® titled “Understanding and Improving Access of Biosimilars in Oncology.”

I am Dr Bruce Feinberg, vice president of clinical affairs and chief medical officer at Cardinal Health Specialty Solutions. Joining me today in this virtual discussion are my colleagues Dr Karina Abdallah, Blue Cross Blue Shield of Michigan; Dr Michael Diaz, Florida Cancer Specialists & Research Institute; Kathy Oubre, Pontchartrain Cancer Center in Covington, Louisiana; and Bhavesh Shah, Boston Medical Center health system.

Today we are going to discuss a number of topics pertaining to the use of biosimilars in oncology, including improving market access and the economic impact. Let’s get started on the first topic.

We’re going to give an overview of biosimilars. I know this can be problematic for many of you. I first started speaking about biosimilars on the circuit 6 years ago. For many, this is old hat, but it raises a question to level set on this subject. Despite the awareness that many seem to have, why has the market uptake been so limited? For that reason, it’s worth going back a bit and understanding the basic pharmacology of biosimilars and what differentiates them from generics. We’re not going to belabor this, but we are going to get into some of these basic questions so that it is clear to everyone on this call and also clear why some of these issues may still be confusing to practitioners, particularly in oncology, where availability has been very limited. What are the similarities and differences of biosimilars from biologic reference brands— again, this difference in regard to generics. The naming has gone through changes and iterations for biosimilars. To get us started with that, I’m going to ask Bhavesh to provide a bit of background and give us some of those basic definitions and understandings. Bhavesh?

 Thank you, Bruce. Obviously, there is a very basic definition that we, as health care providers, understand. Biosimilars are biologics that are similar to the reference product with no clinically meaningful differences in regard to potency, purity, and safety. I think the biggest aspect is trying to explain to a patient what a biosimilar is using that definition, so I see that as a gap in patient education. Another gap in regard to biosimilars is interchangeability. We know that it is 1 of those standards that is a regular trade term. A lot of the time, providers and patients think there is a higher designation given to a biosimilar and that if a product doesn’t have that, it doesn’t actually function the same as a biologic.

There’s definitely a lot of provider and patient education that is needed to help close the gap. One of the other aspects that I still see people struggle with is that providers come to me and say, “How is it that the FDA did a phase 3 randomized control trial in 1 indication and then extrapolated it to 7 different indications?” There’s definitely an education gap in terms of the whole process, besides the definition, from my perspective.

 Bhavesh, you bring up some great points. The first point has to do with the clinical trial design by which biosimilars gain their approval. Their comparison to the reference brand was often in a noninferiority trial. We have a trial design in and of itself that is held as more suspect in the world of oncology. Then we have the issue of extrapolation across indications, which is also something that is anathema in oncology, whereas it may be accepted in inflammatory diseases to a greater degree. Then we’ve got this issue of interchangeability, which is problematic. To some degree, interchangeability is difficult even for the reference brand because of the manufacturing process, in which that product continues to evolve. The Rituxan [rituximab] that was manufactured 20 years ago may be very different from the Rituxan that is being manufactured today. Could you touch on that for a moment too?

 Sure. I think the manufacturing is a different aspect, as well. Another myth that I have always heard is that each lot of rituximab is a biosimilar of itself, and that’s not true because the manufacturing process is completely different—it is called product drift&mdash;versus a biosimilarity process that is established for a biologic to go through to be approved as a biosimilar. There are actually critical quality attributes that the manufacturing process has established from the reference product and basically, the manufacturer has to meet those critical quality attributes for it to go into production. Outside that reference range, there are implications on the mechanism of action and the potency of the drug. Those reference ranges are established more for manufacturing and not for a biosimilarity product process.

 That’s great. That is the kind of answer that really gets people to open their eyes and say, “Wow, this is more complicated.” This is an aspirin where 21 atoms are going to now be made by someone else who is going to string together 21 atoms, and it’s going to be exactly the same. These are the exact same chemical. There are no differences among them. You can call them something different, but it is what it is. When you get into 20,000 atoms that are not identically strung together, then you have to look not at their chemical signature and identity but more in some kind of a surrogate by which you say they’re equivalent. It almost becomes more about the process of manufacturing than it does the end product.

 Whenever I’m trying to explain things to patients, as you alluded to, generic medications are a simple molecule that is made in a chemical process in a chemical plant. It has 1 unique structure. These are chains of hundreds, if not thousands, of those molecules that are assembled by a living organism, and by nature, it’s much more complex. There are all sorts of subtle differences that can exist and develop even in the same process over time. Not only that, but whenever you’re looking at it for an indication—and I’ll use filgrastim as an example&mdash;there are many different indications for the use of this medication to stimulate the growth of white blood cells. But in each of these indications, they might be stimulated for different reasons. You’re looking at not only different drugs or different biosimilars but also different, unique applications.

Biosimilars in Oncology: Addressing Awareness

 Bhavesh, given the complexity, the FDA went through a pretty elaborate process to determine approvals. Taking what Michael just said in mind, as well as the prior comments you made, are you comfortable with the process the FDA is using? Do you think the extent of comfort that you have is easy to share with clinicians who don’t have the same of pharmacology background?

 This is where pharmacists really play a huge role, because we understand a lot of the structural, pharmacokinetic, and pharmacodynamic similarities that you see in the process that the FDA has established for looking at a biosimilar versus a reference product. In the primary structure—which is the amino acid&mdash;the secondary structure, and even the tertiary structure, there have to be similarities established before they actually move on to the next stage, which has to do with the pharmacokinetics. You’re looking at T

, and AUC [area under the curve]; all these things have to be similar to the biologic reference product. If they’re not, then it can’t move on to the next phase of the FDA process in approval.

I think that it is a well-established process. We are a bit behind compared with our European colleagues, right? They have over a decade of experience with these agents in practice, so the safety and efficacy of these drugs are well established across the waters.

 That efficacy is an important issue for biosimilars. The number of large studies done in this country are fewer, and the number in oncology are really quite a few, even across the pond. Most of that experience in the European Union is around the drugs that have been used in the rheumatologic population.

In this country, other than filgrastim, I don’t know if there are 7 or 9 now that have been approved, but it seems that all those approvals have not necessarily resulted in market availability and market access.

Bhavesh, from your perspective, if we focus a little on oncology, what do we really have now, in terms of available biosimilars on the market in the immediate term and in the near term? Give me some thoughts about the data that support their efficacy.

 Looking at the oncology landscape for biosimilars, we have 5 trastuzumab biosimilar molecules. We have 4 pegfilgrastim biosimilar molecules. There are 2 rituximab molecules for biosimilars, and then there are 2 bevacizumab molecules. Of course, there are more biosimilars coming for each of these other agents, so we anticipate that that’s going to continue to go up.

In terms of efficacy, it all depends on the drug and the indication that you are testing in. For example, for pegfilgrastim, as you know, the FDA didn’t need that molecule to be tested in patients with chemotherapy-induced neutropenia for it to be approved. They actually had a great structural and functional comparison, which showed that this was highly similar. Basically, they had the studies done in healthy subjects, which makes sense if you’re thinking about looking for immunogenicity. You want to look for it in patients who are not getting chemotherapy, which could blunt the immunogenicity signals that you’re looking for. There is a well-established process in oncology in which the FDA decides where you need to test these drugs, what indications are more sensitive, and how the trials need to be designed.

 Michael, I want to bring you back in because given all the biosimilars that are going to be entering the oncologic market, it brings up a lot of interesting questions for the oncologist who may be prescribing them.

One is, are they too late? Many of the reference brands for these drugs are already experiencing competitors that may be called next-generational. We are clearly seeing that with regard to some of the products—whether it’s Gazyva as next generation to rituximab. Clearly, we could argue the same with others.

Then we have questions about how, as we’re moving into cell and gene therapy, immuno-oncology, and a greater amount of targeted therapy, it feels like the monoclonal antibodies are almost in a prior generation.

I’m curious about where you see the current environment. We have filgrastim; we’re waiting for pegfilgrastim. We’ve got pegfilgrastim now, which to a large extent, is delivered via Onpro. We have a delivery device that is patented and is not being copied by the biosimilar. There is that “Is it too little too late” phenomenon, and I’m curious what you think about that, because it sounds like a lot of drugs and a lot of opportunity, but where is that reality check?

 That’s a very good question. They’ve had biosimilars available in other countries for many years. The U.S. is a bit late getting to this market, compared with others, but I look at biologics as being here to stay for some time. There are so many different disease indications. There are so many unique disease indications for which it would still take many years to find an equivalent or better substitute for a lot of the biologics that we have.

You also have to look at it from a couple of other perspectives. For newer medications, as they come out, they tend to be a little more economically costly. If you can achieve the same thing with a less expensive product, then I think we owe it to society to make the best use of our resources and use the less expensive product if we can. We could have used them a long time ago, but there are a lot of advantages that we can use to treat patients and to make sure all patients have access to appropriate, good-quality, economically reasonable medical care as well.

I don’t think that it is too late. I think it is better late than never. It’s 1 of those situations, and I think we need to continue to evolve our use of biosimilars as much as we can and try to integrate them into our practice and care of patients, as medically responsible.

Current State of Biosimilars: Approval, Availability, and Efficacy

 Michael, you set us up very nicely in regard to the next topic of evidence-based care. You introduced this issue of cost. Cost and shared risk are relatively new to the provider space. We were always very segmented, and cost was the purview of the payer, but to large degree, not the purview of the provider or patient who via their payer was covered. There has been a lot of debate, and we’re not getting into the data around that shared risk story, but it exists today.

To some degree, when you have shared financial risk for treatment, it can be seen as in conflict with evidence-based care. Does evidence drive, and if it does, where does cost fit in?

I want you to touch on that next and tell me how you, as a clinician, align at a practice level and on a national level, because you’re involved with various organizations. How do you start to align the cost and evidence, especially given the fact that in biosimilars, the evidence is—by nature of the way they’ve been approved&mdash;less robust?

 That’s a really good question. I remember from back in my medical school days in 1 of my ethics classes that it is in the AMA Code of Medical Ethics: as physicians and health care providers, we’re ethically obliged to try to make the best use of the resources that we have. As a society we are growing to realize that we don’t have unlimited resources. That’s something that’s always going to be in the back of my mind. But first of all, just because it’s part of how we practice medicine, is to make sure that we’re giving our patients the best care possible.

That’s where evidence-based care has evolved. We have learned through clinical trials and studies what seems to be the most efficacious for our patients. When we have more than 1 option that seems to be equally effective and there are no unique contraindications for treatments or preferences for treatments based on patients’ comorbid medical conditions, then in the big picture of things, 1 of the ways we’re starting to approach medicine is, what’s the most cost effective way to try to manage this? That’s an interesting concept for doctors because most doctors aren’t even aware of how much these drugs or medications cost.

 No, and I think there’s also complexity in the cost, right? Is it actual cost? Is it the cost to society, the cost to the practice, or the cost to the patient out of pocket? It gets very confusing in terms of payer contracting, rebates, and contract design, to determine what that total cost picture is. There’s not a lot of transparency to it, which makes it that much more difficult to try to address.

 It’s layers of complexity upon layers of complexity. You might have 2 treatments that are equivalent, and 1 is a third of the cost of the other treatment, but it requires 3 times as many treatments. Where are you in that mix? That’s why there are multiple things to take into consideration, and it’s not as simple as people would like. This is not as simple as looking at the flat drug cost. We’re trying to look at the total cost of care.

Given the unique situations, in which you have something like a biosimilar and a reference product where they have the same protocols and the same number of visits, it makes it a bit easier in that scenario. If the biosimilar is approved for the same indications as the reference product and it is of a lower cost, then that’s where you have a discussion with the patient and you let them know why you’re recommending it. Explain the evidence behind the rationale, not just the fact that it costs less. Explain that it has been demonstrated to be noninferior and that for all that we know and all we’ve seen, it looks like it should work just as well. Patients are getting to be more and more inclined to say, “Yes, that sounds like a reasonable option. That’s something that I would like to try.”

Biosimilars in Oncology: Equivalency and Cost

In your experience with patients, if that cost difference isn’t directly impacting them and it’s something that seems less obvious, like the drug’s list price is lower but your out-of-pocket is the same, where it doesn’t translate in any way to a lower premium cost for you, is cost a factor for patients? Are the doctors putting themselves in a position of trying to make the case? It’s almost like, “Why do I want to go down that rabbit hole?”

It’s no difference for the patient. They don’t really understand it. It’s too hard to explain. If it’s going to cost the patient $1000 less, it’s a great story. When there is no impact on the patient, what is that incentive for the physician to go down that path, which raises that question about OCM [Oncology Care Model] shared risk?

Yes, that’s another fair question. We usually don’t know what patients’ economic thresholds are, and so we tend to have the discussion with them in the first place. In some situations, very rarely, you might have a patient say, “Well, doesn’t make a difference in my co-pays. I don’t pay anything. I want the brand-name product.” That’s not the case, and we’re not seeing that as much anymore.

They’re also trying to take into account the cost of care to the system. I am seeing that more and more patients are more socially aware that they do have a bit of an obligation to try to make sure that they’re making the right call for society as well. Even though it makes no difference to them economically, that helps their insurance company, or whoever is paying the bill on the other end. It helps them make better use of their dollars. We’re starting to see that more and more with patients, as we have these discussions, but if you don’t have the discussions, you won’t know, and that’s the thing.

I want to get Kathy’s thought on this, because at Pontchartrain Cancer Center, you’re obviously seeing a lot of patients come through. Is there any gestalt or sense that patients are more socially aware in regard to the cost?

Yes, I was going to echo what Dr Diaz said. We are seeing that. We have always been early adopters of biosimilars, and to Dr Diaz’s point, it is part of that ethical or moral idea of being able to lower the costs for that system and for the patient.

We are having those conversations with patients. Biosimilars are very important at the beginning of a year when patients’ deductibles reset. During that time, it’s really nice when you’re having to make those decisions, as those patients are, between rent and paying for their therapy and all those other factors. Financial toxicity is real, and it continues to grow and be more entwined in the fabric of medical care every single day.

To go back a step or 2 to your larger question, we are seeing patients be more socially aware. It is hard to turn on the news, prior to COVID-19 [coronavirus disease 2019], and not see health care and those costs be part of that news, so they do understand that. Very rarely do we see a patient argue for an originator, even if it costs someone more, because at the end of the day, there is still an extremely healthy respect for that physician-patient relationship and the shared medical decision-making between that physician and their patient.

The way I like to explain it to a patient is that they may not actually see the direct cost sharing right now, but the way a payer looks at it is per member, per month, right? How much they are spending right now is going to determine what your premiums are for next year. I think that if you’re able to lower the cost now by taking on a lower-cost option, you’re probably changing your deductibles and premiums in the future.

If you look at Medicare, which is the biggest payer, unfortunately, those are the patients that get hit the hardest because they are responsible for 20% on the infusion side. If you think about it, if you have a biosimilar that costs 40% less and Medicare is spending a billion dollars on that drug, you’re actually saving Medicare $400 million by switching to that biosimilar. That means next year, they are not going to increase the premiums and deductible for Medicare patients by 7%, which is what they did this year.

Just to echo a bit what Bhavesh just said, insurance design is definitely at the point now where it is coinsurance. It is very similar to what Medicare implemented many years ago. Most private payers are also beginning to move into the coinsurance versus co-pay insurance design when it comes to anything that is a specialty drug or high cost.

To your point, Bruce, that really does hit that patient aspect as to their total out-of-pocket costs. We have to work together to get that message across so they can definitely benefit.

Are Biosimilar Costs a Factor for Patients?

 All right, guys. You’re making me feel as if this is such a powerful argument in favor of biosimilars that they should all be incredibly successful. But that’s not the reality. There is a disconnect here. There seems to be this great alignment of patients, providers, and payers all in favor, yet that’s not what we are seeing in the marketplace. Something is not right here, and I’m not sure what it is. We started this conversation over evidence-based care. You are all, to some degree, leaders. For those who are not spending their whole day on the front lines dealing with the patients but who have more administrative roles and bigger, almost public-health-type perspectives, do they see this but the rank-and-file level is not seeing it, so they’re not doing it? Then they’re confronted with evidence and the heuristics of behavioral economics. “I’ve been giving this drug for 20 years. It’s always worked for me. I’m not trying this new thing.” I’m not quite sure what the deal is. Help me understand, because there’s some disconnect between the way you are all expressing the power and the compelling nature of the story around biosimilars and, at least in everything that I read, their market adoption. Who is going first on that?

 I can take that. Payers can be the biggest roadblock, obviously. We’ve seen in Europe that they have a significant conversion for biosimilars. Their conversion is anywhere from 70% to 80%.

, are we talking about a patient who is on a reference biologic being converted to a biosimilar? There are 2 things we have to establish and get into. One would be the clinical scenario. I think the potential for using something novel—even a brand-new drug or the case of a biosimilar, a new design&mdash;is a different threshold for supportive care versus palliative care versus curative intent care.

That’s 1 aspect. The other would be the conversion factor. I might start a new patient, but I’m not going to have an established patient who is being effectively treated and switch them, because it’s not fair to them. I’m introducing some, albeit small, element of the unknown. I want to make sure we address both of those issues in this part of the conversation.

 Sure. I’ll have Dr Diaz address some of those concerns too, but I’ll give you my perspective. I think that because Europe is actually a single-payer system, you have a much better chance of converting because the government controls what biosimilar you are going to use for the health care system. If that was the case in the US, we would actually have a pretty big conversion rate from a reference product to a biosimilar as well.

I think we leave it up to the payers to make that decision, and of course, it makes sense for them to take whatever cost savings they were able to get and to use that for their plan design.

In regard to your question about efficacy of supportive care versus cancer indications, from a pharmacist’s perspective, if a drug actually has the same mechanism of action and its pharmacokinetics and pharmacodynamics are the same, I do not anticipate that you’re going to see different results in an adjuvant setting versus a metastatic setting. If that was truly the case, the FDA would make them do a much longer clinical trial to show that. The scientific rationale has been established, and I truly believe there is no difference, but that may be 1 of the issues where there is a hesitance from providers. They think that maybe not using this in the metastatic setting is OK, but in the adjuvant setting, I don’t have data for 5 or 10 years for me to say that you’re going to have the same type of efficacy in that setting. I’ll let Dr Diaz talk about what his perspective is on that.

 I think this issue is more than that. When we take a compound and we make it orally bioavailable, even though we can measure the exact same chemical in the blood, we are still doing all that same testing. We are still starting that new orally bioavailable compound in salvage therapy, then first line, then adjuvant. There is a big difference here, and it has got to bring about some kind of emotional responses, even when you get outside pure logic.

 Whenever I look at it from my perspective, historically speaking, at least in the US, the biosimilars first became more available for the rheumatologic products, and they’ve been out for a while. I’ll be quite frank with you. I don’t prescribe those, so I am not going to comment a lot on those. Where the biosimilars came into play in oncology was the supportive care of medications, and we started having those available last year. This is still a little recent, and even more recently, within the past several months, we have the biosimilar therapeutics available.

It has not been a lot of time, but there are so many different factors that play into whether something is going to be entertained as an alternative. I’ll just give a generic empiric example. If you have a biosimilar that comes out that is priced the same as the originator product, what is the incentive to do or change anything, from a patient perspective, in all reality? Pricing is a little component in there, and then on top of that are the most important things, efficacy and indications.

As long as you have the same efficacy and indications, doctors will look at pricing, and that is 1 of the things that has to be taken into account. We are just starting to get our arms around it and getting comfortable with choosing a biosimilar instead of a reference product. We have been bombarded with a lot of education, in a positive way, for the past several years while oncologists have been waiting for the biosimilars to become available. I know so many doctors I talk with who were excited as the products came to market and they could actually prescribe them for the patients, and then they would see that their hands are tied. They can’t prescribe it. Why? It is not approved by the payer. It is not on formulary with the payer or in the system. That could happen for a multitude of reasons. Each different system, whether it’s Medicaid, Medicare, or commercial, is so complex and unique that you have to be a specialist just to understand what those differences are and how they function in each of those environments.

There are a multitude of factors that have made practices slow to adopt, but now that we have them, especially with the therapeutics, for example, my practice is at least at 60% conversion, and we are trying to shoot for 80% to 90%.

Biosimilars: Addressing Roadblocks to Market Adoption

 Let’s go down the therapeutics that are available. There are trastuzumab-dkst and trastuzumab-anns, so you’re converting those using those biosimilars?

 You are taking active patients who are on them and making the conversion?

 Correct—after we talk about it with the patient. We want their approval. We want their buy-in, and we want to make sure they feel comfortable. We want to make sure they understand they’re not getting an inferior product, and we also want them to be aware so that they can help us. They can help us and notify us if they notice any differences or changes.

Once again, these are biosimilars are highly similar, but we can still see unique differences in patient to patient. It is very rare, but it can happen. When I say 

, sometimes a patient may have an adverse effect with 1 that they did not have with the other, and that’s why we want to make sure the patient is aware. We want to get their buy-in. We want them to be aware to look out for adverse effects, and we want them to notify us if they’re having any issues or problems that are unique.

 Yes, we are using that where clinically indicated. It has most of the indications that the reference product does, so yes, we are trying to use it where we can.

 One of the reasons why we would see this hindrance in adoption rates with some of the biosimilars in oncology is that they do not carry all the indications that the reference product has. A lot of the time, providers do not know that it is because it is an orphan indication and not because there is a difference in mechanism for ovarian cancer versus lung cancer that the FDA didn’t grant this biosimilar an indication in that setting. If you go into the NCCN [National Comprehensive Cancer Network] Guidelines, they actually recommend indications besides those that are already approved on the label. That is important to understand because as we see more indications that the reference product may be getting, the biosimilar may not have those indications. The difference is because it’s an IP [intellectual property]—related issue and not because of efficacy or mechanism of action of the drug.

Switching to Available Biosimilars in Oncology

 Kathy, I want to bring you back in because as an administrator for a cancer center, you’re probably actively involved in contracting and likely working directly with the group purchasing organization. You’re having to deal with the issue of your contract and the potential for rebates because you’re running a business. You’ve got the social responsibility, the practice responsibility, and the business responsibility, and it can weigh heavy as you make those decisions. You may, in your heart of hearts, believe we should bring down the total cost of care, but as a practice, we have to also run a business and be viable as a business, and that contract for that reference brand is really attractive. We may have to do that.

Tell me more about that and to what extent—you don’t have to be specific or name names&mdash;that is a reality in the same way it’s reality on the payer side, which Karina can address. It’s a reality of the practice side because we’re mixing this business with the science and the medicine.

 I’d like to back up for a second and add to what Dr Michael Diaz was saying earlier. For biosimilars to be successful in community oncology, which is my world, you do have to have that physician champion within the organization, but you also have to have that administrative champion. Then you have to have the marriage of the 2. The physician has to tell me it is efficacious to be able to give this. Then it’s my job to figure out how we’re going to handle that. I take those products, and what I generally do is look at my patient data from the last year. I figure out who is on what, and then I take all those biosimilars, put them together in a spreadsheet, and look at my rebates. Then I come up with my delta on the end.

Then I also have to look at my payer issues. We’re not going to name names, but to go back to what Bhavesh Shah brought up earlier, rebates and those rebate walls that we have can be a problem and can tie our hands in making those successful within a practice. If I’m required by a payer to use an originator, and I have a large percentage of my patients on that particular health plan, then we have a problem on our hands. That changes the way my formula works.

 Right, so now you have to think about your contract, and what threshold can you hit? You have to go all in for the originator, even though you might have wanted to really pursue the biosimilar. At least for this current year, until you can get face time with the payer and talk this out to make the case for both, or until the biosimilar is willing to match that rebate with the payer, you’re still going to have to make the decision.

 It’s a couple of things. It’s contract design, whether I’m having to hit a market share and what that market share looks like. Most of the market shares for the biosimilars sit kind of low because they do want adoption of the product. We’re also having issues of GPO [group purchasing organization] parity. Biosimilars have brought out some very interesting market forces that a lot of us haven’t seen before, so perhaps an originator manufacturer making a parity deal with the GPO. That happened last year when the biosimilars started coming out. If you were aligned with a particular GPO, you had access to 1 biosimilar, and that was the way it looked.

That was fascinating because we’ve never really seen that kind of parity hit, and it was not the 1 we chose to use. Then that becomes an issue. It has really presented some interesting problems and challenges. If you have multiple payers that all require something different, you do have to evaluate your processes and maybe accept that you have to split your basket several different ways.

I find it better to have those contract conversations with the biosimilar manufacturers, because at the end of the day, they need their products to be successful. They understand the economics and the market forces that we’re facing, and you’ve seen a lot of movement and flexibility in contract design from those biosimilar manufacturers.

Determining Biosimilars' Role in the Formulary

 Thanks for setting that up so well. It brings us to that conversation around market-access considerations. I wanted to involve Karina in this, because we’re starting to get a little more flesh on the bone. In that first segment, it was starting to sound as if we had this uniform, very optimistic response around biosimilars and their adoption, and it seemed to be out of sync with what the marketplace is telling us. In this last segment, we started to peel the onion a bit. We got a sense that it is more complicated than that. The stakeholders may be aligned philosophically, but perhaps not aligned operationally. That’s leading into some of that. Karina, help me understand at a payer level. You also have a complex situation, and you have to deal with your bottom line, as well as trying to make good medical policy. Help me understand that approach and why Kathy Oubre is conflicted. She also has multiple payers, not just 1 payer, but she has to try to make this decision of what’s best for her practice environment and if she can afford to stock multiple versions of the same drug. I’m curious from that payer side, so get me started here and we’ll all join it.

 Thank you, Bruce. I completely agree. We’re starting to peel back these layers and realize the complexity. I’ll start by saying that I agree with what Kathy said. Bruce set it up really well in terms of, where are we sitting when we’re making these decisions? I think you brought up, Kathy, the marriage between your providers versus what the physician is saying on the clinical end and then what you’re going to do on your practice side.

Payers have a very similar setup where we’re kind of in the middle, as well. What we’re really looking for is our providers in not only our network of physicians but also large health systems. Looking at last year and into the future, where we’re going to really change and upset the market a bit with strategy is being a lot more collaborative. I think that is really what is missing and what has been missing.

What I’ve noticed in the industry so far has been almost a waiting game, in which the payer is looking to the large health systems where most of their membership is affected to see which product they are going to use. Are they going to stick with the reference? Are they going to go ahead and make a deal with the biosimilar? Vice versa, I think that the large health institutions and even smaller practices are also looking to the payer to make a decision, and without the collaboration that’s necessary, it really just becomes a waiting game.

Of course, we really haven’t touched on this much, but I think that’s a big segment of this and the decision-makers are largely affected. We talked a bit about contracting, but we have our colleagues in pharmaceuticals that are like the go-betweens. It does become a bit of a strategic game of what the other payers are doing, versus what the health systems are doing and what the providers and patients are going to tolerate in terms of pricing and contract. It is a bit cloak-and-dagger, but I do see that we are starting to move away from that and try to work together much more collaboratively. Looking to the past, I believe that is the biggest issue that caused a lot of the price setting and market share disruption that happened when biosimilars came in and didn’t get as big a market share as we were hoping for.

 Karina, while I’ve got you, I’m going to ask 1 more question because I’m curious. Payers, even in the US, have been fairly quick to look at infliximab in the rheumatologic space and started to mandate substitution, whether they were thinking about step therapy, tiering, and mandatory substitutions. Do you think there is a very different tolerance for that with regard to oncology?

 If that does happen, it’s going to be much slower and in quite a bit of time. It’s not going to be a rapid change?

 Yes, I completely agree with that. We look to infliximab. We at Blue Cross Blue Shield of Michigan had a really high adoption rate—a mixture between new starts using the biosimilar products versus switching over. We had fairly decent adoption. I will make a note that it is indication based, which then will lead us into your point, Bruce, about oncology being different. Even looking at different indications, we had the most work being done on both our side, as the payer, and the provider’s side in the gastrointestinal and pediatric spaces when it came to the infliximab biosimilars. We did spend a lot of time looking at clinicals, looking at postmarket research and studies, and even case-by-case, indication-specific differences. We did tailor our strategy according to that.

That brings up, again, what I mentioned. Looking at indication based, we are treating it as such and being a lot more collaborative with the high touch-point indications. Of course, oncology is 1 of them. One that is going to be coming up soon is rituximab. That’s going to be pretty big, as well as bevacizumab.

 There is a disproportionate market share between nononcology drugs versus oncology drugs. If you look at the current market share for infliximab products, it’s about 14% nationally. Then if you look at the oncology market share for biosimilar adoption, it’s about 25% to 30%. There is definitely a higher and faster adoption because infliximab has been around for 40 years and it’s such a slow adoption rate. But with oncology, there is a much higher adoption rate for biosimilars, and I think 1 of the biggest payer examples is Kaiser Permanente. They have 12.5 million lives, and they’ve converted over 80% of their patients to biosimilars in oncology.

It really speaks to the difference in practice. Oncologists are probably more comfortable using biosimilars than nononcologists are, just based on the adoption rate that I’m seeing across the country.

 Those are pretty high numbers. They are surprising to me. I didn’t realize they were that high. It feels as if it’s awfully early to make those kinds of estimates. Availability has been a matter of months.

 Yes. Kaiser Permanente actually publicized their data. Within 6 months, they were able to get that market share for bevacizumab when it was approved, and the same with trastuzumab. IQVIA is the company that publishes the market share. It’s on their website.

Market-Access Considerations for Biosimilars in Oncology

 Michael, I hear those numbers, and I think, “Will this be fleeting?” Trastuzumab has 3 very provocative competitors. One or 2 are already approved, and a third likely will be, and that will dramatically change that space. I think bevacizumab is being called into question more and more. You finally have data suggesting Gazyva may be a better CD20 monoclonal antibody.

Even if there is an adoption, if it’s evidence based and you have the next-generation version that’s better, will it be fleeting or do you think it’s longer lasting?

 That’s not an easy question to answer. Why? We might find that 1 of these newer-generation reference drugs works better in some situations, or maybe it doesn’t. That’s where we’re going to have to rely on the detailed information and hopefully well-developed clinical trials. If we do see that we need to use 1 of the newer-generation reference products because there is not a biosimilar available for it yet, then we’ll know that we’re using it based on evidence, and hopefully we’ll be able to identify those who can benefit from that. Hopefully, it’s not necessarily the whole patient population. There has to be some social responsibility to try to make sure that those patients are identified so that we can more carefully tailor which patients could possibly be treated equivalently with a biosimilar and which patients might require a newer-generation medication.

I don’t think the biosimilars are going to be a fleeting thing. They’re going to be here for a while because of the large amount of evidence that does exist. I’m just hopeful that our researchers will be very thoughtful in their designs in the future.

Where Do Biosimilars Fit in to the Treatment Landscape?

 Kathy, you could realistically have 3, 4, or 6 biosimilars to the same reference brand and your desire is to have 1. Your payer complexity might dictate that you have 2 or 3. How do you make the decision? It’s hard to make that decision clinically because they’re all proven based on the same data. It’s not a tremendous amount. It is 1 inferiority study for each of them.

Is it a throw of the dice or a flip of the coin? What is the mechanism?

 Evaluate your patients who are currently on those drugs. Then take that number, see who their payers are, and look at formulary design for that. Put all that into a spreadsheet. I would love to be able to pick 1. That’s not our reality. Then I have to look at what I’m required to carry and what pieces I can move around within my patient population to achieve some good performance on 1 or 2, or maybe 3 contracts.

 Let’s just say you have an outlier. Let’s say you have a national payer or small regional payer who has a 2% market penetration for your practice, but they have a fourth. Do you have to stock it on formulary, or do you tell them, “sorry?”

 No, we’ll stock it. We’re going to treat the patient. I can’t take a loss on the product, but then you get into a little bit of operations. We set up pop-ups for the nurses and everyone who would even be close to touching that product, because I can’t give the wrong product to the wrong patient.

 Karina, we’re dealing with, let’s say, 6 potential biosimilars of the same reference brand. Do you have to have all 6 available? Can you approve 1 and not another when the basis for most plans is medically necessary and not experimental? Can you make 1 not medically necessary if the other 5 are? Can you restrict them that way?

 Well, I have 2 answers for that. On the commercial side, yes, you can choose whichever 1. Costs to the health plan are going to be a factor. The other factor is any sort of abrasion to the patients or providers. We do take that into consideration and make the decisions based on those inputs. On the Medicare side, you really could do only step therapy. If it’s available, on the market, and FDA approved, you can require step therapy. If for some reason they have a trial and failure, or they have some issue with the biosimilar, we would have to be able to pay for whichever product the physician feels is most necessary.

Does that change how they access it? No. If it’s not there—if the hospitals are not stocking it and if the outpatient facilities are not stocking it&mdash;then they’re going to have to use what’s available.

 For Michael and Bhavesh, it is related because you both represent entities that have considerable size and market influence.

Do you tell payers, “This is what we’re using,” if they’re a small payer, and there’s not an option? Will you do what Kathy said, and try to limit it to the fewest number but end up stocking all of them, if any payer comes along and says, “Yes, you’ve got to use this?”

 Similar to Kathy’s approach, we would actually work with our local payers to see if we can negotiate a preference based on our preference. If not, then we may have to carry 1 or 2 for formulary. We’ve been pretty fortunate in the market in Massachusetts, where we’re able to use 98% of the formularies that we have for biosimilars across various institutions.

 In my practice, in an ideal world, you would like to try to have everyone agree on 1 biosimilar option. It just makes things much simpler and reduces chances of errors in any shape or form. In the future—say, if we have 10 or 12 different options available and we have different payers saying that they’re only going to provide 1 over the other option, and it’s not necessarily 1 that’s our preferred&mdash;obviously, we’re going to try to do everything we can to encourage acceptance of our preferred medication. I think everything else may have to be on a case-by-case basis.

If it’s something that is not economically viable and puts us underwater and they’re not willing to budge, then we might not be able to treat that patient. It’s just that simple. If it’s something we could permit and it’s not an alternative that would put us underwater, we might be willing to entertain it. We haven’t faced that reality yet because there isn’t that wide number of biosimilar options.

There’s going to be a bit of a wait and see as things evolve, but we’re always going to be pushing for 1 preferred biosimilar option.

Multiple Biosimilars for a Single-Reference Biologic  

 As Karina said, early conversations with payers are really the way to drive this. We got burned in the infliximab market when it came out. We didn’t have the conversations with payers saying that we are going to go and make this change in our formulary. By the time they actually decided which formulary they were going to use, we were still deciding which 1 we were going to use for our formulary. Of course, they couldn’t wait for us to make that decision because there were millions of dollars at stake for them.

What we do now is go to our local payer market and let them know that we are evaluating these for adoption and we are very interested in switching. We don’t want them to actually choose a biosimilar. We would like to be the entity that chooses it. We have a blanket statement from our local payers that for oncology biosimilars, they will not be choosing 1 versus the other.

In the states in which they haven’t been able to do that, I’ve seen very extreme levels of regulation that a lot of institutions have pushed through, where they actually do not allow payers to choose a biosimilar in that state.

There is definitely government influence that can be used, but I think it is more appropriate to work collaboratively with the payer to give them a heads-up and have those early conversations. That will help reduce the number of biosimilars you have to carry in your formulary.

It’s hard when you have institutions that actually have a majority of the patients coming from out of state for consults and treatment. Those are the most challenging, where you have hundreds and hundreds of payers from out of state to deal with and it’s impossible to control the formulary there.

 Michael, is there some saving grace in that, for the most part, oncology is more weighted toward Medicare than any other specialty? Almost every oncology practice’s dominant payer is Medicare, and you don’t have to deal with playing these games and figuring it out.

 That is partially correct. I have to agree with that, but it really depends where you are. You can see a lot of geographical differences. A lot of people tend to retire in Florida—which is where I am&mdash;so obviously it’s the dominant payer here.

I think I agree with what I’ve heard so far in that it requires a lot of collaboration with your payers. It just so happens that the largest overall percentage of our patient care is covered under some form of a value-based contract. Medicare is under a value-based contract with the oncology care model. The vast majority of our commercial plans are as well. The only plans that aren’t are Medicaid and some of the Medicare Advantage plans. In those value-based contracts, all the incentives are aligned. The overall goal is to take the best care of patients and to do it in the most reasonable fashion.

If you remove the obstacles and align incentives, then you can get the best results overall for your patients. It helps make the situation win-win for everybody, not only for the patients but also for the providers and the payers. It’s the collaboration that’s required.

 Are your value-based care collaborations with your commercial payers as well?

 Kathy, are you seeing any interest or willingness among the commercial payers? In every state, it is going to be the state’s Blue Cross Blue Shield that is going to be, by far, the No. 1 commercial payer on the list you want to collaborate with. Are they receptive?

 Funnily enough, yes, we are working on that. They do have an interest in bringing down that total cost of care, and we have had that discussion. Yes, we are working on a biosimilar value-based contract with our state Blue.

Strategies for Incorporating Biosimilars Into Care Plans

 Karina, the state Blue Cross Blue Shields are coming through. Actually, Blue Cross Blue Shield of Michigan was 1 of the earliest collaborators. I was doing some payer-pathway work in 2010, and they were already collaborating with private practices as well as institutions.

I look at this and Florida Cancer Specialists & Research Institute, and they’re not necessarily representative of the mainstream. Then we have Blue Cross Blue Shield of Michigan, and it was early in their collaborative nature and not necessarily representative.

I wonder how much of the story resonates if we were talking to every Joe oncologist who is out there and not in these practices or in states. Although Bhavesh said the numbers are pretty impressive in this early period in terms of adoption, it’s not the story I’m hearing on the street and in the market research work I do with Cardinal Health Specialty Solutions.

Do you think these are representative? You’re all involved in the national organizations. Do you think that because of your positions and your institutions or organizations that you’re in better shape than most? Anyone?

 I’ll take that 1, Bruce. I do think that. Even within the Blue Cross Blue Shield system, I work as collaboratively as I can with the smaller state plans, which don’t have that big hole or years of experience that Michigan had, in terms of coming up with these collaborative agreements. Also, it is beneficial to have that designated department or area that is able to interface with not only the providers or the big health systems but also pharmaceutical companies on those rebate-contracting portions. It does get very complicated, and there are a lot of interests to deal with. A lot of the smaller plans, as you mentioned, really don’t have the dedicated staff or resources that are required to make these big offers and collaborations.

 Bruce, to answer your question, I do think, because of where we all sit and what we do for a living, that we view this very different from what is probably going on in the much larger landscape. As I mentioned earlier, you really have to have that physician champion who is going to adopt biosimilars. I’m hearing hesitancy from oncologists because they’re very concerned about giving a product that’s similar when they have much more confidence with the reference product.

Some people are doing only new treats. A lot of people are not as forward-thinking as Dr Diaz and his partners at Florida Cancer. Then what do you do? Some people do only those new treats and then start to track them. They track them for adverse-effect profile, scan results, and those kinds of things, but you also passed that physician champion. You need to have a nurse champion; let’s not forget the nurses in this. There needs to be a lot more nurse education around biosimilars. Nurses take that relationship with their patients very seriously. They love their little patients and need to have confidence in the medicines they are giving their patients. They’ve been forgotten in this whole process a little.

You also need to have that administrative champion who is doing that modeling based on contract pricing, even just from a revenue-cycle standpoint, because we do build those things differently. You have to talk to your payers to make sure they’re covered. We track all our new drugs when they come to market. When we bill them, we track them differently. I’ve had revenue-cycle people come back to me and say, “We don’t give biosimilars because we won’t get paid.” That’s not my experience, but it needs to start at the top and it needs to work its way through the life cycle of a practice for successful adoption.

Incorporating Biosimilars in Oncology: Working Collaboratively

 Kathy set us up beautifully on the issue of economic impact. There are so many layers of the economic impact. We’ve touched on them. I want to focus our thoughts on them. It’s no longer about the operational aspect. It’s not about the efficacy. It’s not about the way in which biosimilars are approved.

Let’s talk numbers. I want a brief response, and then I want to dig in. You’ve all described that there’s effort involved in the adoption of biosimilars, and it raises the question, on an economics argument alone, is the juice worth the squeeze? Who is going first?

 I can go first. I have to say that in value-based contracts, it will definitely accelerate your ability to get to your goal, and therefore it provides incentives. With that in mind, we’re seeing that it’s definitely beneficial.

 I think you need to look at it from a global perspective, right? If we don’t adopt biosimilars, how do you actually make room for more innovative therapies? There have been a lot of great models out there that basically show what happens to our cost of medications and biologics for the next 3 or 4 years if we don’t adopt biosimilars. It’s going to go up by $100 billion.

That should be the biggest reason, but I also think that there are so many different factors that play a role. It all depends on what type of model your institution uses. If you’re a risk-based model, and that’s how you practice, then you’re the provider and the payer, so you’re going to be using more biosimilars.

If you’re in a revenue-generating model, then that is going to drive your decision to use more costly drugs. As Kathy mentioned, ASP [average selling price] is important, and this is what also influences some of the biosimilar companies not to have aggressive pricing. They don’t want to dilute the ASP so much because it doesn’t make it appealing for providers to use an ASP they’re eventually going to lose money on.

There are a lot of economic factors, but we need to think about the global picture of the price we’re going to pay for adopting the bigger and more costly innovations we’re seeing, especially in oncology with CAR [chimeric antigen receptor] T-cell therapy and the combination of immunotherapies that are coming out.

 Yes. I think we can all agree that health care costs are too high.

 When you look at it at a practice level and a prescriber level, and you look at your contracts, rebates, and drug costs, I’m hearing that differences to the bottom line are 10% or less. Are they greater than that? For the most part, I’m not hearing that patients are seeing a lot of the impact. In the current modeling or current benefit design, if they’ve got a $5000 deductible, they’ve already hit it by the time they’re getting on a drug that’s a biosimilar. They have surgery or whatever else, and whether their deductible is $5000 or $10,000, they’ve consumed it.

 They don’t have a drug coinsurance, at that point, for infusional therapy. Most do not in design, so nothing is happening at the patient level. From an economic preference, it is happening at the practice level. If that difference is only 10%, is the juice worth the squeeze?

If you’re telling me it’s 20% or 30%, I’m going to be all ears. But what is that difference?

 I think it’s a little more complicated than that. Yes, it’s worth the squeeze. I believe in the innovation. I believe in the science. The cost of health care is too high. When we talk about cost to the patient, yes, there is a $5000 deductible. I’m not going to argue that. But at times it’s like buying a car for people who are already in a financially toxic situation. Whether that’s $5000 within 60 days or because of a biosimilar, I can make that not due for 120 or 180 days, it allows them some flexibility. Therefore, it decreases a bit of that financial stress on them. Margins are tight in practices. As for the 10%, we see more. I see closer to 20%, but even 10% is better than 5%.

Again, it’s not just that 1 thing I’m looking at. I’m looking at the whole larger picture. As long as we can keep the biosimilar market open and can continue to increase physician confidence and adoption, that the market will continue to grow, and those advantages will continue to grow as well.

 Karina, is the juice worth the squeeze at the payer level?

 Year 1, no, the juice is not worth the squeeze. In the short game, no. That’s a general statement. You’ve got some drugs that are worth the squeeze right away. Most are not. It’s really the long game at this point. We’re looking at a 3- to 5-year strategy on our end, which is how we work anyway. I’ll give you an example. I won’t mention any names, but we’ve had to take several year-1 losses to be able to make a biosimilar work in year 2 and beyond.

Economic Impact of Biosimilars in Oncology

 It’s interesting that I’m hearing a lot of long-term strategy. Bhavesh, you went long term and big picture. Michael, for the most part, you went long term in your big picture because it’s a value-based care strategy and not about this year’s numbers. Kathy, you went long, and Karina went long.

I wonder how many community practices with 3 or 5 doctors can afford to think long term. Are they thinking in the business next year? I wonder about that thought process, and they are not an insignificant segment of the oncology provider space.

 In terms of what the financial impact has been for us, from our biosimilar experience, by adopting about 98% of our patients, we’re able to save our health system $1.5 million. What does that mean to us and the patients? From a global perspective, 50% of our payments come from a risk-based model. If we’re able to lower that cost, we’re actually able to help sustain our business with our payers longer and also offset the cost of more innovative therapies.

It helps to continue to adopt new therapies and continue the path you need to have in oncology. As you said, it’s long term. You’re not going to see an immediate effect at the time of your switching.

Something that’s really quirky with list pricing is that you see a lot of contracts that are not publicized, which are not reflective of what you see in a list price. You might be seeing a list price as 10% or 15%, but there are institutions that are getting 30% or 40%, which is really helping to drive that cost down. Based on Kaiser Permanente, they publicize that they’re going to be saving $200 million from switching to oncology biosimilars. That’s a huge impact for a single payer, so there is a long-term benefit that we’re going to see.

 You bring up a very good point, Bruce. Many practices are used to looking at things from a day-to-day perspective. Do I have the ability to keep my practice open month to month? Overall, the best way to plan long-term survival is to be able to create an environment in which you can change from that philosophy to a longer-term philosophy, which will allow you to keep your doors open.

That’s where we’re working with the smaller practices, so they have the ability to play these long-term games and remain economically viable. That’s happening on all levels. Our institutions are helping with that. I know that some of the payers are investigating and encouraging these types of relationships. We have to constantly evolve in order to continue to meet needs and stay in business, so to speak.

 Michael, if your practice was not so heavily engaged in risk-based models or value-based care models, do you think this would have been something you could have sold to the rank-and-file physician members?

 That’s a very good question. It would have been a lot more difficult because people wouldn’t understand how that would benefit them long term, help keep their doors open, and ensure that they can pay their staff and all their overhead. There is a lot of overhead associated with our practices, and not everyone is aware of that. Most are, but it would have been a much more difficult sell. I can tell right now that we’d be facing a lower conversion rate, compared with what we’re seeing, so yes.

 I think about that because estimates are that 50% of adult oncology patients are being cared for in a non-risk-sharing practice. It’s not just OCM [Oncology Care Model]. If you include OCM and ACOs [accountable care organizations], we’re still talking about 50% who are being managed outside that.

The economic impact is interesting, as we’ve been hearing this. It seems like a lot of that is related to the value-based care design that either you have or you’re working toward that’s going to do this. Certainly, if you’re smaller, you’re not going to get the face time with the payer. You’re not going to likely have the quality of the contracts and the opportunity for the volume that’s going to give you leverage. It is going to make it tough.

I want to bring that up for our audience. We want to have people like you all in these panels who are incredibly knowledgeable, but it often means they aren’t fully representative. I’m sure it’s been talked about at COA [Community Oncology Alliance Annual Conference] and in other meeting environments, where I imagine this is not the same story across all practice types.

Biosimilars in Oncology: Long-Term Financial Benefit

 It sounds as if the value is high for biosimilars. You all have a good long-term strategy and believe they are critical for that long-term strategy. Kathy, you’ve said that even a 5% difference could be meaningful. When we talked about what biosimilars have to do to gain market adoption and make an impact 2 or 3 years ago, there was this notion that it had to be 30%.

We talked earlier about limitations, and yet I’m hearing as little as 5% could be significant. All that sounds like it’s really strong.

One of the things I forgot to mention is that, as you see multiple biosimilars coming onto the market, the wholesale acquisition cost with the list price of the reference product actually stops increasing. Then the ASP [average selling price] starts going down. That’s 1 of the things we don’t actually think about. We’re lowering the cost. If we didn’t have the biosimilars, the cost of the reference product would continue to go up and the ASP would also continue to go up.

 Let me challenge you with the counterpoint. As a result of what we’re saying today and the compelling case you’re making for biosimilars, a company that has significantly impacted biosimilars, Genentech Inc, decides they’re going to go to parity with the best of the current biosimilar contracts for each of their brands. Do you go back to the established brand that has all the evidence?

Yes, if they’re going to lower their price to the level of the biosimilars or even lower, if it’s more competitive, then of course.

All right. Anyone else want to weigh in? If it’s strictly a price story, then the question is, how close a price parity?

These companies have enjoyed exclusivity for such a long time, right? It’s not fair that the health care system, the patients and the insurance companies actually pay for the increase in price. For a Genentech drug that you talked about, when they actually increased the price of that drug in 2 years, it resulted in almost a $1 billion increase to the health care system. That would have never been resolved if we didn’t have a biosimilar coming through. They would have to come down to the level.

We have had that conversation, and the answer within our organization is that certain originator companies had their chance to be good partners. Some chose to; some chose not to. To your point, we will not be going back to certain originator manufacturers because we’re looking at that much larger picture, even with a parity contract. We believe in the science and the innovation behind the whole biosimilar market.

, and this is making the nightly news. Thank you, Kathy. We just did that. That was great. I think it’s realistic, and the candor is so important for the audience to understand that this is a complex issue.

I’d like to add the point that we made earlier about infliximab versus oncology biosimilars. What happened in the infliximab space was that the originator product came out, dropped its price really low, and dangled that in front of a lot of payers and health systems. Some did choose to take that early on, saying, “Let me get this cost savings right away in year 1,” and some chose to wait it out. I do think it’s a bit of both, and it depends on the financial situation of the decision maker at that point in time.

This is a really complicated subject. We always look at it from this perspective: how can we add the most value to the patient and the health care process? We’re seeing examples where, because of the larger rebates the originator product can provide—even though it’s a more expensive product for the patient&mdash;or the provider’s hands being tied, they have to give the originator product. That’s where it gets complicated so quickly. Each situation is not only unique but complicated.

Competition in the Biosimilar Marketplace

That may be a good place to finish because it is complicated, and over the course of the conversation today we’ve introduced that complexity at so many different levels.

There is a lot for viewers to take from this.

Again, this was great. It was informative. I had a lot of fun. When you can both inform and, to some degree, entertain, especially since we’re doing everything virtually these days, you can’t ask for more than that.

My thanks to all of you for this rich and informative discussion. Before we conclude, I want to go around the horn and get a 30-second final thought on the future of biosimilars. We’ll go in reverse order, so we’ll start with Karina and then Kathy, Michael, and Bhavesh. Karina, you’re on.

Thank you, Bruce. Just to echo what everyone else has said, I think that strategically, we are looking at a 1- to 3-year plan to disrupt the market a bit, make room, and make decisions that do look at overall cost of care in a long-term method.

I encourage everyone. We believe in the science and the innovation, and we do believe that biosimilars have a place in our long-term strategic plans to help bring down health care costs for the system and the payers, as well as the patients.

We believe biosimilars have the potential to permit us to provide high-value care that is at more affordable to patients and society. That is an invaluable tool that we can add to our arsenal as we try to figure out the best ways to take care of our cancer patients. I’m glad they’re here. They’re here to stay, and we want to do everything we can to encourage their use as appropriate.

What I want to see happen is more real-world evidence published by health systems and providers of their experience with biosimilars. That would really help the adoption rate increase, because that is tied to the cost savings that we want to see to adopt the innovation we have.

One of the biggest challenges that we have not addressed, until this day, is actually having payers control the market. Until that is taken away, we’re still going to have this impedance of adopting biosimilars to the full extent that we need to and that providers want to, so that is going to require some government regulation.

Essentially, we’re not even going to be talking about a biosimilar in a couple of years. We’re going to be using multiple biosimilars 1 week, next week, and next month. This is all going to be obsolete, hopefully.

Thanks, Bhavesh. And thanks to everyone on the panel. Thanks to our viewing audience. We hope you found the Center for Biosimilars® 

® discussion to be useful and informative, and maybe a bit entertaining. I’m Dr Bruce Feinberg. Be well, everyone.

Understanding and Improving Access of Biosimilars in Oncology