Antithrombotic use and bleeding risk in patients with atrial fibrillation: findings from a multipayer analysis.

AIMS: To analyze administrative claims data from Medicaid, Medicare and commercial insurance sources to estimate stroke risk, bleeding risk, and the use of antithrombotic treatment in patients with atrial fibrillation (AF). METHODS: Included patients were aged ≥18 years with a new or existing diagnosis of AF. Outcomes were assessed over 1 year and included stroke risk (CHADS2/CHA2DS2-VASc score), bleeding risk (ATRIA score) and anticoagulant use. RESULTS: A total of 115,906 patients with AF met inclusion criteria between six databases. Among patients with high stroke risk (CHADS2 ≥2) and low bleeding risk (ATRIA 0-3), 42-82% did not receive an antithrombotic. CONCLUSION: Levels of thromboprophylaxis for high-risk AF patients in real-world data differ significantly from current medical guidelines for stroke prevention.

Daily costs of hospitalization in non-valvular atrial fibrillation patients treated with anticoagulant therapy.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in the US, with an estimated prevalence of 2.7-6.1 million persons in 2010. OBJECTIVE: This study evaluates the progression of daily hospitalization costs among non-valvular atrial fibrillation (NVAF) patients treated with anticoagulant therapy. METHODS: A claims analysis was conducted with Premier Perspective Comparative Hospital Database records from January 2009-March 2013. Patients of 18 years or older who were diagnosed with NVAF and used anticoagulant therapy were studied. Treatment patterns and mean daily costs of hospitalization per patient as well as total costs of hospitalization were reported. Comparisons of mean daily costs with those of the previous day were presented to identify statistical cost differences between hospitalization days. RESULTS: A total of 375,560 patients were identified; 67,017 with AF as admitting/primary diagnosis, and 308,543 with AF as a secondary diagnosis. The mean age of the overall population, primary AF diagnosis cohort, and secondary AF diagnosis cohort was 73.8, 67.9, and 75.0 years, while their proportion of females was 46.3%, 45.6%, and 46.5%, respectively. The mean length of stay was 6.8 days, 3.7 days, and 7.5 days for the overall population, the primary AF diagnosis cohort, and the secondary AF diagnosis cohort, respectively. For all cohorts, mean daily costs stabilized on the third day (overall population: $2103; primary AF diagnosis cohort: $1505; secondary AF diagnosis cohort: $2208). LIMITATIONS: Claims data may have contained inaccuracies or omissions in coded procedures, diagnoses, or pharmacy claims. CONCLUSION: The study showed that daily hospitalization costs for NVAF patients stabilized on the third day of hospitalization and that any reduction or prolongation in hospital length of stay could have a significant impact on the cost burden associated with AF.

Daily hospitalization costs in patients with deep vein thrombosis or pulmonary embolism treated with anticoagulant therapy.

BACKGROUND: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects about 900,000 persons in the United States each year. OBJECTIVES: To quantify the progression of daily hospitalization costs among DVT and PE patients. PATIENTS/METHODS: A retrospective claims analysis was conducted from 01/01/2009 to 03/01/2013 using the Premier Perspective Comparative Hospital Database. Patients≥ 18years of age with an admitting/primary diagnosis of DVT or PE and receiving anticoagulant therapy were identified. Treatment patterns, mean daily costs, and total hospitalization costs were reported for the DVT and PE populations. Comparisons of mean daily costs with those of the previous day were presented to identify statistical cost differences between hospitalization days. RESULTS: A total of 28,953 and 35,550 patients were identified with a diagnosis of DVT and PE, respectively. The daily costs were at their highest during the first three days for DVT patients at $2,321, $1,875, and $1,558, respectively. Similar results were found for PE patients with costs at their highest in the first three days, at $2,981, $2,034, and $1,564, respectively. Among the DVT and PE populations, mean daily costs were $1,594 and $1,735, respectively, and daily hospitalization costs became stable on the third day of the hospitalization (standardized differences<10%). CONCLUSIONS: Daily hospitalization costs of patients with an admitting/primary diagnosis of DVT or PE were high in the first days and became stable on the third day. It was further suggested that any change in the LOS could significantly affect hospitalization costs.

The economic implications of switching to rivaroxaban from enoxaparin plus vitamin K antagonist in the treatment of venous thromboembolism.

OBJECTIVE: Venous thromboembolism (VTE) impacts ∼900,000 individuals annually in the US, causing up to 100,000 deaths. Patients experiencing VTE have heightened risk of recurrence. Initial parenteral anti-coagulation is standard therapy for acute VTE followed by ≥3 months of warfarin, which introduces the risk of major bleeding. Balancing increased risks of bleeding and recurrent VTE remains challenging. Recent clinical trials suggest that rivaroxaban, an oral direct inhibitor of factor Xa, provides an effective, safe, simplified approach to treatment. This study considers the economic implications of these data. METHODS: This study modeled inpatient, acute, and 1-year VTE costs for a hypothetical commercial plan with 1 million members. At baseline, all VTE patients receive standard therapy. Alternatively, 25% are instead treated with rivaroxaban. Model inputs are trial- and literature-based. RESULTS: Standard therapy for VTE consumes 9474 inpatient days ($31.6 million). Added to that is treatment for 74 recurrences ($1.4 million); major and non-major bleed events ($1 million); and direct costs of anti-coagulation ($5.3 million). Alternatively, a 25% shift to oral anti-coagulation with rivaroxaban reduces inpatient days (by 5%); associated acute-care costs (by 2%); recurrences and costs (by 6%). Four major bleeding events are prevented, at the cost of one additional non-major bleeding event, which, taken together, reduce net utilization by 9%. Direct costs of anti-coagulation increase by 5%. CONCLUSION: The reduction in inpatient utilization, recurrences, and major bleeding resulting from a 25% shift from standard therapy to rivaroxaban following acute VTE would conserve ∼$860,475 for every 1 million commercial health plan enrollees.

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.

Inpatient resource use and cost burden of deep vein thrombosis and pulmonary embolism in the United States.

PURPOSE: Venous thromboembolism (VTE), which comprises deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with significant morbidity and mortality. VTE frequently leads to hospitalization and represents a considerable economic burden to the US health care system. However, little information exists on the duration of hospitalization and associated charges among patients with an admitting or primary diagnosis of DVT or PE. This study assessed the charges associated with hospitalization length of stay in patients with DVT or PE discharged from US hospitals in 2011. METHODS: Using data from the Nationwide Inpatient Sample of the Healthcare Utilization Project database, this analysis examined hospital length of stay and associated charges in patients with DVT or PE discharged from US hospitals in 2011. Both initial and subsequent hospitalizations were analyzed. FINDINGS: DVT was responsible for fewer hospitalizations than PE. In 2011, among 330,044 patients with VTE discharged from US hospitals, 143,417 had DVT and 186,627 had PE. Mean length of stay for patients with DVT was 4.7 days (median, 3.9 days) compared with 5.1 days (median, 4.5 days) for patients with PE. For initial hospitalizations, the mean (SE) charge amounted to $30,051 ($246) for DVT compared with $37,006 ($214) for PE. Older patients with PE incurred greater hospital charges than younger ones, and for both DVT and PE patients, women incurred greater charges than men. Of 31,463 patients admitted to the hospital with PE, 4.0% had a subsequent admission, which was more costly than the initial admission. Many patients with both DVT and PE were discharged to specialist nursing facilities, indicating continuing posthospitalization charges. IMPLICATIONS: Hospital stays for DVT and PE represent a substantial cost burden to the US health care system. Health care systems have the potential to reduce the clinical and economic burden of VTE by ensuring that evidence-based, guideline-recommended anticoagulation therapy is adhered to by patients with an initial VTE. Appropriate anticoagulant therapy and continuity of care in these patients may reduce the incidence and frequency of hospital readmissions and VTE-related morbidity and mortality and have a potential effect on health care resources.

Gastrointestinal comorbidities associated with atrial fibrillation.

This observational study was conducted to describe the risk of gastrointestinal (GI) events among patients with atrial fibrillation (AF). We analyzed Thomson Reuters MarketScan® data from 2005 to 2009. Subjects aged ≥18 years with ≥ 1 AF diagnosis were selected. GI events were identified from claims with a primary or secondary diagnosis code for any GI condition. The risk of GI events was assessed using cumulative incidence (new GI events/patients with AF without GI condition at baseline) and incidence rates (IRs), calculated as the number of patients with new GI events divided by patient-years of observation. In addition, the CHADS2 score was evaluated at baseline to determine the patient's risk of stroke. A total of 557,123 AF patients were identified. The mean (median) AF patient age was 68.2 years (70); 45% were female. The cumulative incidences of any GI event and dyspepsia were 40% and 19%, respectively. The corresponding IRs were 38.8 and 14.7 events per 100 patient-years. IRs of any GI events for female and male patients were 43.6 and 35.5; for patients in the age groups <65, 65-74, 75-84, and ≥85 years, IRs were 32.3, 38.9, 44.6, and 52.7; for patients with a CHADS2 score of 0, 1-2, 3-4, and 5-6, IRs were 30.3, 41.6, 56.9, and 74.5, respectively. In this large claims database, 40% of AF patients experienced a GI event, predominantly dyspepsia. Physicians should take age and comorbidities into consideration when managing AF patients.

Length of stay and economic consequences with rivaroxaban vs enoxaparin/vitamin K antagonist in patients with DVT and PE: findings from the North American EINSTEIN clinical trial program.

OBJECTIVE: Venous thromboembolism (VTE) (deep vein thrombosis [DVT] and pulmonary embolism [(PE]) represents a substantial economic burden to the healthcare system. Using data from the randomized EINSTEIN DVT and PE trials, this North American sub-group analysis investigated the potential of rivaroxaban to reduce the length of initial hospitalization in patients with acute symptomatic DVT or PE. METHODS: A post-hoc analysis of hospitalization and length-of-stay (LOS) data was conducted in the North American sub-set of patients from the randomized, open-label EINSTEIN trial program. Patients received either rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily; n = 405) or dose-adjusted subcutaneous enoxaparin overlapping with (guideline-recommended 'bridging' therapy) and followed by a vitamin K antagonist (VKA) (international normalized ratio = 2.0-3.0; n = 401). The open-label study design allowed for the comparison of LOS between treatment arms under conditions reflecting normal clinical practice. LOS was evaluated using investigator records of dates of admission and discharge. Analyses were carried out in the intention-to-treat population using parametric tests. Costs were applied to the LOS based on weighted mean cost per day for DVT and PE diagnoses obtained from the Healthcare Cost and Utilization Project dataset. RESULTS: Of 382 patients hospitalized, 321 (84%), had acute symptomatic PE; few DVT patients required hospitalization. Similar rates of VTE patients were hospitalized in the rivaroxaban and enoxaparin/VKA treatment groups, 189/405 (47%) and 193/401 (48%), respectively. In hospitalized VTE patients, rivaroxaban treatment produced a 1.6-day mean reduction in LOS (median = 1 day) compared with enoxaparin/VKA (mean = 4.5 vs 6.1; median = 3 vs 4), translating to total costs that were $3419 lower in rivaroxaban-treated patients. CONCLUSION: In hospitalized North American patients with VTE, treatment with rivaroxaban produced a statistically significant reduction in LOS. When treating DVT and PE patients, clinicians should consider newer anti-coagulants with less complex treatment regimens.

Prescription opioid abuse: a literature review of the clinical and economic burden in the United States.

Between 2002 and 2007, the nonmedical use of prescription pain relievers grew from 11.0 million to 12.5 million people in the United States. Societal costs attributable to prescription opioid abuse were estimated at $55.7 billion in 2007. The purpose of this study was to comprehensively review the recent clinical and economic evaluations of prescription opioid abuse. A comprehensive literature search was conducted for studies published from 2002 to 2012. Articles were included if they were original research studies in English that reported the clinical and economic burden associated with prescription opioid abuse. A total of 23 studies (183 unique citations identified, 54 articles subjected to full text review) were included in this review and analysis. Findings from the review demonstrated that rates of opioid overdose-related deaths ranged from 5528 deaths in 2002 to 14,800 in 2008. Furthermore, overdose reportedly results in 830,652 years of potential life lost before age 65. Opioid abusers were generally more likely to utilize medical services, such as emergency department, physician outpatient visits, and inpatient hospital stays, relative to non-abusers. When compared to a matched control group (non-abusers), mean annual excess health care costs for opioid abusers with private insurance ranged from $14,054 to $20,546. Similarly, the mean annual excess health care costs for opioid abusers with Medicaid ranged from $5874 to $15,183. The issue of opioid abuse has significant clinical and economic consequences for patients, health care providers, commercial and government payers, and society as a whole.

A cost-analysis model for anticoagulant treatment in the hospital setting.

BACKGROUND: Rivaroxaban is the first oral factor Xa inhibitor approved in the US to reduce the risk of stroke and blood clots among people with non-valvular atrial fibrillation, treat deep vein thrombosis (DVT), treat pulmonary embolism (PE), reduce the risk of recurrence of DVT and PE, and prevent DVT and PE after knee or hip replacement surgery. The objective of this study was to evaluate the costs from a hospital perspective of treating patients with rivaroxaban vs other anticoagulant agents across these five populations. METHODS: An economic model was developed using treatment regimens from the ROCKET-AF, EINSTEIN-DVT and PE, and RECORD1-3 randomized clinical trials. The distribution of hospital admissions used in the model across the different populations was derived from the 2010 Healthcare Cost and Utilization Project database. The model compared total costs of anticoagulant treatment, monitoring, inpatient stay, and administration for patients receiving rivaroxaban vs other anticoagulant agents. The length of inpatient stay (LOS) was determined from the literature. RESULTS: Across all populations, rivaroxaban was associated with an overall mean cost savings of $1520 per patient. The largest cost savings associated with rivaroxaban was observed in patients with DVT or PE ($6205 and $2742 per patient, respectively). The main driver of the cost savings resulted from the reduction in LOS associated with rivaroxaban, contributing to ∼90% of the total savings. Furthermore, the overall mean anticoagulant treatment cost was lower for rivaroxaban vs the reference groups. LIMITATIONS: The distribution of patients across indications used in the model may not be generalizable to all hospitals, where practice patterns may vary, and average LOS cost may not reflect the actual reimbursements that hospitals received. CONCLUSION: From a hospital perspective, the use of rivaroxaban may be associated with cost savings when compared to other anticoagulant treatments due to lower drug cost and shorter LOS associated with rivaroxaban.

Cost-effectiveness analysis of extended duration anticoagulation with rivaroxaban to prevent recurrent venous thromboembolism.

INTRODUCTION: Extended duration anticoagulation with rivaroxaban for an additional 6-12 months can reduce recurrent venous thromboembolic events (VTE) compared to placebo by ~82%, but at the detriment of increased bleeding. We sought to estimate the cost-effectiveness of extended duration prophylaxis of recurrent VTE with rivaroxaban. MATERIAL AND METHODS: A Markov model was developed to estimate the cost-effectiveness of extended duration rivaroxaban, 20mg daily, compared to placebo using a Medicare perspective, a one-monthcycle length and a 40-year time horizon. The model assumed a cohort of 58-year-old patients who had already completed an initial 6-12 months of anticoagulation with rivaroxaban or a vitamin K antagonist; and whom prescribers had clinical equipoise with respect to the need for continued anticoagulation. Data sources included EINSTEIN-Extension and other published studies of VTE. Outcomes included direct treatment costs (in 2013US$), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). RESULTS: Extended duration rivaroxaban resulted in higher treatment costs ($22,645 vs. $22,083) but yielded greater QALYs (16.167 vs. 16.134) as compared to placebo; corresponding to an ICER of $17,030/QALY gained. Our model was most sensitive to the baseline risk of bleeding and recurrent VTE, the hazard ratio of developing a recurrent event while on rivaroxaban and time horizon. Monte Carlo Simulation suggested rivaroxaban would be cost-effective in 66% of 10,000 iterations, assuming a willingness-to-pay threshold of $50,000/QALY. CONCLUSION: Despite the cost of rivaroxaban and an increased risk of bleeding, extending VTE treatment for an additional 6-12 months with rivaroxaban was found cost-effective compared to the placebo over a 40-year time horizon.

The economic burden to medicare of stroke events in atrial fibrillation populations with and without thromboprophylaxis.

Some 3 million people in the United States have atrial fibrillation (AF). Without thromboprophylaxis, AF increases overall stroke risk 5-fold. Prevention is paramount as AF-related strokes tend to be severe. Thromboprophylaxis reduces the annual incidence of stroke in AF patients by 22%-62%. However, antithrombotics are prescribed for only about half of appropriate AF patients. The study team estimates the economic implications for Medicare of fewer stroke events resulting from increased thromboprophylaxis among moderate- to high-risk AF patients. The decision model used considers both reduced stroke and increased bleeding risk from thromboprophylaxis for a hypothetical cohort on no thromboprophylaxis (45%), antiplatelets (10%), and anticoagulation (45%). AF prevalence, stroke risk, and stroke risk reduction are adjusted for age, comorbidities, and anticoagulation/antiplatelet status. Health care costs are literature based. At baseline, an estimated 24,677 ischemic strokes, 9127 hemorrhagic strokes, and 9550 bleeding events generate approximately $2.63 billion in annual event-related health care costs to Medicare for every million AF patients eligible for thromboprophylaxis. A 10% increase in anticoagulant use in the untreated population would reduce stroke events by 9%, reduce stroke fatalities by 9%, increase bleed events by 5%, and reduce annual stroke/bleed-related costs to Medicare by about $187 million (7.1%) for every million eligible AF patients. A modest 10% increase in the use of thromboprophylaxis would reduce event-related costs to Medicare by 7.1%, suggesting a compelling economic motivation to improve rates of appropriate thromboprophylaxis. New oral anticoagulants offering better balance between the risks of stroke and major bleeding events may improve these clinical and economic outcomes.

The economic impact of acute coronary syndrome on length of stay: an analysis using the Healthcare Cost and Utilization Project (HCUP) databases.

OBJECTIVE: To assess the economic impact of initial and repeat hospitalizations associated with acute coronary syndrome (ACS) over 1 year (2009). DESIGN AND METHODS: National- and state-level data on length of stay (LOS) and related charges for ACS-associated hospital admissions were assessed using two Healthcare Utilization Project databases. The first, the Nationwide Inpatient Sample (NIS), provided clinical and resource use information from ∼8 million hospital stays, representing a 20% stratified sample of ∼40 million annual hospital stays in the US in 2009. The second, the State Inpatient Databases, provided 100% of inpatient data from nine states that included both patient age and linked information on multiple patient admissions within the same calendar year. For patients with repeat admissions, the LOS, primary diagnosis, and total charges between the first and subsequent admissions were evaluated. All patients≥18 years of age with at least one diagnosis of ACS, defined using the International Classification of Diseases, 9th Revision, were included (code 410.xx [except 410.x2], 411.1x and 411.8x). Variables evaluated for each discharge included demographics, cardiovascular events and procedures, LOS, discharge status, and total charges. RESULTS: The NIS reported 1,437,735 discharges for ACS in 2009. In this dataset, mean LOS for an initial ACS event was 5.56 days. Patients>65 years of age had the highest numbers of admissions; this group also had the most comorbidities. Approximately 40% of ACS patients with data on repeat visits had more than one admission, >70% of these within 2 months of the primary discharge. Mean charges were $71,336 for the first admission and $53,290 for the second admission. CONCLUSION: Despite a variety of new therapies to prevent ACS, it remains a common condition. Better therapies are called for if the clinical and cost burden of ACS is to be alleviated.

Cost-effectiveness of rivaroxaban compared with enoxaparin plus a vitamin K antagonist for the treatment of venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE), comprised of deep vein thrombosis (DVT) and pulmonary embolism (PE), is commonly treated with a low-molecular-weight heparin such as enoxaparin plus a vitamin K antagonist (VKA) to prevent recurrence. Administration of enoxaparin + VKA is hampered by complexities of laboratory monitoring and frequent dose adjustments. Rivaroxaban, an orally administered anticoagulant, has been compared with enoxaparin + VKA in the EINSTEIN trials. The objective was to evaluate the cost-effectiveness of rivaroxaban compared with enoxaparin + VKA as anticoagulation treatment for acute, symptomatic, objectively-confirmed DVT or PE. METHODS: A Markov model was built to evaluate the costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios associated with rivaroxaban compared to enoxaparin + VKA in adult patients treated for acute DVT or PE. All patients entered the model in the 'on-treatment' state upon commencement of oral rivaroxaban or enoxaparin + VKA for 3, 6, or 12 months. Transition probabilities were obtained from the EINSTEIN trials during treatment and published literature after treatment. A 3-month cycle length, US payer perspective ($2012), 5-year time horizon and a 3% annual discount rate were used. RESULTS: Treatment with rivaroxaban cost $2,448 per-patient less and was associated with 0.0058 more QALYs compared with enoxaparin + VKA, making it a dominant economic strategy. Upon one-way sensitivity analysis, the model's results were sensitive to the reduction in index VTE hospitalization length-of-stay associated with rivaroxaban compared with enoxaparin + VKA. At a willingness-to-pay threshold of $50,000/QALY, probabilistic sensitivity analysis showed rivaroxaban to be cost-effective compared with enoxaparin + VKA approximately 76% of the time. LIMITATIONS: The model did not account for the benefits associated with an oral and minimally invasive administration of rivaroxaban. 'Real-world' applicability is limited because data from the EINSTEIN trials were used in the model. Also, resource utilization and costs were based on the US healthcare system. CONCLUSION: Rivaroxaban is a cost-effective option for anticoagulation treatment of acute VTE patients.

Budget impact analysis of tapentadol extended release for the treatment of moderate to severe chronic noncancer pain.

BACKGROUND: Opioids are commonly used to manage chronic pain. Although traditional µ-opioids are effective in reducing pain, they are often associated with opioid-induced side effects (OISEs) that can limit treatment effectiveness. Studies have shown that tapentadol extended release (ER) has a lower incidence of gastrointestinal adverse events than oxycodone controlled release (CR) at equianalgesic doses. OBJECTIVE: A model was developed to estimate the budget impact of placing tapentadol ER on a hypothetical US health plan formulary of Schedule II long-acting opioids. METHODS: We estimated annual direct health care costs for patients who received 6-month therapy with long-acting formulations of tapentadol, oxycodone, morphine, hydromorphone, oxymorphone, or fentanyl. Costs included medications, copayments, OISE management, and switching/discontinuation. Published estimates of incidence/prevalence, OISEs, and pain management resources and costs were used. The base case analysis assumed a 10% formulary share of tapentadol ER with a 10% decrease of oxycodone CR. The resulting per-member per-month (PMPM) formulary cost differences and results of a 1-way sensitivity analysis are reported. RESULTS: In a health plan of 500,000 members, 2600 (0.52%) are estimated to experience chronic pain annually. Adding tapentadol ER to the formulary was associated with an annual budget savings of $148,945 ($0.0248 PMPM). This savings was achieved through a decrease in both pharmacy costs ($144,062; $0.0240 PMPM) and medical costs ($4883; $0.0008 PMPM). Cost decreases were driven by lower daily average consumption and fewer OISEs with tapentadol ER versus oxycodone CR, leading to reduced resource utilization over 6 months of treatment. Sensitivity analyses showed results were most sensitive to drug acquisition costs. CONCLUSIONS: Our results suggest that replacing 10% of oxycodone CR's formulary share with tapentadol ER would decrease the overall budget of a health plan with 500,000 members. Placing tapentadol ER on a health plan formulary may result in a reduction in both pharmacy and medical costs.

Warfarin anticoagulation after total hip or total knee replacement: clinical and resource-utilization outcomes in a university-based antithrombosis clinic.

PURPOSE: Clinical and resource-utilization outcomes associated with warfarin anticoagulation after major orthopedic surgery were evaluated. METHODS: Consecutive patients who received postsurgical prophylaxis with warfarin within 24 hours of total knee replacement (TKR) or total hip replacement (THR) surgery and who were referred to and had outpatient follow-up for anticoagulation management in a single-center, university-based antithrombosis clinic from January 1, 1998, to January 1, 2009, were included in the study. Data were obtained from existing inpatient and outpatient medical records and retrospectively reviewed. Patient follow-up and data collection were conducted from the time of admission until 90 days after surgery. RESULTS: A total of 400 patients were included in the study; 179 (44.8%) underwent THR and 221 (55.3%) underwent TKR. The mean length of hospital stay was 5.0 ± 1.9 days, and the mean length of warfarin therapy was 50 ± 21 days. The mean time required to reach the target International Normalized Ratio (INR) of 2.0-3.0 was 10.0 ± 9.1 days. The within-patient percentage of INR levels spent in the target range was 28% ± 18%. Objectively confirmed symptomatic venous thromboembolism (VTE) occurred in 16 patients (4%), with 14 events (87.5%) occurring with INR values of ≤2.0 and 2 events (12.5%) occurring with INR values of >2.0. CONCLUSION: THR and TKR surgical patients at one institution who were receiving postsurgical VTE prophylaxis with warfarin spent a substantial proportion of time with their INR below the target range and had a high rate of symptomatic VTE.

Burden of comorbidities among patients with atrial fibrillation.

OBJECTIVE: This study examined comorbidity prevalence and general medication use among individuals with atrial fibrillation in the United States to convey a more comprehensive picture of their total disease burden. METHODS: This was a retrospective, observational evaluation of responses to the 2009 wave of the annual Internet-based National Health and Wellness survey, which collects health data including epidemiologic data and information on medical treatment from a representative nationwide sample of adults in the United States. Responses were assessed to determine three measures of comorbidity: mean number of comorbidities, CHADS2 score reflecting stroke risk (0-6 points; low risk: 0; moderate risk: 1; high risk: ≥ 2), and scores on the Charlson Comorbidity Index, which is a measure of general comorbidity reflecting presence of a wide range of comorbidities. RESULTS: Of the overall sample, 1297 participants reported having been diagnosed with atrial fibrillation. Almost all (98%) of the predominantly male (65.1%) and older (≥ 65 years of age, 65.7%) population with atrial fibrillation had at least one additional comorbidity, and 90% had cardiovascular comorbidities. On the Charlson Comorbidity Index, 44.9% of the respondents had scores of 1-2 and 20.5% had scores of 3 or higher. High risk for stroke, demonstrated by a CHADS2 score of at least 2, was present in 45% and moderate risk (CHADS2 score 1) in 36%. Of the respondents with atrial fibrillation, 71% reported current use of medication to manage the condition, but only 48% of individuals at high risk for stroke reported use of anticoagulation therapy. Of those who reported having common risk factors for stroke, the majority reported receiving prescription therapy for these conditions. CONCLUSIONS: The health burden carried by patients often extends far beyond atrial fibrillation. Physicians should carefully consider comorbidities and concomitant medications when managing patients with atrial fibrillation.

Clinical simulation model of long-acting opioids for treatment of chronic non-cancer pain in the United States.

OBJECTIVE: To evaluate costs and outcomes associated with initial tapentadol ER vs oxycodone CR for the treatment of chronic non-cancer pain (CNCP) in the US. METHODS: This study developed a Monte-Carlo simulation based on the scientific foundation established by published models of long-acting opioids (LAO) in patients having moderate-to-severe CNCP. It estimates costs and outcomes associated with the use of tapentadol ER vs oxycodone CR over a 1-year period from the perspective of a US payer. LAO effectiveness and treatment-emergent adverse event (TEAE) rates are derived from clinical trials of tapentadol ER vs oxycodone CR; other inputs are based on published literature supplemented sparingly with clinical opinion. Sensitivity analyses consider the impact of real-world dosing patterns for LAO on treatment costs. RESULTS: Initial tapentadol ER consistently demonstrates better outcomes than initial oxycodone CR (proportion of patients achieving adequate pain relief and no GI TEAE; acute TEAE-free days; days free of chronic constipation; quality-adjusted life days; productive working hours). While total costs with initial tapentadol ER are slightly (2.2%) higher than with initial oxycodone CR, nearly twice as many modeled patients in the initial tapentadol ER arm (29% vs 15%) achieve adequate pain relief and no GI TEAE compared to initial oxycodone CR. In sensitivity analyses, tapentadol ER becomes a dominant strategy when real-world dosing patterns are considered. CONCLUSION: The additional costs to produce better outcomes (pain relief and no GI TEAE) associated with tapentadol ER are small in the context of double the likelihood of a patient response with tapentadol ER. When daily average consumption (DACON) for oxycodone CR is factored into the analysis, initial tapentadol ER becomes a dominant strategy. Our findings are both strengthened, and limited by the use of randomized trial-centric input parameters. These results should be validated as inputs from clinical practice settings become available.

Physician management of moderate-to-severe acute pain: results from the Physicians Partnering Against Pain (P³) study.

OBJECTIVE: To evaluate differences among physician specialties in the management of acute pain including prescribing practices and management of opioid-related side effects. DESIGN AND PARTICIPANTS: The Physicians Partnering Against Pain (P³) survey was a nationwide study of US physicians and their patients with severe to moderate acute pain (<3 months). MAIN MEASURES: Physicians were surveyed about volume of patients with moderate-to-severe acute pain in their practice, frequency of prescribing opioid analgesics, percentage of these patients returning for a follow-up visit after treatment, reasons patients discontinue treatment, frequency of recommending or prescribing treatment for opioid-related gastrointestinal (GI) side effects, and frequency of patients taking opioid analgesics that take additional treatments to manage GI side effects. RESULTS: The 5,982 participating physicians represented primary care physicians (PCPs; 52 percent), pain specialists (25 percent), and other specialists (23 percent). PCPs and other specialists were less likely than pain specialists to prescribe opioid analgesics to patients (25.8 percent, 29.5 percent, and 44.8 percent, respectively). The vast majority of pain specialists (78 percent) also indicated that more than three quarters of their patients returned for a follow-up visit compared with only 40 percent of PCPs and 65 percent of other specialists. When ranking the reasons why they think patients discontinue opioid analgesics, pain specialists ranked unacceptable side effects higher than PCPs and other specialists. PCPs and pain specialists were more likely than other specialists to recommend or prescribe treatments to manage opioid-related side effects, such as nausea, vomiting, and constipation (38.3 percent, 38.5 percent, and 23.1 percent, respectively). CONCLUSION: The P(3) Study confirms the challenge of pain management while balancing tolerability of opioid treatments from the physician perspective.

Opioid utilization patterns among medicare patients with diabetic peripheral neuropathy.

BACKGROUND: Diabetic peripheral neuropathy (DPN) affects a large percentage of patients with type 2 diabetes and is associated with moderate-to-severe pain. Patients with DPN bear a substantial economic burden as a result of increased overall healthcare utilization. The reported costs of treating DPN are nearly $11 billion, with elderly (aged ≥65 years) patients with type 2 diabetes accounting for 93.1% ($10.2 billion) of the total costs. OBJECTIVES: To describe the real-world utilization patterns of long-acting opioids (LAOs) and chronic short-acting opioids (SAOs) use in a sample of Medicare enrollees (aged ≥65 years) with painful DPN, and to identify potential areas for improvement in the management of elderly patients with painful DPN who are treated with opioids. METHODS: In this retrospective pharmacy claims analysis, the Chronic Opioid Medication Use Evaluation (MUE) software was used to import and analyze individual plan, retrospective pharmacy utilization claims data from the MarketScan claims databases. Patients aged ≥65 years who had painful DPN as identified by ≥2 International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for painful DPN (250.6X or 357.2) in at least 2 quarters in 2009, and who had ≥1 claims for LAO and/or chronic use of SAO (≥60 days of continuous therapy), were selected for analysis. Pharmacy claim data were extracted for 12 months, and various opioid utilization measures were reported. RESULTS: A total of 1448 unique Medicare patients with painful DPN were identified who had 11,740 claims for an LAO and/or chronic use of an SAO. Of the 1448 patients, 62% had chronic use of an SAO, and of these, 89% had no concurrent claim for LAO (minimum, 60-day overlap). The most frequently filled LAOs were fentanyl transdermal (38%), oxycodone controlled release (CR; 26%), and morphine CR/extended release (ER)/sustained release (SR; 20%). The daily average consumptions for fentanyl transdermal, oxycodone CR, and morphine CR/ER/SR were 0.3, 2.5, and 2.4, respectively. Among the study population, 15.2% of the patients filled an LAO or SAO prescription at ≥2 pharmacies. Furthermore, these elderly patients with painful DPN used greater doses of LAOs than what is recommended in the package insert, and 1.6% of patients used high doses of acetaminophen and 15.2% utilized multiple pharmacies to obtain their opioid prescriptions. Moreover, this population had prevalent concomitant use of opioids and prescribed gastrointestinal (GI) medications. CONCLUSION: Results from our retrospective pharmacy claims analysis demonstrated that elderly patients with painful DPN use doses of LAOs above those recommended in the package insert, with some patients using high doses of acetaminophen and utilizing multiple pharmacies to obtain their opioid prescriptions. In addition, this population had prevalent concomitant use of opioids and prescription GI medications. The use of software, such as the Opioid MUE, to monitor opioid drug utilization trends and examine other utilization measures can assist healthcare decision makers and payers in their utilization reviews to appropriately manage this population.