James Spalding

Annual Costs Associated With Diagnosis of Uterine Leiomyomata

OBJECTIVE: To describe the annual care, direct health care, and indirect work loss costs for women with a diagnosis of uterine leiomyomata. METHODS: We examined data from an employer claims database of 1.2 million beneficiaries (1999 to 2003). Analysis was restricted to women with at least 12 months of continuous coverage and ages 18 to 64 years with at least one diagnosis of leiomyomata (International Classification of Diseases, 9th Revision, 218.xx, 654.1x). We selected a comparison group of women without a leiomyoma diagnosis using a 1:1 match on age, employment, region, health plan type, and length of enrollment. We compared resource use, disability claims, and excess costs in the year after the index diagnosis. RESULTS: The average age of women diagnosed with leiomyomata in this study was 43.7 years. Women with leiomyomata (N=5,122) had more clinic visits (relative risk [RR] 1.2, 95% confidence interval [CI] 1.2–1.2), diagnostic tests (RR 3.1, 95% CI 2.9–3.2), and procedures (RR 34.6, 95% CI 25.8–46.5) than controls (N=5,122). Within 1 year of the diagnosis of leiomyomata, 42% of women had a complete blood count, 66% had pelvic imaging, and 30% had surgery (68% of surgical procedures involved hysterectomy). Women with leiomyomata were 3-fold more likely to have disability claims (RR 3.1, 95% CI 2.7–3.6). Estimated average annual excess cost for each woman with leiomyomata (adjusted for confounders) was

Drug-Drug Interaction Associated with Mold-Active Triazoles among Hospitalized Patients

4,624 (

Cost-Effectiveness Analysis of Isavuconazole vs. Voriconazole as First-Line Treatment for Invasive Aspergillosis.

771 in work loss costs). Total costs for women with leiomyomata were 2.6 times greater than for controls. CONCLUSION: Diagnosed uterine leiomyomata are associated with increased resource use and with substantially higher health care and work loss costs. LEVEL OF EVIDENCE: II-3

Hospital resource use of patients receiving isavuconazole vs voriconazole for invasive mold infections in the phase III SECURE trial.

ABSTRACT The majority of hospitalized patients receiving mold-active triazoles are at risk of drug-drug interactions (DDIs). Efforts are needed to increase awareness of DDIs that pose a serious risk of adverse events. Triazoles remain the most commonly utilized antifungals. Recent developments have included the mold-active triazoles (MATs) itraconazole, voriconazole, and posaconazole, which are first-line agents for the treatment of filamentous fungal infections but have the potential for DDIs. This objective of this study was to evaluate the prevalence of triazole DDIs. Hospitalized U.S. adults with MAT use were identified in the Cerner HealthFacts database, which contained data from over 150 hospitals (2005 to 2013). The severities of DDIs with MATs were categorized, using drug labels and the drug information from the Drugdex system (Thompson Micromedex), into four groups (contraindicated, major, moderate, and minor severity). DDIs of minor severity were not counted. A DDI event was considered to have occurred if the following two conditions were met: (i) the patient used at least one drug with a classification of at least a moderate interaction with the MAT during the hospitalization and (ii) there was a period of overlap between the administration of the MAT and that of the interacting drug of at least 1 day. A total of 6,962 hospitalizations with MAT use were identified. Among them, 88% of hospitalizations with voriconazole use, 86% of hospitalizations with itraconazole use, and 93% of hospitalizations with posaconazole use included the use of a concomitant interacting drug. A total of 68% of hospitalizations with posaconazole use, 34% of hospitalizations with itraconazole use, and 20% of hospitalizations with voriconazole use included the use of at least one drug with a DDI of contraindicated severity. A total of 83% of hospitalizations with posaconazole use, 61% of hospitalizations with itraconazole use, and 82% of hospitalizations with voriconazole use included the use of at least one drug that resulted in a severe DDI. The findings of this study demonstrate that a majority of hospitalized patients receiving MAT are at risk for severe drug-drug interactions and highlight the need for antifungal stewardship.

Epidemiology and Outcomes of Hospitalizations With Invasive Aspergillosis in the United States, 2009–2013

IntroductionInvasive aspergillosis (IA) is associated with a significant clinical and economic burden. The phase III SECURE trial demonstrated non-inferiority in clinical efficacy between isavuconazole and voriconazole. No studies have evaluated the cost-effectiveness of isavuconazole compared to voriconazole. The objective of this study was to evaluate the costs and cost-effectiveness of isavuconazole vs. voriconazole for the first-line treatment of IA from the US hospital perspective.MethodsAn economic model was developed to assess the costs and cost-effectiveness of isavuconazole vs. voriconazole in hospitalized patients with IA. The time horizon was the duration of hospitalization. Length of stay for the initial admission, incidence of readmission, clinical response, overall survival rates, and experience of adverse events (AEs) came from the SECURE trial. Unit costs were from the literature. Total costs per patient were estimated, composed of drug costs, costs of AEs, and costs of hospitalizations. Incremental costs per death avoided and per additional clinical responders were reported. Deterministic and probabilistic sensitivity analyses (DSA and PSA) were conducted.ResultsBase case analysis showed that isavuconazole was associated with a

The clinical and economic impact of cytomegalovirus infection in recipients of hematopoietic stem cell transplantation

7418 lower total cost per patient than voriconazole. In both incremental costs per death avoided and incremental costs per additional clinical responder, isavuconazole dominated voriconazole. Results were robust in sensitivity analysis. Isavuconazole was cost saving and dominant vs. voriconazole in most DSA. In PSA, isavuconazole was cost saving in 80.2% of the simulations and cost-effective in 82.0% of the simulations at the

Healthcare utilization and costs with fixed-source versus variable-source tacrolimus in patients receiving a kidney transplant

50,000 willingness to pay threshold per additional outcome.ConclusionIsavuconazole is a cost-effective option for the treatment of IA among hospitalized patients.FundingAstellas Pharma Global Development, Inc.

Epidemiology and Clinical Features of Invasive Fungal Infection in a US Health Care Network

Abstract Objective: In the phase III SECURE trial, isavuconazole was non-inferior to voriconazole for all-cause mortality for the primary treatment of invasive mold disease (IMD) caused by Aspergillus spp. and other filamentous fungi. This analysis assessed whether hospital resource utilization was different between patients treated with isavuconazole vs voriconazole in SECURE. Methods: The analysis population comprised adults with proven/probable/possible IMD enrolled in SECURE. The primary endpoint was hospital length of stay (LOS) in the overall trial population. Patients were also stratified by estimated glomerular filtration rate-modification of diet in renal disease category (< 60 mL/min/1.73 m2 [moderate-to-severe impairment] and ≥60 mL/min/1.73 m2 [mild or no impairment]), body mass index (BMI; <25, ≥25–<30, and ≥30 kg/m2), and age (≤45, >45–≤65, and >65 years). Results: Data from 516 patients (258 per arm) were evaluated. Overall, median LOS was not statistically significantly different between the isavuconazole (15.0 days) and voriconazole (16.0 days; p = 0.607) arms. Median LOS was statistically significantly shorter in patients with moderate-to-severe renal impairment treated with isavuconazole (9.0 days) vs voriconazole (19.0 days; hazard ratio [HR]: 3.44; 95% confidence interval [CI] = 1.51–7.83). Median LOS was shorter, but not significantly, in patients with a BMI ≥30 kg/m2 (isavuconazole 13.5 days vs voriconazole 22 days; HR = 1.57; 95% CI = 0.70–3.52) or aged >65 years (isavuconazole 15.0 days vs voriconazole 20.0 days; HR = 1.37; 95% CI = 0.87–2.16). Limitations: As the patient subgroups analyzed were small, sub-group findings should be interpreted with caution in light of the lack of statistical significance for each sub-group-by-treatment interaction. Conclusions: Isavuconazole may reduce hospital LOS in certain subgroups of patients with IMD, especially those with moderate-to-severe renal impairment.

Attributes of nuclear imaging centers impacting physician referrals for single-photon emission computed tomography myocardial perfusion imaging tests

Background Though invasive aspergillosis (IA) complicates care of up to 13% of patients with immunocompromise, little is known about its morbidity and mortality burden in the United States. Methods We analyzed the Health Care Utilization Projects data from the Agency for Healthcare Research and Quality for 2009-2013. Among subjects with high-risk conditions for IA, IA was identified via International Classification of Diseases, Ninth Revision, Clinical Modification codes 117.3, 117.9, and 484.6. We compared characteristics and outcomes between those with (IA) and without IA (non-IA). Using propensity score matching, we calculated the IA-associated excess mortality and 30-day readmission rates, length of stay, and costs. Results Of the 66634683 discharged patients meeting study inclusion criteria, 154888 (0.2%) had a diagnosis of IA. The most common high-risk conditions were major surgery (50.1%) in the non-IA and critical illness (41.0%) in the IA group. After propensity score matching, both mortality (odds ratio, 1.43; 95% confidence interval, 1.36-1.51) and 30-day readmission (1.39; 1.34-1.45) rates were higher in the IA group. IA was associated with 6.0 (95% confidence interval, 5.7-6.4) excess days in the hospital and

Prevalence, clinical and economic burden of mucormycosis-related hospitalizations in the United States: a retrospective study

15542 (