Recurrent hospitalization and healthcare resource use among patients with deep vein thrombosis and pulmonary embolism: findings from a multi-payer analysis

The objective of this study was to assess deep vein thrombosis and pulmonary embolism (DVT/PE) recurrence rates and resource utilization among patients with an initial DVT or PE event across multiple payer perspectives. Retrospective analyses were performed using a software tool that analyzes health plan claims to evaluate treatment patterns and resource utilization for various cardiovascular conditions. Six databases were analyzed from three payer perspectives (Commercial, Medicare, and Medicaid). Patients were ≥18 years old with a primary diagnosis of DVT or PE associated with an inpatient and/or emergency room claim, had received an antithrombotic within 7 days before or 14 days after index, and had no diagnosis of atrial fibrillation during follow-up. Outcomes were assessed over a 1 year period following index. More PE patients were hospitalized for their index event than DVT patients (42–59 % DVT and 69–86 % PE) and had longer mean length of stay (2.35–2.95 days DVT and 3.26–3.76 days PE). Recurrent event rates among PE patients (12–32 %) were higher than those for DVT patients (6–16 %) across all payers. The highest rate of recurrence was observed among the Medicaid population [23 % overall (VTE); 16 % DVT; 32 % PE]. All-cause hospitalization in the year following their VTE episode occurred in 23–67 % DVT patients and 30–68 % PE patients. Medicaid had the highest proportion of patients with hospitalizations and ER visits. Recurrent VTE events and all-cause hospitalizations are relatively common, especially for patients who had a PE, and among those in the Medicaid payer population

Clinical and economic outcomes with rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and obstructive sleep apnea: retrospective analysis of US healthcare claims

Background: Atrial fibrillation (AF) and obstructive sleep apnea (OSA) are often comorbid and associated with increased risk of cardiovascular events such as stroke. We evaluated the effectiveness, safety, healthcare resource utilization, and costs of rivaroxaban versus warfarin in patients with nonvalvular AF (NVAF) and comorbid OSA. Methods: We used the IQVIA PharMetrics® Plus adjudicated claims database to evaluate patients with NVAF, OSA, and moderate-to-severe stroke risk who initiated rivaroxaban or warfarin between November 2011 and December 2022. We adjusted for potential confounders with propensity score overlap weighting. Primary endpoints were evaluated based on intent-to-treat (ITT) and on-treatment follow-up to compare stroke or systemic embolism risk, major bleeding risk, all-cause healthcare resource utilization (inpatient hospitalizations, emergency department visits, outpatient visits, and pharmacy fills), and costs (per patient per year [PPPY]) by treatment cohort. Results: In total, 14,765 patients were included (9133 received rivaroxaban; 5632 received warfarin). Rivaroxaban significantly reduced stroke or systemic embolism versus warfarin by 26% (ITT—hazard ratio, 0.74 [95% CI 0.60–0.91]; P = 0.004) and 30% (on-treatment—hazard ratio, 0.70 [95% CI 0.55–0.89]; P = 0.004). Major bleeding was not significantly different between rivaroxaban and warfarin in either analysis. All-cause healthcare resource utilization was significantly reduced with rivaroxaban versus warfarin, leading to significantly reduced PPPY costs. Conclusions: Among patients with NVAF and OSA, rivaroxaban was associated with a significant reduction in stroke or systemic embolism risk versus warfarin with no difference in major bleeding. Rivaroxaban significantly reduced healthcare resource utilization and costs compared with warfarin, providing support for the use of rivaroxaban in this population

Impact of Once-Daily Versus Twice-Daily Dosing Frequency on Adherence to Chronic Medications among Patients with Venous Thromboembolism

BACKGROUND: Multiple daily dosing may be negatively associated with patient medication adherence; however, adherence-related data are lacking in a patient population with venous thromboembolism (VTE). OBJECTIVE: To assess the adherence rates between once-daily (OD) and twice-daily (BID) dosing regimens of chronic medications in patients with VTE. METHODS: We analyzed the PharMetrics Integrated Claims database (claims of commercial insurers in the US) from 1 January 2004, through 31 December 2009. Adult patients with continuous insurance coverage, newly initiated on diabetes mellitus or hypertension medication, and having at least one VTE diagnosis were included. Adherence to OD and BID therapies was calculated by using two measures: medication possession ratio (MPR) and proportion of days covered (PDC). Adherence was defined as an MPR or PDC ≥0.8. Multivariate logistic regressions were conducted to compare the probability of adherence between the OD and BID groups adjusting for baseline confounders. RESULTS: A total of 4,867 OD and 1,069 BID patients were identified. Mean duration of exposure to therapy for OD and BID patients was 386 and 356 days (p = 0.011), respectively. Based on MPR, 69 % of OD and 62 % of BID patients were adherent (p < 0.001). For PDC at 12 months, the proportion of adherent patients for the OD and BID groups was 45 and 36 % (p < 0.001), respectively. Adjusted odds ratios (95 % CI) of adherence for the OD relative to BID group were 1.61 (1.37–1.89) based on MPR (p < 0.001) and 1.46 (1.16–1.83) based on PDC at 12 months (p = 0.001). CONCLUSIONS: This study demonstrates that VTE patients treated with chronic medications on OD dosing regimens were associated with an approximately 39–61 % higher likelihood of adherence compared with subjects on BID dosing regimens. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40271-013-0020-5) contains supplementary material, which is available to authorized users

Abstract 136: Non-Adherence to Anticoagulant Therapy Among Employed and Unemployed Patients With Venous Thromboembolism

Objective: To identify self-reported non-adherence to anticoagulant therapy among patients with venous thromboembolism (VTE) and determine whether non-adherence differs among these patients based on employment status. Methods: This study was conducted using the 2010 wave of the National Health and Wellness Survey (NHWS). The NHWS is a self-administered, Internet-based questionnaire from a nationwide sample of adults (N=75,000). Only patients with a diagnosis of VTE (defined as a self-reported diagnosis of deep vein thrombosis [DVT] or pulmonary embolism [PE]) and receiving medication for VTE were included in the analysis. Patients completed the 4-item Morisky Medication Adherence Scale (MMAS), tailored specifically to VTE medications. Complete adherence was defined as a score of 0 on the MMAS, while non-adherence was defined as a score of 1 through 4. Based on this definition, the proportion of patients reporting non-adherence was determined. Non-adherence was determined separately for patients with DVT and those with PE. Patients’ employment status was collected from the NHWS. Bivariate differences for non-adherence between the employed and unemployed patient groups were assessed using Chi-squared tests. Findings: A total of 261 patients with DVT and 129 patients with PE were included in the analysis. Among these patients, 28% (n=72) of those with DVT and 29% (n=37) of those with PE reported being non-adherent to their medication regimens. Of the patients with DVT, 39% (n=102) were employed; of those with PE, 37% (n=48) were employed. Employed patients were more likely to be non-adherent than their unemployed counterparts. Specifically, 36% (n=37) of the employed DVT patients reported being non-adherent, versus 22% (n=35) of the unemployed DVT patients ( P &lt;0.05). Similarly, 40% (n=19) of the employed PE patients reported non-adherence, versus 22% (n=18) of the unemployed PE patients ( P &lt;0.05). The most commonly reported reason for non-adherence among both DVT and PE patients, regardless of employment status, was forgetting to take their medication. Conclusions: Among patients with VTE, self-reported non-adherence to anticoagulant therapy is higher among those who are employed, indicating that adherence may be a greater challenge for them. Therefore, selecting less burdensome VTE treatment options may be of particular importance among patients with VTE who are employed. </jats:p

Abstract 155: Prevalence of Self-Reported Risk Factors for Myocardial Infarction Among Patients With Venous Thromboembolism

Objective: To identify the prevalence of risk factors that may be associated with a future myocardial infarction (MI) among patients with venous thromboembolism (VTE). Methods: This study was conducted using the 2010 wave of the National Health and Wellness Survey (NHWS). The NHWS is a self-administered, Internet-based questionnaire from a nationwide sample of adults (N=75,000). Only patients with a diagnosis of VTE, defined as a self-reported diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or both, were included in the analysis. Self-reported patient characteristics that may be potential risk factors for MI were collected, including sociodemographic characteristics, family medical history, and health behaviors (such as smoking status), as well as comorbidities. Included risk factors were based on a literature search. The risk factors were not weighted based on the strength of their potential association with a future MI. Thus, risk factors of varying significance were included and weighted equally. Findings: A total of 814 patients with VTE (519 with DVT, 196 with PE, and 99 with DVT and PE) were included in the analysis. Approximately 53% of the patients were female, and the mean age was 57 years. Among these patients, the mean number of reported risk factors that may be associated with a future MI was 5.6. Approximately 23% (n=189) of patients reported ≤3 risk factors, 55% (n=446) of patients had 4-7 risk factors, and 22% (n=179) of patients had ≥8 risk factors. Some of the more commonly reported risk factors included male gender (47%, n=381), obesity (53%, n=428), hypertension (53%, n=427), hyperlipidemia (49%, n=401), type 2 diabetes (21%, n=167), a family history of cardiovascular disease (81%, n=663), and currently smoking (22%, n=175). Conclusions: A high proportion of patients with VTE have risk factors for a future MI. Awareness of the prevalence of MI risk factors among patients with VTE may support optimal clinical decision-making for these patients. Providers should be cognizant of the potential risk for MI among patients with VTE when selecting treatment approaches. Additional research that considers the relative importance of each potential risk factor is needed to elucidate these findings. </jats:p

Kidney Function and Anemia Prevalence in Patients with HIV Infection.

Abstract Background: Recent guidelines from the Infectious Diseases Society of America (IDSA) for the management of Chronic Kidney Disease (CKD) in HIV+ patients highlight that up to 30% of HIV+ patients have abnormal kidney function. These guidelines also discuss the effects of CKD on HIV disease progression and the need to diagnose and manage CKD in patients with HIV. While the presence of CKD is associated with an increased rate of anemia in the general population, the prevalence of anemia among HIV patients with CKD is less well known. This is of particular importance as anemia is known to occur in at least 20% of HIV patients overall. The current analysis was undertaken to determine the distribution of kidney function levels among HIV patients and to stratify anemia risk based on these levels. Methods: In a retrospective cross-sectional analysis of data collected between 1996 and 2004 from an integrated, commercial database of claims and laboratory values, subjects with HIV infection designated by ICD-9 code were identified. Subjects were included if they were at least 17.5 years old and had at least 1 value during this time period for plasma creatinine (PCr), serum urea nitrogen (SUN), albumin (Alb) and hemoglobin (Hb). If a subject had multiple lab values recorded, only the most recent lab value was utilized for the analysis. Subjects with any diagnosis or procedure code pertaining to dialysis were excluded. Kidney function was assessed by glomerular filtration rate (GFR) and calculated using the modification of diet in renal disease (MDRD) method as follows: GFR= 170 x [PCr]−0.999 x [Age] −0.176 x [SUN] −0.170 x [Alb]+0.318 x [0.762 if female] x [1.18 if black]. Since race was not reported in the database, this parameter was not included in the calculation. Anemia was defined as Hb &lt;13 g/dL for men; &lt;12 g/dL for women. Results: Of the 2,032 subjects identified with HIV, 840 (41%) met the inclusion criteria. The mean age of these subjects was 43.7±12.6 years; 72% were male; mean Hb was 14.3±1.6 g/dL. Mean GFR was 91.1±21.1 mL/min/1.73m3. See Table 1 for the incidence of anemia associated with increasing severity of CKD. Conclusions: Overall prevalence of GFR &lt;90 mL/min/1.73m3 among HIV patients was 48.5%. This is similar to the 43.5% demonstrated in a recent analysis of HIV patients,1 and higher than the 35.9% seen in the general population.2 It may, however, be an overestimate of the actual prevalence of CKD, since race was not analyzed. In addition, patients with GFRs ≥ 60 mL/min/1.73m3 require data on proteinuria to diagnose CKD. As is the case in the general population, anemia increases in prevalence with severity of CKD. Anemia in either CKD or HIV patients is associated with increased morbidity and mortality3,4; therefore, a prompt diagnosis of anemia is warranted, as it may impact clinical treatments and outcomes in this population. Table 1: Incidence of anemia associated with worsening GFR GFR (mL/min/1.73m3)* N (%) Anemia N (% total) *lower values mean worsening kidney function. ≥ 90 433 (51.5) 52 (12) 60–89 359 (42.7) 32 (9) 30–59 44 (5.3) 11 (25) 15–29 4 (0.5) 3 (75) &lt;15 0 0</jats:p

Abstract 251: The Economic Implications Of Avoidable Therapeutic Obstacles In The Treatment Of Venous Thromboembolism

Objective: Venous thromboembolism - deep vein thrombosis (DVT) and pulmonary embolism (PE) - affects an estimated 900,000 individuals, and is responsible for as many as 100,000 deaths each year in the US. Patients with a history of DVT/PE have heightened risk of recurrence. Initial parenteral anticoagulation (low molecular weight heparin [LMWH]) is standard treatment for acute DVT/PE followed by ≥3 months of warfarin, which itself introduces the risk of major bleeding. Balancing the increased risks of major bleeding and recurrent DVT/PE remains a challenge. Recent clinical trials show that rivaroxaban, an oral direct inhibitor of factor Xa, is as effective as standard therapy for acute DVT/PE and, when continued into the outpatient setting, may provide an effective, safe, single-drug, and simplified approach to treatment. We consider the economic implications of these data in the context of a commercial health plan. Methods: We used a decision-analytic model to estimate the annual economic burden of DVT/PE to a hypothetical commercial plan. Hospital days, acute and 1 year cost were assessed. The baseline scenario assumes that all patients with DVT/PE receive standard treatment (LMWH/warfarin). A projected scenario assumes that 75% of patients receive standard treatment, and 25% are treated with rivaroxaban. Rates of major bleed, non-major bleed, and recurrent DVT/PE events in the year following the acute DVT/PE are drawn from clinical trials. DVT/PE prevalence and healthcare costs are estimated based on published literature. Results: In a hypothetical plan of 1 million, our baseline model projects that management of acute DVT/PE (standard treatment) would consume 12,786 inpatient days (69% associated with DVT; 31% with PE) and $59.6 million (2013 USD). Treatment for 74 recurrent DVT/PE events (84$1.4 million; major bleed events (39; 64% DVT) and non-major bleed events (207; 70% DVT) would require an additional $1 million to treat. In the projected scenario, a 25$57.7 million (73% DVT), a reduction of $1.9 million (3$82,000). In the projected scenario, 4 (10%) major bleeding events were prevented, at the cost of 1 (0.5%) additional non-major bleeding event which, taken together, reduced net healthcare utilization to manage bleeding events by about $91,000. Conclusion: Our model suggests that the reduction in inpatient utilization, recurrent DVT/PE events, and major bleed events resulting from a shift of 25$2 million in savings for every 1 million patients enrolled in a commercial health plan. </jats:p

Warfarin INR Patterns Following Total Knee Arthroplasty.

Abstract Abstract 2100 Poster Board II-77 Introduction: Anticoagulant therapy is recommended for preventing venous thromboembolism (VTE) among patients undergoing total knee arthroplasty (TKA). During warfarin therapy, monitoring of international normalized ratio (INR) is necessary to avoid underdosing (which can lead to VTE and associated events) or overdosing (which can lead to significant bleeding). The purpose of this project was to investigate the distribution of out-of-range INR results among warfarin-treated patients undergoing TKA. Patients and Methods: A retrospective cohort analysis was conducted using the MedMining® database of electronic medical record data. Data were obtained for patients with a TKA procedure and a prescription for warfarin issued within 3 days of surgery from January 1, 2004 through January 31, 2009. We identified INR results during warfarin therapy following surgery for up to 90 days. INR results were categorized as in therapeutic range (2–3), below range (&lt; 2), or above range (&gt; 3). For each patient, we calculated the proportion of INR results in each category. Time to first in-range INR was calculated as days from warfarin start to first in-range level for those with at least 1 in-range level. Results: Of 1801 eligible patients, 63.3% were aged 65 years and above, 62.7% were female, and 98.3% were White/Caucasian. The most common reason for surgery was osteoarthritis (96.6%) and the mean length of hospital stay was 3.6 days (SD, 1.4 days). Most patients (82.7%) had 2 or more INR levels during warfarin exposure; 44.2% had 5 or more INR values. Among the 1173 patients with at least 2 INR levels available, patients had a mean of 15.3% of INR values within therapeutic range, 82.9% of INR levels below the therapeutic range and 1.8% of values above range. A total of 52.8% of patients with at least 2 INR levels had no INR fall within the therapeutic range. The median time to first in-range INR was 7 days (range 1-90 days). Conclusions: This population-based observational study found poor warfarin anticoagulation control in TKA patients with only about half of patients having INRs within the therapeutic range. INR levels above the therapeutic range were rare, but many patients received insufficient doses of warfarin to achieve therapeutic INR levels. Among those who did achieve at least one in-range INR, the time to achieve this was long, exposing the patient to the risk of VTE during the highest post-op risk period (i.e., within the first7 days after surgery). It is possible surgeons are targeting sub therapeutic INR ranges or patients have poor adherence to warfarin therapy; the data do not permit an investigation of physicians' targets or whether patients took the medication as prescribed. These research findings may not be generalizable to the broader US population. A study of the consequences of INR values below the therapeutic range in the TKA population is warranted. Disclosures: Kachroo: United BioSource Corp: Employment; Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Nordstrom:United BioSource Corp: Employment; Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Nutescu:Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Schein:Ortho-McNeil Janssen Scientific Affairs, LLC: Employment. Bookhart:Ortho-McNeil Janssen Scientific Affairs, LLC: Employment, Equity Ownership. </jats:sec