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

December 15, 2021 updated by: Novartis Pharmaceuticals
The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1839

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936-1080
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study included the Aimovig migraine patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Full cohort
patients newly initiating Aimovig therapy
Other: Aimovig
patients newly initiating Aimovig therapy
Other Names:
  • Erenumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in migraine-related medical and prescription costs
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in all-cause costs
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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 pain specialist office visits
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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 preventive migraine medications included anticonvulsants, antidepressants, Botox, beta blockers, calcium channel blockers, renin-angiotensin system antagonists. The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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
Time Frame: 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
Acute migraine medications included ergots, prescription NSAIDs, opioids, and triptans. The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMG334A2029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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