Part 1: Ali McBride Discusses ACCC Initiatives and Biosimilar Uptake

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 [Association of Community Cancer Centers]. He's also the co-chair of the ACCC's biosimilar project.

To start off, it's clear that we're moving into the age of biosimilars. What does that mean for oncology practices and providers?

McBride: It's a great question. It's a multifaceted approach. Right now, with the advent of the number of biosimilars coming into the market, it provides open access to patients, which really means we're going to be driving down health care costs. In an age where we're looking at alternative payment models, we're looking at reducing overall total health care costs. The introduction of biosimilars provides probably the best option for that decrease. As we look through and actually see the evolution of biosimilars in the United States versus the European Union and also other European countries, we have other issues to address.

Again, some of the things that we have faced with the United States versus the European Union are very different. We have a lot of different payers involved, [whereas] they have a socialized medicine system in some of those areas. But looking through this and kind of gleaning through in a very short and succinct answer, the biggest piece will be increasing access to the lower costs for our health care system—decreasing the national health care costs with biosimilars in oncology, supportive care, and even, for example, in rheumatology and for patients who need insulin. [That is] another area to where biosimilars are coming into play, as they've reclassified biologics as well, which happened this year in 2020.

The other piece, which is going to be the implementation of this process is, of course, the focus on how we integrate, which is one of the things ACCC [can do well]. And that will mean looking at monographs, addressing formulary, looking at reimbursement, and also understanding how it actually integrates into your IT system, especially for oncology drugs, a very large part of our workflow.

Also delving into the education. We have a large number of people involved: physicians, nurses, advanced practitioners, pharmacists, just to name a few. But one of the key ingredients that we don't talk about is our financial advocates. We're always dealing with getting the drug out, giving it to the patient, [figuring out if it's] paid for. Well, we're adding on 4 to 6, maybe 6 biosimilars for 1 disease state; our financial advocates are the ones who are working on patient assistance, copay support, and evaluating anything else that may actually lead to free drug as well. So, they have to get that information correct upfront, as well as the coding and billing system.

So, for the big pieces, yes, it's going to have great influx and decreased costs, but on the other end, the back end work—the things being done behind the scenes—is going to be a salient discussion that will actually [involve participation] among many stakeholders across the board. We have a large number of members involved in these discussions. ACCC has really kind of developed this workflow and modality of how and who's going to be affected, and I think we have a lot of different discussions to have, probably over the next 3 to 5 years with education, of course. But also, what it means to have this in the therapeutic arena, which is 1 of the areas that we're actually addressing right now, is therapeutic outcomes with oncology.

CfB: To follow up on that, the ACCC is launching an initiative to help with biosimilar integration into daily practice. Can you tell us a little bit about this?

McBride: The process pieces for the members involved—this is across the interprofessional health care team—really addressing multidisciplinary roles [for] biosimilar implementations. So, we have physicians on board. For example, Kashyap Patel, MD, is my co-chair on the biosimilar panel committee here. We also have our nurses, our advanced practitioners, we have financial advocates, and we have other pharmacists involved as well. So, just looking at that, we have the "A to Z" of who's going to be involved in that committee. That’s the first step, making sure we have representation from different members of the community practice and also our larger health system practice that integrates the information and eases the way for understanding how to integrate biosimilars into the practice. That's what we've done.

We're starting on several initiatives which we'll be addressing, the how to’s, as we talked about. But 1 of the things that we have to address is what reimbursement looks like with a biosimilar. Are you doing that correctly? What does patient assistance look like? Patient assistance is a key piece of the puzzle nowadays with oncology therapies. Other areas that we have to address are IT, EMR [electronic medical record] systems, and pharmacovigilance, which is a key issue across the board and is really looking at the outcomes.

One of the things with biosimilars is, a key initiative by FDA was to make sure that we address pharmacovigilance, which, for many of us, we've been doing in the pharmacy world for many years. They are often called retrospective studies. So, rather simply put, we have the ability here to address that pharmacovigilance and really address the outcomes as well.

But the education piece is one of the biggest areas we need to delve into. ACCC has put forth this piece of the community to really address the education for all members, as well as the patients who may actually receive these therapies to really ensure that we all are on the same foundation or level for integrating biosimilars into practice. We are right now looking at 4 to 5 to maybe 6 trastuzumab therapies, bevacizumab therapies, just had 2 rituximab-based therapies approved with more coming online here shortly. So, you can imagine some of the repetition that may occur, and also some of the issues that may occur with payers as they may prefer 1 therapy over another.

So, really, for my presidency, I actually wrote a column called "The Year of the Biosimilar," which is 2020. And this is 2020, and we're already seeing the onset. The amount of work being done by our health care teams, regardless of who you are, where you are in that structure, takes a lot of time to integrate these biosimilars into practice, because we have to address [getting] the orders in correctly. We do that, we have our own formulary, but then the payer may have their own form line. Well, that's going to cause some creation of havoc. So, then we have to change orders, we have to make sure that we can actually put those biosimilars into the stock and make sure we have them available to the patients so we can actually bill appropriately based on that payer.

You may also have issues with transition of care. We know that in some cases, for example, you may be using a short-acting growth factor in patients, and they may be discharged. You may get a short-acting growth factor outpatient. Well, you may get a different drug because you're working with an inpatient formulary versus potentially a specialty pharmacy formulary. So, how do you work to really reduce any type of time associated [with delays in receipt of the drug]?

We have a lot of work to do. [With] this committee with the members involved, which are actually leaders in the biosimilar field, we hope to really address what's happening in the community and also the health system setting to really reduce those burdens and barriers for implementation of biosimilars.

CfB: You kind of just alluded to this, but what are the biosimilar knowledge gaps that need to be filled in the oncology community?

McBride: Oh, that's kind of scary. I think it's not just oncology. It's, we're talking about oncology right now, but it's actually oncology and nononcology—rheumatology is a big one. I think also with diabetes. We have insulin coming down the pipeline, too. We have a follow-on biologic, which did not go through the biosimilar pathway for long-acting insulin. We'll probably see more of those shortly.

So really, it's across the board. Let me just say that very [simply there] is an across-the-board lack of education. So, we have about, like I said, 3 to 5 years of education to really pin down these issues. We're looking at oncology—where the biggest issue coming up is really education on these therapeutic areas—we often are not really educating the members—can be the health care teams, the physicians, nurses, pharmacy team members, and pharmacy technicians, as well also being in this area. We have live education on what a biosimilar is.

So, going back to Biosimilars 101, we're almost there, but not there yet. Also addressing what is the therapeutic outcome of using a biosimilar. ASCO [American Society of Clinical Oncology] back in 2018, if I'm not mistaken, actually had a survey where they show that a lot of the physicians did not want to use biosimilars in oncology, for first-line therapeutic curative therapies. That has slowly been reduced over the last year and a half when the recent survey came out. But that just means that there's a feeling of uneasiness when using biosimilars in this area, especially for therapeutic outcomes which can be curative. Rituximab, trastuzumab for lymphoma and breast cancer, respectively.

But other areas which I think hit the practices across the country is the pure lack of knowledge for reimbursement. And to me, I think that is across the board, the biggest area that we can address. We see people who are experienced with reimbursements and not aware of pass-through status for biosimilars, not be aware of the potentials for these therapies in these areas, and also the reimbursement coming up front.

And if you're in an alternative payment model—again with ACCC's experienced in this area, this is an easy way to invest in the education area—it is to really look at how [advanced payment models] will actually benefit with the introduction of biosimilars and utilization for patients. And that will probably continue until the next iteration of OCM [Oncology Care Model] or OCF [Oncology Care First], or it may actually change thereafter—we'll see what happens there. But with that, we have now the means to reduce some of those costs of care, especially as biologic therapies continue to rise in price, and also with the advent of newer biosimilars we'll see some introduction in these cases, too.