监测炎症性肠病患者从原药到生物仿制药英夫利昔单抗的强制性非医疗转换政策:一项基于人群的队列研究

IF 2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY
Anat Fisher, Jason D Kim, Colin R Dormuth
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引用次数: 0

摘要

背景:2019年9月5日,不列颠哥伦比亚省宣布了一项新政策(生物类似药倡议),将炎症性肠病患者的英夫利昔单抗从原研药转为生物类似药。目的:监测政策实施第一年对药物使用和卫生服务的影响。方法:在这项以人群为基础的队列研究中,我们使用行政卫生数据构建了使用原药英夫利昔单抗的炎症性肠病患者的三个历史队列和一个政策队列。然后我们监测药物和卫生服务的累积发生率。对数似然比用于量化政策队列与历史队列平均值之间的差异。结果:队列包括1839-2368名原药英夫利昔单抗使用者,年龄4-90岁,平均年龄43岁。在第一年的随访中,我们发现:(1)英夫利昔单抗、生物仿制药或原研药的首次配药增加了0.9%;(2)英夫利昔单抗剂量增加16.2%;(3)抗生素配药减少2.4%,泼尼松新用药减少2.6%;(4)为管理转向生物仿制药而到内科医生和胃肠病学家就诊的人数预计会增加(24.0%);(5)出院人数减少4.0%;(6)急诊入院率下降2.9%。结论:不列颠哥伦比亚省的生物类似药倡议将炎症性肠病从原研药转向英夫利昔单抗生物类似药,与药物和卫生服务使用的有害影响无关。剂量增加的同时,健康状况指标也有所改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study.

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study.

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study.

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study.

Background: On September 5, 2019, British Columbia announced a new policy (the Biosimilars Initiative) to switch from originator to biosimilar infliximab for patients with inflammatory bowel diseases.

Objective: To monitor the impacts of the policy on the use of medications and health services during the first year of the policy.

Methods: In this population-based cohort study, we used administrative health data to construct three historical cohorts and one policy cohort of patients with inflammatory bowel diseases who used the originator infliximab. We then monitored the cumulative incidence of medications and health services. Log-likelihood ratios were used to quantify differences between the policy cohort and the average of the historical cohorts.

Results: The cohorts included 1839-2368 users of the originator infliximab, ages 4-90 years, mean age 43 years. During the first year of follow-up, we found: (1) a 0.9% increase in the first dispensation of infliximab, biosimilar, or originator; (2) a 16.2% increase in infliximab dose escalation; (3) a decrease of 2.4% in the dispensation of antibiotics and a 2.6% decrease in new use of prednison; (4) an anticipated increase in visits to physicians and gastroenterologists to manage switching to biosimilars (24.0%); (5) a 4.0% decrease in discharges from hospital; and (6) a 2.9% decrease in emergency admissions to hospital.

Conclusion: British Columbia's Biosimilars Initiative for nonmedical switching from originator to biosimilar infliximab for inflammatory bowel diseases was not associated with harmful impacts on medications and health services use. An increase in dose escalation was accompanied by an improvement in health status proxies.

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来源期刊
Gastroenterology Research and Practice
Gastroenterology Research and Practice GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
4.40
自引率
0.00%
发文量
91
审稿时长
1 months
期刊介绍: Gastroenterology Research and Practice is a peer-reviewed, Open Access journal which publishes original research articles, review articles and clinical studies based on all areas of gastroenterology, hepatology, pancreas and biliary, and related cancers. The journal welcomes submissions on the physiology, pathophysiology, etiology, diagnosis and therapy of gastrointestinal diseases. The aim of the journal is to provide cutting edge research related to the field of gastroenterology, as well as digestive diseases and disorders. Topics of interest include: Management of pancreatic diseases Third space endoscopy Endoscopic resection Therapeutic endoscopy Therapeutic endosonography.
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