Ali McBride, PharmD, MS, BCOP, clinical coordinator of Hematology and Oncology in the Department of Pharmacy at the University of Arizona Cancer Center and past president of the Association of Community Cancer Centers (ACCC), discusses physician struggles tied to biosimilar utilization, the upcoming initiatives for the ACCC Biosimilars Center, and why physicians should be keeping an eye on biosimilars.
The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences News Network, The Center for Biosimilars® is pleased to welcome Dr Ali McBride, clinical coordinator of hematology and oncology in the Department of Pharmacy at the University of Arizona Cancer Center and past president of the ACCC. He's also the co-chair of the ACCC's biosimilar project.
You just touched upon reimbursement. What other problems do providers encounter once you can utilize biosimilars?
McBride: I think the first thing is going to be what can we give? Right? In the outpatient setting, it's very different than inpatient. Inpatient, you can actually run your DRG [diagnosis related group] code and you get billed a certain amount. Therefore, the reduction in price is rather easy to implement. In the outpatient setting, we have our own formularies—institutions have their own formulary—but you're beholden to the payer. So, if the payer tells you that we're using 1 therapy, you'll have to align yourself to make sure you have the correct reimbursement model for that therapy.
In these cases, we do have to do a large amount of education about what those biosimilars are and how we actually integrate those into our system. We also have to make sure people understand what interchangeability is, which is still a pending designation. We don't have [an interchangeable biosimilar yet]. But we do have finalized FDA guidance [on interchangeability], as well.
So, those are 2 areas, but the biggest area, how did you get reimbursed with the pass-through status for biosimilars, and again that's really looking at how you're basing that reimbursement off the reference product over a certain period of time, and what that relates to in terms of OCM [Oncology Care Model] practice. There's also a lot of need for understanding what the cost reductions can be and will be under an OCM practice utilizing biosimilars.
If you're using one of the top 4 or 5 drugs right now, immunotherapy is usually very high, but for example, pegfilgrastim, which is a top-5 drug therapy across the country for outpatient clinics, is now a biosimilar. So, we're seeing the large savings being implemented. Don't forget [about the] short-acting growth factor for filgrastim—the Sandoz product called Zarxio. It was initially a 15% reduction. We have seen a reduction in price by about 50% over the last few years, based on some practices reporting this.
So, from that standpoint, if we can implement these correctly, we can see a drop in cancer care costs for a lot of standard base regimens, as well as new regiments in combination with treatments. So, I think we have a good foothold to really work on the education of reimbursement in this field. Well, long discussion on medication assistance and patient assistance as well.
CfB: In reference to these issues, how will the ACCC Biosimilar Center and integration pathway address these needs?
McBride: Well, we're still developing formats for integration right now. So, right now in the early stages, we can get everything right or everything wrong. I'm joking. We'll actually get everything right in the first try here because we have some great members involved－really leaders in the field. The big things that we'll be doing is looking at education and also extension of this information. I think that's really what we've been doing with ACCC over the last few years, if not decades. Even before I was here, there was always a leader in the thought process of "how to."
So, it'd be a large amount of education, working with team members working with different layers of the integrated multidisciplinary field, to work on addressing education for practitioners, education for reimbursement, and also even education in terms of differences in biosimilars. For example, we know that the trastuzumab biosimilar does come in a multidose vial, which reduces drug waste. If we can reduce drug waste, we decrease overall cost of care, or burden of care, and we reduce some of these other things that we didn't think about. So, how we innovate with biosimilars and that really is an important discussion as well, and we'll be doing that across the board with these education pieces.
CfB: Part of the ACCC initiative involves providing tools for team assessment within a given oncology practice. Can you tell us how these will provide value for members?
McBride: Now, this is a great ROI [return on investment]. ACCC always provides our return on investments for their members and really, dollar for dollar, ACCC delivers exactly on that. The key pieces for these checklists, as I call them—really kind of providing information—we'll be looking at integrating the understanding how to get that drug therapy on your formulary, how to interpret a biosimilar formulary, also looking at integration for your EMR [electronic medical record] systems and IT systems, and lastly also looking at that reimburse file. So, those checklists which are being developed right now as we speak, will help actually look at those practice evolutions for biosimilar integration.
More so will be the impact of biosimilars on the APM [advanced practice model] that are currently being performed right now. As we've seen, the macro discussion with MIPS [Merit-Based Incentive Payment System] coming on board, there's a larger amount of focus on cost. In fact, it's gone up to 30%—if I'm not mistaken—on that evaluation for the equation.
Therefore, even under these models outside the OCM, there's a large push to reduce that cost, and this is the means to do that. That checklist will help provide practices to support the need; in many cases, [it] means practices may not have the number of people to really do a large amount of dissemination information or integration these practices. The checklist that we provide will provide the exact information needed to actually switch and also address other areas that may have been outside their scope or spectrum for understanding what that will mean for their practice and reimbursement models too.
CfB: Can you discuss the plan tools for improving the provider patient conversation about biosimilars and why is that an area that needs attention?
McBride: Now, this has been a very interesting discussion as many practices have actually had their own discussions across the board on how to integrate biosimilars. When the physician or prescriber—whether it's an advanced practitioner or a physician－when they're actually talking to patients to make sure they're aware of this change, or at least aware of what a biosimilar is, it can be a very touchy situation. What we're telling them is that we're actually switching their therapy to a, for example, pegfilgrastim product. In these cases, the patient may actually have some fears. The goal with this education piece that ACCC is providing is counseling measurement to assuage those fears, so that the patient actually feels comfortable, just like the physician, on these intensive therapies.
I think it's an easy way to define this. We're looking at insulin levels, for example, [we're] using a very simplified process for this. How do you actually talk to a patient about switching to a biosimilar insulin? Well, in this case, we're looking at blood glucose levels and that's how insulin works—addressing the blood glucose levels of the patients and therefore, monitoring and measuring to make sure those glucose levels are at goal. With supportive care, we provide [that same information to] the patients and how to simplify those discussions, as well. And also with therapeutic oncology therapies, too. We are new to this. We are very naive to biosimilars. Europe had over 10 years of experience before we even touched upon this discussion.
As we move into this, we have to also integrate the processes to talk to the patients who may not be aware of biosimilars but may be aware of their price reduction. So, having those tough conversations may be very easy with some patients based on the therapies, a little bit more cognizant [than] for other patients.
So, looking at these key pieces will be one of the processes that we will try to integrate and also remove some of those tough discussions, so it's actually more of an adequal discussion to make sure that patients are aware. And also, the physician is aware of the therapeutic outcomes or similarity in this case (no pun intended) of that information.
CfB: Why is it important now for providers and healthcare workers to pay more attention to biosimilars?
McBride: I think the biggest thing right now that we have to keep our eye on－and this is almost a yearly issue—is what the payers prefer. And this is going to be a key point. We [have to] keep our eye [on] the ball about what's happening with payers. So, if one payer wants to use 1 biosimilar, and another payer wants to use a brand name product, we have to actually address that evaluation upfront. In some cases, if it's a higher copay cost with a brand new product, we have to be aware of this.
That may be an unfortunate circumstance, [dealing with] what the payers are utilizing for their biosimilar based product. In other cases, they're using a biosimilar, so we have to actually redefine what that means for our system, our patients and also our community-based sites to ensure [patients are getting] the right drug, and also making sure that they don't get denied—or the institution doesn't get denied—because many practices may actually have to be dealing with this on a daily basis.
In addition, pharmacies cannot stock 3 to 5 [versions] of the [same] biosimilar product, right? There may be preferences of one product over another, but we cannot continue to stock 4 or 5 biosimilars based on payer preferences. So, that leads to another issue as well. So, those are just some of the things that we see as moving targets as we integrate into biosimilars.
As we move [forward], probably at the end of this year, we're gonna have a large amount of biosimilars. So, as we get these processes approved, we'll also have to address any type of patent issues about what's off label based on the biosimilar and labeled based on the reference product as well. It's called a "skinny label"—it's probably more of a slang term these days for the vernacular in biosimilars. How do payers actually address that? We've seen NCCN come out [with] information really providing some guidance, saying that they're finding that bevacizumab [Avastin] can work in all its indications. So, therefore, you should accept it for all those indications as listed. And that really helps guide us when we're looking at compendia for approval.
So, that's the other issue that we have to address with with these therapies—and again, utilizing rituximab [Rituxan] or bevacizumab, as example—it really shows you there are differences in terms of what's going to happen with indications based on patent protection as well over the next few years. You can only imagine what will happen when we see, for example, nivolumab [Opdivo], come up for a biosimilar product. How many patents will you have to look at for that actual immunotherapy? So, another case in point for a current therapy, but just looking a few years into the future, what that may mean. As well as if adalimumab [Humira] will also come up rather shortly, under the biosimilars list as well. So, that's another target for biosimilar entry into the IO [immuno-oncology] spectrum.
CfB: And lastly, is there a timeline for the ACCC Biosimilar Center and Integration Pathway initiative?
McBride: We don't have a timeline, yet we're working feverishly right now. We're really garnering information for the education processes that will occur, the checklist that we talked about, and also the movement for education at different sites and community-based practices across the country. So, we're working on that now. I think the COVID-19 [coronavirus disease 2019] crisis, actually put a little bit of a heel and hamper on this movement, but we're actually moving forward on this rather quickly. Again, it's unfortunate but the most important thing is we're taking care of our patients as well and also ourselves, our health care team members, during this crisis. So, we'll hopefully see this out shortly, as well.
CfB: Thanks, Dr McBride.
McBride: Thank you very much. You have a wonderful day and be safe.
CfB: OK, you, too. To learn more, visit our website at centerforbiosimilars.com, I'm Matthew Gavidia. Thanks for joining us.
Listen to Part 1 of this interview here.