Real-world Dose Escalation and Associated Direct Costs of Biologics in Management of Ulcerative Colitis: A Retrospective Database Study.

Introduction: Dose escalation with biologics is common among patients with ulcerative colitis (UC). We investigated the dose escalation and associated incremental costs among patients treated with biologics for UC.

Methods: This study utilized the Merative™ MarketScan® database in the United States (US) to identify adults with at least two claims for UC and at least two refill/infusion claims for maintenance doses of biologics (including adalimumab, infliximab, ustekinumab, and vedolizumab) from January 1, 2015, through December 31, 2022. Patients were stratified by the presence (bio-experienced) or absence (bio-naïve) of other advanced therapy claims during the baseline period (12 months before index date). Descriptive statistics were used to summarize the dose escalation measures (frequency and magnitude of dose escalation, incremental cost due to dose escalation, and time-to-first dose escalation).

Results: Of 1,812 patients with UC who were on biologics during the maintenance phase, 56.3% had dose escalation. Overall, magnitude of dose escalation was 119.9% adalimumab, 34.9% infliximab, 81.6% ustekinumab, and 55.4% vedolizumab. Overall, median time-to-first dose escalation after initiating maintenance therapy ranged from nearly a month to 5 months (adalimumab: 0.8, infliximab: 5.1, ustekinumab: 1.3, and vedolizumab: 5.1). Estimated incremental annual cost per patient incurred due to dose escalation in US dollars was $37,359 for adalimumab (bio-naïve: $36,367; bio-experienced: $44,180) and $73,765 for ustekinumab (bio-naïve: $74,554; bio-experienced: $73,599).

Conclusions: Dose escalation with biologics for UC in the US is common. This practice has substantially increased the average medication cost of biologics to payers/patients compared to their approved doses.