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The American Journal of Managed Care March 2011
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Joan C. Lo, MD; Alice R. Pressman, MS, PhD; Malini Chandra, MS; and Bruce Ettinger, MD
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Osnat C. Melamed, MD, MSc; Gilad Horowitz, MD; Asher Elhayany, MD; and Shlomo Vinker, MD
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COPD-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenanc
Anand A. Dalal, PhD, MBA; Manan Shah, PhD; Anna O. D'Souza, PhD; and Douglas W. Mapel, MD

COPD-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenanc

Anand A. Dalal, PhD, MBA; Manan Shah, PhD; Anna O. D'Souza, PhD; and Douglas W. Mapel, MD
Initiation of fluticasone propionate–salmeterol after a COPD-related hospitalization or ED visit decreased the risk of a recurrent event and reduced COPD-related medical costs.

Objectives: To quantify healthcare use and costs associated with chronic obstructive pulmonary disease (COPD) among patients discharged from a COPD-related hospitalization or emergency department (ED) visit on a regimen of fluticasone propionate–salmeterol combination versus other inhaled maintenance therapies.

 


Study Design: Retrospective cohort study.

 

Methods: Managed care enrollees with an index hospitalization (with a primary or secondary [ie, in the second position] diagnosis of COPD) or ED visit (with a primary diagnosis of COPD) were identified for placement into study cohorts during a 60-day period following the index date. Time to COPD-related events and healthcare costswere compared during up to 1 year of follow-up between the 2 cohorts.

 

Results: The sample comprised 5677 patients (1291 in the fluticasone propionate–salmeterol cohort and 4386 in the other maintenance therapies cohort). The adjusted rate of COPD-related hospitalizations or ED visits was 35% lower in the fluticasone propionate–salmeterol cohort (P <.05). Adjusted COPD-related total (medical plus   pharmacy) costs were lower in the fluticasone propionate–salmeterol cohort ($240 vs $279 per patient per month, P <.05), mostly because of lower medical costs ($113 vs $160 per patient per month, P <.05). Pharmacy costs did not differ between fluticasone propionate–salmeterol and other maintenance therapies. Results were similar in the subset of patients 65 years or older.

 

Conclusions: Initiation of fluticasone propionate– salmeterol after discharge from a COPD-related hospitalization or ED visit significantly reduced the risk of a recurrent event during the ensuing months and decreased COPD-related medical costs, without an increase in COPD-related pharmacycosts, in a real-world setting.

(Am J Manag Care. 2011;17(3):e55-e65)

The occurrence of an exacerbation of chronic obstructive pulmonary disease (COPD) increases the risk of subsequent exacerbations.

 

  • Risk of rehospitalization for a recurrent exacerbation is particularly high during the months after an initial exacerbation-related hospitalization.

 

  • Compared with other maintenance therapies, initiation of fluticasone propionate–salmeterol after discharge from a COPD-related hospitalization or emergency department (ED) visit significantly reduced the risk of a COPD-related return to the hospital or ED during the ensuing months and decreased COPD-related medical costs, without an increase in COPD-related pharmacy costs, in a real-world setting.
The fourth leading cause of death (after coronary artery disease, cancer, and stroke), chronic obstructive pulmonary disease (COPD) affects approximately 12 million adults  in the United States, where COPD accounts for approximately 1.5 million emergency department (ED) visits, 726,000 hospitalizations, and 119,000 deaths annually and an estimated $32 billion in direct and indirect costs.1,2 The personal and economic effects of COPD in developed countries derive primarily from acute exacerbations, which  cause significant morbidity and mortality and are associated with poor prognosis.3-9 Because acute exacerbations of COPD often require intensive care, inpatient costs of COPD are particularly high. For example, per capita expenditures for hospitalization of patients with COPD exceed those for patients without COPD by almost 3-fold.10

Given the large human and economic tolls of acute exacerbations of COPD, prevention and treatment of acute exacerbations are primary goals of therapy.8,11,12 Of several categories of maintenance therapy available for the management of COPD, combination inhaled corticosteroid–long-acting beta-agonist (LABA) treatment has recently emerged as offering significant promise in the control of acute exacerbations. Combination inhaled corticosteroid–LABA therapy in a single inhaler was found in Cochrane reviews of randomized controlled clinical trials to be more effective than placebo,13 LABAs,14 and inhaled corticosteroids15 at reducing the rate of exacerbations of COPD. In the Towards a Revolution in COPD Health (TORCH) study, a landmark trial included in the Cochrane reviews, the inhaled corticosteroid–LABA combination fluticasone propionate–salmeterol significantly reduced the annual rate of exacerbations by 25% versus placebo over a 3-year period and was associated with a 17.5% reduction in the risk of death (P = .05 vs placebo).16 All-cause mortality rates were 12.6% in the fluticasone propionate– salmeterol group, 15.2% in the placebo group, 13.5% in the salmeterol group, and 16.0% in the fluticasone group. It has been suggested that LABAs may increase the effectiveness of inhaled corticosteroids by amplifying their anti-inflammatory effects.17

The efficacy of combination inhaled corticosteroid–LABA therapy at reducing exacerbations seems to translate to less healthcare resource use and lower total costs (medical plus pharmacy) compared with component monotherapies or other classes of COPD maintenance therapy.18-26 In a retrospective analysis, combination inhaled corticosteroid–LABA therapy was associated with a lower risk of rehospitalization within 1 year of an index COPD-related hospitalization than treatment with LABAs only, inhaled corticosteroids only, or short-acting beta-agonists (SABAs) only.20 Furthermore, in observational studies19,21-24,26 using medical and pharmacy claims, combination inhaled corticosteroid–LABA therapy, particularly fluticasone propionate–salmeterol, was associated with a significantly lower risk of COPD-related  hospitalizations and with lower healthcare costs compared with the use of anticholinergic bronchodilators in various populations of patients with COPD. Cost-benefit fluticasone propionate–salmeterol data have also been reported from controlled clinical trials. For example, the estimated cost per quality-adjusted life-year reflected greater cost-effectiveness of fluticasone propionate–salmeterol than either component monotherapy alone in an analysis of data from the TORCH trial.25

Current guidelines recommend that patients with COPD who have exacerbations should be started on regular treatment with an inhaled medication proven to reduce the risk of exacerbations.2 What is unknown is whether starting with a combined therapy, such as fluticasone propionate–salmeterol, has advantages over monotherapies, such as tiotropium bromide, LABAs, ipratropium bromide, and inhaled corticosteroids. Furthermore, while health outcomes and costs with fluticasone propionate–salmeterol vs other maintenance therapies have been thoroughly elucidated, the effect of fluticasone propionate–salmeterol therapy vis-à-vis other classes of maintenance therapy (besides its monotherapy components) on health outcomes and costs has not been systematically studied during the months immediately after an exacerbation. The occurrence of a COPD exacerbation increases the risk of subsequent exacerbations, and the risk of rehospitalization for a recurrent exacerbation is particularly high during the months after an initial exacerbation-related hospitalization.7-9 In a prospective study8 of 129 patients hospitalized for an acute exacerbation of COPD, 58.5% were readmitted to the hospital over the ensuing year. The study reported herein was conducted to quantify healthcare utilization and costs attributed to COPD after discharge from a COPD-related hospitalization or ED visit on a regimen of fluticasone propionate–salmeterol combination versus other maintenance therapies.

METHODS

This observational retrospective cohort study was conducted to compare postdischarge COPD-related healthcare use and costs among patients discharged from a COPD-related hospitalization or ED visit on a regimen of fluticasone propionate–salmeterol combination versus other inhaled maintenance therapies. Figure 1 shows the study design.

Data Source

Data were obtained from the IMS LifeLink Health Plans Claims Database,27 an integrated source of fully adjudicated managed care claims containing data from more than 90 managed healthcare plans covering over 60 million lives across the United States. Data available for each patient include inpatient and outpatient diagnoses (by International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code) and procedures (in Current Procedural Terminology, Version 4 and Health Care Financing Administration Common Procedural Coding System formats), as well as retail and mail-order prescription records, which include the National Drug Code and the quantity dispensed. Charged, allowed, and paid amounts are available for all services rendered, as are dates of service for all claims. Additional data elements include demographic variables (age, sex, and geographic region), payer type (ie, private [such as health maintenance organization or preferred provider organization] or public [such as Medicaid]), provider specialty, and start and stop dates for plan enrollment. The data are fully deidentified and are compliant with the Health Insurance  Portability and Accountability Act of 1996.

Study Sample

The target population was managed care enrollees who had an index event of at least 1 hospitalization with a primary or secondary [ie, in the second position] diagnosis of COPD or at least 1 ED visit with a primary diagnosis of COPD between January 1, 2003, and July 31, 2008 (the study period) and who initiated fluticasone propionate–salmeterol combination at 250/50 mcg or other maintenance therapies (ie, inhaled corticosteroids, LABAs, tiotropium, or ipratropium alone or in combination with albuterol) during the treatment assessment period (ie, within 60 days after the date of discharge from the index event). The index date was defined as the date of discharge from the index event. To be eligible for analysis, patients had to be at least 40 years old and have continuous eligibility during the preindex period (defined as the 1-year period before the admission date of the index event), the treatment assessment period, and the follow-up period (a maximum of 1 year after the end of the treatment assessment period). Patients were excluded from the sample who during the preindex, treatment assessment, or follow-up periods had any of the following comorbid conditions: respiratory tract cancer, cystic fibrosis, fibrosis from tuberculosis, bronchiectasis, pneumonoconiosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis. Patients were also excluded if during the treatment assessment period they used or switched to other maintenance therapies different from the one that they initiated. For example, if patients started a tiotropium regimen but then switched or added fluticasone propionate–salmeterol, they were excluded from the study. Finally, patients were excluded if they had a hospitalization, COPD-related ED visit during the treatment assessment period, or physician visit with a prescription for an oral corticosteroid or antibiotic within 3 days of the visit during the treatment assessment period.

Outcomes

Outcomes of interest were compared between the following cohorts, defined by the maintenance therapies initiated during the treatment assessment period: the  fluticasone propionate–salmeterol combination cohort (which initiated fluticasone propionate–salmeterol) and the other maintenance therapies cohort (which initiated inhaled corticosteroids, LABAs, tiotropium, or ipratropium). Outcomes of interest were COPD-related events (defined as hospitalizations, COPDrelated ED visits, or physician visits with a prescription for an oral corticosteroid or antibiotic within 3 days of the visit) and COPD-related total (medical plus pharmacy), medical, and pharmacy costs. Emergency department visits, physician visits, and hospitalizations were assumed to be COPD related if the claim included a primary diagnosis of COPD (discharge diagnosis of COPD for hospitalizations).

For COPD-related events, time to event (defined as the number of days between the start of the follow-up period and the date of the first COPD-related event) was computed. The COPD-related medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. The COPD-related pharmacy costs  were computed from the paid amounts of COPD-related prescription medications (including anticholinergics, SABAs, LABAs, inhaled corticosteroids, combination inhaled corticosteroids–LABAs, methylxanthines, oral corticosteroids, and antibiotics for respiratory tract infections), identified using the National Drug Code.

Study outcomes were assessed during a follow-up period of variable duration. The follow-up period was defined as the period from the index date to the first date of any of the following events: the end of the study period, the end of continuous eligibility in the health plan, the end of the follow-up period (which lasted a maximum of 1 year), a switch to any study medication different from the medication dispensed during the treatment assessment period, more than a 60-day gap between the end of days’ supply  of the preceding prescription and the fill date of the next consecutive prescription, or a COPD-related hospitalization or ED visit, or physician visit with a prescription for an  oral corticosteroid or antibiotic within 3 days of the visit. To accurately capture resource use attributable to both cohorts, costs were assessed during the entire length of variable follow-up and were not censored with a COPD-related event. Costs were computedon a per-month basis because of interpatient differences in the length of follow-up and were standardized to 2008 US dollars using the medical component of the consumer price index.

 
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