Retrospective study of total healthcare costs associated with chronic nonvalvular atrial fibrillation and the occurrence of a first transient ischemic attack, stroke or major bleed.

OBJECTIVE: To determine the direct healthcare costs associated with the onset of chronic nonvalvular atrial fibrillation (CNVAF), warfarin utilization and the occurrence of cerebrovascular events in a commercially-insured population. RESEARCH DESIGN AND METHODS: This retrospective, observational cohort study utilized medical and pharmacy claims from a large, geographically diverse managed-care organization (N = 18.5 million) to identify continuously benefit-eligible CNVAF patients > or =45 years of age without prior valvular disease or warfarin use between January 1, 2001 and June 1, 2002. All patients were followed at least 6 months, until plan termination or the end of study follow-up. Stroke risk was assessed using the CHADS(2) (stroke-risk) index; warfarin use was defined as having filled at least one pharmacy claim. Inpatient and outpatient cost benchmarks were utilized to estimate total direct healthcare costs (pre- and post-AF index claim). For patients with transient ischemic attacks (TIA), ischemic stroke (IS) and major bleed (MB) total direct healthcare costs were also assessed. The limitations of this study included a descriptive retrospective study design without a comparison group or adjustment for baseline disease severity and drug exposure, as well as, the reliance upon administrative claims data and use of a standardized reference costing methodology. RESULTS: The pre- and post-AF onset total direct healthcare costs (pmpm) for 3891 incidence CNVAF patients were $412 and $1235, respectively, a 200% increase. Of the 448 (12%) patients with a cerebrovascular event, pmpm costs post-AF ranged from $2235 to $3135 correlating with CHADS(2) stroke-risk status and exposure to warfarin. Total cohort pmpm costs pre and post event increased 24% from $3446.91 to $4262.12. Approximately 20% of all events occurred <2 days and 46% within 1 month after the index AF claim. Any warfarin exposure, regardless of CHADS(2) risk had an 18% to 29 % decrease in pmpm costs. CONCLUSIONS: Post-AF total direct healthcare costs were 3 times greater than pre-AF costs. For those with a TIA, IS or MB, post-AF total direct healthcare costs increased 4.5 times from pre-AF costs; overall post-event costs in this cohort increased approximately 25% over pre-event costs. Nearly half of the events occurred within 1 month of a claim associated with an AF diagnosis. Warfarin exposure appeared to be associated with lower pmpm costs in this population.

Resource use associated with topiramate in migraine prophylaxis.

PURPOSE: The effect of topiramate prophylaxis on medication use and medical resource use for migraine patients was studied. METHODS: Medical and pharmacy claims from a commercially insured population were analyzed from July 1, 1999, to March 31, 2004. The study sample included patients with at least one physician encounter or facility claim with a diagnosis of migraine at any point during the study's time frame. Patients either were naive to drugs labeled for migraine prophylaxis or had switched to topiramate from another drug labeled for migraine prophylaxis. The date of topiramate initiation was between January 1, 2000, and September 30, 2003; topiramate initiation was the index date. Demographic and clinical characteristics were evaluated. Migraine-related medication use and resource use were compared between the pre- and postindex periods. RESULTS: Of the 1749 patients analyzed, 90.2% were female. Neurologists wrote 54% of the index prescriptions. The mean +/- S.D. topiramate dosage was 98 +/- 65 mg/day. Statistically significant decreases occurred in the proportion of patients using drugs not labeled for migraine prophylaxis, nonopioid analgesics, nonsteroidal antiinflammatory drugs, and headache and migraine relief medications (p < 0.05). There was a 44.9% reduction in emergency room services, 53.2% reduction in migraine- related diagnostic procedures, and 57.1% reduction in migraine-related hospitalization days. Encounter claims for physicians' office visits did not change significantly. CONCLUSION: Migraine patients within commercially insured health plans incurred substantial resource use. Within six months following initiation of topiramate preventive therapy, reductions in acute migraine medication and medical resource use were observed among this population of migraine sufferers.

Topiramate in migraine prophylaxis: long-term impact on resource utilization and cost.

OBJECTIVE: To evaluate the medical resource utilization and overall cost of care among patients treated with topiramate (TPM) for migraine prevention in a commercially insured population. Background.-Preventive migraine therapy with TPM significantly reduces the frequency of migraine attacks. Limited data exist on the real-world health care consumption associated with TPM therapy for migraine prevention. METHODS: Data were obtained from a large geographically diverse integrated medical and pharmacy claims database representative of the commercially insured population. The date of the first TPM claim between July 2000 and December 2003 was considered the index date. Patients needed at least 1 triptan prescription (Rx) claim during the 6-month preindex period, and > or =2 TPM Rx claims in the 12 months following index TPM Rx to be included in the analysis. Headache-related inpatient and outpatient resource use were compared: preindex vs postindex period 1 (months 1-6) and preindex vs postindex period 2 (months 7-12). Subgroup analyses were conducted based on the triptan consumption during the 6-month preindex period: Cohort L (low triptan users) with < or =36 triptan doses, and Cohort H (high triptan users) with >36 triptan doses. RESULTS: The sample included 2645 plan members (1778 patients in Cohort L, and 867 patients in Cohort H). TPM utilization was associated with significantly less triptan utilization in the first (34.8 quantity dispensed; 7.5% decrease) and second (30.2; 19.6% decrease) follow-up periods compared to the preindex period (37.6; both P < .0001). In postindex period 1, there was a 46% decrease in emergency department (ED) visits, 39% decrease in diagnostic procedures (eg, CT scans and MRIs), and a 33% decrease in hospital admission; physician office visits were unchanged. In postindex period 2, there was a 46% decrease in ED visits, 72% decrease in diagnostic procedures, 61% decrease in hospital admissions, and a 35% decrease in physician office visits. Decreases in resource use were observed in both cohorts L and H. Mean +/- SD total headache-related cost was $2118 +/- $3406 per patient in the preperiod, versus $2450 +/- $3318 in follow-up period 1 and $2009 +/- $3136 in follow-up period 2. CONCLUSION: In this sample of patients from a diverse set of health plans receiving TPM, significant decreases in resource use were observed within 6 months of TPM initiation, and this trend continued in follow-up period 2. Although there was an initial increase in total headache-related cost upon introduction of TPM (follow-up period 1), the cost in follow-up period 2 was lower than in the preindex period, suggesting that benefits of long-term treatment with TPM can be achieved without increasing total cost.

Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome.

PURPOSE: Deep-vein thrombosis (DVT) and pulmonary embolism (PE) are associated with major morbidity and mortality, with their burden often extending to longer-term complications such as event recurrence and post-thrombotic syndrome (PTS). Few data exist on the overall economic burden of DVT and PE and their sequelae. A retrospective observational cohort study was conducted to determine the direct medical costs of a DVT or PE patient across the entire continuum of care. SUMMARY: Administrative claims data for patients with a DVT or PE diagnosis (ICD-9-CM code) and patients with possible evidence of PTS between January 1, 1997, and March 31, 2004, were extracted from the PharMetrics Patient-Centric Database, which comprises fully adjudicated medical and pharmaceutical claims for U.S. health care-plan enrollees. Resource utilization and annualized direct medical costs of care for patients with DVT and/or PE were calculated and compared with matched controls. A total of 26,958 patients met the study inclusion criteria. Of the 17,634 patients evaluable for the PTS cohort, 663 (3.8%) patients experienced PTS. Patients with DVT, PE, or DVT and PE had higher annualized direct medical costs before the index (initial) DVT and/or PE event (median: $7227, $6381, and $6771, respectively) than controls (median: $1045). During and after the DVT/PE event, annualized median costs rose to $17,512, $18,901, and $25,554, respectively, compared with $680 in the control group. Annualized median total costs for the PTS group were $20,569 compared with $15,843 in matched controls with DVT and/or PE and no PTS. CONCLUSION: These data suggest that the initial acute DVT or PE event is associated with high total health care costs and that these costs are further increased by subsequent events such as recurrent DVT or PE and PTS. Early detection and appropriate treatment of this high-risk population have the potential for both clinical and economic benefits.

Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting.

BACKGROUND: The effectiveness of chronic therapies can be compromised by poor adherence and persistence. MATERIALS AND METHODS: Investigators identified a continuously benefit-eligible cohort of women from a large, geographically diverse, national managed care plan who were newly diagnosed and treated for osteoporosis with alendronate, risedronate, or raloxifene. Drug utilization parameters were evaluated over a 12-month follow-up period for the study population. Adherence was assessed using a medication possession ratio calculated as total days of therapy for medication dispensed/365 days of study follow-up. Persistence was defined as continuous therapy on the same drug for each month over the entire study period. Adherence and persistence were also evaluated for all three study agents in women > or = 65 years of age. RESULTS: In the study cohort (N = 10,566), 12-month adherence/ persistence rates were alendronate 61%/21%, risedronate 58%/19%, and raloxifene 54%/16%. Rates in women > or = 65 years were similar to those in the entire study cohort. Weekly bisphosphonate users had slightly higher 12-month adherence (63% versus 54%, P < 0.05) and persistence (22% versus 19%, P = NS) rates than did daily users, independent of agent. CONCLUSION: Chronic oral-dosed osteoporosis therapies are associated with poor adherence and persistence, regardless of age or dosing regimen. Drug therapies and patient management approaches associated with improved adherence and persistence could improve the likelihood of achieving the therapeutic benefits observed in rigorously controlled clinical trials.

Effectiveness of tegaserod therapy on GI-related resource utilization in a managed care population.

This study sought to determine the real-world effectiveness of tegaserod therapy on gastrointestinal (GI)-related resource utilization in a managed care population with a retrospective, longitudinal pre-/post-parallel cohort study of tegaserod users and a matched reference cohort of tegaserod nonusers through medical and pharmacy claims data from a large, geographically diverse, managed care organization. Continuously enrolled benefit-eligible patients newly initiated on tegaserod therapy (index prescription) were identified between August 1, 2002, and June 30, 2003, and were categorized (using International Statistical Classification of Diseases, 9th Revision, Clinical Modification codes) as having irritable bowel syndrome (IBS) or another GI-related disorder (e.g., gastroesophageal reflux disease). GI-related resource utilization (office visits, hospitalizations, emergency department visits, endoscopic and nonendoscopic procedures, and GI drug prescriptions) was determined for the 6-month period before and after the index prescription date for tegaserod users and nonusers. The study population consisted of 3365 tegaserod users and 3364 matched nonusers. Within-cohort differences before and after therapy were tested using the Wilcoxon signed rank test. The mean age of 3365 tegaserod users and 3364 matched nonusers was 47 years (+/-15 years); 92% were women, 47% had an index diagnosis of IBS, and 53% had an index diagnosis of another GI-related disorder. Within-cohort GI resource utilization comparisons before and after therapy initiation showed significant decreases (P < .01) in all utilization categories, except GI drug prescriptions, for tegaserod users; these decreases were not consistently observed for matched nonusers. Tegaserod use appeared to be associated with consistent decreases in GI-related resource utilization after 6 months of therapy; similarly consistent reductions were not observed in tegaserod nonusers. These early findings suggest that tegaserod may provide important clinical and economic benefits.

Frequency of concurrent use of warfarin with potentially interacting drugs.

STUDY OBJECTIVE: To determine the rates of concomitant use of drugs known to interact with warfarin by increasing the prothrombin time expressed as the international normalized ratio (INR), decreasing the INR, or increasing bleeding risk without apparent changes in INR in a cohort of patients receiving long-term warfarin therapy. DESIGN: Retrospective, longitudinal cohort study. SETTING: Large pharmacy benefits manager database. PATIENTS: A total of 134,833 patients who were prescribed long-term warfarin from June 1, 1999-May 31, 2000. MEASUREMENTS AND MAIN RESULTS: Longitudinal pharmacy claims from the pharmacy benefits manager database were reviewed to identify coprescription of warfarin and drugs associated with significant interactions with warfarin. Of the 134,833 patients receiving long-term warfarin therapy, 109,998 (81.6%) were prescribed a concurrent prescription for at least one potentially interacting drug, including 87,346 (64.8%) who were prescribed one or more concomitant drugs associated with interactions known to increase the INR. Acetaminophen-containing products, prescribed for 22.7% of patients receiving concomitant prescriptions, and thyroid hormones, prescribed for 17.5%, were the most commonly prescribed concurrent drugs associated with an increased INR response. The most frequently prescribed interacting agents associated with a decreased INR response were trazodone (2.2%) and carbamazepine (1.1%). The most commonly prescribed agents independently associated with increased bleeding risk were cyclooxygenase-2 inhibitors. CONCLUSION: Many patients receiving warfarin therapy are treated with concomitant drugs that may interact with the warfarin. The high percentage of patients taking drugs that may increase INR or bleeding risk is a reminder that bleeding events are a likely adverse outcome of combining drugs that interact with warfarin. Careful warfarin management is necessary to avoid adverse events associated with drug interactions.