XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States

Novartis Pharmaceuticals16,246 enrolled

Overview

A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months

This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders. For this study, any persons from the Marketscan database with an asthma diagnosis and \>= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab. Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases.

Study Type

OBSERVATIONAL

Enrollment

16,246

Conditions

Asthma

Interventions

OmalizumabDRUG

Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. "Responders" were defined as individuals with at least 4 administrations of omalizumab.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion criteria: We used all eligible Marketscan beneficiaries with an asthma diagnosis and omalizumab use between 07/07/2016 - 12/31/2018 (index period). Continuous enrollment in the Marketscan database was required to ensure the availability of claims data to capture study outcomes and covariates. * Omalizumab cohort was defined as ≥1 prescription claims within the index period, with the date of first dispensing deemed the index date. * Asthma was defined by ≥1 diagnosis code in any available diagnosis field on or prior to index date. ICD-9-CM: 493.xx OR ICD-10-CM: J45.x * 6-11 years of age at the time of index * ≥12-months pre-index and ≥12-months post-index continuous eligibility in medical and pharmacy benefits * Enrollment gap of ≤30 days will be considered continuous enrollment Exclusion criteria: Patients were excluded from the study if they had one or more of the following: * Bronchial Thermoplasty at any time during data capture. Current Procedural Terminology (CPT): 31660, 31661 * Prior asthma-indicated biologic use during the 12 months pre or post-index Omalizumab: NDC: 50242004062; 50242004201 or HCPCS: J2357; S0107; C9217 Mepolizumab: NDC: 00173088101, 00173088185 or HCPCS: J2182 Reslizumab: NDC: 5931061031 or HCPCS: J2786 Benralizumab: NDC: 0310173030 or HCPCS: C9466 Dupilumab: NDC: 0024591400 or 0024591800

Locations (1)

Novartis Investigational Site

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation

Uncontrolled asthma was based on either impairment or risk criteria in a 12- month consecutive period. * Impairment was identified as ≥6 Short-acting Beta Agonist (SABA) prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. * Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. * The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria) or the first exacerbation outcome during a consecutive 12-months (risk criteria).

Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

Proportion of patients with excessive SABA use (≥6 SABA prescriptions dispensed in 12 months) (impairment criteria)

Proportion of patients with uncontrolled asthma (impairment criteria) were reported. Impairment was identified as ≥6 SABA prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. \- The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria).

Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

Proportion of patients with exacerbations requiring IP visits (risk criteria)

Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. \- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).

Data from ClinicalTrials.gov

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