Gottesman Sara, Xiao Karen, Nguyen Hang P, Hernandez Elizabeth, Saweris Emily, Jagannathan Priyanka, Jafri Faraz, Davis Jonathan, Tong Kimhouy, Tang Zhouwen, Gaidos Jill K J, Feagins Linda A
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Dell Medical School at The University of Texas at Austin, Austin, Texas, USA.
Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA .
Clin Transl Gastroenterol. 2025 Mar 1;16(3):e00808. doi: 10.14309/ctg.0000000000000808.
Because biologic and small molecule therapy is expensive, payors have mandated preauthorizations for these medications, often resulting in a lengthy approval process. The aims of this study were to assess the frequency of and risk factors for delays in starting advanced therapies assessing insurance, care team, and patient-related factors.
Retrospective, multicenter study of patients with adult inflammatory bowel disease with prescriptions for an advanced therapy in 2 geographically distinct academic gastroenterology practices: one with and the other without a dedicated pharmacist. A priori , we defined a delay in starting therapy as >14 days between prescription and the first dose. Logistic regression analysis was performed to assess for risk factors for delay.
A total of 388 patients were prescribed advanced therapies with 46.6% receiving their first dose within 14 days. Patients who were on time vs delayed were similar in baseline demographics, disease characteristics, and disease activity. After adjusting for confounders, 3 independent risk factors remained significant as predictors for delay: study site (OR = 5.2, 95% CI 2.894, 9.333), intravenous drug delivery as opposed to subcutaneous or oral (OR = 3.07, 95% CI 1.845, 5.099), and insurance denial (OR = 2.72, 95% CI 1.082, 6.825).
In a multicenter study, we found that a delay between prescription and administration of the first dose of an advanced therapy is common, with > 50% of patients having the first dose delayed by > 2 weeks. Delays in starting therapy were significantly more likely if denied by insurance, given by intravenously induction, or at a study site without a dedicated pharmacist.
由于生物制剂和小分子疗法费用高昂，付款方要求对这些药物进行预先授权，这往往导致审批过程漫长。本研究的目的是评估启动先进疗法延迟的频率和风险因素，评估保险、护理团队和患者相关因素。
对两个地理位置不同的学术性胃肠病科诊所中开具先进疗法处方的成年炎症性肠病患者进行回顾性多中心研究：一个诊所有专职药剂师，另一个没有。我们预先将开始治疗的延迟定义为处方开具与首剂给药之间间隔超过14天。进行逻辑回归分析以评估延迟的风险因素。
共有388例患者开具了先进疗法处方，46.6%的患者在14天内接受了首剂治疗。按时用药与延迟用药的患者在基线人口统计学、疾病特征和疾病活动方面相似。在对混杂因素进行调整后，有3个独立的风险因素仍然是延迟的显著预测指标：研究地点（比值比=5.2，95%置信区间2.894，9.333）、静脉给药而非皮下或口服给药（比值比=3.07，95%置信区间1.845，5.099）以及保险拒付（比值比=2.72，95%置信区间1.082，6.825）。
在一项多中心研究中，我们发现先进疗法首剂处方开具与给药之间的延迟很常见，超过50%的患者首剂延迟超过2周。如果被保险拒付、采用静脉诱导给药或在没有专职药剂师的研究地点进行治疗，开始治疗的延迟可能性显著更高。
