Biosimilar Switching Study Demonstrates Value of Patient Support, Education

Through a series of patient interviews, investigators in Canada say they have discovered what others around the global biosimilars community are discovering. Namely, that well-supported switching to biosimilars, in the form of solid education efforts about biosimilar equivalence, leads to successful clinical outcomes and, importantly, patient acceptance of these agents.

The findings are important as multiple Canadian provinces attempt to switch patients to biosimilars in order to reduce spending on costly biologic drugs. These mandatory switch programs follow years of biosimilar availability but rejection by physicians and patients, many of whom approach switching to biosimilars with fears that they will be less efficacious and result in unpleasant adverse events.

New Brunswick, Alberta, and, most recently, Quebec have each moved forward with mandatory biosimilar switching programs.

The patient perspective on mandatory switching was investigated in a qualitative study of interviews with patients from 2 practices in British Columbia (BC). Investigators concluded that their findings showed patients experienced “apprehension and anxiety” prior to switching from reference biologics to biosimilars, but these concerns could be “addressed with adequate patient-provider communication and support.”

The BC Biosimilars Initiative

The government of BC, through the BC Biosimilars Initiative, implemented mandatory switching of some patient populations on originator drugs to biosimilars in 2019. In the first phase, patients on reference biologics including etanercept (Enbrel) and infliximab (Remicade) for ankylosing spondylitis, rheumatoid arthritis, and plaque psoriasis were switched to biosimilars. The authors said 78% of patients in this population in BC were switched to biosimilars by March 2020 and noted “this policy change was the first of its kind in Canada and North America.”

To characterize the patient perspective of the BC Biosimilars Initiative, the authors interviewed 9 patients before the switch took place, from October to November of 2019. Three patients did not return for postswitch interviews in July 2020. The average age of the patients was 60.7 (range, 47-80) years. Investigators hypothesized that “patients would be anxious about the switch and reluctant to change to biosimilars for nonmedical purposes, but that if the biosimilars were (as evidence suggests) equivalent, that their perspectives would change post-switch.”

Interviews consisted of open-ended questions regarding patients’ perceptions of the policy change, knowledge of originator biologics and biosimilars, and concerns about the potential effects of the switch on their disease management. In the postswitch interview, patients were asked to reflect on their initial perceptions, expectations, and opinions. Also, because the study duration overlapped with the onset of the COVID-19 pandemic, patients were asked how the pandemic affected their switch to biosimilars and overall care.

Concerns About Effectiveness and Safety

Preswitch interview questions included “Do you feel you understand the reason for the change?” and “What do you think are the impacts of switching from originators to biosimilars?”

According to study authors, some of the most common concerns about the switch to biosimilars were whether they would be as effective as originator drugs and whether there would be more adverse events. As expressed by one participant, “Well, I am hoping that it’s going to work as well as the Enbrel, with no side effects, because that’s always a big concern. Any time you switch, it’s not a guarantee that it’s going to work, so it can take you out of any kind of remission that you are in.”

Some patients were concerned about potential disruption to their quality of life from switching and any departure from good results they’d enjoyed with the originator drug. For example, one patient commented, “You have a nice, quiet life going. Everything is working well, and now we’re going to switch drugs. Who knows what’s going to happen?” The authors noted such concerns were common in surveys of patients in the United States and France prior to switching to biosimilars. Those surveys found that almost two-thirds of patients had no knowledge of biosimilars prior to their switch, and more than 40% were not notified they would be switching from a reference biologic to a biosimilar.

However, in this survey, participants had a “good grasp of the similarities and differences between biologics and biosimilars” and understood the cost savings rationale for the policy change. One patient described the rationale, “I think the government is just doing it to save money. It’s the same type of drug, just made by a different company.”

Some participants had a positive outlook on the switch, saying for example, “I’m convinced that it’ll be okay.” Others expressed displeasure with the mandatory nature of the switch, saying “No, I am not supportive of the change. It’s being forced upon me,” or, “I have no say in this matter. It’s being decided for me.”

Post-Switch Interviews

Participants described “an overall positive experience” in postswitch interviews. After the mandatory switch, participants answered questions such as, “What has the biosimilar experience been like for you?” and “Do you feel like any of your prior expectations or opinions regarding the switch have remained the same or changed?”

Overall, the authors said, “participants shared positive attitudes towards their experiences switching to biosimilars.” The initial concerns of some patients were not realized, for example, “I just didn’t know if it would work as well as the other medication I was taking. So that was my only concern, and it hasn’t been an issue.” Others’ expectations for a positive experience were met: “My expectation was it was going to be the same and things would just carry on.”

Not all patients had positive experiences. A change in the needle type accompanying the switch to a biosimilar resulted in increased discomfort or pain at the injection site for a few patients.

Participants reported that out-of-pocket costs either stayed the same or increased. According to one patient, “I never paid for anything with Enbrel. The first time I go in to fill a prescription, they ask me for $75 over and above my plan.” One participant of the 6 interviewed after the switch experienced a reduction in disease control, saying “I’ve had some flare-ups...I don’t think it works as well.”

Regarding the effect of the COVID-19 pandemic on their care, patients reported increased feelings of anxiety, difficulty making in-person appointments, and increased use of telehealth.

Communication Was Integral to Success

The importance of support from family and health care providers during the switch was a theme running throughout these interviews, according to the authors. Participants appreciated their rheumatologists answering their questions and showing confidence in biosimilars: “He answered the question beforehand....He said that, in most cases, there weren’t any real problems, any real transition issues, and that it was just as effective [as the originator]. He also said that ‘If you find that you are degrading, we will get you back on the original.’”

The responses of participants in the preswitch interviews suggested they felt well-informed about biosimilars and the upcoming policy change. The authors said this contrasted with findings from the surveys conducted in the US and France, which revealed poor patient knowledge of biosimilars prior to switching and lack of patient notification that switching would occur.

Authors of the BC study said it was noteworthy that “despite our patient population’s knowledge base, participants still approached their switch to biosimilars with apprehension and anxiety.”

The authors concluded, “proper and effective communication strategies from health care providers to patients regarding the switch [are] integral to the success of their changeover and disease management,” and they said this helps prevent the nocebo effect, which is when patients’ doubts about biosimilar effectiveness appear to diminish the effectiveness of these therapies.

They said these interviews suggested that “for the most part, participants were able to successfully manage their disease regardless of their baseline concerns about efficacy and safety.” The authors acknowledged the small sample size, the narrow sampling from only 2 practices, and failure to complete 3 of the 9 postswitch interviews. However, they view their study as providing valuable insight into the patient perspective “during a limited window of opportunity ahead of the first mandatory switching policy in Canada.”

This information on the patient perspective and patient-physician communication, they said, “can help to inform future nonmedical switching policy changes.”

Reference

Chew C, Aguiar M, Bansback N, Law MR, Harrison M. Patient perspectives on the British Columbia Biosimilars Initiative: a qualitative descriptive study. Rheumatol Int. Published online May 7, 2021. doi:10.1007/s00296-021-04874-8