Oral anticoagulant underutilization among elderly patients with atrial fibrillation: insights from the United States Medicare database.

BACKGROUND: Oral anticoagulants (OACs) mitigate stroke risk in patients with atrial fibrillation (AF). The study aim was to analyze prevalence and predictors of OAC underutilization. METHODS: Newly diagnosed AF patients with a CHA2DS2-VASc score ≥ 2 were identified from the US CMS Database (January 1, 2013-December 31, 2017). Patients were stratified based on having an OAC prescription versus not and the OAC prescription group was stratified by direct OAC (DOACs) versus warfarin. Multivariable logistic regression models were used to examine predictors of OAC underutilization. RESULTS: Among 1,204,507 identified AF patients, 617,611 patients (51.3%) were not prescribed an OAC during follow-up (mean: 2.4 years), and 586,896 patients (48.7%) were prescribed an OAC during this period (DOAC: 388,629 [66.2%]; warfarin: 198,267 [33.8%]). Age ≥ 85 years (odds ratio [OR] 0.55, 95% confidence interval [CI] 0.55-0.56), female sex (OR 0.96, 95% CI 0.95-0.96), Black race (OR 0.78, 95% CI 0.77-0.79) and comorbidities such as gastrointestinal (GI; OR 0.43, 95% CI 0.41-0.44) and intracranial bleeding (OR 0.29, 95% CI 0.28-0.31) were associated with lower utilization of OACs. Furthermore, age ≥ 85 years (OR 0.92, 95% CI 0.91-0.94), Black race (OR 0.78, 95% CI 0.76-0.80), ischemic stroke (OR 0.77, 95% CI 0.75-0.80), GI bleeding (OR 0.73, 95% CI 0.68-0.77), and intracranial bleeding (OR 0.72, 95% CI 0.65-0.80) predicted lower use of DOACs versus warfarin. CONCLUSIONS: Although OAC therapy prescription is the standard of care for stroke prevention in AF patients, its overall utilization is still low among Medicare patients ≥ 65 years old, with specific patient characteristics that predict underutilization.

The direct and indirect health care costs associated with pulmonary arterial hypertension among commercially insured patients in the United States.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a rare, progressive, and fatal disease associated with considerable overall clinical and economic burden. Although the direct health care costs of PAH have been well described, there are few data regarding indirect costs and productivity loss associated with PAH. Patient data were assessed until the earliest of death, end of full-time employment, end of continuous enrollment, or end of study period. OBJECTIVES: To update data on the direct burden and address the knowledge gap regarding the indirect burden associated with PAH. METHODS: This is a retrospective case-control study with prevalent and incident patients with PAH aged 18-64 years identified from the MarketScan Commercial and Health and Productivity management datasets during the identification period (January 1, 2016, to November 30, 2018). Patients were required to have continuous enrollment for 12 months or longer from the baseline period and 1 month or longer from the follow-up (post-index) period. Among patients with PAH (cases), the first observed PAH diagnosis claim date during the identification period was the index date. Patients without PAH (controls) were selected and assigned a random index date during the same period. Controls were matched 1:1 by age, sex, and region to prevalent and incident PAH cases. Per patient per month (PPPM), all-cause health care resource utilization, costs, and short-term disability (STD) were examined for cases and controls during the follow-up period. Multivariable analysis was performed using the generalized linear model to determine the adjusted direct and indirect health care utilization and costs. RESULTS: A total of 1,293 prevalent and 455 incident patients with PAH were identified. During the follow-up period, prevalent patients with PAH had significantly higher total mean all-cause health care costs ($9,915 vs $359, P < 0.0001) and inpatient length of stay (0.63 vs 0.02 days, P < 0.0001) PPPM as compared with controls. Prevalent patients with PAH had significantly longer STD (6.0 vs 1.5 days, P < 0.0001) and higher STD-related costs ($1,226 vs $277, P < 0.0001) PPPM as compared with controls. Incident patients with PAH had significantly higher total mean all-cause health care costs ($9,353 vs $336, P < 0.0001) and inpatient length of stay (0.92 vs 0.01 days, P < 0.0001) PPPM as compared with controls. Incident patients with PAH also had longer STD (8.1 vs 1.5 days, P < 0.0001) and higher STD-related costs ($1,706 vs $263, P < 0.0001), as compared with controls. CONCLUSIONS: This study showed that incident and prevalent patients with PAH had significantly higher direct and indirect health care resource utilization and costs as well as productivity loss compared with patients without PAH. DISCLOSURES: Ms Ogbomo and Mr Mallampati were paid employees of STATinMED Research at the time of study completion; STATinMED Research is a paid consultant to Janssen Scientific Affairs, LLC. Drs Tsang and Panjabi are employees of Janssen Scientific Affairs LLC, a subsidiary of Johnson and Johnson, the study sponsor.

Contemporary clinical and economic outcomes among oral anticoagulant treated and untreated elderly patients with atrial fibrillation: Insights from the United States Medicare database.

BACKGROUND: Oral anticoagulants (OACs) mitigate the risk of stroke in atrial fibrillation (AF) patients. OBJECTIVE: Elderly AF patients who were treated with OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin) were compared against AF patients who were not treated with OACs with respect to their clinical and economic outcomes. METHODS: Newly diagnosed AF patients were identified between January 2013 and December 2017 in the Medicare database. Evidence of an OAC treatment claim on or after the first AF diagnosis was used to classify patients into treatment-defined cohorts, and these cohorts were further stratified based on the initial OAC prescribed. The risks of stroke/systemic embolism (SE), major bleeding (MB), and death were analyzed using inverse probability treatment weighted time-dependent Cox regression models, and costs were compared with marginal structural models. RESULTS: The two treatment groups were composed of 1,421,187 AF patients: OAC treated (N = 583,350, 41.0% [36.4% apixaban, 4.9% dabigatran, 0.1% edoxaban, 26.7% rivaroxaban, and 31.9% warfarin patients]) and untreated (N = 837,837, 59.0%). OAC-treated patients had a lower adjusted risk of stroke/SE compared to untreated patients (hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.68-0.72). Additionally patients receiving OACs had a lower adjusted risk of death (HR: 0.56; 95% CI: 0.55-0.56) and a higher risk of MB (HR: 1.57; 95% CI: 1.54-1.59) and this trend was consistent across each OAC sub-group. The OAC-treated cohort had lower adjusted total healthcare costs per patient per month ($4,381 vs $7,172; p < .0001). CONCLUSION: For the OAC-treated cohort in this elderly US population, stroke/SE and all-cause death were lower, while risk of MB was higher. Among OAC treated patients, total healthcare costs were lower than those of the untreated cohort.

Persistence, Dosing, and Other Treatment Patterns Among Crohn's Disease Patients Initiating Biologics in United States.

Background: This study examined biologic persistence, dosing, and other treatment patterns among Crohn's disease (CD) patients that initiated adalimumab (ADA), certolizumab pegol (CZP), infliximab (IFX), ustekinumab (UST), and vedolizumab (VDZ). Methods: This descriptive study pooled data from IBM MarketScan, IQVIA PharMetrics, and Optum databases and identified CD patients who initiated the above biologics. Due to low sample size, CZP was not included in the analyses. Persistence was defined as the proportion of patients that remained on the index biologic without a gap of >30 days for ADA and >120 days for UST, IFX, and VDZ between two claims. A sensitivity analysis using fixed gap (90-day) was also conducted. Dose titration (based upon mean maintenance dose) including 50% dose escalation, and 50% dose reduction was assessed among patients with ≥2 maintenance doses during follow-up among ADA, UST, and VDZ patients. Results: After applying all selection criteria, patients were selected into bio-naive (ADA: 2047; IFX: 1127; UST: 296; VDZ: 342) and bio-experienced cohorts (ADA: 300; IFX: 341; UST: 801; VDZ: 593) based on the biologics used. Unadjusted persistence was numerically higher among bio-naive and bio-experienced UST (87.2%, 86.3%) patients followed by VDZ (78.9%, 80.8%), IFX (79.0%, 77.4%), and ADA (64.9%, 60.7%). Similar trends were observed using sensitivity analysis. Dose escalation was numerically higher for ADA patients (16.1%-16.4%) followed by UST (13.4%-16.9%), and VDZ (12.4%-14.7%). Dose reduction followed a similar trend. Conclusions: Among CD patients, unadjusted persistence using variable and fixed gap definition was numerically highest for UST patients whereas dose escalation was numerically highest among ADA patients. Further research is needed to examine treatment patterns after adjusting for confounders and baseline differences among biologic users.

Surgical Outcomes, Health Care Utilization, and Costs Associated with Staple Line Buttressing Among Primary Sleeve Gastrectomy Patients.

PURPOSE: Staple line buttressing is a method of reinforcing surgical staple lines using buttress materials. This study evaluated surgical outcomes, hospital utilization, and hospital costs associated with staple line buttressing among patients who underwent primary laparoscopic sleeve gastrectomy (PLSG) in the United States. METHODS: This was a retrospective cohort study using Premier Healthcare Database data from January 1, 2012 to December 31, 2017. Patients aged ≥ 18 years who underwent PLSG were selected and assigned to buttress or non-buttress cohorts based on the use of buttress material during their hospitalization for PLSG (index). Propensity score matching (PSM) was conducted to balance patient demographic and clinical characteristics between the cohorts. Generalized estimating equation models were used to compare the clinical and economic outcomes of the matched buttress and non-buttress users during the index hospitalization. RESULTS: A total of 38,231 buttress and 27,349 non-buttress patients were included in the study. After PSM, 24,049 patients were retained in each cohort. Compared with non-buttress cohort, the buttress cohort patients had a similar rate of in-hospital leaks (0.28% vs 0.39%; p = 0.160) and a lower rate of bleeding (1.37% vs 1.80%, p = 0.015), transfusion (0.56% vs 0.77%, p = 0.050), and composite bleeding/transfusion (1.57% vs 2.04%, p = 0.019). Total costs ($12,201 vs $10,986, p < 0.001) and supply costs ($5366 vs $4320, p < 0.001) were higher in the buttress cohort compared with the non-buttress cohort. CONCLUSIONS: Staple line buttressing was associated with an improvement in complication rates for bleeding and transfusion. Total and supply costs were higher in the buttress cohort, necessitating further research into cost-effective buttressing materials.

Persistence, Dose Titration, and Health Care Resource Utilization Among Crohn's Disease Patients Treated With Ustekinumab: A Real-World Analysis in the United States.

INTRODUCTION: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. This real-world study evaluated persistence, dose titration, health care resource utilization (HCRU) and associated costs, and medication use among CD patients treated with ustekinumab (UST) in several pooled US commercial database populations. METHODS: CD patients aged ≥ 18 years with medical or pharmacy claims for UST were selected from pooled data from 3 large, national commercial databases. The first observed medical or pharmacy claim for UST was the index date. Patients were required to have had ≥ 1 medical claim with a CD diagnosis during the 12 months prior to the index date and continuous health plan enrollment for a minimum of 12 months prior to and 12 months after the index date. Comparisons of outcomes during the baseline and follow-up periods were conducted using inferential statistical tests. RESULTS: A total of 214 eligible UST patients were selected. The majority (74.8%) were biologic experienced (mean age: 41 years), and 83.6% remained treatment persistent during the 12-month post-index period. Among discontinuers, 25.7% restarted UST, and 8.6% switched from UST in the 12-month observation period. The mean treatment duration was 329 days. Most patients (77%) used the recommended UST dose, as defined as being within a 20% dose variation from label (90 mg/8 weeks ± 20%), 17.9% experienced dose escalation, and 5.1% experienced dose reduction. Post-index immunomodulator and corticosteroid use reduced by 20% and 28%, respectively, as compared with pre-index use among CD patients using UST. Annual all-cause ER visits and inpatient stays decreased by 20.5% and 30.3%, respectively, with similar downward trends for annual CD-related HCRU. CONCLUSIONS: The majority of CD patients prescribed UST were biologic experienced, and persistence was high over the 1-year follow-up. UST treatment initiation was associated with reductions in ER visits, inpatient stays, and steroid and other medication use.