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.

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Manufacturers and the Cost of Biosimilars and Biologics

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

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

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

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

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

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

 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

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 

 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.