Breadcrumb
Biologic Options in the Evolving Immunology Landscape
Show Notes
Health care expert Fred Goldstein, host of the AMCP Podcast Series — Listen Up!, sits down with Michael Rothrock MHA, MBA, Former Vice President of Pharma Strategy and Contracting, Express Scripts and Chronis H. Manolis, RPh, Sr. Vice President, Pharmacy Services Chief Pharmacy Officer, UPMC Health Plan to discuss/explore the range of options for biologics available to treat immunologic conditions, including originator biologics, unbranded biologics, and biosimilars, and their impact on market landscape dynamic. This podcast aims to raise awareness and provide clarity among formulary decision-makers as well as health care providers around this evolving immunology market landscape and the impact to their business.
Transcript
[SPEAKERS: Fred Goldstein, Michael Rothrock, Chronis Manolis]
Fred Goldstein 00:01
Hello and welcome to the AMCP Podcast Series, Listen Up, as we take a deep dive into the challenges, trends, and opportunities in managed care pharmacy. Follow the show social hashtag AMCPListenUp. And to learn more about AMCP Visit amcp.org. I'm your host, Fred Goldstein. On today's episode brought to you by Janssen, our guests are Chronis Manolis, who is Senior Vice President of pharmacy services and the chief pharmacy officer at UPMC Health Plan, and Michael Rothrock, former vice president of pharmacy strategy and contracting for Express Scripts. Welcome Chronis and Michael.
Michael Rothrock 00:39
Welcome Fred. Happy to be here. This is Michael. I spent over 20 plus years in both the Regional Health Plan and National Insurance PBM industry with formulary management responsibilities, manufacturer contracting, and specialty injectables looking forward to the podcast.
Fred Goldstein 00:54
Fantastic, and you, Chronis?
Chronis Manolis 00:55
Yeah, likewise Fred, my name is Chronis Manolis and I have been with UPMC Health Plan as the SVP of pharmacy for 17 years, responsible for all aspects of the pharmacy benefit; prior to that worked in the PBM and specialty pharmacy industry. And looking forward to our discussion.
Fred Goldstein 01:13
Yeah, it's great to get you both on with all the experience you bring. So let's begin by discussing the three categories of biologics. We've got the originator, a biologic, a biosimilar, and an unbranded biologic. Perhaps you could start with what are they and how are they similar? How are they different? And why don't we go with you first, Michael?
Michael Rothrock 01:32
Great question. So, when we think about biologics in general, whether they are the innovator, a biosimilar, or an unbranded biologic, they're all reviewed kind of similarly, and I'm using that word very loosely within the P and T in the walls of the PBM. The indications are going to be critical; the interchangeability designation will be critical. The coverage and formulary access will be driven a lot by manufacturer relationships, pricing and contracting, and current volume on the market, whether it's an established brand and/or a new chemical entity, or a new biosimilar, or unbranded option. So regardless of the approval pathway, whether it is the innovator or a biosimilar, or an interchangeable designation, they still all go through our P&T. To us, they're the same to us in our P&T, they will be viewed as interchangeable meaning with whether we have to grandfather or not, will be based on the interchangeable designation. But our P&T committee does not believe we only have to influence new starts. We can switch patients if we so chose to do so on any patient today.
Fred Goldstein 02:43
And how about yourself, Chronis?
Chronis Manolis 02:45
Yeah, I mean, I agree with pretty much everything that Michael said, I think what I would add is that, you know, an unbranded, if it's coming off the same line, as the innovator product, you know, may provide at least emotional advantages. I don't know that it's gonna matter the P&T. I mean, it may matter to prescribe or as a matter, et cetera. But, you know, essentially, these are all products that we look at from a coverage standpoint. And it really again, depends on things like interchangeability, timing, indications, etc.
Fred Goldstein 03:19
And I think perhaps, Michael, you could discuss just the fact how are they chemically similar or dissimilar for some of the people that may not understand that?
Michael Rothrock 03:29
Well, chemically, they should technically be very similar, every biologic batch whether it's an innovator, a biosimilar, or an unbranded is going to have sensitivity as of the amount of true molecule in that batch because there's variations among batches. So from a chemical entity perspective, it doesn't matter if you're an infliximab and adalimumab. They're all still based off that core molecule, whether it's innovator, biosimilar, unbranded, the infliximab in my example, is still the core for each of them, how they're named, how they're designated, and the approval pathway is really determined from the FDA process. But our P&T and our payor community will view those as the same molecule. The differences are going to be A do they have a brand name? B, are they truly interchangeable at the point of sale, and C, formulary access and coverage is going to determine how a physician and or a patient is becomes aware of those three different types of entities, I'm sorry, product lines, innovator, biosimilar biologic, unbranded.
Chronis Manolis 04:41
And I would add this notion of extrapolation on indication will certainly play out if you think about interchangeability, everyone thought that was really a showstopper. There is an assumed interchangeability, to Michael's point, that they're all the same chemical, even an innovator is going to vary batch to batch. I think the indication piece is, you know, can you extrapolate indications, I think that played very favorably on the medical side of the house. And I don't expect it to be any different on the pharmacy side of where these products are used. So, to me, it's all about the chemical. And we're going to assume that it got through FDA approval that they're essentially the same.
Fred Goldstein 05:33
And when you think about it, I mean, maybe some people have not heard much about unbranded biologics, but obviously coming out, how are they in terms of safety and efficacy, as compared to the originator or innovator molecule?
Chronis Manolis 05:48
Again, I mean, they should be the same. I mean, that's, that's what, that's what the trials are for. That's why the data package that goes to the FDA is looked at, but unless you have some major differences, I would say in the manufacturing process, or different excipient ingredients, I would expect them to be the same.
Michael Rothrock 06:10
And this is why I would agree 100%. With that, I mean, the FDA is going to make that determination about if it's safe and efficacious, whether that's through indication they've studied and the extrapolation process. As long as we have that, we're off to the races, then to us as payers, and P&T committee members and influences for coverage. It's going to be determined by these are the same, the molecule is the molecule and we can intertwine them each amongst each other, whether that's innovator, biosimilar, unbranded, I think the hang up with an unbranded product is going to be won't have a name. So if it only comes out as a molecule name, maybe with a suffix at the end of it, and not a true brand. It's like the Field of Dreams. If you build it will they come. So if no one knows about it, and isn't promoting it that way, who's going to technically write it? So the physician awareness, the patient awareness, maybe a little challenge, unless that is being driven through a payor's formulary choice to drive that out in the marketplace? And I haven't seen that happen up to this point.
Chronis Manolis 07:17
And I just to add to that, Fred, I think there's two things. You know, oncology is arguably one of the most sensitive categories that we have. And I think you saw biosimilar adoption, just, you know, there was a little bit of hesitation, certainly no hesitation on supportive care agents like the white cell stimulators, etc. But even now, with the big products that are, you know, that are chemo, there was pretty widespread adoption. So that tells me the confidence level is there. And to Michael's point, on the unbranded, I think timing has so much to do with it. Right. If you come out as the last biosimilar, you've already the markets already been saturated? If you come out, you know, very the first, there may be some advantages that, you know, it may make for a more confident switch, particularly in areas like inflammatory disease, where you've got three physician specialties that are trying to all get on the same page around a specific product in their specific disease state.
Fred Goldstein 08:30
And you've touched on the health plan, looking at it, what are real points they should consider when they look at the is it price, what are they looking for?
Chronis Manolis 08:41
I think it's the same rubric. I don't think there's any different process. I think Michael described that, you know, we're going to put it through all of the typical things that we do, we're going to look at the clinical data package, make sure that it satisfies everything that we need. And then we'll look at the various other considerations, right? What's the disease specialty, do we see anything there? Is price in line, is it what we expect, all those kinds of things. You know, this isn't your, you know, your Lipitor that goes generic one day and within 30 days, you have 99% saturation, a lot more considerations here. And I think that doesn't change the review process just adds considerations. For example, you know, will the biosimilar manufacturer support the program like the innovator does from a patient hub and resources and education and all of those kinds of things, it has to be the same.
Michael Rothrock 09:46
And I would even add to that the unbranded biologic manufacturer needs to do the same type of support services, and how are they going to differentiate it versus maybe the innovator and what is their message out to the market in order to get physician uptake and buy-in, whether it's for established patients or maybe converted patients, so you got to build the resources around it in order to make sure that awareness gets out there because again, an unbranded biologic, can kind of sit on a shelf without any awareness, if no one's promoting it.
Fred Goldstein 10:22
As you think about that, you've talked about the health plan or the payer and or PBM, looking at this, what about from the physician or healthcare system perspective? How should they be approaching this?
Chronis Manolis 10:35
Well, you know, I, again, not to overcomplicate things, but you know, you've got medically administered biosimilars, and then you've got pharmacy dispensed. And so the added wrinkle when you have a health system that has revenue tied to some of these drugs, you know, they're gonna look, first and foremost, a lot of it is driven by the payer in their catchment area. That's what's going to drive the formulary. Now, they could have their own house brand, if you will, that they like to use when there's no specification or there's, there's no formulary involved, but from a prescribing perspective, and that transcends both of these, you know, they have to have confidence that what they're prescribing is going to be, you know, on par for the patient. You know, most physicians, it's certainly true in our world, a lot of physicians are in shared savings arrangements, partner arrangements, and they want to be a part of the solution. They can look at biosimilars as having less out-of-pocket for their patient, and less overall cost to the system in general. And so I think those are very powerful, but physicians, you know, they study the data they are offering and they go to their meetings, their society meetings, and you know, Europe has got a lot of data that's ahead of the US. And so what I've found is that there's a general general comfort level with biosimilars.
Fred Goldstein 12:09
Anything you'd like to add, Michael?
Michael Rothrock 12:12
The only thing I would add is, you know, we know biosimilars will have separate and dedicated J codes, so they can all be reimbursed on their own independent unit price based on the CMS regulatory per milligram dose, or whatever it is, and they're own ASP, but an unbranded does that fall under the innovator J code like a generic would, because if it does, then it's going to come down to the financials that a physician can ascertain through margin, if they can buy the unbranded version at a much lower price. And use that as their in-house as Chronis mentioned house brand product of choice for when they want to write that innovator product. So then they'll make more spread, they definitely have all the clinical buy-in and in the same as seen from the review process, and that they're going to do no harm to the patient and get the same outcomes. But there's an opportunity for them to get lift on the margin side, under the same J code as an innovator that at least until ASP catches up, they might be more influenced to do that, in the next few quarters until you know ASP kind of falls to match that new number.
Chronis Manolis 13:19
And that's one of the pitfalls Fred of medically administered J codes. You know, in pharmacy, it's a little easier. You've got an AWP and you've got a WAC on the medical side, you have everything from ASP-based reimbursement schedules, to percentage charges to everything. And so, you know, I haven't met a doc yet that will use a biosimilar that doesn't cost the patient less. And the variation and fee schedules that all of these payers have with health systems can cause some confusion. And then you overlay that with every manufacturer has their own strategy they want to go they want to go high ASP they want to go low ASP high WAC low WAC, and I think we have to do extra due diligence there to make sure that; I use a wheel when I think about how biosimilars get adopted. There's five key stakeholders, right? There's a patient, the physician, the health plan, the specialty pharmacy, and pharma. And, you know, can we check the box for all five of them, then we got a pretty good shot at getting, you know, real adoption there. Again, provided the drug is equivalent and clinically right and all those kinds of things.
Fred Goldstein 14:46
This episode of the AMCP podcast series, listen up on innovator biologics biosimilars and unbranded biologics with Chronis Manolis and Michael Rothrock, is brought to you by Janssen. Now back to the interview As we move to more value-based contracting, you've touched on this risk-based contracting is like that, does it make more sense to really investigate stuff like that and say, This is where we got to move with this within your plan or within your healthcare system?
Chronis Manolis 15:14
You know, and again, I know it's early, we haven't had a whole lot of appetite. You know, we've got a center for value-based pharmacy initiatives here at UPMC. Were our doors are always open and lights are always on. Right. But with biosimilars so far, it's been really a financial game, right? It's been, you know, where's the WAC compared to the ASP, etcetera? Will that change over time? You know, I don't know, Michael probably has good perspective on that as well. I don't know that. I think access is King right now. And I don't know that people were thinking about value-based contracts in that space.
Michael Rothrock 15:56
Yeah, I would add to this story, Fred, that Chronis hit it on the head here. From a biosimilar, innovator, unbranded competition, market basket. Pricing is really driving a lot of the decisions today in that in that environment, whether that's under the pharmacy benefit and or the medical benefit. When we talk about value-based or outcomes-based and there's very limited options in the market today, particularly in the autoimmune space. That's not the right model for this. I think a value-based outcome-based model kind of lends itself to be more fruitful for discussion around rare disease, gene therapy, high cost drugs that have limited long-term outcome in their trial that the manufacturer is willing to put some type of endpoint at risk here in this today and now autoimmune space, whether it's an infliximab molecule, and or adalimumab, or any autoimmune drug, it's so price competitive, even pre biosimilars, and it's just exacerbated with biosimilars that there's minimal interest to do anything that puts the payer at risk for not achieving the best price.
Fred Goldstein 17:06
And I guess what I should really phrase that was from instead of value-based payment, which is as you as an organization, for example, UPMC moves into risk-based contracts, maybe capitation, or things like that, then obviously, you begin to look at these issues a little bit differently and focus more potentially on price for the product.
Chronis Manolis 17:24
Yeah, I mean, I think as long as everybody's aligned, you know, look, we've got a pipeline out there of products that are incredible, and they're just starting to bear fruit and now we've got the diabetes drugs, you know, we're going and I look at biosimilars, regardless if they're the unbranded or just regular biosimilars as the answer to create the headspace so we can cover a lot of this innovation. You know, out of the gate, it's been a little clunky. And, you know, I think that's to be expected if there's a lot of complexity. And HUMIRA was really complex right in the autoimmune space for a lot of different reasons. So I think we're gonna get who's going to continue to get better and better. We'll see how it evolves. But I think the underlying feature is the more competition, the more the price should get better. Whether that competition comes from the innovator itself, it's unbranded, you know, sister, or biosimilar products.
Michael Rothrock 18:28
Fred, what I want to add to the audience here is an understanding that if I'm the manufacturer, I'm an innovator and an unbranded biologic today. Your message to the market needs to be a few points that are going to maybe illustrate the value of why you did this. One, it's the same as the Legacy product, we manufacture both. This innovative product has been on the market for many years. It's trusted, it's tried, it's well known. We have a lower-cost unbranded biologic that we're bringing to the market to compete in the overall space to provide cost savings to the plan and to patients. That's your message. It's almost like they came out with an authorized generic as a branded pill and tablet comes off the same line, it just has a different name, or it's an unbranded name. So that the purity of the molecule, the trust in the molecule, the legacy of the molecule, that's their selling point, to physicians and patients and to payers. Now the payers are going to look at that and say, that's great, but you need to compete on price because as both Chronis and I alluded to our P&T committees have viewed the entire molecule, whether it's innovator, biosimilar, on unbranded as same and same so you got to have both sides of it. You gotta hit on everything in order to get the uptake that you may want for that type of product.
Chronis Manolis 19:54
Yeah, and let me let me just add to this and this is a tricky one. So you know, take this with a grain of salt. Branded generics haven't been received too favorably in the market. Now, this is a long way from a branded generic however, sometimes we look at things and we say, make, make the choice, stick with the innovator, or stick with the unbranded. But when you have both, can you really you know, the tendency is to say, well, look, we have both products, but then it really can confuse the market. I know it confused our docs a lot. As to hey, why wouldn't we do this? This is a no-brainer. Well, I think, the strategy with an unbranded, I think Michael hit it on the head, I mean, go with the value prop and there's no stronger value prop than familiarity. But, it's got to be priced like a but like don't expect the payer to pay a premium or when there's biosimilars in the market that we think are equivalent.
Fred Goldstein 20:59
Right, and you've touched on this a little bit. It's a really interesting point, you've talked about the need to have these extra services, educate the physicians, let's talk a little about the patient. Because when you think about health literacy and the patient's understanding this area, major issue, so what should the products be doing around that? These with these unbranded biologics?
Chronis Manolis 21:18
I mean, you've got to support the product, you know, physicians will change behavior when they know patients will pay less. And they have the competence to prescribe. I think it's really about the support. And I think that I think that where the challenge comes into play are, these are all high-cost patients. And you know, going back to my Lipitor example, you know, patients went from a $50 copay to a $10 copay, they could feel it, their doc, their pharmacist, and their doc reassured them, and life went on. These are products where chances are, you're not paying for the innovator product copay. You just aren't, right? Because there's a copay card that's out there. And then we're gonna have to try to convince you to get a different product at that same zero copay or more, that's a challenge. Right? So I think the, you know, again, we're not going to solve for these sort of market, you know, we didn't get here overnight, these market dynamics, but I think the overarching theme is you're going to launch a biosimilar regardless of what it is, you've got to it's table stakes payers, patients are going to expect that they have the resources, and they have everything, and then some that they had with the innovator product.
Michael Rothrock 22:40
Fred, I would take this even a little bit higher than that. And I agree the support services and the wraparound services is critical. But think of it from a patient's perspective back in the early days when generics started hitting the market. Generic, is it the same? Is there something different? Well, I was on a brand. It's a generic, what does that mean? Am I going to be okay? Patients will listen to their physician if their physician believes in the product's efficacy and safety. If I'm gonna manufacture as an unbranded biologic play off of the word biosimilar, which we are not, because I word similar doesn't mean same. It's similar. Kind of like the old generic literacy would have been back in the early days. If you come out and say unbranded biologic back to my purity legacy, stability, history. And it's just a new, cheaper alternative for the tried and true product you've used for many years, then maybe you can pivot that mentality away from similar is maybe not what I'm looking for as a patient I want same, and that means unbranded. So it really comes down to the messaging. Now, again, a lot has changed in the last 12 to 24 months, that even biosimilar adoption, biosimilar awareness, biosimilar education has hyped to kind of kind of diffuse some of that fear. But it's not all gone. And it will take a little bit, a couple more years, a couple more products to get the comfort for patients, payers, and physicians know it, that the patient community may not see it right away.
Fred Goldstein 24:15
Anything you'd like to add to that Chronis?
Chronis Manolis 24:18
No, it's spot on. You've got to kind of lean on what your strengths are. And then just support the stakeholders and I think we're going to, again, this isn't gonna get pulled through like small molecule, this can take some effort, and we've got to get there.
Fred Goldstein 24:37
In this final thoughts, are there any areas we didn't cover or things you'd like to come in on? You, Michael, or Chronis?
Michael Rothrock 24:45
I would just say if you're having an unbranded biologic as well as your innovator, you have to definitely differentiate from a list price perspective. Today, in today's environment, pricing across biologic biosimilars and unbranded within the same markers, so significantly influenced by price. You have to have clear delineation of Church and State meaning my innovators here, by unbranded it's at a lower price. And we're out here to help patients, physicians, and payers see that same product coming to the market at a much lower list price for those who need a low-cost option?
Chronis Manolis 25:22
Yeah, and, you know, I think the tendency, and this isn't a specific manufacturer, this is just years of dealing with manufacturers, is the tendency is to overvalue that familiarity and that same product off the line, and then you kind of get into a competitive problem, especially when the class has set the established floor plan. You know, what, if any premium are you going to be trying to get in I think, I think that's the wrong, it's the wrong strategy.
Fred Goldstein 26:02
Well, Chronis and Michael, I'd like to thank you both for joining us on this episode, brought to us by Janssen. It's been a pleasure.
Chronis Manolis 26:09
Thanks for the opportunity. Appreciate it.
Fred Goldstein 26:13
And thank you for joining us today. If you like the 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 AMCP.org on LinkedIn, Twitter, Instagram, and Facebook. I'm Fred Goldstein for AMCP. Until next time.
About the Hosts
Fred Goldstein is the founder and president of Accountable Health, LLC, a healthcare consulting firm focused on population health, health system redesign, new technologies and analytics. He has over 30 years of experience in population health, disease management, HMO, and hospital operations. Fred is an Instructor at the John D. Bower School of Population Health at the University of Mississippi Medical Center and the editorial Board of the journal Population Health Management.
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