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1.  Rising Costs of COPD and the Potential for Maintenance Therapy to Slow the Trend 
Background
Chronic obstructive pulmonary disease (COPD) affects an estimated 14% of adults in the United States between the ages of 40 and 79 years. This progressive disease is characterized by persistent airflow limitation. The management of patients with COPD is focused on reducing risk factors, relieving symptoms, and preventing exacerbations.
Objective
To examine the peer-reviewed literature on the impact of maintenance therapy on the direct treatment costs of patients with COPD in the United States.
Methods
PubMed was searched for articles written in English that were published between 2000 and 2013, using the search terms “COPD,” “economics,” “exacerbation,” “maintenance,” and related terms. Articles reporting the results of longitudinal studies of the costs associated with the management of patients with COPD, the costs associated with hospitalizations for acute exacerbations of COPD, and randomized clinical trials evaluating the effects of maintenance therapy on the incidence of COPD exacerbations were included in this review.
Results
The search identified a total of 277 articles, and 11 of these articles were deemed appropriate for inclusion in this review. The direct healthcare costs for patients with COPD increased by 38% between 1987 and 2007, and continued to increase by approximately 5% annually between 2006 and 2009. The costs associated with hospital admissions for patients with COPD accounted for the largest absolute increase ($2289 per admission in constant 2007 US dollars). Recent estimates suggest that the aggregate costs associated with the treatment of acute exacerbations are between $3.2 billion and $3.8 billion, and that annual healthcare costs are 10-fold greater for patients with COPD associated with acute exacerbations than for patients with COPD but without exacerbations. The results of 2 large clinical trials of maintenance therapy, including a long-acting cholinergic antagonist or a long-acting beta-2 agonist, showed a 16% to 17% reduction in the incidence of exacerbations compared with placebo. Nevertheless, maintenance therapy remains underutilized, with only 30% to 35% of patients with COPD in private and public health insurance plans receiving prescriptions for maintenance therapy.
Conclusions
The treatment of acute exacerbations of COPD remains the major driver of increasing healthcare costs associated with this condition. The appropriate use of maintenance therapy has been shown to reduce the incidence of exacerbations and has the potential to reduce overall costs associated with the management of patients with COPD.
PMCID: PMC4049119  PMID: 24991394
2.  Probabilistic data linkage: a case study of comparative effectiveness in COPD 
Drugs in Context  2013;2013:212258.
Background:
In this era of comparative effectiveness research, new, advanced techniques are being investigated by the research community to overcome the limitations of existing data sources. We describe the approach of probabilistic data linkage as a means to address this critical issue.
Methods:
We employed a historical retrospective cohort design. Patients aged 40 and older with a principal or secondary diagnosis of COPD (ICD-9-CM codes 491.xx, 492.xx, and 496) and at least 3 years of continuous enrollment between January 1, 2004 and April 30, 2009 were selected from two US-based commercial administrative claims databases. The index date was designated as the date of the first claim (defined by a 12-month wash-out pre-index period) for the study drugs, for illustration purposes referred to as Treatment 1 or Treatment 2. The primary effectiveness measure was risk of any COPD-related exacerbation observed in the 12-month post-index period, with baseline characteristics being identified in the 12-month pre-index period.
Results:
The percentage of the study sample receiving Treatment 1 at index who had an exacerbation was 39.3% for Database A and 39.7% for Database B; for Treatment 2, the percentages were 46.3% and 47.1%, respectively. The event rate of hospitalizations in each database sample was nearly identical as were the odds ratio and corresponding confidence intervals from the adjusted logistic regression models (OR – Database A: 0.72, Database B: 0.74, Database A with imputed outcomes: 0.72).
Conclusions:
The probabilistic linkage demonstrated that patients from different databases matched on similar pre-index characteristics may demonstrate similar outcomes in the post-index period.
doi:10.7573/dic.212258
PMCID: PMC3884745  PMID: 24432045
data linkage; medical record linkage; comparative effectiveness research; treatment effectiveness; COPD; outcomes research; ambulatory care; prescription drugs
3.  Depression Following Thrombotic Cardiovascular Events in Elderly Medicare Beneficiaries: Risk of Morbidity and Mortality 
Purpose. Depression and antidepressant use may independently increase the risk of acute myocardial infarction and mortality in adults. However, no studies have looked at the effect of depression on a broader thrombotic event outcome, assessed antidepressant use, or evaluated elderly adults. Methods. A cohort of 7,051 community-dwelling elderly beneficiaries who experienced a thrombotic cardiovascular event (TCE) were pooled from the 1997 to 2002 Medicare Current Beneficiary Survey and followed for 12 months. Baseline characteristics, antidepressant utilization, and death were ascertained from the survey, while indexed TCE, recurrent TCE, and depression (within 6 months of indexed TCE) were taken from ICD-9 codes on Medicare claims. Time to death and first recurrent TCE were assessed using descriptive and multivariate statistics. Results. Of the elders with a depression claim, 71.6% had a recurrent TCE and 4.7% died within 12 months of their indexed TCE, compared to 67.6% and 3.9% of those elders without a depression claim. Of the antidepressant users, 72.6% experienced a recurrent TCE and 3.9% died, compared to 73.7% and 4.6% in the subset of selective serotonin reuptake inhibitor (SSRI) users. Depression was associated with a shorter time to death (P = .008) in the unadjusted analysis. However, all adjusted comparisons revealed no effect by depression, antidepressant use, or SSRI use. Conclusions. Depression was not associated with time to death or recurrent TCEs in this study. Antidepressant use, including measures of any antidepressant use and SSRI use, was not associated with shorter time to death or recurrent TCE.
doi:10.4061/2009/194528
PMCID: PMC2800999  PMID: 20069046
4.  Economic burden of chronic bronchitis in the United States: a retrospective case-control study 
Background
Chronic bronchitis (CB) is often misdiagnosed or diagnosed at a later stage of chronic obstructive pulmonary disease (COPD). We examined how this later diagnosis may impact health care costs and utilization during the 12 months prior to and 24 months post initial CB diagnosis.
Methods
This retrospective case-control analysis used claims data from a large US database from July 1, 2003 through June 30, 2007. Patients with CB aged 40 years and older were propensity matched (N = 11,674) to patients without evidence of COPD or asthma by demographics, CB diagnosis quarter/year, and comorbidities. Group differences were assessed using Student’s t-test and Pearson chi-square test statistics.
Results
Six months prediagnosis, CB patients had higher frequencies of any hospitalization (9.6%, 6.7%; P < 0.05), emergency department/urgent care visits (13.3%, 6.7%; P < 0.05), and prescriptions (97.3%, 94.1%; P < 0.05). Six months postdiagnosis, CB patients had 5.6 times more hospitalizations (P < 0.05) and 3.1 times more emergency department/urgent care visits (P < 0.05) compared with controls. Mean total costs (US$) for CB patients 12 months prediagnosis were significantly higher than controls (months 12–7: $4212, $3826; P < 0.05; months 6–1: $5289, $4285; P < 0.05). CB patients had higher mean total costs ($8919; P < 0.05) 6 months postdiagnosis. Costs remained $2429 higher for CB patients 19–24 months postdiagnosis (P < 0.05).
Conclusion
Health care costs and utilization among CB patients are increased both prior to diagnosis and during the 2 years postdiagnosis. This study suggests that not accurately diagnosing CB early has a substantial impact on health care costs, and that the economic burden for CB patients remains elevated even after adjustment for comorbidities associated with COPD.
doi:10.2147/COPD.S15882
PMCID: PMC3034282  PMID: 21311695
chronic bronchitis; burden; economic; chronic obstructive pulmonary disease
5.  Cost-effectiveness of combination fluticasone propionate–salmeterol 250/50 μg versus salmeterol in severe COPD patients 
Objective:
To estimate the cost-effectiveness of fluticasone propionate–salmeterol combination (FSC) compared to salmeterol for maintenance therapy in severe chronic obstructive pulmonary disease (COPD).
Study design:
Pooled economic analysis.
Methods:
We performed an economic analysis of pooled data from two randomized clinical trials (combined N = 1554) that evaluated the effect of maintenance therapy with FSC (250/50 μg twice daily) or salmeterol (50 μg twice daily) on exacerbation rates in patients with severe COPD. We calculated exacerbation rates and applied standardized costs to exacerbation-related health care utilization reported in the trials (office, urgent care, and emergency department visits; hospitalizations; and oral corticosteroids and antibiotics) to determine cost differences between FSC and salmeterol treatment outcomes.
Results:
Annual rates of any exacerbation and moderate/severe exacerbation were lower in the FSC group than the salmeterol group (4.91 vs 5.78 and 1.32 vs 2.00 respectively, both P < 0.05). Total adjusted annual COPD related exacerbation and therapeutic costs were $4,842 (95% CI; $4,731–$4,952) in the FSC group and $5,066 (95% CI; $4,937–$5,195) in the salmeterol group.
Conclusions:
FSC combination therapy is associated with reduced risk of any exacerbation and moderate/severe exacerbation, and incurs lower annual COPD-related health care costs compared to treatment with salmeterol. This analysis demonstrates that FSC therapy may be advantageous from both a clinical and cost-benefit standpoint for patients with severe COPD.
PMCID: PMC2921685  PMID: 20714371
COPD; cost-effectiveness analysis; economic; maintenance therapy
6.  Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims 
Purpose
This study was conducted to determine COPD severity at the time of diagnosis as confirmed by spirometry in patients treated in a US managed care setting.
Patients and methods
All patients with one or more inpatient stays, one or more emergency department visits, or two or more outpatient visits with diagnosis codes for COPD during 1994–2006 were identified from the Lovelace Patient Database. From this group, a subset of continuously enrolled patients with evidence in claims of a first available pulmonary function test or pulmonary clinic visit and a confirmatory claim for a COPD diagnosis was selected. Medical chart abstraction was undertaken for this subset to gather information for diagnosis and severity staging of each patient based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria for COPD.
Results
Of the 12,491 patients with a primary or secondary COPD diagnosis between 1994 and 2006, there were 1520 continuously enrolled patients who comprised the study cohort. Among the 648 eligible records from patients with evidence of a pulmonary function test, 366 were identified by spirometry as having COPD of GOLD stage I or higher (average percentage of predicted forced expiratory volume in 1 second: 60%): 19% were diagnosed at the stage of mild disease (GOLD stage I); 50% at moderate disease (GOLD stage II); and 31% at severe or very severe disease (GOLD stage III or IV, respectively). The majority of patients in these groups were not receiving maintenance treatment.
Conclusion
The results demonstrate a very low incidence of early-stage diagnosis, confirmed by a pulmonary function test, of COPD in a large US sample and support calls for increased screening for COPD and treatment upon diagnosis.
doi:10.2147/COPD.S16975
PMCID: PMC3224652  PMID: 22135490
lung function; Global Initiative for Chronic Obstructive Lung Disease (GOLD); detection; early treatment
7.  The Positive Predictive Value of a Hyperkalemia Diagnosis in Automated Health Care Data 
Pharmacoepidemiology and drug safety  2010;19(11):1204-1208.
Purpose
Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying 1) clinically-evident hyperkalemia and 2) serum potassium ≥ 6 mmol/liter.
Methods
This retrospective observational study included 8,722 patients with diabetes within an integrated healthcare system who newly-initiated an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or spironolactone. The primary outcome was first hyperkalemia-associated event (hospitalization, emergency department visit or death within 24 hours of coded diagnosis and/or potassium ≥ 6 mmol/liter) during the first year of therapy. Medical records were reviewed.
Results
Among a random sample of 99 patients not coded as having hyperkalemia, none had hyperkalemia upon record review. Among all 64 patients identified as having hyperkalemia, all had hospitalization or emergency department visit associated with coded diagnosis or elevated potassium. Of 55 with coded diagnosis, 42 (PPV 76%) had clinically-evident hyperkalemia; 32 (PPV 58%) had potassium ≥ 6. Of 9 identified using only potassium ≥ 6, 7 (PPV 78%) had clinically-evident hyperkalemia.
Conclusions
Nearly one-fourth of patients with coded diagnosis do not have clinically-evident hyperkalemia and nearly one-half do not have potassium ≥ 6. Because both false positives and negatives occur with coded diagnoses, medical record validation of hyperkalemia-associated outcomes is necessary.
doi:10.1002/pds.2030
PMCID: PMC2996391  PMID: 20878650
Hyperkalemia; positive predictive value; sensitivity; specificity; ACEi; ARB
8.  Wood Smoke Exposure and Gene Promoter Methylation Are Associated with Increased Risk for COPD in Smokers 
Rationale: Wood smoke–associated chronic obstructive pulmonary disease (COPD) is common in women in developing countries but has not been adequately described in developed countries.
Objectives: Our objective was to determine whether wood smoke exposure was a risk factor for COPD in a population of smokers in the United States and whether aberrant gene promoter methylation in sputum may modify this association.
Methods: For this cross-sectional study, 1,827 subjects were drawn from the Lovelace Smokers' Cohort, a predominantly female cohort of smokers. Wood smoke exposure was self-reported. Postbronchodilator spirometry was obtained, and COPD outcomes studied included percent predicted FEV1, airflow obstruction, and chronic bronchitis. Effect modification of wood smoke exposure with current cigarette smoke, ethnicity, sex, and promoter methylation of lung cancer-related genes in sputum on COPD outcomes were separately explored. Multivariable logistic and poisson regression models were used for binary and rate-based outcomes, respectively.
Measurements and Main Results: Self-reported wood smoke exposure was independently associated with a lower percent predicted FEV1 (point estimate [± SE] −0.03 ± 0.01) and a higher prevalence of airflow obstruction and chronic bronchitis (odds ratio, 1.96; 95% confidence interval, 1.52–2.52 and 1.64 (95% confidence interval, 1.31–2.06, respectively). These associations were stronger among current cigarette smokers, non-Hispanic whites, and men. Wood smoke exposure interacted in a multiplicative manner with aberrant promoter methylation of the p16 or GATA4 genes on lower percent predicted FEV1.
Conclusions: These studies identify a novel link between wood smoke exposure and gene promoter methylation that synergistically increases the risk for reduced lung function in cigarette smokers.
doi:10.1164/rccm.201002-0222OC
PMCID: PMC3001253  PMID: 20595226
wood smoke; cigarette smokers; airflow obstruction; gene promoter methylation in sputum DNA
9.  Diabetes and Drug-Associated Hyperkalemia: Effect of Potassium Monitoring 
BACKGROUND
Renin-angiotensin-aldosterone system (RAAS) inhibitors are associated with hyperkalemia, but there is little evidence demonstrating patients who receive potassium monitoring have a lower rate of hyperkalemia.
OBJECTIVE
To evaluate the association between potassium monitoring and serious hyperkalemia-associated adverse outcomes among patients with diabetes newly initiating RAAS inhibitor therapy.
DESIGN
Retrospective observational study.
PARTICIPANTS
Patients with diabetes without end-stage renal disease initiating RAAS inhibitor therapy between 2001 and 2006 at three integrated health care systems.
MEASUREMENTS
Potassium monitoring and first hyperkalemia-associated adverse event during the initial year of therapy. Hyperkalemia-associated adverse events included hospitalizations, emergency department visits or deaths within 24 h of hyperkalemia diagnosis and/or diagnostic potassium ≥6 mmol/l. Incidence rates were calculated in person-years (p-y). We used inverse probability propensity score weighting to adjust for differences between patients with and without monitoring; Poisson regression was used to obtain adjusted relative risks.
RESULTS
A total of 19,391 of 27,355 patients (71%) received potassium monitoring. Serious hyperkalemia-associated events occurred at an incidence rate of 10.2 per 1,000 p-y. Compared to patients without monitoring, adjusted relative risk of hyperkalemia-associated adverse events among all patients with monitoring was 0.50 (0.37, 0.66); in the subset of patients who also had chronic kidney disease (n = 2,176), adjusted relative risk was 0.29 (0.18, 0.46).
CONCLUSIONS
Patients prescribed RAAS inhibitors who have both diabetes and chronic kidney disease and receive potassium monitoring are less likely to experience a serious hyperkalemia-associated adverse event compared to similar patients who did not receive potassium monitoring. This evidence supports existing consensus-based guidelines.
doi:10.1007/s11606-009-1228-x
PMCID: PMC2842549  PMID: 20087674
hyperkalemia; hyperpotassemia; angiotensin-converting enzyme inhibitor; ACEi; angiotensin receptor blocker; ARB; spironolactone; RAAS inhibitor
10.  Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease 
Purpose
Relative costs and utilization-related outcomes of a fluticasone propionate 250 μg + salmeterol 50 μg combination (FSC), tiotropium bromide, and ipratropium as initial maintenance therapy in COPD have not been compared in a commercially-insured population.
Methods
This retrospective, observational cohort study used health care claims data from January 2004 to June 2009 from a large administrative database for patients aged ≥40 years with COPD. Time-to-first COPD-related health care event beginning 30 days following therapy initiation with FSC (n = 16,684), ipratropium alone or in fixed dose combination with albuterol (n = 14,449), or tiotropium (n = 12,659) was estimated using Cox proportional hazard models that controlled for differences in patient demographic characteristics, health care utilization, and comorbidities at baseline. Mean adjusted costs and numbers of COPD-related health care encounters and prescription medication fills were compared among patients with 12 months of follow-up (FSC, n = 12,595; ipratropium, n = 10,617; tiotropium, n = 9126).
Results
With FSC as the reference, risk for a COPD-related hospitalization and/or emergency department visit was significantly higher for ipratropium (hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.50–1.79) and tiotropium (HR 1.29, CI 1.17–1.41). Mean adjusted 12-month COPD-related total health care costs were lower for FSC ($2068, standard deviation [SD] $1190) than for ipratropium ($2841, SD $1858) and tiotropium ($2408, SD $1511, both P <0.05). Mean number of COPD-related hospitalizations, emergency department visits, and outpatient visits associated with an oral corticosteroid or antibiotic were also lower for FSC than for ipratropium and tiotropium (all P <0.05).
Conclusions
In this retrospective “real-world” observational sample of COPD patients, initiating treatment with FSC was associated with significantly better clinical and economic outcomes compared with short- and long-acting anticholinergic therapy. Consistent with the goal of preventing and reducing exacerbations advocated by global guidelines, the findings suggest that initiation of maintenance treatment with FSC may afford clinical benefits at a lower cost than anticholinergic treatment.
doi:10.2147/COPD.S15455
PMCID: PMC3034283  PMID: 21311689
chronic obstructive pulmonary disease; Advair®; tiotropium; ipratropium; utilization; costs
11.  Drug Use Patterns in Severely Mentally Ill Medicare Beneficiaries: Impact of Discontinuities in Drug Coverage 
Health Services Research  2008;43(2):496-514.
Objective
To describe the extent of drug coverage among severely mentally ill Medicare beneficiaries and to determine whether and to what extent discontinuities in prescription drug coverage influence the use of medications used to treat serious mental health conditions.
Data Source
1997–2001 Medicare Current Beneficiary Surveys.
Study Design
We use a zero-inflated negative binomial model to estimate: (1) the probability of not receiving any mental health drug and (2) the number of medications received, adjusting for age, race, income, census region, health status, and comorbidity. Severe mental illness is defined using inpatient and outpatient claims with ICD-9 codes of schizophrenia, other psychotic disorders, bipolar disorders, and major depression. Mental health medications include antidepressants, antipsychotics, mood stabilizers, anxiolytic/sedative-hypnotics, and stimulants. Prescription drug coverage is assessed as full coverage (0 percent discontinuities), no coverage (100 percent discontinuities), or as discontinuous coverage, measured as 1–25, 26–50, and 51–99 percent of time without coverage.
Data Collection/Extraction Methods
We constructed three 3-year longitudinal cohorts of severely mentally ill Medicare beneficiaries residing in the community (n = 901).
Principal Findings
Severely mentally ill Medicare beneficiaries with drug coverage discontinuities are more likely than their continuously insured peers not to receive medications used to treat mental health disorders, with the most significant impact seen in the probability of receiving any psychiatric medications. Analysis of two therapeutic classes—antidepressants and antipsychotics—revealed varying impacts of drug gaps on both probability of any drug use, as well as number of medications received among users.
Conclusions
Severely mentally ill Medicare beneficiaries may be particularly vulnerable to the Medicare Part D drug benefit design and, as such, warrant close evaluation and monitoring to insure adequate access to and utilization of medications used to manage mental illness.
doi:10.1111/j.1475-6773.2007.00779.x
PMCID: PMC2442367  PMID: 18370965
Drug coverage; mental health; prescription drugs; Medicare; access
12.  Cost and utilization of blood transfusion associated with spinal surgeries in the United States 
European Spine Journal  2006;16(3):353-363.
The purpose of this study was to examine factors associated with the utilization and cost of blood transfusion during and post-spinal fusion surgery. A retrospective, observational study of 42,029 inpatients undergoing spinal fusion surgery in United States hospitals participating in the PerspectiveTM Comparative Database for inpatient use was conducted. Descriptive analysis, logistic regression, and ordinary least squares (OLS) regression were used to describe the factors associated with the use and cost of allogeneic blood transfusion (ABT). Hospitalization costs were $18,690 (SD=14,159) per patient, erythropoietin costs were $85.25 (SD=3,691.66) per patient, and topical sealant costs were $414.34 (SD=1,020.06) per patient. Sub-analysis of ABT restricted to users revealed ABT costs ranged from $312.24 (SD=543.35) per patient with whole blood to $2,520 (SD=3,033.49) per patient with fresh frozen plasma. Patients that received hypotensive anesthesia (OR,1.61; 95% CI, 1.47–1.77), a volume expander (OR,1.95; 95% CI, 1.75–2.18), autologous blood (OR, 2.04; 95% CI, 1.71–2.42), or an erythropoietic agent (OR=1.64; 95% CI, 1.27–2.12) had a higher risk of ABT. Patients that received cell salvage had a lower risk of transfusion (OR=0.40; 95% CI, 0.32–0.50). Most blood avoidance techniques have low utilization or do not reduce the burden of transfusion associated with spinal fusion.
doi:10.1007/s00586-006-0066-3
PMCID: PMC2200697  PMID: 16463198
Spinal fusion surgery; Burden of illness; Blood transfusion; Cost

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