Webinar as an Informational Resource on Trastuzumab Biosimilars: Planning, Promotion, Execution, and Evaluation

Figures & data

Table 1. Panel composition – names, affiliations, role on the panel, and biographies.

Name Affiliation Role on Panel	Biography
Lustberg, Maryam, MD, Medical oncologist Yale University, New Haven, CT Facilitator	She currently serves as Chief of Breast Oncology and Director of the Breast Center at Yale Cancer Center in New Haven Connecticut. She is the co-chair of Symptom Intervention for Alliance Clinical Trials and is the incoming President of MASCC, an international organization devoted to improving cancer supportive care throughout the globe. Clinically she treats men and women with all stages of breast cancer with a focus on personalizing all aspects of cancer care.
Lyman, Gary, MD Medical oncologist, biosimilars expert Fred Hutchinson Cancer Research Center, Seattle, WA Speaker & panelist	He is a Professor in the Public Health Sciences and Clinical Research Divisions at the Fred Hutchinson Cancer Research Center and Professor of Medicine at the University of Washington in Seattle. He is a Medical Oncologist with a focus on breast cancer and cancer supportive care and has a background in biostatistics and research methodology. He has written and spoken extensively on biosimilars in oncology and serves on the ASCO Task Force on Biosimilars.
Harvey, R. Donald, PharmD Pharmacist Emory University School of Medicine, Atlanta, GA Panelist	He is an oncology pharmacist and Professor in the Department of Hematology and Medical Oncology and Pharmacology at Emory University School of Medicine. He also serves as Medical Director of Winship's Clinical Trials Office and leads the Phase I clinical trials section.
Valero, Leeann Infusion nurse University of Illinois Hospital, Chicago, IL Panelist	She is an infusion nurse at UI Health. She has worked there for 6 years. She has been a nurse for 12 years, all focused in oncology.
Johnson, Sheila Patient Advocate Belleville, IL Panelist	She is a 25-Year Air Force Veteran and a 11 Year MBC patient. Sheila's extraordinary platform and advocacy is to help end racial disparities in the Black community and to enroll more Black patients into clinical trials.

Figure 1. Event flyer.

Figure 2. The sequence of activities during the webinar.

Figure 3. Screenshot of the panelists and one of Dr. Lyman’s presentation slides.

Table 2. Discussion questions and responses.

Questions	Responses
It appears that a potential challenge in talking about trastuzumab biosimilars with patients, but even between clinicians, is terminology. To what extent do you think it is important to be using accurate terminology to refer to trastuzumab biosimilars by either that term or by their brand names (as opposed to continuing to use the term ‘Herceptin’ to refer to them, or ‘generic,’ or ‘generic-like,’ etc.)? (source: predetermined question)	Dr. Lyman: “It is impossible…to remember the names of these four-letter suffixes that occur and relate them to specific agents.” “Even if the FDA conventions are important and necessary for monitoring.” “As physicians we have been taught…to focus on the brand name.” “...looking for some four letter referent that is more meaningful.” Dr. Harvey: “It is most helpful to focus on the generic name of the drug.” “Herceptin will always be in the mindset of individuals who are prescribing, using, and receiving these drugs.” “I do believe using the term trastuzumab is probably the best way forward.” “Even though we treat them like generics, how we communicate the generic versus similarity of the biosimilars is critical between clinicians and patients.” Dr. Lyman: Biosimilars are complicated and it takes a longer conversation to flesh them out. “These issues of extrapolation, immunogenicity, interchangeability, these are things we didn’t talk a whole lot about in the past…it is important, at some level…to reassure them, here are the steps they have gone through…it takes up a lengthy conversation sometimes, but it’s important.”
What would you say to someone who might suggest that patients don’t have anything to worry about (because safety and efficacy are comparable) and therefore there is no need to notify them? The idea that ‘we don’t want to worry patients unnecessarily.’ What about the idea that notifying them might put an additional strain on clinicians, with patients getting distressed and asking additional questions? (source: predetermined question)	Ms. Johnson: “Becoming a patient advocate, I learned more about it…I didn’t know about biosimilars so I had to literally research it myself and see oh, this is what a biosimilar is.” “Even the slightest change in your healthcare, you should be able to ask your doctor about it or your doctor should be able to talk to you.” “Communication should always be there.” “25% of Black patients aren’t even offered Herceptin, so what if they could get on a biosimilar at a cheaper price, are they even introduced to biosimilars?…I think it’s important that we continue the conversation.”
Are these rare experiences that the side effect profiles can be different among biosimilars? (source: audience member question)	Dr. Harvey: “From a pharmacy and pharmacological perspective, [Biosimilars] are some of the most targeted drugs we have.” “These are much more specific than other drugs we use, like cytotoxic chemotherapy.” “If you feel like, as a patient, [side effects] are due to something that is new, something that has changed, it’s always good to chat with your health care providers to talk about...oh I got this and I felt this way and you then need to contextualize that with everything else that is happening in the care of a given cancer patient, including other drugs and their timelines.” “Side effects are important, we certainly want to make sure we help patients manage them, think through them, and prevent them, ideally.” Dr. Lyman: Its important for patients to communicate with their providers and there are no dumb questions.” “If you don’t tell the clinician, then the clinician can’t appraise it and then report it if it seems appropriate.” “There is a formal FDA process for tracking emergent symptom trends.” “These are large proteins and they may cause allergic responses, so patients are monitored. … look to see if symptoms affect efficacy, note and report when certain biosimilars seem more effective.” “Communication from the patient to the clinician and from the clinician to the either the FDA or the pharmacy and therapeutics committee - these are really important avenues to keep open and to use regularly.”
As an oncology infusion nursing leader, you’re often in the front lines where sometimes you are fielding a lot of questions from patients about trastuzumab biosimilars, and I would love to hear your perspective in terms of what you have experienced about how we can improve on this project in terms of communication and patient care (source: audience member question).	Ms. Valero: “I think what’s really important is that [biosimilar education] starts from the beginning.” “When [providers] are consenting [patients]. I think its important to not use the word Herceptin…and to say ‘the trastuzumab’ or ‘the trastuzumab biosimilars’ and give them that opportunity to ask those questions, because that’s what informed consent is, right? They should have that ability to ask those questions. Our physicians and providers should be answering that.” “[When] our pharmacists and their students and residents do education…talk to the patients about what they are getting, and the side effects…say, OK, the side effects - are they similar or different than the original biologic?” “I, as the nurse…I make sure I am available to answer those questions…at every point, make sure everyone is involved in being able to provide education to the patients if they ever have any questions.” “Starting from the beginning, and letting them be aware that this is what they are getting, I think is the most important.” “Clinicians should be educated in how to give consent and field those questions. Everyone should be involved in answering and asking questions, but it needs to start well (with clarity, etc).” Dr. Lyman: Patients underreport because otherwise doctors may stop their treatment, or perhaps just don’t want to bother the doctor. Nurses may figure it out before doctors. Ms. Johnson: Patients may be afraid that doctors will take them off medications if they report symptoms, but patients should report side effects because the doctors are there to help work through and manage those symptoms. Suggests to provide patients the fact sheet.
Who makes the decisions about the switch to the biosimilar? Do patients have a say? (source: audience question)	Dr. Lyman: “We like to think the decision was made after a discussion between the clinician and the patient about what’s best for them and appropriate. The reality is it’s often reimbursement options, and negotiated contracts between either companies and institutions and practices, or between the payer (who defines preferred agents), and often there’s some penalty if you don’t use a preferred agent, and that penalty increasingly falls on the patients…What has concerned clinicians is that it’s really cost, not care, which is driving these decisions and we like to think it’s just the opposite.” “It really is complicated, and unfortunately, patients again are caught in the middle of all this. In the end…we do hope that the savings to institutions and insurers get passed on to patients….It’s too early to know for most of the biosimilars in oncology.” “The more competitors there are…the lower the price.” Paraphrase: “Doctors (should be) should be focusing on clinical reasons, not economic reasons (to use biosimilars).” Dr. Harvey: Agrees with Dr. Lyman and reiterates that competition will drive prices down. There is some confusion when multiple products are allowed by insurance, the problem of supply and storage. Would like lower cost medications, which would benefit pharmacists too.
What are ways we can improve on this process? (source: Dr. Lustberg question)	Ms. Valero: Has seen situations in which patients were on Herceptin and then the insurance switched. “The second they tell me, personally, ‘I didn’t know I switched,’ then I stop right there. I’m not going to just continue hanging it. I’m going to talk to the doctor or talk to our nurse practitioner and say ’hey, this patient was never made aware, so they have questions. Can you take the time to speak with this patient?’ And they don’t always have time, but giving the patient reassurance and time to process the switch is good, asking for questions. Insurance is a big thing and a lot of paperwork.”
Question addressed to Drs. Lyman and Harvey: “When the patient switches like that, are you reconsenting them, or is it part of your consent that biosimilars are an OK change without having that discussion or having them pre-sign consent?”	Dr. Lyman: Varies from practice to practice. The emphasis should be more on the communications (to mitigate surprise). Biosimilars are heading toward interchangeability, though skeptical about it achieving it due to the expense of the trials. Clinicians and insurance are treating them as interchangeable anyway (so there is low incentive to fund those trials). Dr. Harvey: His clinic does not reconsent, but agrees the area and the terminology is cloudy, using the analogy and lack of reconsenting for generics. But the consensus medically, is that there are not meaningful clinical differences between them. There is benefit to biosimilar use in 3rd world countries due to cost profile. Dr. Lyman: Agrees that biosimilars are good for accessibility.
Is it really safe if I started on Herceptin, and switched back to one biosimilar, and then to another? And what I’m hearing from you experts is that this is safe, ok to do, is that correct?”	Dr. Harvey: “A pharmacist at the point of dispensing can say: ’If you have brand name Novadex, and we have generic Tamoxifin on the shelf, we’re going to give you generic Tamoxifen,’ and we can do that legally, because states tend to have generic substitution laws that are effectively interchangeable laws.” “Interchangeability was something the FDA tried to kind of make that process the same.” Thinks interchangeability will become less important over time as this switching happens organically.

Note: Content is comprised of direct quotes, as well as summary statements.

Figure 4. Word cloud comprised of elicited adjectives regarding trastuzumab biosimilars.