Biosimilars: What to Expect | Ep. 75

Full Transcript:
Released 3/21/2023

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You’re listening to the Live Yes! With Arthritis podcast, created by the Arthritis Foundation to help people with arthritis — and the people who love them — live their best lives. If you’re dealing with chronic pain, this podcast is for you. You may have arthritis, but it doesn’t have you. Here, learn how you can take control of arthritis with tips and ideas from our hosts and guest experts. 

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Steve Taylor: 
Hello, everyone. I'm Steve Taylor, president and CEO of the Arthritis Foundation, and I want to welcome you to this episode of the Live Yes! With Arthritis Podcast. Today, we're going to discuss biosimilars. If you have an autoimmune form of arthritis, like rheumatoid or psoriatic arthritis, ankylosing spondylitis or juvenile arthritis, you might be taking a biologic medication such as Enbrel, Remicade or Humira. 

Until about 2015, only the brand name drugs were available. But in recent years, drug manufacturers have produced medications that could compete with them called biosimilars. They aren't exact copies of the originals, which are called reference products. But they are so close that the FDA says there is no clinical difference between biosimilars and brand name drugs, and they say that they are just as safe and effective. Today, I'm thrilled to welcome my colleague, Anna Hyde, to this important conversation. 

Anna is the Arthritis Foundation's vice president of advocacy and access. She oversees both federal and state legislative programs in addition to grassroots engagement. Her focus is to raise the visibility of arthritis as a public health priority; build support for federal and state legislation that ensures access to affordable, high quality health care; and enhance patient engagement and the policymaking process. Anna has been actively engaged in representing arthritis patients and biosimilars regulations for nearly 10 years. Anna, I know that you were on past podcasts, so welcome again to the Live Yes! With Arthritis Podcast. I'm looking forward to having you join me today. 

Anna Hyde: 
Thank you for that introduction, Steve. It's great to be back. Let me return the favor by telling the audience a little more about you. Steve Taylor is a mission-first leader — I love that description — in the voluntary health space. He has over three decades of experience devoted to making life better for patients with life-altering diseases. Prior to being named our president and CEO in 2022, Steve served as the Arthritis Foundation's executive vice president for mission and strategic initiatives during the prior year, where I had the pleasure of working with him to build some of our strongest advocacy programming ever. Previously, he served as president and CEO of the Sjögren's Foundation for 18 years, from 2003 to 2021. 

Steve, we're so glad you're leading the Arthritis Foundation and that you truly walk the walk. In fact, do you even know how many Walk to Cure or Jingle Bell Runs you've attended in your only two years here at the Arthritis Foundation? 

Steve Taylor:
Well, I have been to plenty, especially this past year. We were live with events, and I was thrilled to be out there with the patients, as you know, and I think that's what excites me most about being the new president and CEO of the Arthritis Foundation is being among our patient population, hearing their personal stories and knowing that we are fighting for them on Capitol Hill and in state legislatures around the country. Somebody asked me recently what excites me about where we are with arthritis right now. Obviously, science and research are very important, and we're making some amazing groundbreaking support and research discoveries. But even more than that, I'm thrilled with our advocacy work here at the Arthritis Foundation. 

And I know Anna hates when I talk about Anna, but, you know, I knew Anna from my previous position and worked with her for a number of years. Anna is a go-to resource in Washington, DC, for all things advocacy. She's known for representing the arthritis voice on Capitol Hill, and her team around the country works very hard with our volunteer advocates to make sure that the arthritis voice is heard in state legislatures as well. So, Anna, I'm thrilled to discuss this important topic. I know you've been working on it for a while and there's a lot of nuances to it. So, are you ready to jump right in? 

Anna Hyde:
Let's do it. 

Steve Taylor:
Some people who might be listening to this probably wonder: What are biosimilars? Which we'll get to in a minute, but why are we discussing biosimilars now? 

Anna Hyde:
The reason we're discussing biosimilars now, in particular, is because this is a really important year. This is the year where at least eight new biosimilars could potentially come to market, and this is the first time we'll see biosimilars in the pharmacy benefit side. That's for the self-injectable drugs. The patent for Humira expired. That's a drug I think we all know the name of, even if we've not taking it. And because of that patent expiration, the biosimilars that had been in the pipeline for Humira for the past several years are able to come to market. In fact, one has come to market already, and we'll see several more come to market in the summer. 

Steve Taylor:
Which I think is exciting for patients to know: There's some more access or availability to additional products. Can we go into kind of what biologics are first and then in regards to how they're different from biosimilars or vice versa? 

Anna Hyde:
Absolutely. And I'm going to do an early plug here for our landing page. We have a landing page on our website that houses all of our resources on biosimilars. It's https://www.arthritis.org/treatments/about-biosimilars We'll, of course, include that in the show notes. 

But I'm gonna read directly from what we wrote there, which is: Biologics are a subset of a class of medication called disease-modifying antirheumatic drugs, which we call DMARDs. Now, there's multiple kinds of DMARDs. There's the conventional DMARDs, like methotrexate, which certainly many of our patients are familiar with. But biologics are different. They are large molecules produced in living cells that makes them really complex medications. They help protect against the effects of inflammation, but in different ways. 

So, biologics block specific parts of the immune system, such as proteins that promote inflammation. They are harder to make, of course, than conventional DMARDs, and they cost much more. We can get into all of that throughout the conversation, certainly. But unlike small-molecule drugs, they don't come in pill form. Some are in the form of self-injection using a prefilled vial and autoinjector, and others are given by infusion in a doctor's office or clinic. 

Steve Taylor:
I want to make a plug for our research, too, because many years ago, the Arthritis Foundation was really leading the research that led to these DMARDs being introduced and approved by the FDA. I'm thrilled with our 75 years of progress here at the Arthritis Foundation. We are entering our 75th year in 2023. And our research really led to those. And that's exciting. But now we've even moved forward with something called biosimilars, and that's what the topic is as we're talking about today. And what are biosimilars, and why are they the same or different from those biologics and the DMARDs that you just spoke about? 

Anna Hyde:
Biosimilars are approved by the FDA as being highly similar and having no clinically meaningful difference. And you may be asking if that's like a generic; it sounds like a generic. The answer is yes, it is like a generic, though with large molecules. You can never have an exact copy. So, we use the term biosimilar instead. You even find batch to batch differences among the brand products. We also use the term reference product. You'll certainly see that in our position statement. We'll never call them generics because they're not truly exact copies. There are very small but not clinically meaningful differences in those large molecules. So, we'll use the term biosimilars from here on out. 

Steve Taylor:
We're saying they're similar, and they're about 98% the same, some are 99, but in the high 90s. So, are they safe in regards to the FDA standards? And should patients be concerned about that at all? 

Anna Hyde:
No, patient should not be concerned about that. The FDA has a rigorous approval process that they go through. There are lots of analytic studies and other data points that these manufacturers have to submit in order to be approved for biosimilarity. It's also, I think, important to note that while this may be new, kind of watershed year, in the United States, these medications have been on market in other countries, in Europe and elsewhere, for many years. In fact, the biosimilars for Humira have been available in Europe since 2019. 

So, there are a lot of patient treatment days that they've been able to capture, and they've been able to look and see: Have there been any major safety signals or adverse events? And the short answer is no, there have not been. They are safe to take, and the approval process is very rigorous. And I think that is a really important point to emphasize, because we certainly understand that it can be scary to make a change in your treatment. 

Steve Taylor:
Biosimilars actually have even higher standards than generic drugs have to get approved by the FDA. And I think for those in the United States, we're very fortunate because we have all that data from Europe and other countries that have had these biosimilars around for a lot longer. And surely, we would know a lot more about if there was any adverse aspects from those drugs. So, I'm happy that we aren't first out the gate, but glad they're finally here. Why haven't they been available sooner in the United States? 

Anna Hyde:
Well, biosimilars have been approved for some time. They're only now coming to market because we have something called the patent system, which allows exclusivity for brand drugs so that they can recoup the investment they put into research and discovery and all of those things that go into developing a drug. It is very expensive to manufacture these medications. 

Humira’s patent just expired at the beginning of this year. The first biosimilars of Humira were approved back in, I believe, 2015, they've had to wait until that patent expiration in order to come to market. So, that is why we're only seeing them now in the United States, whereas in other countries, they've had them on the market sooner. 

PROMO: 
Biologics and biosimilars. What’s the difference? And what does it mean for you? It can be confusing. That’s why the Arthritis Foundation provides guidance on what to consider in your own situation. Get the facts from the arthritis community’s most-trusted source of information. Visit https://www.arthritis.org/treatments/about-biosimilars.  

Steve Taylor:
I get a lot of questions in my 20 years in rheumatological diseases around patents and why they're important. You know, I just want to emphasize that pharmaceutical companies spend billions of dollars, and that's billions with a B, to basically discover a drug that'll treat a disease. And they do need some type of patent protection for so long in order to recoup those funds that it cost to invent them. And if we did not have pharmaceutical companies entering disease spaces, we would not have drugs on the market. No one is out there fighting except for us, as a nonprofit, the Arthritis Foundation, for new drugs and compounds and assets to be discovered, and the pharmaceutical companies. 

The FDA is not looking down over a landscape and deciding, “Hey, there's no drug for X disease, we should promote this and try to get somebody to do it.” The FDA does not get proactively involved. They're reactive to applications for approval. If it wasn't for the pharmaceutical companies and the Arthritis Foundation and other nonprofits fighting for better treatments for our patients, drugs would not be discovered. A lot of drugs don't make it to the market, where they fail. So, pharmaceutical companies are losing more money than they are gaining in some, in regards to acceptances through the FDA. 

They definitely lose money in high-risk trials that don't come to forbear anything that helped us. But then there are the successes, and they deserve some patent protection in order to recoup that investment money. We do believe there needs to be a time when drugs either go generic or now, in the form of DMARDs, big molecule drugs, that they go to biosimilars. Do you think access is going to be possible for patients? Will they have access? Will they be able to even get these biosimilars? 

Anna Hyde:
Time will tell, certainly. A lot of these are kind of hypothetical questions at the moment, but ones we've certainly been asking. And we've been doing a lot of discussions with health plans, pharmacy benefit managers, who help determine coverage decisions with their clients, who are payers, with manufacturers, with pretty much anyone in the supply chain, to kind of understand what access is going to look like. Some of the large pharmacy benefit managers have come out and said that they are going to offer the biosimilars of Humira at parity with Humira itself. 

Humira is still available to patients, and many patients who are currently on Humira are probably still on Humira. But what parity means — in terms of access and how health plans are going to treat the biosimilars in terms of how that kind of trickles down to the patient — still remains to be seen. 

Steve Taylor:
I think that's the other million-dollar question, which is, literally, is a money question. Is it going to save patients' money if they end up on a biosimilar? 

Anna Hyde:
We're not sure. We hope so. Our position statement certainly says that we believe biosimilars should be available to patients at a cost savings to them. 

But what a lot of stakeholders will say is that the promise of biosimilars is in savings to the system. And if there are savings in the health care system, in theory, that would trickle down to the patient in the form of lower premiums, perhaps low copays, things like that. So, it's a really complex kind of web that may or may not ultimately benefit the patient. But that's why we have our advocacy program so dedicated to this right now, because we want to ensure that any coverage policies that happen really result in savings to the patient. 

Steve Taylor:
Doctors knowing about more treatment availability helps them keep things like rheumatoid arthritis or ankylosing spondylitis at top-of-mind for diagnosis even. Because they've heard of a new drug for rheumatoid arthritis. They happen to read a little bit more about the symptoms, and they realize some of their patients may have this. I'm not talking rheumatologists, but typically primary care doctors maybe treating patients for things they don't know is related to some of these diseases. But because of awareness and advertising, and this idea that there's this new competition out there, re-elevates our disease and diseases that we represent. 

Sometimes, when a drug comes on the market, it gets great accessibility and awareness, but then it wanes off after a while. Sometimes our diseases, those that we represent, are not well known or aren't discussed as much or aren't diagnosed as fast as they need to be. So, I do think there's some unknown advantages to biosimilars that will really be helpful, but patients that are currently diagnosed might not see them. 

If a patient gets switched, do they have to switch? Can they stay on their biologic? If it's working, how's that going to work in some insurance plans, Anna? 

Anna Hyde:
This is an interesting tension point. Because to have that promise realized, where that competition is doing its job and resulting in cost savings to the patient, you need to have volume. And how do you get volume? You're going to have to ensure that enough patients are taking these medications in order to make that work. So, it is likely that, at some point, we will see plans requiring patients to take the biosimilar instead of the brand products. 

If that happens, what do you do? If you are notified that you are going to be switching to a new medication, the biosimilar, and you're stable on the brand product, you may be nervous about that. And we understand that. We know that it's really difficult to find the right treatment that works for you. And once you are stable, you really want to remain on your treatment plan and not make any changes. 

We certainly hope that those kinds of decisions are made between the patient and the provider in the exam room. However, if your health plan does make that decision for you, what we would say is that the process for determining what recourse you have, if you don't want to make the change, is really going to depend on your health plan. 

So, my recommendation would be, first, have a conversation with your provider. They're going to have a lot of information to share with you about whether they think it's safe for you to make the change. And then you can talk to your health plan directly about what their process is, if you want to file for an exception or make an appeal or something to that effect. 

One of the core questions that we got back from our patients who are stable on Humira was: What if it doesn't work as well? And I think the most important thing for us to say upfront is: It is expected to work as well. These are approved by the FDA as safe and effective; there should be no clinically meaningful difference. However, if you are concerned about that and want to make sure that you know what to do if it doesn't work as well, then again, that same process would apply: having a conversation with your provider and then having a conversation with your health plan about what the appeals process is, so that you can get back on to the brand drug. 

Steve Taylor:
Working, as I mentioned, in the field for so long, patients get to a new normal on a drug or on a treatment plan and it's, basically, they feel 80% better, maybe not 100% better, or 70%. But it was way better than they were before a drug was introduced into their treatment plan. And what happens is: It is always scary to switch to a new kind of drug, a different type of treatment, and/or generic or biosimilar. So, it definitely scares people to test that new normal. However, I would rely on their doctor to really walk them through that. 

Anna and her team, along with volunteers, helped us to evaluate all aspects of the biosimilar space, from the pharmacy side to the physician/prescription side to the patient side, to make sure that we put out a representative statement that showed where we stand on all of those parts of the health ecosystem. So, can you talk a little bit about what they can do with their doctor as they're prescribed with a biosimilar and/or if it doesn't work? 

Anna Hyde:
Absolutely. Our position statement really segments by stakeholder because we believe that every stakeholder in the ecosystem has a unique responsibility and patient-centered policies around biosimilars. Some of the key points that we talked about, and then we can dig in if you'd like: Biosimilars are safe and effective per the FDA approval standards and current data. So, we will emphasize that over and over again. 

Also, though, the decision to use a biosimilar should occur between the patient and the provider. We are very focused on making sure that both the patient and the provider are comfortable and confident in prescribing and taking these medications. 

Steve Taylor:
Anna, I just want to put an exclamation point on that. Our position is that the decision should be between the patient and the health care provider, and we will be advocating for that anywhere and everywhere we can. However, to be honest, some of that might not exactly happen. Some may be switched, and there might be some states that allow that switching to happen. But we definitely are standing behind that statement. 

We always believe that. Let your doctors decide with the patients what they should be on for treatment. And that goes across our advocacy platform — from step therapy to everything else… is a good partnership on risk and benefit needs to be done between the patient and the provider before they're forced to go on something. 

Anna Hyde:
Absolutely. Going from there, we believe every health care stakeholder holds responsibility in educating and communicating with patients about biosimilars. No matter who you are in the ecosystem. If you're a pharmacist, you're making that proactive communication. If you know that you're going to be sending a different box in the mail to the patient, you need to make sure that the patient is prepared for that. 

If you got a different box in the mail, what would you do? And a lot of patients said, “We would assume that somebody sent us the wrong drug.” Because if you haven't communicated and notified the patient, of course they're going to think that. If you're a manufacturer, making sure that the label, the product itself, the box, whatever format you can take, to make sure that it's clear what this product is. If you're the payer, we say that you should provide at least 30 days advance notice, because patients told us that over and over again: that they want to know ahead of time, well in advance, if they're going to be switched to a biosimilar. 

We've put together a very specific set of recommendations to each of these stakeholder groups saying exactly what we mean when we say advanced notification or communicate with patients in this way. We're getting as specific as we can so that they know what patients want. They want to be communicated with in multiple formats. Don't just send a letter. Some want text, some want information through patient portals. Most patients want to have the conversation directly with their provider, face-to-face conversation, where they can get all of their questions answered. 

Last but not least, patients who use biosimilars should benefit from out-of-pocket cost savings and receive those cost-sharing protections. And that's including, but not limited to, the use of copay assistance. This is another question that we’ve consistently gotten is: “If I rely on copay assistance right now to afford Humira, am I going to have access to that assistance if I switch to the biosimilar?” 

The answer to the question is: It depends on the manufacturer. We know that the biosimilar that's on market right now for Humira does offer copay assistance. Will the others who come on market offer copay assistance? Many of them will, but we'll have to kind of return to that question later on, once we know more. 

PROMO: 
Whenever you need help, the Arthritis Foundation’s Helpline is here for you. Whether it’s about insurance coverage, a provider you need help from or something else, get in touch with us by phone toll-free at 800-283-7800. Or send us a message at https://www.arthritis.org/helpline. 

Steve Taylor:
The one thing I want to remind our listeners is that, if you have challenges, you can reach out to us on social media, send us your stories in regards to issues that we're finding, either in the copay assistance program or if you end up on a biosimilar that doesn't have that. We always want to know. Because we will try our best to advocate, not on an individual case basis, but we need to know a collective case basis where we should put our statements and where we really need to go focus on, making sure we represent the patients. 

Biosimilar companies that are coming on the market have reached out to the Arthritis Foundation. They have been working with us to engage patients in their learning about their diseases and/or their writing of their websites or materials, to make sure that they are patient-friendly and that patients can understand them. I am proud to say that they've reached out to us and been involved; not every company, but most companies have. Because really, it's important that these materials are done for a patient to understand them. 

Do you want to talk a little bit about the appeal process and what we have available to help appeal that? 

Anna Hyde:
We have a wonderful toolkit, called “Your Coverage, Your Care,” that is a soup-to-nuts approach to managing your health plan, from open enrollment all the way through to if you do need to file an appeal. What an appeal is and what common kind of policies are around appeals. It is going to be health plan-specific. So ultimately, you're going to need to go into your health plan, find the information there and/or call your health plan. But at least this toolkit will give you some of the terminology and background information about how health plan policies work, to just kind of help you feel empowered to do that. 

Steve Taylor:
I think it's always important to have a patient advocate for themselves. To make sure they stand up for themselves. And that's why we have that kit on our website for people to be able to do that, because there's a number of cases where you might need to appeal or argue with an insurance company. 

We didn't talk about this, Anna, yet — patients hear it all the time —What is a formulary? Which is basically a list. Share what a formulary is. And then: Will all these drugs end up on every insurance company's formulary? 

Anna Hyde:
A formulary is essentially just a list of drugs that are available to you through your health plan. They are drugs that are covered. And typically, formularies are placed in different tiers. So, you'll have a generic tier, which is typically the lowest cost tier, and then it goes up from there depending on the cost and complexity of the drug. Biologics are typically on a specialty tier. Not every health plan uses specialty tiers, but that's growing in practice. It's just a way for health plans to kind of manage different kinds of policies, cost-sharing, different utilization management. That's another term that we use a lot, which is: Do you have to go through prior authorization or kind of step therapy, try one drug before you're able to access another drug, those sorts of things. Those are all protocols that are managed through a formulary. 

It's unclear how many of the eight plus biosimilars for Humira will be on any given formulary. I would not anticipate that every single approved biosimilar will be on a formulary. Those are going to be really negotiations and contract decisions between those manufacturers and each health plan about whether they'll be covered on formulary. My guess is that there may be two or three. 

Let's introduce another complicated word: interchangeability, just a kind of a legal pathway that allows pharmacists to directly substitute the biosimilar. Manufacturers have to go through some extra layers of providing clinical data and other things in order to achieve the status of interchangeability. That is a designation that comes from the FDA. 

Right now, there is one biosimilar for Humira that has interchangeability status, and we know that others will be seeking that as well. So, that raises another set of questions. If there are several drugs that have that interchangeability status, is your pharmacist going to take advantage of that sort of legal option and make that substitution on their own? 

There are a lot of questions about that that we still have, and we've posed to pharmacists and other stakeholders. And as we get closer to that point, when interchangeable biologics are on the market, we can kind of go back to them and better understand how they're thinking about it and how that may impact patients. 

Steve Taylor:
Yeah, you know, interchangeability is a challenge. We also, I know, in our statement, talk about the requirement that we believe should be there that a pharmacist must tell or give warning so far out that they're going to change you automatically from X brand name drug to a biosimilar. Is that going to be state-by-state basis in regards to laws to interchangeability? 

Anna Hyde:
Every state is required to have a substitution law. This goes all the way back to the Affordable Care Act that sort of created this designation of interchangeable. I think it's also important to point out other countries don't have this designation. This is a uniquely American situation. 

All 50 states do have laws on the books that dictate what interchangeability substitution looks like. It doesn't really impact whether the drug is substituted; it just dictates the process by which a drug is substituted. Many of those state laws have provider notification requirements. So, if you're going to make that substitution, you've got to let the provider know, so that the provider can have that in their records. 

Most of the states do not have patient notification requirements. I think that's really important because it emphasizes, again, why we are spending so much time interacting with the pharmacist community to make sure that distinction between notification, what the law says, and proactive communication, what we're seeing, is best for patients. 

If a patient gets a different box in the mail, any of us — if any of us got a different box in the mail — we would be curious: What is this? And the first thing we would do is: We would call the pharmacist, or we would call the health plan or the provider having questions. Our suggestion is: Be proactive about it so that they're prepared, and it builds their comfort and confidence level in the change that's going to come their way. 

Steve Taylor:
Switching is scary, but I want to remind people that sometimes, switching can be a good thing in regards to maybe access, maybe some assistance or lower out-of-pocket costs. We're not promising that by any means with biosimilars. But also, to remember that, when you're switched to a new product, to make sure that you're documenting any symptoms you might have, but also to make sure that it's not a reaction that you're kind of feeling but not necessarily reality. 

But there will be those one-offs that cause challenges for some patients, and that's when you need to appeal and talk. Some newly diagnosed patients won't ever know the difference. They'll just end up on a biosimilar. It worked great for them. But as we know with Humira, Remicade and others, you sometimes have to switch around, and so that's normal, too. 

Even in the biosimilar case, when you're diagnosed in the next year or two years, and you're put on a biosimilar to start with, you might not end up on that biosimilar long term. You might need to switch to a different biosimilar or Humira or to another drug, as I mentioned, Remicade or others, till you get your treatment plan right. 

Last year, when I joined the Arthritis Foundation, I did some research with a major rheumatological practice around why patients don't follow up with their medications. And the majority of reasons were because of manageable symptoms that they had from their taking the drug, either nausea or fatigue or whatever it might be, and the drug might have caused those extra symptoms. They feel it was the drug, stop the drug, not do it anymore, because they didn't feel any better or they had these other symptoms, instead of talking to their doctor about those symptoms, which can be managed in other ways, and some subside over time. 

Sometimes, we want instant gratification, immediate gratification, from a drug or any treatment we do. And sometimes, it takes time to get leveled off. Talk to your provider about those symptoms or challenges you might have with it before you just automatically decide to stop it. 

We know, in the long run, these drugs have changed lives for patients. They get them back to living, as we say, living the Yes life that we want them to live, which means we want them to say Yes to more things in life and not have to say No to so many things. 

Anna Hyde:
I think another term that's really important to introduce here is one called the nocebo effect. Some people may be asking, “Well, if these are just now coming on market, how could you have switched to a biosimilar?” Well, because we have had biosimilars in other brand drugs for arthritis. We're making a big deal about the year 2023 because this is the first time we're seeing this on the pharmacy benefit side. And Humira, of course, has a really big footprint. Many people take Humira. 

But the first brand drug that we had biosimilars on the market for was actually Remicade. That's an infused drug. We don't have as many patients who are on infused drugs, but there are multiple biosimilars of Remicade on market now. So, there are likely many patients who could be listening to this right now who have been on, or are currently on, a biosimilar for Remicade. And we certainly have heard anecdotes where patients have switched to the biosimilar and have not had as positive of a response. 

Going back to the nocebo effect, this is interesting. It's similar, in some ways, only kind of the inverse of the placebo effect. We all know the placebo effect. There's a drug that doesn't actually have any clinical properties to it, but you perceive a benefit. The drug is working in you regardless. 

The nocebo effect is kind of the opposite of that. And this has been documented. There is research showing that this exists in the biosimilars world. If you are going to switch to a biosimilar and you perceive that the drug is not going to work as well for you, you may in fact have a negative response to that drug. And if you look at the actual clinical indicators, the drug is meeting its targets, yet you don't feel as well. You are not having a positive response. It is possible that you are experiencing that nocebo effect. We can't be positive of that, but I think it's important to let listeners know how important it is. 

And this is why we're emphasizing the need for that comfort and confidence, and we're saying these are FDA-approved medications, they are safe and effective. The studies that exist right now suggest that there are no adverse events that patients need to worry about, safety signals, that sort of thing. If we have a good understanding, level of confidence and comfort, both on the patient and the provider side, I think it can make a big difference in patients having a positive experience with the biosimilar. 

Steve Taylor:
It's really talking to your doctors through that. And asking for extra time with the doctor, a month after you're on a biosimilar, or two months after, to make sure you're following up with them to talk about how you're feeling and if it's working as well as you thought it would or is it working the same as the brand name reference product was. So, I think that relationship with a doctor is so important. 

We pay for our health insurance. When we go to a doctor or a nurse practitioner, whoever it might be, we have the right to ask questions and be heard. Sometimes we think we aren't paying, like you do when you go get your car repaired and you leave and your tire wasn't fixed; you drive back in and say my tire wasn't fixed, it's still flat. We don't somehow seem to do that with a doctor sometimes. 

It's OK to say, “My questions weren't answered. I need to come back in and see you, or can I send an email, because I had questions that didn't get asked in my appointment. We paid for that, even though your copay might have been $25 or $50. We feel it's less valued because we didn't pay as much. But don't forget, if you're on Medicare or insurance, you've paid somewhere for those providers, and it's right to get your questions answered, to get your problem fixed. 

When you go to an appointment, I always tell people: Bring a list of questions with you and hand them to your doctor. If you print a copy out for them with your questions on them and hand it to them, they can quickly look down and say, “Question 2, 4 and 10, you don't even have to worry about right now. But 1 and 3, I'm a little concerned about, let's jump into that.” 

Especially around the biosimilars: If you have questions, bring them with you and hand them to the doctor so they know where your mind is, so they can put some things at ease for you and have that partnership that you really want to have with them. 

PROMO: 
If you have arthritis or are taking care of someone who does, we’ve got information you can trust. Get tips on healthy treatments, plus news and inspirational stories. Learn all about arthritis and the resources we offer. Go to https://www.arthritis.org.  

Steve Taylor:
Anna, as we wrap up, is there anything that we didn't hit that you want to make sure we hit? 

Anna Hyde:
I think we covered the waterfront pretty well. But there is certainly more information in the form of one-pagers, FAQs… We've done previous podcasts on this with rheumatologists… and other kinds of things like that around biologics and biosimilars. And that is all on this landing page that we launched in the fall, a one-stop shop for you to find anything that you are looking for around this topic. It's https://www.arthritis.org/treatments/about-biosimilars. You can find everything that you need there. 

Steve Taylor:
That website will be in the show notes as well. You can go to the Arthritis Foundation website and put in biosimilars up in our search bar, and it'll bring up all things biosimilars on our webpage. 

At the end of our podcast, we ask about the three takeaways. So, what are kind of your three takeaways from today's call? 

Anna Hyde:
Well, number one, that if anyone has any doubt, I would reemphasize once again, for probably the sixth time today, that biosimilars have been approved by the FDA as safe and effective and having no clinically meaningful difference. 

Two, that we really want those decisions to be made between the patient and the provider. We really want that conversation to happen in the exam room, so that they can have a conversation about: Is this a good option for you? What are the kind of indicators I should be thinking about if I do make the switch? Ask all of the questions that we know patients have about: How different is it going to be? Is the injection device going to be different? All these sorts of things are prepared. They know exactly what to expect. 

And then three, that we firmly believe that patients should realize the cost savings that come from biosimilars as a whole. We all talk about the promise of biosimilars and bringing down costs for these high-cost drugs. Patients need to be at the center of realizing that cost savings. Steve, what are your three takeaways? 

Steve Taylor:
Almost identical to yours. One is that to remind our listeners that biosimilars are safe and effective. Obviously, the FDA has put them through their rigorous standards here in the U.S., and that they've been out in other countries before now for three and four years.  

The second takeaway is that patients should stand up for their rights and appeal if possible, but also not be as concerned with the switching if they have to switch, to possibly give it a try with their doctor's approval and support. And keeping the doctors in the loop about how they're feeling if they are switched.

Finally, Anna has done an amazing job in the nearly 10 years here with the Arthritis Foundation, but that the Arthritis Foundation is fighting for patients in a number of areas on state legislatures and on Capitol Hill in DC. Our biosimilar statement is available on our website. We stand with the patients, and we want to make sure patients are represented in every part of the health ecosystem. 

Anna, I appreciate you joining us. I encourage you to learn more by going to the Arthritis Foundation's website on biosimilars, and you can learn a lot more around there. But also, we have an amazing webinar that you can watch on demand on biosimilars that is on our webinars page: https://www.arthritis.org/events/webinars. Or go to the Arthritis Foundation website and, at the top or in the little magnifying glass, you can type in webinars, and all of our amazing educational webinars will come up.  

So again, Anna, thanks for joining with me. Thank you to our listeners. And just always know, the Arthritis Foundation is always going to be there for patients, fighting for you and incorporating the patient voice in everything that we do. So, thanks everybody, and have a great day. 

PODCAST CLOSE:      
As part of their support of the Arthritis Foundation, this episode was brought to you in part by Amgen, Boehringer Ingelheim and Pfizer. To learn more, visit https://www.arthritis.org/treatments/about-biosimilars. 

The Live Yes! With Arthritis podcast is independently produced by the Arthritis Foundation. This podcast aims to help people living with arthritis and chronic pain live their best life. People like you. For a transcript and show notes, go to https://www.arthritis.org/liveyes/podcast. Subscribe and rate us wherever you get your podcasts. And stay in touch!