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Pharmacoeconomic Evaluation of Acute Exacerbations of Chronic Bronchitis and COPD^*

^* From the Center Servei de Pneumologia (Drs. Miravitlles and Murio), Hospital General Universitari Vall d’Hebron, Barcelona; Pharma Research (Ms. Guerrero), Division of Pharma Consult Services S. A., Barcelona; and SOIKOS S. L. (Dr. Gisbert), Barcelona, Spain.

Correspondence to: Marc Miravitlles, MD, Rocafort 173-177, 3-1a, 08015 Barcelona, Spain; e-mail: marcm{at}separ.es

	Abstract

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Background: Although exacerbations are the main cause of medical visits and hospitalizations of patients with chronic bronchitis and COPD, little information is available on the costs of their management.

Objective: This study attempted to determine the total direct costs derived from the management of exacerbations of chronic bronchitis and COPD in an ambulatory setting.

Method: A total of 2,414 patients with exacerbated chronic bronchitis and COPD were recruited from 268 general practices located throughout Spain. Patients were followed up for 1 month.

Results: A total of 507 patients (21%) relapsed; of these, 161 patients (31.7%) required attention in emergency departments and 84 patients (16.5%) were admitted to the hospital. The total direct mean cost of all exacerbations was $159; patients who were hospitalized generated 58% of the total cost. Cost per failure was $477.50, and failures were responsible for an added mean cost of $100.30/exacerbation. Exacerbations of the 1,130 patients with COPD had a mean cost of $141. Sensitivity analysis showed that a 50% reduction in the failure rate (from 21 to 10.5%) would result in a total cost of exacerbation of $107 (33% reduction).

Conclusion: Exacerbations of chronic bronchitis and COPD are costly, but the greatest part of costs derives from therapeutic failures, particularly those that end in hospitalization.

Key Words: chronic bronchitis • COPD • cost • exacerbation • failure • pharmacoeconomics • primary care • treatment

	Introduction

TOP Abstract Introduction Materials and Methods Results Discussion References

 
It is estimated that > 15 million persons in the United States have COPD and > 12 million have chronic bronchitis.¹ Furthermore, the number of individuals affected has grown in recent decades.² In Spain, the prevalence of COPD is 9% in adults between 40 years and 70 years of age,^{3 4} although only 22% of cases are diagnosed.⁴

The economic impact of COPD in 1993 was estimated to be > $15.5 billion in the United States, with $6.1 billion for hospitalization.⁵ Patients with COPD have a mean of two exacerbations per year,⁶ and exacerbations are the main cause of medical visits and hospitalizations.⁷ The median cost of hospital stay due to exacerbated COPD in the United States was estimated⁷ through the analysis of a prospective cohort of 1,016 patients to be $7,100. However, there is little information relating to the costs of ambulatory management of acute exacerbations of chronic bronchitis (AECB) and acute exacerbations of COPD.

A study⁸ demonstrated that hospitalization costs represent 40.4% of total health-care costs for patients with mild COPD, and 62.6% of total costs for patients with severe COPD. However, no estimation of costs derived from the management of acute exacerbations was given. The appropriate treatment of acute exacerbations is crucial, since the relapse rate in observational studies is unexpectedly high, ranging from 15 to 25%.^{9 10 11 12} Strategies designed to reduce the relapse rate (treatment with a short course of oral steroids¹³ and appropriate antibiotic choice¹² ) may lead to decreased morbidity and mortality and reduced economic burden of the disease. The aims of this study were to determine the total costs derived from the management of AECB and acute exacerbations of COPD, and to estimate the cost associated with relapse.

	Materials and Methods

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Study Design
This was a prospective study on ambulatory patients with exacerbated chronic bronchitis in a primary care setting. The study was conducted between December 1, 1996, and April 30, 1997, in 268 general practices located throughout Spain and selected by regionally stratified sampling. Patients with a diagnosis of COPD, emphysema, and/or chronic bronchitis as defined by the American Thoracic Society were eligible for inclusion.¹ Information was sought on the first 10 unselected consecutive adults (> 40 years old) seen for an acute exacerbation of their respiratory disease. A more detailed description of the study has been provided elsewhere.¹⁴

Diagnosis of acute exacerbation was based on the presence of any combination of the following symptoms: increased dyspnea and increased production and purulence of sputum that led to a change or increase in treatment. Exclusion criteria included diagnosed cystic fibrosis, asthma, or severe bronchiectasis. Evidence of pneumonia either at presentation or during follow-up was also considered an exclusion criterion.

All information relevant to the study was collected by general practitioners (GPs) at the time of the patient’s medical visit. Patients were characterized as much as possible; although spirometry is not readily available in primary care in Spain,¹⁴ as in many other countries,^{15 16} spirometric data could be collected from a significant sample of patients. Eligible subjects had a maximum ratio of FEV₁/FVC < 0.7 and a maximum FEV₁ 80% of predicted. Since chronic bronchitis is defined on clinical grounds, patients without spirometric values but with criteria of chronic bronchitis were included in the study. However, comparison of demographic, clinical, and AECB evolution variables between patients with pulmonary function tests (PFTs) [demonstrated COPD cases] and patients without PFTs was performed to test the hypothesis that both groups had similar characteristics. Thus, for the purpose of the study (evaluation of costs of AECB), all patients were studied together.

Since this was an observational study aimed at identifying current practice and real failure rates and costs associated with usual medical care and not under experimental conditions, treatment of the exacerbation was left to the criteria of the attending physician. Patients were rescheduled to see their GP 1 month after the first visit in all cases, or as requested in cases of persistence of or increase in symptoms.

Cost Analysis
Costs in this analysis were identified for drugs, oxygen therapy, outpatient visits, emergency department visits, and hospitalizations. Costs of laboratory tests, diagnostic tests, and procedures were included in the costs of emergency department visits and hospitalizations. None of these latter tests were performed on an ambulatory basis; therefore, patients not requiring an emergency department visit or hospitalization did not generate costs derived from such tests.

Expenditures were calculated in US dollars (exchange rate at the time of the study, 140 Spanish pesetas per dollar). Acquisition costs of pulmonary drug therapy were based on the official registered price.¹⁷ Average wholesale prices were based on the actual product and treatment regimen used. Pulmonary drugs included short-acting and long-acting ß-agonists, ipratropium, theophylline, inhaled and oral steroids, and antibiotics. Initial drug treatment was defined as pulmonary drug therapy used regularly prior to the medical visit for the AECB. Add-on drug therapy was defined as pulmonary drug therapy added during the AECB. Continuous oxygen therapy cost was estimated to be $4.28/d.

Costs per outpatient visit, emergency department visit, and hospitalization were estimated using data from the SOIKOS health database (unpublished data). This database is compiled from > 350 different sources of published data on costs of health resources in Spain, including official statistics. The method used for obtaining the cost per resource began with a search for the different published costs for the given resource, which were then updated to 1997 prices, and finally the mean value of all prices was calculated. The cost per outpatient visit was considered to be in primary care, and the hospitalization in a pneumology department with a mean stay duration of 8 days, according to some published data.^{18 19} The calculated costs were as follows: clinic visit, $7.50; emergency department visit, $103.57; and hospitalization, $2,652.62. The cost of the scheduled follow-up visit was not included in the analysis, since this visit was required by the protocol.

The cost of treatment failure was calculated by adding the costs derived from the health resources used by all patients who had treatment failure, divided by the total number of treatment failures, according to the following formula:

where Cv = cost of extra outpatient visit, Ce = cost of emergency department visit, Ch = cost of hospitalization, nv = No. of extra medical visits, ne = No. of emergency department visits, nh = No. of hospitalizations, and nf = No. of treatment failures. Treatment failure was defined as an unscheduled visit to the GP before 1 month owing to persistence or increase in symptoms and which led to either a change in drug prescription, an emergency department visit, or a hospital admission.

Sensitivity Analysis
We conducted sensitivity analyses on selected utilization and relapse parameters to account for uncertainties. Estimates were varied using published ranges or clinically meaningful ranges. Four different assumptions were considered: (1) length of hospitalization was extended to 15 days,⁷ (2) a new course of antibiotics and oral steroids was prescribed for all patients who were seen because of relapse, (3) only patients with a confirmed diagnosis of COPD were included in the analysis, and (4) decreased failure rate. For this last purpose, we analyzed the savings hypothetically produced by any treatment effective in reducing the failure rate of AECB. For calculation purposes, we assumed that the proportion of patients who needed emergency department visits or hospitalization, among those who relapsed, remained constant. Calculations were made by using the same formula, but changing the expected number of ambulatory and emergency department visits and hospitalizations according to the new treatment failure rate.

Statistical Analysis
The Statistical Analysis Systems software package (version 6.08; SAS Institute; Cary, NC) was used for analysis of data. Mean values of quantitative variables for each group were compared by one-way analysis of variance. In cases of statistically significant differences, the Mann-Whitney U test was used for specific comparisons. Categorical variables were compared by means of the ² test. A p value < 0.05 was considered significant.

	Results

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Data were collected on 2,414 individuals with exacerbated chronic bronchitis. A total of 1,794 patients (74.3%) were men, with a mean age of 66.7 years (SD, 11.2 years). Spirometric results were available for 1,130 individuals (46.8%), and mean FEV₁ was 56.4% of predicted (SD, 15.9%). Demographic and clinical characteristics of the patients and comparison between characteristics of patients with and without spirometry are summarized in Table 1 . Significant differences were observed only in the proportion of male patients and number of exacerbations in the previous year. Patients without spirometry were more frequently women (28.7% vs 22.4%, p = 0.0004) and had had more exacerbations (3.1 ± 2.3 vs 2.9 ± 1.9, p = 0.029). Differences in other characteristics between patients with and without spirometry did not reach statistical significance.

View larger version (14K): [in this window] [in a new window] [Download PPT slide]   Figure 1. Evolution of AECB. dept = department.

View larger version (14K): [in this window] [in a new window] [Download PPT slide]   Figure 2. Distribution of costs of AECB.

Under the second assumption, a new course of antibiotics and oral steroids would be prescribed for all patients who visited their GP for a relapse. This would add $28.70 for each of the 346 patients who required a second medical visit; thus, the cost of AECB would increase by $4.10 to a total of $163.10.

The third scenario would include in the calculations only the 1,130 patients with a diagnosis of COPD demonstrated by clinical and spirometric criteria. The treatment failure rate and percentage of emergency department visits and hospitalizations for this cohort are shown in Table 1 . Calculation of the cost of acute exacerbation of COPD resulted in a total cost of $141.

Finally, the hypothetical saving in total costs associated with a decrease in treatment failure rates is presented in Table 4 . A 10% reduction from 21 to 19% would reduce the cost of AECB from $159 to $148, and a reduction of 50% from 21 to 10.5% would result in a total cost of $107.

	Discussion

TOP Abstract Introduction Materials and Methods Results Discussion References

Although patients with COPD have a mean of two acute exacerbations per year, only a small proportion need to be admitted to the hospital.⁶ An observational study²³ performed in a cohort of COPD patients followed up by primary care physicians observed that only 22% were admitted to the hospital during 1 year. In the present study, 3.4% of all exacerbations ended in hospital admission. Therefore, the costs of hospitalization reflect only a part of the costs associated with AECB and acute exacerbations of COPD.

To our knowledge, this is the first comprehensive cost analysis of AECB and acute exacerbations of COPD. The total mean cost of an AECB was $159, the main part being due to hospitalizations, which represented 58% of the total cost, followed by the total drug acquisition cost of 32.2%. The 3.4% of the patients who required hospital admission were responsible for > 50% of overall costs.

Cost analysis was performed using a database that contained information from > 350 different sources. Since this was a multicenter study, the use of such a database allowed us to minimize the problems derived from the variability of costs between centers, even in the same country. Results presented here may not be applicable to other countries because of the differences in reference prices, management practices, and health-care systems. In this respect, the price of medicines is somewhat lower in Spain than in other similar countries; it should also be taken into account that medical fees in Spain are among the lowest in Europe. Thus, costs obtained in our study are probably lower than they may be in other countries in Europe or the United States. As a comparison, the cost of hospitalization for COPD was calculated to be $7,100 in a study in the States⁷ and $2,652 in Spain. Nevertheless, the results of the present work are useful for comparing the magnitude of costs derived from the different aspects of medical attention for patients with exacerbations, and also for comparing the cost of treatment with the cost of treatment failure. By replacing the mean sanitary costs published in Spain and used in the present study by the costs published in different countries, it is possible to estimate the economic impact of AECB in different scenarios, assuming the same clinical evolution of the patients.

Our results may not be representative of all patients with AECB, since patients were recruited from primary care practices. Therefore, severely affected patients may seek attention directly at a hospital and these patients could not be included in our study; this can be demonstrated by the fact that no patient died or required admission to ICUs during the study. Results of the present study must be interpreted as minimum costs, representing the milder end of the spectrum of patients with chronic lung disease, while costs of hospitalization obtained in the study by Connors et al⁷ may reflect the other end of the spectrum, with patients being older, with a mean FEV₁ of only 0.8 L and recruited from hospital charts.

One of the main results of the study is the finding that failure implies a cost that is three times higher than the cost of management of AECB, particularly due to the high cost of hospitalization. Sensitivity analysis has shown the importance of hospitalization costs, since increasing the length of stay to 15 days (the longest stay in the study by Connors et al⁷ ), the cost of failure would increase by 50%, from $159 to $236. If percentages of relapse could be reduced, especially in severe cases, or if switching a patient from parenteral to oral therapy could reduce the length of hospital stay, valuable resources could be saved.²⁴ This is particularly important considering that one study¹¹ demonstrated that patients with stage III COPD (FEV₁ < 35% predicted) had a significantly greater percentage of failures than successful exacerbations, with 52% of failures requiring hospitalization; therefore, treatment must still improve.

The cost of failure depends on disease severity in the study population. In a study on respiratory infections in one general practice, Davey et al²⁵ observed that a repeated consultation due to failure incurred a maximum cost of 28.54 lb, including indirect costs; it is of note that their population included patients of all ages with a great variety of respiratory infections, some of which were benign. In this situation, it is difficult for a new, more expensive drug to be cost-effective. Conversely, in a population of patients with chronic bronchitis, Grossman et al²⁶ found that the extra cost associated with the use of a more expensive antibiotic for treatment of exacerbations, such as ciprofloxacin, was a cost-effective strategy in more severe patients, since it is active against Gram-negative bacteria, including Pseudomonas aeruginosa, which is responsible for a significant number of exacerbations in severe patients.²⁷ Based on the data generated in our study, a 50% decrease in the treatment failure rate of 21 to 10.5% would signify a saving of $52/patient. Therefore, any strategy that reduces the failure rate by 50% would be cost-effective if the cost is < $52/patient.

We had no information on the second-line treatment administered in case of failure. To circumvent this problem, we calculated the cost of AECB on the maximum supposition that all patients requiring a second ambulatory medical visit for persistence of symptoms were prescribed a second course of antibiotics and a 2-week course of oral steroids. In this case, the total cost of AECB would increase by only $4.1 (2.5%), signifying that it has little influence on the global cost of AECB. Sputum Gram stains, as well as other diagnostic tests, were not required for the study, as reflected by current practice. Settings in which different diagnostic tests are readily available and widely used by primary care physicians may slightly modify these results.

Some confusion might arise when classifying our patients. Clinical criteria of chronic bronchitis are mild, and some patients might have been misclassified as having simple acute bronchitis. However, a comparison with patients who really met clinical and spirometric criteria of COPD showed that patients without spirometry results were similar, or even more severely affected, thereby reasonably ruling out the possibility that they had a milder bronchial disease. In any event, a calculation of costs was made in patients with demonstrated COPD to obtain the estimated cost of an acute exacerbation of COPD, calculated to be $141. The cost of exacerbation was higher for patients without spirometry, due particularly to a slightly higher relapse and hospitalization rate. This could mean that primary care physicians who do not have spirometry available have more difficulties in the management of COPD patients, or that a subgroup of physicians exists who are not familiar with the management of COPD and do not require spirometry.^{14 15} Both circumstances may lead to worse management of patients.

In summary, costs of management of AECB are high, due particularly to the high costs associated with relapse. Strategies to improve the outcome of ambulatory treatment of exacerbations may easily be cost-effective, especially in more severe patients who are at increased risk of being admitted to the hospital as a consequence of therapeutic failure.

	Acknowledgements

 
The authors thank Irene Marimón, BSc, for monitoring the study, Christine O’Hara for editorial assistance, and all of the primary care physicians who provided information on their patients.

	Footnotes

 
Abbreviations: AECB = acute exacerbations of chronic bronchitis; GP = general practitioner; PFT = pulmonary function test

The DAFNE Group (Decisiones sobre Antibioticoterapia y Farmacoeconomía en la EPOC) is funded by MERCK Farma y Química S. A.

Received for publication February 21, 2001. Accepted for publication November 27, 2001.

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