Comparison of all-cause, stroke, and bleed-specific healthcare resource utilization among patients with non-valvular atrial fibrillation (NVAF) and newly treated with dabigatran or warfarin.

BACKGROUND: We compared healthcare utilization outcomes and persistence among non-valvular atrial fibrillation (NVAF) patients newly treated with dabigatran or warfarin. METHODS: Using a nationwide, US administrative claims database, a retrospective matched-cohort of newly diagnosed NVAF patients (age≥18 years) treated with dabigatran or warfarin (propensity score matched 1:1) in 01/01/2011-12/31/2013 was evaluated. All-cause, stroke-, and bleed-specific per patient per month (PPPM) healthcare resource utilization (HCRU), incidence rate of hospitalization for stroke or bleed, 30-day readmission, and persistence were reported. RESULTS: In total, 18,890 dabigatran patients were matched to corresponding warfarin patients. Compared to warfarin users, dabigatran users PPPM had significantly fewer all-cause hospitalizations (0.04 vs 0.05), total outpatient visits (3.98 vs 5.87), and lower 30-day readmissions (14.5% vs 17.4%, all p < 0.001). Dabigatran users had lower incidence rate for stroke (0.65 vs 1.06) and bleed (1.69 vs 2.20), stroke (0.0006 vs 0.0011, p < 0.001) and bleed-specific hospitalizations (0.002 vs 0.003, p = 0.008), and stroke (0.03 vs 0.04, p < 0.001) and bleed-specific outpatient visits (0.07 vs 0.08, p = 0.018), and significantly lower non-persistence (62.1% vs 66.3%, p < 0.001). CONCLUSION: Among newly diagnosed newly treated NVAF patients, dabigatran users had significantly lower all-cause, stroke- and bleed-specific HCRU, lower risk of hospitalization for stroke or bleed events, lower 30-day readmissions, and higher persistence than warfarin users.

Comparison of stroke- and bleed-related healthcare resource utilization and costs among patients with newly diagnosed non-valvular atrial fibrillation and newly treated with dabigatran, rivaroxaban, or warfarin.

BACKGROUND: This is one of the first head-to-head real-world evidence studies comparing stroke-related and bleed-related healthcare and resource utilization (HCRU) and costs among non-valvular atrial fibrillation (NVAF) patients initiating oral anticoagulants. METHODS: Adult NVAF patients newly diagnosed and treated with dabigatran, rivaroxaban, or warfarin between 10/01/2010 and 12/31/2014 were identified using MarketScan Commercial and Medicare Supplemental databases. Per-patient-per-month stroke and bleed-related HCRU and costs were reported. RESULTS: Dabigatran patients were matched 1:1 to 26,592 rivaroxaban and 33,024 warfarin patients (mean age=68 years). Compared to rivaroxaban, dabigatran patients had lower bleed-related inpatient and outpatient HCRU (0.004 vs. 0.005; 0.099 vs. 0.145) and significantly lower adjusted bleed-related costs ($116 vs. $172), all p <0.05. Compared to warfarin, dabigatran patients had significantly lower stroke-related outpatient visits (0.034 vs. 0.048, p<0.001) and higher bleed-related outpatient visits (0.101 vs. 0.091, p=0.045). Multivariate adjusted bleed-related costs were significantly lower for dabigatran patients than warfarin patients ($94 vs. $138, p<0.001). CONCLUSIONS: The results suggest that dabigatran patients had lower bleed-related HCRU and costs than rivaroxaban patients, and lower outpatient stroke-related HCRU, higher bleed-related outpatient HCRU, and lower bleed-related costs than warfarin patients. It provides valuable stroke-related and bleed-related HCRU and costs information among commercially insured and Medicare patients.

Treatment and persistence with oral anticoagulants among newly diagnosed patients with non-valvular atrial fibrillation: a retrospective observational study in a US commercially insured and Medicare Advantage population.

OBJECTIVES: With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics. DESIGN: Retrospective observational administrative claims study in the USA. SETTING: Patients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013. PARTICIPANTS: 45 092 patients with NVAF were included. OUTCOMES: The proportion of OAC-treated patients was stratified by CHADS2 score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first. RESULTS: Almost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS2<2: 39.8%; CHADS2=2 or 3: 42.4%; and CHADS2>3: 40.3%: p<0.001). Treated patients were slightly younger (70±12.2 vs 71±14.3 years; p<0.001), more likely male (59.7% vs 52.5%; p<0.001) and had a slightly elevated stroke risk (CHADS2: 2.03±1.3 vs 1.98±1.4; p<0.001) and a lower bleeding risk (HEMORR2HAGES: 2.55±1.8 vs 2.80±1.9; p<0.001) relative to untreated patients. Overall, patients with higher CHADS2 scores had higher HEMORR2HAGES scores. The mean follow-up was 2.25 years (2.25±0.85) and 72.7% of patients discontinued OACs; nearly 25% within 3 months and 55% within 12 months. The mean time to discontinuation was 255±249 days. CONCLUSIONS: The proportion of patients with NVAF who received OAC treatment was lower than previously reported and differed slightly by stroke risk. Patients with an elevated stroke risk had a higher bleeding risk, suggesting that clinicians may incorporate both in the treatment decision.

Factors influencing dabigatran or warfarin medication persistence in patients with nonvalvular atrial fibrillation.

Factors influencing differences in persistence between dabigatran and warfarin in patients with nonvalvular atrial fibrillation (NVAF) remain unclear. AIM: Compare differences in persistence between new dabigatran and warfarin users in patients newly diagnosed with NVAF, adjusting for sociodemographics, clinical characteristics, patient out-of-pocket cost and other covariates. METHODS: A retrospective matched-cohort study was conducted using a US claims database of Medicare and commercially insured patients with NVAF aged≥ 18 years. Persistence and monthly out-of-pocket costs for dabigatran or warfarin were calculated and adjusted for covariates using Cox proportional hazard models. RESULTS & CONCLUSION: Unadjusted persistence was significantly lower among dabigatran users (n = 1025) compared with matched warfarin users (38 vs 46%). Adjusting for covariates rendered this difference insignificant (hazard ratio = 0.930).

Differences in All-Cause Health Care Utilization and Costs in a Type 2 Diabetes Mellitus Population with and Without a History of Cardiovascular Disease.

BACKGROUND: Multiple studies have reported that type 2 diabetes mellitus (T2DM) is a major risk factor for cardiovascular diseases (CVD), and presence of T2DM and CVD increases risk of death. There is growing interest in examining the effects of antidiabetic treatments on the reduction of cardiovascular events in T2DM adults with a history of CVD and thus at higher risk of cardiovascular events. OBJECTIVE: To estimate the incremental all-cause health care utilization and costs among adults with T2DM and a history of CVD compared with adults without a history of CVD, using a national linked electronic medical records (EMR) and claims database. METHODS: Adults aged ≥ 18 years with evidence of at least 1 T2DM-related diagnosis code or antidiabetic medication (date of earliest occurrence was defined as the index date) in calendar year 2012 were identified. The population was divided into 2 cohorts (with and without a history of CVD) and followed until the end of their enrollment coverage, death, or 12 months, whichever came first. Multivariable generalized linear models were used to assess differences in health care utilization and per patient per month (PPPM) total costs (plan- and patient-paid amount for health care services) between the 2 groups during the post-index year, while adjusting for an a priori list of demographic and clinical characteristics. RESULTS: A total of 138,018 adults with T2DM was identified, of which 16,547 (12%) had a history of CVD. The unadjusted resource utilization (outpatient: 27.5 vs. 17.8; emergency room [ER]: 0.8 vs. 0.4; inpatient: 0.4 vs. 0.2 days; and total unique drug prescriptions: 10.1 vs. 8.3) and PPPM total health care costs ($2,655.1 vs. $1,435.0) were significantly higher in T2DM adults with a history of CVD versus T2DM adults without a history of CVD. The adjusted models revealed that T2DM adults with a history of CVD had a 31% higher number of ER visits (rate ratio [RR] = 1.31, 95% CI = 1.25-1.37); 27% more inpatient visits (RR = 1.27, 95% CI = 1.21-1.34); 15% longer mean inpatient length of stay (RR = 1.15, 95% CI = 1.06-1.25); and 11% more outpatient visits (RR = 1.11, 95% CI = 1.09-1.13) compared with T2DM adults without a history of CVD. Furthermore, the difference in total PPPM health care cost was found to be 16% ($200) higher in adults with a history of CVD (RR = 1.16, 95% CI = 1.13-1.19). PPPM costs associated with outpatient and ER visits were approximately 21% and 19% higher among adults with a history of CVD, respectively (P < 0.0001), while costs for inpatient visits were similar between the 2 groups. In addition, a subgroup analysis revealed that adjusted differences in PPPM total cost was larger in the younger age group (56% higher cost in those aged < 45 years) and diminished in the older age group (only 2% higher in those aged ≥ 65 years). CONCLUSIONS: Study findings showed that resource utilization and costs remains significantly higher in T2DM patients with a history of CVD compared with patients without a history of CVD even after controlling for significant patient comorbid and demographic characteristics. Also, younger age groups had higher differences in outcomes compared with older age groups. This study underscores the importance of cost-effective interventions that may reduce economic burden in this T2DM population with a history of CVD. DISCLOSURES: This study was funded by Boehringer Ingelheim. At the time of this study, Mehta and Mountford were employed by IQVIA, which received funding from Boehringer Ingelheim to conduct this study. Mountford is employed by Allergan, which has no connection with this study. Ghosh, Sander, and Kuti are employed by Boehringer Ingelheim. Study concept and design were contributed by Mountford, Mehta, and Ghosh, along with Sander and Kuti. Mountford and Mehta collected the data, and data interpretation was performed by all the authors. The manuscript was written by Sander and Kuti, along with the other authors, and revised by Mehta and Gosh, along with the other authors.

The cost of cardiovascular-disease-related death in patients with type 2 diabetes mellitus.

OBJECTIVES: To assess the magnitude of difference in all-cause healthcare resource utilization (HCRU) and costs between patients with type 2 diabetes mellitus (T2DM) who died from a cardiovascular disease (CVD)-related cause in the year preceding death vs. those who did not die during this same period. METHODS: A large US administrative claims database was used to identify patients with T2DM who died of a CVD-related cause from July 2012 to April 2015. These patients were matched 1:1 to patients with T2DM who did not die, using direct matching methods. HCRU and costs were assessed in each of the four quarters (Q4: 12-10 months; Q3: 9-7 months; Q2: 6-4 months; and Q1: 3-0 months) prior to death and compared between patient cohorts using paired t-tests and McNemar's tests. RESULTS: A final matched cohort of 7648 patients who died and 7648 patients who did not die were identified. A significantly higher proportion of patients who died utilized inpatient services vs. those who did not die (Q4: 12.6% vs. 4.6%, p < .001; Q3: 14.6% vs. 4.6%, p < .001; Q2: 17.6% vs. 5.5%, p < .001; and Q1: 65.0% vs. 10.1%, p < .001). In addition, patients who died incurred significantly higher all-cause costs (Q4: $8882 vs. $3970, p < .001; Q3: $10,462 vs. $3661, p < .001; Q2: $12,564 vs. $4169, p < .001; and Q1: $36,076 vs. $6319, p < .001). CONCLUSIONS: T2DM patients with a CVD-related death had significantly greater HCRU and costs in the year including and preceding death compared to those who did not die.

Incremental burden of type 2 diabetes in patients experiencing cardiovascular hospitalizations.

OBJECTIVE: To evaluate the incremental economic burden of type 2 diabetes in patients experiencing cardiovascular (CV) hospitalizations. RESEARCH DESIGN AND METHODS: Adults with ≥1 CV hospitalization were identified using a US-based healthcare claims database from 1 July 2011 to 30 June 2014. Outcomes for patients surviving the index hospitalization were compared between patients with vs. without type 2 diabetes (cohorts were identified in the pre-index period). Subsequent CV hospitalizations were evaluated using Cox proportional hazards models. All-cause and CV-related healthcare resource utilization (HCRU) and costs captured on a per-patient per-month (PPPM) basis during a variable follow-up period were evaluated using appropriate multivariable regression models. RESULTS: Of 316,207 patients with ≥1 CV hospitalization, 23% had comorbid type 2 diabetes. The mean age ± SD was 62.6 ± 12.3 years and 64.4% were male. During follow-up, the type 2 diabetes cohort had a 19% higher risk of subsequent CV hospitalizations compared to the non-type-2-diabetes cohort (p < .001). This difference in risk was highest in patients aged 35-44 years. Subsequent all-cause hospitalizations for the type 2 diabetes cohort were longer (mean length of stay, 6.7 vs. 6.3 days; p < .001), with higher total bed-days PPPM (mean, 0.52 vs. 0.43; p < .001), compared to the non-type-2-diabetes cohort. The type 2 diabetes cohort had a significantly higher incremental cost for both the index CV hospitalization (mean cost difference, $1046; p < .001) and all-cause costs PPPM following discharge (mean cost difference, $749; p < .001). CONCLUSIONS: Comorbid type 2 diabetes was associated with an increased risk of subsequent CV hospitalizations and higher costs and HCRU during the follow-up period.

Health Care Resource Utilization and Costs Among Newly Diagnosed and Oral Anticoagulant-Naive Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran or Warfarin in the United States.

BACKGROUND: Warfarin has a long history of use to reduce the risk of stroke in patients with atrial fibrillation (AF), but it requires frequent laboratory monitoring to maintain international normalized ratio levels in the therapeutic range. Dabigatran, a novel oral anticoagulant (OAC), has demonstrated efficacy in reducing the risk of stroke and systemic embolism and does not require laboratory monitoring. OBJECTIVE: To compare health care resource utilization (HCRU) and costs of OAC-naive patients newly diagnosed with nonvalvular atrial fibrillation (NVAF), using dabigatran or warfarin. METHODS: This retrospective observational study used data from medical and pharmacy claims extracted from the HealthCore Integrated Research Database representing commercial and Medicare Advantage members. Adults aged > 18 years with a medical diagnosis claim of NVAF were identified between October 1, 2010, and December 31, 2011. The date of first observed OAC prescription claim was the index date. Patients were followed for up to 12 months after the index date. Patients were assigned to the dabigatran or warfarin treatment groups based on their first OAC prescription fills. To reduce potential for selection bias, the cohorts were matched on baseline characteristics using propensity score matching. HCRU was measured and compared between groups on a per-patient-per-month (PPPM) basis for all-cause HCRU, as well as stroke, myocardial infarction, and bleed-specific HCRU. Pharmacy, medical, and total costs were also compared and adjusted to 2012 U.S. dollars. Generalized linear models were conducted to compare all-cause health care costs between cohorts. RESULTS: After propensity score matching, 1,648 patients were included in the analysis (824 each in the dabigatran and warfarin treatment groups). In the post-index period, patients in the dabigatran group had significantly fewer all-cause PPPM physician office visits (mean [SD] 1.29 [± 0.95] vs. 2.02 [± 1.53], P < 0.001) and outpatient visits (mean [SD] 2.17 [± 2.90] vs. 3.52 [± 3.32], P < 0.001) compared with those in the warfarin group. There were no between-group differences in outcomes for the number of stroke, myocardial infarction, or bleeding-related office visits. All-cause medical costs for the dabigatran cohort were lower than the warfarin cohort; however, the difference did not reach statistical significance ($2,696 [SD ± $6,699] vs. $2,893 [± $6,819], P = 0.179). All-cause pharmacy costs were higher in the dabigatran group versus the warfarin group ($455 [± $429] vs. $328 [± $517], P < 0.001). The dabigatran cohort also had significantly higher stroke-related ($32 [± $71] vs. $20 [± $55], P = 0.006) and nonstroke-related pharmacy costs ($423 [± $422] vs. $308 [± $515], P < 0.001). Despite higher pharmacy costs for the dabigatran cohort, both treatment groups had statistically similar all-cause total costs ($3,151 [± $6,744] vs. $3,221 [± $6,869], P = 0.701). CONCLUSIONS: This real-world study showed that among patients newly diagnosed with NVAF who were OAC naive, dabigatran use was associated with significantly less HCRU in terms of physician and outpatient visits but higher pharmaceutical costs in up to 12 months of follow-up. Similar to other real-world studies, this research supports the finding that higher pharmacy costs for dabigatran users was offset by lower medical costs, making total health care costs comparable between dabigatran and warfarin. DISCLOSURES: This work was supported by Boehringer Ingelheim Pharmaceuticals, which is the manufacturer of dabigatran, one of the products included in the analysis of this work. The authors were responsible for all content and editorial decisions. Jain and Tan are employed by HealthCore, a research consultancy which was funded by Boehringer Ingelheim Pharmaceuticals for work on this study. Fu was employed by HealthCore at the time of this study. Lim, Wang, Elder, and Sander are employees of Boehringer Ingelheim Pharmaceuticals. Study concept and design were contributed by Wang, Sander, and Tan, along with Fu and Jain. Fu, Tan, and Jain collected the data, and data interpretation was performed by Lim, Wang, and Sander, along with Jain, Tan, and Fu. The manuscript was written by Jain, Elder, Tan, and Wang, along with Lim and Fu, and revised by Jain, Wang, Elder, and Tan. Some of the results of this study were presented at Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke (QCOR) 2014 Scientific Sessions on June 2-4, 2014, in Baltimore, Maryland.

Comparison of all-cause costs and healthcare resource use among patients with newly-diagnosed non-valvular atrial fibrillation newly treated with oral anticoagulants.

OBJECTIVES: Compare costs and healthcare resource utilization (HCRU) among newly-diagnosed non-valvular atrial fibrillation (NVAF) patients newly treated with dabigatran vs apixaban, rivaroxaban, or warfarin. METHODS: Newly-diagnosed adult NVAF patients initiating dabigatran, apixaban, rivaroxaban, or warfarin (index event) between October 1, 2010-December 31, 2014 were identified using MarketScan claims data, and followed until medication discontinuation, switch, inpatient death, enrollment end, or study end (December 31, 2015). Dabigatran patients were propensity-score matched 1:1 separately with apixaban, rivaroxaban, and warfarin patients. Per-patient-per-month (PPPM) all-cause cost, HCRU, and 30-day re-admissions were reported. Costs were analyzed using generalized linear models. RESULTS: Final cohorts, each matched with dabigatran patients, included 8,857 apixaban patients, 26,592 rivaroxaban patients, and 33,046 warfarin patients. Dabigatran patients had lower adjusted PPPM total healthcare, inpatient, and outpatient costs compared to rivaroxaban ($4,093 vs $4,636, $1,476 vs $1,862, and $2,016 vs $2,121, respectively, all p ≤ .001) and warfarin ($4,199 vs $4,872, $1,505 vs $1,851, and $2,049 vs $2,514, respectively, all p < .001). Adjusted costs were similar for dabigatran and apixaban. Dabigatran patients had significantly fewer hospitalizations, outpatient visits, and pharmacy claims than rivaroxaban patients (0.06 vs 0.07, 4.84 vs 4.96 and 4.80 vs 4.93, respectively, all p < .020) and warfarin patients (0.06 vs 0.07, 4.77 vs 6.88, and 4.76 vs 5.89, respectively, all p < .001). Dabigatran patients had similar hospitalizations to apixaban, but higher outpatient visits (4.70 vs 4.31) and pharmacy claims (4.86 vs 4.61), both p < .001. CONCLUSIONS: This real-world study found adjusted all-cause costs were lower for dabigatran compared to rivaroxaban and warfarin patients and similar to apixaban patients.

All-Cause, Stroke-, and Bleed-Specific Healthcare Costs: Comparison among Patients with Non-Valvular Atrial Fibrillation (NVAF) Newly Treated with Dabigatran or Warfarin.

OBJECTIVE: Our objective was to compare all-cause and stroke- and bleed-specific healthcare costs among patients with non-valvular atrial fibrillation (NVAF) treated with dabigatran or warfarin. METHODS: Administrative claims data from the MarketScan® Databases for 2009-2014 were used. Patients with NVAF newly treated with dabigatran were matched 1:1 to those treated with warfarin. All-cause and stroke- and bleed-specific costs per patient per month (PPPM) ($US, year 2015 values) up to a 12-month follow-up period were analyzed. Stroke- or bleed-specific costs were defined as hospitalizations with stroke or bleed as the primary discharge diagnosis and outpatient claims with stroke or bleed diagnosis in any position. Differences in costs between dabigatran and warfarin users were assessed using descriptive and multivariate analyses. RESULTS: A total of 18,980 dabigatran-treated patients were matched to corresponding warfarin-treated patients. Adjusted all-cause total healthcare, inpatient, and outpatient costs were significantly lower for the dabigatran cohort ($US3053 vs. 3433; $US904 vs. 1194; $US1594 vs. 1894, respectively; all p < 0.001), but mean pharmacy costs were significantly higher ($US556 vs. 345, p < 0.001). Stroke-specific total healthcare and outpatient costs were significantly lower for the dabigatran than for the warfarin cohort ($US30.37 vs. 40.99 and $US7.36 vs. 12.20, respectively; p < 0.05 for both values). Similarly, bleed-specific total healthcare and inpatient costs were significantly lower for the dabigatran than for the warfarin cohort ($US50.00 vs. 73.49 and $US27.75 vs. 48.66, respectively; p < 0.01 for both values). CONCLUSION: Patients receiving dabigatran had significantly lower total all-cause, inpatient, and outpatient costs but higher pharmacy costs than those receiving warfarin. In addition, stroke-specific total and outpatient costs and bleed-specific total and inpatient costs were significantly lower in dabigatran users compared with warfarin users.

Healthcare utilization and costs for patients initiating Dabigatran or Warfarin.

BACKGROUND: Novel oral anticoagulants (NOAC) such as dabigatran, when compared to warfarin, have been shown to potentially reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) together with lower healthcare resource utilization (HCRU) and similar total costs. This study expands on previous work by comparing HCRU and costs for patients newly diagnosed with NVAF and newly initiated on dabigatran or warfarin, and is the first study specifically in a Medicare population. METHODS: A retrospective matched-cohort study was conducted using data from administrative health care claims during the study period 01/01/2010-12/31/2012. Cox regression analyses were used to compare all-cause risk of first hospitalizations and emergency room (ER) visits. Medical, pharmacy, and total costs per-patient-per-month (PPPM) were compared between dabigatran and warfarin users. RESULTS: A total of 1110 patients initiated on dabigatran were propensity score-matched with corresponding patients initiated on warfarin. The mean number of hospitalizations (0.92 vs. 1.13, P = 0.012), ER visits (1.32 vs. 1.56, P < 0.01), office visits (21.43 vs. 29.41; P < 0.01), and outpatient visits (10.86 vs. 22.02; P < 0.01) were lower among dabigatran compared to warfarin users. Patients initiated on dabigatran had significantly lower risk of first all-cause ER visits [hazard ratio (HR): 0.84, 95% confidence interval (CI): 0.73-0.98] compared to those initiated on warfarin. Adjusted mean pharmacy costs PPPM were significantly greater for dabigatran users ($510 vs. $250, P < 0.001); however, mean medical costs PPPM ($1912 vs. $1956, P = 0.55) and mean total costs PPPM ($2381 vs. $2183, P = 0.10) were not significantly different compared to warfarin users. CONCLUSIONS: Dabigatran users had significantly lower HCRU compared to warfarin users. In addition, dabigatran users had lower risk of all-cause ER visits. Despite higher pharmacy costs, the two cohorts did not differ significantly in medical or total all-cause costs.

Cardiovascular event incidence and cost in type 2 diabetes mellitus: a Medicare claims-based actuarial analysis.

OBJECTIVE: To assess the economic burden of cardiovascular events in Medicare beneficiaries with type 2 diabetes mellitus (T2DM). METHODS: This claims-based actuarial analysis queried 2013 and 2014 Medicare 5% samples, defining a denominator of fee-for-service beneficiaries. Average per patient per month allowed cost ($PPPM) was calculated for T2DM, demographically adjusted non-T2DM, and denominator. Per member per month allowed cost ($PMPM) was calculated by dividing total population cost by member months in the denominator. Costs of five pre-specified cardiovascular events were calculated as a contribution to denominator $PMPM, as contribution to $PPPM in T2DM, and as incremental cost. RESULTS: During the study period, 22.1% of Medicare fee-for-service beneficiaries had T2DM; of these, 9.68% experienced a cardiovascular event or cardiovascular-related death. T2DM cost represented 37.9% of total allowed $PMPM for the denominator. Average total allowed $PPPM for a T2DM beneficiary was $1,834, compared with $850 for a non-T2DM beneficiary (2.2-times higher). Annual rates of myocardial infarction, stroke, unstable angina admission, heart failure admission, and coronary revascularization in T2DM were 3.3-, 2.4-, 3.2-, 4.0-, and 2.8-times higher than in non-T2DM, and utilization of health services was also greater in T2DM. Cardiovascular events in T2DM accounted for 50% of denominator cardiovascular event cost; 3.6% of denominator population $PMPM was attributable to cardiovascular events in T2DM. Risk-adjusted incremental cardiovascular event cost represented 18.1% of $PPPM in T2DM or 6.9% of $PMPM in the denominator population. CONCLUSIONS: Cardiovascular events in Medicare fee-for-service beneficiaries with T2DM contribute substantially to Medicare cardiovascular events, resource utilization, and cost.

Health Care Resource Utilization, Costs, and Persistence in Patients Newly Diagnosed as Having Nonvalvular Atrial Fibrillation and Newly Treated With Dabigatran versus Warfarin in the United States.

PURPOSE: This study compared health care resource utilization (HCRU), costs, and persistence among patients newly diagnosed as having nonvalvular atrial fibrillation (NVAF) and newly treated with dabigatran versus warfarin. METHODS: This retrospective claims-based study used data from a large US managed care organization. The earliest claim for dabigatran or warfarin during October 1, 2010 through October 31, 2011 was the index date, with cohort assignment based on index medication. Evidence of newly diagnosed NVAF within 30 days before the index date and no claims for oral anticoagulants during the 12-month preindex period were required. Cohorts were matched using propensity scores. Per-patient-per-month HCRU, costs, and persistence were calculated during the variable follow-up period of up to 12 months after the index date. Descriptive and multivariable analyses were used to examine differences in outcomes. FINDINGS: After matching, 869 patients per cohort were identified (mean age, 67.8 years; 40.4% female). Compared with warfarin, dabigatran had fewer per-patient-per-month emergency department (0.10 vs 0.13, P = 0.010), office (1.98 vs 2.96, P < 0.001), and outpatient (1.05 vs 1.48, P < 0.001) visits. Despite higher mean pharmacy costs for dabigatran (P < 0.001), mean total health care (P = 0.309) and medical costs (P = 0.568) were similar to warfarin. Persistence was higher with dabigatran versus warfarin (median, 204 vs 161 days; mean, 213.7 vs 195.5 days, P = 0.001). IMPLICATIONS: Among patients newly diagnosed as having NVAF, those newly treated with dabigatran had lower HCRU, higher persistence, and similar total health care costs compared with those treated with warfarin.

Hospital Admissions, Costs, and 30-Day Readmissions Among Newly Diagnosed Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran Etexilate or Warfarin.

BACKGROUND: Oral anticoagulation such as warfarin and dabigatran is indicated for atrial fibrillation (AF) patients at risk of ischemic stroke. Dabigatran etexilate was developed to address the limitations of warfarin, including the need for regular blood monitoring, which has the potential to lead to higher health care resource use, particularly in hospitalized patients. OBJECTIVE: To evaluate whether hospitalization cost, length of hospital stay (LOS), likelihood of readmission within 30 days, and cost of readmissions differed across inpatient encounters among nonvalvular atrial fibrillation (NVAF) patients that were newly diagnosed and newly treated with either dabigatran or warfarin. METHODS: A retrospective cohort study was conducted using IMS Health's Charge Detail Master (CDM) database. Hospitalizations were identified based on a primary or secondary AF diagnosis, dabigatran or warfarin use, and a discharge date from January 2011 through March 2012. The identified patients without valvular procedures and transient AF were required to have a minimum of 12 months of pharmacy and private practitioner records prior to the inpatient encounter to ensure that they were newly treated on dabigatran or warfarin. Propensity score matching was used to balance baseline characteristics between treatment cohorts. Outcomes assessed were LOS, 30-day readmissions, and costs. Because individual patients could have more than 1 hospital observation, generalized estimating equations (GEE) with a gamma distribution (log link) were used for the analysis of continuous outcome measures (e.g., LOS and costs) and a binominal distribution for dichotomous outcomes (hospital readmissions). RESULTS: Two cohorts were propensity score matched (1:2) on demographic and clinical characteristics. The dabigatran cohort included 646 hospitalizations, and the warfarin cohort included 1,292 hospitalizations. Hospitalizations were on average 13% shorter (4.8 vs. 5.5 days, P less than 0.001) and cost 12% less ($14,794 vs. $16,826, P = 0.007) when dabigatran was used versus warfarin. No differences in 30-day readmissions were observed. CONCLUSIONS: Hospital encounters among newly diagnosed NVAF patients during which warfarin was initiated had longer lengths of stay and incurred higher costs than those during which dabigatran was initiated.

Healthcare utilization and costs associated with dabigatran compared to warfarin treatment in newly diagnosed patients with non-valvular atrial fibrillation.

PURPOSE: Real-world healthcare resource utilization and costs were compared among patients with non-valvular atrial fibrillation (NVAF) receiving either dabigatran or warfarin. METHODS: A retrospective cohort study was conducted using administrative claims data from the United States Department of Defense (DOD) Military Health System. Patients with newly diagnosed AF initiated on dabigatran or warfarin were identified using ICD-9 diagnosis, procedure and drug codes. Patients were observed for 3 months prior to treatment initiation to ascertain a diagnosis of valvular heart disease and 12 months for exclusion of those with a history of anticoagulation therapy. Propensity score matching was used to balance baseline characteristics between the two treatment cohorts. Medical and pharmacy utilization and costs were compared between the dabigatran and warfarin treatment groups for 3 and 12 months following treatment initiation. RESULTS: A total of 1102 patients with newly diagnosed NVAF initiated on dabigatran were matched with corresponding warfarin-treated patients. In the 12 months following initiation of anticoagulation, the mean medical costs for patients initiated on dabigatran were significantly lower than for patients initiated on warfarin (-$6299, p < 0.001), largely due to fewer hospitalizations (-0.162, p = 0.009). While pharmacy costs were higher ($4369, p < 0.001) for dabigatran, overall healthcare costs were significantly lower compared with patients on warfarin (12 months: -$1940, p < 0.001). Mean hospital length of stay between these two groups were similar (6.033 days for dabigatran vs 6.318 days for warfarin, p = 0.139). CONCLUSION: Despite higher pharmacy costs for NVAF patients initiated on dabigatran vs warfarin, this was more than offset by lower utilization of medical care resources.

Efficacy and cost-effectiveness of dabigatran etexilate versus warfarin in atrial fibrillation in different age subgroups.

This study aims to estimate the cost-effectiveness of dabigatran 150 mg twice daily versus warfarin for stroke and systemic embolism risk reduction in patients with nonvalvular atrial fibrillation initiating treatment before age 75 (<75), at or after age 75 (≥ 75), and the overall population (All) from a US Medicare payer perspective. Clinical event rates by age cohort with dabigatran or warfarin for safety-on-treatment and intent-to-treat populations were estimated from Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY). An economic model was adapted using these data to evaluate the impact of starting age on clinical and economic outcomes. Costs were obtained from Medicare payment schedules and utilities from publications. Model outputs included event rates, costs, quality-adjusted life-years, and incremental cost-effectiveness ratios. The RE-LY analysis shows that the <75 cohort has lower rates of all events than the ≥ 75 cohort; versus warfarin, dabigatran performed better in main efficacy and safety in all age cohorts with the exception of extracranial hemorrhage in the ≥ 75 cohort. The clinical event costs avoided per patient for dabigatran were $1,100, $135, and $713 for cohorts <75, ≥ 75, and All, respectively. Extrapolating over a lifetime horizon, the model found that dabigatran resulted in lower rates of stroke and intracranial hemorrhage and higher rates for extracranial hemorrhage versus warfarin for all age cohorts. Lifetime quality-adjusted life-years and costs were higher for dabigatran than warfarin, resulting in incremental cost-effectiveness ratios of $52,773, $65,946, and $56,131 for cohorts <75, ≥ 75, and All, respectively. In conclusion, dabigatran was cost-effective versus warfarin in US patients with atrial fibrillation regardless of age of treatment initiation.

Higher persistence in newly diagnosed nonvalvular atrial fibrillation patients treated with dabigatran versus warfarin.

BACKGROUND: Oral anticoagulation therapy is the primary tool in reducing stroke risk in patients with nonvalvular atrial fibrillation but is underused. Patients nonpersistent with therapy contribute to this underuse. The objective of this study was to compare persistence rates in newly diagnosed nonvalvular atrial fibrillation patients treated with warfarin versus dabigatran as their oral anticoagulation. METHODS AND RESULTS: US Department of Defense administrative claims were used to identify patients receiving warfarin or dabigatran between October 28, 2010, and June 30, 2012. Patient records were examined for a minimum of 12 months before index date to restrict the analyses to those newly diagnosed with nonvalvular atrial fibrillation and naive-to-treatment, identifying 1775 on warfarin and 3370 on dabigatran. Propensity score matching was used to identify 1745 matched pairs. Persistence was defined as time on therapy to discontinuation. Kaplan-Meier curves were used to depict persistence over time. Cox proportional hazards model was used to determine the factors significantly associated with persistence. Using a 60-day permissible medication gap, the persistence rates were higher for dabigatran than for warfarin at both 6 months (72% versus 53%) and 1 year (63% versus 39%). Patients on dabigatran with a low-to-moderate risk of stroke (CHADS2<2) or with a higher bleed risk (HEMORR2HAGES>3) had a higher likelihood of nonpersistence (hazard ratios, 1.37; 95% confidence interval, 1.17-1.60; P<0.001; and hazard ratios, 1.24; 95% confidence interval, 1.04-1.47; P=0.016). CONCLUSIONS: Patients who initiated dabigatran treatment were more persistent than patients who began warfarin treatment. Within each cohort, patients with lower stroke risk were more likely to discontinue therapy.

Readmission among hospitalized patients with nonvalvular atrial fibrillation.

PURPOSE: Hospital readmission rates for patients with nonvalvular atrial fibrillation (NVAF), as well as reasons and risk factors for rehospitalization, were investigated. METHODS: Demographic, clinical, and prescription claims data on patients hospitalized for atrial fibrillation (AF) over a five-year period were extracted from insurance claims databases; from that data set, a subset of adults with NVAF on whom continuous data were available before and after the index admission (n = 6439) was identified, and their 30-day readmission rate was examined. RESULTS: The overall 30-day readmission rate was 18.0%. The five most common readmission diagnoses (grouped per International Classification of Diseases codes) were general and other nonspecific symptoms (12.8% of readmitted patients), AF (10.2%), ischemic heart disease (7.2%), heart failure (7.1%) and cerebrovascular disease (6.0%). Controlling for demographic and clinical variables,index admission factors associated with an increased risk of readmission included a longer hospital length of stay, higher Charlson Comorbidity Index scores, and admission through the emergency room (p ≤ 0.01 for all). For the subset of patients discharged from the index admission to home self-care (n = 1161), no individual follow-up care measure evaluated (a physician or other medical office visit, International Normalized Ratio testing, filling an anticoagulant prescription) taken within 7 days of discharge correlated with reduced readmission risk during postdischarge days 8-30. CONCLUSION: The 30-day readmission rate for patients hospitalized with NVAF was comparable to rates previously documented among patients with other cardiac conditions. Symptoms, AF, ischemic heart disease, heart failure, and cerebrovascular disease were the most common reasons for readmission.

Long-Term Costs of Ischemic Stroke and Major Bleeding Events among Medicare Patients with Nonvalvular Atrial Fibrillation.

Purpose. Acute healthcare utilization of stroke and bleeding has been previously examined among patients with nonvalvular atrial fibrillation (NVAF). The long-term cost of such outcomes over several years is not well understood. Methods. Using 1999-2009 Medicare medical and enrollment data, we identified incident NVAF patients without history of stroke or bleeding. Patients were followed from the first occurrence of ischemic stroke, major bleeding, or intracranial hemorrhage (ICH) resulting in hospitalization. Those with events were matched with 1-5 NVAF patients without events. Total incremental costs of events were calculated as the difference between costs for patients with events and matched controls for up to 3 years. Results. Among the 25,465 patients who experienced events, 94.5% were successfully matched. In the first year after event, average incremental costs were $32,900 for ischemic stroke, $23,414 for major bleeding, and $47,640 for ICH. At 3 years after these events, costs remained elevated by $3,156-$5,400 per annum. Conclusion. While the costs of stroke and bleeding among patients with NVAF are most dramatic in the first year, utilization remained elevated at 3 years. Cost consequences extend beyond the initial year after these events and should be accounted for when assessing the cost-effectiveness of treatment regimens for stroke prevention.

Anticoagulant use, the prevalence of bridging, and relation to length of stay among hospitalized patients with non-valvular atrial fibrillation.

OBJECTIVE: The objectives of this study were to describe inpatient anticoagulation and bridging in patients with non-valvular atrial fibrillation (NVAF) and to identify whether differences exist in length of stay (LOS) among bridged versus non-bridged NVAF patients. DESIGN: Administrative claims data were used to select patients ≥18 years with a primary or secondary discharge diagnosis of NVAF and inpatient warfarin use from 1 July 2004 to 30 September 2009. Patients with valvular or transient causes of NVAF or pregnancy were excluded. Inpatient bridging was defined as receipt of an anticoagulant in addition to warfarin during the hospitalization. LOS was reported for non-bridged patients (warfarin only) and compared with three bridging regimens: low molecular weight heparin/pentasaccharide (LMWH/PS); unfractionated heparin (UFH); and two-agent bridging (LMWH/PS and UFH). Multivariate analyses were performed to evaluate the association between bridging and LOS, adjusting for demographic and clinical variables. RESULTS: Of 6340 NVAF patients, 48% received inpatient warfarin (mean LOS 5.5 days); among them, 64% received bridging therapy (mean LOS 6.3 days) [LMWH/PS 45% (mean LOS 5.6 days), UFH 36% (mean LOS 6.0 days), two-agent bridging 18% (mean LOS 8.4 days)]. Following multivariate analysis, relative to patients who received inpatient warfarin only, LOS was significantly higher for patients with UFH (19.3%) and patients with two-agent bridging (45.1%). Patients with pre-period warfarin, cancer, or diabetes mellitus who received bridging agents had significantly longer LOS than patients with those conditions who were not bridged. CONCLUSION: LOS was longer for bridged than non-bridged patients. Further studies are needed to identify predictors of bridging and to explain why bridged NVAF patients had longer LOS.