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临床试验/NCT05177406
NCT05177406已完成不适用

Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 1,839 人开始时间: 2020年8月31日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,839
试验地点
1
主要终点
Change in migraine-related medical and prescription costs
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health

详细描述

The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health.

Study data included adjudicated and paid medical and pharmacy claims in the US between November 1, 2017 and September 1, 2019 provided by Komodo Health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •General Cohort
  • •Adult (18 years or older)
  • •Newly initiating on Aimovig (no other claims during a 180-day wash-in period)
  • •Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 180-days post-index
  • •Primary & Secondary Objectives Sub-Cohort
  • •Had 3 consecutive months with a claim for Aimovig (≤15 days gap between days supply and the subsequent claim to be considered consecutive)
  • •Primary & Secondary Objectives Cost Sensitivity Analyses Sub-Cohorts
  • •Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 270-days post-index to permit assessment of cost outcomes (all-cause and migraine-related) during days 91-270 post-index
  • •Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig to the maximum follow-up time post-index with continuous medical and prescription insurance eligibility until the data end date (September 1, 2019)

排除标准

  • •Patients with any claim for another CGRP-targeted medication (Ajovy or Emgality) during entire study period

结局指标

主要结局

Change in migraine-related medical and prescription costs

时间窗: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19

Migraine-related costs included: acute and preventive migraine-related prescription costs \& drug administration costs, as well as hospitalizations, emergency room (ER) visits, outpatient visits (including urgent care), provider-office visits, and diagnostic imaging with a primary diagnosis of migraine

次要结局

  • Change in percentage of patients with all-cause pain specialist office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with migraine-related physical therapy visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause hospitalizations or ER visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause provider-office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with all-cause neurologist office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with anxiety-related psychiatrist/psychologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with any prescriptions for acute migraine medications(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in all-cause costs(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with all-cause outpatient visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with migraine-related pain specialist office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with all-cause physical therapy visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of migraine-related hospitalizations or ER visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of migraine-related outpatient visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause physical therapy visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with migraine-related provider-office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with migraine-related neurologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of migraine-related provider-office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of migraine-related physical therapy visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with all-cause hospitalizations or ER visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with migraine-related hospitalizations or ER visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with migraine-related outpatient visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with all-cause provider-office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with all-cause psychiatrist/psychologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with depression-related psychiatrist/psychologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in percentage of patients with any 30-day adjusted prescription for other preventive migraine medications(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of migraine-related pain specialist office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of anxiety-related psychiatrist/psychologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause outpatient visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause neurologist office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause pain specialist office visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of all-cause psychiatrist/psychologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of migraine-related neurologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in number of depression-related psychiatrist/psychologist visits(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in the number of 30-day adjusted prescriptions for other preventive migraine medications(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)
  • Change in the number of prescriptions for acute migraine medications(From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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