Interview With Maria Lopes, MD, MS: Payer Considerations in Treatment Selection for Atopic Dermatitis

I'm a physician by training, and I've been on the payer side for a very long time. So part of P&T (pharmacy & therapeutics) committees as we look at what's the value of a new treatment and also [who the treatment is] for. And also looking at the clinical data, the clinical comparators assessing efficacy [and] safety of a product, where it should be used, and in the context of patient safety, clinical effectiveness, the severity of the condition, as well as unmet need. And then ultimately also, what's the budget impact, especially if we're looking at biologics, what's the budget impact of a biologic overall [and] the impact on formulary and ultimately how we make decisions as well as ultimately also how we justify to employers what our value is in developing authorization criteria.

Treatment guidelines certainly have a role in defining a standard of care. As payers, we want to make sure that we are evidence-based. Also to the extent that guidelines are specific about what to use and when, those can be very, very helpful in helping us...reframe [and ask] "where is the treatment appropriate? Where is it not appropriate?" On appeal, if we don't have updated guidelines, that can sometimes be a reason why appeals end up getting reversed. So it's important for payers to understand if there are updated guidelines, and especially if they're based on and grounded on evidence-based care and good data that suggest what to use when and for whom. As well as that helps us understand maybe sizes of populations and how that may impact budgets, but fundamentally also sometimes the cost of failure. If we're using alternative products and they're not safe or they're not effective, it helps to contextualize again, right treatment, right approach in the right setting and at the right time.

Well, other considerations are the comparative efficacy. We don't many times have head-to-head trials, so we rely on indirect comparisons across different trials. We look at H bands, we'll look at the delta in terms of scales that were used, we look at [if there is] a clinically meaningful difference and things like EASI (eczema area and severity index) scores and itch scores. We sometimes have to learn what these scores even mean and what is a clinically meaningful difference? As we look across different trials, that's also important because these are in direct comparisons. So at the end of the day, we're looking at deltas vs placebo and try to understand is there a real difference or not. And then there's safety considerations. So if [a] product has REMS (Risk Evaluation and Mitigation Strategies), it has a lot of safety concerns. It's sometimes difficult to, even if at a lower price to say, step through the product that has a lot of safety issues. But we may leave it more open and at the end of the day, that product is allowed by the prescriber if they see fit. And many times, the similar PAs apply across high-cost products, which in this case it's not uncommon again to have the corticosteroid step, the calcineurin step. And then at that point, perhaps leave it open. This could be subject also contracting in terms of which products are preferred, non-preferred, even by mechanism of action, which ones you're preferring, including the JAK (Janus kinase) [inhibitors]. But at that point, leaving it perhaps more open for the provider to decide, do they want to use a JAK? ...JAKs are usually used more third line because of safety considerations. But if a payer has a contract in place and it's a preferred JAK, the PA can be left open in terms of do you go to an IL (interleukin), do you go to a JAK at that point, leaving it more open for the prescriber to decide which treatment option they want to use, as long as you've sort of stepped through the background of lower-cost agents that are common to a lot of the higher-cost products. And again, some of this behind the scenes is driven by contracting some of the products that you mentioned. One of them, dupilumab, has lots of indications, not just atopic dermatitis. And some of these [have] bigger indications including asthma, corticosteroid-dependent asthma, etc. So market share is important, contracting is also important as we think about one product that does multiple things.

So it's interesting how payers utilize ICER (Institute for Clinical and Economic Review) reports. I think we look forward to ICER reports. ICER, I think, is becoming more transparent [in]...their methodology for how they're looking at value from different stakeholder perspectives. I think at the end of the day though in a P&T committee or medical policy committee, we incorporate ICER as a reference point, but it's very much business as usual. And by that I mean, if an ICER report helps us with looking at evidence-based care, look at total costs, look at if ICER report's very definitive about if the cost vs the value and the net price were to be a specified endpoint, that sometimes gives us a lot more leverage in terms of contracting or justifying how aggressive we are in terms of the prior authorization criteria. But if the ICER report leaves it open, then we may not even really even review it or devote much time in a P&T committee to ICER. So the best way to characterize ICER is if the end justifies the mean in using ICER, we'll use it. But otherwise, we'll do our own analysis, we'll compare across different treatment options. There's looking at efficacy, safety, net cost, and contracting is very much part of where product ends up sitting on formulary and where it's going to get used rather than relying on ICER.

For other articles and videos in this AJMC® Perspectives publication, please visit "Managing Atopic Dermatitis: Clinical Considerations, Payer Perspective, and 2024 Guidelines"