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复杂的生物制剂审批流程延误了中重度哮喘患者的治疗。

Elaborate biologic approval process delays care of patients with moderate-to-severe asthma.

作者信息

Sehanobish Esha, Ye Kenny, Imam Kamran, Sariahmed Karim, Kurian Joshua, Patel Jalpa, Belletti Daniel, Chung Yen, Jariwala Sunit, White Andrew, Jerschow Elina

机构信息

Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY.

Scripps Clinic, San Diego, Calif.

出版信息

J Allergy Clin Immunol Glob. 2023 Jan 11;2(2):100076. doi: 10.1016/j.jacig.2022.10.007. eCollection 2023 May.

Abstract

BACKGROUND

mAbs (biologics) are indicated in patients with poorly controlled moderate-to-severe asthma. The process of prior authorization and administration of a biologic requires exceptional commitment from clinical teams.

OBJECTIVE

Our aim was to evaluate the process of approval and administration of biologics for asthma and determine the most common reasons associated with denials of biologics and delays in administration.

METHODS

We examined the records of patients with asthma who were prescribed biologics from January 2018 to January 2020 at 2 centers, Montefiore Medical Center (Bronx, NY) and Scripps Clinics (San Diego, Calif). Demographics, insurance information, and details on the approval process were collected.

RESULTS

After querying of electronic health records, the records of 352 and 70 patients with moderate-to-severe asthma were included from Montefiore and Scripps, respectively. Most patients at Montefiore (58.2%) were insured under Managed Care Medicaid (MC Medicaid), whereas most patients at Scripps (61.4%) had commercial insurance. The median times from prescription to administration of a biologic were similar: 34 days (interquartile range [IQR] = 18-63 days) and 34 days (IQR = 22.5-56.0 days) ( = .97) for Montefiore and Scripps, respectively. However, the median approval time for Montefiore was 6 days (IQR = 1-20 days) and that for Scripps was 22 days (IQR = 10-36 days) ( < .001). Approval times for prescriptions requiring appeals were significantly longer than for prescriptions approved after the initial submission: 23 days versus 2.5 days and 40.5 days versus 15.5 days (for Montefiore and Scripps, respectively [ < .001 for both]).

CONCLUSIONS

Lengthy appeals contribute to delays between prescribing and administering a biologic. Site-specific practices and insurance coverage influence approval timing of the biologics for asthma.

摘要

背景

单克隆抗体(生物制剂)适用于中重度哮喘控制不佳的患者。生物制剂的预先授权和给药过程需要临床团队付出非凡的努力。

目的

我们的目的是评估哮喘生物制剂的批准和给药过程,并确定与生物制剂被拒和给药延迟相关的最常见原因。

方法

我们检查了2018年1月至2020年1月在两个中心(纽约州布朗克斯区的蒙特菲奥里医疗中心和加利福尼亚州圣地亚哥的斯克里普斯诊所)开具生物制剂处方的哮喘患者的记录。收集了人口统计学、保险信息以及批准过程的详细信息。

结果

查询电子健康记录后,蒙特菲奥里和斯克里普斯分别纳入了352例和70例中重度哮喘患者的记录。蒙特菲奥里的大多数患者(58.2%)通过管理式医疗医疗补助(MC医疗补助)参保,而斯克里普斯的大多数患者(61.4%)拥有商业保险。从开具生物制剂处方到给药的中位时间相似:蒙特菲奥里为34天(四分位间距[IQR]=18 - 63天),斯克里普斯为34天(IQR = 22.5 - 56.0天)(P = 0.97)。然而,蒙特菲奥里的中位批准时间为6天(IQR = 1 - 20天),斯克里普斯为22天(IQR = 10 - 36天)(P < 0.001)。需要上诉的处方的批准时间明显长于初次提交后获批的处方:分别为23天对2.5天以及40.5天对15.5天(分别针对蒙特菲奥里和斯克里普斯[两者P < 0.001])。

结论

冗长的上诉导致生物制剂处方开具和给药之间出现延迟。特定地点的做法和保险覆盖范围会影响哮喘生物制剂的批准时间。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0bed/10509902/9a0cd1dadd8f/gr1.jpg

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