DEMOCRATIC DELIBERATION TO ASSESS VETERAN PREFERENCES FOR BIOSIMILAR MEDICATION SWITCHING FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE IN A RESOURCE CONSCIOUS SETTING

Abstract

Abstract BACKGROUND To optimize care while being resource conscious, the Veterans Health Administration (VHA) must develop equitable policies that incorporate Veterans’ values and beliefs. Switching patients with Inflammatory Bowel Disease (IBD) from biologic medications (originators) to less expensive biosimilars offers the opportunity to explore potential policies. Unlike originators, the FDA did not require disease-specific randomized controlled trials for approval of biosimilars, creating 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 policy approaches. 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, use of biologics (including biosimilars), and related implementation challenges. Participants engaged in facilitated small group discussions designed to 1) identify Veterans views about biosimilar switching and their preferences for informing Veterans about switching, and 2) evaluate responses to five approaches for switching: (a) “status quo”–switching policies vary by VHA facility, (b) “sickest last”–Veterans with the most severe IBD are switched last, (c) “opt-out”–Veterans may opt-out of switching, (d) “next appointment”–Veterans are switched at their next appointment, 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. Discussion transcripts were analyzed 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 information and transparency around biosimilar switching. Participants emphasized the importance of informed choice, prioritizing based on health status, personalization, and shared decision-making (e.g., treatment should be geared to individual patient in discussion with their provider). CONCLUSION DD methods are effective for soliciting Veterans' opinions and preferences for health policies. Veterans favored 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.