By Anna Rose Welch, Editor, Biosimilar Development
A few months ago, I had the pleasure of moderating a panel on education at the CBI Biosimilars Summit, which comprised three experts from different stakeholder organizations. One of these experts was Laura Wingate, SVP of education, support, and advocacy for the Crohn’s and Colitis Foundation. She guides the organization’s education strategies including supporting biosimilar strategies, manages multi-stakeholder engagement, and translates information from the FDA and other relevant sources to ensure these resources meet the patient and physician communities’ needs.
During the panel, I spoke with Wingate about the work the Crohn’s & Colitis Foundation has done over the past few years, especially as the gastroenterology community grows increasingly familiar with biosimilars. As we see more real-world evidence (RWE) released in the gastroenterology community, I wanted to pick her brain on how she and the Foundation are approaching biosimilar education, what challenges the organization is facing, and how the industry and FDA can better reach patients and physicians. The following Q&A includes my questions and her answers from the panel.
Anna Rose Welch: What has been your biggest challenge in working with biosimilars, and why?
Laura Wingate: I’m approaching this from two sides — the education side and the advocacy side, because the challenges are slightly different. On the advocacy side, there are still many questions surrounding interchangeability. For instance, what is that guidance going to look like, and are we going to have interchangeable products? Then, on the education side, I think one of the biggest challenges is patients’ fear. But I do think with chronic diseases, like Crohn’s disease and ulcerative colitis, there are well-educated patients, and they’re looking for education around biosimilars. But there is hesitancy to switch, because they want to see that price differential. They want to see the savings passed along to them, and that’s a big hurdle, seeing as the price savings currently are not going back to the patient. I think we’ll see a better uptake of biosimilars when that pricing is finally reflected down to the patient community.
Welch: What, if any, potential solutions can address or make up for the fact that patients aren’t yet seeing financial savings from biosimilar use?
Wingate: The more a manufacturer or payer can provide the same wraparound services — for instance, copay programs, nurse assistance, and hotlines to match those of the originator — will make the patient comfortable. They’re not losing a service that helps them either navigate the health system more easily or afford their medication.
Even though we know this is a long-term opportunity, it’s also a paradigm shift. We are changing the way we’re thinking about healthcare in this country, and we’re thinking about cost much more than we ever did. I think biosimilars will mirror the same journey as generics in some ways, though I hope we can shorten that time frame. But the challenge is that patients have their bills to pay now, and that’s what they have to focus on. I think globally, advocacy-wise, we’re thinking long-term. Day to day, it’s about helping the patient now.
Welch: What is your take on the need for interchangeability education and, perhaps more importantly, physician-led substitution and switching? What is the Crohn’s & Colitis Foundation doing about that, and how can the FDA better participate in that discussion?
Wingate: The FDA materials are very valuable, and we often link to them in our provider and patient education. But the agency’s information is quite broad, and more often providers are looking to answer questions around how the particular disease state they treat will be impacted and how this should be used in their disease state. That’s why we are always encouraging work with the FDA across different advocacy groups. We work with the American Gastroenterological Association and the European Crohn’s and Colitis Organisation (ECCO). In particular, with ECCO, we talked a lot about switching in Europe, how that worked, and what the data was. More programs that leverage real-world evidence studies and share disease-state-specific data, while also linking to the FDA resources for a deeper dive are really beneficial. Having the FDA promote education for the patient and the provider is really important, but there needs to be a deeper dive for the physician in their disease state.
Welch: It’s perhaps a lesser-known/ lesser-understood concept that innovator manufacturers undertake manufacturing changes which result in slight differences of the innovator from batch-to-batch. Is the fact the reference biologics are also, essentially, biosimilars of themselves a meaningful conversation to have with patients?
Wingate: We did include this discussion in our first round of biosimilar education, but we don’t have any data telling me this resonated with patients. I do think it’s an important message, but I think it’s a sophisticated message. For our newly diagnosed patients, I don’t know that that message is going to be heard. We can say it, but I don’t think it’s going to be taken in and learned when someone is newly diagnosed Now, as we see patients more experienced in their disease they are more comfortable with the notion of making a switch when educated appropriately from their current biologic to a biosimilar, that message perhaps would be stronger. But I think it gets lost on the newly diagnosed.
Overall, patient groups need to educate on all available options, and we need to bring biologics and biosimilars onto the same plane. We’ve been separating them, and I think that separation gives an inherent bias. We’re in the midst of redoing our website, and when we relaunch, you’re going to see more integration of biologics and biosimilars into the same resources, so we’re talking about them simultaneously, rather than as separate entities. I think that will help us change behavior.
Welch: How has the Foundation been integrating RWE into its current educational efforts?
Wingate: We’ve shared RWE with both patients and providers, and we’re always looking to partner with biosimilar companies in this area. Advocacy groups don’t always have the resources to stay abreast of every single study coming out. So, any time a manufacturer is aware of a new study being released or it has a study coming out, I’d urge them to please share it with their advocacy group partners. That helps us stay on top of all of this information. Share any challenges you’re having as well. I think having a dialogue with the advocacy organizations and finding common ground on what we’re all trying to achieve is really important. There are also several not-for-profits that have launched registries with which you can do clinical trial comparative effectiveness research. I highly encourage engagement with the not-for-profit groups to leverage these, whether they’re patient-reported or other types of registries to help get the data the doctors in the U.S. are seeing. This way, we can build that arsenal of data, so we can translate that material and research out to the patient. Both patients and physicians need the same confidence and comfort with biosimilars in order to improve uptake.
Welch: It’s clear that RWE is important for the Foundation and all patients and physicians. Are there ways we as an industry could promote, distribute, or present these studies to better educate stakeholders?
Wingate: Well, for every advocacy group I’ve ever talked to, getting information in the hands of providers is a challenge, because they’re inundated with information. But in addition to physician education, I think it’s important to consider pharmacists, because they do play a pivotal role — along with nurse providers and physician assistants (PAs). In fact, nurses are often the ones spending the most time educating patients, so helping them get that RWE data in short, digestible chunks would be a great place to start. For one, infographics are a great way to present complex data in an easy, digestible way.
Welch: What are some of the efforts the Foundation is exploring to familiarize the community with biosimilar performance globally and to promote transparency?
Wingate: The Crohn’s & Colitis Foundation is working on launching an open-access journal. The Foundation has a journal which is part of our membership program. But moving forward, we’re going to make research, evidence, and white papers available through open access, so not only can members of our organization get access, but the general public and the general provider community as well. Finding those open-access journals and leveraging them to get all the data available so anyone can access it is beneficial. I know the Foundation, at least, is looking to then translate that into patient-facing information.
I don’t think there’s a panacea in terms of getting good research information in front of providers, and there are so many different provider audiences. For example, in my world, it’s not just the gastroenterologists, but also the nurses and PA’s. But then we also have to think about the primary care docs, because they prescribe biologics and biosimilars, and we want to make sure they’re doing so with the best information. There’s no easy answer, but I think having a multi-pronged strategy is essential.