Specialty Pharmacy Benefit Management With AscellaHealth

Winston Wong: Welcome to the Journal of Clinical Pathways. My name is Winston Wong, Editor-in-Chief of the Journal, and I will be moderating today's discussion.

I'm joined today by Dea Belazi, President and CEO of AscellaHealth, a leader in specialty pharmacy benefit management, based in Berwyn, Pennsylvania. You may be thinking that Ascella is simply another specialty pharmacy, but I can tell you that they are not.

Dea will be sharing with us today what differentiates Ascella from the rest of the market and why the services he provides is important, especially as we enter this era of new and pricey gene therapies.

Dea, can you please tell us a bit about your background and a bit about AscellaHealth?

Dea Belazi: Sure. First of all, thank you, Winston. It's, obviously, a pleasure to be with you and to have this discussion. Super excited about that.

I'm a pharmacist by training. At Ascella, when we started this business about eight years ago or so, we were looking at trying to offer the marketplace a different model, in terms of prescription drug management.

I would say about five years ago or so, we pivoted and came to realize that specialty, to say that it's out of control might be a bit passive, but we've realized that specialty pharmacy requires additional focus, even to the level of disease states.

Putting together programs, both clinical, administrative, financial, and others, to tackle all the different aspects of specialty pharmacy, both, to your point, whether it's gene therapy or even some larger and more common diseases and disorders that have use for these innovative products.

Rather than coming to the market to say, "No, let's try to limit use," let's try to create a better model out there.

That's been the backbone of what we've been trying to do over the years with Ascella and are continuing to innovate about, how do we help the broader health care system manage specialty pharmacy?

Dr Wong: It is great. Thank you for joining us today. Let's start with maybe talking about that better model and maybe going into a little more detail of the basic services that you provide and what value does that provide to your customer base.

Dr Belazi: If you think about our overall approach is to take a deeper dive into specialty. Again, whether we're talking about autoimmune to SMA and anything in between. What does that involve, is our focus, we're not focused on, "Hey, this is not good. It's not important." Hypertension is an example or things of that nature.

We have an extremely experienced staff in these both rare diseases all the way to more common diseases, in terms of autoimmune conditions, etc. We have the same capabilities, if not perhaps even better, as it relates to technology, claims adjudication services, both on the medical and the pharmacy benefit. We don't differentiate the two.

If a patient has to be infused by a product or a medication that needs to be administered by a health care professional all the way to something that's an oral pill, is not a challenge for us. We have created processes, workflows, and use of technology and other things to manage all of this. That variability doesn't affect it, and we don't care.

At the end of the day, whether there's a medical or pharmacy benefit in the sense that that inhibits our ability to manage these conditions, these patients, providers, and so on and so forth.

To that end, we've built a significant specialty pharmacy network that encompasses all medications. We have access to every pharmaceutical product, again, whether it's intended to be infused or administered by the patient themselves.

We have access to ambulatory infusion sites throughout the country, so we can facilitate patients, perhaps managing site of care, out of hospitals or more expensive areas and moving them to the home, or perhaps these ambulatory infusion sites and reduce costs and provide better service offering.

We've had a lot of traction over the past year, particularly around COVID, with folks wanting to be serviced at home. The home model has continued to accelerate.

If you think about our approach to the patient, which is what I'm proud about, is that we have a whole hub and work and coordinators —we call them specialty coordinators in our organization—that get to know the patient.

They are their gatekeeper in the sense that they're their coach. They're there for them to help them, whether in getting an appointment at the doctor's office, scheduling that next refill, finding a place where they could be infused, and all the dynamics that could cause in between. "I can't afford my copay." "Well, let's get you enrolled into a copay assistance program."

If you think about having that level, one-on-one coordination, is a big part of that. What we're also trying to do is make sure the patient has the best experience.

If they don't feel like calling us, that's OK. Text us. We have a secure text platform. Text us, ask us those questions. Our folks will either call you, or text you back, or call your physician or your provider and help coordinate care.

Those are some of the things that I believe differentiates us. Obviously, in addition to all of that, our pricing. We've had so much tremendous success going to employers, and health plans, and other payers and offered them a better price, which is a big part of this.

Being a managed care or a payer in my previous roles, that was always the big thing, and it continues to be so. This is the big issue with specialty. For us, it's, how do we affect the patient, how do we improve quality, and obviously, how do we bring the cost down?

Dr Wong: Thanks, Dea. That was a great explanation and covers a lot of, at least from what I know of AscellaHealth, that's what differentiates you. You talk about managing on both the pharmacy side and the medical side.

Are there specific categories that you focus yourself into, or are you pretty much whatever the needs of the customer are?

Dr Belazi: I will say it's whatever the needs are. Obviously, we, like many others, obviously, there's challenges in certain therapeutic areas or conditions. Oncology comes to mind, albeit it's much easier to manage oncology today than it was five or even ten years ago.

I will tell you, we have some very unique programs in areas like hereditary angioedema, or HAE. Hemophilia is another one. That's particularly on the medical side, so your infusion products, Tysabri, Ocrevus, so on and so forth.

We have some very unique programs. When I say unique, both in the sense of patient engagement, as I mentioned earlier, where we're engaging the patients, also additional clinical support and services.

We've done a very good job in combining with our specialty pharmacies in our network to say, "All right, if you guys do these three things really well, we're going to add two more things and do it in a complementary fashion so the patient doesn't feel like they're being bombarded by five different organizations, and phone calls, and so on and so forth."

Again, we have, and I would even say rare diseases. Things like mucopolysaccharidosis or SMA, things of that nature.

We're taking some extra steps, because, again, we get called, or at least the phone is ringing, or we're asked by our customers and say, "I've got a really expensive case. It's a multimillion-dollar a year HAE patient, or hemophiliac, or SMA patient that I'm about to provide or approve a two and a half million-dollar product gene therapy for."

We will get deep into these, even on a case-by-case basis. If we have to adjust or create additional pathways for our existing models to facilitate, we do that pretty quickly and dynamically and not have to create a cookie-cutter model and force our customers, our patients, our providers into that.

Again, it is broad, but we do have some very strong expertise, again, in areas like HAE, hemophilia, and orphan and rare disease conditions.

Dr Wong: You're definitely talking different categories and different therapeutic areas that I know that keeps my colleagues awake at night trying to figure out how to go and work through the process and finance them.

With all the services that you provide, do you find that the services that are in need differ by the different lines of business that you help support?

Dr Belazi: The answer is yes. We do have different approaches, financial, administrative, and clinical, depending on the line of business. These vary, whether it's Medicare, Medicaid, and commercial.

I would even say there's even subtlety differences within commercial, for example. Even within Medicare, whether we're supporting a PDP plan or an MAPD plan. Whether we are in the commercial side, whether we're talking to a large employer versus a smaller employer or a third party administrator versus a health plan. There are some variabilities.

I would say we're still learning a lot of this, because I would almost say that every health plan or every TPA and employer is unique to its own end.

That's what's exciting about what we've been able to do is that we pivot well, we're very flexible, and we create customized solutions almost on a weekly basis to support whatever those questions or dynamics that our clients are providing to us.

Dr Wong: One of the buzzwords of this particular era, and especially as we go into the specialty pharmacies, and because of the financials that are involved with these new drugs and therapies, is the concept of value-based contracting.

Is this something that Ascella pretty much can become a part of, or they support, or even administer?

Dr Belazi: The answer is yes. I would say this is probably what we see today and going forward being perhaps the most exciting, call it evolution to what we're doing to the specialty pharmacy and even pharmacy business as a whole.

We are, today, significantly engaged, both with pharmaceutical manufacturers, with payers, as being that coordinator of taking value-based contracts and agreements and applying it with additional discounting models, financial models.

Being that organization that's managing this, that's facilitating either both the positive outcomes and the negative outcomes and connecting the dots together. This is what's going to be a big part of this.

If you think about where therapeutics are going, the day of the five-dollar pill is long behind us. The idea of these higher, more innovative, whether it's gene therapies, cell therapies, and even ultra-expensive specialty products for patients that cost up to a million, if not more, a year.

There has to be some, in essence, value-based or outcomes-based or warranty, for lack of a better term, that further proves and suggests that, "Hey, if I'm going to spend a million dollars or seven figures on a therapeutic, for whether rare condition or not, it has to work. It has to work. It has to provide value and there needs to be a sense of responsibility for that."

That's what's amazing. We're in these discussions, we're administering some of these now. We're, in a big part, going to be doing a lot more of this over the rest of this year and into next year as our new value-based and alternative payment models are being launched into the industry.

Dr Wong: Two of the barriers that I keep on hearing as I talk to our colleagues when it comes to value-based contracting is, first of all, trying to go and develop the metric per se of whether the therapy has provided the intended clinical outcome or not.

Depending upon what the follow-up period is for that performance-based, it's the actual follow-up of that patient to make sure that the clinical impact did materialize. Is that something that you also support as part of your value-based contracting support?

Dr Belazi: It is. What we've been able to do is try to change. There's all different types of cases of these.

If you think about SMA with a Zolgensma being a one-time infusion to more of a chronic-based condition where somebody's getting millions of dollars of hemophilia factor on an annual basis, every month, every week, whatever the frequency is, those are very much two different models or two different cases.

If you think about the idea of an episode of care and if you think about the challenge, whether you're spending half a million, or a million, or two and a half million, it's a lot of money.

Us, as an organization, to your point, managing that patient, being a hub, not just for the payer, as us administering and managing that patient, but also for the pharmaceutical manufacturer...Even today, many of our discussions have been, they want these therapies. They do feel a sense of responsibility that, "If I'm going to charge seven figures for a product, we want it to work." They want to take some responsibility for when it doesn't work.

We're in a great position to be on both sides of this, to both manage the patient and make sure that we're following up, reporting these outcomes, and, in essence, activating those value-based contracts and facilitating that back and forth. That's an important piece, as you've stated. It is a challenge, but we believe we've figured out a lot of this.

A lot of that has to do with, how do we pay for these products? How do we create an episode of care where it's not just a one and done, even in that Zolgensma example, where we are looking at the patient, we're evaluating the patient months, if not years, after that infusion to make sure things are going according to plan?

Dr Wong: A good portion of our audience is focused in on oncology. You touched upon it that, within oncology, we have five CAR-T gene therapies that are now approved by the FDA. The administration of CAR-T product is not an easy one, especially from a payer perspective.

You've touched upon it already how you support the CAR-T therapies. For our oncology audience, can you maybe talk a little more about how you help streamline that process?

Dr Belazi: If you think about the basis of this, this is a very unique, very highly-structured therapeutic. You're not walking into your local oncologist office or a hospital to get these therapies. There are very limited areas. There are, in essence, centers of excellence that do these.

There's a whole bit of a process on how you get these, how you get this done, engaging the patient. There are situations where patients might have to travel to go to the appropriate option.

A lot of that, call it administrative, even in some extent, a clinical aspect, many of our customers don't understand that and have a challenge with, "Oh my God, I've got a prior auth here for a CAR-T therapy. I just know it's a half-a-million bucks or a million bucks. What do I do?"

Facilitating that, even with the logistics on that process and how to connect all those dots is extremely important. We do facilitate and help with that.

The next thing becomes, "Well, how do I forward this? As a payer, how do I pay for this?"

That's where we come in with some of our unique capabilities to create payment models that facilitate. They're not going to their stop-loss provider and getting this patient lasered out or having to get their premiums on a reinsurance or stop-loss perspective, doubling, tripling for that following year.

We created maybe a payment plan for those kinds of situations. Maybe you pay for this over the course of four or five years. Maybe we're able to work with those manufacturers and get an outcomes agreement along with that, in the event that there's a negative outcome that occurs, and there's a number of variations of what that might be.

Maybe they come in and provide some financial relief if the product doesn't work. These are the things that we come in that are additive to streamlining this process and supporting an organization, whether it's an employer, or a health plan, etc., to getting access to these therapies in the appropriate way.

It's a challenge. Our health care system is complex. When you think about CAR-T therapies, always a complex. There's a lot more, call it I's being dotted, T's needing to be checked. To support an organization that perhaps doesn't have the capability or the capacity to do that is a big deal.

Dr Wong: How do you get plugged into the CAR-T process? Is it the practice that contacts you to start the services, or is it the payer, or is it the patient? What I'm trying to ask is how do you get yourself into the process so that you can help streamline it?

Dr Belazi: A lot of times, if you think about our engagement is, in essence, with the payer, so whether it's the employer, or the plan, or the TPA. Then, what happens is, typically, a diagnosis occurs.

We're typically not seeing that just yet until the request of, "I need CAR-T therapy," as an example, or, "I need a therapeutic." That's when it hits our process.

At that point, we're reaching out to the provider, we're reaching out to the patient, we're facilitating, we're helping streamline this and provide the education and insight to the payer.

Again, whether it's an employer who, if you think about it, employers don't know anything about this, for the most part. Even large ones, where they may have a couple of CAR-T patients or patients that have gone through that process. This is a very technical model, and that's where we come in.

Generally speaking, a payer isn't just going to come and walk into our processes or organization. We're generally contracted with our payer customers, and then when they get those cases, we get referred to supporting them.

Dr Wong: The final question would be, with all of the work that you do, especially as we all try to go and make sure that the right drug is getting to the right patient at the right time, and with the focus of the Journal being clinical pathways, how do you think AscellaHealth supports the use of the clinical pathways with your customer base?

Dr Belazi: All in all, we are big believers in evidence-based models, and pathways, and treatment plans, etc. With that saying, as payers think about their policies, whether it's clinical pathways, or prior auth criteria, or medical necessity policies, etc., those are important to have those reviewed accordingly, gone through some formal committees and processes.

Being up to date, as it relates to whether it's guidance from guidelines and so on and so forth. At the same time, if you think about where we are as a health care system, we have some of the best health care on the planet. Some of the worst, but the fact that we have some of the best is because we're super innovative as a process or as a system.

That, trying a new therapy on a condition that maybe isn't necessarily indicated or has significant amount of literature on it, shouldn't necessarily be stifled all the time. That's our biggest thing is case-by-case assessment.

Understanding, getting involved with the provider, understand what's going on, and doing some extra additional homework, where if we need to reach out to a KOL in a particular area to further shed some light into potentially what's being asked for, then that's what we're going to do.

We're going to try to bring in as much resources, and education, and information to help create the appropriate guidance and support those pathways and criteria that help us make the best evidence-based decision.

That's been our philosophy as an organization is you try to create guidance in a general sense but have flexibility to pivot in any particular direction as the data is coming out, and be participating in that.

If we try to take more of a stern approach into things, we definitely will miss on trends or miss on the ability to pivot and see where the marketplace is going and being in the forefront of that. That's something that we want to make sure we're on top of and understanding how treatments, whether it's oncology to any other condition, for that matter.

We want to be on top of that and make sure we're in the know and adjust accordingly.

Dr Wong: Anything else that you would like to have our audience know about AscellaHealth?

Dr Belazi: As I mentioned, we believe we have an incredible solution and set of solutions that are unique to the management of specialty pharmacy, both clinically, administratively, and financially.

I would say we are developing new things every single day or every single month. That is our focus, almost exclusively, is the specialty pharmacy world. We will continue to do so as long as we can.

Dr Wong: Thank you, Dea, for a very informative discussion. It's clear to me that the services AscellaHealth is providing are innovative and are very much needed to manage these costly gene therapies that are approved today. We know that there are many more in the pipeline. As I said earlier, you're just not another specialty pharmacy.

As always, thanks to the Journal of Clinical Pathways for the opportunity to have this discussion. Finally, thanks to the audience for taking the time to listen in on this discussion.

For the latest updates on issues related to the development, implementation, and evaluation of clinical pathways, please check out our website at www.journalofclinicalpathways.com. Have a good day.