Abstract
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 USA 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, to 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 USD 37,359 for adalimumab (bio-naïve: USD 36,367; bio-experienced: USD 44,180) and USD 73,765 for ustekinumab (bio-naïve: USD 74,554; bio-experienced: USD 73,599). CONCLUSIONS: Dose escalation with biologics for UC in the USA is common. This practice has substantially increased the average medication cost of biologics to payers/patients compared to their approved doses.
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