Using Real-World Evidence for HIV PrEP Policies

EP: 1.Introduction: From Evidence to Implementation: Clarifications Around USPSTF Recommendations for HIV Pre-Exposure Prophylaxis (PrEP)

EP: 2.Uptake of HIV PrEP Therapy

EP: 3.Unmet Needs for HIV PrEP Therapy

EP: 4.Barriers to Access for HIV PrEP

EP: 5.Overcoming Barriers to Access HIV PrEP

EP: 6.Role of USPSTF Guidelines for Access to HIV PrEP

EP: 7.Implications of USPSTF Grade A Rating of HIV PrEP

EP: 8.Understanding Implementation of USPSTF Guidelines for HIV PrEP

EP: 9.USPSTF Guidelines for HIV PrEP: Coverage for Drugs vs Ancillary Services

EP: 10.USPSTF Guidelines for HIV PrEP: Using Medical Management Techniques

EP: 11.USPSTF Guidelines: Approaching Optimal Therapy for HIV PrEP

EP: 12.Unmet Needs for USPSTF Guidelines for HIV PrEP

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EP: 13.Using Real-World Evidence for HIV PrEP Policies

EP: 14.COVID-19’s Effect on Access to HIV PrEP Therapy

EP: 15.Improving Access and Uptake of HIV PrEP

EP: 16.Overcoming HIV PrEP Access Barriers With Advocacy Groups

EP: 17.Key Takeaways for the Management of HIV PrEP

Ryan Haumschild, PharmD, MS, MBA: Those optimizations make me think of future opportunities too, because we continue to see PrEP [pre-exposure prophylaxis] developing, not only from a medication standpoint, convenience, policy, implementation by payers and providers, but this brings up a great point, what are those future opportunities, and how do we improve PrEP uptake now that we’ve done this work? How do we build off our first area, talking about how we improve access? How do we improve requirement of coverage? And how do we even move forward on that? What are those future opportunities to identify and make sure the right patients are utilizing PrEP therapy? Many of us play a role in this, but I want to start with the payer and look at Ryan, and at your organization, what type of decision-making do you utilize? Do you utilize real-world evidence when creating policies for PrEP agents at all? Is that how you go about looking at some of these policy updates and how you operationalize these recommendations? And what kind of information do you as a payer find helpful as you’re developing your policies?

Ryan Bitton, PharmD, MBA: Great question. I wish we had an alternative world to run types of analyses on our data and look at national trends and investigate real-world evidence of data surrounding that. It’s not necessary to create some of these policies of product A being preferred over product B, and the exceptions when you use product B. You don’t need real- world evidence to do that. But as we move forward and we look at these and think, “Now, we’ve got some long-term options, we have more options,” it’s finding the right therapy for the right patient, and what benefits the health system the most in these general patient populations. Real-world evidence is going to become more important as we look at talking about adherence, we’re talking about follow-up, we’re talking about self-administration, going to the office daily, monthly, 6 months, whatever. That’s going to become more important as the data evolve on what do patients use and use best, and how does that work. In the future it’s going to become more important. I think up to this point it hasn’t been overly necessary for policy creation.

Ryan Haumschild, PharmD, MS, MBA: Even building upon policy creation, the future is we’re looking at the value medications provide, not only as providers but for payer organizations. We want to know, is this medication going to cause more adverse effects that are going to cause more outpatient utilization that we’re going to have to pay for? And when you look at these therapies, do you consider sometimes characteristics around pill burden, adherence, things that’ll drive adherence, that’ll drive compliance, that’ll reduce some of those negative adverse effects? Or do you even consider doing analysis sometimes when you’re looking at medications between a therapeutic area and looking at total cost of care and which medication may reduce total cost of care to the plan and to the health system? What kind of analysis do you do, Ryan, and maybe you don’t do it for PrEP, maybe you do, but do you ever incorporate total cost of care when you’re trying to preference products? And what are some of those unique considerations that you look at when there’s maybe multiple agents within a therapeutic area?

Ryan Bitton, PharmD, MBA: That’s a big question because there are a lot of ways to come at this. Pharmaceutical manufacturers have done lots of analyses around total cost of care in all diseases, and I think that we can look into our own data. We can do that and see what does it look like, it’s not to be siloed. Let’s look at medical costs, let’s look at pharmacy costs, let’s look at the patient experience. How often are the people having to engage in care? That’s going to be a consideration going forward. I’m not sure that we’ve done that specifically at this point because I’m not sure what we’d get out of it at this point, but we can as it grows. There are third-party organizations that are looking at the value that a specific product will bring and is the price appropriate, and things of that nature.

While we may not do a lot of the total cost of care for every drug, every category on our formulary that we cover, it’s very interesting to understand whether the outcomes are there. You mentioned how when we are comparing 2 products, we look at the adverse effect profile and the tolerability, and the mechanism of action, route of administration. Yes, all of those come into it because there’s no point in choosing a product or preferring a product that has lots of barriers to use and that no one wants to use. Many times it’s hard in the system, and we feel it from a PA [prior authorization] appeal perspective, and it doesn’t end up being an inappropriate strategy. We do balance those things, and if we can see,we don’t really want to hurt someone’s kidneys other than they are already, so let’s do the right thing from a long-term total cost of care perspective. I think some organizations are better than others at that. Those are my thoughts, I hope I answered the question.

Ryan Haumschild, PharmD, MS, MBA: I appreciate that. That’s the decision-making that we’re all trying to look into, how to reduce the burden on the health system, make a pharmacoeconomic responsible decision when preferencing products, and realizing what are the data you look at. You mentioned external organizations, does ICER [incremental cost-effectiveness ratio] come into play? Do we leverage real-world evidence when available? That’s what we were looking for, and I appreciate your thoughts on that.

Transcript Edited for Clarity