Clinical and Economic Burden of Patients With Chronic Obstructive Pulmonary Disease in a Medicaid Population

Reports suggest that the Medicaid population includes a higher percentage of smokers than the general population. A high prevalence of smokers in a population is likely to lead to a higher burden of chronic obstructive pulmonary disease (COPD). Few studies have evaluated the economic burden of COPD in a Medicaid population. The objective of this observational, retrospective cohort study is to estimate the economic burden of COPD in subjects with a COPD diagnosis who are enrolled in Medicaid and are receiving maintenance treatment covered by Medicaid.

Specifically, the null hypothesis for the primary outcome measure is that no difference is observed in all-cause costs between subjects with and without COPD. The test hypothesis is that there is a difference in all-cause costs between subjects with and without COPD.

Secondary outcomes to be evaluated include all-cause resource use and COPD-related costs for the COPD cohort.

The study uses a medical and pharmacy administrative claims database called MarketScan Medicaid Database that contains the medical, surgical, and prescription drug experience of nearly 7 million Medicaid recipients. This analysis will use data from 8 states.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Subjects with COPD; Other: Subjects without COPD

• Study Type: Observational
• Enrollment (Actual): 40884

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medicaid recipients (aged >=40 years) diagnosed with COPD (International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9 CM) codes: 491.xx, 492.x, 496.xx) and newly initiated on Chronic Obstructive Pulmonary Disease (COPD) maintenance medication (maintenance therapies include ipratropium alone/combination ipratropium-albuterol (IPR), tiotropium (TIO), inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and combination product of inhaled corticosteroid and long-acting beta-agonist (ICS/LABA)) will be identified and matched in a 1 to 3 ratio to non-COPD Medicaid recipients on age (exact), gender, race, index year, Medicare dual eligibility, pre-index long-term care use. Index date was defined as the date of the first chronologically-occurring COPD maintenance medication during an identification period (01/01/2004 to 12/31/2006) for COPD patients, and as the date of the first medical or prescription claim during the index year of the corresponding matche

Description

Inclusion Criteria:

• at least 40 years of age at index date
• continuously eligible to receive healthcare services through Medicaid in the pre-index and follow-up period
• enrolled in fee-for-service plans
• without a diagnosis code of exclusionary comorbid conditions - cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, pulmonary tuberculosis (including fibrosis due to tuberculosis)

Exclusion Criteria:

• age less than 40 at index dates

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medicaid beneficiaries; Medicaid beneficiaries with at least one medical or pharmacy claim during each year in the identification period (2004-2006)	Other: Subjects with COPD; Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication; Other: Subjects without COPD; Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental costs of COPD	Mean difference in all-cause costs between subjects with and without COPD. Incremental total costs and components of incremental total costs including pharmacy, medical, and long-term care will be reported	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause resource use	The mean number of visits of each type of medical resource use including inpatient hospitalizations, emergency department [ED] visits, physician visits, outpatient visits, home healthcare visits/durable medical equipment, and long-term care visits.	1 year
COPD-related costs	Mean total, pharmacy, medical and long-term care costs associated with COPD in the cohort of subjects with a COPD diagnosis	1 year

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Estimate): June 25, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Resource utilization; Medicaid; Costs
• Additional Relevant MeSH Terms: Behavioral Symptoms; Respiratory Tract Diseases; Stress, Psychological; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Financial Stress
• Other Study ID Numbers: 113900