Overview of Crohn’s Disease and Current Gaps in Access

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EP: 1.Overview of Crohn’s Disease and Current Gaps in Access

EP: 2.Treatment Landscape of Crohn’s Disease and Mechanisms of Action

Crohn’s Disease Treatment Overview and Access Issues

Clinical Management Philosophy

This educational program discusses critical treatment considerations for Crohn’s disease management, focusing on the GALAXI-2 and GALAXI-3 trials that supported Food and Drug Administration approval of a new therapeutic agent. The fundamental principle emphasized is maintaining patients on effective therapy rather than switching between different mechanisms of action. When patients achieve and maintain both clinical and endoscopic remission, continuing the same effective treatment is strongly preferred. Switching between mechanisms should be reserved only for situations involving loss of response, intolerance or clear safety concerns, not for routine rotations, as this practice can negatively impact both efficacy and treatment durability while potentially increasing drug-related and disease-related complications.

Treatment Sequencing and Efficacy Considerations

The discussion highlights significant concerns regarding treatment switching and its impact on clinical outcomes. Each time a therapy switch occurs, whether premature or justified, clinicians lose valuable treatment options from an already limited therapeutic arsenal for moderate to severe Crohn’s disease. Clinical trial evidence demonstrates that sequential therapies may be associated with progressively diminished clinical and endoscopic efficacy. This underscores the critical importance of selecting initial therapy with high levels of both clinical and endoscopic remission potential and maintaining that treatment when successful. The top-down approach of finding the right treatment for the right patient at the right time is emphasized over the traditional step-up methodology.

Access Barriers and Healthcare System Challenges

Significant access issues persist in Crohn’s disease treatment, particularly regarding biologics, biosimilars and advanced therapies. In the United States, insurance companies and payers continue mandating fail-first or step therapy approaches, which conflicts with optimal clinical practice. These policies create barriers through formulary tier restrictions and high out-of-pocket costs, limiting physicians’ ability to prescribe the most appropriate treatment. International perspectives reveal similar challenges, with Canada experiencing forced switches from originator to biosimilar drugs through nonmedical switch policies on the public side, whereas some European countries require biosimilar anti-tumor necrosis factor therapy as first-line treatment. These access limitations compromise shared decision-making between clinicians and patients and reduce healthcare provider autonomy in treatment selection.