Migraine
Conditions
Keywords
Migraine,, Erenumab,, Aimovig
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.
Interventions
OTHERAimovig
patients newly initiating Aimovig therapy
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in migraine-related medical and prescription 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
Countries
United States
Outcome results
None listed