Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study.

Aims: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services. Methods and results: The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided cardioversion than in patients who underwent TOE-guided cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively. Conclusions: The convenience of edoxaban therapy over warfarin in patients undergoing cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.

Cost-effectiveness of edoxaban vs warfarin in patients with atrial fibrillation based on results of the ENGAGE AF-TIMI 48 trial.

BACKGROUND: In 21,105 patients with atrial fibrillation (AF), the ENGAGE AF-TIMI 48 trial demonstrated that both higher dose (60mg/30mg dose reduced) and lower dose (30mg/15mg dose reduced) once-daily regimens of edoxaban were non-inferior to warfarin for the prevention of stroke or systemic embolism (SE), with significantly lower rates of bleeding and cardiovascular death. Higher dose edoxaban was associated with a greater reduction in the risk of ischemic stroke than lower dose edoxaban, and the FDA approved higher dose edoxaban in patients with creatinine clearance ≤95mL/min. This study evaluated the economic value of higher dose edoxaban vs warfarin based on data from patients in ENGAGE within the FDA-approved population. METHODS: We assessed the cost-effectiveness of edoxaban vs warfarin over a lifetime horizon from the US healthcare system perspective using a Markov model based on a combination of ENGAGE AF-TIMI 48 trial data, US life tables, and published literature on the costs and long-term outcomes of non-fatal cardiovascular and bleeding events. Data from the ENGAGE AF-TIMI 48 trial were used to calculate age-adjusted event rates for warfarin and hazard ratios (HRs) for the relative impact of edoxaban on embolic and bleeding complications. Based on the wholesale acquisition price, edoxaban and warfarin were assumed to cost $9.24 and $0.36/day, respectively. RESULTS: For edoxaban vs warfarin, lifetime incremental costs and QALYs were $16,384 and 0.444, respectively, yielding an incremental cost-effectiveness ratio (ICER) of $36,862/QALY gained, using data from patients with creatinine clearance ≤95mL/min in ENGAGE AF-TIMI 48. ICERs were more favorable for patients without compared to those with prior warfarin use; ICERs differed minimally by CHADS2 score. CONCLUSIONS: Despite its higher acquisition cost, edoxaban is an economically attractive alternative to warfarin for the prevention of stroke and SE in patients with atrial fibrillation and creatinine clearance ≤95mL/min. These results were robust to variation of key model parameters, including assumptions regarding the cost and quality-of-life impact of stroke and bleeding events, and were favorable across both CHADS2 score stroke-risk categories.

Real-World Treatment Patterns and Outcomes Following First-Line Pertuzumab and Trastuzumab Among Patients with HER2+ Metastatic Breast Cancer.

INTRODUCTION: Many patients with human epidermal growth factor receptor-2-positive metastatic breast cancer (HER2+ mBC) require subsequent lines of therapy (LOTs) after being treated with pertuzumab and trastuzumab-based regimens in the first line (1L). Although the efficacy of the second-line (2L) therapies has been demonstrated in clinical trials, the real-world effectiveness of these treatments is understudied. This retrospective cohort study assessed the real-world treatment patterns and outcomes for patients with HER2+ mBC following 1L therapy with pertuzumab and trastuzumab-based regimens in the United States (US) during 2015-2019. METHODS: Adults with HER2+ mBC in the US who initiated 1L pertuzumab and trastuzumab-based regimens between 01/01/2015 and 09/30/2019 and had ≥ 60 days of follow-up after 1L initiation were identified from the IQVIA Oncology Electronic Medical Records database. The regimens utilized in 2L following 1L pertuzumab and trastuzumab-based regimens were described. Median treatment duration and time to treatment failure were reported for 2L based on Kaplan-Meier analyses. RESULTS: Of the 710 eligible patients who received pertuzumab and trastuzumab-based regimens in 1L (median age: 57.0 years [interquartile range: 48.0-65.0]; median follow-up: 20.3 months; median 1L duration: 15.3 months), 222 (31.3%) initiated 2L. The most common regimens in 2L were ado-trastuzumab emtansine (T-DM1)-based regimens (n = 159 [71.6%]), followed by lapatinib-based (n = 21 [9.5%]) and neratinib-based (n = 18 [8.1%]) regimens. The median treatment duration and time to treatment failure were 5.9 (95% CI: 5.0, 8.7) and 8.6 (7.3, 11.5) months, respectively, among patients initiating 2L, and 5.7 (4.7, 7.8) and 7.9 (6.5, 10.0) months among those receiving 2L T-DM1. CONCLUSIONS: Most patients with HER2+ mBC requiring additional treatments after 1L pertuzumab and trastuzumab-based regimens utilized T-DM1 in 2L during 2015-2019. The short median treatment duration and time to treatment failure highlight an unmet need that can potentially be fulfilled by recently approved treatment options.

Understanding the Effect of Osteoarthritis on Surgical Treatment Patterns, Healthcare Resource Utilization, and Costs Among Patients With Tenosynovial Giant Cell Tumors.

BACKGROUND: Tenosynovial giant cell tumor (TGCT) may be misdiagnosed as osteoarthritis (OA), or the chronic course of TGCT may lead to development of secondary OA. However, little is known about the effect of comorbid OA on long-term surgical patterns and costs among TGCT patients. METHODS: This cohort study used claims data from the Merative MarketScan Research Databases. The study included adults diagnosed with TGCT from January 1, 2014, to June 30, 2019, who have at least 3 years of continuous enrollment before and after the first TGCT diagnosis (date of the first TGCT diagnosis = index date) and no other cancer diagnosis during the study period. Patients were stratified by the presence of an OA diagnosis relative to the index date. Outcomes included surgical procedure patterns, healthcare resource utilization, and costs in the 3-year pre- and postindex periods. Multivariable models were used to assess the effect of OA on the study outcomes, controlling for baseline characteristics. RESULTS: The study included 2856 TGCT patients: 1153 (40%) had no OA before or after index (OA[-/-]), 207 (7%) had OA before index but not after (OA[+/-]), 644 (23%) had OA after index but not before (OA[-/+]), and 852 (30%) had OA before and after index (OA[+/+]). The mean age was 51.6 years, and 61.7% were female. During the postperiod, joint surgery was more common among OA(-/+) and OA(+/+) patients compared with OA(-/-) and OA(+/-) patients (55.7% vs 33.2%). The mean all-cause total costs in the 3-year postperiod were $19,476 per patient per year. Compared with OA(-/-) patients, OA(-/+) and OA(+/+) patients had a higher risk of undergoing recurrent surgery and higher total healthcare costs postindex. DISCUSSION: Higher rates of surgery and increased healthcare cost observed in TGCT patients with postindex OA underscore the need for effective treatment options to reduce joint damage, especially among patients with comorbid OA.

Real-World Treatment Patterns and Economic Burden Following First-Line Trastuzumab in Patients with Metastatic Gastric Cancer in the USA.

BACKGROUND: Trastuzumab in combination with chemotherapy is the standard first-line (1L) treatment for HER2+ metastatic gastric cancer (mGC) in the USA. OBJECTIVE: This study characterizes the real-world treatment patterns, healthcare resource use (HRU), and costs in patients with HER2+ mGC post-1L trastuzumab before approval of fam-trastuzumab deruxtecan-nxki. PATIENTS AND METHODS: This retrospective study used the IQVIA PharMetrics® Plus Database (October 2014-September 2019) to identify adults with HER2+ mGC who discontinued trastuzumab-based regimens in 1L. Patient characteristics, second-line (2L) treatment patterns, and treatment duration were summarized. HRU and costs before and after discontinuation of 1L trastuzumab-based regimens as well as during 2L treatment were described. RESULTS: Of the 190 HER2+mGC patients who discontinued 1L trastuzumab-based regimens, 136 (71.58%) initiated 2L treatments. Trastuzumab-based regimens were the most common in 2L (50.74%), followed by ramucirumab + paclitaxel (19.85%). The median time to 2L discontinuation was 2.37 months. During a mean follow-up of 9.8 months, mean per-patient-per-month (PPPM) healthcare costs post-1L trastuzumab-based regimens were higher in patients receiving 2L treatment than those without subsequent treatment (US$25,178 vs. US$14,812). The mean PPPM cost during 2L treatment was US$30,838, primarily driven by outpatient infusion costs (US$22,262). CONCLUSIONS: The short duration of 2L treatment observed in this study is consistent with a lack of effective treatments post-1L trastuzumab prior to 2020. Re-use of trastuzumab treatment was common despite its limited efficacy and high treatment cost. The findings highlight the unmet medical needs and substantial burden faced by patients with HER2 +mGC previously treated with trastuzumab.

Retrospective Observational Study of Outcomes in HER2-Positive Metastatic Breast Cancer (mBC) Patients Treated with Ado-Trastuzumab Emtansine (T-DM1) and Subsequent Treatments After T-DM1 in the United States.

BACKGROUND: Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies. OBJECTIVE: This study evaluated treatment patterns and outcomes of patients treated with T-DM1 and post-T-DM1 therapy in the United States. PATIENTS AND METHODS: Adult patients with HER2-positive (HER2+) metastatic breast cancer (mBC) initiating treatment with T-DM1 between 1/1/2013 and 9/30/2018 were included and followed through 12/31/2018. Data were obtained from the iKnowMed electronic health record. Demographic, clinical, and pre- and post-T-DM1 treatment characteristics were described. The Kaplan-Meier method was used to estimate time to treatment discontinuation (TTD) and overall survival (OS). RESULTS: Of 318 patients treated with T-DM1, 184 (57.9%) had prior treatment with pertuzumab. The median age was 58 years. Most patients had visceral disease (93.4%), and 62.3% had two or more prior treatments for mBC before T-DM1 (range 0-9). The most common subsequent regimens were trastuzumab + vinorelbine (22.5%), HER2-targeted monotherapy (22.5%), and trastuzumab + other chemotherapy (19.6%). Median TTD with T-DM1 was 5.9 months (95% confidence interval [CI] 4.6-6.9); median OS from the start of T-DM1 therapy was 19.2 months (95% CI 16.8-24.5). CONCLUSIONS: Patients treated with T-DM1 in this study appeared to have more advanced disease than patients in clinical trials and were treated in later lines of therapy. Variability was observed across subsequent therapy selections. Treatment patterns and outcomes appeared comparable for patients who received prior pertuzumab. The short treatment durations and survival with T-DM1 therapy in the real-world setting underscore the need for effective post-trastuzumab therapies.

Patient-Reported Outcomes After Ferric Carboxymaltose Treatment for Iron Deficiency Anemia: A Prospective Observational Study.

Background: Iron deficiency anemia (IDA) is a common cause of fatigue and impaired quality of life. The present study aimed to evaluate the impact of intravenous iron supplementation with ferric carboxymaltose (FCM) on fatigue, physical function, and general health among patients with IDA attending routine clinical care. Methods: This was a prospective, single arm, observational study of adult patients prescribed with intravenous FCM for the treatment of IDA during routine clinical care. We used Patient-Reported Outcomes Measurement Information System (PROMIS) instruments to evaluate fatigue (PROMIS Short Form v1.0 13a [FACIT-Fatigue]), general health status (PROMIS Scale v1.2), and physical function (PROMIS Short Form v2.0 4a) before and at 3 and 6 months after FCM treatment. Results: A total of 152 patients were enrolled. Mean age was 47.4 ± 16.0 years and 82.2% were female. Mean serum hemoglobin was 10.2 ± 1.4 g/dL at baseline. All patients were treated with at least one FCM dose at baseline, with 77.6% receiving a two-dose treatment course. The mean baseline FACIT-Fatigue score was 61.0 ± 9.0, improving significantly to 50.2 ± 9.5 at 3 months after FCM treatment. A minimum 5-point improvement, pre-defined as clinically meaningful, was seen in the FACIT-Fatigue, PROMIS Global Physical Health, Global Mental Health and PROMIS Physical Function scores for 72.7%, 52.8%, 41.7% and 39.8% of patients at 3 months (p < 0.0001 for each change from baseline), with statistically significant improvement continuing at 6 months. Mean serum hemoglobin was significantly increased at both 3 and 6 months (12.8 g/dL [N = 44] and 12.4 g/dL [N = 54], respectively). Conclusion: IDA patients attending routine clinical practice reported substantial levels of fatigue and impairments in physical function and global health prior to intravenous iron treatment. Patients experienced significant improvements in fatigue symptoms, physical function, and global health at 3 months after treatment with FCM, which were sustained at 6 months.

Surgical Treatment Patterns, Healthcare Resource Utilization, and Economic Burden in Patients with Tenosynovial Giant Cell Tumor Who Underwent Joint Surgery in the United States.

Background: Tenosynovial giant cell tumors (TGCT) are rare and locally aggressive neoplasms in synovium, bursae, and tendon sheaths, which cause pain, joint dysfunction, and damage to the affected joints. Objective: To evaluate the surgical patterns and economic burden among patients with TGCT who underwent joint surgery in the United States. Methods: Patients newly diagnosed with TGCT, aged 18-64 years, who underwent joint surgery post-TGCT diagnosis were identified from the OptumHealth Care Solutions, Inc database (Q1/1999-Q1/2017). Patients were required to be continuously enrolled for ≥1 year before and ≥3 years after the first TGCT diagnosis (index date). Surgical patterns were assessed post-index. Healthcare resource utilization and associated healthcare costs, and indirect costs related to work loss in year 1, year 2, and year 3 post-index, were compared with those at baseline. Results: Of 835 eligible TGCT patients, 462 (55%) patients who had ≥1 joint surgery post-index were included. During a median follow-up of 5.7 years, 78% of patients underwent their first joint surgery in year 1 and 41% had ≥1 repeat surgery. Magnetic resonance imaging utilization was highest during baseline (46%) and declined afterward (28%, 17%, and 19% in years 1, 2, and 3, respectively). Opioids and nonsteroidal anti-inflammatory drugs (NSAIDs), and physical therapy, occupational therapy, and rehabilitation services, were commonly used during baseline (45%, 40%, and 30%, respectively). More patients used opioids in year 1 vs baseline (78% vs 45%; P<0.0001), while its utilization return to baseline levels in year 2 (41%) and year 3 (42%). A similar pattern was observed for NSAIDs and physical/occupational therapy/rehabilitation services. Healthcare resource utilization and associated healthcare costs surged in year 1 and returned to baseline or lower in years 2 and 3. A similar pattern was observed for indirect costs associated with work loss. Discussion: The high proportion of patients undergoing repeat surgeries and prevalent use of opioids, NSAIDs, and physical/occupational therapy/rehabilitation services suggests an unmet medical need after surgical treatment. Conclusions: Surgical resection alone might be inadequate to control TGCT. New treatment options may complement surgery and alleviate the clinical and economic burden experienced by patients with TGCT who had received prior surgery.

Erratum: Author Correction: Surgical Treatment Patterns, Healthcare Resource Utilization, and Economic Burden in Patients with Tenosynovial Giant Cell Tumor Who Underwent Joint Surgery in the United States.

[This corrects the article DOI: 10.36469/jheor.2022.32485.].

The Economic Burden of Tenosynovial Giant Cell Tumors Among Employed Workforce in the United States.

OBJECTIVE: To assess the economic burden of tenosynovial giant cell tumor (TGCT) among US employed workforce. METHODS: Patients with TGCT medical claims (N = 1395) and matched controls (1:10) without TGCT claims (N = 13,950) were identified from the OptumHealth Care Solutions, Inc. database (January 1, 1999 to March 31, 2017). Adjusted regression models were used to compare healthcare resource utilization, time lost from work, and associated costs between cohorts. RESULTS: In patients with TGCT, the rates of inpatient admissions, emergency room visits, outpatient visits, and work loss days were 2.8, 1.5, 2.2, and 2.6 times those of matched controls, respectively (all P < 0.001). Total annual all-cause healthcare costs and work loss-related costs were $9368 and $2708 higher for TGCT patients than for matched controls, respectively (all P < 0.001). CONCLUSIONS: TGCT was associated with a significant healthcare and work loss burden on US employers.

Is Adherence to the American College of Chest Physicians Recommended Anticoagulation Treatment Duration Associated With Different Outcomes Among Patients With Venous Thromboembolism?

Clinical and economic outcomes associated with venous thromboembolism (VTE) patient adherence to the American College of Chest Physicians (ACCP) anticoagulant (AC) treatment guidelines are incompletely understood. Patients with ≥1 inpatient or ≥2 separate outpatient claims for deep vein thrombosis and/or pulmonary embolism, based on International Classification of Diseases, Ninth Revision, Clinical Modification codes, were identified from the IMS PharMetrics Plus database. Patients had continuous insurance coverage for 12 months before (baseline) and after (follow-up) the index event (first VTE claim) but no baseline VTE claims. The ACCP recommends minimum AC treatment durations (3 or ≥6 months) dependent upon patient risk profiles. Patients were grouped into study cohorts based on their adherence status (adherent vs nonadherent) to the recommended minimum treatment durations. Patient baseline characteristics, health-care resource utilization, and associated costs were evaluated. The VTE recurrence and bleed-related hospitalization were measured during follow-up. Multivariate regression analysis was utilized to compare clinical and economic outcomes of cohorts. Of the 81 827 study patients, 74% (n = 60 550) were AC adherent. After controlling for key patient characteristics, risks for all-cause hospitalization (adjusted odds ratio [AOR]: 0.85, P < .0001), VTE recurrence (AOR = 0.92, P = .0014), and bleeding-related hospitalization (AOR = 0.74, P < .0001) were lower among adherent patients, as were all-cause health-care cost (-US$2121, P = .0003) and VTE-related (-US$2294, P < .0001) and bleed-related (-US$248, P < .0001) medical costs during the follow-up period. Approximately one-quarter of the study population was AC nonadherent; these nonadherent patients had more VTE recurrences, utilized more inpatient services, and had higher health-care costs.

Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial.

BACKGROUND: The impact of different types of extracranial bleeding events on health-related quality of life and health-state utility among patients with atrial fibrillation is not well understood. METHODS AND RESULTS: The ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) Trial compared edoxaban with warfarin with respect to the prevention of stroke or systemic embolism in atrial fibrillation. Data from the EuroQol-5D (EQ-5D-3L) questionnaire, prospectively collected at 3-month intervals for up to 48 months, were used to estimate the impact of different categories of bleeding events on health-state utility over 12 months following the event. Longitudinal mixed-effect models revealed that major gastrointestinal bleeds and major nongastrointestinal bleeds were associated with significant immediate decreases in utility scores (-0.029 [-0.044 to -0.014; P<0.001] and -0.029 [-0.046 to -0.012; P=0.001], respectively). These effects decreased in magnitude over time, and were no longer significant for major nongastrointestinal bleeds at 9 months, but remained borderline significant for major gastrointestinal bleeds at 12 months. Clinically relevant nonmajor and minor bleeds were associated with smaller but measurable immediate impacts on utility (-0.010 [-0.016 to -0.005] and -0.016 [-0.024 to -0.008]; P<0.001 for both), which remained relatively constant and statistically significant over the 12 months following the bleeding event. CONCLUSIONS: All categories of bleeding events were associated with negative impacts on health-state utility in patients with atrial fibrillation. Major bleeds were associated with relatively large immediate decreases in utility scores that gradually diminished over 12 months; clinically relevant nonmajor and minor bleeds were associated with smaller immediate decreases in utility that persisted over 12 months. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00781391.

Bowel function after tapentadol and oxycodone immediate release (IR) treatment in patients with low back or osteoarthritis pain.

OBJECTIVES: Constipation is a common side effect of opioid therapy. Tapentadol immediate release (IR) was better tolerated than oxycodone IR in 2 clinical trials involving patients with low back or osteoarthritis pain. The objective of this study was to examine patient-reported bowel function during those trials. METHODS: Bowel function was assessed during secondary post hoc analyses using: the bowel movement questionnaire (BMQ; 10-d trial); the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM; 90-day trial); and laxative use (both trials). Random effects maximum likelihood regressions were run to examine PAC-SYM data. BMQ data were analyzed using 1-way analyses of variance and a multinomial logistic regression. Rates of laxative use were compared using χ(2) statistics. RESULTS: The 10- and 90-day trials consistently showed that tapentadol IR caused less impairment of bowel function than oxycodone IR. BMQ data were comparable between patients receiving tapentadol IR and placebo, and better versus oxycodone IR including: lower proportion of days where bowel movement was absent (P<0.05); lower risks of reporting hard stools (P<0.001); and moderate or severe straining (P<0.001). All PAC-SYM summary scores (abdominal, rectal, stool, overall) indicated fewer symptoms among patients receiving tapentadol IR versus oxycodone IR (P<0.001). In both trials, rates of laxative use was lower for tapentadol IR treatment groups versus oxycodone IR (P<0.001). DISCUSSION: Patient-reported bowel function associated with tapentadol IR treatment was similar to that associated with placebo (10-d trial) and significantly better than that associated with oxycodone IR treatment (10- and 90-d trials).

Impact of atrial fibrillation on stroke-related healthcare costs.

BACKGROUND: Limited data exist on the economic implications of stroke among patients with atrial fibrillation (AF). This study assesses the impact of AF on healthcare costs associated with ischemic stroke (IS), hemorrhagic stroke (HS), or transient ischemic attack (TIA). METHODS AND RESULTS: A retrospective analysis of MarketScan claims data (2005-2011) for AF patients ≥18 years old with ≥1 inpatient claim for stroke, or ≥1 ED or inpatient claim for TIA as identified by ICD-9-CM codes who had ≥12 months continuous enrollment prior to initial stroke. Initial event- and stroke-related costs 12 months post-index were compared among patients with AF and without AF. Adjusted costs were estimated, controlling for demographics, comorbidities, anticoagulant use, and baseline resource use. Data from 23,807 AF patients and 136,649 patients without AF were analyzed. Unadjusted mean cost of the index event was $20,933 for IS, $59,054 for HS, $8616 for TIA hospitalization, and $3395 for TIA ED visit. After controlling for potential confounders, adjusted mean incremental costs (index plus 12-month post-index) for AF patients were higher than those for non-AF patients by: $4726, $7824, and $1890 for index IS, HS, TIA (identified by hospitalization), respectively, and $1700 for TIA (identified by ED) (all P<0.01). In multivariate regression analysis, AF was associated with a 20% (IS), 13% (HS), and 18% (TIA) increase in total stroke-related costs. CONCLUSION: Stroke-related care for IS, HS, and TIA is costly, especially among individuals with AF. Reducing the risk of AF-related stroke is important from both clinical and economic standpoints.

All-cause and bleeding-related health care costs in warfarin-treated patients with atrial fibrillation.

BACKGROUND: Bleeding is a major complication of warfarin therapy. Assessing the cost of warfarin-associated bleeding may more fully describe the costs associated with warfarin use. OBJECTIVE: To assess health care costs related to warfarin-associated bleeding in patients with newly diagnosed atrial fibrillation (AF). METHODS: Medical and pharmacy claims were analyzed for patients with AF (ICD-9-CM code 427.31) in the Medstat MarketScan database from January 2003 to December 2007. Eligible patients had no warfarin pharmacy claim or AF diagnosis in the 4 months prior to AF index date, a warfarin pharmacy claim within 30 days of AF diagnosis, and 12 months follow-up data after the index warfarin claim. Subjects were categorized based on the first type of bleeding event observed during follow-up, and only bleeding events occurring within 30 days following a warfarin claim were considered. Intracranial hemorrhage (ICH) and gastrointestinal (GI) events were assessed based on primary or secondary ICD-9-CM codes, and major GI bleeding was defined as a GI bleed associated with hospitalization. Annual total all-cause allowed charges in patients with and without bleeding events after the index warfarin claim were compared using generalized linear model (GLM) regression with gamma distribution and log link, controlling for demographics, insurance status, and comorbidities. Costs for claims with a primary or secondary diagnosis of bleeding were calculated separately. RESULTS: Of the 47,437 patients who were analyzed, 194 (0.4%) had an ICH, 919 (1.9%) had a major GI bleed, and 1,804 (3.8%) had a minor GI bleed within 30 days after a warfarin claim during follow-up. Compared with patients who had no bleeding events after a warfarin claim (n = 44,520, 93.9%) during the study period, patients with at least 1 bleeding event were older and had more comorbidities (P < 0.01). Patients with at least 1 ICH or major GI bleed had more all-cause hospitalizations (P < 0.05) and hospital days (P < 0.01) than patients without bleeding events. Patients with at least 1 ICH, major GI bleed, or minor GI bleed had more all-cause emergency room visits (P < 0.01) than patients without bleeding events. Mean (SD) unadjusted all-cause health care costs in the 12 months after the warfarin index claim were $41,903 ($56,654), $40,586 ($65,164), and $24,347 ($56,488) for patients with at least 1 ICH, major GI bleed, and minor GI bleed, respectively, compared with $24,129 ($36,425) for patients with no bleeding events. Claims with a primary or secondary diagnosis of bleeding accounted for 49.6%, 30.2%, and 2.6% of annual cost in patients with ICH, major GI bleeding, and minor GI bleeding, respectively. On average, 50.9%, 33.5%, and 10.8% of annual all-cause costs occurred within 30 days after the first ICH, major GI bleeding event, and minor GI bleeding event, respectively. GLM regression showed that annual all-cause costs were 64.4% and 49.0% higher (P? less than ?0.001) for patients with ICH and major GI bleeding, respectively, than for patients with no bleeding events. CONCLUSION: ICH and major GI bleeding associated with warfarin therapy are rare but costly.

Determinants of migraine emergency department utilization in the georgia medicaid population.

OBJECTIVE: This study examined factors that may predispose migraine patients to emergency department (ED) visits. BACKGROUND: Headache is noted as the sixth most common reason for ED visits. Previous studies found that migraine headache patients may repeatedly use ED services for headache care. An understanding of the profile of patients who are at high risk of using the ED is important so that interventions to reduce ED use for nonurgent care can be targeted to those that are affected the most. METHODS: Retrospective analysis of medical and prescription claims data was performed. Patients who had at least 1 migraine medical claim (ICD-9 of 346.xx) or 1 prescription claim of a triptan or ergot medication between January 2002 and December 2005, and were continuously eligible for at least 6 months before and 12 months after the date of the first migraine medical or prescription claim (index date) were included in the analysis. RESULTS: A total of 43,791 migraine patients met the inclusion criteria. Mean age was 31 years (SD = 17). About 77% were females and 56% were whites. About 7% patients used a butalbital medication and 28% used a narcotic medication 6 months before index date. About 3% (n = 1211) patients had at least 1 migraine ED visit during the 12 months after index date. Female, non-white patients or patients residing in counties that had fewer general practice physicians or more hospitals were significantly more likely to use the ED for migraine. Prior butalbital use had no effect on ED use, but prior narcotic medication use significantly increased the risk of ED visit. CONCLUSIONS: Patient demographics and health care resource availability significantly affected the likelihood of ED use of diagnosed migraine patients. Additional research is needed for the undiagnosed migraine population to inform the development of interventions to reduce ED utilization for migraines.