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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177406
• Other study ID #: CAMG334A2029
• Status: Completed
• Start date: August 31, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1839
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Aimovig
patients newly initiating Aimovig therapy

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in migraine-related medical and prescription costs	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	Change in all-cause costs	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
Secondary	Change in percentage of patients with all-cause hospitalizations or ER visits	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
Secondary	Change in percentage of patients with migraine-related hospitalizations or ER visits	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
Secondary	Change in percentage of patients with all-cause outpatient visits	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
Secondary	Change in percentage of patients with migraine-related outpatient visits	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
Secondary	Change in percentage of patients with all-cause provider-office visits	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
Secondary	Change in percentage of patients with migraine-related provider-office visits	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
Secondary	Change in percentage of patients with all-cause neurologist office visits	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
Secondary	Change in percentage of patients with migraine-related neurologist visits	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
Secondary	Change in percentage of patients with all-cause pain specialist office visits	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
Secondary	Change in percentage of patients with migraine-related pain specialist office visits	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
Secondary	Change in percentage of patients with all-cause physical therapy visits	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
Secondary	Change in percentage of patients with migraine-related physical therapy visits	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
Secondary	Change in percentage of patients with all-cause psychiatrist/psychologist visits	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
Secondary	Change in percentage of patients with anxiety-related psychiatrist/psychologist visits	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
Secondary	Change in percentage of patients with depression-related psychiatrist/psychologist visits	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
Secondary	Change in percentage of patients with any 30-day adjusted prescription for other preventive migraine medications	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
Secondary	Change in percentage of patients with any prescriptions for acute migraine medications	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
Secondary	Change in number of all-cause hospitalizations or ER visits	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
Secondary	Change in number of migraine-related hospitalizations or ER visits	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
Secondary	Change in number of all-cause outpatient visits	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
Secondary	Change in number of migraine-related outpatient visits	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
Secondary	Change in number of all-cause provider-office visits	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
Secondary	Change in number of migraine-related provider-office visits	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
Secondary	Change in number of all-cause neurologist office visits	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
Secondary	Change in number of migraine-related neurologist visits	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
Secondary	Change in number of all-cause pain specialist office visits	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
Secondary	Change in number of migraine-related pain specialist office visits	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
Secondary	Change in number of all-cause physical therapy visits	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
Secondary	Change in number of migraine-related physical therapy visits	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
Secondary	Change in number of all-cause psychiatrist/psychologist visits	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
Secondary	Change in number of anxiety-related psychiatrist/psychologist visits	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
Secondary	Change in number of depression-related psychiatrist/psychologist visits	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
Secondary	Change in the number of 30-day adjusted prescriptions for other preventive migraine medications	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
Secondary	Change in the number of prescriptions for acute migraine medications	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