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Biomedical subjects

S D Sullivan

Publications and source records attributed to S D Sullivan.

At least 19 recordsLinked to original sources
PubMed2005

Cost effectiveness of inhaled steroid withdrawal in outpatients with chronic obstructive pulmonary disease.

BACKGROUND: The evidence for the effectiveness and safety of inhaled corticosteroids (ICS) in chronic obstructive pulmonary disease (COPD) is inconclusive. This study determined the cost effectiveness of withdrawing fluticasone propionate (FP) in outpatients with COPD. METHODS: The cost effectiveness analysis was based on a randomised, placebo controlled FP withdrawal study. After a 4 month run in period on FP, patients were randomly assigned to continue FP 500 microg twice daily or to receive placebo for 6 months. A decision analytical model evaluated the 6 month incremental cost effectiveness of the ICS versus ICS withdrawal strategy. One way sensitivity analyses and a Monte Carlo simulation were performed to evaluate the robustness of the findings. RESULTS: The average patient with COPD in the FP group generated 511 in direct medical costs, including 238 for FP. The cost of the placebo strategy was 456. The higher direct drug cost of 212 per patient for the FP strategy during the 6 month follow up period compared with the placebo group was partially offset by a lower exacerbation and hospital admission cost of 157. The 6 month incremental cost effectiveness of the FP strategy compared with placebo was 110 per exacerbation prevented and 1286 per hospital admission prevented. CONCLUSIONS: Over a 6 month period, withdrawing FP in a pre-selected trial population of COPD patients led to absolute cost savings but with a higher rate of exacerbations and hospital admissions.

Administration, Inhalation↗
PubMed2004

Cost-effectiveness of combination peginterferon alpha-2a and ribavirin compared with interferon alpha-2b and ribavirin in patients with chronic hepatitis C.

BACKGROUND: Sustained virological response (SVR) is the primary objective in the treatment of chronic hepatitis C (CHC). Results from a recent clinical trial of patients with previously untreated CHC demonstrate that the combination of peginterferon alpha-2a and ribavirin produces a greater SVR than interferon alpha-2b and ribavirin combination therapy. However, the cost-effectiveness of peginterferon alpha-2a plus ribavirin in the U.S. setting has not been investigated. METHODS: A Markov model was developed to investigate cost-effectiveness in patients with CHC using genotype to guide treatment duration. SVR and disease progression parameters were derived from the clinical trials and epidemiologic studies. The impact of treatment on life expectancy and costs were projected for a lifetime. Patients who had an SVR were assumed to remain virus-free for the rest of their lives. In genotype 1 patients, the SVRs were 46% for peginterferon alpha-2a plus ribavirin and 36% for interferon alpha-2b plus ribavirin. In genotype 2/3 patients, the SVRs were 76% for peginterferon alpha-2a plus ribavirin and 61% for interferon alpha-2b plus ribavirin. Quality of life and costs were based on estimates from the literature. All costs were based on published U.S. medical care costs and were adjusted to 2003 U.S. dollars. Costs and benefits beyond the first year were discounted at 3%. RESULTS: In genotype 1, peginterferon alpha-2a plus ribavirin increases quality-adjusted life expectancy (QALY) by 0.70 yr compared to interferon alpha-2b plus ribavirin, producing a cost-effectiveness ratio of $2,600 per QALY gained. In genotype 2/3 patients, peginterferon alpha-2a plus ribavirin increases QALY by 1.05 yr in comparison to interferon alpha-2b plus ribavirin. Peginterferon alpha-2a combination therapy in patients with HCV genotype 2 or 3 is dominant (more effective and cost saving) compared to interferon alpha-2b plus ribavirin. Results weighted by genotype prevalence (75% genotype 1; 25% genotype 2 or 3) also show that peginterferon alpha-2a plus ribavirin is dominant. Peginterferon alpha-2a and ribavirin remained cost-effective (below $16,500 per QALY gained) under sensitivity analyses on key clinical and cost parameters. CONCLUSION: Peginterferon alpha-2a in combination with ribavirin with duration of therapy based on genotype, is cost-effective compared with conventional interferon alpha-2b in combination with ribavirin when given to treatment-naïve adults with CHC.

Antiviral Agents↗
PubMed2004

Country-specific cost-effectiveness of early intervention with budesonide in mild asthma.

Early intervention with budesonide is an effective strategy for mild persistent asthma, which has been shown to provide additional clinical benefits at a low incremental cost using USA cost data. The present authors analysed whether this strategy would be cost-effective using cost data for other countries. Based on the 3-yr prospective, randomised, double-blind inhaled Steroid Treatment As Regular Therapy (START) in early asthma study (comparing budesonide and placebo combined with usual asthma therapy), the cost-effectiveness was estimated separately for eight different countries, from both healthcare payer and societal perspectives, of adding budesonide to usual asthma therapy. Local unit costs were applied to data for the total trial population. Incremental cost-effectiveness ratios (ICER) were estimated as cost per symptom-free day (SFD) gained. Budesonide increased SFDs by an average of 14.1 days annually. From a healthcare payer perspective, budesonide would reduce the total cost of asthma care in Australia. In Sweden, Canada, France, Spain, UK, China and the USA, the ICER ranged from US$2.4-11.3 per SFD. From a societal perspective, budesonide would be cost-saving in Australia, Canada and Sweden. In conclusion, for countries where costs with budesonide are higher, the policy implication has to be determined by that health system's willingness to pay for an additional symptom-free day. However, where budesonide therapy increases symptom-free days and reduces total costs, the policy conclusion clearly favours early intervention.

Administration, Inhalation↗
PubMed2003

The burden of illness and economic evaluation for COPD.

In today's cost-conscious environment, understanding the economic implications associated with disease processes and their treatments is as important as understanding their clinical impact. Medical expenditures for treating chronic obstructive pulmonary disease (COPD) and the indirect costs of morbidity can represent a substantial economic and social burden. Very little economic information concerning COPD is available, however, particularly outside of a few very well-developed Western nations. This article will provide an approach for conducting high-quality studies aimed at estimating the economic burden of chronic obstructive pulmonary disease and for making economic evaluations of healthcare interventions aimed at preventing and treating this disease.

Aged↗
PubMed2001

Economic analysis of lung volume reduction surgery as part of the National Emphysema Treatment Trial. NETT Research Group.

BACKGROUND: In today's cost-conscious health care environment, obtaining timely and accurate economic information regarding new medical technologies has become extremely important. The National Emphysema Treatment Trial, a multicenter, randomized controlled trial of lung volume reduction surgery (LVRS) plus medical therapy, versus medical therapy for patients with severe emphysema, includes a parallel cost-effectiveness analysis. METHODS: The analysis is designed to determine the cost-effectiveness of LVRS versus medical therapy for those who are eligible for the procedure. After describing theoretical foundations of cost-effectiveness analysis as they apply to this study, we describe the economic and quality of life data that are being collected alongside the clinical trial, methods of analysis, and approach to presenting the results. RESULTS: The cost-effectiveness of LVRS relative to medical therapy will be presented as costs per quality-adjusted life years gained. CONCLUSIONS: This analysis will provide timely economic data that can be considered alongside the clinical results of the National Emphysema Treatment Trial. As one of the largest clinical trials to include a parallel, prospective cost-effectiveness analyses, this study will also provide valuable practical information about conducting an economic analysis alongside a multicenter clinical trial.

Cost-Benefit Analysis↗
PubMed2001

Design and analytic considerations in determining the cost-effectiveness of early intervention in asthma from a multinational clinical trial.

Demand for economic and outcomes data in support of drug formulary listing in private and government-sponsored health programs has led to fundamental changes in drug development. In part as a response to these pressures, the pharmaceutical industry has begun to include economic and quality-of-life endpoints in clinical trials with the hope of providing information to answer health policy questions on the economic value of its products. Here, the design and health economic techniques that will be used to analyze the START (inhaled Steroid Treatment As Regular Therapy in early asthma) study-a multinational (31 countries), randomized, placebo-controlled trial of 7240 patients with mild asthma over 3 years-will be presented. START compares the effect of once-daily administration of an inhaled glucocorticosteroid (Pulmicort Turbuhaler to conventional therapy in the management of newly diagnosed asthma, for which the use of this therapy is currently not the standard. The START study will examine both clinical effectiveness (measured as symptom-free days) and asthma-related costs for both treatment arms, aggregated for all patients across all countries. We believe that presenting the analytical plan prior to disseminating the results is an important way of increasing the credibility of economic evaluations. However, using clinical trials for collecting economic data poses several challenges, and the methods for conducting such evaluations are being developed. This paper will present and discuss several methodological options and the current state of the art for conducting economic evaluations alongside multinational clinical trials.

Administration, Inhalation↗
PubMed2001

The health economics of asthma and rhinitis. I. Assessing the economic impact.

As new health care strategies compete with existing ones for limited resources, the health care system and its providers are beginning to turn to health economic analyses to help inform choices in the delivery of care. This 2-part review examines the current health economic literature for asthma and rhinitis. This first installment of the review focuses on studies that characterize the economic burden of asthma and rhinitis and examines how resources are allocated to the care of persons with asthma and rhinitis. In 1998, asthma in the United States accounted for an estimated 12.7 billion dollars annually. Similarly, in 1994, allergic rhinitis was estimated to cost 1.2 billion dollars. Most of the costs for these conditions are attributed to direct medical expenditures, with medications emerging as the single largest cost component. Indirect costs also represent an important social effect. While cost-of-illness studies help to characterize the economic burden, comparative health economic studies evaluate the value of new and existing strategies for clinical care. The second part of this review will explore how comparative studies have contributed to understanding how to best diagnose and treat asthma and allergic rhinitis.

Asthma↗
PubMed2001

Health economics of asthma and rhinitis. II. Assessing the value of interventions.

Health care providers and payers are being asked to weigh data on the economic impact of new interventions along with clinical evidence when making decisions about the care of patients. The notion of incorporating formal health economic assessments into clinical and resource decisions is a difficult concept for many in the health care sector. However, it is the reality in today's environment. To effectively participate in these ongoing discussions, clinicians and other decision makers must be able to understand and critically assess the evidence on economic impact of medical interventions. This second of 2 articles describes the elements of comparative economic evaluations, reviewing the published literature on asthma and rhinitis in an attempt to critically appraise the studies from the perspective of one who might use data for decision making. Unfortunately, the quality of the economic evidence in these two disease states is not extensive. Until better economic analyses are conducted and made available, the allocation of resources for asthma and allergic rhinitis will continue to primarily rely on expert opinion rather than evidence-based literature.

Asthma↗
PubMed2001

Cost and cost-effectiveness of universal screening for hearing loss in newborns.

OBJECTIVE: To estimate the cost and cost-effectiveness of universal newborn hearing screening. STUDY DESIGN AND SETTING: Decision analysis model utilizing the hospital perspective. This model evaluated 4 distinct protocols for screening a fixed and defined hypothetical cohort of newborn infants. OUTCOME MEASURES: Cost of screening and the number of infants with hearing loss identified through universal screening. RESULTS: Otoacoustic emissions testing at birth followed by repeat testing at follow up demonstrated the lowest cost ($13 per infant) and had the lowest cost-effectiveness ratio ($5100 per infant with hearing loss identified). Screening auditory brainstem evoked response testing at birth with no screening test at follow-up was the only protocol with greater effectiveness, but it also demonstrated the highest cost ($25 per infant) and highest cost-effectiveness ratio ($9500 per infant with hearing loss identified). These findings were robust to sensitivity analysis, including best-case and worst-case estimation. The prevalence of hearing loss and the fraction of infants returned for follow-up testing had a large impact on the absolute level, but not relative level of protocol cost and cost-effectiveness. CONCLUSION: The otoacoustic emissions testing protocol should be selected by screening programs concerned with cost and cost-effectiveness, although there are certain caveats to consider. SIGNIFICANCE: The most significant barriers to implementation of universal newborn hearing screening programs have been financial, and this study compares the most common protocols currently in use. This study can assist program directors not only in the decision to initiate universal screening but also in their choice of screening protocol.

Child Health Services↗
PubMed2001

Design issues for conducting cost-effectiveness analyses alongside clinical trials.

In response to rising demands for timely economic data on new medical technologies, cost-effectiveness studies are increasingly being conducted alongside clinical trials. Because of the historical differences in perspective and methods between cost-effectiveness studies and clinical trials, the design phase of these hybrid trials requires special consideration. Cost-effectiveness studies require more comprehensive evaluations of outcomes than the endpoints typically measured in clinical trials. Often, these comprehensive outcome measures (such as quality of life) prove useful for interpreting the other endpoints measured in the trial, as well as for estimating the cost-effectiveness of the intervention. In this manuscript, we discuss several aspects related to the design of joint clinical/economic trials, including study perspective, hypothesis testing, sample size estimation, and methods for collecting cost and outcome data. We also discuss issues that may limit the external validity of the cost-effectiveness results of these trials. Many potential threats to external validity can be successfully addressed if they are identified and accounted for in the design phase of the study.

Clinical Trials as Topic↗
PubMed2001

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.

Adult↗
PubMed2001

Modeling the cost and outcomes of pharmacist-prescribed emergency contraception.

OBJECTIVES: This study investigated the effect on the risk and cost of unintended pregnancies of emergency contraceptive pills obtained directly from a pharmacist. METHODS: We used a decision model to compare outcomes for private and public payers following unprotected intercourse from. RESULTS: Obtaining emergency contraceptive pills from a pharmacy, compared with obtaining them from a physician or clinic, resulted in a $158 (95% confidence interval (CI) =$76, $269) reduction in costs for private payers and a $48 (95% CI = $16, $93) reduction for public payers. CONCLUSIONS: Our findings suggest that under varied assumptions, obtaining emergency contraceptive pills directly from a pharmacist reduces the number of unintended pregnancies and is cost saving.

Ambulatory Care Facilities↗
PubMed2001

Economic evaluation of systemic treatments for cytomegalovirus retinitis in patients with AIDS.

OBJECTIVE: To determine the cost of using systemic therapy to treat newly diagnosed cytomegalovirus (CMV) retinitis in persons with AIDS. DESIGN: Incidence-based simulation model of CMV treatment from a government payer perspective. SETTING: Swiss healthcare system. PATIENTS AND PARTICIPANTS: Patients with AIDS and newly diagnosed CMV retinitis. INTERVENTIONS: Patients were assigned to 1 of 4 treatment regimens for induction and maintenance therapy: (i) intravenous (IV) cidofovir induction and maintenance (cidofovir IV/IV); (ii) IV foscarnet induction and maintenance (foscarnet IV/IV); (iii) IV ganciclovir induction and maintenance (ganciclovir IV/IV); and (iv) IV ganciclovir induction and oral (PO) ganciclovir maintenance (ganciclovir IV/PO). Following a second relapse, patients were assigned to one of the other regimens. MAIN OUTCOME MEASURES: Time to first and subsequent progression, duration of maintenance treatment and direct medical expenditures [1998 Swiss francs (SwF)] . RESULTS: The median time to first progression was longest for cidofovir IV/IV, followed by foscarnet IV/IV, ganciclovir IV/IV and ganciclovir IV/PO. Mean survival was 13 months and mean costs for this period in the base case were lowest in those initially treated with cidofovir (SwF146,742), followed by initial treatment with foscarnet IV/IV (SwF194,809), ganciclovir IV/PO (SwF195,190) and ganciclovir IV/IV (SwF243,964). Costs were most sensitive to changes in efficacy estimates. CONCLUSIONS: Of the regimens studied, initiation of treatment with systemic cidofovir appears least costly over a 13-month period.

AIDS-Related Opportunistic Infections↗
PubMed2001

Showing outcomes and proving value brings success.

Today's pharmacoeconomics have shown how critical it is to find value in formulary drug products. For Regence BlueShield, Seattle, this means outcomes; making sure a drug truly works better than well-established alternatives, not just placebos. In 1998, Regence adopted formulary submission guidelines that have proven a solid success, and have been adopted by the Academy of Managed Care Pharmacy, Alexandria, Virginia, for evaluation nationwide.

Blue Cross Blue Shield Insurance Plans↗
PubMed2000

The potential clinical and economic benefits of silver alloy urinary catheters in preventing urinary tract infection.

BACKGROUND: Catheter-associated urinary tract infection (UTI) is associated with increased morbidity, mortality, and costs. A recent meta-analysis concluded that silver alloy catheters reduce the incidence of UTI by 3-fold; however, clinicians must decide whether the efficacy of such catheters is worth the extra per unit cost of $5.30. OBJECTIVE: To assess the clinical and economic impact of using silver alloy urinary catheters in hospitalized patients. METHODS: The decision model, performed from the health care payer's perspective, evaluated a simulated cohort of 1000 hospitalized patients on general medical, surgical, urologic, and intensive care services requiring short-term urethral catheterization (2-10 days). We compared 2 catheterization strategies: silver alloy catheters and standard (noncoated) urinary catheters. Outcomes included the incidence of symptomatic UTI and bacteremia and direct medical costs. RESULTS: In the base-case analysis, use of silver-coated catheters led to a 47% relative decrease in the incidence of symptomatic UTI from 30 to 16 cases per 1000 patients (number needed to treat = 74) and a 44% relative decrease in the incidence of bacteremia from 4.5 to 2.5 cases per 1000 patients (number needed to treat = 500) compared with standard catheters. Use of silver alloy catheters resulted in estimated cost savings of $4.09 per patient compared with standard catheter use ($20.87 vs $16.78). In a multivariate sensitivity analysis using Monte Carlo simulation, silver-coated catheters provided clinical benefits over standard catheters in all cases and cost savings in 84% of cases. CONCLUSIONS: Using silver alloy catheters in hospitalized patients requiring short-term urinary catheterization reduces the incidence of symptomatic UTI and bacteremia, and is likely to produce cost savings compared with standard catheters.

Alloys↗