So we recently just published a manuscript that we effectively call “the gaps paper.” It's a thought leadership commentary paper to highlight all of our experience that we've had so far as BBCIC. We were looking at what are the strengths and limitations of doing this type of research.

Data-source selection is obviously 1 element in there that can play a role in how successful you are in answering the research questions that you want to answer, and that also plays a role, as I said before, with cohort identification, exposure identification, outcomes identification.

But then there's also other considerations in terms of, within any data system, what can we and can't we answer? So one project that we had done is a mapping from ICD-9 and ICD-10 codes, which is essential if you're using data that's more current or more recent than October of 2015. Considering our first biosimilar in the US was not approved until 2015, you can't really do research with biosimilars if you can't use data more current than then.

So we had a group do mapping for all of the relevant disease states and conditions that BBCIC is currently interested in, which is a much more complex undertaking than it sounds like. But that was a way for us to build up our capabilities and our infrastructure within the constraints that we have with our administrative claims data.

We also were looking at the extent to which products biosimilars says particularly are coded in medical claims from physician offices. Many biologics and biosimilars are our physician-administered medications, so we were looking at to what extent the those were coded with [National Drug Codes, NDC] codes, or product-specific J-codes, because that plays a major role in our ability to identify the products that we're looking at. So that was another way that we could shed light on some opportunities for us to improve our data sources.

Videos

Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), discusses the challenges inherent in conducting large-scale comparative effectiveness research on biologics and biosimilars.

Cate Lockhart, PharmD, PhD: Challenges With Large-Scale Comparative Effectiveness Research

I think we'd be remiss not to acknowledge the third party in the room when a physician and a patient are interacting and making treatment decisions, and that's the payer in the mix. Unfortunately, a lot of our decisions in medicine do have some payer implications in what a person's insurance will or won't cover. And so that's certainly a consideration when we talk about patients, so there is access impact with regards to what the payer will cover.

From an individual patient decision-making process, there are a lot of considerations that go into how we choose which biologic medication to use. So first is the efficacy. What do we think this particular biologic will do to the disease process itself? Then we talk about risks. What are the risks with each biologic medication? And there's several different classes. We talk about risk of infections, risk of malignancy, risk of potential rejection of the medication by the body over time. And…we talk about the dosing strategy of each medication because they all do differ in some way, shape, or form.

And so generally, when I'm talking to a patient, we talk about their individual disease state. We also talk about what do I think will happen with their disease if left under or untreated over time, and how do we kind of find the common avenue with regards to all those different factors and choosing a biologic medication, and of course, recognizing that we also have to consider which will be covered from an insurance standpoint.

Benjamin Click, MD, staff gastroenterologist, the Cleveland Clinic, discusses the process to select the right biologic for a patient with inflammatory bowel disease (IBD).

Benjamin Click, MD: Choosing the Right Biologic in IBD

We're really excited about some of the shifts in biosimilars. And this comes from a number of things. The first is the advancement of science in this space really is going to pave the future for opportunities for new drug classes to come into community oncology and oncology in general.

The second is, as we go into value-based arrangements, the important thing that comes with value-based is total cost of care. And with the introduction of biosimilars and a lot of the new relationships that OneOncology is going into, we're going to really be able to reduce the total cost of care with all these new agents being introduced to the marketplace.

And as you may have seen from our press release, we've gone into a large partnership on this front. And with the technology that we have, we can now really track and identify where we're complying with biosimilars, and where there are opportunities to shift some of our existing drug agents to new therapies that are coming out.

Robin Shah, chief commercial officer of OneOncology, addresses the role that biosimilars have in community oncology.
 

Robin Shah: Biosimilars in Community Oncology

Yeah, it's a good question. So the rituximab biosimilar is very exciting, to be launched, the first one is just launched. And I think it's going to have a significant impact in oncology care. But I'm not sure it's going to be immediate.

Part of that is really the 10% pricing strategy that they came out with. I think it's safe to say that most providers and health system perspectives are hoping and anticipating at least a 15% to 30% discount based off of the originator biologic, which is what we've seen pretty consistently with other biosimilars.

So the 10% is hard to gauge because what you have to think about from a health system perspective is there is a significant cost of change. So for any new therapeutic, when you evaluate a drug for a [pharmacy and therapeutics, P and T] committee, and it becomes approved, there's a whole downstream effect of how to make it implemented within the health system.

So that includes IT updates to order sets, procurement and storage considerations, administration considerations, and then of course, the finance piece of doing prior authorizations and making sure the products are covered. So there's a whole downstream effect that becomes the cost of change that needs to be considered.

I don't think the 10% is going to be received with excitement from the provider lens, but I think it's going be interesting to see when additional competitors come to the market in this space, what that impact will be.

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses the launch of the first rituximab biosimilar in the United States.
 

Sonia T. Oskouei, PharmD: The Launch of Biosimilar Rituximab and Its Impact on Cancer Care

So regarding biosimilars, I think anything new is always difficult, any change, so I'm not sure that I may have any problems with biosimilars. You know, as a whole, I think the problem more is just having less familiarity and then having to explain to a patient that “I'm going to put you on something that I don't have any experience with.”

I think that's where the perhaps uncomfortable part lies. It's not so much in, you know, maybe what a particular biosimilar is, it’s that we are asked to use these drugs without any prior experience, we're asked to use them just because they are biosimilar.

I think we have to take a step back and think about what we're being asked to do. So many times when I'm asked to do a treatment that's not a biosimilar, I gain experience from it, and I start the medication. This is mandated, in a way, a switch. So meaning, I don't have prior experience with a biosimilar but yet I have to convince the patient that this is their first-line treatment.

Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic, discusses how comfortable rheumatologists are with using biosimilars. 

Elaine Husni, MD, MPH: Rheumatologists' Comfort With Biosimilars 

So that is something that, as deductibles and out-of-pockets continue to rise, is something that is prevalent. Being able to be aggressive about reaching out finding copay assistance or foundations or grants that are appropriate for the patient is one way that, you know, we work to alleviate that.

But then also, again, knowing those drug costs and being able to put together successful payment plans that cover, you know, the cost of the drug, and kind of looking at the whole episode of care to really make an aggressive payment plan that fits, that's something that the patient can make and then also covers the cost of the drug.

Rhett Wilkerson, associate director of patient financial services, Florida Cancer Specialists, discusses financial toxicity in cancer care.

Rhett Wilkerson: Financial Toxicity in Cancer Care

So the way that we think about communicating with patients in general about this whole cost of care is being transparent through the initial consult process. So in all of our clinics, we have financial counselors that work with all of our practices and patients so they truly understand what treatment they're getting, then what the cost of that care is. And with biosimilars being introduced, we can now show and represent that the patients are getting the same outcomes, with the lower cost of care, with the agents that are available.

Robin Shah, chief commercial officer of OneOncology, addresses how practices can communicate the value of biosimilars to patients.
 

Robin Shah: Communicating With Patients About the Value of Biosimilars 

So I think everybody is different, and everybody has different priorities and thoughts on dosing and routes of administration. And so, some people are scared of giving themselves injections, for example. That certainly plays into whether or not I may recommend the utilization of a subcutaneous injection-based therapy.

In some patients, you know, logistics coming in for an infusion are challenging. And even if it is every 8 weeks or a shorter potential timeframe, that poses potential travel, caregiving from family members, as well as lost opportunity at work or school.

And so I think everybody is different in how they prioritize those. I'd say there's some pros and cons to each of those from a provider perspective. For example, with infusions, I can see if a patient is getting their infusions on time and making sure that they're administering and receiving them appropriately. Whereas with subcutaneous I have to trust that patient is administering that medication on time. And so there are nuances to each of these considerations.

Benjamin Click, MD, staff gastroenterologist, the Cleveland Clinic, discusses how route of administration impacts patient adherence to inflammatory bowel disease (IBD) therapy.

Benjamin Click, MD: Route of Administration and Patient Adherence to IBD Therapy

Well, it's fundamental to what OneOncology hopes we can bring to the clinical care marketplace. The biosimilar advances have allowed us to not only continue to bring great clinical care, but to lower the cost thereof. Financial toxicity is one of the greatest barriers to effective treatment in the cancer continuum, and biosimilars provide comparable, and sometimes even better, clinical care for a significantly lower cost. And that allows us to reduce costs over the long term and certainly can help to reduce out-of-pocket costs for our patients.

Tracy L. Bahl, president and chief executive officer of OneOncology, discusses why his organization felt it was key to adopt biosimilars.

Tracy L. Bahl: The Importance of Adopting Anticancer Biosimilars

You know, anything that can decrease the cost to the patient is the best thing for the patient.

We have financial counselors, we have a lot of copay cards, we have a lot of drug assistance, drug replacement. We as a practice work very hard to get therapies to the patients that they cannot afford. And so, if there's a way that these biosimilars coming into the market can not only lower the total cost of care, but they can lower the patients’ out-of-pocket and that stress and anxiety that the patient has, I think that's fantastic.

I don't know how it will play out because it's so new, and right now, like I said, they're kind of marketing like the brand; they're not that much cheaper. They don't want to disrupt [average selling price, ASP]; it's more about, “we’ll give you a contract to use all of our stuff, including our biosimilar, instead of using this other guy’s, right?”

Nina Chavez, MBA, FACMPE, chief operating officer, New Mexico Oncology Hematology Consultants, Ltd, discusses the role that biosimilars have to play in reducing patients’ out-of-pocket costs in cancer care. 

Interviews