AMCP Podcast Series - Listen Up: Adam Hoye-Simek AMCP Format 5.0

Fred Goldstein 00:01

Hello and welcome to the ACMP Podcast Series Listen up as we take a deep dive into the challenges, trends and opportunities in managed care pharmacy. Follow the show's social hashtag at #amcplistenup and to learn more about AMCP, visit amcp.org I'm your host. Fred Goldstein. On this episode, my guest is Adam Hoye-Simek, senior pharmacy manager of utilization management at devoted health and current AMCP Format Committee member and incoming chair. Welcome Adam. 

Adam Hoye-Simek 00:32

Yeah, great to be here. 

Fred Goldstein 00:33

So why don't you give our audience a little sense of your background, and then a little bit about Devoted Health 

Adam Hoye-Simek 00:37

Sure. I started with Devoted Health Plan back in 2019 we had just over 2,000 members that year. It was me and one other pharmacist and a few technicians. Back then, we were doing a little bit of everything. I started our diabetes program that year. I was doing MTM calls. I was working with our PBM. I was calling members about medication adherence, you name it. I was involved in it. And then over the last several years, our membership's grown quite a bit, and I've settled into the pharmacy medical benefit. And so today I manage clinical strategy and operations for the pharmacy medical benefit. We're Medicare Advantage, so it's everything pharmacy under Part B 

Fred Goldstein 01:15

that's got to be pretty comprehensive. I think, with the Medicare population, 

Adam Hoye-Simek 01:18

It's a busy day on most days. So yeah, it's a lot 

Fred Goldstein 01:22

Fantastic. And talk a little bit about the AMCP committee and their review with the Format Committee, 

Adam Hoye-Simek 01:29

Sure. So I joined the committee about two years ago. Over the last couple of years, we've spent a lot of time working on the most recent revision of the Format, and so we targeted five different areas that we wanted to revise and work on in particular, and we broke into four subcommittees to focus on those five topics. And that's all we've been doing for the last couple of years. And the recent publishing of version 5.0 is a testament to that. 

Fred Goldstein 01:55

And tell us a little bit about what the Format Committee does. What is the Format? 

Adam Hoye-Simek 01:59

So the Format Committee develops the Dossier Dormat for how manufacturers share information with healthcare decision makers. It's a platform for efficient exchange of scientific information about pharmaceutical products. It describes the evidence required by healthcare decision makers to support formulary and coverage policy decisions. Within this framework, manufacturers share all the comprehensive clinical and pharmacoeconomic information data with healthcare decision makers, including off label information, which is, which is a really nice part of this. 

Fred Goldstein 02:32

So this is done by the manufacturers. And then you, as a health plan, get these dossiers, and then you can review it to make decisions regarding the products. 

Adam Hoye-Simek 02:41

That's right. Yeah, a lot of the pharmacists and health plans who are working with P and T committees or utilization management committees, when they're gathering all the information they need to present to those committees, they use this format and dossier that they get from the manufacturers to start compiling that information.

Fred Goldstein 02:55

And what are some of the differences that came out in the newest version, 5.0?

Adam Hoye-Simek 03:01

Yeah. So we focused on for 5.0 we focused on five different areas, digital therapeutics, health disparities, how to incorporate PIE Decks, and then Real World Evidence. We were really focused on that. And then we also wanted to streamline the format as well, so we get a lot of feedback that it's too long. A lot of these can be upwards of 100 pages long, sometimes a lot less than that, but it can vary quite widely. So we wanted to be able to shorten that if we could.

Fred Goldstein 03:27

And you mentioned PIE? Obviously, we're in New Orleans, the beignet capital beignets is here. But what is PIE? Talk about that a little bit 

Adam Hoye-Simek 03:34

Sure. Yeah, I had a beignet today. Delicious. So yeah, for PIE decks, with the with the PIE Act that was passed in 2022 we were getting a lot of questions about, how does that fit in with, with what the format is intended for, and so AMCP recommends that manufacturers provide healthcare decision makers with unapproved product and unapproved use dossiers six to 12 months ahead of time. It kind of there is some overlap with with how PIE decks work,

Fred Goldstein 04:03

and this really came from the PIE Act, which was Pre-Information Exchange and allowing the the manufacturers to begin to provide information earlier in the process.

Adam Hoye-Simek 04:12

That's right, yeah. So how do you make sure that more information exchange happens as early as possible in the process? So when all the different committees that are working on coverage policies are looking at budget forecasting, how do they manage to do that appropriately? And so the format committee was in the dossier that we produced was originally meant to be, you know, approved product dossiers and getting that out, but now people want more and more information earlier in the process. And so the format was working on that, and then the PIE legislation really helped nail that down. 

Fred Goldstein 04:41

Yeah, I would think as a health plan, it's a little bit difficult to suddenly have the information when the product's released and then say, how do we plan for this? How to actually work with this? How do we budget for this?

Adam Hoye-Simek 04:51

Exactly, yeah, a lot of economic modeling. 

Fred Goldstein 04:53

Yeah, excellent. And talk some about the digital therapeutics area and addressing that, because obviously that's a hot topic right now. Now we're seeing a lot of companies try to get into this space. Obviously the requirement of FDA approval for approved digital therapeutic, but talk some about that. 

Adam Hoye-Simek 05:08

Yeah, digital therapeutics was a really cool topic to start looking at again. We started this process a couple of years ago, and back then, digital therapies were coming out and scaring a lot of people, so it was really fun to start digging in and figure this part out. We were getting feedback from both manufacturers and for payers on you know, how do we deal with prescription digital therapeutics? Can these be in dossiers Where do Dossiers  not quite fit the perfect image for prescription digital therapeutics. And so, given the breadth and the volume of the digital therapeutic space now, with how many products are becoming available, standardized resources are really critical to allowing the healthcare decision makers to be able to evaluate those and get pharmacists and physicians a lot more comfortable with how to handle them and build them into treatment regimens.

Fred Goldstein 05:51

And before we get on the next sort of area you worked on within the dossier, what are some of the areas that that covers? What sort of information is put into that by the manufacturer for the health plans to take a look at.

Adam Hoye-Simek 06:04

Yes, there's six sections in the in the dossier. Section One is the executive summary, just kind of a high level overview of what we're working with for that product. Section Two is product information and description, as well as disease description for the product. And then the approved product dossier will also include some additional information in that section about place and therapy. Section Three is clinical evidence from the research studies by the manufacturer. Section Four is the economic section, so projected pricing for unapproved products, and then the approved products will include pricing, value assessments and economic modeling. Section Five is really great section it's actually a summary of the other clinical information outside of the original research studies, so things like guideline recommendations, systematic reviews, compendious support and effects on equity. And then section Six is appendices. That's where you'll see stuff from PIE Decks and for things like prescription digital therapeutics.

Fred Goldstein 06:57

So it's really a comprehensive information system to get this information from the manufacturers to the plans, so you can then make rational decisions regarding how you're going to work with these products , and cover.

Adam Hoye-Simek 07:08

It is, it is a lot of times it can be almost all you need to really make a decision in a policy committee.

Fred Goldstein 07:13

And you mentioned also Real World Evidence . Obviously, that's of great interest to me as a population health person. You do clinical trials. You have the random control trial. Here's the product, here's what does, but then ultimately it gets out there in the real world. So what are you looking at from that perspective?

Adam Hoye-Simek 07:26

Now, yeah, Real World Evidence  was previously discussed in the format, but we expanded quite a bit on this topic. The definitions of Real World Evidence and real world data can be found in the in the format now. We pretty much made Real World Evidence  synonymous with other types of commonly accepted forms of research. So now, anytime you see randomized control trials or perspective or retrospective studies, we've added Real World Evidence  and how that fits in. So before, Real World Evidence  is kind of sparsely mixed in here and there, and now you'll find it just about everywhere we're talking about clinical evidence, we expanded what sources of data may be an option, so data from chart reviews, medical and pharmacy claims, electronic medical records, product and disease registries, things like that. And while, while the data may be more limited due to quality and it's because of its observational nature, it may enhance the robustness and transparency of the modeling, we think that Real World Evidence  can be a good supplement to randomized, controlled trials, as it may include a larger population and more accurately reflect the real world treatment conditions, right,

Fred Goldstein 08:22

right? That's That's excellent. And then the other area you mentioned was this whole issue that's really come to the fore now, and appropriately so is, how do we reduce health disparities, and how do we make the system work better for individuals, so that we can reduce that? Obviously,

Adam Hoye-Simek 08:36

yeah, health disparities are really important topic, so phase three trials and cost effectiveness analyzes typically do not address the barriers to equitable use of these products, things like access to specialists, stigma, social and demographic barriers, like race, ethnicity, gender, income, geographic region, things like that. So when manufacturers are thinking about a dossier and whether a product is meeting an unmet need, well, we want them to address the traditional unmet needs. We want them to address those related to health disparities as well. So we've suggested places where studies on pharmacoequity can be included.

Fred Goldstein 09:09

You've been on this committee for a while. I can imagine the workloads rather heavy compared to some other committees.

Adam Hoye-Simek 09:15

It is, it is, yeah, breaking it down to the subcommittees was great. So we could really focus on the the issues at hand. It's definitely a lot of work for this committee, but it's the committee for the last couple years has been filled with really great people, and we have a great committee starting again here in April. So the people on the committee are so qualified for this work to really be able to do it the justice that it needs.

Fred Goldstein 09:37

That's excellent. As you think about this, obviously a lot of work for you, but you also talked about streamlining it, because that's a lot of work for the manufacturer too, as well, right? 

Adam Hoye-Simek 09:47

Yeah, it's a lot of work for the manufacturer to put together, and it's a lot of work for the payers to interpret. It is really robust, but a lot of work nonetheless. So we presented ways for the dossier to be more succinct. We don't want manufacturers repeating information. Across the dossier, payers have also provided a lot of feedback that these can be a bit long, so we tried to remove some redundant directions and explanations. Also, a big piece of this was hyperlinking, and so instead of copying and pasting a lot of information from an external document, can a manufacturers include the hyperlink to that external document. Links can be broken over time. It takes some work to maintain, but this was a priority for both manufacturers and payers to get hyperlinking in there, so we accomplished that this time. 

Fred Goldstein 10:26

I think about this, and it's not really a one and done, right? So if a manufacturer does this, they need to update it over time as things change or new data comes in, right? 

Adam Hoye-Simek 10:35

That's right, yeah, it does need to be updated from time to time. We leave that to the manufacturer's discretion. We don't have strict instructions in there about when it needs to be updated. So if a new phase trial comes out, if significant, publishing comes out with guidance, those are good times to update it. Anytime a new guideline is published that may change how much a drug is recommended that can certainly do it. Clinical areas that previously didn't have treatment options are big ones. So if you're getting an expanded use into a new area. That's great. And so, yeah, we leave it up to the manufacturer's discretion, but they're pretty good about knowing when that new information is needed, or they'll definitely hear from the healthcare decision makers when they need those.

Fred Goldstein 11:13

Well, really fantastic. A great overview of the whole process and the committee's work to get these dossiers out in the new format, 5.0 so I want to thank you and congratulations, I guess, as you're the new chair of this committee coming up, and also for your work at devoted fantastic. 

Adam Hoye-Simek 11:28

That's right. Thank you so much. We're really excited about this version 5.0 and we're working on disseminating it in the in the near future. So it's very exciting.

Fred Goldstein 11:37

And thank you for joining us today. If you like this show. You can find all our episodes at amcp.org/podcast, on our show page at HealthcareNOWRadio.com or on your favorite listening platform by searching Healthcare NOW Radio. You can follow our show's social hashtag at #AMCPListenUp and don't forget to share, like and follow amcporg, on LinkedIn, Twitter, Instagram and Facebook. I'm Fred Goldstein for AMCP, until next time you.