PrEP Pipeline: Effects of USPSTF Grading

EP: 1.Overview of HIV Prevention with PrEP

EP: 2.CDC PrEP Care System Process and Assessing Risk of HIV

EP: 3.Initiating PrEP: Patient Clinical Evaluation

EP: 4.Payer Barriers to PrEP

EP: 5.Addressing Patient Persistence and Adherence to PrEP in the Clinical Setting

EP: 6.Challenges to Monitoring PrEP Adherence and Persistence

EP: 7.Barriers to PrEP Uptake

EP: 8.Improving PrEP Use Among Clinicians

EP: 9.Abandoned PrEP: Targeting Nonadherent Patients

EP: 10.Grade A Recommendation: Impact of USPSTF Grading on PrEP

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EP: 11.PrEP Pipeline: Effects of USPSTF Grading

EP: 12.Ideal Patient Selection for Long-Acting Injectable PrEP

EP: 13.Future of PrEP

Neil Minkoff, MD: As we talk about PrEP [pre-exposure prophylaxis], let’s discuss the pipeline. What’s coming down the road, long-acting therapies and injectables, and so on? What does the promise of the pipeline mean to you guys? Where do you think the most promise is? What are you looking forward to in terms of how those things can help address the barriers that we’ve been discussing in terms of people getting on or staying on PrEP therapy?

Jeffrey Crowley, MPH: I’ll jump in. I’ve done a little work trying to get ready for the policy implications of these new long-acting products. I’m very excited, but I also think, it’s interesting when we have payers represented, I don’t think we’re just going to open the flood gates and every PrEP candidate or person with HIV is going get the most expensive product. Interestingly, before she became the CDC [Centers for Disease Control and Prevention] Director, Rochelle Walensky, [MD, MPH,] did some modeling work on this. If we say sort of generically within the HIV community that not everybody is going to get access to a long-acting product, we worry that people who need it the most will be least likely to get it. Let me round some numbers here. I think her work assumed an antiretroviral therapy regimen of $25,000 a year. She, I think, found it would be cost effective to the health system to give it broadly to everybody if the cost of the drug was $29,000. These products will probably be more than that. But she found with a cohort of people who are homeless, it could be $100,000 and cost effective. I think in more of these kinds of studies you’ll find similar analyses showing that for young Black and Latino gay men who really need PrEP, the cost could be more effective if we focus on some of these longer-acting products that could improve adherence and persistence for them without thinking we’re just going to give it to everybody. However, I also think there are so many questions about will it be acceptable to individuals, will it be acceptable to providers, and will they have access? The differences in our health care programs, Medicaid, Medicare, and private insurance will have very differential access, and I think there’s a lot to work through before we get to a great new place. However, I’ll say I’m really excited about the promise of these new technologies.

Neil Minkoff, MD: I’m going to take what you said, and I’m going to put Ryan on the spot here. There is a tension between the U.S. Preventive Services Task Force and the need for zero co-pays, zero cost-share preventive services, and then when you start to get into management of what qualifies for that. This is probably not a great analogy, but it’s the one that occurs to me, you don’t necessarily have the same rules that you would for Cologuard, for a colonoscopy, as a preventive service. There’s the ability to manage as long as something is being covered for colon cancer screening. In a preventive service where you are dealing with a zero cost-share as a payer, are you going to be managing the differences between the types of PrEP, or are you going to feel like you don’t have a lot of options for managing that? Again, I’m putting you on the spot, and you can answer that as broadly as you can. I’m not asking for official policy from your organization.

Ryan Bitton, PharmD, MBA: I wouldn’t give this as official, but I think something to consider is that, for example, if you’re thinking about birth control or other things that have lots of options, from a management perspective, we attempt to manage because there are a lot of products that could take advantage of task force recommendations that raise costs but provide no additional value. I think that’s where we try to build systems and make decisions that make sure we have valuable products made available as recommended. I think that, not that our hands are completely tied, but if we were to get 4 once-daily pill options for PrEP, and even with the 2 we have currently, there’s opportunity, potentially, to manage. I think it’s more difficult when you’ve got, let’s say a once monthly injection, or biweekly injection, or every 3-month injection, it’s tough to say, well we’re going manage by preferring a daily pill. Who knows what’s going to happen? I think pricing is an important consideration when we go forward with this, but yes, I think we look to provide options. The contraception area is a great way to look at it. There are a multitude of ways to have contraception, and we offer those. We offer all of those options, not all the products on the market, but all those options are available. I think that’s probably a good framework in which to look at it. We want to manage, but we’re not going to overly manage it because these have got a recommendation from the task force.

Carl Schmid, MBA: I’m really looking forward to the new opportunities for PrEP, and the next one is most likely a long-acting injectable. The interesting thing about the PrEP out there and what’s on the horizon, is we know the prices already because they’re treatments. They’re used for treatment, and we know how to implement them. We still have to go through a U.S. Preventive Services Task Force review for those, which will take time. First, it has to be approved by the FDA. Then, it has to be vetted through the U.S. Preventive Services Task Force; I hope before that, plans will cover it. They already are for treatment. However, usually what the U.S. Preventive Services Task Force does, they not only give you the zero cost-sharing, but for birth control, for example, there’s 17 different types of birth control, and the plans are required, I believe, to cover at least 1 option within those different types. Ryan correct me if I’m wrong on all of this, but I would anticipate, and this is where we need federal guidance as well, that they will ask the plans to cover, within each type of PrEP, at least 1 of them. That would be my hope, and that’s also based on past preventive services. I think that’s what they’re requiring of the plans.

Ian Frank, MD: I would say I hope that plans include at least 1 long-acting option. The study that was done that compared an every-2-month injection versus a daily pill showed that an every-2-month injection is more effective than a daily pill. This is not going to be an area where I think we’re going to have a lot of me-too products. I think there will be a number of long-acting options. We may see injectables that can be given every 6 months. We may see a once-a-week or once-a-month pill. We will see implantable products. Thus, they’ll be a variety of different kinds of options. From a provider’s perspective, it’s great because there’s something I will be able to offer any of my patients that they will be willing to choose. It’s always bad when I’ve offered somebody a choice, and then they go to the pharmacy and they learn that’s not a choice available to them. A lot of times the difference in cost in a real-world sense, not an individual person, but how it’s affecting anybody’s profitability, is marginal. I don’t quite understand how sometimes formularies get constructed, and I’m often being asked to write prior authorizations that seem silly to me quite honestly. I wish some of the insurers would think through these in a clearer way, and not look at it and say, “Oh, we could save $50 a month here or there,” because in the long run I’m not sure there’s much cost savings that end up happening, and a clever provider can always figure a way around it.

Transcript edited for clarity.