This interview was conducted at the Drug Information Association’s Biosimilar conference, held virtually October 5–6, 2021. This conversation with Laura Wingate, Executive Vice President of Education, Support, and Advocacy, the Crohn’s & Colitis Foundation, is an edited version of our discussion.
BR&R: Laura, what do you think are the key differences, if any exist, between what patients really want to know about biosimilars and what we in the health care community think they want to know? Is there a disconnect?
Laura Wingate: There is some disconnect, but it is really important to emphasize that patients want to hear first from their health care providers when it comes to biosimilars. We’ve done focus groups and surveys with the inflammatory bowel disease (IBD) community, and their doctor is the primary source of information. Having the health care provider introduce the subject of biosimilars is really a key part of the conversation with patients.
Often, we hear from patients that they are receiving biosimilar information from their insurance company first, and that can be off-putting to the patients. The more we can proactively talk about biosimilars the better, but it needs to be explained in ways that reflect their own understanding of switching and interchangeability. The need for education is similar in both communities, but it should be adapted to the audience.
BR&R: If the patient first hears about the biosimilar from the health insurer, it may create a bias against the biosimilar. Patients may perceive that the insurer is making a coverage change solely as an opportunity for cost savings. They may believe that clinical implications for the patient is a secondary concern.
Wingate: I totally agree. I’ve had conversations with insurance companies when they are making a formulary change, which happens often. We need to proactively educate the community before those notifications about switches are sent out.
BR&R: That makes a lot of sense. Do you think patients have different questions about biosimilars based on the drug category (e.g., autoimmune vs. oncology)?
Wingate: That’s an interesting question. From my experience in the focus group setting, the questions are often the same: Is the drug safe? Does my doctor support the switch? Will I be able to stay on this drug long term or will I have to make another change next year? Patients with an autoimmune disease often take the reference product for many years. If they are being switched to a biosimilar, they really want to understand that the biosimilar is safe.
I don’t think that’s very different from the oncology community. When I talk to my colleagues in the oncology world, the physicians in oncology seem to be receptive to biosimilars and are comfortable having those dialogues with the patients. In the Crohn’s disease and colitis community, our thought leaders understand biosimilars are doing a lot of work to help patients and their colleagues understand the value of biosimilars. However, we’re not yet as comfortable having those conversations as physicians in the oncology space.
Patient Incentives to Use a Biosimilar
BR&R: That comfort level comes with experience, and infliximab is the one molecule with biosimilar options today for inflammatory bowel disease. How big a question in the patient’s mind is cost and cost differentials for a biosimilar versus the reference product?
Wingate: Our foundation’s stance has always been this: In addition to the incentives that are negotiated between manufacturers and insurance companies, patients should also receive a discount or incentive to utilize biosimilars. In the generic space, patients almost always pay less money out of pocket when using a generic compared with the branded drug. We know biologics are complex drugs, but there should also be a discount for the patient when using a preferred biosimilar. That would increase utilization and make patients more comfortable.
BR&R: Some health plans have tried unique ways of convincing the patients to switch to a preferred drug product. For instance, CIGNA recently launched a program that offers $500 gift cards to their members if they would switch from one interleukin product to another preferred interleukin agent. Would that work in the biosimilar setting?
Wingate: We’ve talked to CIGNA. We support any effort to ultimately encourage patients to manage their health care costs effectively, and biosimilars are a part of that.
We’d rather see ongoing discounts from a copay or not applying accumulators to biosimilars or something along those lines. We prefer incentives that have a lasting impact on the patient rather than a one-time gift card. Of course, anything that would encourage patients to utilize biosimilars is a move in the right direction. We’d just like to see a more long-term effort at cost reduction for the patient.
BR&R: Right, the gift cards are one-time incentives to motivate the patient to switch to the preferred drug. With the adalimumab biosimilar launches in 2023, do you expect that health plans will widely implement differential cost sharing, which they have haven’t yet done. For example, creating biosimilar tiers?
Wingate: I’m optimistic that differential cost sharing will be created with the adalimumab biosimilars entering the market. For the inflammatory bowel disease area, the entry of biosimilars for adalimumab will be a huge shift, possibly a gamechanger.
My hope is that we can help educate patients and providers in the next year to become more comfortable, so that the shift isn’t dramatic for them. We’d like to start seeing those cost reductions on the patient side as well as on the insurer side.
Providing the Educational Component
BR&R: What is the role of organizations like the Crohn’s and Colitis Foundation in providing patients with biosimilar education today?
Wingate: Well, I do think the main source should be their health care provider, but organizations like the Crohn’s and Colitis Foundation are great places to encourage that education.
We recently updated our own resources to show more stories of patients talking to patients about their experience with biosimilars and their switch. Hearing it from other patients who have walked in their journey is so important. They really want to hear from other patients who had made this change and how it worked out for them.
We also need to hear about the caregiver experience, in two ways: The caregiver of an adult patient supporting their decision making but also that of a pediatric patient. This is not often discussed: children are prescribed the biosimilars, and we need to help their parent understand the transition.
BR&R: What are your organizations’ priorities in speaking to patients or their caregivers about biosimilars?
Wingate: Number 1 is answering the question, “Are they safe?” Once we explain all the evidence and the FDA’s approval process, they want to understand why there’s a change. Then we need to help explain the terminology that’s being used—switching, interchangeability—what those words mean. We also focus on why biosimilars are so important to the overall health care system. Finally, we want patients to talk proactively with their doctors, and find out how biosimilars fit in the health plan’s formulary design.
BR&R: The plans and insurers tend to communicate with their members quite often, tracking which medications have been added to the formulary, which ones have now been excluded from coverage, network provider changes, and planning for the new year’s premium changes. Are these communications adequate to the task when it comes to biosimilars, or do we need a different level of information being passed between the health plans and their members?
Wingate: I am an advocate for greater partnership with insurance companies and group practices in communicating these decisions in advance, because when you educate a patient about biosimilars and answer their questions proactively and make them comfortable, then the switch goes more smoothly.
Dr. Shubha Bhat has done some great research on this: When you educate and help the patient along the journey, they are more receptive to using a recommended drug. On the other hand, when they get these letters from insurers, patients will often ignore the first one, because the number of communications can be overwhelming. Then they get this urgent, “You are being switched” notification. “Your next infusion, or your next treatment, is going to be with this drug.” That sets off a panic, which can be avoided if we do a better job of partnering with each other, leveraging the resources—whether they are the Crohn’s & Colitis Foundation or other groups—to help educate these patients.
We wouldn’t want every insurance company to create their own resources, there are plenty of excellent patient-facing materials available from the FDA or from organizations like our own. These can be utilized proactively before the transition letter hits somebody’s mailbox.
BR&R: And I would expect there will be many more such communications once the adalimumab biosimilars begin launching in 2023.
BR&R: At that time, there will be an increasing potential for biosimilar-to-biosimilar switches. If patients change health plans from year to year, and health plans prefer one or two of these biosimilars over the reference product (or vice versa) from year to year, we can expect many confusing notifications of formulary changes or letters detailing the exclusion of a changeable set of products. Do you expect that we will reach a comfort level at some point, where the patients will almost consider these adalimumab biosimilars products like interchangeable generic drugs, and they don’t even want to be necessarily made aware of these changes? If so, how long will it take to occur?
Wingate: Ultimately, that would be my hope, that we get to a space where they are viewed more as generics and less like unique pharmaceuticals. A few years down the road, people should be very comfortable with the change being made at a pharmacy level without a lot of communication and the need for extensive education and coaching. But that will take time. At the Foundation, our position is that we’d still like more evidence on the biosimilar-to-biosimilar switches. We want more information about the possibility and appearance of immunogenicity, especially in conditions like Crohn’s disease and ulcerative colitis.
BR&R: Maybe by the time Stelara® is subject to biosimilar competition?
Wingate: We’re maybe talking about 2025 or 2026. After 3 years of experience with adalimumab biosimilars, perhaps GI providers will be more comfortable with prescribing them, and patients will feel that switching therapies is not a dramatic change.
BR&R: Over time, the number of biosimilars across categories has increased greatly. We’re seeing some dynamic changes in the uptake of various biosimilars across categories, with the possible exception of infliximab. In your opinion, why have gastroenterologists been slower than other specialists to prescribe biosimilars? Why the resistance?
Wingate: Rather than referring to it as resistance, we call it hesitancy. I believe that a lot of this hesitancy exists because most of the biologic therapies for IBD were originally tested in other disease states, like rheumatoid arthritis or psoriasis. Eventually, they get approved for IBD. This has slowed uptake of the biosimilars in the IBD community, as they awaited more evidence on patient safety and efficacy.
Remember, many of these drugs carry black box warnings, and that history, along with the fact that these drugs are extrapolated from other chronic disease states to IBD caused some of the concern.
Today, major institutions and IBD centers are trying to help increase the uptake of biosimilars. The greater resistance may be coming from community providers who sees only five IBD patients a month. Getting them comfortable with the biosimilars is where we need to spend a lot of our effort.
BR&R: Right. You mentioned the issue of extrapolation, when alluding to GI providers’ hesitancy. Do patients understand extrapolation? Do they care?
Wingate: We do educate patients about extrapolation, but we don’t spend a ton of time talking about it. We think it is important that patients understand the concept, because it shows that the FDA is taking their safety into account, that this isn’t a cost-reduction decision; first and foremost, these drugs are safe. They go through an appropriate FDA review, and then we go on to explain the other part of it.
It is more important that providers understand this process and why extrapolation makes sense, that the science supports these approvals.