ABSTRACT
This observational study was conducted to describe the risk of gastrointestinal (GI) events among patients with atrial fibrillation (AF). We analyzed Thomson Reuters MarketScan® data from 2005 to 2009. Subjects aged ≥18 years with ≥ 1 AF diagnosis were selected. GI events were identified from claims with a primary or secondary diagnosis code for any GI condition. The risk of GI events was assessed using cumulative incidence (new GI events/patients with AF without GI condition at baseline) and incidence rates (IRs), calculated as the number of patients with new GI events divided by patient-years of observation. In addition, the CHADS2 score was evaluated at baseline to determine the patient's risk of stroke. A total of 557,123 AF patients were identified. The mean (median) AF patient age was 68.2 years (70); 45% were female. The cumulative incidences of any GI event and dyspepsia were 40% and 19%, respectively. The corresponding IRs were 38.8 and 14.7 events per 100 patient-years. IRs of any GI events for female and male patients were 43.6 and 35.5; for patients in the age groups <65, 65-74, 75-84, and ≥85 years, IRs were 32.3, 38.9, 44.6, and 52.7; for patients with a CHADS2 score of 0, 1-2, 3-4, and 5-6, IRs were 30.3, 41.6, 56.9, and 74.5, respectively. In this large claims database, 40% of AF patients experienced a GI event, predominantly dyspepsia. Physicians should take age and comorbidities into consideration when managing AF patients.
ABSTRACT
OBJECTIVE: To determine from a health plan perspective the cost-effectiveness of cyclooxygenase-2 (COX-2) specific inhibitors, with and without a prior-authorization (PA) process. METHODS: A modeling exercise was employed, based on prescription drug claims for a managed care organization with 3.8 million health maintenance organization (HMO) and preferred provider organization (PPO) members. Drug claims revealed 96154 members (2.9% of the 3.3 million members with a pharmacy benefit) who received either one or more prescriptions for a COX-2 drug or a nonspecific nonsteroidal anti-inflammatory drug (NSAID). These patients were stratified into 2 groups for further analysis, those having a concurrent proton pump inhibitor (PPI) and those without a concurrent PPI. Decision analysis was used to estimate the cost-effectiveness of COX-2 therapy. Actual health plan drug claims data were used to determine utilization and prescribing patterns of nonspecific NSAIDs, COX-2 specific inhibitors, and PPIs. Results from the literature from 8 clinical trials were employed to determine the probability of a serious gastrointestinal (GI) event. Cost-effectiveness analysis (CEA) was used to determine the cost of each therapy, including the predicted cost to treat a serious GI event in a drug benefit design with PA versus a benefit design without PA. RESULTS: Cost-effectiveness analysis (CEA) showed that the cost per success no serious GI event) for Cox-2 specific inhibitors with PA was US dollars 278 versus US dollars 422 without PA. CONCLUSIONS: The one-year model predicted that costs associated with an increase in COX-2 utilization after removal of PA would exceed the costs to administer PA and treat NSAID-related serious GI events in the managed care population. Based upon this CEA, PA appears to be an effective tool to manage COX-2 pharmacy costs. Further examination of the medical claims would be useful to validate the assumed GI event rates with or without PA and to further demonstrate more definitively the value of a PA program for COX-2 drugs.
