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Baddley J.W.,University of Alabama at Birmingham | Stephens J.M.,Pharmerit North America LLC | Ji X.,Pharmerit North America LLC | Gao X.,Pharmerit North America LLC | And 2 more authors.
BMC Infectious Diseases | Year: 2013

Background: Few data are available regarding the epidemiology of invasive aspergillosis (IA) in ICU patients. The aim of this study was to examine epidemiology and economic outcomes (length of stay, hospital costs) among ICU patients with IA who lack traditional risk factors for IA, such as cancer, transplants, neutropenia or HIV infection.Methods: Retrospective cohort study using Premier Inc. Perspective™ US administrative hospital database (2005-2008). Adults with ICU stays and aspergillosis (ICD-9 117.3 plus 484.6) who received initial antifungal therapy (AF) in the ICU were included. Patients with traditional risk factors (cancer, transplant, neutropenia, HIV/AIDS) were excluded. The relationship of antifungal therapy and co-morbidities to economic outcomes were examined using Generalized linear models.Results: From 6,424 aspergillosis patients in the database, 412 (6.4%) ICU patients with IA were identified. Mean age was 63.9 years and 53% were male. Frequent co-morbidities included steroid use (77%), acute respiratory failure (76%) and acute renal failure (41%). In-hospital mortality was 46%. The most frequently used AF was voriconazole (71% received at least once). Mean length of stay (LOS) was 26.9 days and mean total hospital cost was $76,235. Each 1 day lag before initiating AF therapy was associated with 1.28 days longer hospital stay and 3.5% increase in costs (p < 0.0001 for both).Conclusions: Invasive aspergillosis in ICU patients is associated with high mortality and hospital costs. Antifungal timing impacts economic outcomes. These findings underscore the importance of timely diagnosis, appropriate treatment, and consideration of Aspergillus as a potential etiology in ICU patients. © 2013 Baddley et al.; licensee BioMed Central Ltd.

Ben-Shlomo A.,Cedars Sinai Medical Center | Sheppard M.C.,University of Birmingham | Stephens J.M.,Pharmerit North America LLC | Pulgar S.,Novartis | Melmed S.,Cedars Sinai Medical Center
Pituitary | Year: 2011

Although acromegaly is a rare disease, the clinical, economic and health-related quality of life (HRQoL) burden is considerable due to the broad spectrum of comorbidities as well as the need for lifelong management. We performed a comprehensive literature review of the past 12 years (1998-2010) to determine the benefit of disease control (defined as a growth hormone [GH] con-centration <2.5 μg/l and insulin-like growth factor [IGF]-1 normal for age) on clinical, HRQoL, and economic outcomes. Increased GH and IGF-1 levels and low frequency of somatostatin analogue use directly predicted increased mortality risk. Clinical outcome measures that may improve with disease control include joint articular cartilage thickness, vertebral fractures, left ventricular function, exercise capacity and endurance, lipid profile, and obstructive apnea events. Some evidence suggests an association between controlled disease and improved HRQoL. Total direct treatment costs were higher for patients with uncontrolled compared to controlled disease. Costs incurred for management of comorbidities, and indirect cost could further add to treatment costs. Optimizing disease control in patients with acromegaly appears to improve outcomes. Future studies need to evaluate clinical outcomes, as well as HRQoL and comprehensive economic outcomes achieved with controlled disease. © Springer Science+Business Media, LLC 2011.

Hammond J.,ETHICON,Inc. | Lim S.,ETHICON,Inc. | Wan Y.,Pharmerit North America LLC | Gao X.,Pharmerit North America LLC | Patkar A.,ETHICON,Inc.
Journal of Gastrointestinal Surgery | Year: 2014

Objective: To evaluate the clinical and economic burden associated with anastomotic leaks following colorectal surgery. Methods: Retrospective data (January 2008 to December 2010) were analyzed from patients who had colorectal surgery with and without postoperative leaks, using the Premier Perspective™ database. Data on in-hospital mortality, length of stay (LOS), re-admissions, postoperative infection, and costs were analyzed using univariate and multivariate analyses, and the propensity score matching (PSM) and generalized linear models (GLM). Results: Of the patients, 6,174 (6.18 %) had anastomotic leaks within 30 days after colorectal surgery. Patients with leaks had 1.3 times higher 30-day re-admission rates and 0.8-1.9 times higher postoperative infection rates as compared with patients without leaks (P < 0.001 for both). Anastomotic leaks incurred additional LOS and hospital costs of 7.3 days and $24,129, respectively, only within the first hospitalization. Per 1,000 patients undergoing colorectal surgery, the economic burden associated with anastomotic leaks-including hospitalization and re-admission-was established as 9,500 days in prolonged LOS and $28.6 million in additional costs. Similar results were obtained from both the PSM and GLM for assessing total costs for hospitalization and re-admission. Conclusions: Anastomotic leaks in colorectal surgery increase the total clinical and economic burden by a factor of 0.6-1.9 for a 30-day re-admission, postoperative infection, LOS, and hospital costs. © 2014 The Author(s).

Patel D.A.,Pharmerit North America LLC | Gao X.,Pharmerit North America LLC | Stephens J.M.,Pharmerit North America LLC | Forshag M.S.,Pfizer | And 2 more authors.
Journal of Medical Economics | Year: 2011

Objectives: Invasive aspergillosis (IA) is reported increasingly in non-traditional hosts, typically patients with chronic obstructive pulmonary disease (COPD). Objectives were to describe the excess burden of IA in COPD, including mortality, resource utilization, and costs, as well as to examine the impact of initial antifungal selection on clinical and economic outcomes. Methods: This retrospective cohort study used national data from 2005 to 2008, from the Premier Perspective hospital database. IA was identified using proxy ICD-9 codes based on published algorithms. The COPD+IA patient cohort was analyzed using descriptive statistics. Excess resource utilization was analyzed by matching cases (COPD+IA) and controls (COPD patients without aspergillosis) on demographic and clinical variables. Multivariate analyses were used to assess the impact of initial antifungal drug selection on outcomes in COPD+IA. Results: In total, 475 COPD+IA patients were identified (mean age 69years, 50% male, 76% Caucasian). COPD+IA cases had significantly higher costs, length of stay, intensive care unit (ICU) stay, and mortality compared to COPD controls (all p<0.01). On average, antifungal therapy was initiated on hospital day6, with mean length of therapy 15days, and one-third of patients were in the ICU when antifungal treatment was initiated. Most commonly used antifungals were voriconazole, fluconazole, and caspofungin. Patients receiving fluconazole as the initial antifungal, an agent inactive against moulds, had almost two times greater mortality (p=0.016), two additional hospital days (p=0.002), and 25% greater costs (p=0.007), compared to patients receiving voriconazole first-line. Findings were consistent in sub-analyses including ICU patients. Limitations: Invasive' form of aspergillosis was identified using proxy ICD-9 codes based on published literature. Additional limitations stem from the study's non-randomized, retrospective design that is typical with any database analyses. Conclusions: COPD+IA patients had significantly higher mortality, resource utilization, and costs versus COPD controls. Treatment with an agent active against Aspergillus was associated with better survival and reduced economic burden, therefore this potential etiology of pneumonia should be considered when contemplating antifungal therapy in COPD patients. © 2011 Informa UK Ltd.

Snedecor S.J.,Pharmerit North America LLC | Carter J.A.,Pharmerit North America LLC | Kaura S.,Novartis | Botteman M.F.,Pharmerit North America LLC
Clinical Therapeutics | Year: 2012

Background: Denosumab has been approved in the United States for the prevention of skeletal-related events (SREs) in metastatic breast cancer. In a Phase III trial in patients with bone-metastatic breast cancer (N = 2033), denosumab was associated with a significantly delayed time to first SRE (by 18%; P < 0.001 noninferiority; P = 0.01 superiority) and time to first and subsequent SREs (by 23%; P = 0.001). Overall survival (HR = 0.95; 95% CI, 0.81-1.11; P = 0.49) and disease progression (HR = 1.00; 95% CI, 0.89-1.11; P = 0.93) did not differ significantly between groups. Denosumab was associated with a nonsignificant reduction in serious adverse events (44.4% vs 46.5%). Objectives: Given the current ambiguity regarding the cost-effectiveness of these agents in light of these trial outcomes, the present analysis assessed, from a US payer perspective, the cost-effectiveness of denosumab versus zoledronic acid in patients with bone metastases secondary to breast cancer. Methods: A literature-based Markov model was developed to estimate the survival, quality-adjusted life-years (QALYs) gained, number and costs of SREs, and drug and administration costs in patients receiving denosumab or zoledronic acid over 27 and 60 months. Clinical inputs reproduced the trial outcomes. SRE-related costs and utilities were literature based. Costs and QALYs were discounted 3% annually. Results: In the 27-month base-case analysis, denosumab was associated with fewer SREs (-0.298), more QALYs (+0.0102), and lower SRE-related costs (-$2016), but higher drug-related (+$9123) and total costs (+$7107) versus zoledronic acid. The cost per QALY gained (ie, incremental cost-effectiveness ratio [ICER]) was $697,499. In sensitivity analyses, the ICER ranged from $192,472 to $1,340,901/QALY, depending on assumptions regarding treatment benefits, drug costs, and analytical horizon. In the probabilistic sensitivity analysis, denosumab was cost-effective in 2 of 5000 modeled replicates (0.04%). Conclusions: Despite the limitations of restricted availability of clinical data and uncertainty regarding the price of generic zoledronic acid, the findings from the present analysis suggest that the use of denosumab is associated with a high ICER compared with zoledronic acid. This finding may raise important questions regarding the economic value of denosumab in bone-metastatic breast cancer. © 2012 Elsevier HS Journals, Inc.

Wolf C.F.,University of Washington | Gu N.Y.,University of Washington | Gu N.Y.,Pharmerit North America LLC | Doctor J.N.,University of Washington | And 3 more authors.
Journal of Bone and Joint Surgery - Series A | Year: 2011

Background: Two-stage revisions of total hip arthroplasties complicated by chronic infection result in reinfection rates that are lower than those following single-stage revisions but may also result in increased surgical morbidity. Using a decision analysis, we compared single-stage and two-stage revisions to determine which treatment modality resulted in greater quality-adjusted life years (QALYs). Methods: A review of the literature on the treatment of patients with an infection at the site of a total hip arthroplasty provided probabilities; utility values for common postoperative health states were determined in a previously published study. With these data, we conducted a Markov cohort simulation decision analysis. Sensitivity analysis validated the model, and comparisons were made in terms of QALYs. Results: The twelve-month model favored direct-exchange revision over the two-stage approach, regardless of whether surgeon or patient-derived utilities were used (0.945 versus 0.896 and 0.897 versus 0.861 QALYs for the patient and surgeon models, respectively). Similar results were observed in a lifetime model with a ten-year life expectancy (7.853 versus 7.771, and 7.438 versus 7.362 QALYs, respectively). The findings were found to be robust in sensitivity analyses in which clinically relevant ranges of input variables were used. Conclusions: This analysis favored the direct-exchange arthroplasty over the two-stage approach. This study should be considered hypothesis-generating for future randomized controlled trials in which, ideally, health end points will be considered in addition to the eradication of infection. Level of Evidence: Economic and decision analysis Level II. See Instructions to Authors for a complete description of levels of evidence. Copyright © 2011 by the journal of bone and joint surgery, incorporated.

Snedecor S.J.,Pharmerit North America LLC | Carter J.A.,Pharmerit North America LLC | Kaura S.,Celgene | Botteman M.F.,Pharmerit North America LLC
Journal of Medical Economics | Year: 2013

Objective: Denosumab has been approved in the US for skeletal-related event (SRE) prevention in bone-metastatic prostate cancer on the basis of a phase III clinical trial in which denosumab reduced SREs relative to zoledronic acid. Overall survival, disease progression, and serious adverse events did not differ significantly between groups. This analysis assessed the cost-effectiveness of denosumab vs zoledronic acid in bone-metastatic prostate cancer from a US payer perspective. Methods: A literature-based Markov model, wherein inputs were selected to reproduce clinical trial outcomes, was developed to estimate the survival, quality-adjusted life-years (QALYs), number and costs of SREs, and drug and administration costs for patients receiving denosumab or zoledronic acid over 27 months. QALYs were estimated by assigning health-state utilities. SRE-related costs and utilities were literature-based. Outcomes were discounted 3% per annum, and model robustness was tested via scenario, univariate, and probabilistic sensitivity analyses. Results: Denosumab resulted in fewer estimated SREs (-0.241; 1.036 vs 1.277), more QALYs (0.0074; 0.9306 vs 0.9232), and lower SRE-related costs (-$2340; $8824 vs $11,164), but higher drug-related costs ($10,181; $23,144 vs $12,963) and total costs ($7841; $31,968 vs $24,127) vs zoledronic acid. The base case estimated cost per QALY-gained was $1,058,741. Conclusion: This analysis was limited by the restricted availability of clinical data and the need to use projection methods beyond the trial time frame. However, a wide range of scenarios predicted denosumab to have an incremental cost/QALY gained above what may be considered acceptable value for money in the US. This raises important questions regarding the pharmacoeconomic value of denosumab in bone-metastatic prostate cancer. © 2013 Informa UK Ltd.

Gao X.,Pharmerit North America LLC | Stephens J.M.,Pharmerit North America LLC | Carter J.A.,Pfizer | Haider S.,Pfizer | Rustgi V.K.,Georgetown University
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2012

Protease inhibitor with pegylated interferon and ribavirin therapy (PI-PR) increases hepatitis C virus treatment efficacy versus standard of care pegylated interferon and ribavarin therapy [PR]. The adverse event (AE) impact of PI-PR remains under-reported. The authors estimated the AE impact on costs, treatment discontinuation and health-related quality of life (HRQoL) in PI-PR- and PR-treated patients through literature review and cost analysis. HRQoL and safety data were synthesized by instrument, AE and discontinuation rate. AE-related treatment costs were estimated with trial-based AE rates and literature-based protocols, resource utilization and standard costs. No PI-PR study reported HRQoL outcomes. Five PR studies reported that anemia, depression, fatigue and/or influenza-like symptoms negatively affected HRQoL. Decreased HRQoL predicted treatment discontinuation in two PR studies. PI-PR and PR had comparable AE-related treatment discontinuation rates (∼12%). Weighted AE-related treatment costs were US$2042, $1835 and $1076 in boceprevir-based PI-PR, PR and telaprevir-based PI-PR, respectively. AE-related burden may increase with PI-PR. Future studies should incorporate AE-related economic and HRQoL outcomes to comprehensively assess costs/benefits. © 2012 Expert Reviews Ltd.

Carter J.A.,Pharmerit North America LLC | Botteman M.F.,Pharmerit North America LLC
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2012

Zoledronic acid is the only bisphosphonate approved for the prevention or delay of skeletal-related events in patients with bone metastases secondary to prostate cancer. Recently, the US FDA and the EMA approved denosumab (a fully human monoclonal antibody) to treat skeletal-related events in bone-metastatic prostate cancer. This article summarizes the cost-effectiveness literature pertaining to these two agents when used in the prevention of skeletal-related events secondary to malignancy. Zoledronic acid (and denosumab in comparison with zoledronic acid) have been found to be cost effective and cost ineffective depending on the analytical perspective and model parameters. © 2012 Expert Reviews Ltd.

Stephens J.,Pharmerit North America LLC | Carpiuc K.T.,Pharmerit North America LLC | Botteman M.,Pharmerit North America LLC
International Journal of General Medicine | Year: 2010

Objectives: To develop an economic analysis of the management of pleural effusions in patients with imatinib-resistant/intolerant chronic myelogenous leukemia (CML). Methods: A cost of treatment analysis was conducted from the US payer perspective, based on resource utilization data for 48 patients with dasatinib-related pleural effusions at a large US cancer center. Probabilities of various procedures and treatment events were derived from published resource use data, supplemented with expert opinion. Cost data was derived from median reimbursements for relevant CPT codes for outpatient services and medical literature for inpatient services. Sensitivity analyses were conducted for types of procedures used. All costs were adjusted to US dollars (2007 rates). Results: Sixty percent of pleural effusions were managed medically costing $750 per episode. Forty percent of pleural effusions were more significant (>25% of one lung volume), with half of those requiring invasive procedures. Cost of inpatient procedures was $10,616 for chest tube and $15,170 with pleural catheter. Cost of outpatient procedures was $713 for ultrasound thoracentesis and $4,598 for pleural catheter. The average cost of treating a pleural effusion was $2,062 to >$2,700 for all severity levels and ∼$6,400 to >$9,000 for invasive procedures. Key cost drivers were invasive procedures and recurrence. Conclusion: This economic analysis using actually observed treatment patterns suggests that the management of pleural effusion adverse events in CML patients is costly, requires intensive resource utilization, and may be an important factor in treatment selection. © 2010 Adedoyin et al, publisher and licensee Dove Medical Press Ltd.

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