P600 Democratic deliberation to assess Veteran preferences for biosimilar medication switching for the treatment of Inflammatory Bowel Disease in a resource-conscious setting.
Ryan, K.(1);Hou, J.K.(2,3)*;Baker, J.(4);Krenz, C.(1);De Vries, R.(1);Waljee, A.K.(4,5);
(1)University of Michigan, Center for Bioethics and Social Sciences in Medicine, Ann Arbor, United States;(2)Michael E. DeBakey VA Medical Center, Center for Innovations in Quality- Effectiveness- and Safety, Houston, United States;(3)Baylor College of Medicine, Department of Gastroenterology, Houston, United States;(4)Ann Arbor VA Healthcare System, Center for Clinical Management Research, Ann Arbor, United States;(5)University of Michigan, Department of Gastroenterology, Ann Arbor, United States;
Background
Optimizing care while being resource-conscious, the Veterans Health Administration (VHA) must develop equitable policies incorporating Veterans’ values and beliefs. Switching patients with Inflammatory Bowel Disease (IBD) from biologic medications (originators) to less expensive biosimilars offers opportunities to explore potential policies. Unlike originators, the FDA did not require disease-specific randomized controlled trials for approval of biosimilars, raising provider and patient concerns about the safety of switching to these medications. Deliberative democratic (DD) methods allow us to assess Veteran views of switching programs, a necessary step in creating equitable policies.
Methods
We carried out two 2-day sessions with Veterans from the Ann Arbor VA (n=17) and Houston VA (n=12). Deliberation began with education about IBD, the use of biologics (including biosimilars), and related implementation challenges. Participants engaged in facilitated small group discussions to 1) identify Veterans views about biosimilar switching and Veteran preferences about switching, and 2) evaluate five approaches for switching: (a) “status quo”–switching policies vary by VHA facility, (b) “sickest last”–Veterans with severe IBD are switched last, (c) “opt-out”–Veterans may opt-out of switching, (d) “next appointment”–Veterans are switched at follow-up, and (e) “lottery”–patients are switched based on random selection. Participants ranked options (1=most preferred, 5=least preferred) and proposed modifications to these approaches. Participants completed pre- and post-DD session surveys. Transcripts were analysed using qualitative methods.
Results
Participant demographics are in Table 1. Most Veterans sessions preferred the “sickest last” (mean rank: 1.8, standard deviation: 0.9) or “opt-out” (2.4,1.4) approaches over the “status quo” (3.1,1.0) or “lottery” (4.6,0.9); preferences did not significantly change after deliberation (Figure 1). Preferences reflected Veterans’ concerns about the risk of switching to biosimilars for the most vulnerable Veterans and their strong preference for transparency around biosimilar switching. Participants emphasized the importance of informed choice, prioritizing based on health status, personalization, and shared decision-making.
Conclusion
DD methods are effective for soliciting Veterans' opinions and preferences for health policies. Veterans favoured policies that provided information and control, promoted shared decision-making, and reduced risk to vulnerable patients. Incorporating patient preferences and insights is critical when implementing health policies in the VHA and other resource-limited settings.