 Amanda Forys, MSPH, and Christy M. Gamble, JD, DrPH, MPH, discuss oncology patients’ awareness of biosimilars and willingness to try these therapies.

 Hello, and thank you for joining The Center for Biosimilars

 Titled “Bringing Oncology Biosimilars to Patients.” I am Amanda Forys, senior director of reimbursement policy insights at Xcenda. With me today is Christy M. Gamble, director of health policy and legislative affairs at Black Women’s Health Imperative. Thank you so much for joining us, let’s begin.

 First we’re going to go ahead and talk a little bit about the biosimilars market for cancer patients. I know we’ve just now recently this year seen 2 FDA approvals for anti-cancer biosimilars: Mvasi, which is a bevacizumab biosimilar, and Ogivri, which is a trastuzumab biosimilar.

We’re seeing payers starting to look at biosimilars and putting them on formularies, maybe not at the rate we were expecting to see for the rheumatoid arthritis products that have come to market, but we might see that pick up a little bit in the next couple months as more and more products are getting approval.

Can you talk a little bit about the patient population that would be using these products in oncology? Do they know what biosimilars are? Are they comfortable with them yet? What do you think about that?

 That’s a great question. It really depends on, like you said, the patient population. In oncology, the patients are more familiar with biosimilars; it’s a familiar concept for them. The providers are more aware, and they’re informing their patients of different biologics and biosimilars on the market. So, when it comes to biosimilars for oncology patients, they’re more willing to take their providers' advice on the different biosimilars that will be most effective in treating their condition.

But when it comes to other disease populations, they’re not as familiar with biosimilars. That’s the group that we’re trying to get to become more familiar. We’re trying to get their providers more familiar with biosimilars and the benefits of them.

 How does it work with the concept of brand loyalty?

Let’s say you have a patient either just being recently diagnosed with something who knows of a brand that they’ve seen a commercial for, or a patient who is continuing a therapy that they’ve been on that may have a change to formulary now in favor of a biosimilar.

How do you handle that as a provider, or as a community, to help people understand that they can switch over to these products, and that they’ve been deemed safe by the FDA?

 We’ve come to find out that patients really seek the advice of their providers. They’re more likely to believe and trust their provider when their provider has told them that a particular drug or therapy has been very successful in treating their condition. They’re more willing to switch over to something that is effective at treating their condition.

So, we’re not really seeing most patients say “No, I’m loyal to this particular brand.” Particularly for oncology patients: they want something that works and they want to get treated and they want an effective drug and therapy, so they’re willing to switch at the advice of their provider. We’re not really seeing that brand loyalty.

 Yeah, I always hear “Is it safe, is it effective, is it going to make me better?” That’s what a patient wants to know and they’re really leaning on those practices.

Patient Awareness of Biosimilars and Loyalty to Branded Drugs

I know that we’re really new to the biosimilars market here in the [United States], but the European community has been doing this for quite a few years now, and they’ve had some significant savings in biosimilars.

I think we’ve also seen some really innovative payment models, kind of structured around the use of products and risk-sharing agreements and outcomes-based type contracts. I think we have a lot of different things going on in the [European Union] that have contributed to that savings.

But here in the [United States], we’re new, and we’re not quite seeing the uptake that we maybe expected from these products. How do you think that’s going to change over time?

 Well, we’re hoping that conversations like this will actually affect the cost that we’re seeing now.

When we’re looking at biologics, the prices are exorbitant. [With] patient populations, you have 2 sets: 1 set that’s willing to take the risk on paying for these medications, and another set that says, “it’s just out of my reach right now.”

When it comes to biosimilars, you’re only seeing about a 10% to 15% difference in price when it comes to biologics and biosimilars, so patients are not really seeing the cost savings when it comes to these drugs. But we’re hoping that, in the future as more drugs come onto the market, as more therapies come onto the market, that we’ll see more competition.

We’re seeing a lot of change in policy right now that will provide some nice incentives to manufacturers and developers that will hopefully add to that competition and lower costs. And then putting pressure on manufacturers to lower the cost if we can start having these discussions of drug pricing.

Patient Savings From Biosimilars

 Do you think that a patient is considering—in oncology sometimes you hear the general sentiment that sometimes patients aren’t as worried about costs as they might be with a different condition because it’s oncology, and it just gets your attention and there’s so much attention to it. Patients will sometimes go to extremes to make sure that they’re able to cover the cost of their medication. I’m not saying they won’t in other diseases, but oncology is just kind of one of those special ones that really gets people’s attention and they’ll do what they can for their care.

What are patients looking for in terms of a cost savings, and is that alone—I know you talked a little bit about efficacy and feeling safe taking it&mdash;how much do you think cost plays in that decision to switch to a biosimilar or take one?

 It really depends on the patient. You have some patients in oncology that are willing to take the risk, like you said: “Whatever it takes to fix or treat my condition or manage my condition.” But you have some patients who just simply can’t afford it. You have populations of color and low-income patients that are oncology patients but they can’t afford it.

That’s when the conversation comes down to what we call the 5 As of access: you have accessibility: is it easy for me to get this medication? Then you have availability: is it available to me immediately? You have accommodation: can I get to it at certain times, can I go to my local pharmacy—my 24-hour pharmacy&mdash;and access this drug? Affordability of course is key. When it comes to those that are insured, am I able to cover the co-pay? That’s where cost comes into play. And then acceptability: am I able to get this from my provider, [and] is my provider willing to offer this as an alternative?

So, there are so many different things that come into play; cost is just one of them. But it’s really the ease of getting to it. The least amount of barriers, the more likely you are to see a patient who’s willing to take a biosimilar versus those who are facing some significant barriers. Like I said, populations of color and low-income patients are more likely 

 to take biosimilars because of all of the barriers including cost that come into play with the therapy. 

Barriers to Biosimilars for Oncology Patients

 I know [it’s] not just patient costs, but looking at the payer implications of biosimilars is a huge deal, because obviously, patients [don’t] even have access to biosimilars if payers aren’t covering them, or manufacturer programs aren’t there that give patients access to the products.

Let’s turn a little bit to the rheumatology space right now. We’ve looked at [rheumatoid arthritis] RA, [and] we now have 2 products on the market. We’re seeing about a year now of Inflectra, that’s been on the market, and then Renflexis is just coming out in the past few months. We’ve seen some legal battles between those 2 products: the issue around potentially bundling services or keeping the products on formulary and kind of setting the payment arrangements so that you are blocking a biosimilar from getting on a formulary.

In thinking about accessibility for a patient, it would be great if you could have the biosimilar on the same formulary and the patient can decide what tier product they want to have, but that might not necessarily be the way it goes.

The manufacturer may work out an arrangement with the payer that either the brand product stays on, or they have both, or they prefer the biosimilar. We have seen instances where the biosimilar product is being placed on formulary and the reference products are coming off of that.

Can you talk a little bit about formulary placement and how that contracting process is influencing things, what you might see from a patient perspective, [or] what would happen to them given some of those decisions?

 So that’s really interesting, because patients who are doing well on a particular therapy want to stay on that therapy. When there’s a formulary change, particularly mid-year, that causes some concern and frustration for patients. It really comes down to sometimes being life or death. Some patients feel like when there’s a formulary change, it’s like pulling the rug out from underneath them.

There starts to be this concern about effectiveness: “Is this new therapy that’s being covered just as effective?” You also have conversations about contraindications: “How is this going to interact with the other medications and drugs that I’m taking?” Then you also have the cost conversation: “How much is this going to cost me in terms of out-of-pocket costs?”

Patients tend to want to stay on medications that are most effective, and [that] their provider sees as most effective. Then it becomes difficult in terms of price once it’s off of the formulary, or it’s not on the preferred list. Patients start to think: “Am I going to be able to cover this?”

It’s very frustrating for those that have autoimmune diseases or rheumatoid arthritis or lupus for instance. They start to think about, “What am I going to do now? Should I switch and possibly have a different reaction to a drug?” As you know, drugs interact differently for different disease states and within certain individuals. So now you’re running the risk of changing to a medication that may have some adverse effects, and now you’re going to be hospitalized, which raises the costs to the US healthcare system.

You have, like I said, this life or death situation here, and patients aren’t really willing to take that risk. It’s really sad that insurers are willing to take that risk with patients. So, you have a lot of frustration and a lot of anxiety for patients, and that’s why you’re seeing states like California and Nevada introduce policies where they prohibit any mid-year changes in the formulary, because if you sign up for a plan and this is a covered drug, and you sign up for it for a year, you should be able to stick with that covered drug for a year unless there’s a medical reason why you should not. We’re really advocating for policies just like that. Medicare does it, unfortunately Medicaid doesn’t.

But, like I said, patients really are anxious about it, and if their provider is saying, “This is the medication for you,” the patient should have access to it, and it should be covered, and cost shouldn’t be a concern.

Biosimilars, Payers, and Formulary Changes

If you said this to a payer, and they said, “That’s what the exceptions process is for,” comment on that a little bit. What does that mean for a patient to go through an exceptions process, what’s the timeline, what’s the stress, what’s the burden of paperwork and evidence that they have to give to the payer?

For the patient, it’s “Do I really want to go through all of this? I just want access to my medication. I don’t want to have to go through this process of filling out paperwork and talking with my provider, my provider is frustrated, I’m even more so frustrated because I don’t understand what’s going on.”

Like I said, for low-income patients and populations of color, who are not really familiar with these therapies, they’re just going to be really frustrated and say, “Just give me the drug that’s going to take away my frustrations and anxiety.” They tend to go with the outdated therapies, unfortunately, that don’t treat their disease states as effectively as these new therapies. So, [it is a] very frustrating process and one that most people will just give up and move on to the easiest route—like I said, the 5 As of accessibility&mdash;and that’s cutting off their access and creating another barrier that they’re not willing to jump over.

The Exceptions Process and its Effect on Patients 

 When these formulary changes happen, you mentioned some mid-year, some end-of-year, and we’re seeing some legislation kind of pushing for that consistent approach to year-by-year changes. What should be out there for patients to understand that change?

I know for Medicare, for example, on Part D open enrollment, you can go online and go to the plan finder and type in all your drugs and it tells you if your plans are covering it. I know that there are some tools for people buying exchange plans that say those things, but what about me? I’m covered under my husband’s insurance; how does that work for me to get that information, or somebody who’s potentially on a Medicaid plan, or someone who has insurance through another avenue. How are they getting it, what do they need, and how should they be receiving it?

 They’re usually given it (hopefully) through their provider, but some providers don’t have that information. In the oncology space, they’re more likely to have that information.

But, once again, talking about populations that don’t have access, populations of color and low-income populations, that information is not readily accessible to them. They’re not able to know which sites to go to in order to look for this information. It’s really important that when it comes to these types of changes, and what’s covered and what’s not covered, that insurers and manufacturers [and] everyone in the system or the chain should really look at working with organizations that advocate for these patients that can “speak their language,” [and] that know how to reach these populations.

A lot of the information that’s out there is at a high education level, and you really have to be “healthcare savvy,” as I say, to understand what’s going on. If you work with these patient advocacy groups, they’re more likely to be able to put the information [and] synthesize it in a way that the patient population can better understand it.

How often do you see providers putting in great counseling for patients? Let’s say in oncology practice, usually you see very well-run practices here where they’re seeing huge numbers of patients, they have great office manager staff, not to say that other practices don’t, but oncology is just known for [a] very streamlined care processes. What type of services are they offering, are they good, could you see them enhanced? Do you have any suggestions for improvement for those that you have seen?

 Oncology is a great example of what the other disease states should actually follow. It’s that counseling, it’s that sitting down with patients and going through, because they know the stress level, and they know the anxiety that comes with having that type of diagnosis that patients are willing to do whatever it takes to find the right therapy for them.

They’re sitting down with the patient, they’re sending them referrals to nurses and other support systems, and there are so many oncology patient groups out there to provide that support. So, it’s really working in tandem and working very well with these groups that I hope that the other groups like the [rheumatoid arthritis, RA] groups and lupus groups can actually take heed and follow that model.

We’re seeing that work very well but once again, working with populations that don’t have that access is where we’re seeing a gap. We’re not seeing them reach these people like they should, and coming up with really innovative ways to reach them, because more than likely they’re having a difficult time getting to the providers office, and transportation is a big issue, and getting that support to come out to them.

We’re always pushing for things like telehealth and telemedicine to reach patients where they are, and having that support come to patients. So that’s one thing that we would definitely like to see that gap filled.

Patient Education on Coverage for Biologics and Biosimilars

I know the oncology care model has been something that we’re testing out to see if more involved provider interaction and treating that patient in the Medicare world on an almost per-member, per-month basis where you’re giving that provider that payment to manage the patient.

Do you think payment systems like that—that do some type of encapsulated full service, or comprehensive service, more involved with Medicaid or more involved for the uninsured even just making sure that offices are doing that beyond Medicare&mdash;that that’s the kind of model that you’d like to see?

Yes, that’s a great model to follow. It really is. Like I said, there’s still those little holes and gaps where if you work with those specific population advocacy groups we can fill those, but really giving that specialized attention to the patient is what’s really needed.

Medicare is doing some things very well, and doing some things not so great. We’re all for innovation and trying out things to see where the gaps are. I would hate to say, “No it’s not working,” I would rather say that “It’s going along very well, but we still see some gaps that we would like to fill there.”

But coming up with ideas and being really innovative in reaching every patient population—we’re always giving a thumb up for that.

 Yes, coordinated care models, I know we’re always trying to figure out better ways to provide coordinated care, so I definitely think that since you mentioned the medical transport, getting people to where they need to be and thinking about that, it’s a broader spectrum of treating the patient, not just the disease that’s important.

Alternative Payment Models and Patient Care

We’re going to talk a little bit about cost, access, and education, and a little bit about patient assistance programs and how these fit in with the whole biosimilars marketplace.

The first thing I want to talk about is just the cost of biologics. We know that biologic products are a little bit more expensive than what we’ve traditionally seen in the market. Now that the biosimilars are coming out, we’ve seen discounts up in the 15% to 20%, some things in the 20% to 30% [range], we’re not really sure where it’s going to go with policies that are still being figured out among payers about biosimilars.

Just in general, what are patients paying for biologics, how is that affecting them, and is it affecting them in their outcomes or their financial health? What are you seeing with the current biologics market?

What we’re seeing [is] the average daily cost of a biologic is $45, versus a non-biologic which is $2. That is an extremely significant difference, and for patients, it is a shock to the system.

What we’re seeing is, you have patients that can afford [biologics] and cannot afford [biologics]. So, for the patients that cannot afford, they’re having to, like I said, resort back to those outdated medications, and they’re being left out of healthcare innovation. They’re dealing with adverse effects from these older medications that they wouldn’t have to [deal with otherwise], and they’re not able to have access to the medication that could effectively treat their disease state versus those who can or are willing to pay. They’re willing to take that risk “at all costs,” so to speak, just to get access to the medication.

So we’re hearing patients say, “I have to decide whether or not I’m going to sell or mortgage my home just to afford this medication. But I have to do what I have to do, because I need to treat and manage this disease.”

It’s unfortunate, because we don’t want patients to have to mortgage their life just to afford medication, and that’s what we’re seeing right now with biologics.

 Yes, and it’s interesting, you raise the drug cost and then on top of that you’ve got the administration fees and visiting the provider, and while some of these programs have out-of-pocket caps, they’re very high. Some of them are extremely high, and you’re looking at people paying—if they’re getting into these programs, and having an almost catastrophic health plan where they’re paying an almost $10,000 out of pocket max, or even some of them at a $5000 to $7000 deductible before the care starts. I think we’ve got an expensive drug, and in addition we’ve got a payer market that’s being designed around very high buy-in costs for a patient’s care to kick in, or their coverage to kick in.

The Cost of Biologics and Biosimilars

CMS this past month put out their part D proposed rule, and they wanted to get some information from industry on the whole rebates scenario.

Right now, in part D, patients are getting their products and they’re going to the pharmacy, they’re paying what their plan’s co-payment is, and then on the back end, the payer is receiving in a lot of cases, a rebate from the manufacturer. The savings that the payer is getting is being translated each year when the plans submit back to Medicare what their monthly premiums are going to be for the next year.

So, the Medicare program says, “We’ve had very, very little growth in our part D premiums year over year, sometimes they stay the same, they might drop a little, they might go up 50 cents, that’s because we’ve been great at controlling the cost.” But also, this rebate concept is keeping that low.

Some people are saying, “Well, why don’t we move that to the point of sale, so the patient is actually getting the discount more when they’re paying at the pump, versus what they’re paying with their premium?”

Some people really like that idea because it’s giving the patient an easier way to pay and see that cost-savings over the year, but then others say, “Well if you do that, all you’re doing is now Medicare is going to have a higher premium because you’re not putting that cost savings at the end.”

What do you think of this kind of policy where a patient might get the savings, kind of at the front end when they’re at the pharmacy, versus the end in the premium, do you see one of those really working out better for a patient?

It’s difficult because, like I said before, you have 2 patient populations. Those who can afford [drugs] when they go to the pharmacy, and they want to have a lower-cost at the pharmacy, versus those who [say] “I would [rather] just pay up front this premium.”

We’ve been walking a thin line on which side to advocate on, and we really would like to find a system in an ideal world, where we can take patients as they are. Kind of like a case by case type of view when it comes to the savings.

But for us, we just want to make sure that the cost of these drugs [is] lower, so then you don’t have to come up with these innovative systems to make sure the patient can see a lower cost, either at the pharmacy or in their premiums. I think that’s where we stand right now, is just by saying, “Okay, we need to advocate for these costs to be lower, period,” and then we won’t really have to have these conversations in the end.

Rebates and Medicare Part D

I always look between what Medicare is doing on the Part B, physician-administered side, and what they’re doing on the Part D side. It looks like they’re trying to encourage a market, a robust market, but then it does look like they’re trying to do things to save money.

On the B side, originally, when they came out with the first rule on biosimilars starting in 2016, any biosimilar to a reference product would share a billing code. Then, all of the reimbursement would be combined and they would get their average sales price blended together, plus 6% of the reference product.

A lot of people in the industry said, “Wait a minute, you’re doing that and you’re grouping us together, you’re treating us like generics but we’re not generic products. We are unique products, we’re not biosimilar to one another, [and] you’re putting challenges of pharmacovigilance by putting a bunch of products that could have different indications together. You’re making it really hard on providers [and] you’re making it really confusing for patients,” and CMS just turned that over. They said…starting in 2018, each biosimilar will get its own J-code. It almost seems like on the B side they’re letting a biosimilar be a brand. But then, on the D side when they came out with their rule this year, they actually want to now change the definition of a generic to include a “follow-on biologic.”

That helps the cost savings for a patient with a low-income subsidy because they were going to have to pay—which, we don’t have a part D drug out yet but when we do&mdash;they would have to pay that brand subsidy amount and now they can pay the generic amount. That’s great for a low-income subsidy patient.

[However], it doesn’t really change much on the non—low-income subsidy. So, a regular part D enrollee now, they’re still treating the product as a generic, but this pretty much says though now if you change this definition, for sure now a manufacturer cannot participate in the coverage gap discount program.

As we all know, for beneficiaries, even though the donut hole is closing, that’s a 50% rebate you get from the manufacturer. It counts towards your true out-of-pocket, and it helps you if you’re on really expensive drugs, [be able to] get into that catastrophic coverage sooner, and then you only have a 5% copay there. So, we’re saying on the D side, generic, we’re saying on the B side, brand, almost.

Think about that, how does that work, how does the coverage gap discount program [work]? How do you think that will all play out? What do you think they should be prioritizing?

We really want biosimilars to be included as part of the coverage gap discount

program because right now, patients are going to be pushed towards these more expensive biologics that have higher out-of-pocket costs, which is very disturbing to us. So that was disappointing. I know we’re pushing for Congress to include biosimilars in the program now, so hopefully that will go through.

We were excited with CMS giving the individual J-codes as you mentioned, because that provides an incentive to manufacturers now and it relieves patients of some of that confusion, same with providers, and we’re more likely to see some more biosimilars come on the market, and patients have access to the lower-cost biosimilar[s]. But it’s really interesting how there’s no consistency here.

We’re kind of running in circles trying to figure out what’s going on and how we can better advocate for patients getting access to these lower-cost biosimilars. Like I said, we were very excited about CMS, and we’re still pushing to make sure that biosimilars are included in this discount program for Medicare on Part D.

 So, to push a little bit more on the B side aspect of the question, a lot of people who said, if you keep them with the same code, you’re going to force the price down and you’re going to get that race to the bottom. You’re going to get the cheapest biosimilars because they’re sharing a code and they’re going to have that competition. If you keep them apart, the price might not go as low but the availability of the products is likely to be higher. So, you all, as an organization kind of went on this case more with the concept of the availability of the market and that it will regulate itself over time.

On the D side, with the LIS, the low-income subsity, I’m sure [with] the lower subsidy you guys are hoping they can count it for the generic, and then on the non-low-income subsidy, you want the coverage gap discount program.

 It’s a tough concept, I mean at the end of the day, the manufacturers want to—where they can&mdash;be involved in this discount program. And people have said to me before, clients that don’t quite get the issue, “Well what does it matter? At the end of the day, for a $100 drug in 2020, the patient pays $25 bucks if it’s a brand, or $25 bucks if it’s a generic.”

[But] no, they pay $25, but if it’s a generic, $25 gets counted towards your out-of-pocket, $75 gets counted toward it if it’s that brand, that’s a huge differential. It doesn’t really give a provider an incentive at all to use a biosimilar for a Part D patient whatsoever.

 Absolutely, and these policies are all about providing those incentives, to make sure that patients get access to that lower-cost biosimilar.

CMS' Changes to Reimbursement for Biosimilars

Do you think that these plans will go far enough to reduce costs? Do you think that these types of ideas of keeping the codes separate—potentially letting this whole manufacturer rebate coverage gap discount program that might play out in Medicare&mdash;do you think this will also push private payers to start developing innovative strategies to encourage uptake and use of biosimilars and help us have system-wide cost-savings?

Yeah, you know, I think it’s a nice step. It’s a good step forward. I really say that we should be hesitant and we should make sure that we don’t push policies that would be harmful to the market or harmful to the patient, is what the end game will actually be.

We need to start thinking innovatively about how to make sure patients can get access to—I’ll continue to say that&mdash;get access to lower-cost drugs. If it takes looking into these types of policies and adding on in the future, [and] seeing if there was any harm that comes from the policies and doing some tweaks and changes, we’re all for that.

Another conversation that we would like to continue is the substitution by pharmacist of biosimilars for biologics [and] making sure patients can get that lower-cost biosimilar, even if they get a prescription for a biologic when they go to the pharmacy.

 Let’s talk a little bit about that, that’s interesting because then you have the whole interchangeability issue. From my understanding, some states have just made their general decision that they would just make for any drug; if the [pharmacist] does change it, they have to notify the doctor within a certain amount of days. We see that in a lot of states. Is it interchangeability, do you want to see biosimilars get interchangeability so the prescriber can just switch it, or do you want to see even just a biosimilar, now that it’s approved for the same indications, be treated as interchangeable?

 Yup, absolutely. We want to make sure—because patients are not, like I said, for certain disease states, patients are not aware of biosimilars so they don’t know to advocate for it. Providers may not be aware of it, but if it’s safe and effective for treating that disease state, we want patients to be able to get access to it with the least amount of barriers possible.

Instead of having to go back to a provider, which travel is an issue, and thinking about the concerns of a patient having to actually go back to a provider to get this prescription, we want to remove some of those barriers and make sure patients get access to [it], making sure it’s still safe and effective. Every patient is different, so we want to make sure that we have what treats their condition effectively, but at a lower cost.

Biosimilars, Private Payers, and Pharmacy-Level Substitution

If they can’t get to it and can’t get access to that product, I know we’ve got this whole concept of the manufacturer assistance program. Innovator brand products have these programs and they offer either co-pay assistance, free drugs; for Medicare they can donate [to] independent charitable co-pay foundations that blindly have the money for the patient, so I know that the rules are set around that for the Medicare program.

I know biosimilar manufacturers are being expected to put these programs out there, they are out there; what do you think about these programs and their role? I know that there’s that dance between payers and the manufacturer programs that a lot of payers say, “This is your due diligence as a manufacturer, you should be doing this.”

Then other payers might think, “Yes but, you’re now putting a patient on a product that isn’t necessarily on our formulary, and now they can get an exception potentially or we can continue that therapy instead of leaning them clinically toward what we would like to see the patient on.”

How does that assistance program work and how do you see biosimilars having to run those?

So, the concept is great: helping patints. We’re seeing sky-rocketing drug prices for all drugs right now. The concept of helping patients pay for their co-pay and getting access to free medication—I know some programs even help with travel and helping patients select the right insurance plan that will cover their medication.

The concept is great. But just thinking about the effects of it on the other end…a lot of these programs are pushing patients to take drugs that are higher priced drugs, that may not be as effective as the drugs that they’re taking. Also, if you have 2 drugs that are just as effective, and 1 is lower cost, and 1 is covered through the patient assistance program that is a higher cost; patients are being pushed now to get that higher cost biosimilar or biologic.

We just don’t see that as a very wise policy to support. On the back-end, we’re seeing that these drugs are going to get paid for, and that it’s coming out of the pockets of taxpayers and we don’t want to participate in “gaming the system,” which is how we really see it.

While the concept and the mission and the goal is accurate and correct for these patients, we’re not really sure that we can support programs that push patients to these higher cost biologics and biosimilars because our goal is to make sure that patients have access to lower cost [drugs] and not have a high out of pocket cost, and that means even if its shifted to other payers such as taxpayers, we don’t think that should be the case at all.

For patients, what they’re looking for is, “Just give me the drug that treats my condition effectively, that manages my disease, and that’s a lower cost for me.” We think that patient assistance programs when having these discussions, this is the best time to talk about, “Okay, we wouldn’t need these programs if the drugs were not so high in cost. So, let’s talk about the cost of your drugs instead of providing co-pay assistance, maybe we should talk about lowering the cost of these drugs.”

Patient Assistance Programs and Biosimilars

what if a manufacturer was sitting here and they said, “But hey Christy, I am providing "the As;" I’m giving the patient accessibility, so they might not want to be on the biosimilar because they might not think it’s effective, or they want to be on the biosimilar but still the biosimilar and the biologic originator were both very expensive, [and] neither one is on their formulary. I’m a program offering the patient that assistance,” what do you say to that manufacturer?

 argument. I would definitely still say that we have to have a conversation about cost here. We have to make sure that we’re putting the patient first. We have to also make sure that we’re not bankrupting taxpayers while we’re trying to get patients these drugs. We want to make sure that patients get the most effective drug, but we also want to make sure that costs are controlled. That’s a discussion that we should be having versus whether or not this patient assistance program should be in existence or not. It’s in existence because of the sky-rocketing price of these drugs.

Manufacturers and the Cost of Biosimilars and Biologics

I’d like to focus a little bit now on the future of the biosimilars market, and also a little bit about the clinical trial process. Let’s talk first about clinical trials.

During the FDA’s Oncologic Drugs Advisory Committee, when they were addressing the approval of Mvasi, some voting members raised concerns about the clinical trial that was submitted. It was a predominantly white, exclusively male population. Do you think that diversity in clinical trials is important?

Oh, it is key, absolutely key. There are certain genetic differences, biologic differences, social differences, social environment differences that have to be taken into consideration when it comes to clinical trials. We always say that you have to incorporate the lived experiences of all individuals to ensure that you are creating therapies and vaccines that are effective in all patient populations. When you only test on 1 particular group of individuals, like we’ve been seeing white males, you do quite a disservice to the rest of the population.

We’re seeing women, and more so racial and ethnic minorities, being left out of a lot of these trials. When it comes to testing the effectiveness of these drugs in those populations, we’re seeing that there are some issues. When you don’t take into consideration the general population, you’re creating drugs that only work in an exclusive population who had the privilege of being a part of a clinical trial.

We’re always advocating for more diversity, [and] oversampling of people of color, women, in trials that make sure that everyone has access to these innovative therapies.

That’s an interesting thought because we see a lot of data coming out from [the Institute for Clinical and Economic Review, ICER] for example, looking at cost-effectiveness studies. I have a lot of discussions with my colleagues about this, and I think the whole concept of cost-effectiveness is great to explore and discuss, as I think value and cost are very important components of healthcare.

But one of the problems I have with it is that we’re always looking at it based on a clinical trial population. If payers are going to start making these decisions about their patients, or if Medicare were to ever start implementing formularies based on these type of reviews, what are you actually seeing in the real world that you can attribute to patient outcomes based on therapies that they use? Are they truly cost-effective?

Here you are looking at a set time period for a clinical trial, you have a set group that have been selected and met very specific criteria. We both know the real world doesn’t work that way.

I think that’s a good, fair warning to everybody to think about not just how you’re designing a formulary, what products you’re bringing to market, [and] how you are effectively covering them for patients, but also, are you making sure that you’re appropriately representing what each of your groups needs through these clinical tests and data that you’re moving through, to make sure that they’re getting coverage and that evidence that you need?

Yes, and you raise a good point, we’re looking at traditional medicine, traditional drugs, right? You’re looking at the US Preventative Services Task Force, creating the list of recommendations for drugs, or therapies that should be covered. Insurers look to those recommendations.

A lot of those recommendations are based off of clinical trials that were conducted and included primarily white men. When we look at the recommendations, we say, “This doesn’t work in our population.” Black women and girls have different genetic expression. When they go to their provider and they ask for a particular drug, it’s not covered. That is an issue, that’s a huge concern for us and we don’t want that same mistake to travel over to these innovative therapies where certain therapies are covered and others are not, and they’re not effective in all populations.

Even just adherence. You were talking about the low-income population, [what if] they had to take a therapy 4 days a week? Are you going to see a person of low-income who can’t get to where they need to go and can’t pay for the ride there, are they getting that drug? You have that whole issue in the real world as well.

Diversity in Clinical Trials for Biosimilars

Do you think the FDA has a position on this? [Should they be] putting more out there on exact guidance for clinical trials, or what they want to see in terms of a mix of patients?

You know, the FDA, they’ve put out a really standard statement on diversity in clinical trials, but they really haven’t taken a step forward to provide those incentives and to push for that diversity.

I know that groups like mine, we’ve written to the FDA, we’ve spoken to certain individuals at the FDA to say how important it is to really take the lead on this issue, as the FDA, because we’re seeing a lot of drugs and vaccines that are not working in our population. It’s not right and it’s not fair because everyone should be included in the healthcare system.

When you have a group that’s been left out of the healthcare system for centuries now, and they don’t have, currently, access to innovative therapies, it’s disturbing and it’s disheartening.

We really would like for the FDA to be a part of pushing us into this century, so-to-speak, or even this decade would be much better when it comes to access to innovative therapies for all patients.

The FDA and Diversity in Clinical Trials

Now moving with this biosimilars market, we as of recently have 9 approved biosimilars. Three of them, we mentioned 2 already, in oncology there’s Zarxio, which was our first biosimilar, that [granulocyte-colony stimulating factor, G-CSF] product for supportive oncology care. That’s been on the market now since 2016.

We do have anti-cancer medications in the pipeline; really, not only is the [Biologics Price Competition and Innovation Act, BPCIA] pathway new for these manufacturers, but they now have to work through it to get approval. You’ve also got biologics that are going to be losing their exclusivity in the next few years, some of the big ones.

We definitely see a market moving in oncology. Can you talk a little bit about where you see biosimilars playing out in oncology, specific cancers, or any other disease states that you think we should really be on the lookout for these products making a difference for patients?

So, in the oncology space, we’re excited. There’s a lot going on there. We see the need to bring on some more biosimilars into the market, and lower that cost, as I’m going to continue to say.

We really want biosimilars, and even biologics for other disease conditions, to come onto the market and really look at oncology and see that as a model. We’re seeing psoriasis—we’ve actually seen some great movement there&mdash;but we need more innovative therapies there [and] biosimilars there.

We’re looking at lupus, the biologic for lupus is completely disturbing because you have to take other treatments in conjunction with the biologic, and it’s proven to be very ineffective. Non-Hodgkin lymphoma, rheumatoid arthritis, we would love to see biosimilars in [those] market[s].

Another thing that we would love to see, when you see these newer biologics come onto the market, the first and second generation, we would like to see the prices being lowered at that point. Seeing biosimilars come onto the market, I know there’s such a conversation around exclusivity and patents, but when you have newer biologics come on the market, that’s the conversation for lowering prices for the older therapies. So that’s what we would love to see too.

 And do you think this cost-savings, I know we’re seeing it in oncology, the CAR T-cell therapy is really coming to life, and [it’s] expensive. I mean, you’re taking a patient’s own DNA and making medication tailored to the patient. Do you think that price point and that biosimilar availability could start lowering prices system-wide to make room for therapies that costs a developer a huge amount of money to develop—we know that there is a cost to them to bring them to market and innovation does have a price tag to it&mdash;do you see this allowing that to happen more and us maybe potentially projecting to a new level of healthcare?

Absolutely, and I hope that we continue to move forward, bring more biosimilars to the market, and just see how this innovative therapy is going to change the healthcare system as we know it.

We definitely don’t want to bankrupt manufacturers because we know the costs that come into developing these drugs, but [we] want to make sure that patients can actually access the drug that they’re developing, and we get more manufacturers into that market where there’s some good competition there.

We’re all for any type of innovative and creative way to getting low-cost drugs and effective drugs to patients.

Oncology Biosimilars Making a Difference for Patients

Well thank you Christy; this has been very informative. Do you have any final thoughts you’d like to share?

Absolutely. We always push for the patient to be at the center of healthcare in the healthcare system and making patients a priority when it comes to healthcare innovation.

The biologics and the biosimilars field is exactly where we’d like to have that conversation that’s making the patient a part of the conversation and the priority. When it comes to healthcare innovation, we want to make sure every patient has access to healthcare innovation. We know that some patients—people of color and low-income patients&mdash;have not been able to realize the benefits of innovative therapies.

We want to really put out there that affordability and access have to go hand-in-hand because when you don’t have access to the right medication, the most effective medication, then you’re essentially not going to have equity in care. That’s going to lower the quality of care and health outcomes for a certain set of this population, which is not fair. We want to make sure that all patients have access to healthcare innovation. One way of doing that is by having conversations like this.

 Absolutely. You know, I spend most of my time thinking about the Medicare patient population, that’s my big focus, and access is a huge issue for them. You have older people on limited incomes being diagnosed [and prescribed] these very expensive therapies, and much of the same issues that you’ve raised—they’re trying to control costs and deciding between eating and paying for their medication.

I think we’ve got big issues for us in the coming years. We want to have innovation we want to have therapies. They are expensive; how do payers manage that? We’ll have to see how they come up with new, innovative models of things that CMS [says] they’re testing out or talking about if those things are going to play out for the Medicare and Medicaid population in the coming years. If we start seeing other means and new products coming to market [such] as biosimilars, what are they going to do and how could they change this? I think we’ve got an interesting time ahead of us to see how this all plays out. T

 Thank you so much for your contributions to this discussion. On behalf of us both, we thank you for joining us and we hope you found this Peer Exchange

Bringing Oncology Biosimilars to Patients

EP 1: Patient Awareness of Biosimilars and Loyalty to Branded Drugs

EP 2: Patient Savings From Biosimilars

EP 3: Barriers to Biosimilars for Oncology Patients

EP 4: Biosimilars, Payers, and Formulary Changes

EP 5: The Exceptions Process and its Effect on Patients

EP 6: Patient Education on Coverage for Biologics and Biosimilars

EP 7: Alternative Payment Models and Patient Care

EP 8: The Cost of Biologics and Biosimilars

EP 9: Rebates and Medicare Part D

EP 10: CMS' Changes to Reimbursement for Biosimilars

EP 11: Biosimilars, Private Payers, and Pharmacy-Level Substitution

EP 12: Patient Assistance Programs and Biosimilars

EP 13: Manufacturers and the Cost of Biosimilars and Biologics

EP 14: Diversity in Clinical Trials for Biosimilars

EP 15: The FDA and Diversity in Clinical Trials

EP 16: Oncology Biosimilars Making a Difference for Patients

EP 17: Putting Patients at the Center of the Biosimilar Conversation