main change that the task force recommendations had for our plan.

The biggest challenge with UM in general, and in this case, we’re really talking about prior authorization, is that it’s complicated. It’s another step in the process for the provider. I think it increases the amount of time it to get a patient on therapy who needs it. That delay and that hassle factor is probably the biggest barrier. When you don’t have utilization management, like we don’t have for the workhorse therapy of generic Truvada, there’s really not a huge barrier there. I think that as a payor, generic Truvada is substantially less expensive than other options out there. There’s a benefit to the plan and to the health care system in general from an affordability perspective by promoting the utilization of generic Truvada first. There’s some UM out there from a barrier perspective that says generic Truvada first and promotes that. I think that can be a barrier to providers and patients who may want to use a different therapy or who automatically go to a different therapy first.

I think as drugs on the medical benefit evolve and there are more of them, we’re doing a better job. The systems are set up relatively similarly. Obviously, pharmacy benefits process more transparently and quicker, but as far as prior authorization and task force recommendations and $0 co-pays, all of those can happen on both benefits.

We can do all things on both benefits, and so there really is no barrier to managing something on the medical benefit versus the pharmacy benefit. We can manage both benefits the same and have interplay between the benefits as needed. We’re only talking about one therapy at a time here, but we can refer to the pharmacy benefit, the medical benefit, approvals in the past, so there’s really not a difference per se in how we would approach therapies on either benefit.

Updates to the US Preventive Services Task Force grade A recommendation for HIV PrEP therapy and payer response to supporting providers and pharmacists who prescribe therapies used as prophylaxis.

Preventive Health Guidelines and Payer Support for HIV PrEP

: How do we evaluate PrEP [pre-exposure prophylaxis] walkaway rates? That’s a good question. It’s a consideration that we’re looking at. How do we do it, and are we doing it? Those are 2 different questions. We have the ability to look into pharmacy claims and say, OK, here are the prescriptions for people who have filled them but are not continuing to fill, and so we could say that would be a walkaway. We would look at pharmacy claims to do that. Do we have an active process to react to that information? That is the next step. Do we have a team to reach out and have those conversations? There are people in the plan who could do that. We do not have an organized program at this point to engage with patients around PrEP walkaway.

: The technology now, we have texts we can send to patients when they have auto care. My pharmacist will text them and say, “You didn’t pick up your medications. How can you get that?” Communication by email—educational email, not personal data by email—but mainly communication by a phone, cell phone. We communicate through different sites, for example, when you have a patient in care, we use a lot of the social media sites to get them into care. But now retaining them in care is a lot about information. It’s a lot about telling them if you’re out of care, what’s going to happen.

I just had a patient recently because of substance abuse, he fell out of care, so we had to address his substance abuse issues first, address the mental health issues related, then get him back into care. But it’s important that there’s a formula here every 3 months, every 6 months. If you’re not seen in 3 months, you have to call the person and say, “Hey, you missed your pill. How can we get you back into care? What is missing?” And a lot of times you hear, “Well, I’m not as sexually active as before. I don’t think about the high risk as before. I stopped taking medication, or I stopped taking my PrEP. I’m out of a relationship.” And then 3 months later, that person will come back into care.

I think it’s important that patients realize or recognize that even if they’re out of care, the door is still open to jump back into care very quickly. Because we still look at other things, it’s not just about PrEP alone. It’s about checking for STDs [sexually transmitted diseases], check for chlamydia, check for syphilis. It’s a whole program that we work with our patients with, recognizing that HIV alone, you have coinfections related to that as well. It’s important to recognize that patient adherence [can come and go]; we see a lot of dropouts. And sometimes we see the dropouts now because of insurance issues. They can’t fill their medications anymore, they’ve lost their insurance. We have a patient assistance program we work with to get them, if you’re out of your insurance, we can jump quickly into the patient assistance program to get you back into PrEP.

Discussion regarding HIV PrEP walkaway rates and strategies that can help support patients and increase adherence to therapy.

Patient Adherence to HIV PrEP

: In terms of trying to meet the quadruple aim for the [Institute for Healthcare Improvement], there are a lot of ways we could work on improving both patient experience and outcome, and clinician experiences, satisfaction and outcome. I think we need to acknowledge that PrEP [pre-exposure prophylaxis] right now is relatively complicated from the perspective of the medical aspects. There’s a fair bit of follow-up. For example, right now, for people taking oral PrEP based on the CDC guidelines, which actually were just updated last week, the idea is to have someone come in quarterly for their adherence and medication and testing. That’s really important from a safety standpoint, but it is burdensome to both patients and providers. I think we need to think about ways to safely de-medicalize PrEP to some degree so that it’s more accessible. We’re meeting patients where they are, because people have busy lives and they may be otherwise completely healthy, and so we don’t want overburden them such that they don’t opt to continue with PrEP or initiate it in the first place.

Same thing on the clinician side. I think we need to figure out ways to give clinicians tools to make HIV testing, PrEP conversations, prescribing, and follow-up much easier on them and their staff. This could be offloading busy clinicians with other health care professionals who can do a lot of the work with clients and patients to make the burden on the clinician who’s prescribing it a little less. We can think about ways to use the electronic health record and automated tools to help remind clinicians about patients who may be at increased risk for HIV acquisition based on their electronic health record history. For example, if they’ve had past sexually transmitted infections, then that would be a way to prompt them to think about talking about PrEP.

In terms of follow-up, if you have people in large numbers on PrEP in a clinician’s panel, we really need population health management tools, whether that’s personnel, where they can offload with a nurse, medical assistant or other professional who can work on managing people’s follow-up after the initial prescription and making sure that they have what they need in terms of laboratory care, adherence counseling, and getting their questions answered. That can really make a good impact on the quadruple aim of everyone’s experience and outcomes.

I think we need to think about innovative ways to get PrEP to people where they are that include giving it completely out of the health care system. That’s already underway with the idea of telemedicine for PrEP, or tele-PrEP, where you can have people at any jurisdiction in the country accessing PrEP centrally with virtual visits, having home-based lab testing, or maybe local testing, but it avoids having to take a day off of work for example, and come into the clinic 4 times a year. There are a lot of ways to innovate and improve the goals of the quadruple aim from the [Institute for Healthcare Improvement].

There are a number of population health challenges in terms of people who might be eligible for PrEP or on it. The first is raising awareness of PrEP, particularly in communities where there have been high rates of new HIV infections, such as the southeastern United States, and where PrEP use has been lower than other regions, and particularly among Black and Latinx populations. I think some of these challenges can be met by well-designed public health campaigns where people are made aware of PrEP in a broad community-wide sense. I think there have been some misconceptions that PrEP is just for certain populations. We’ve heard from research we’ve done that cisgender women have heard that PrEP is just for gay men, for example, and we know that’s not true at all. In fact, PrEP is underused among cisgender women. We need to think about ways to inform the public that this is something that’s a benefit to them so that they can access it.

I think we also need to make the access easier instead of asking people to exclusively come into health care settings where some people are otherwise healthy and don’t see a health care provider regularly. Other people may have faced stigma and discrimination or judgments by health care providers in terms of sexual health care. People may not want to see clinicians for things like PrEP. So if we can think about creative ways to use community-based organizations to implement PrEP in the future, I think those would be ways to improve access more broadly on a population level.

Once people are using PrEP and they are engaged, I think accessing paraprofessionals who are not necessarily the prescribing clinician for PrEP can also improve the number of people we can support on PrEP. For example, at the hospital where I work, there’s a pharmacist who has been really motivated to work on the PrEP-using population in the primary care clinic. It’s a very busy, big primary care clinic, and there are a number of primary care providers who prescribe PrEP to their patients. But having the pharmacist as a central person who has expertise, maybe a bit more time to manage the group, and also using the electronic health record to keep track of people, these are ways where you can really scale up on a population level without overburdening the clients or the health care professionals who are managing the PrEP.

Thinking about ways to use telemedicine for PrEP is a really creative way to do this as well for people who are in rural areas, or frankly, people who just prefer to do things virtually. The COVID-19 pandemic has given people opportunities to try new ways of accessing and using health care. While I don’t think that the whole world is going to be virtual in terms of health care, for the indefinite future, there’s no question that there are certain people and aspects of health care that can be done more efficiently and more effectively using full telemedicine or maybe a combination-hybrid model. PrEP, I think, is a really good way to do that.

There are already academic, public health, and private organizations that have robust tele-PrEP programs that have been going for several years now. These haven’t been as rigorously studied yet as I would like to know the outcomes, but my sense from talking to people who have engaged in them is that these are excellent opportunities to expand PrEP on a population level to more people. Colleagues of mine here in Boston are doing studies with colleagues in the South to see if a tele-PrEP model keeps people engaged and adherent to PrEP compared to a standard in-person model. Over the next few years, we’ll learn a lot more about some of these innovative approaches to delivering PrEP as well.

In terms of programs that can help make PrEP more effective for patients and for providers in the health care system, I think having a team-based approach is an excellent way to approach PrEP. There’s the prescribing clinician, but engaging nurses, pharmacists, medical assistants, a whole series of people on the team who may have different levels of expertise and different amounts of time.

For example, in terms of adherence counseling, research has shown that using behavioral cognitive methodologies can be really effective to help people problem-solve with their adherence, but a primary care clinician with a huge panel of patients may not have time to do that. This involves engaging nurses who can be trained in some of these methods, or behavioral health specialists, and even peer navigators who can talk at the level of a peer with someone using PrEP about their experiences and the way they’ve overcome challenges to accessing PrEP, integrating into their lives, some of the social considerations of using PrEP in terms of disclosing to partners, peers, and family. I see the future and the present, frankly, is using a team-based approach.

At one of the places where I work, we have an excellent nurse who basically manages the PrEP program except for the actual prescribing and refilling, and does an excellent job. This person has gained all the expertise as being a specialist as an infectious diseases nurse, and so the jump to PrEP is really quite straightforward. She’s able to manage many more patient cases than I could alone. Using team-based approaches and integrating those with technological tools, such as using population health management tools from the electronic health record, are ways you can scale this up most effectively. I think those have been helpful for me personally at our institution. I know that I’m not always in the clinic. I do some research as well as clinical care, and even the busiest clinicians have been pulled in so many directions with all that they’re asked to do, so we need to be offloading and working in teams to make sure this is scalable and sustainable.

: The utilization management strategies for PrEP have changed over the years. Initially, some plans had prior authorization, some plans didn’t. They are to the point where there’s not a lot of prior authorization; PrEP is a pretty standard of care recommendation. There’s really not utilization management on some of the therapies. Things like generic Truvada are available without prior authorization with a $0 co-pay, I’m assuming for most plans, including ours. There are obviously multiple therapies out there. Some of the other therapies may have prior authorization and requirements around a generic-Truvada-first type of policy. If generic Truvada doesn’t work, which I don’t know if we see failure in this population, Truvada failing may not be the issue, but contraindication or intolerance or reasons why you wouldn’t want to use generic Truvada, there are allowances to get into other therapies.

Payer perspective regarding strategies that can be deployed to help improve the patient/provider experience and utilization of PrEP therapy as prophylaxis against HIV.

Ryan Bitton, PharmD, MBA

Articles

Long-Acting Injectable PrEP Therapy for HIV

Developments in HIV Prophylaxis: New PrEP Options

Preventive Health Guidelines and Payer Support for HIV PrEP

Patient Adherence to HIV PrEP

Population Health and HIV PrEP