REAL-WORLD USE OF BIOLOGICS IN CROHN’S DISEASE: ALIGNMENT WITH HEALTH PLAN COVERAGE REQUIREMENTS

Author(s)

Lu Shi, BA, MPH, PhD, Yichen Lin, BA, Arkady Levine, PhD, James Chambers, MSc, PhD;
Tufts Medical Center, The Center for the Evaluation of Value and Risk in Health, Boston, MA, USA
OBJECTIVES: Treatment options for Crohn’s disease (CD) have expanded substantially in recent decades, with growing evidence supporting treat-to-target strategies using biologic therapies. However, patients’ journeys to biologic treatment and the role of health plan coverage policies in shaping access remain poorly understood. This study examined biologic utilization patterns among patients with newly diagnosed CD and assessed alignment between real-world treatment pathways and health plan coverage requirements, specifically regarding (1) failure of conventional therapies (e.g., corticosteroids) and (2) selection of biologic agents.
METHODS: We used the Virginia All-Payer Claims Database and the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database to analyze biologic utilization patterns and their consistency with insurance coverage requirements among patients aged 0-64 years with newly diagnosed CD during 2018-2021. Patients were required to have a single primary insurer and at least one year of continuous enrollment following the index diagnosis.
RESULTS: Among patients with newly diagnosed CD (n=1,378), 62.3% received either biologic or conventional therapy. Most biologic users (532/604, 88.1%) received a single biologic agent, while the remainder switched biologics at least once. Among patients treated with one biologic agent, 23.5% (125/532) received conventional therapy prior to receiving a biologic; however, almost half of these patients (61/125, 48.8%) were not required to fail conventional therapy under their health plan coverage policies. 90.8% (483/532) of patients treated with a single biologic received the plan-designated preferred biologic at the time of treatment.
CONCLUSIONS: Among patients with newly diagnosed Crohn’s disease, real-world treatment pathways only partially aligned with health plan coverage requirements. Biologic selection generally reflected plan-designated preferred agents, whereas use of conventional therapies prior to biologic initiation frequently diverged from step-therapy requirements. These findings highlight gaps between coverage policies and clinical practice.

Conference/Value in Health Info

2026-05, ISPOR 2026, Philadelphia, PA, USA

Value in Health, Volume 29, Issue S6

Code

RWD65

Topic

Real World Data & Information Systems

Topic Subcategory

Health & Insurance Records Systems

Disease

SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)

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