Costs associated with adverse events in patients with metastatic renal cell carcinoma.

OBJECTIVE: To estimate adverse event (AE) costs in patients receiving targeted therapies for the first line treatment of metastatic renal cell carcinoma (mRCC). METHODS: Retrospective study based on healthcare claims data for patients with mRCC, aged ≥18 years, receiving first-line treatment with targeted therapies. AEs of interest comprised of abdominal pain, back pain, diarrhea, dyspnea, extremity pain, fatigue/asthenia, hand-foot syndrome, hypertension, lymphopenia, nausea/vomiting, neutropenia, proteinuria, and thrombocytopenia. Healthcare encounters for AEs were based on ICD-9-CM diagnosis/procedure codes on healthcare claims. AE costs were examined over a 30-day period, beginning with the date of first mention of AE, and were estimated based on the difference in total costs between patients with and without events. Drug costs of targeted agents were excluded from the analysis. Multivariate generalized linear models with a log-link function and gamma response probability distribution were utilized to control for differences in baseline characteristics between patients with and without evidence of AEs. RESULTS: A total of 533 patients were included in this analysis: 418 patients with AE and 115 patients without AE. Baseline characteristics were generally similar between patients in the two groups. The GLM-based estimate of incremental 30-day post-event costs among patients with evidence of any adverse events was $9807 (95% CI = $4386-$22,947). For all types of adverse events examined, the estimated difference in costs between evented and non-evented patients was positive; the 95% CI did not include zero for all of the adverse events considered, except hypertension and proteinurea. Study limitations include errors of commission/omission, especially as they may affect case-finding methods that rely on ICD-9-CM diagnosis and procedure codes, as was the case in the current study. CONCLUSION: Costs associated with AEs of first-line targeted therapies are substantial in patients with mRCC. Efforts to prevent and/or better manage these events may reduce overall healthcare costs.

Epidemiology, treatment patterns, and outcomes of metastatic soft tissue sarcoma in a community-based oncology network.

Purpose. To assess epidemiology, treatment patterns, and outcomes of metastatic soft tissue sarcoma (mSTS) patients in USA community oncology practices. Methods. This retrospective, descriptive study used US Oncology's iKnowMed electronic health records database. Adults (≥18 years) with mSTS and at least two visits between July 2007 and June 2010 were included. Key outcomes were practice patterns, overall survival (OS), and progression-free survival (PFS). Results. 363 mSTS patients (174 treated and 189 untreated) met the prespecified exclusion/inclusion criteria. The most common subtypes were leiomyosarcoma (n = 104; 29%), liposarcoma (n = 40; 11%), and synovial sarcoma (n = 12; 3%); the remainder (n = 207; 57%) comprised 27 histologic subtypes. Treated patients were younger and had lower ECOG scores; 75% and 25% received first-line combination or monotherapy, respectively. Median OS of treated and untreated patients was 22 and 17 months, respectively, and 29 months in patients with the three most common subtypes. Before controlling for effects of covariates, younger age and lower ECOG scores were associated with better OS and PFS. Conclusion. This study provides insights into mSTS epidemiology, treatment patterns, and outcomes in a large community-based oncology network. These results warrant further studies with larger cohorts.

Economic burden of adverse events in patients with metastatic renal cell carcinoma.

BACKGROUND: Although targeted therapies (ie, tyrosine kinase inhibitors and antiangiogenesis agents) are effective as first-line treatment of metastatic renal cell carcinoma (mRCC), moderate-to-severe adverse events have been reported in clinical trials of these agents. Information concerning the economic burden of these events is limited. OBJECTIVE: The purpose of this study was estimate the costs associated with adverse events in patients with mRCC receiving selected targeted agents indicated for first-line treatment of this disease. METHODS: Retrospective study based on health care claims data for patients with mRCC, aged ≥18 years, receiving first-line treatment with targeted therapies. Adverse events of interest included abdominal pain, back pain, diarrhea, dyspnea, extremity pain, fatigue and/or asthenia, hand-foot syndrome, hypertension, lymphopenia, nausea and/or vomiting, neutropenia, proteinuria, and thrombocytopenia. Patients receiving care for these events were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis and procedure codes on health care claims. Costs were examined during a 30-day period, beginning with date of first mention of each event; nonevented patients similarly were assigned a shadow index date. We estimated total costs during 30 days after the index date for patients with and without adverse events, excluding the costs of targeted therapy. RESULTS: Sixty-four percent of patients receiving targeted therapies for mRCC had health care encounters for ≥1 adverse events. Events that occurred with a frequency >20% included severe abdominal pain, back pain, fatigue and/or asthenia, and nausea and/or vomiting, respectively; 10% to 20% of patients had encounters for diarrhea, dyspnea, and extremity pain, respectively. Mean (SD) total costs of care during the 30-day, postevent period were substantially higher among patients with versus without adverse events-$12,177 ($19,621) versus $4070 ($8142). Adjusting for differences in baseline characteristics, the estimated cost difference was $11,373 (95% CI, $5286-$21,419). CONCLUSIONS: Costs of adverse events are substantial in patients receiving targeted therapies, specifically, sunitinib, sorafenib, or bevacizumab, for mRCC. Efforts to prevent and/or better manage these events may reduce health care costs.

Treatment patterns: targeted therapies indicated for first-line management of metastatic renal cell carcinoma in a real-world setting.

BACKGROUND: Limited information on real-world treatment patterns of targeted agents for metastatic renal cell carcinoma (mRCC) is available to inform their use in clinical practice. PATIENTS AND METHODS: This retrospective observational study used US claims data (from January 2007 to November 2010) to identify treatment patterns, including treatment duration and dosing, for molecular-targeted agents (sunitinib, sorafenib, pazopanib, bevacizumab, and temsirolimus) indicated in first-line management of advanced and/or mRCC. The study included adult patients with mRCC who were observable for ≥3 months after initiation of their first-line therapy with a targeted agent. Descriptive analyses were conducted for observed treatment patterns. RESULTS: Of the 273 patients on first-line therapy identified and included in the sample, 235 patients were treated with sunitinib, 16 patients with sorafenib, and 15 patients with temsirolimus. Pazopanib and bevacizumab were excluded from the analysis due to the small sample size, n < 10. The median observed treatment durations were sunitinib 98 days, sorafenib 121 days, and temsirolimus 78 days. Approximately 76% (178/235) of patients who received sunitinib initiated therapy at the indicated dose of 50 mg; 65% of these patients were not observed filling a fourth prescription, whereas 23% maintained their starting dose and 12% experienced dose reduction at their 4+ fill. The mean starting dose for patients who initiated on sorafenib (n = 16) was 725 mg and for temsirolimus (n = 15) was 25 mg: their study samples were insufficient for further, meaningful dosing analyses. CONCLUSIONS: Results of this study suggest that opportunities exist to improve treatment duration in clinical practice and to better understand influences on treatment and dose changes.

Healthcare costs in patients with metastatic lung cancer receiving chemotherapy.

BACKGROUND: To characterize healthcare resource utilization and costs in patients with metastatic lung cancer receiving chemotherapy in the US. METHODS: Using data from a large private multi-payer health insurance claims database (2000-2006), we identified all patients beginning chemotherapy for metastatic lung cancer. Healthcare resource use (inpatient, outpatient, medications) and costs were tallied over time from date of therapy initiation ("index date") to date of disenrollment from the health plan (in most instances, presumably due to death) or the end of the study period, whichever occurred first. Healthcare utilization and costs were characterized using Kaplan-Meier sample average methods. RESULTS: The study population consisted of 4068 patients; mean (SD) age was 65 (11) years. Over a median follow-up of 334 days, study subjects averaged 1.5 hospital admissions, 8.9 total inpatient days, and 69 physician office and hospital outpatient visits. Mean (95% CI) cumulative total healthcare costs were $125,849 ($120,228, $131,231). Costs of outpatient medical services and inpatient care constituted 34% and 20% of total healthcare costs, respectively; corresponding estimates for outpatient chemotherapy and other medication were 22% and 24%. CONCLUSION: Our study sheds additional light on the burden of metastatic lung cancer among patients receiving chemotherapy, in terms of total cost thru end of life as well as component costs by setting and type of service, and may be useful in informing medical resource allocation in this patient population.

Healthcare costs in women with metastatic breast cancer receiving chemotherapy as their principal treatment modality.

BACKGROUND: The economic costs of treating patients with metastatic breast cancer have been examined in several studies, but available estimates of economic burden are at least a decade old. In this study, we characterize healthcare utilization and costs in the US among women with metastatic breast cancer receiving chemotherapy as their principal treatment modality. METHODS: Using a large private health insurance claims database (2000-2006), we identified all women initiating chemotherapy for metastatic breast cancer with no evidence of receipt of concomitant or subsequent hormonal therapy, or receipt of trastuzumab at anytime. Healthcare utilization and costs (inpatient, outpatient, medication) were estimated on a cumulative basis from date of chemotherapy initiation ("index date") to date of disenrollment from the health plan or the end of the study period, whichever occurred first. Study measures were cumulated over time using the Kaplan-Meier Sample Average (KMSA) method; 95% CIs were generated using nonparametric bootstrapping. Findings also were examined among the subgroup of patients with uncensored data. RESULTS: The study population consisted of 1444 women; mean (SD) age was 59.1 (12.1) years. Over a mean follow-up of 532 days (range: 3 to 2412), study subjects averaged 1.7 hospital admissions, 10.7 inpatient days, and 83.6 physician office and hospital outpatient visits. Mean (95% CI) cumulative total healthcare costs were $128,556 ($118,409, $137,644) per patient. Outpatient services accounted for 29% of total costs, followed by medication other than chemotherapy (26%), chemotherapy (25%), and inpatient care (20%). CONCLUSIONS: Healthcare costs-especially in the outpatient setting--are substantial among women with metastatic breast cancer for whom treatment options other than chemotherapy are limited.

Healthcare costs in postmenopausal women with hormone-positive metastatic breast cancer.

OBJECTIVES: This study examines costs for postmenopausal women with hormone receptor positive (HR+) metastatic breast cancer (mBC). METHODS: Data were obtained from the IHCIS National Managed Care Benchmark Database from 1/1/2001 to 6/30/2006. Women aged 55-63 years were selected for the study if they met the inclusion criteria, including diagnoses for breast cancer and metastases, and at least two fills for a hormone medication. Patients were followed from the onset of metastases until the earliest date of disenrollment from the health plan or 6/30/2006. Patient characteristics were examined at time of initial diagnoses of metastases, while costs were examined post-diagnosis of metastases and prior to receipt of chemotherapy (pre-chemotherapy initiation period) and from the date of initial receipt of chemotherapy until end of data collection (post-chemotherapy initiation period). Costs were adjusted to account for censoring of the data. RESULTS: The study population consisted of 1,266 women; mean (SD) age was 59.05 (2.57) years. Pre-chemotherapy initiation, unadjusted inpatient, outpatient, and drug costs were $4,392, $47,731, and $5,511, while these costs were $4,590, $57,820, and $38,936 per year, respectively, post-chemotherapy initiation. After adjusting for censoring of data, total medical costs were estimated to be $55,555 and $70,587 in the first 12 months and 18 months, respectively in the pre-chemotherapy initiation period. Post-chemotherapy initiation period, 12-month and 18-month adjusted total medical costs were estimated to be $87,638 and $130,738. LIMITATIONS: The use of an administrative claims database necessitates a reliance upon diagnostic codes, age restrictions, and medication use, rather than formal assessments to identify patients with post-hormonal women with breast cancer. Furthermore, such populations of insured patients may not be generalizable to the population as a whole. CONCLUSIONS: These findings suggest that healthcare resource use and costs - especially in the outpatient setting - are high among women with HR+ metastatic breast cancer.

Cost-effectiveness of early versus late cinacalcet treatment in addition to standard care for secondary renal hyperparathyroidism in the USA.

OBJECTIVES: The objective of this research was to estimate lifetime cost-effectiveness of treating patients with cinacalcet early (when parathyroid hormone [PTH] levels are in the range of 300-500 pg/ml) versus delaying treatment with cinacalcet (cinacalcet initiated when PTH levels are > 800 pg/ml) in patients with secondary hyperparathyroidism (SHPT) in the US setting. METHODS: A Markov model was developed to simulate the effects of early versus delayed use of cinacalcet (plus standard of care). Four different PTH ranges (< or = 300 pg/ml; 301-500 pg/ml; 501-800 pg/ml; > 800 pg/ml) were used to represent four different health states within the Markov model. Associated with each Markov state (PTH range) were varying risks of major SHPT complications, including cardiovascular disease (CVD), fracture (Fx), and parathyroidectomy (PTx). Baseline cohort characteristics and risks of CVD, Fx, and PTx by PTH category were derived from a large US renal database and published sources. Costs were estimated from the US Renal Data System database and reported in 2006 US Dollars ($). Clinical and economic outcomes were discounted at 3.0% per annum. RESULTS: Early treatment was projected to improve quality-adjusted life years (QALYs) by 0.337 years compared to delaying treatment. The incremental cost-effectiveness ratio was $17,275 per QALY gained. CONCLUSIONS: Early treatment with cinacalcet was associated with improvements in QALYs and would represent good value for money compared to delaying treatment with cinacalcet.

Adherence to K/DOQI practice guidelines for bone metabolism and disease.

OBJECTIVE: To determine adherence to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for frequency of testing and control of parathyroid hormone (PTH), calcium, and phosphorus levels among patients with chronic kidney disease (CKD). STUDY DESIGN: Retrospective cohort. METHODS: The analysis was performed with administrative claims data from large US managed care plans. Patients with CKD were identified based on claims and laboratory data. Patients were excluded if they were <18 years or >or=65 years old, had fewer than 18 months of continuous eligibility, or had renal cancer. RESULTS: A total of 793 patients were identified with CKD stages 3, 4, or 5 (n = 424, n = 212, and n = 157, respectively). Serum calcium testing was conducted according to guidelines (once a year) in a high percentage of patients with stage 3 CKD (91%); however, the percentage dropped among patients with stage 4 CKD (64%), for whom the guidelines recommend testing 4 times a year. Plasma PTH and serum phosphorus levels were tested infrequently. Among those tested, a high percentage of both stage 3 and 4 CKD patients were in K/DOQI target ranges for calcium and phosphorus. However, fewer than half of the patients tested had PTH values within the target ranges. CONCLUSION: There remains substantial opportunity to improve the quality of care with respect to bone and mineral metabolism in patients with CKD.

A cost-effectiveness analysis of first-line controller therapies for persistent asthma.

BACKGROUND: Asthma is one of the most common chronic diseases in the US, and its prevalence continues to increase. Despite the availability of effective asthma controller medications, many patients with asthma are still not meeting therapeutic goals because of poor disease management. The high disease prevalence combined with the high costs associated with the poor management of asthma, make patients with asthma a costly group to treat for managed care organisations (MCOs) and this motivates decision makers in MCOs to consider both the clinical and economic value of asthma therapies. OBJECTIVE: To compare the cost effectiveness of first-line controller asthma therapies in patients with mild-to-moderate persistent asthma from an MCO payer perspective. METHODS: A decision-analysis model was developed to evaluate the cost effectiveness of fluticasone propionate and salmeterol administered in a single inhaler (salmeterol/fluticasone propionate 50/100microg), compared with fluticasone propionate inhaled corticosteroids (FPIC), non-fluticasone propionate inhaled corticosteroids (nFPIC) and leukotriene modifiers. The model estimated costs ($US, year 2005 values) and health outcomes over a 1-year period. Costs and outcomes data were obtained from published clinical trials and observational studies, and model assumptions on the relationship between adherence and effectiveness were evaluated by a panel of experts. Effectiveness measures included symptom-free days and rescue medication-free days. The cost effectiveness of first-line asthma therapies was compared using a step-wise approach, with FPIC as the reference case. Both one-way and probabilistic sensitivity analyses were performed to assess the robustness of results over a range of assumptions. RESULTS: The step-wise comparison found that the additional costs for achieving an incremental effectiveness unit (incremental cost-effectiveness ratio) using single-inhaler salmeterol/fluticasone propionate compared with FPIC was $US9.55 per symptom-free day and $US8.93 per rescue medication-free day. Sensitivity analyses indicated that the model was robust to changes in base-case assumptions. A probabilistic sensitivity analysis showed that, corresponding to a benchmark value of $US14.8 per symptom-free day, the probabilities that single-inhaler salmeterol/fluticasone propionate, n-FPIC and leukotriene modifiers were more cost effective than FPIC were 98%, 30.7% and 2.1%, respectively. CONCLUSION: Based on our decision analysis, the additional costs for achieving incremental effectiveness with single-inhaler salmeterol/fluticasone propionate treatment compared with FPIC and nFPIC may be lower than the commonly accepted benchmark value for cost effectiveness, based on published estimates of the utility losses associated with asthma symptoms. Single-inhaler salmeterol/fluticasone propionate may also be more cost effective than leukotriene modifiers.

Economic burden of cardiovascular events and fractures among patients with end-stage renal disease.

OBJECTIVE: To quantify direct medical costs of fractures and cardiovascular diseases among end-stage renal disease (ESRD) patients. METHODS: Medicare claims data from year 2001 of the United States Renal Data System were used to quantify direct medical costs of acute episodic events (acute myocardial infarction (MI), stroke, heart valve repair, heart valve replacement, fractures) and chronic conditions (arrhythmia, peripheral vascular disease (PVD), heart valve disease (HVD), congestive heart failure (CHF), coronary heart disease, and non-acute stroke). Costs of hospitalized episodes of arrhythmia, PVD, CHF, and angina were also quantified. For acute events, costs were quantified using an episode-of-care approach. For chronic conditions, annualized costs were reported. Only costs specific to the events or conditions of interest were included and reported, in 2006 US dollars. Drug and dialysis-related costs were excluded. Diagnosis and procedure codes were used to identify these events and conditions. RESULTS: Among acute events analyzed as clinical episodes, PVD ($358 million) was associated with the greatest economic burden, followed by CHF, arrhythmia, angina, acute MI, heart valve replacement, hip fracture, acute stroke, heart valve repair, vertebral fracture, and pelvic fracture ($8.6 million). The cost per episode ranged from approximately $12,000 to 104,000. Among chronic conditions, CHF ($681 million) contributed the greatest economic burden; HVD ($100 million) contributed the least. The costs per patient-year ranged from $23,000 to 45,000 among chronic conditions. The costing methodology utilized could contribute to an underestimate of the economic impact of each condition; therefore these results are considered conservative. CONCLUSION: The economic burden of these selected conditions was substantial to health services payers who finance ESRD patient care. Episodic costs were high for most acute events.

Determining economic feasibility of fluticasone propionate-salmeterol vs montelukast in the treatment of persistent asthma using a net benefit approach and cost-effectiveness acceptability curves.

BACKGROUND: The choice of treatment can have a major impact on the total costs associated with asthma care. OBJECTIVE: To determine the relative cost-effectiveness of twice-daily treatment with inhaled fluticasone propionate-salmeterol via Diskus, 100/50 microg, with that of once-daily treatment with oral montelukast as initial maintenance therapy in patients with persistent asthma uncontrolled with a short-acting beta2-agonist alone. METHODS: Data from a randomized, double-blind, double-dummy, 12-week clinical trial were analyzed. Efficacy end points included (1) symptom-free days (SFDs) during the 12-week period and (2) a 12% or greater increase in forced expiratory volume in 1 second (FEV1) from baseline. The economic analysis was performed from a payer's perspective, and hence only direct costs were included in the analysis. The incremental cost-effectiveness ratio (ICER), which is the mean difference in average costs divided by the mean difference in average effectiveness, was calculated for both effectiveness outcomes (SFDs and FEV1). RESULTS: For the SFDs end point, the ICER for fluticasone propionate-salmeterol vs montelukast was $2.87 (95% confidence interval, -$1.08 to $6.65), indicating that it costs, on average, an extra $2.87 per day for an additional SFD with fluticasone propionate-salmeterol than with montelukast. With regard to FEV1, the ICER was $1.79 (95% confidence interval, -$0.72 to $3.86), indicating that it costs, on average, an extra $1.79 per day to achieve a lung function improvement of 12% or greater from baseline with fluticasone propionate-salmeterol than with montelukast. At a widely acceptable ceiling ratio of $9.95 per day, the probability of fluticasone propionate-salmeterol being more cost-effective than montelukast was 99.8% for SFDs and was almost 100% for an FEV1 improvement of 12% of greater. CONCLUSIONS: Treating 2 main components of asthma, inflammation and smooth muscle dysfunction, using fluticasone propionate-salmeterol is more cost-effective than using a single mediator antagonist alone, such as montelukast, as initial maintenance therapy for persistent asthma in patients treated with a short-acting beta2-agonist only.

A comparison of the risk of hospitalizations due to chronicobstructive pulmonary disease in medicaid patients with various medication regimens, including ipratropium, inhaled corticosteroids, salmeterol, or their combination.

OBJECTIVE: The aim of this study was to compare the risk of hospitalizations related to chronic obstructive pulmonary disease (COPD) among Medicaid patients prescribed various medication regimens. METHODS: This was an observational, retrospective study set in the Texas Medicaid program. Eligible patients were aged 40 to 65 years, had a primary or secondary diagnosis of COPD, and had >/=1 prescription for ipratropium (IPR), inhaled corticosteroids (ICS), or salmeterol (SAL) between January 1, 1998, and August 31, 2000. Five index therapy groups were included in the risk analysis: IPR alone, ICS alone, SAL alone, ICS + IPR, and ICS + SAL. RESULTS: A total of 4447 patients were included in the study (IPR alone, n = 2435; ICS alone, n = 1088; SAL alone, n = 299; ICS + IPR, n = 410; and ICS + SAL, n = 215). After adjusting for baseline characteristics, ICS + SAL was associated with a 35% lower risk of COPD-related hospitalization (hazard ratio [HR], 0.653 [95% CI, 0.428-0.997]) versus IPR alone. ICS alone was associated with a 16% lower risk (HR, 0.844 [95% CI, 0.693-1.028]) and SAL alone was associated with a 24% lower risk (HR, 0.756 [95% CI, 0.539-1.060]) versus IPR alone, but neither of these was statistically significant. There was no decrease in risk with ICS + IPR versus IPR alone (HR, 1.111 [95% CI, 0.870-1.420]). Variables that indicated increased risk were as follows: increasing age (HR, 1.015 [95% CI, 1.003-1.027]); number of preindex emergency department visits (HR, 1.189 [95% CI, 1.080-1.309]); number of preindex hospitalization visits (HR, 1.342 [95% CI, 1.220-1.477] ); number of nonrespiratory comorbid diagnoses (HR, 1.046 [95% CI, 1.012-1.081]); and having a diagnosis of influenza/pneumonia (HR, 1.276 [95% CI, 1.062-1.533]) or other respiratory diseases (HR, 1.356 [95% CI, 1.134-1.622]). Comorbid asthma was not associated with increased risk. CONCLUSIONS: ICS + SAL was associated with a significantly lower risk of COPD-related hospitalization compared with IPR alone during the initial 12 months of therapy in a Medicaid population. Additional studies are needed to confirm these findings across different populations.

Assessing predictors of influenza and pneumonia vaccination in rural senior adults.

The overall purpose of this study was to identify predictors of influenza and pneumonia vaccination among rural senior adults. A mail survey was conducted in eight rural counties. Reported immunization rate for influenza (81.5%) among respondents was higher as compared to pneumonia (74.7%). Knowing someone with influenza was the strongest predictor of influenza vaccination, and knowing someone with pneumonia was the strongest predictor of pneumonia vaccination. Belief that vaccinations are always beneficial was also a significant predictor. While several of the findings of this study are consistent with factors reported in literature to be significant predictors of immunization behavior for this age group, surprisingly, access was not a significant predictor for this rural sample.

Cost effectiveness of fluticasone propionate plus salmeterol versus fluticasone propionate plus montelukast in the treatment of persistent asthma.

BACKGROUND: Asthma is a chronic disease, the two main components of which are inflammation and bronchoconstriction. Fluticasone propionate (FP) and salmeterol, a strategy that treats both main components of asthma, has been recently compared with FP plus montelukast in a randomised clinical trial. The present study reports economic evaluation of these two strategies. OBJECTIVE: To determine the relative cost effectiveness when persistent asthma is treated with FP/salmeterol 100/50 microg twice daily administered via a single Diskus inhaler device versus treatment with FP 100 microg twice daily via a Diskus inhaler plus oral montelukast 10mg once daily. STUDY DESIGN: A cost-effectiveness analysis was performed by applying cost unit data to resource utilisation data collected prospectively during a US randomised, double-blind, 12-week trial of FP/salmeterol (n = 222) versus FP + montelukast (n = 225). Patients were > or =15 years of age and were symptomatic despite inhaled corticosteroid (ICS) therapy. PATIENTS AND METHODS: Efficacy measurements in this analysis included improvement in forced expiratory volume in 1 second (FEV(1)) and symptom-free days. Direct costs included those related to study drugs, emergency room department visits, unscheduled physician visits, treatment of drug-related adverse events (oral candidiasis), and rescue medication (salbutamol [albuterol]). The study assumed a US third-party payer's perspective with costs in 2001 US dollars. RESULTS: Treatment with FP/salmeterol resulted in a significantly higher proportion (p < 0.001) of patients who achieved a > or =12% increase in FEV(1) than treatment with FP + montelukast (54% [95% CI 47%, 61%] vs 32% [95% CI 26%, 38%]). Lower daily costs and greater efficacy of FP/salmeterol resulted in a cost-effectiveness ratio of US6.77 dollars (95% CI US5.99 dollars, US7.66 dollars) per successfully treated patient in the FP/salmeterol group compared with US14.59 dollars (95% CI US12.12 dollars, US17.77 dollars) for FP + montelukast. In addition, FP/salmeterol achieved similar efficacy in terms of symptom-free days compared with FP + montelukast (31% [95% CI 26%, 35%] vs 27% [95% CI 23%, 32%]), but at a significantly lower daily per-patient cost (US3.64 dollars [95% CI US3.60, US3.68 dollars] vs US4.64 dollars [95% CI US4.56 dollars, US4.73 dollars]). Sensitivity analyses demonstrated the stability of the results over a range of assumptions. CONCLUSION: From a US third-party payer's perspective, these findings suggest that treating the two main components of asthma (inflammation and bronchoconstriction) with FP/salmeterol may not only be a more cost-effective strategy but may actually lead to cost savings compared with the addition of montelukast to low-dose FP in patients with persistent asthma. The results were found to be robust over a range of assumptions.

Immunization predictors in rural adults under 65 years of age.

The specific study goal was to identify predictors of influenza and pneumonia immunizations in rural adults 18 to 64 years of age in Appalachia. The survey data used were collected from 931 adults from eight rural counties as part of a larger study. Information collected included influenza and pneumonia vaccination status, demographic and insurance coverage information, and immunization-related knowledge and beliefs. Immunization rates were 41.3 percent for influenza and 19.9 percent for pneumonia. Logistic regression analysis indicated that perceived disease susceptibility, perceived benefit, perceived harm, and insurance coverage for immunizations were significant predictors of both types of immunization, with insurance coverage being the strongest predictor. The findings can be used in development of promotional campaigns for increasing immunizations in this underserved rural population.

Assessing predictors of influenza and pneumonia vaccination in rural senior adults.

The overall purpose of this study was to identify predictors of influenza and pneumonia vaccination among rural senior adults. A mail survey was conducted in eight rural counties. Reported immunization rate for influenza (81.5%) among respondents was higher as compared to pneumonia (74.7%). Knowing someone with influenza was the strongest predictor of influenza vaccination and knowing someone with pneumonia was the strongest predictor of pneumonia vaccination. Belief that vaccinations are always beneficial was also a significant predictor. While several of the findings of this study are consistent with factors reported in literature to be significant predictors of immunization behavior for this age group, surprisingly, access was not a significant predictor for this rural sample.

Cost-effectiveness comparison of salmeterol/fluticasone propionate versus montelukast in the treatment of adults with persistent asthma.

OBJECTIVE: To compare the relative cost effectiveness of salmeterol (50 microg)/ fluticasone propionate (100 microg) with that of oral montelukast (10mg) as initial maintenance therapy in patients with persistent asthma uncontrolled on short-acting beta2-agonist therapy alone. STUDY DESIGN: A cost-effectiveness analysis was performed based on effectiveness and resource utilisation data that was prospectively collected from a randomised, double-blind, double-dummy, 12-week trial. PATIENTS AND METHODS: Patients (>15 years of age) who had asthma for at least 6 months. Effectiveness measurements in this analysis included improvement in forced expiratory volume in 1 second (FEV(1)) and symptom-free days (SFDs). Cost of asthma drug treatment as well as costs related to an asthma exacerbation were used in the cost analysis. The study assumed a payer's perspective. All costs are in 2001 US dollars. RESULTS: Of the 423 patients eligible for the study, 211 were randomised to salmeterol/fluticasone propionate and 212 to montelukast. Treatment with salmeterol/fluticasone propionate resulted in a significantly higher proportion of patients who achieved a 12% increase in FEV(1) (successful treatment) [salmeterol/fluticasone propionate: 71% vs montelukast: 39%; p < 0.001] and percentage of SFDs (salmeterol/fluticasone propionate: 46.8% vs montelukast: 21.5%; p < 0.001) compared with montelukast. The mean daily costs per successfully treated patient were lower in the salmeterol/fluticasone propionate group (US dollars 5.03, 95% CI US dollars 4.61 to US dollars 5.50) compared with the montelukast group (US dollars 8.25, 95% CI US dollars 6.98 to US dollars 9.93). Furthermore, per patient mean daily cost per SFD was lower with salmeterol/fluticasone propionate (US dollars 7.63, 95% CI US dollars 6.90 to US dollars 8.50) compared with montelukast (US dollars 14.89, 95% CI US dollars 12.36 to US dollars 17.98). Incremental cost-effectiveness ratios (ICERs) showed that the additional costs to achieve these benefits with salmeterol/fluticasone propionate were minimal. With regards to improvement in lung function, the ICER was US dollars 1.33 (95% CI US dollars 0.80 to US dollars 2.02) and with regards to SFD, the ICER was US dollars 1.69 (95% CI US dollars 1.01 to US dollars 2.48). Sensitivity analysis demonstrated the stability of the results over a range of assumptions. CONCLUSIONS: From a third-party payer perspective, this analysis shows that based on increased efficacy and only a slight increase in cost, twice-daily treatment with salmeterol/fluticasone propionate is more cost effective than once-daily treatment with montelukast as initial maintenance therapy for persistent asthma. This finding complements the results of the clinical analyses indicating that treatment of both inflammation and bronchoconstriction with products such as salmeterol/ fluticasone propionate may be more cost effective as initial maintenance asthma therapy than the use of leukotriene modifiers such as montelukast.