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North Bethesda, MD, United States

Recht M.,Oregon Health And Science University | Neufeld E.J.,Boston Childrens Hospital | Sharma V.R.,James Graham Brown Cancer Center | Solem C.T.,Pharmerit North America | And 3 more authors.
Value in Health

Objectives: There is limited understanding of the effects of bleeding episodes on the daily lives of patients with congenital hemophilia with inhibitors and their caregivers. This analysis of the Dosing Observational Study in Hemophilia examined the impact of acute bleeding episodes on work, school, and family activities. Methods: Patients and caregivers participated in a diary study for 90 or more days or until patients experienced four bleeding episodes. All bleed treatments, interference with daily activities, and quality-of-life assessments were captured in daily records. Patients and caregivers reported planned workdays or school days eligible to be "lost" so as to differentiate from days lost because of disability or nonworking status, weekends, and vacations. Results: Diaries were completed for 39 patients (18 adults and 21 children). Bleeding episodes that continued for 3 or more days (16.4%) accounted for most of the major changes to family plans. For the 38 patients with bleeding episodes, 47% of 491 bleed days fell on planned workdays or school days; the remainder fell on weekends, holidays, or nonworkdays or non-school days and therefore did not count as "lost days." Patients reported a loss of productivity on a greater percentage of eligible bleed days than did caregivers (3.9% vs. 0.8%, respectively). Patients and caregivers reported 13.5%/9.3% fully missed and 3.5%/7.6% partially missed days. Conclusions: This study demonstrated that in hemophilia with inhibitors, bleeding episodes interfere with the daily activities of patients and their caregivers. Furthermore, documenting only lost days underestimated the impact of bleeding episodes because of the high percentage of days without planned work or school. Copyright © 2014, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. Source

Stephens S.,Pharmerit Ltd. | Botteman M.F.,Pharmerit North America | Cifaldi M.A.,Abbvie Inc. | Van Hout B.A.,University of Sheffield
BMJ Open

Objective: To estimate the cost-effectiveness of adalimumab plus methotrexate (MTX) versus MTX monotherapy in early, aggressive rheumatoid arthritis (RA) when explicitly modelling short-term (reversible) and long-term (irreversible, ie, joint damage) disease activity and physical function. Methods: A microsimulation model was developed to unify, in a single cost-effectiveness model, measures of reversible and irreversible disease activity and physical function based on data from the PREMIER trial. Short term, reversible disease activity was modelled using DAS28 variables, including swollen joint counts, tender joint counts, C reactive protein concentration and pain. The DAS28 variables were then used in a logistic regression to predict short-term American College of Rheumatology (ACR) responses, which informed treatment continuation and switches. Long term, irreversible, radiographically documented joint damage was modelled using modified Total Sharp Score (mTSS). The model then linked both short-term disease activity and mTSS to the Health Assessment Questionnaire score, which was used to calculate direct and indirect costs, and quality adjusted life-years (QALYs). Results: When both reversible and irreversible effects of therapy were included, combination therapy was estimated to produce 6-month 50% ACR responses in 75% of patients versus 54% in MTX monotherapy. Compared to MTX monotherapy, combination therapy resulted in 2.68 and 3.04 discounted life years and QALYs gained, respectively. Combination therapy also resulted in a net increase in direct costs of $106 207 for a resulting incremental cost/QALY gain of $32 425. When indirect costs were included in the analysis, the ICER (incremental cost-effectiveness ratio) decreased to $27 238. Disregarding irreversible effects increased the incremental cost-effectiveness ratio to $78 809 (when only direct costs were included). Conclusions: Starting with adalimumab plus MTX combination therapy in early, aggressive RA is costeffective when irreversible damage is adequately considered. Source

Abudagga A.,HealthCore Inc. | Sun S.X.,Forest Research Institute | Tan H.,HealthCore Inc. | Solem C.T.,Pharmerit North America
Journal of Medical Economics

Objectives: This study aimed to examine the real-world healthcare resource utilization (HCRU) and direct costs among chronic bronchitis (CB) patients treated with chronic obstructive pulmonary disease (COPD) maintenance medications. Methods: This retrospective analysis utilized administrative claims data from 14 US commercial managed care plans. Eligible patients were ≥40 years old, had ≥2 years of continuous enrollment, ≥1 CB (ICD-9-CM code 491.xx) hospitalization or emergency department (ED) visit or ≥2 office visits between 1/1/2004 and 5/31/2011, and had ≥2 pharmacy fills for COPD medications during follow-up (first fill served as the index date). All-cause and COPD-related HCRU and costs were assessed during follow-up. Multivariate models were utilized to identify predictors of total costs. Results: Treated CB patients (n = 17,382; 50.6% female; mean age 66.7 (SD = 11.4) years) had a mean of 7.6 (SD = 6.3) COPD maintenance medication fills during follow-up. Overall, 32.6% of patients had ≥1 COPD-related inpatient hospitalizations, 12.9% had ≥1 ED visit, and 81.8% had ≥1 office visit. Mean all-cause and COPD-related total costs were $25,747 (SD = $51,105) and $12,609 (SD = $36,801), respectively, during follow-up. Among the sub-group with ≥1 exacerbation during baseline year, 42.3% had ≥1 COPD-related inpatient hospitalization, 18.5% had ≥1 ED visit, and 88.2% had ≥1 office visit. Mean follow-up all-cause and COPD-related total costs were $29,861 (SD = $49,799) and $16,784 (SD = $34,170), respectively. The number of baseline exacerbations was a significant predictor of all-cause and COPD-related total costs during follow-up. Limitations: This study lacked standard measures of CB severity; however, severity proxies were utilized. Conclusion: HCRU and costs among CB patients were substantial during follow-up, despite treatment with COPD maintenance medications. Additional interventions aiming to prevent or reduce HCRU and costs among CB patients warrant exploration. © 2013 Informa UK Ltd All rights reserved. Source

AbuDagga A.,HealthCore Inc. | Sun S.X.,Forest Research Institute | Tan H.,HealthCore Inc. | Solem C.T.,Pharmerit North America
International Journal of COPD

Purpose: Chronic obstructive pulmonary disease (COPD) exacerbations are the leading cause of hospital admission and death among chronic bronchitis (CB) patients. This study estimated annual COPD exacerbation rates, related costs, and their predictors among patients treated for CB. Methods: This was a retrospective study using claims data from the HealthCore Integrated Research Database (HIRDSM). The study sample included CB patients aged ≥ 40 years with at least one inpatient hospitalization or emergency department visit or at least two office visits with CB diagnosis from January 1, 2004 to May 31, 2011, at least two pharmacy fills for COPD medications during the follow-up year, and ≥2 years of continuous enrollment. COPD exacerbations were categorized as severe or moderate. Annual rates, costs, and predictors of exacerbations during follow-up were assessed. Results: A total of 17,382 individuals treated for CB met the selection criteria (50.6% female; mean ± standard deviation age 66.7 ± 11.4 years). During the follow-up year, the mean ± standard deviation number of COPD maintenance medication fills was 7.6 ± 6.3; 42.6% had at least one exacerbation and 69.5% of patients with two or more exacerbations during the 1 year prior to the index date (baseline period) had any exacerbation during the follow-up year. The mean ± standard deviation cost per any exacerbation was $269 ± $748 for moderate and $18,120 ± $31,592 for severe exacerbation. The number of baseline exacerbations was a significant predictor of the number of exacerbations and exacerbation costs during follow-up. Conclusion: Exacerbation rates remained high among CB patients despite treatment with COPD maintenance medications. New treatment strategies, designed to reduce COPD exacerbations and associated costs, should focus on patients with high prior-year exacerbations. Source

Neufeld E.J.,Childrens Hospital Boston | Neufeld E.J.,Harvard University | Recht M.,Oregon Health And Science University | Sabio H.,Wake forest University | And 6 more authors.
Value in Health

Introduction: Quality-of-life (QOL) assessments in frequently bleeding patients with congenital hemophilia with inhibitors and their families are confounded by preexisting arthropathy and family circumstances. Periodic QOL assessments typically made on nonbleed days may not provide complete reflections of the burden on patients/families. Aim: To evaluate the impact of bleeding episodes on patients/caregivers/families and the association between monthly QOL scores and patients' average diary experiences. Methods: Frequently bleeding inhibitor patients ( Source

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