ABSTRACT
INTRODUCTION: Drug-induced liver injury (DILI) is the most frequent cause of acute liver failure in North America and Europe, but it is often missed because of unstandardized diagnostic methods and criteria. This study aimed to develop and validate an automated algorithm to identify potential DILI cases in routine pharmacovigilance (PV) activities. METHODS: Post-marketing hepatic adverse events reported for a potentially hepatotoxic drug in a global PV database from 19 March 2017 to 18 June 2018 were assessed manually and with the automated algorithm. The algorithm provided case assessments by applying pre-specified criteria to all case data and narratives simultaneously. RESULTS: A total of 1456 cases were included for analysis and assessed manually. Sufficient data for algorithm assessment were available for 476 cases (32.7%). Of these cases, manual assessment identified 312 (65.5%) potential DILI cases while algorithm assessment identified 305 (64.1%) potential DILI cases. Comparison of manual and algorithm assessments demonstrated a sensitivity of 97.8% and a specificity of 79.3% for the algorithm. Given the prevalence of potential DILI cases in the population studied, the algorithm was calculated to have positive predictive value 56.3% and negative predictive value 99.2%. The time required for manual review compared to algorithm review suggested that application of the algorithm prior to manual screening would have resulted in a time savings of 42.2%. CONCLUSION: An automated algorithm to identify potential DILI cases was developed and successfully implemented. The algorithm demonstrated a high sensitivity, a high negative predictive value, along with significant efficiency and utility in a real-time PV database.
Subject(s)
Chemical and Drug Induced Liver Injury , Drug-Related Side Effects and Adverse Reactions , Algorithms , Chemical and Drug Induced Liver Injury/diagnosis , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , Databases, Factual , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , PharmacovigilanceABSTRACT
OBJECTIVE: To evaluate the healthcare costs and resource utilization associated with pediatric Crohn's disease (PCD) from a payer perspective. METHODS: A retrospective analysis was conducted using claims from 1 January 2003 through 31 December 2006 from the HealthCare Partners database. Patients were younger than 18 years of age, had a new diagnosis of PCD, and continuous health plan eligibility 6 months before and 12 months after the disease index date (the date of the first claim with a PCD diagnosis). For comparison, a non-PCD cohort was matched on age, sex, and birthday (within 30 days). RESULTS: Data from 30 patients with PCD and 10,864 non-PCD controls were included. The total cost per member per month (PMPM) for the PCD cohort was $2,547 compared with $101 for the non-PCD cohort. Inpatient admissions accounted for the largest portion (54%) of the total cost PMPM for PCD patients. There were 500 admissions per thousand members per year (PTMPY) for the PCD cohort and 11 admissions PTMPY for the non-PCD cohort. The average lengths of stay were 7.6 and 4.4 days for the PCD cohort and the non-PCD cohort, respectively, and the inpatient costs PMPM were $1,409 and $18, respectively. Costs and resource utilization were also higher for PCD patients treated with systemic therapies. CONCLUSION: PCD was associated with higher costs and resource utilization, compared with non-PCD controls, primarily driven by inpatient stays. Treating PCD appropriately before the disease progresses to a level requiring hospitalization may help reduce the costs associated with this disease.
Subject(s)
Delivery of Health Care/statistics & numerical data , Health Care Costs , Outcome and Process Assessment, Health Care/economics , Adolescent , Ambulatory Care/economics , California , Case-Control Studies , Crohn Disease/diagnosis , Crohn Disease/economics , Crohn Disease/therapy , Databases as Topic , Female , Hospital Costs , Humans , Insurance, Health/economics , Length of Stay/economics , Male , Patient Admission/economics , Retrospective Studies , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Fistulas are a common complication of Crohn's disease (CD) and are difficult to treat effectively. This study aimed to assess the effects of fistula on annual costs of healthcare and resource utilization for patients with CD. METHODS: A retrospective analysis, using the PharMetrics database, of patients with a diagnosis of CD from January 1, 2000 through June 30, 2005 was conducted. Using paid claim amounts, healthcare costs and resource utilization were compared for patients with and without fistula in the year following diagnosis. Further analysis compared costs for adult, pediatric, and older adult patients with and without fistula. RESULTS: This analysis included 13,454 patients with CD, of whom 12,683 (94.3%) had no diagnosis of fistula. The total median (range) cost per patient was higher for the fistula cohort ($10,863 [$0-$1,307,019]) than the nonfistula cohort ($6268 [$0-$1,181,485]), driven mainly by higher hospital and surgery costs. Median healthcare costs and resource utilization rates were generally higher for patients with fistula compared with those without fistula in all 3 age groups, with some of the largest differences observed in the pediatric cohort. CONCLUSIONS: Fistulas are often a difficult and costly complication of CD. This study determined that patients with fistulizing CD have higher healthcare costs and resource consumption than patients without fistula. Use of therapies that heal fistulas may help deter some of the high costs and intensive resource utilization found in this study. Economic analyses need to account for these issues when assessing the cost-effectiveness of therapies targeting fistulizing disease.
