Clinical and economic outcomes in an observational study of COPD maintenance therapies: multivariable regression versus propensity score matching.

PURPOSE: To investigate equivalency of results from multivariable regression (MR) and propensity score matching (PSM) models, observational research methods used to mitigate bias stemming from non-randomization (and consequently unbalanced groups at baseline), using, as an example, a large study of chronic obstructive pulmonary disease (COPD) initial maintenance therapy. METHODS: Patients were 32,338 health plan members, age ≥40 years, with COPD initially treated with fluticasone propionate/salmeterol combination (FSC), tiotropium (TIO), or ipratropium (IPR) alone or in combination with albuterol. Using MR and PSM methods, the proportion of patients with COPD-related health care utilization, mean costs, odds ratios (ORs), and incidence rate ratios (IRRs) for utilization events were calculated for the 12 months following therapy initiation. RESULTS: Of 12,595 FSC, 9126 TIO, and 10,617 IPR patients meeting MR inclusion criteria, 89.1% (8135) of TIO and 80.2% (8514) of IPR patients were matched to FSC patients for the PSM analysis. Methods produced substantially similar findings for mean cost comparisons, ORs, and IRRs for most utilization events. In contrast to MR, for TIO compared to FSC, PSM did not produce statistically significant ORs for hospitalization or outpatient visit with antibiotic or significant IRRs for hospitalization or outpatient visit with oral corticosteroid. As in the MR analysis, compared to FSC, ORs and IRRs for all other utilization events, as well as mean costs, were less favorable for IPR and TIO. CONCLUSION: In this example of an observational study of maintenance therapy for COPD, more than 80% of the original treatment groups used in the MR analysis were matched to comparison treatment groups for the PSM analysis. While some sample size was lost in the PSM analysis, results from both methods were similar in direction and statistical significance, suggesting that MR and PSM were equivalent methods for mitigating bias.

Rehospitalization risks and outcomes in COPD patients receiving maintenance pharmacotherapy.

OBJECTIVE: To determine clinical and economic outcomes following COPD-related hospitalization/emergency department (ED) care in patients receiving COPD maintenance therapy. METHODS: In this retrospective, observational study using administrative claims data, we identified COPD patients age ≥40 years who received maintenance therapy within 30 days of an initial COPD-related hospitalization or ED visit with: (1) fluticasone propionate/salmeterol combination (FSC 250 mcg/50 mcg) as new therapy, or (2) an anticholinergic (AC; tiotropium or ipratropium with or without albuterol). The FSC and AC patients were matched (1:3 ratio) on various baseline characteristics using propensity scores to mitigate selection bias at baseline. The proportion of patients with COPD-related healthcare events, the mean event rates, and the mean costs in the subsequent 12 months were calculated. RESULTS: The FSC cohort (N = 484) had a significantly lower proportion of rehospitalized patients during follow-up than did the AC cohort (N = 1452), 3.1% versus 4.6% (P = 0.047). The mean number of rehospitalizations was 0.03 in the FSC cohort and 0.07 in the AC cohort (P = 0.001). The proportion of patients with an exacerbation resulting in an ED or physician-outpatient visit and the mean number of such visits did not differ between cohorts. Total annual COPD-related medical costs were lower for FSC than for AC ($2080 versus $2636, P = 0.006), with lower medical and higher pharmacy costs. CONCLUSIONS: Patients receiving FSC as maintenance therapy following an initial COPD-related hospitalization or ED visit experienced better clinical and economic outcomes than patients receiving AC.

Comparative health-care cost advantage of ipratropium over tiotropium in COPD patients.

OBJECTIVE: To compare the total direct health-care costs of patients treated with tiotropium and ipratropium. METHODS: We conducted a cohort study of health-care costs in British Columbia, Canada, by comparing new patients on tiotropium with new patients on ipratropium. Direct health-care costs for study patients were measured in the first 2 years after initiating inhaled anticholinergic treatment. Differences in direct health-care costs between tiotropium and ipratropium patients were estimated by using quantile regression. We analyzed cost differences in the 10th percentile, median, and 90th percentile of patients by cost. High-dimensional propensity score analysis was used as a method of adjustment for potential confounding factors. RESULTS: The study population had 3,140 tiotropium patients and 26,182 ipratropium patients. Higher health system costs in patients who started on tiotropium instead of ipratropium were observed in patients in the median and 10th percentile. The magnitude of these increases was comparable to the price difference between the two drugs. Health system costs in the 90th percentile were not significantly different between tiotropium and ipratropium patients. CONCLUSIONS: The results of this study did not support the preferential use of tiotropium over ipratropium as a basis for savings in direct health-care costs.

A new method for examining the cost savings of reducing COPD exacerbations.

BACKGROUND: Some treatments for chronic obstructive pulmonary disease (COPD) can reduce exacerbations, and thus could have a favourable impact on overall healthcare costs. OBJECTIVE: To evaluate a new method for assessing the potential cost savings of COPD controller medications based on the incidence of exacerbations and their related resource utilization in the general population. METHODS: Patients with COPD (n = 1074) enrolled in a regional managed care system in the US were identified using administrative data and divided by their medication use into three groups (salbutamol, ipratropium and salmeterol). Exacerbations were captured using International Classification of Diseases, Ninth Edition (ICD-9) and current procedural terminology (CPT) codes, then logistic regression models were created that described the risk of exacerbations for each comparator group and exacerbation type over a 6-month period. A Monte Carlo simulation was then applied 1000 times to provide the range of potential exacerbation reductions and cost consequences in response to a range of hypothetical examples of COPD controller medications. RESULTS: Exacerbation events for each group could be modelled such that the events predicted by the Monte Carlo estimates were very close to the actual prevalences. The estimated cost per exacerbation avoided depended on the incidence of exacerbation in the various subpopulations, the assumed relative risk reduction, the projected daily cost for new therapy, and the costs of exacerbation treatment. CONCLUSIONS: COPD exacerbation events can be accurately modelled from the healthcare utilization data of a defined cohort with sufficient accuracy for cost-effectiveness analysis. Treatments that reduce the risk or severity of exacerbations are likely to be cost effective among those patients who have frequent exacerbations and hospitalizations.

Economic analyses comparing tiotropium with ipratropium or salmeterol in UK patients with COPD.

AIMS: This study presents a cost-effectiveness and budget impact analysis comparing cost and outcomes for UK patients with COPD treated with either tiotropium, ipratropium or salmeterol. METHODS: A previously-published COPD cost-effectiveness model was adapted for the UK, then used to estimate the cost-effectiveness of tiotropium compared to salmeterol and ipratropium. Additional epidemiological data were used to estimate the budget impact of switching patients from ipratropium or salmeterol to tiotropium. RESULTS: In England, the estimated annual cost per patient on tiotropium was pound1350, on salmeterol was pound1404, and on ipratropium was pound1427; in Scotland/Wales/Northern Ireland (S/W/NI) these costs were pound1439, pound1565, and pound1631, respectively. Tiotropium patients experienced better quality-adjusted life-years (QALYs) across all comparisons, and this option was therefore dominant compared to salmeterol and ipratropium. The probability of tiotropium being dominant ranged from 72% to 87% across comparisons. At a willingness to pay threshold of pound20,000 per QALY, tiotropium had at least a 97% chance of being cost-effective. The estimated annual saving per primary care trust (PCT) of switching patients from salmeterol and ipratropium to tiotropium in England was pound230,000 and in S/W/NI was pound160,000. CONCLUSIONS: Tiotropium is a cost-effective alternative to ipratropium and salmeterol, and switching COPD patients from ipratropium and salmeterol to tiotropium could result in considerable cost savings for PCTs along with improvements in quality-of-life.

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.

Healthcare costs associated with initial maintenance therapy with fluticasone propionate 250 µg/salmeterol 50 µg combination versus anticholinergic bronchodilators in elderly US Medicare-eligible beneficiaries with COPD.

OBJECTIVE: To compare, in elderly Medicare beneficiaries, chronic obstructive pulmonary disease (COPD)-related healthcare costs for patients initiating treatment with fluticasone propionate/salmeterol 250 µg/50 µg (FSC) with those for patients initiating treatment with ipratropium bromide/albuterol (IPA), ipratropium bromide (IPR), and tiotropium bromide (TIO). METHODS: In this retrospective, observational, cohort study, COPD-related medical costs (inpatient/emergency department, outpatient) and pharmacy costs were assessed in Medicare beneficiaries ≥ 65 years old who were enrolled in a commercial Medicare health maintenance organization plan and had a diagnosis of COPD (ICD-9-CM codes 491.xx, 492.xx, or 496.xx) within 12 months before initial treatment with FSC, IPA, IPR, or TIO. RESULTS: In these ≥ 65-year-old patients (N=14,689), initial maintenance treatment with FSC was associated with total COPD-related cost savings (medical + pharmacy) of $295 versus IPA, $1,235 versus IPR, and $110 versus TIO (p<0.05, each comparison) over a 1-year follow-up period. CONCLUSIONS: Initiation of maintenance therapy with FSC was associated with significant reduction in total costs (medical + pharmacy) relative to costs associated with the short-acting anticholinergic bronchodilators IPR and IPA and the long-acting anticholinergic bronchodilator TIO in an elderly Medicare-eligible population. These data considered in the context of the substantial efficacy and effectiveness data suggest that early introduction of maintenance treatment with FSC has both clinical and economic benefits. Limitations inherent in handling of administrative data include lack of objective clinical measures such as spirometry and smoking status. Furthermore, accuracy of diagnosis codes cannot be verified.

Effect of educational and policy interventions on institutional utilization of wet nebulization respiratory drugs and portable inhalers.

BACKGROUND: Asthma and chronic obstructive pulmonary disease treatment guidelines support the preferential use of portable inhalers (PIs) over wet nebulization (WN) respiratory therapy. Hospital- and community-based educational initiatives and a community-based provincial drug program policy change were previously implemented to promote the conversion of WN therapy to PI and spacer device use in Nova Scotia. OBJECTIVE: To examine the effect of these interventions on salbutamol, ipratropium bromide, and spacer device (Aerochamber) use at the Queen Elizabeth II Health Sciences Centre (QEII HSC). METHODS: We conducted a time-series analysis of drug utilization data from August 1998 to July 2005. We used two intervention phases compared to the pre-intervention phase to determine whether the educational and policy interventions were associated with significant changes in monthly drug and spacer device utilization rates at the QEII HSC (1000-bed teaching hospital; Halifax, Nova Scotia). RESULTS: Salbutamol and ipratropium bromide PI use significantly increased in both intervention phases, compared to the pre-intervention phase. Mean (SD) defined daily doses/100 bed-days for salbutamol PI increased from 30.4 (0.4) in the pre-intervention phase to 34.6 (0.9) and 37.0 (0.4) in intervention phases I and II respectively (p<0.001 for both), and ipratropium bromide PI increased from 27.3 (3.5) to 32.8 (2.5) in intervention phase I (p=0.004) and 35.6 (3.5) in intervention phase II (p<0.001). However, a significant corresponding decrease was observed with salbutamol WN only. Mean (SD) Aerochamber units/100 bed-days significantly increased. CONCLUSIONS: Educational and policy interventions had limited effects on converting WN to PI use at the QEII HSC.

Using cost-effectiveness analysis to sharpen formulary decision-making: the example of tiotropium at the Veterans Affairs health care system.

OBJECTIVE: To identify a cost-saving subset of criteria for the use of tiotropium at a Veterans Affairs Medical Center based on a cost-effectiveness analysis with ipratropium as the comparator. METHODS: Retrospective analysis of electronic medical records for the calendar year 2004 was conducted. The sample was drawn from a population at the Baltimore Veterans Affairs Medical Center that had a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) and had filled prescriptions for ipratropium. The tiotropium sample was based on a modeled cohort of COPD patients who had received tiotropium. The analysis was conducted from the perspective of the Veterans Affairs Health Care System. The outcome was the incremental cost-effectiveness of tiotropium versus ipratropium. RESULTS: The incremental cost-effectiveness ratio (ICER) was $2360 per avoided exacerbation. Tiotropium cost-effectiveness increased with COPD severity and was cost-saving in patients with very severe disease (ICER = $-1818) and in patients with a previous COPD-related hospitalization (ICER = $-4472). The ICER was most sensitive to the relative effectiveness and price of tiotropium. Results identified the levels of treatment effectiveness and price beyond which tiotropium would become cost-saving relative to ipratropium. CONCLUSIONS: The results support the existing Veterans Affairs practice of offering tiotropium to patients with COPD-related hospitalizations. Periodic review of the effectiveness data to determine whether tiotropium would be cost-saving in patients with very severe COPD is suggested. Cost-effectiveness analyses that identify practical criteria-for-use should become an integral part of the formulary process.

Expected value of perfect information: an empirical example of reducing decision uncertainty by conducting additional research.

OBJECTIVE: Value of information (VOI) analysis informs decision-makers about the expected value of conducting more research to support a decision. This expected value of (partial) perfect information (EV(P)PI) can be estimated by simultaneously eliminating uncertainty on all (or some) parameters involved in model-based decision-making. This study aimed to calculate the EVPPI, before and after collecting additional information on the parameter of a probabilistic Markov model with the highest EVPPI. METHODS: The model assessed the 5-year costs per quality-adjusted life year (QALY) of three bronchodilators in chronic obstructive pulmonary disease (COPD). It had identified tiotropium as the bronchodilator with the highest expected net benefit. Total EVPI was estimated plus the EVPPIs for four groups of parameters: 1) transition probabilities between COPD severity stages; 2) exacerbation probabilities; 3) utility weights; and 4) costs. Partial EVPI analyses were performed using one-level and two-level sampling algorithms. RESULTS: Before additional research, the total EVPI was Euro 1985 per patient at a threshold value of Euro 20,000 per QALY. EVPPIs were Euro 1081 for utilities, Euro 724 for transition probabilities, and relatively small for exacerbation probabilities and costs. A large study was performed to obtain more precise EQ-5D utilities by COPD severity stages. After using posterior utilities, the EVPPI for utilities decreased to almost zero. The total EVPI for the updated model was reduced to Euro 1037. With an EVPPI of Euro 856, transition probabilities were now the single most important parameter contributing to the EVPI. CONCLUSIONS: This VOI analysis clearly identified parameters for which additional research is most worthwhile. After conducting additional research on the most important parameter, i.e., the utilities, total EVPI was substantially reduced.

Exploratory economic evaluation of patients with COPD on a combination product versus individual components (ipratropium bromide and albuterol).

A population-based, retrospective claims analysis was undertaken to explore the economic profile of a nebulized ipratropium and albuterol combination product (DuoNeb(R) [DN], DEY, L.P., Napa, Calif). This analysis was performed to review expenditures and resource utilization of patients with chronic obstructive pulmonary disease (COPD) who were taking DN or generic ipratropium and albuterol (dual single agents [DSA]). Cohort selection criteria applied to the PharMetrics managed care claims database yielded 1531 patients: 468 DN and 1063 DSA. Total per-member-per-month (PMPM) expenditures were $1,840.36 for DN and $2,046.73 DSA (Delta$206.37; P=.22). Emergency department (ED) costs were $36.67 for DN and $52.84 for DSA (Delta$16.17; P=.03). Differences in regression analysis adjusted least squares means between DSA and DN were $264.62 (P=.083) for total expenditures and $20.81 (P=.03) for ED costs. Resource utilization reflected expenditure observations; ED visits were 0.93 for DN and 1.33 for DSA (P<.001). Inpatient expenditures (DN $874.97, DSA $1,105.80; Delta$230.83) represented the largest portion of total costs: 45% with DN and 54% with DSA. The DN cohort was associated with statistically fewer individuals who reported interruptions (0.78 vs 0.85; P=.003). The DN cohort did not appear to be more expensive than the DSA group, was associated with statistically lower ED expenditures, and included fewer individuals with therapy interruptions. Future analyses should include clinical data to better elucidate the full impact of DN on healthcare resources and compliance in the COPD population.

Comparison of hospitalizations, emergency department visits, and costs in a historical cohort of Texas Medicaid patients with chronic obstructive pulmonary disease, by initial medication regimen.

BACKGROUND: Limited information is available on the relative outcomes and treatment costs of various pharmacotherapies for chronic obstructive pulmonary disease (COPD) in a Medicaid population. OBJECTIVE: This study compared the effects of initial medication regimens for COPD on COPD-related and all-cause events (hospitalizations and/or emergency department [ED] visits) and COPD-related and all-cause costs. METHODS: The study population was a historical cohort of Texas Medicaid beneficiaries aged 40 to 64 years with COPD-related medical costs (International Classification of Diseases, Ninth Revision, Clinical Modification codes 491.xx, 492.xx, 496.xx), 24 months of continuous Medicaid enrollment (12 months before and after the index prescription), and at least 1 prescription claim (index) for a combination product containing fluticasone propionate + salmeterol, an inhaled corticosteroid, salmeterol, or ipratropium between April 1, 2001, and March 31, 2003. The analyses of events employed Cox proportional hazards regression, controlling for baseline factors and preindex events. The analyses of costs used a 2-part model with logistic regression and generalized linear model to adjust for baseline characteristics and preindex utilization and costs. RESULTS: The study population included 6793 patients (1211 combination therapy, 968 inhaled corticosteroid, 401 salmeterol, and 4213 ipratropium). Only combination therapy was associated with a significantly lower risk for any COPD-related event (hazard ratio [HR] = 0.733; 95% CI, 0.650-0.826) and any all-cause event (HR = 0.906; 95% CI, 0.844-0.972) compared with ipratropium. COPD-related prescription costs were higher in all cohorts compared with the ipratropium cohort, but COPD-related medical costs were lower, offsetting the increase in prescription costs. For all-cause costs, prescription costs were higher in the combination-therapy cohort (+$415; P < 0.05) and the salmeterol cohort (+$247; P < 0.05) compared with the ipratropium cohort, but significant reductions in all-cause medical costs in the combination-therapy cohort (-$1735; P < 0.05) and salmeterol cohort (-$1547; P < 0.05) more than offset the increase in prescription costs. CONCLUSIONS: In this historical population of Texas Medicaid beneficiaries, the combination-therapy cohort was 27% less likely to have a COPD-related event than the ipratropium cohort, 10% less likely to have any all-cause event, had similar COPD-related costs, and had reduced all-cause costs. Thus, compared with the ipratropium cohort, the combination-therapy cohort had an improvement in outcomes (based on the decreased time to a hospitalization or ED visit), with similar or decreased direct medical costs. Future research is needed in other patient groups.

Cost-effectiveness of long-acting bronchodilators for chronic obstructive pulmonary disease.

OBJECTIVE: To evaluate and compare the cost-effectiveness of long-acting bronchodilators by estimating incremental costs per quality-adjusted life-year (QALY) gained in patients with moderate to severe chronic obstructive pulmonary disease. METHODS: This cost-effective analysis was conducted from a third-party payer's perspective. The study was a retrospective pooled analysis, and the effectiveness evidence was derived from a systematic review of literature published from January 1, 1980, to April 14, 2006. Incremental QALYs were estimated by converting the St George's Respiratory Questionnaire scores into EuroQoL-5D scores and using these combined scores as the summary benefit measure. RESULTS: The incremental cost per additional QALY was $26,094 (range, $11,780-$77,214) for tiotropium and $41,000 (range, $23,650-$98,750) for salmeterol compared with placebo. The cost per QALY gained was lower with tiotropium compared with salmeterol or ipratropium based on either the pooled data of available trials or a head-to-head trial. Treatment with tiotropium could save $391 per year while gaining 13 quality-adjusted days compared with ipratropium. CONCLUSION: Tiotropium appears to be more cost-effective than the alternatives and may be the preferred agent for maintenance therapy in patients with moderate to severe chronic obstructive pulmonary disease. Compared with ipratropium, tiotropium could be cost saving. Because of the wide ranges of cost-effectiveness ratios for tiotropium and salmeterol and the significant overlap between them, a large prospective head-to-head trial would help address the uncertainty and confirm the results of this analysis.

Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain.

Our objective was to assess the 5-year cost effectiveness of bronchodilator therapy with tiotropium, salmeterol or ipratropium for chronic obstructive pulmonary disease (COPD) from the perspective of the Spanish National Health System (NHS). A probabilistic Markov model was designed wherein patients moved between moderate, severe or very severe COPD and had the risk of exacerbation and death. Probabilities were derived from clinical trials. Spanish healthcare utilisation, costs and utilities were estimated for each COPD and exacerbation state. Outcomes were exacerbations, exacerbation-free months, quality-adjusted life years (QALYs), and cost(-effectiveness). The mean (SE) 5-year number of exacerbations was 3.50 (0.14) for tiotropium, 4.16 (0.40) for salmeterol and 4.71 (0.54) for ipratropium. The mean (SE) number of QALYs was 3.15 (0.08), 3.02 (0.15) and 3.00 (0.20), respectively. Mean (SE) 5-year costs were 6,424 euro (305 euro) for tiotropium, 5,869 euro (505 euro) for salmeterol, and 5,181 euro (682 euro) for ipratropium (2005 values). Ipratropium and tiotropium formed the cost-effectiveness frontier, with tiotropium being preferred when willingness to pay (WTP) exceeded 639 euro per exacerbation-free month and 8,157 euro per QALY. In Spain, tiotropium demonstrated the highest expected net benefit for ratios of the willingness to pay per QALY, well within accepted limits.

Utilization of bronchodilators in ventilated patients without obstructive airways disease.

OBJECTIVE: To examine physician practice in, and the costs of, prescribing inhaled bronchodilators to mechanically ventilated patients who do not have obstructive lung disease. METHODS: This was a prospective cohort study at 2 medical intensive care units at 2 tertiary-care academic medical centers, over a 6-month period. Included were the patients who required > or = 24 hours of mechanical ventilation but did not have obstructive lung disease. Excluded were patients who had obstructive lung disease and/or who had undergone > 24 hours of mechanical ventilation outside the study intensive care units. RESULTS: Of the 206 patients included, 74 (36%) were prescribed inhaled bronchodilators without clear indication. Sixty-five of those 74 patients received both albuterol and ipratropium bromide, usually within the first 3 days of intubation (58 patients). Patients prescribed bronchodilators were more hypoxemic; their mean P(aO(2))/F(IO(2)) ratio was lower (188 mm Hg versus 238 mm Hg, p = 0.004), and they were more likely to have pneumonia (53% vs 33%, p = 0.007). The mean extra cost for bronchodilators was 449.35 dollars per patient. Between the group that did receive bronchodilators and the group that did not, there was no significant difference in the incidence of ventilator-associated pneumonia, tracheostomy, or mortality. The incidence of tachyarrhythmias was similar (15% vs 22%, p = 0.25). CONCLUSION: A substantial proportion of mechanically ventilated patients without obstructive lung disease received inhaled bronchodilators.

Cost reduction strategies used by elderly patients with chronic obstructive pulmonary disease to cope with a generic-only pharmacy benefit.

BACKGROUND: Generic-only pharmacy benefits may present more of a burden to patients with chronic disease conditions such as chronic obstructive pulmonary disease (COPD), where generic drug therapy choices are more limited. OBJECTIVE: To evaluate the strategies that elderly patients with COPD use to manage their out-of-pocket (OOP) prescription expenses in a generic-only pharmacy benefit compared with similar patients with a single-tier copayment or a 2-tier pharmacy benefit with coverage of brand formulary drugs. METHODS: Surveys were mailed to a sample of 3,000 Kaiser Permanente (California) patients (aged > or = 65 years) who had a diagnosis for COPD and received at least 1 prescription for a COPD-related medication during 2003. The sample was stratified by type of pharmacy benefit: generic-only, single copayment tier, and 2 copayment tiers. The survey contained questions about strategies used to reduce OOP prescription expenses, such as stop taking a prescribed medication, purchase prescriptions out of the country, or discuss OOP prescription expenses with a physician. The likelihood of using specific strategies to reduce OOP prescription expenses was modeled using logistic regression. Covariates included social support, quality of life, smoking status, socioeconomic status, total prescription costs, and demographics. RESULTS: A total of 1,624 surveys were returned, for a 54% response rate. Results from logistic regressions indicate that COPD patients with a generic-only benefit are significantly more likely to report that they discussed their OOP costs with their physician (odds ratio [OR]=9.02; 95% confidence interval [CI], 6.15- 13.22), purchased their medications from another country (OR=6.70; 95% CI, 3.17-14.16) and reduced spending on food and clothing (OR=4.06; 95% CI, 2.70-6.12). They are also more likely to report that they had taken less than the prescribed amount of a regular medication (OR=1.70; 95% CI, 1.25-2.31) and that they stopped taking one or more of their regular medications (OR=1.77; CI, 1.27-2.47). Patients with low annual household incomes (<25,000 US dollars) were significantly more likely to discuss their OOP costs with their physician (OR=1.47; 95% CI, 1.08-2.00 ) and to reduce spending on food and clothing (OR=1.97; 95% CI, 1.42-2.73) than those with higher incomes. Approximately 15% of COPD patients obtained drug samples from their physicians as a method to reduce OOP costs, and there was no difference among the 3 groups in the prevalence of this cost management strategy. Overall, patients in the generic-only pharmacy benefit used an average of 3 methods to reduce OOP pharmacy costs compared with approximately 1.5 cost reduction methods used by patients in single-tier and 2-tier copayment designs who had coverage of formulary brand as well as generic drugs. CONCLUSION: Elderly patients with COPD and a generic-drug-only pharmacy benefit are more likely to report using a variety of strategies to reduce their OOP costs compared with similar patients with single-tier copayment or 2-tier copayment pharmacy benefits. The most common strategy was discussing OOP costs with their physician, and use of this strategy was inversely related to household income. There was no difference in the proportion of COPD patients among the 3 pharmacy benefit groups that used drug samples from their physicians as a means to reduce OOP costs.

Evaluating the pharmacoeconomic effect of adding tiotropium bromide to the management of chronic obstructive pulmonary disease patients in Singapore.

OBJECTIVE: To perform a pharmacoeconomic analysis on the treatment of chronic obstructive pulmonary disease (COPD) with the addition of tiotropium bromide. METHODS: Pharmacoeconomic modeling was performed utilizing the efficacy of tiotropium bromide from the literature on different settings and severity of COPD. Reductions in exacerbations, hospitalizations, and number of exacerbation days per year were derived from these studies. Cost of drug treatment, exacerbations, hospitalization, and loss of income were derived from local data in Singapore and reported in Singapore dollars (US$1=S$1.71). A model was constructed to calculate the impact of one-year treatment with tiotropium bromide, and the results were reported for the total incremental cost per year, cost per year needed to reduce one hospitalization in one year, and cost-savings from hospitalizations in one year. Sensitivity analysis were performed for different number of patients treated per year, differing cost of hospitalization, different cost for tiotropium bromide, different impact of tiotropium bromide on clinical outcomes, and the different amount of substitution drug utilized in the comparator group. RESULTS: Using the different clinical effects and looking at the impact on treating 1000, 2000, and 10,000 patients per year, most of the results showed a high level of decrease in overall cost per year that ranged from S$145.40 to S$840.37 per patient treated. Cost per year needed to reduce one hospitalization in one year ranged from S$3217.31 to S$18,148.92. Cost-savings from hospitalizations in one year per patient treated ranged from $57.16 to $322.49. This may contribute as high as 83% of the overall cost saving. Sensitivity analysis supports the cost savings finding. CONCLUSION: Adding tiotropium bromide for severe COPD patients would lead to a significant cost savings for the economy.

[Economic value of tiotropium in the treatment of chronic obstructive pulmonary disease]. / Die Wirtschaftlichkeit von Tiotropium (Spiriva) bei chronisch obstruktiver Lungenerkrankung.

The economic value of tiotropium in patients with moderate to severe COPD was analysed in a cost-effectiveness study for the Swiss public health insurance system. The results show a drop in COPD exacerbations in comparison to Ipratropium, Salmeterol and standard care (without use of anticholinergics and beta-adrenergics). The numbers-needed-to-treat of tiotropium in comparison to the other medications in order to avoid severe exacerbations amounted to 8 patients (ipratropium versus tiotropium), 13 patients (standard care versus tiotropium) and 33 patients (salmeterol versus tiotropium) during 12 months. As a result fewer episodes of hospitalisations and shorter hospital stays can be expected. The direct yearly total cost for COPD therapy is CHF 4788 for tiotropium and CHF 5820 for ipratropium. Furthermore, they amount to CHF 4881 and CHF 4920 for salmeterol and standard care. The higher acquisition cost for tiotropium is compensated by fewer exacerbations. No other medication was similarly cost-effective with regard to total cost and number of exacerbations.

[Cost-effectiveness analysis of tiotropium compared to ipratropium and salmeterol]. / Análisis del coste-eficacia del tiotropio frente al ipratropio y salmeterol.

OBJECTIVE: The constant increase in health care costs, in a context of limited resources and the appearance of more costly though more effective drugs, justifies an assessment of the pharmacoeconomics of these drugs. The objective of this study was to evaluate the cost-effectiveness of one of the newest drugs for the treatment of chronic obstructive pulmonary disease (COPD)-tiotropium. MATERIAL AND METHOD: A cost-effectiveness analysis (costs and outcomes) within the framework of the Spanish National Health System was done. The alternatives to tiotropium analyzed were ipratropium and salmeterol. Direct health care costs associated with hospital treatment were calculated. Forced expiratory volume in 1 second, quality of life (with the Saint George's Respiratory Questionnaire), dyspnea transitional index, mean stay in hospital, and exacerbations were the variables used to measure effectiveness. Values for these variables were taken from the main reviews and randomized clinical trials published for tiotropium. RESULTS: For COPD patients, treatment with tiotropium leads to a greater reduction in exacerbations (37% compared to ipratropium and 25% compared to salmeterol 25%), and a reduction in the number of days in hospital (33% compared to ipratropium and 14% compared to salmeterol). Therefore, use of tiotropium could save ;100 000 for the current rates of admission and lengths of hospital stay in Spain. CONCLUSIONS: Tiotropium was more effective than ipratropium and salmeterol as measured by objective clinical variables (forced expiratory volume in 1 second) and subjective ones (the Saint George's Respiratory Questionnaire and dyspnea transitional index). Hospital stays were shorter and exacerbations fewer with tiotropium. In all cases, tiotropium was more cost-effective than the alternatives, thus use of tiotropium could help hospitals to save money.