From The Editor | November 30, 2018

The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?

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By Anna Rose Welch, Chief Editor, Biosimilar Development

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We’re living at a time when it’s possible to find all the information we could possibly ever want on a topic — and then some. In the pharma space, there is an overabundance of resources on health conditions and treatments for patients and physicians. These resources are compiled and provided by patient advocacy groups, manufacturers, trade groups, physician/pharmacist organizations, and regulatory agencies via websites, social media, pharmacy handouts/consults, doctors’ offices, magazine print ads, scholarly journals, webinars, seminars, and conferences. (Did I forget any?) We walk a fine line between being overwhelmed by education and not having enough credible information.

Though many stakeholders are tackling biosimilar education head-on, there’s often little discussion surrounding best educational practices — e.g., how companies are choosing what information to present and in what ways. As such, a few months ago, I wrote an article discussing one of the biggest educational gaps I’ve encountered thus far and provided suggestions as to how the industry can get this information in front of the right eyes and ears.

It goes without saying that securing success for biosimilars requires a multi-stakeholder effort. And that, in turn, means more attention needs to be paid to stakeholders off the beaten education path. Though biosimilars’ success depends on physician and patient trust, there is one stakeholder that doesn’t get the same amount of attention in the biosimilar space as it should. In this article, I’ll discuss the importance of these experts and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.  

Issue: Patients & Physicians Are Critical — But We’re Missing This Touchpoint

I’ve started to ask more people which stakeholders are being overlooked in biosimilar education. It’s natural to argue the parties that need the most education right-off-the-bat are physicians and patients, as their behavior will crucially impact the uptake of biosimilars. We also can’t talk about prescribing habits without giving a nod to the payer and their role influencing which treatments patients receive (like it or not). In addition, I’d call attention to the employer and the pharmacist, as well, for a variety of reasons I’ve argued in past articles.

But one group of stakeholders has received little to no attention at conferences or on this site (my bad) — and that’s the nurse.

Simply by googling the (nonsensical) phrase “biosimilars nurses,” it became clear that various scholarly journals have published articles over the past few years encouraging biosimilar education for nurses and other practitioners. After all, nurses are the most common touchpoint between patients and their physicians. They interact most regularly with each patient, answer questions, distribute medicines, and monitor for, document, and report adverse events. In fact, as one expert at a recent conference shared, specialized nurses can have quite a bit of power within a healthcare organization. Not only are they responsible for data management, education and training, clinical trial administration, and data management, some nurses even have prescribing power. And when it comes to biosimilars, nurses are likely to be the experts managing a patient’s transition from a reference biologic to a biosimilar.

In a 2015 issue of the Journal of The Advanced Practitioner in Oncology, the authors of “Biosimilars in the United States: Considerations for Oncology Advanced Practitioners” discussed the importance of educating nurses on several aspects: the scientific differences between generics and biosimilars, as well as any differences between biologic and biosimilar labels, delivery devices, administration methods, and shipping and handling needs. Substitution practices between interchangeable and noninterchangeable biosimilars may also be important — though the jury is still out if interchangeability will truly matter in the hospital setting.

I imagine many of these 2015 suggestions are still in-line with the education nurses need today. But I’d also argue they’re slightly dated. In the past year especially, an increasingly loud suggestion from medical practitioners in Europe (where, reminder, there’s a lot more biosimilar use) was for practical information. For example, physicians want to know when and how the biosimilar dialogue should occur with patients. What information do patients need to know, and how should that dialogue progress? As one of my editorial board experts shared in an article, these needs could be met by putting together a tool to guide the patient-physician conversation.

Case Study: A Deep Dive Into The ESNO Switch Management Guide

That’s why I was so excited about the release of the European Specialist Nurses Organisation (ESNO)’s document earlier this year, entitled, “Switch Management Between Similar Biological Medicines: A Communication and Information Guide for Nurses.” It aims to support the conversations between patients and healthcare professionals using a “nurse’s narrative.”

It’s a hefty document, coming in at 48 pages, though this also includes reference material pages. Despite its length, I was drawn to the overall organization of information. There are three major sections of the guide: “Information about biologics, including biosimilars;” “The benefits of biosimilars;” and “Switching to a biosimilar.” Rather than presenting full pages of straight information, however, each page is broken up by text boxes, each containing a single question from a patient. (In fact, if you look at the table of contents for each section, FAQs dominate each chapter.) Following the patient’s question is a list of bullet-pointed information which a nurse can relay straight to the patient. (In fact, these bullet-point responses rely on the second person “you,” turning this guide into a sample script a nurse can use with a patient.)

Take, for instance, one of the questions discussed within the section on biosimilar switching: “Why are you doing more tests, and why is my treatment taking longer?” The authors also included examples of phrases from patients who don’t want to switch — “I am stable on this medicine and don’t want to change,” and, more determinedly, “I’m not going to change!”

The nurse’s sample answers are provided in simple, science-free language, grounding the patient in facts. For a patient unclear about the testing required surrounding the switch, the nurse can articulate that they are measuring the amount of the treatment in a patient’s blood to ensure the proper dose. (No fancy pharmacokinetics, pharmacodynamics, or immunogenicity here.) In addition to simple, clear language, a common theme reiterated throughout the dialogue is the partnership between the nurse and the patient. In many cases, the sample script emphasizes how the nurse will closely and continuously monitor the patient — e.g., “We will support you through the change and monitor your disease before and after so that you, and we, are happy that nothing has changed.” (Notice they avoid using any phrases or words, such as “if,” that imply something may or may not change.)

There was a lot of focus paid not only to these sample dialogues, but also to theories guiding patients’ responses to change. The Kubler-Ross model of change, presented in the table on page 20, is a great example of this. Following a discussion of this model, there is a chart highlighting the eight steps a nurse can take to build patient confidence during a biosimilar transition. If there is one resource in this document that is the most all-encompassing, it’s the chart on pages 21 and 22. This breaks down the communication and biosimilar implementation procedures nurses must take and what the patient’s response is likely to be following each of the eight steps. Resources such as this provide a broad, no-frills outline of what needs to be done to take patients from saying, “I’ve heard about biosimilars,” to “I will try one,” all the way to the broader understanding that these more cost-effective medicines are beneficial on the national level — “biosimilars are ours.” Indeed, by the end of the journey, patients, ideally, will come to realize that transitioning to biosimilars — and biosimilars themselves as a class of medicines — are a natural aspect of treatment. (Think along the lines of how we approach generic medicines today.)

As if all these aspects aren’t strong enough on their own, I was also impressed by the incorporation of real-world evidence throughout each section of the guide. It’s important in any educational effort to emphasize that these treatments are not being used hypothetically or within a bubble. As such, the authors ground us in reality by including brief snapshots of case studies from the U.K., Sweden, Denmark, and Belgium. In varying levels of detail, each example reveals how the biosimilar transition was introduced and enacted and how it impacted patients, healthcare workers, and the healthcare system as a whole. This information can go a long way to reinforcing the decision to implement these products in a healthcare worker’s own clinic or hospital.

As companies and health systems brace for the entrance of each new biosimilar and the prospect of large-scale transitioning, it’s become increasingly necessary to establish these new treatment procedures and policies well in advance. Take, for instance, all of the work done in the U.K. to prepare for the transition to biosimilars of Humira. That’s why I think this guide is a great example for future educational efforts — especially in countries outside of Europe that are still trying to solidify their biosimilar footing. Instead of simply defining biologics and biosimilars, extrapolation, interchangeability, and switching as so many educational efforts do, this instead delves into the practical. It establishes frameworks for the real conversations occurring on the treatment frontlines, as well as gives those of us in the U.S. (or elsewhere) a leg-up into more advanced educational territory. As biosimilar use and switching become more common in the U.S., we will need to present similar types of multi-faceted educational outreach.