Perceptions of Biosimilar Switching Among Veterans With IBD

Findings of a study using deliberative sessions to assess patient perceptions found that veterans with inflammatory bowel disease (IBD) have concerns about the relative risks and benefits of switching and view physician-patient communication, transparency, shared decision making, and individualized care as important considerations. Participants favored approaches that would switch patients with the most severe disease last and those that would offer patients more control of biosimilar switching.

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Biosimilar switching programs offer the opportunity to mitigate drug costs and expand access to biologics, and the authors suggest a patient-centered approach that emphasizes communication and shared decision-making. Understanding and addressing patient concerns and preferences is crucial, they wrote, because “decreased patient acceptance and adherence to biosimilar medications have been reported, which can lead to loss of treatment response, adverse reactions, and inefficient resource utilization.”

Although previous survey studies have provided insight into patients’ perception of biosimilars and switching, surveys and focus groups have limitations, the authors said. With a complex issue such as biosimilar switching, they wrote, patients “may only have a cursory knowledge of these medications, thus limiting insights into their preferences.” The study used democratic deliberation, which combines education with facilitated group discussion, to better understand the perceptions of patients with IBD in the Veterans Health Administration (VHA) on biosimilars and biosimilar switching programs.

Invitations were sent to 175 patients with IBD from the VHA, of whom 29 attended and completed the virtual deliberation sessions in 5 small groups. Participants also completed surveys before and after the 2 days of deliberation. On the first day, participants received background information on IBD, originators and biosimilars, and the potential benefits and concerns regarding switching. Then, participants were asked how risky they believed switching to a biosimilar compared to switching from a name-brand drug to a generic. Overall, participants rated switching to a biosimilar as significantly riskier than switching to a generic.

Preferences Regarding Biosimilar Switching Approaches

On day 2, 5 potential approaches to biosimilar switching with pros and cons associated with each were presented, and participants were asked to rank them: the “status quo,” in which switching policies vary by VHA facility, a “sickest last” approach in which patients with the most severe disease are switched after those with less severe disease, “opt-out” in which patients can choose to opt-out of switching, “next appointment” in which patients are switched at their next appointment, and “lottery” in which randomly selected patients are switched. Participants ranked these choices again in the post-deliberation survey.

Participants’ preferred approaches were “sickest last” and “opt-out.” They cited the importance of personalization and risk reduction for the “sickest last” approach. However, some participants had reservations about this approach because of the lack of patient control and consent. Others had reservations about the “opt-out” approach, stressing the need to make an informed decision and expressing concern about the cost to the VHA of the ability of patients to opt-out.

Perceived Risk of Biosimilar Switching

Concerns about switching included reduced efficacy, symptom re-emergence, and development of an immune response that could prevent switching back to the originator. Participants felt that the risks and benefits associated with switching from an originator to a biosimilar were less clear than those associated with switching from a brand name drug to a generic.

Transparency and Information

Participants also discussed the importance of transparency in healthcare and of health care professionals keeping patients informed. A few participants framed transparency as an ethical requirement and also important to maintain trust in the health care system. Others preferred to be informed about an upcoming switch to better monitor symptoms and manage their care.

Shared Decision Making

However, transparency and patient information were “necessary but insufficient for most of our participants,” the authors said. Participants desired to have a role in the decision when discussing treatment switches with a health care provider. Although participants expressed trust in their providers to give them accurate information, they also thought that both the provider and patient have important roles in the decision to switch to a biosimilar.

Cost and Access

According to the authors, participants had “diverse attitudes” about how to balance transparency and shared decision making with reducing costs and improving access to biologics. Some supported switching for the cost and access benefits, whereas others did not feel that the personal risk was worthwhile to save money.

Personalization and Prioritization

Participants consistently preferred a personalized approach to the issue of switching and IBD care overall based on each patient’s needs. As such, participants were “generally supportive of policies that prioritized switching patients based on some criteria.” Some participants felt that new patients should be initiated on biosimilars, or that patients should be prioritized by risk, with lower-risk patients switched first. They said that those cases could inform the next steps.

The authors noted that participants’ responses to questions about IBD showed their knowledge significantly increased after the deliberation and concluded that participants in their study “do not perceive biosimilars as equivalent to originators, indicating the need for targeted educational efforts to address these concerns.” They recommended that approaches to switching should take into account patient preferences for transparency, effective communication, and shared decision-making.

Reference

Ryan KA, Cohen-Mekelburg S, Baker JA, et al. Public deliberation to assess patient views on biosimilar medication switching for the treatment of inflammatory bowel disease. BMC Health Serv Res. 2024;24(1):1209. doi:10.1186/s12913-024-11570-3