Clinical trial NCT05177406: Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data
Official title: Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Migraine,
Erenumab,
Aimovig
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 1839
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included the Aimovig migraine patients

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Change in migraine-related medical and prescription costs
timeFrame: 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
Secondary outcomes:
measure: Change in all-cause costs
timeFrame: 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
measure: Change in percentage of patients with all-cause hospitalizations or ER visits
timeFrame: 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
measure: Change in percentage of patients with migraine-related hospitalizations or ER visits
timeFrame: 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
measure: Change in percentage of patients with all-cause outpatient visits
timeFrame: 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
measure: Change in percentage of patients with migraine-related outpatient visits
timeFrame: 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
measure: Change in percentage of patients with all-cause provider-office visits
timeFrame: 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
measure: Change in percentage of patients with migraine-related provider-office visits
timeFrame: 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
measure: Change in percentage of patients with all-cause neurologist office visits
timeFrame: 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
measure: Change in percentage of patients with migraine-related neurologist visits
timeFrame: 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
measure: Change in percentage of patients with all-cause pain specialist office visits
timeFrame: 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
measure: Change in percentage of patients with migraine-related pain specialist office visits
timeFrame: 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
measure: Change in percentage of patients with all-cause physical therapy visits
timeFrame: 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
measure: Change in percentage of patients with migraine-related physical therapy visits
timeFrame: 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
measure: Change in percentage of patients with all-cause psychiatrist/psychologist visits
timeFrame: 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
measure: Change in percentage of patients with anxiety-related psychiatrist/psychologist visits
timeFrame: 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
measure: Change in percentage of patients with depression-related psychiatrist/psychologist visits
timeFrame: 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
measure: Change in percentage of patients with any 30-day adjusted prescription for other preventive migraine medications
timeFrame: 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
measure: Change in percentage of patients with any prescriptions for acute migraine medications
timeFrame: 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
measure: Change in number of all-cause hospitalizations or ER visits
timeFrame: 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
measure: Change in number of migraine-related hospitalizations or ER visits
timeFrame: 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
measure: Change in number of all-cause outpatient visits
timeFrame: 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
measure: Change in number of migraine-related outpatient visits
timeFrame: 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
measure: Change in number of all-cause provider-office visits
timeFrame: 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
measure: Change in number of migraine-related provider-office visits
timeFrame: 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
measure: Change in number of all-cause neurologist office visits
timeFrame: 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
measure: Change in number of migraine-related neurologist visits
timeFrame: 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
measure: Change in number of all-cause pain specialist office visits
timeFrame: 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
measure: Change in number of migraine-related pain specialist office visits
timeFrame: 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
measure: Change in number of all-cause physical therapy visits
timeFrame: 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
measure: Change in number of migraine-related physical therapy visits
timeFrame: 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
measure: Change in number of all-cause psychiatrist/psychologist visits
timeFrame: 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
measure: Change in number of anxiety-related psychiatrist/psychologist visits
timeFrame: 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
measure: Change in number of depression-related psychiatrist/psychologist visits
timeFrame: 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
measure: Change in the number of 30-day adjusted prescriptions for other preventive migraine medications
timeFrame: 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
measure: Change in the number of prescriptions for acute migraine medications
timeFrame: 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
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: