Survey: Most Patients Received Inadequate Information About Switching to a Trastuzumab Biosimilar

A survey of 143 patients with breast cancer and 33 medical oncologists assessed their experiences during non-medical switching to a biosimilar trastuzumab from the reference product (Herceptin). The findings, which were published in Breast Cancer Research and Treatment, suggested there is inadequate information for patients, which is “inconsistent with best practices of patient-centered communication,” the investigators wrote, and is a challenge to both the uptake of trastuzumab biosimilars and the patient-oncologist relationship.

Trastuzumab, a monoclonal antibody to human epidermal growth factor receptor 2 (HER2) approved by the US FDA in 1998, “has been revolutionary in improving survival for early stage and metastatic HER2-positive breast cancer,” the authors noted. Five lower-cost trastuzumab biosimilars have been approved by the FDA (Kanjinti, Ontruzant, Ogivri, Trazimera, and Herzuma). Since non-medical switching is often initiated by insurers or health care systems, and the guidelines for switching are often “vague,” the investigators sought to “characterize the experiences of patients and oncologists” when the switch was either proposed or required by the cancer center or insurer.

They cited previous surveys in which patients had concerns about effectiveness and side effects and reported lack of awareness, education, and understanding of biosimilars. Surveys of oncologists similarly reported uncertainty about switching, a lack of confidence in biosimilars, and safety concerns.

More than half (63.9%) of patient respondents reported having switched from the trastuzumab reference product to a biosimilar, just over half (55.2%) reported that they were given an option to switch, and 8.6% said they declined switching.

Patients Switched Without Notification, “Resulting in Negative Emotions”

In 40.8% of responses, patients reported receiving no prior notification that they would be switching to a biosimilar. Negative emotions regarding the lack of notification were common. A physician discussed biosimilars with 26.4% of patients before switching, a chemotherapy nurse discussed the switch with 15.5% of patients, and in other cases, an advanced practice provider, pharmacist, or insurer discussed biosimilars with the patient prior to non-medical switching.

Patients reported a variety of experiences with non-medical switching, and the authors provided quotes from patients illustrating those experiences. Some patients being treated with a trastuzumab biosimilar were unaware of biosimilars: “I thought [the biosimilar] was the same.”

Some were switched without any notification or information about biosimilars: “Literally any information would have been more than I was given.”

Some patients only found out about the switch when they noticed the name of the medication on their chart or insurance documents: “I always check my meds and asked why it was called something different.”

Only 11% of Patients Surveyed Were Satisfied With The Information They Received About Biosimilars

Over 60% (61.0%) of patients said they learned about biosimilars primarily through self-directed learning, compared to 33.3% who learned from their health care provider, and 35.2% by asking on social media.

Patients reported wanting more time to discuss the switch with their physician (41%), more time between notification and treatment (35%), to gain a better understanding of biosimilars (52.5%), and access to printed materials (41.3%). Over half of patients surveyed (54.8%) reported not receiving any pharmaceutical manufacturer material on the biosimilar.

This lack of information, leading patients to seek information outside their health care team, signals “that the healthcare team is not central to the patient’s understanding of their care, thereby making the patient more vulnerable to misinformation, incomplete information, and lack of comprehension.”

Oncologists Also Lacked Information

The oncologists’ responses to the survey “highlight that the decision to switch patients to trastuzumab biosimilars is often not made by them, but rather by the healthcare systems or by insurance companies,” the investigators reported. Some oncologists reported that switching occurred without their knowledge.“Despite their central role in cancer patient care, oncologists lack complete information” that is important for their relationships with patients, the authors wrote.

The survey also found that oncologists’ perceptions of the patient experience of non-medical switching were more positive than patients’ reported experiences. Oncologists rated more positively than patients: patients’ opportunity to ask questions, adequacy of resources about the trastuzumab biosimilar, effectiveness of biosimilar trastuzumab treatment, level of patient worry about switching, and the switch being a minor change.

Lack of Notification About Switching as an Ethical Issue

Since patients have the right to be informed about their treatment, the authors wrote, “the issue of lack of notification about switching to trastuzumab biosimilars is an ethical one,” and

that effective communication about trastuzumab biosimilars is “in need of systems-level interventions.”

In addition to a need for “tailored and effective patient and oncologist information and education on trastuzumab biosimilars” to be in line with the goals of patient-centered care, they wrote, “there is an urgent need to mitigate avoidable emotional distress to patients—especially populations that are already vulnerable on multiple levels.”

The investigators added that their findings “have the potential to inform more effective communication regarding trastuzumab biosimilars” and “extend to communication regarding treatment options in general.”

Reference

Papautsky EL, Carlson M, Johnson SM, Montague H, Attai DJ, Lustberg MB. Characterizing experiences of non-medical switching to trastuzumab biosimilars using data from internet-based surveys with US-based oncologists and breast cancer patients. Breast Cancer Res Treat. 2022;194(1):25-33. doi:10.1007/s10549-022-06615-2