Impact of changes to reimbursement of fixed combinations of inhaled corticosteroids and long-acting ß2 -agonists in obstructive lung diseases: a population-based, observational study.

BACKGROUND: In 2010, the Icelandic government introduced a new cost-saving policy that limited reimbursement of fixed inhaled corticosteroid/long-acting ß2 -agonist (ICS/LABA) combinations. METHODS: This population-based, retrospective, observational study assessed the effects of this policy change by linking specialist/primary care medical records with data from the Icelandic Pharmaceutical Database. The policy change took effect on 1 January 2010 (index date); data for the year preceding and following this date were analysed in 8241 patients with controlled/partly controlled asthma and/or chronic obstructive pulmonary disease (COPD) who had been dispensed an ICS/LABA during 2009. Oral corticosteroid (OCS) and short-acting ß2 -agonist (SABA) use, and healthcare visits, were assessed pre- and post-index. RESULTS: The ICS/LABA reimbursement policy change led to 47.8% fewer fixed ICS/LABA combinations being dispensed during the post-index period among patients whose asthma and/or COPD was controlled/partly controlled during the pre-index period. Fewer ICS monocomponents were also dispensed. A total of 48.6% of patients were no longer receiving any respiratory medications after the policy change. This was associated with reduced disease control, as demonstrated by more healthcare visits (44.0%), and more OCS (76.3%) and SABA (51.2%) dispensations. CONCLUSIONS: Overall, these findings demonstrate that changes in healthcare policy and medication reimbursement can directly impact medication use and, consequently, clinical outcomes and should, therefore, be made cautiously.

The respiratory pyramid: From symptoms to disease in World Trade Center exposed firefighters.

BACKGROUND: This study utilizes a four-level pyramid framework to understand the relationship between symptom reports and/or abnormal pulmonary function and diagnoses of airway diseases (AD), including asthma, recurrent bronchitis and COPD/emphysema in WTC-exposed firefighters. We compare the distribution of pyramid levels at two time-points: by 9/11/2005 and by 9/11/2010. METHODS: We studied 6,931 WTC-exposed FDNY firefighters who completed a monitoring exam during the early period and at least two additional follow-up exams 9/11/2005-9/11/2010. RESULTS: By 9/11/2005 the pyramid structure was as follows: 4,039 (58.3%) in Level 1, no respiratory evaluation or treatment; 1,608 (23.2%) in Level 2, evaluation or treatment without AD diagnosis; 1,005 (14.5%) in Level 3, a single AD diagnosis (asthma, emphysema/COPD, or recurrent bronchitis); 279 (4.0%) in Level 4, asthma and another AD. By 9/11/2010, the pyramid distribution changed considerably, with Level 1 decreasing to 2,612 (37.7% of the cohort), and Levels 3 (N = 1,530) and 4 (N = 796) increasing to 22.1% and 11.5% of the cohort, respectively. Symptoms, spirometry measurements and healthcare utilization were associated with higher pyramid levels. CONCLUSIONS: Respiratory diagnoses, even four years after a major inhalation event, are not the only drivers of future healthcare utilization. Symptoms and abnormal FEV-1 values must also be considered if clinicians and healthcare administrators are to accurately anticipate future treatment needs, years after initial exposure.

Lung function in adults and future burden of obstructive lung diseases in a long-term follow-up.

Spirometry is recommended in symptomatic smokers to identify obstructive lung diseases. However, it is unknown whether there are certain characteristics that can be used to identify the individual risk of developing obstructive lung diseases. The aim of this study was to examine the association between lung function in adults and burden of lung diseases throughout 27 years of follow-up. We performed a cohort study among individuals aged 30-49 years at baseline (1991). Spirometry measurements were divided into three groups: (1) FEV1/FVC < 70, (2) FEV1/FVC: 70-75, (3) FEV1/FVC > 75 (reference). Using negative binominal regression, the burden of lung diseases was measured by contacts to general practice, hospitalisations, redeemed respiratory medicine and socioeconomic parameters between 1991 and 2017. A total of 905 citizens were included; mean age of 40.3 years, 47.5% were males and 51.2% were smokers at baseline. The group with an FEV1/FVC: 70-75 received more respiratory medicine (IRR = 3.37 (95% CI: 2.69-4.23)), had lower income (IRR = 0.96 (95% CI: 0.93-0.98)), and had more contacts to general practice (IRR = 1.14 (95% CI: 1.07-1.21)) and hospitals for lung diseases (IRR = 2.39 (95% CI: 1.96-5.85)) compared to the reference group. We found an association between lung function and the future burden of lung diseases throughout 27 years of follow-up. In particular, adults with an FEV1/FVC: 70-75 need extra attention in the case finding.

Health care utilization in chronic obstructive pulmonary disease. A case-control study in a health maintenance organization.

BACKGROUND: Information about health care utilization and costs among patients with chronic obstructive pulmonary disease (COPD) is needed to improve care and for appropriate allocation of resources for patients with COPD (COPD patients or cases) in managed care organizations. METHODS: Analysis of all inpatient, outpatient, and pharmacy utilization of 1522 COPD patients continuously enrolled during 1997 in a 172,484-member health maintenance organization. Each COPD case was matched with 3 controls (n = 4566) by age (+/-5 years) and sex. Information on tobacco use and comorbidities was obtained by chart review of 200 patients from each group. RESULTS: Patients with COPD were 2.3 times more likely to be admitted to the hospital at least once during the year, and those admitted had longer average lengths of stay (4.7 vs 3.9 days; P<.001). Mean costs per case and control were $5093 vs $2026 for inpatient services, $5042 vs $3050 for outpatient services, and $1545 vs $739 for outpatient pharmacy services, respectively (P<.001 for all differences). Patients with COPD had a longer smoking history (49.5 vs 34.9 pack-years; P =.002) and a higher prevalence of smoking-related comorbid conditions and were more likely to use cigarettes during the study period (46.0% vs 13.5%; P<.001). CONCLUSIONS: Health care utilization among COPD patients is approximately twice that of age- and sex-matched controls, with much of the difference attributable to smoking-related diseases. In this health maintenance organization, inpatient costs were similar to and outpatient costs were much higher than national averages for COPD patients covered by Medicare.

Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial.

PURPOSE: Pulmonary rehabilitation programs are effective in patients with severe chronic obstructive pulmonary disease (COPD) in the short term, but their long-term effects are not known. We investigated the short- and long-term effects of a 6-month outpatient rehabilitation program in patients with severe COPD. SUBJECTS AND METHODS: One hundred patients were randomly assigned to receive either an exercise training program that included cycling, walking, and strength training (n = 50) or usual medical care (n = 50). Thirty-four patients in the training group were evaluated after 6 months (end of training), and 26 were evaluated after 18 months of follow-up. In the control group, 28 patients were evaluated at 6 months and 23 after 18 months. We measured pulmonary function, 6-minute walking distance, maximal exercise capacity, peripheral and respiratory muscle strength, and quality of life (on a 20 to 140-point scale), and estimated the cost-effectiveness of the program. RESULTS: At 6 months, the training group showed improvement in 6-minute walking distance [mean difference (training - control) of 52 m; 95% confidence interval (CI), 15 to 89 m], maximal work load (12 W; 95% CI, 6 to 19 W), maximal oxygen uptake (0.26 liters/min; 95% CI, 0.07 to 0.45 liters/min), quadriceps force (18 Nm; 95% CI, 7 to 29 Nm), inspiratory muscle force (11 cm H(2)O; 95% CI, 3 to 20 cm H(2)O), and quality of life (14 points; 95% CI, 6 to 21 points; all P <0.05). At 18 months all these differences persisted (P <0.05), except for inspiratory muscle strength. For 6-minute walking distance and quality of life, the differences between the training group and controls at 18 months exceeded the minimal clinically-important difference. CONCLUSION: Among patients who completed the 6-month program, outpatient training resulted in significant and clinically relevant changes in 6-minute walking distance, maximal exercise performance, peripheral and respiratory muscle strength, and quality of life. Most of these effects persisted 18 months after starting the program.

The use of cutaneous oximetry in the prescription of long-term oxygen therapy.

Using current Medicare guidelines for the prescription of long-term oxygen therapy, we studied the impact on decision-making of substituting cutaneous oxyhemoglobin saturation measurements (SaO2) for direct arterial oxygen tension measurements (PaO2). Fifty-five patients with chronic lung disease and resting hypoxemia were studied. More than 80 percent of patients with a resting PaO2 of 7.33 kPa (55 mm Hg) or less had a cutaneous oximetry SaO2 greater than 85 percent. These patients would not have met the guidelines for long-term oxygen therapy if the cutaneous oximetry measurements were used instead of direct PaO2 measurements. Substituting a threshold criterion of 88 percent instead of 85 percent resulted in fewer patients being denied oxygen therapy but also included patients with PaO2 values greater than 7.33 kPa (55 mm Hg). We conclude that cutaneous oximetry cannot be substituted equivalently for PaO2 measurements in prescribing long-term oxygen therapy.

Economic analysis of respiratory rehabilitation.

STUDY OBJECTIVE: We report on the incremental costs associated with improvements in health-related quality of life (HRQL) following 6 months of respiratory rehabilitation compared with conventional community care. DESIGN: Prospective randomized controlled trial of rehabilitation. SETTING: A respiratory rehabilitation unit. PARTICIPANTS: Eighty-four subjects who completed the rehabilitation trial. INTERVENTION: Two months of inpatient rehabilitation followed by 4 months of outpatient supervision. MEASUREMENTS AND RESULTS: All costs (hospitalization, medical care, medications, home care, assistive devices, transportation) were included. Simultaneous allocation was used to determine capital and direct and indirect hospitalization costs. The incremental cost of achieving improvements beyond the minimal clinically important difference in dyspnea, emotional function, and mastery was $11,597 (Canadian). More than 90% of this cost was attributable to the inpatient phase of the program. Of the nonphysician health-care professionals, nursing was identified as the largest cost center, followed by physical therapy and occupational therapy. The number of subjects needed to be treated (NNT) to improve one subject was 4.1 for dyspnea, 4.4 for fatigue, 3.3 for emotion, and 2.5 for mastery. CONCLUSION: Cost estimates of various approaches to rehabilitation should be combined with valid, reliable, and responsive measures of outcome to enable cost-effectiveness measures to be reported. Comparison studies with the same method are necessary to determine whether the improvements in HRQL that follow inpatient rehabilitation are cheap or expensive. Such information will be important in identifying the extent to which alternative approaches to rehabilitation can influence resource allocation. A consideration of cost-effectiveness from the perspective of NNT may be useful in the evaluation of health-care programs.

The costs of treating COPD in the United States.

STUDY OBJECTIVES: COPD affects millions of people in the United States. The purpose of this study was to describe the medical resource use and costs incurred by persons with COPD in the United States in 1987. DESIGN: Data for this study were derived from the 1987 National Medical Expenditure Survey. A societal perspective was adopted for this analysis. PATIENTS OR PARTICIPANTS: All persons > or = 40 years old with resource use or expenditures for chronic bronchitis, emphysema, or nonspecific chronic airway obstruction were included in this study. RESULTS: Mean per-person direct medical expenditures among persons with COPD were $6,469 (1987 US dollars), about 25% of which was COPD related. Approximately 68% of direct medical expenditures in persons with COPD were for inpatient hospitalization. CONCLUSIONS: COPD causes a large societal burden of illness that is expected to increase. This study provides a valuable foundation and historical measure against which to compare other estimates.

Respi-Care. An innovative home care program for the patient with chronic obstructive pulmonary disease.

The purpose of the present study was to evaluate the effectiveness of a hospital-based home care program for a group of patients with severe COPD. Respi-Care was a multidisciplinary home care program administered by Norwalk Hospital in cooperation with the public health nursing departments of the city of Norwalk and the town of Wilton, Conn. The overall goal of Respi-Care was to provide more comprehensive home care services to patients previously requiring frequent hospitalizations by combining the advantages of hospital resources and community agencies through a unique cooperative effort. Preprogram and on-program data were collected on the following variables for the 48 months of Respi-Care operation: hospitalizations; hospital days; emergency room visits; home care services; and the costs of these services. Costs of operating the Respi-Care program were included in on-program data. Seventeen subjects completed 320.5 months on Respi-Care. Each subject was matched to an equal length of time prior to entering the program, for a total of 641 months analyzed. There were 88 preprogram hospitalizations for the group; hospitalizations while participating in Respi-Care dropped to 53 (p = 0.022; paired t statistics). On-program hospital days showed a significant decrease, from 1,181 preprogram days to 667 on-program days (p = 0.024). Emergency room visits decreased from 105 before the program to 64 during the program (p = 0.017). Costs of care also decreased. Costs for hospitalizations, emergency room visits, and home care fell from $908,031 to $802,999, resulting in a $105,032 savings or $328 per patient per month.(ABSTRACT TRUNCATED AT 250 WORDS)

The cost of treating COPD patients with long-term oxygen therapy in a French population.

OBJECTIVE: In greater Paris and its surrounding (as it is in all France), oxygen is home delivered by not-for-profit (NP) associations or profit-making (PM) health organizations. Both are financed by the national health insurance. This dual context and the current economic climate justify an economic evaluation of all respiratory care for patients with COPD receiving long-term oxygen therapy (LTO). This pragmatic approach identifies the variables that have the greatest impact on direct medical costs and estimates the annual cost for respiratory care per COPD patient. DESIGN: Retrospective study. SETTING: Health insurance scheme for self-employed professionals (CANAM). PATIENTS AND METHODS: Between July 1985 and March 1994, 234 patients registered in CANAM files began LTO, 24% in the PM sector, 76% in the NP sector, mainly using concentrator (78%), mean age of 74 +/- 10 years, male predominance (74%), PaO2 of 56.2 +/- 10.5 mm Hg, FEV1/FVC of 43 +/- 15%, and 51% having 1 or more severe illness(es) associated. The economic appraisal was performed on a representative sample of 61 patients and measured the total resources consumption for respiratory care per COPD patient and per year (physician visits and tests, drugs, physiotherapy, oxygen therapy, hospitalizations for acute respiratory failure, transport costs). RESULTS: A quarter of the patients in each sector did not meet the LTO prescription guidelines (PaO2 > 60 mm Hg). For patients having their oxygen delivered by NP sector, the total ambulatory cost for respiratory care was lower ($4,506 per patient and per year vs $5,399) because they mainly used concentrator, all the other direct ambulatory costs being equal. The total annual cost for respiratory care of a COPD patient receiving LTO amounted to $11,672 (NP and PM sectors merged). Oxygen therapy represented 73% of the total ambulatory cost. In a multiple linear regression model, hospitalization represented the largest share of cost, significantly higher when PaO2 was 55 mm Hg or less ($2,287 per patient per year vs $8,717). In contrast, none of the covariates (age, sex, PaO2, FEV1/FVC) influenced at a significant level the total cost of visits, tests, drugs, and physiotherapy, amounting to $1,507. CONCLUSION: As oxygen treatment plays an important role in the variation of costs, further pragmatic studies should help to better understand what are the real motivations to choose one mode of oxygen administration more than another and should determine factors that may lead physicians sometimes not to comply with clinical guidelines.

Utilization in COPD: patient characteristics and diagnostic evaluation.

STUDY OBJECTIVES: Information on current practices of COPD diagnosis and treatment is needed to identify opportunities for improving care. This study describes the clinical characteristics and diagnostic evaluations of COPD patients in a health maintenance organization (HMO) and a university-affiliated county medical center (UMC). DESIGN: Cross-sectional survey performed in a 174,484-member regional HMO and in The University of New Mexico Hospitals and Clinics (UNMH). PATIENTS: Two hundred COPD patients from each system randomly selected from administrative databases based on discharge diagnoses. RESULTS: COPD patients in the UMC, compared to those in the HMO, were younger (mean age, 59.3 vs 66.9 years, respectively), were more likely to be using home oxygen (33% vs 20%, respectively), and had fewer chronic medical conditions (mean number of conditions, 3.1 vs 3.7, respectively) (p < 0.01 for all differences). Approximately half of the COPD patients in both groups continued to smoke cigarettes during the study year. Only 38% of patients in the HMO and 42% in the UNMH system had spirometry results documented in their medical records. CONCLUSIONS: The demographic and clinical characteristics of the COPD patients in these two health-care systems were very different, but smoking status and utilization of diagnostic tests were similar. The diagnosis of COPD in most patients was based only on a history of chronic respiratory symptoms and smoking; spirometry often was not used to confirm the diagnosis. An increased emphasis on smoking cessation and more effective utilization of spirometry are needed to improve the management of COPD in these health-care systems.

The economic burden of COPD.

COPD is one of the leading causes of morbidity and mortality worldwide and imparts a substantial economic burden on individuals and society. Despite the intense interest in COPD among clinicians and researchers, there is a paucity of data on health-care utilization, costs, and social burden in this population. The total economic costs of COPD morbidity and mortality in the United States were estimated at $23.9 billion in 1993. Direct treatments for COPD-related illness accounted for $14.7 billion, and the remaining $9.2 billion were indirect morbidity and premature mortality estimated as lost future earnings. Similar data from another US study suggest that 10% of persons with COPD account for > 70% of all medical care costs. International studies of trends in COPD-related hospitalization indicate that although the average length of stay has decreased since 1972, admissions per 1,000 persons per year for COPD have increased in all age groups > 45 years of age. These trends reflect population aging, smoking patterns, institutional factors, and treatment practices.

How can the implementation of guidelines be improved?

Guidelines for a variety of diseases have now been produced. However, implementation of guidelines requires that the medical profession is willing to conform to patterns of diagnostic and treatment behavior set down by others. This may not happen in practice. Early experience in the United Kingdom was gained with the introduction of guidelines for the management of asthma. For a number of years, there have been improvements in practice, but deficiencies still exist. When the introduction of guidelines for the management of COPD was planned, a new approach was taken with a consortium of the British Thoracic Society, pharmaceutical companies, and medical equipment companies being formed to promote their use. Early studies show that COPD care starts from an even lower baseline than asthma; there is poor understanding of objective diagnosis of COPD in both primary and secondary care.

Disease management of COPD with pulmonary rehabilitation.

Pulmonary rehabilitation is a set of tools and disciplines that attends to the multiple needs of the COPD patient. It extends beyond standard care by addressing the disabling features of chronic and progressive lung disease. It centers on self-management, exercise, functional training, psychosocial skills, and contributes to the optimization of medical management. Exercise enables other components by building strength, endurance, confidence, and reducing dyspnea. Patients who have undergone rehabilitation often enjoy a reduced need for health-care utilization. On the downside, rehabilitation is a one-time intervention, the benefits of which dissolve over time. The patient's physician is rarely a participant in the program; thus, the physician is at a disadvantage in being able to support a long-term response. Rehabilitation is available to a small percentage of a large patient population who could benefit. Optimal disease management would entail redesigning standard medical care to integrate rehabilitative elements into a system of patient self-management and regular exercise. It should emphasize physician involvement in self-management, which is essential in developing and maintaining an effective exacerbation protocol. Pulmonary rehabilitation should take its place in the mainstream of disease management through its integrative and reconciliative role in the multidisciplinary continuum of services, as defined by the National Institutes of Health, Pulmonary Rehabilitation Research, Workshop of 1994.

The impact of combined inhaled bronchodilator therapy in the treatment of COPD.

BACKGROUND: Treatment guidelines recommend concomitant use of ipratropium bromide and inhaled beta2-agonists as severity of COPD progresses. While the use of these two agents in a single inhaler may enhance patient compliance and result in cost savings, it may, by itself, increase medication use. We assessed whether the introduction of a combined inhaled bronchodilator in the treatment of COPD modifies the use and costs related to prescribed medications. METHOD: A cohort of subjects > or =45 years old initiating treatment with either a combined inhaled bronchodilator (641 subjects) or ipratropium bromide and inhaled beta2 -agonist (411 subjects) between July 1, 1996, and June 30, 1997, was identified using the Saskatchewan Health databases. The primary outcomes were prescribed medication usage and the subsequent related costs during a 1-year follow-up period. Poisson regression analysis was used to estimate rate ratios (RRs) adjusted for drug use and hospitalization during the year prior to cohort entry. RESULTS: The adjusted RR of inhaled bronchodilator use was elevated for combined inhaled bronchodilator therapy (adjusted RR, 1.16; 95% confidence interval [CI], 1.07 to 1.26). However, the overall costs associated with these inhaled bronchodilators were reduced with combined inhaled bronchodilator therapy (adjusted mean ratio, 0.83; 95% CI, 0.76 to 0.92). The rate of use of other respiratory drugs and antibiotics was similar (adjusted RR, 1.03; 95% CI, 0.93 to 1.16). Applying the rate ratio for cost savings to all new, combined inhaled bronchodilator users led to estimated annual savings in Canadian dollars of 103,468 dollars (95% CI, 48,694 dollars to 146,082 dollars) in this province. CONCLUSION: The introduction of a simpler bronchodilator dosing regimen did not significantly alter the treatment of COPD and resulted in appreciable cost savings.

Cost-benefit comparison of aerosol bronchodilator delivery methods in hospitalized patients.

We compared two modes of aerosol bronchodilator delivery in 34 patients hospitalized with obstructive airways diseases. The standard mode, therapist-administered up-draft nebulization (UDN), is labor-intensive and therefore relatively costly. The alternative mode, self-administration by a metered dose inhaler (MDI), is less costly, but its efficacy over an entire hospitalization has heretofore not been established. Patients were enrolled after transfer to the pulmonary ward from the emergency room or intensive care units (ICU). We then randomized them to receive metaproterenol q4h either via MDI or UDN. Daily spirometry revealed that MDI and UDN were associated with equivalent bronchodilation initially and equivalent improvement at discharge. The duration of hospitalization for the two groups was also the same. Thus, the two delivery methods were equally effective. We could not attribute this equivalence to pretreatment intergroup differences or to differences in concomitant therapy with steroids, theophylline, other bronchodilators, or antibiotics. Routine use of MDI rather than UDN in all non-ICU adult patients would save $253,487 per year at our institution alone.

The effect of respiratory therapist-initiated treatment protocols on patient outcomes and resource utilization.

CONTEXT: Physicians frequently prescribe respiratory treatments to hospitalized patients, but the influence of such treatments on clinical outcomes is difficult to assess. OBJECTIVE: To compare the clinical outcomes of patients receiving respiratory treatments managed by respiratory care practitioner (RCP)-directed treatment protocols or physician-directed orders. DESIGN: A single center, quasi-randomized, clinical study. SETTING: Three internal medicine firms from an urban teaching hospital. PATIENTS: Six hundred ninety-four consecutive hospitalized non-ICU patients ordered to receive respiratory treatments. MAIN OUTCOME MEASURES: Discordant respiratory care orders, respiratory care charges, hospital length of stay, and patient-specific complications. Discordant orders were defined as written orders for respiratory treatments that were not clinically indicated as well as orders omitting treatments that were clinically indicated according to protocol-based treatment algorithms. RESULTS: Firm A patients (n = 239) received RCP-directed treatments and had a statistically lower rate of discordant respiratory care orders (24.3%) as compared with patients receiving physician-directed treatments in firms B (n = 205; 58.5%) and C (n = 250; 56.8%; p < 0.001). No statistically significant differences in patient complications were observed. The average number of respiratory treatments and respiratory care charges were statistically less for firm A patients (10.7 +/- 13.7 treatments; $868 +/- 1,519) as compared with patients in firms B (12.4 +/- 12.7 treatments, $1,124 +/- 1,339) and C (12.3 +/- 13.4 treatments, $1, 054 +/- 1,346; p = 0.009 [treatments] and p < 0.001 [respiratory care charges]). CONCLUSIONS: Respiratory care managed by RCP-directed treatment protocols for non-ICU patients is safe and showed greater agreement with institutional treatment algorithms as compared with physician-directed respiratory care. Additionally, the overall utilization of respiratory treatments was significantly less among patients receiving RCP-directed respiratory care.

Should health-care systems pay for replacement therapy in patients with alpha(1)-antitrypsin deficiency? A critical review and cost-effectiveness analysis.

STUDY OBJECTIVES: Assess cost effectiveness for providing alpha(1)-antitrypsin (alpha(1)-AT) replacement therapy to individuals with severe COPD and alpha(1)-AT deficiency. MATERIALS AND METHODS: The electronic databases MEDLINE and EMBASE were searched, and relevant bibliographies were reviewed. Effect size, defined as the absolute risk difference between treated and untreated groups, was taken from the highest level of supporting evidence. The cost for providing alpha(1)-AT replacement therapy was analyzed from a payer perspective and was based on Medicare reimbursement rates. Effect size and costs were varied. The year of life saved was discounted up to 7%. RESULTS: The incremental cost per year of life saved for alpha(1)-AT replacement therapy (60 mg/kg/wk IV) in a 70-kg subject with severe alpha(1)-AT deficiency and an FEV(1) < 50% of predicted based on the National Institutes of Health (NIH) Registry mortality rate data is $13,971. The incremental cost depends substantially on the mortality rate reduction. When the effect size is altered from 10 to 70%, with the cost fixed at $52,000, the incremental cost per year of life saved ranges from $152,941 to $7,330. When effect size is 55% (as in the NIH Registry) but costs are increased almost 300%, from $52,000 to $150,000 per year, then the incremental cost per year of life saved increases from $13,971 to $40,301. CONCLUSION: No randomized, placebo-controlled trials are available to assess mortality rate reduction with alpha(1)-AT replacement therapy. The best currently available data are observational, from the NIH Registry. Based on these data, alpha(1)-AT replacement therapy is cost-effective in individuals who have severe alpha(1)-AT deficiency and severe COPD.

Suboptimal medical therapy in COPD: exploring the causes and consequences.

Effective outpatient management of COPD requires prescription of and adherence to appropriate therapies. Although practice guidelines for outpatient management of COPD are widely available, evidence suggests that these guidelines are not being implemented widely in clinical practice. Furthermore, several studies have shown that patient compliance with recommended therapy is poor. This paper discusses several reasons why implementation of practice guidelines and adherence with prescribed therapies may be poor. Potential clinical and economic consequences of suboptimal management are reviewed. Although the evidence suggests that improved compliance with guideline-recommended practice will improve symptoms and disease-specific quality of life, further work needs to be done to establish the cost-effectiveness of chronic therapies for COPD relative to other chronic conditions. Without such data, managed care organizations will be reluctant to allocate scarce resources toward expensive guideline implementation programs for individuals with this condition.

Comparative cost-effectiveness analysis of theophylline and ipratropium bromide in chronic obstructive pulmonary disease. A three-center study.

The charts of 311 patients receiving theophylline (T) and 289 patients receiving ipratropium bromide (IB) for COPD were reviewed to determine the total costs and cost-effectiveness of these 2 agents in 3 different health-care settings. A direct cost-accounting method assessed cost, and a Markov decision-analysis model calculated cost-effectiveness. Costs to treat toxic effects were greater for T versus IB. The types and incidences of toxic effects, by drug, were similar among the three centers. Overall costs for T were $121.40 per patient per therapy-month versus $84.56 per patient per therapy-month for IB, as determined by the cost-accounting method. The marginal cost was $366 for T over IB when extrapolated over 1 year using the Markov model. The Markov model also predicted that patients receiving IB had a greater number of complication-free therapy-months (measurement of effectiveness) than patients receiving T. We conclude that treatment with IB was less costly and more cost-effective than T.