By Anna Rose Welch, Chief Editor, Biosimilar Development
It seems appropriate that, as I sat down to write this article about the importance of nurses in the biosimilar space, I fortuitously learned that the United Nations has declared 2020 the International Year of the Nurse. As the World Health Organization and the UN strive to make universal health coverage by 2030 a reality, both organizations have made it a central pillar of their mission to support nurses and midwives so that these critical healthcare professionals can better perform their duties in the next decade.
In the biosimilar space, nurses play an even more important role as the support system for patients, especially seeing as nurses administer the oncology and immunology treatments in inpatient or outpatient settings. In many European countries, nurses have also often been the primary communicator of the social reasons for transitioning from the innovator to the biosimilar.
We can’t say that nurses have been entirely overlooked. I’ve heard patient advocacy groups emphasizing just how important it is to engage the nurse in biosimilar educational campaigns. I’d also point once again to the European Specialist Nurses Organization’s switching guide which was published in 2018. This remains the pinnacle educational document for nurses I’ve come across for a few reasons. Not only does it highlight the different conversations nurses can have with their patients about biosimilars, but the document also successfully integrates case studies highlighting the savings incurred by biosimilars.
Though there are, no doubt, similar efforts to engage nurses in the U.S., it’s rare that I actually encounter nurses at conferences or on conference panels. But I’m hoping the tides are changing in that regard. A few months ago, I saw an announcement for a biosimilars forum in Washington, D.C., put on by HealthyWomen, a non-profit organization dedicated to women’s health information and education. Though I was unable to attend in person, I was thrilled to hear about this event for several reasons, the biggest being that, as the cancer biosimilars hit the market, they will be critical for the treatment of breast, cervical, and ovarian cancer. This event also included several speakers that represented stakeholders not typically represented on the conference circuit, including nurses.
Hence why I jumped at the opportunity to chat with one speaker, Dr. Lisa Kennedy Sheldon, the chief clinical officer of the Oncology Nursing Society (ONS) and a member of the HealthyWomen Advisory Council. Seeing as Sheldon has been in oncology care for almost 40 years and still works as an oncology nurse practitioner, she was the perfect person to speak to about the trends she’s observing in oncology care, in addition to the current role biosimilars play — and could still play — in oncology. Though Sheldon explained that the transition to supportive care biosimilars so far has not been a large concern to the nursing community, it’s critical that the industry maintain close contact with these crucial stakeholders as we begin launching more complex, curative oncology biosimilars.
Cancer Care: A Changing Landscape
Sheldon has worn many different hats throughout her career in healthcare. She has been a radiation therapy nurse, a clinical nurse specialist, a nurse practitioner, and is currently an oncology nurse in a cancer center in New Hampshire. She’s earned a PhD, been appointed a tenured university faculty member, and was even the editor of the Clinical Journal of Oncology Nursing. (Editors unite!) In her role at the cancer center, she works with a team that boasts diverse perspectives and experiences, including oncologists, pharmacists, social workers, clinical trial nurses, office staff, and financial advisers. The fact that she works with such a broad group of stakeholders is just one of the ways she’s seen cancer care change over the past four decades. Not only are we in the decade of implementing patient-centered care, but there is also a great need to include caregivers in treatment decisions and to discuss financial considerations which requires a large network of healthcare professionals (HCPs).
These dynamics only grow more complex as medicine advances. As she shared, “When I first started working in cancer care 20 years ago in my current clinic, we had one poster in the back of the room depicting all the treatments you could administer for any type of cancer. Now, I don’t think I could fit all the biomarkers and targets on one poster.”
It’s no wonder that the treatment landscape in oncology has grown increasingly complex as we continue to pursue personalized therapies, culminating in the market launch of cell and gene therapies. There were 15 new drugs approved in oncology launched last year, and 39 new oncological indications in 2018. “This tsunami of treatments is extraordinary,” she said. “There are also over 1,700 clinical trials including immuno-oncology [IO] agents.” (For a list of recently approved and soon-to-be approved antibodies to watch in 2020, check out this recently published article from the journal mAbs.)
Though it’s just a hypothesis, she suggested that one of the reasons biosimilar knowledge has been slow to take root in the oncology community is because of the sheer number of new oncology treatments coming to market. On the innovative side of drug development, there have been new IO combination treatments introduced, as well as conversations about the promise of CAR-T treatments and oncolytic viruses. Given the buzz around originator treatment milestones and the overall pace of the industry, it’s hard to keep biosimilars at the forefront of discussions — especially at the professional conference setting (which we all know is critical for bolstering biosimilars’ credibility).
On the nursing and clinical operations side of things though, Sheldon painted a positive picture of biosimilar knowledge and usage. Her clinic adopted Zarxio upon its arrival to the market in 2015. Though they didn’t transition current patients receiving filgrastim to the biosimilar, new starts were immediately put on Zarxio, thanks to a formulary change. When a new patient entered the clinic, the supportive care order sheet no longer provided the option for the brand; the pharmacists had made the decision for the clinic to include only the biosimilar on the formulary for new patients. “I didn’t see this move as a big issue, and I didn’t notice that the other nurses and patients did, either,” she shared. Though she admitted that there was a bit of confusion over the term biosimilar to start, education and communication around this change was simply that the biosimilar would perform the same as the originator for less cost — and this has been the case.
In addition to the growing number of originator and biosimilar agents entering the market, Sheldon also shared some interesting trends in terms of the healthcare professional landscape, which continues to solidify the important role nurses play in improving biosimilar uptake. Though many biosimilar educational efforts have targeted the physician, Sheldon explained that we’ve been seeing quite a few oncologists leaving their practices — and they’re not being replaced. Today, there are roughly 15,000 medical oncologists in the U.S. Compare that, however, to the whopping 110,000 oncology nurses. In addition, “Somewhere between 5,000 and 7,000 advanced practice providers, the majority of which are nurse practitioners, list oncology as their specialty,” she said. “So, there are huge parts of the workforce that need to work to the full scope of practice in the state in which they’re licensed.” The more these nursing professionals are employed to their full capacity, the more time the doctor has to spend with patients whose diseases require their advanced, therapeutic-specific knowledge.
In particular, she pointed out that there are currently 23 states in which nurse practitioners (NPs) have full independent practice. This means they do not require physicians to cosign orders on routine and supportive care prescriptions or provide oversight on clinical care. Most have National Provider Identifier (NPI) numbers and DEA licenses. In oncology, NPs can renew prescriptions for cancer treatments without the need for physician involvement. Though they may not be able to write the initial prescription, they are able to adjust the prescription as necessary in line with the patient’s clinical needs, such as changing body weight, symptoms, or organ function. Should a patient’s renal function or body weight change, this can lead to alterations in the prescription, dosage, or supportive care treatment — which, as we know, include Zarxio or the three (!!) pegfilgrastim biosimilar options. Many of these nurses may not be as well targeted for educational efforts by biosimilar manufacturers as they could be, she added.
Though the cancer space remains ripe with opportunity, I also found it incredibly important to note that upwards of 240,000 nurse practitioners can prescribe independently within the rheumatology space in 23 states. Seeing as a majority of the U.S. biosimilar uptake frustrations have been around the creeping biosimilar infliximab market share, this seemed like a particularly salient point to emphasize as we educate patients and physicians in the rheumatology and (especially) gastroenterology spaces. In fact, one advocate from a gastroenterology patient group did not hesitate to point out at a conference last year just how important a source of information the nurse is in that community.
What Must Biosimilar Makers Consider For Nurse Education, Healthcare Advances?
Seeing as I was unable to attend the HealthyWomen Biosimilar Forum, I wanted to hear the key takeaways Sheldon posed to the group of attendees. When we talk about cancer care today — and, in turn, biosimilars — the discussion inevitably turns to cost. Despite the current financial toxicity, there remains a significant lack of education around the different billing and patient-support efforts within the healthcare space for nurses and other HCPs. When she poses questions to HCPs at conferences about whether they’ve had courses dedicated to healthcare finances — for example, copays, patient support programs, prior authorization, and peer-to-peer consultations with physicians at private insurers — the response is typically a resounding no.
“In this climate of high-cost care, there is no better partner for you than a nurse or a nurse practitioner,” she said. “We see how much affordability upsets our patients and how it requires patients to make treatment decisions based on cost. In the world of biosimilars, manufacturers can emphasize biosimilars’ value.”
As ONS’ chief clinical officer, one of her duties is to ensure that her nurse and nurse practitioner teammates have the most up-to-date information they need to perform their jobs. Now that there are more oncology candidates in the curative setting making their way onto the market in the upcoming months, I was heartened to hear that she has been engaging with industry partners to ensure that unbranded education documents are being created. She thinks this will be an important move so nurses will understand what this transition means clinically following any formulary changes. In the wake of biosimilars and the growth of oral therapies in cancer care, the ONS has also published upwards of 90 patient education sheets in partnership with the Association of Community Cancer Centers and National Community Oncology Dispensing Association.
However, Sheldon also remained optimistic that nurses are not going to be hesitant or resistant to the entrance of the more complex curative biosimilars. Not only have many nurses already been exposed to supportive care biosimilars over the past three years, but they have also had access to articles on biosimilars which were published in the Clinical Journal of Oncology Nursing.
“When we were first meeting with industry partners, there was a general sense of concern that patients weren’t going to be comfortable transitioning to biosimilars,” she explained. This has certainly been the case in some patient populations. But as Sheldon reminded, “Formulary changes are a natural part of care in the oncology setting. Nurses don’t see an issue with the move towards biosimilars, and it hasn’t been a problem thus far. Nurses are the most trusted profession for 18 years in a row, and if we know it’s safe and effective and will cost our patients less, nurses and nurse practitioners will be fine with that transition.”
She did however suggest that biosimilar manufacturers pay attention to the site of care discussions occurring in this space, especially as the healthcare system strives to reduce the cost and value of healthcare overall. As I’ve written in the past, rather than allowing patients to get their infusions in the more costly hospital outpatient setting, a plan may stipulate that patients go to a specific independent clinic or even receive the treatment at home.
Of course, this requires well-educated infusion nurses who can train patients to safely handle and dispose of chemotherapy and other supportive and curative treatments. But in some cases, this is proving to be a more affordable investment for the payer and a more patient-centric approach to care. Hence why my interest has been peaked by the work being done by some biosimilar manufacturers to explore additional or new methods of administration for their biosimilars — a good example of this being Celltrion’s EMA-approved subcutaneous biosimilar of Remicade.
“If there are ways to do more home-based care and an insurer will pay for injectable rituximab biosimilar at home, for example, why wouldn’t a manufacturer explore that?” she ventured. “Conversations around home care are only going to grow. As nurses, we’re going to be meeting patients where they live, and this shift in site of care is also going to give patients more options. Healthcare is going to take on a whole new realm.”