Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden.

OBJECTIVE: The objective of this study was to quantify the impact that longer battery life of cardiac resynchronization therapy defibrillator (CRT-D) devices has on reducing the number of device replacements and associated costs of these replacements from a Swedish health care system perspective. METHODS: An economic model based on real-world published data was developed to estimate cost savings and avoided device replacements for CRT-Ds with longer battery life compared with devices with industry-standard battery life expectancy. Base-case comparisons were performed among CRT-Ds of three manufacturers - Boston Scientific Corporation, St. Jude Medical, and Medtronic - over a 6-year time horizon, as per the available clinical data. As a sensitivity analysis, we evaluated CRT-Ds as well as single-chamber implantable cardioverter defibrillator (ICD-VR) and dual-chamber implantable cardioverter defibrillator (ICD-DR) devices over a longer 10-year period. All costs were in 2015 Swedish Krona (SEK) discounted at 3% per annum. RESULTS: Base-case analysis results show that up to 603 replacements and up to SEK 60.4 million cumulative-associated costs could be avoided over 6 years by using devices with extended battery life. The pattern of savings over time suggests that savings are modest initially but increase rapidly beginning in the third year of follow-up with each year's cumulative savings two to three times the previous year. Evaluating CRT-D, ICD-VR, and ICD-DR devices together over a longer 10-year period, the sensitivity analysis showed 2,820 fewer replacement procedures and associated cost savings of SEK 249.3 million for all defibrillators with extended battery life. CONCLUSION: Extended battery life is likely to reduce device replacements and associated complications and costs, which may result in important cost savings and a more efficient use of health care resources as well as a better quality of life for heart failure patients in Sweden.

Current challenges in health economic modeling of cancer therapies: a research inquiry.

BACKGROUND: The demand for economic models that evaluate cancer treatments is increasing, as healthcare decision makers struggle for ways to manage their budgets while providing the best care possible to patients with cancer. Yet, after nearly 2 decades of cultivating and refining techniques for modeling the cost-effectiveness and budget impact of cancer therapies, serious methodologic and policy challenges have emerged that question the adequacy of economic modeling as a sound decision-making tool in oncology. OBJECTIVES: We sought to explore some of the contentious issues associated with the development and use of oncology economic models as informative tools in current healthcare decision-making. Our objective was to draw attention to these complex pharmacoeconomic concerns and to promote discussion within the oncology and health economics research communities. METHODS: Using our combined expertise in health economics research and economic modeling, we structured our inquiry around the following 4 questions: (1) Are economic models adequately addressing questions relevant to oncology decision makers; (2) What are the methodologic limitations of oncology economic models; (3) What guidelines are followed for developing oncology economic models; and (4) Is the evolution of oncology economic modeling keeping pace with treatment innovation? Within the context of each of these questions, we discuss issues related to the technical limitations of oncology modeling, the availability of adequate data for developing models, and the problems with how modeling analyses and results are presented and interpreted. DISCUSSION: There is general acceptance that economic models are good, essential tools for decision-making, but the practice of oncology and its rapidly evolving technologies present unique challenges that make assessing and demonstrating value especially complex. There is wide latitude for improvement in oncology modeling methodologies and how model results are presented and interpreted. CONCLUSION: Complex technical and data availability issues with oncology economic modeling pose serious concerns that need to be addressed. It is our hope that this article will provide a framework to guide future discourse on this important topic.

Cost-effectiveness analysis of interferon beta-1b for the treatment of patients with a first clinical event suggestive of multiple sclerosis.

OBJECTIVES: To assess, from a Swedish societal perspective, the cost effectiveness of interferon ß-1b (IFNB-1b) after an initial clinical event suggestive of multiple sclerosis (MS) (ie, early treatment) compared with treatment after onset of clinically definite MS (CDMS) (ie, delayed treatment). METHODS: A Markov model was developed, using patient level data from the BENEFIT trial and published literature, to estimate health outcomes and costs associated with IFNB-1b for hypothetical cohorts of patients after an initial clinical event suggestive of MS. Health states were defined by Kurtzke Expanded Disability Status Scale (EDSS) scores. Model outcomes included quality-adjusted life years (QALYs), total costs (including both direct and indirect costs), and incremental cost-effectiveness ratios. Sensitivity analyses were performed on key model parameters to assess the robustness of model results. RESULTS: In the base case scenario, early IFNB-1b treatment was economically dominant (ie, less costly and more effective) versus delayed IFNB-1b treatment when QALYs were used as the effectiveness metric. Sensitivity analyses showed that the cost-effectiveness results were sensitive to model time horizon. Compared with the delayed treatment strategy, early treatment of MS was also associated with delayed EDSS progressions, prolonged time to CDMS diagnosis, and a reduction in frequency of relapse. CONCLUSION: Early treatment with IFNB-1b for a first clinical event suggestive of MS was found to improve patient outcomes while controlling costs.

The economic burden of metastatic breast cancer: a systematic review of literature from developed countries.

OBJECTIVE: Breast cancer, the most common malignant cancer among women in Western countries, has poor prognosis following metastasis. New therapies potentially extend survival, but their value is questioned when benefits are incremental and expensive. The objective of our study was to understand the economic impact of metastatic breast cancer (MBC) and its treatment, and to evaluate the designs of these studies. METHODS: We systematically reviewed the MEDLINE-indexed, English-language literature, identifying 31 articles on the economic evaluation of MBC in 10 developed countries, including studies of per-patient costs, gross national costs, and cost-effectiveness models. We also included health technology assessments (HTAs) from government and regulatory agencies. RESULTS: Total per-patient costs of MBC are only available for Sweden ($17,301-$48,169 annually, depending on patient age (2005 USD)). Most economic analyses of per-patient direct costs originate from the US; across all countries, data indicate that this burden is substantial. Gross national costs of MBC are available only for the UK (cost of incident MBC cases is estimated to be $22 million annually (2002 GBP)). Many cost-effectiveness analyses suggest that a number of new and established treatments are cost-effective compared to standard care in various countries, but many offer small increments in survival. The cost-effectiveness of trastuzumab, capecitabine, and nab-paclitaxel has been evaluated in many recent studies. CONCLUSION: Most economic evaluations of MBC have utilized secondary rather than primary data, and have used scenarios and assumptions which may be inaccurate or outdated. The quality of evidence disseminated to decision-makers could be improved by adherence to best practices in cost-effectiveness analyses.

Cost-effectiveness analysis of tapentadol immediate release for the treatment of acute pain.

BACKGROUND: Tapentadol immediate-release (IR) tablets are indicated for the treatment of moderate to severe acute pain. In clinical trials, tapentadol IR effectively reduced moderate to severe pain with improved tolerability compared with oxycodone IR at doses providing comparable analgesia. OBJECTIVE: This analysis compared the cost-effectiveness of tapentadol IR with doses of oxycodone IR providing comparable analgesia in the outpatient treatment of acute postsurgical and nonsurgical pain. The perspective was that of a US managed care health plan as third-party payer. METHODS: A Markov model was developed to simulate clinical-economic outcomes for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute postsurgical pain (3 days) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain (10 days). The model simulated changes in pain relief; occurrence of opioid-related adverse events (AEs); opioid switching, discontinuation, and dose change; and number of quality-adjusted life-days (QALDs). Data inputs for the model were obtained from clinical trials, claims databases, surveys, Medicare fee schedules, and other published sources. Only direct costs were included. Drug costs were based on the wholesale acquisition cost. Prescription copayments were set at $5 for oxycodone IR and $25 for tapentadol IR. All costs were in 2008 US dollars. Sensitivity analyses were conducted on key model parameters. RESULTS: The cost of pain medication per patient was higher for tapentadol IR than for oxycodone IR in both the surgical pain setting ($15.23 vs $9.57, respectively) and the nonsurgical pain setting ($57.17 vs $21.31). However, this cost difference was offset by reductions in pharmacy and medical costs associated with the treatment of AEs and opioid switching/discontinuation, resulting in a lower mean treatment cost per patient for tapentadol IR 100 mg compared with oxycodone IR 15 mg in the treatment of acute surgical pain ($52.90 vs $55.99) and for tapentadol IR 50 mg compared with oxycodone IR 10 mg in the treatment of acute nonsurgical pain ($139.48 vs $144.79). Tapentadol IR also was associated with a greater mean number of treatment days with ≥30% improvement in pain intensity without opioid-related AEs compared with oxycodone IR and a greater mean number of QALDs (surgical pain: 1.73 vs 1.68; nonsurgical pain: 6.03 vs 4.92). Because both doses of tapentadol IR were dominant (ie, lower treatment costs and greater effectiveness) relative to the corresponding doses of oxycodone IR providing com- parable analgesia, incremental cost-effectiveness ratios were not calculated. CONCLUSION: The results of this model suggest that at doses providing comparable analgesia, tapentadol IR is a cost-effective alternative to oxycodone IR for the treatment of acute surgical and nonsurgical pain.

Economic burden of follicular non-Hodgkin's lymphoma.

Follicular non-Hodgkin's lymphoma (FNHL), a slow-growing cancer of the immune system, constitutes about 15-30% of all incident non-Hodgkin's lymphoma in developed countries. Its incidence is rising worldwide. Patients can live many years, but FNHL is considered incurable. We systematically reviewed the English-language MEDLINE-indexed and non-indexed economic literature published in the past 10 years on FNHL, identifying 23 primary economic studies. The economic burden of FNHL is significant, but available data are generally limited to retrospective considerations of hospital-based direct treatment costs, with little information available regarding societal cost of illness. Most direct cost information originates from the US, with one estimate of $US36 000 for the per-patient incremental cost of FNHL care during the first year following diagnosis. The most studied treatment is rituximab, which may offer similar overall costs to fludarabine considering higher resource use with fludarabine complications. Nearly all cost-effectiveness models identified by this review evaluated rituximab for relapsed/refractory FNHL responding to chemotherapy induction. Rituximab is supported as a cost-effective addition to standard chemotherapy by two models in the UK and one in the US, as maintenance therapy instead of stem-cell transplant by one UK model, and as maintenance therapy instead of observation alone by one model each in France, Spain and Canada. The UK National Institute for Health and Clinical Excellence updated guidance on rituximab in February 2008, concluding that it is cost effective when added to induction chemotherapy, and when used as maintenance therapy. No studies of per-patient or national indirect costs of illness were identified, with the only study of indirect costs a Canadian survey documenting lost work productivity. Across all study types identified by our review, the most common focus was on the direct costs of rituximab. As new treatments for FNHL come to market, more real-life cost data are imperative to calculate their relative cost effectiveness.

A retrospective study on the impact of comorbid depression or anxiety on healthcare resource use and costs among diabetic neuropathy patients.

BACKGROUND: Diabetic neuropathy (DN) is a common complication of diabetes that has significant economic burden, especially for patients with comorbid depression or anxiety. This study examines and quantifies factors associated with healthcare costs among patients diagnosed with diabetic neuropathy (DN) with or without a comorbid diagnosis of depression or anxiety (DA) using retrospective administrative claims data. No study has examined the differences in economic outcomes depending on the presence of comorbid DA disorders. METHODS: Over-age-18 individuals with 1+ diagnosis of DN in 2005 were selected. The first observed DN claim was considered the "index date." All individuals had a 12-month pre-index and follow-up period. For both under-age-65 commercially insured and over-age-65 individuals with employer-sponsored Medicare supplemental insurance, we constructed 2 subgroups for individuals with DA (DN-DA) or without (DN-only). Patients' clinical characteristics over pre-index period were compared. Multivariate regressions were performed to assess whether DN-DA patients had higher utilization of healthcare resources and costs than DN-only patients, controlling for demographic and clinical characteristics. RESULTS: We identified 16,831 DN-only and 1,699 DN-DA patients in the Medicare supplemental cohort, as well as 17,205 and 3,105 in the commercially insured. DN-DA patients had higher prevalence of diabetes-related comorbidities for cardiovascular disease, cerebrovascular/peripheral vascular disease, nephropathy, obesity, and hypoglycemic events than DN-only patients (all p < 0.05). Controlling for differences in demographic and clinical characteristics, DN-DA patients had $9,235 (p < 0.05) higher total healthcare costs than patients with DN-only among those with Medicare supplemental coverage ($26,718 vs. $17,483), and $10,389 (p < 0.05) more total costs among commercially insured ($29,775 vs. $19,386). Factors associated with increased costs included insurance type, geographical region, diabetes-related comorbidities, and insulin therapy. CONCLUSION: These findings indicate that the healthcare costs were significantly higher for DN patients with depression or anxiety relative to those without such comorbid disorders.

Impact of comorbid depression or anxiety on patterns of treatment and economic outcomes among patients with diabetic peripheral neuropathic pain.

OBJECTIVE: The objective of this retrospective analysis was to assess the correlation of comorbid depression and/or anxiety to patterns of treatment, healthcare utilization, and associated costs among diabetic peripheral neuropathic pain (DPNP) patients, employing a large US administrative claims database. RESEARCH DESIGN AND METHODS: Patients under age 65 with commercial insurance and patients aged 65 and older with employer-sponsored Medicare supplemental insurance were selected for the study if they had at least one diagnosis of DPNP in 2005. The first observed DPNP claim was considered the 'index date.' All individuals had a 12-month pre-index and 12-month follow-up period. For both populations, two subgroups were constructed for individuals with depression and/or anxiety (DPNP-DA cohort) or without these disorders (DPNP-only cohort). Patients' demographic characteristics, clinical characteristics, and medication use were compared over the pre-index period. Healthcare expenditures and resource utilization were measured for the post-index period. Two-part models were used to examine the impact of comorbid depression and/or anxiety on healthcare utilization and costs, controlling for demographic and clinical characteristics. RESULTS: The study identified 11,854 DPNP-only and 1512 DPNP-DA patients in the Medicare supplemental cohort, and 11,685 and 2728 in the commercially insured cohort. Compared to DPNP-only patients over the follow-up period, a significantly higher percentage of DPNP-DA patients were dispensed pain and DPNP-related medication. All components of healthcare utilization, except home healthcare visits and physician office visits, were more likely to be provided to DPNP-DA patients versus the DPNP-only cohort (all p < 0.01). Controlling for differences in demographic and clinical characteristics, DPNP-DA patients had significantly higher total costs than those of DPNP-only patients for Medicare ($9134, p < 0.01) and commercially insured patients ($11,085, p < 0.01). LIMITATIONS: Due to the use of a retrospective administrative claims database, limitations of this study include the potential for selection bias between study cohorts, mis-identification of DPNP and/or depression, and inability to assess indirect costs as well as use and cost of over-the-counter medications. CONCLUSIONS: These findings indicate that the healthcare costs were significantly higher for DPNP patients comorbid with depression and/or anxiety relative to those without such disorders.

Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): a literature review.

Renal cell carcinoma (RCC), the most common form of kidney cancer, initially has an asymptomatic clinical course; 25-30% of patients present with metastatic disease at time of diagnosis. Worldwide incidence and mortality rates are rising at a rate of approximately 2-3% per decade. Metastatic RCC (mRCC) is one of the most treatment-resistant malignancies; outcomes are generally poor and median survival after diagnosis is less than one year. Surgery and chemotherapy have limited or no effect, leaving mRCC patients underserved in the realm of cancer treatment. As the world's population ages and the prevalence of risk factors (obesity, hypertension) increases, the burden of mRCC is predicted to increase significantly. With a shift in treatment of mRCC to novel therapies, such as molecularly targeted therapies (MTTs) (e.g., sorafenib and sunitinib), clinicians, payers, and other healthcare decision-makers must re-evaluate the optimal role for new treatments. Timely understanding of the burden of mRCC on individuals and society clearly is needed at this juncture. Using a comprehensive literature review, we assessed the epidemiologic, economic, and health-related quality of life (HRQOL) burdens of mRCC. The annual incidence of mRCC in major European countries, the US, and Japan ranges from 1500 to 8600 cases. However, prevalence data were lacking. The estimated economic burden of mRCC is large; $107-$556 million (2006 USD) in the US and $446 million-$1.6 billion (2006 USD) collectively in select countries worldwide. MTTs have potential to reduce the burden of mRCC and provide substantial value beyond their clinical effectiveness.

Excess mortality, length of stay, and costs associated with serious hemorrhage among trauma patients: findings from the National Trauma Data Bank.

Trauma is a serious injury or shock to the body from violence or crash and is an important and growing global health risk. Using 2000 to 2004 data from a comprehensive trauma registry, we estimated the prevalence of serious blunt and penetrating trauma-related hemorrhage among patients admitted to U.S. trauma centers along with excess in-hospital mortality, length of hospital stay, and inpatient costs. There were 65,750 patients with blunt trauma and 12,992 patients with penetrating trauma included in our analyses. Of patients sustaining blunt trauma, 7.6 per cent had serious hemorrhage; 18.8 per cent of patients sustaining penetrating trauma had serious hemorrhage. In-hospital mortality rates were significantly (P < 0.05) higher for patients with serious hemorrhage than for patients without (24.9 per cent versus 8.4 per cent for blunt; 23.4 per cent versus 4.2 per cent for penetrating). Patients with serious hemorrhage had adjusted mean excess lengths of stay of 0.4 days for blunt trauma and 2.7 days for penetrating trauma (P < 0.05); adjusted excess costs were $296 per day for patients sustaining blunt trauma and $637 per day for patients sustaining penetrating trauma (P < 0.05). In both blunt and penetrating trauma cases, serious hemorrhage is significantly associated with excess mortality, longer hospital stays, and higher costs.

The economic burden of intracerebral hemorrhage: evidence from managed care.

Data from the Integrated Healthcare Information Services managed care database were used to estimate per-patient costs of intracerebral hemorrhage (ICH) for up to one year after an initial ICH event. Plan enrollees (age > or = 18 yr) hospitalized with a primary International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis of ICH (431.xx) during July 1999 to June 2002 were selected. Resource utilization/costs associated with the initial hospitalization were calculated for all patients. Postdischarge use/cost of health care services (repeat hospitalization, skilled nursing/rehabilitation services, outpatient use, pharmacy) were estimated for up to 365 days after hospital discharge for patients surviving the initial stay. Forty-six percent of the 493 patients selected were at least 65 years of age and 60% had private health insurance. Patients who died during their initial ICH hospitalization (N = 189 [38.4%]) incurred average treatment costs of $16,466. Survivors incurred initial hospitalization costs of $28,360 and first-year postdischarge costs of $16,035. Among survivors, 8% had repeat hospitalizations and 41% required inpatient skilled nursing/rehabilitation. Treatment costs for ICH to private payers appear to be considerable and may reflect a sizable long-term financial burden to U.S. health plans.

Cost-utility of somatropin (rDNA origin) in the treatment of growth hormone deficiency in children.

OBJECTIVE: The objective of this study was to generate estimates of cost-effectiveness/utility of somatropin (rDNA origin) in the treatment of growth hormone deficiency (GHD) in children. METHODS: A decision-analytic model of the epidemiology and treatment of GHD in children was developed. Treatment of GHD was assessed in two hypothetical cohorts compared to no treatment--treatment with somatropin 0.030 mg/kg/day from ages 5 to 16 years, and treatment from ages 3 to 18 years. Costs (stated in 2005 US$) included those related to drug acquisition, endocrinologist consultations, and primary care office visits. Estimates of patient weight by age and sex were derived from published literature, as was the proportion of patients achieving normal height through somatropin treatment and pre/post-treatment patient utilities. Cost-effectiveness/utility was estimated over patients' expected lifetimes, and was stated alternatively as discounted (3% per annum) US dollars per normal height year (NHY) gained, and cost per quality adjusted life-year (QALY) gained. Multivariate sensitivity analyses were conducted to ensure robustness of the model. RESULTS: The cost-effectiveness and cost-utility of treating children from ages 5 to 16 years with somatropin was estimated at approximately $8,900 per NHY gained and $37,000 per QALY gained, respectively. Corresponding ratios pertaining to treatment of children from ages 3 to 18 years were $9,300 per NHY gained and $42,600 per QALY gained. Findings were relatively insensitive to variation in most model parameters. CONCLUSIONS: For both age cohorts, the cost-effectiveness/utility of somatropin in the treatment of GHD compares favorably to well-accepted threshold values. The use of somatropin represents reasonable value for money for the treatment of GHD in children.

Assessment of the economic burden of COPD in the U.S.: a review and synthesis of the literature.

The costs of chronic obstructive pulmonary disease (COPD) pose a major economic burden to the United States. Studies evaluating COPD costs have generated widely variable estimates; we summarized and critically compared recent estimates of the annual national and per-patient costs of COPD in the U.S. Thirteen articles reporting comprehensive estimates of the direct costs of COPD (costs related to the provision of medical goods and services) were identified from searches of relevant primary literature published since 1995. Few papers reported indirect costs of COPD (lost work and productivity). The National Heart, Lung, and Blood Institute (NHLBI) provides the single current estimate of the total (direct plus indirect) annual cost of COPD to the U.S., $38.8 billion in 2005 dollars. More than half of this cost ($21.8 billion) was direct, aligning with the $20-26 billion range reported by two other recent analyses of large national datasets. For per-patient direct costs (in $US 2005), studies using recent data yield attributable cost estimates (costs deemed to be related to COPD) in the range of $2,700-$5,900 annually, and excess cost estimates (total costs incurred by COPD patients minus total costs incurred by non-COPD patients) in the range of $6,100-$6,600 annually. Studies of both national and per-patient costs that use data approximately 8-10 years old or older have produced estimates that tend to deviate from these ranges. Cost-of-illness studies using recent data underscore the substantial current cost burden of COPD in the U.S.

Direct costs of COPD in the U.S.: an analysis of Medical Expenditure Panel Survey (MEPS) data.

Chronic obstructive pulmonary disease (COPD) is a costly cause of morbidity and mortality in the U.S. The objective of this study was to use contemporary national data-specifically, those from the 2000 Medical Expenditure Panel Survey (MEPS)-to estimate direct costs of COPD in the U.S. from an all-payer perspective. Due to constraints of MEPS data, indirect costs were excluded from our analyses, as were costs of long-term oxygen therapy and costs from nursing homes and long-term care facilities. Two methods of cost estimation were employed. First, we estimated resources used and expenditures incurred by individuals with COPD that were directly attributable to the disease (attributable cost approach). Second, we compared overall medical expenditures of patients with COPD to those of the non-COPD population; the resulting difference represented excess costs of COPD. Approximately 1.7% (n = 144) of the nearly 8,300 persons in the analysis data set aged > or = 45 years used medical resources and incurred expenditures related to treatment of COPD. Mean attributable costs per patient were estimated at dollar 2,507, with more than one-half of these costs (dollar 1,365) associated with hospitalization. Mean excess costs of COPD, after adjustment for sociodemographic factors and smoking status, were substantially higher, at dollar 4,932 per patient. Results of our study indicate that COPD-associated healthcare utilization and expenditures are considerable, and that annual per-patient costs of COPD are comparable to those of other chronic diseases of the middle-aged and elderly.

Consequences of increased systolic blood pressure in patients with osteoarthritis and rheumatoid arthritis.

OBJECTIVE: To estimate the potential effect on cardiovascular event occurrence and treatment costs associated with increases in systolic blood pressure (SBP) among patients with osteoarthritis (OA) and rheumatoid arthritis (RA). METHODS: We used cardiovascular risk prediction models from the Framingham Heart Study and data on risk factors from the Third National Health and Nutrition Examination Survey (NHANES III) to estimate occurrences of ischemic heart disease and stroke over one year among US adults with OA/RA. Separate analyses were conducted for treated hypertensive patients, and untreated hypertensive and normotensive patients, respectively. Published estimates were used to assign costs to these events and to follow care. The effect of incremental increases in SBP on events and costs was then assessed. Monte Carlo simulation was undertaken to assess the range of event occurrence and costs associated with alternative assumptions regarding the distribution of increased SBP in the at-risk population. RESULTS: Of the estimated 30 million adults in the US aged > or = 35 years with OA and RA, roughly 11.8 million (39%) receive pharmacologic treatment for hypertension. Increases in SBP of 1-5 mm Hg were associated with 7,100-35,700 additional ischemic heart disease and stroke events over one year, with corresponding costs (year 2000 USD) of 114-569 million year 2000 USD. A 20 mm Hg increase in SBP experienced by 15% of the at-risk population (equivalent to a population-average 3 mm Hg increase) is associated with about 21,700 additional events (95% CI 19,120, 24,221) and 346 million year 2000 USD (95% CI 305 year 2000 USD, 387 million) in associated costs. CONCLUSION: Relatively small changes in SBP associated with use of common arthritis medications can have a significant effect on the cardiovascular risk profile. It is important that clinicians who treat patients with OA/RA accurately weigh the potential risks of these medications against their benefits.

Prevalence of cardiovascular disease risk factors among US adults with self-reported osteoarthritis: data from the Third National Health and Nutrition Examination Survey.

OBJECTIVE: To estimate the prevalence of traditional risk factors for cardiovascular disease (CVD) among US adults with osteoarthritis (OA). METHODS: Using survey data from the Third National Health and Nutrition Examination Survey, we estimated the prevalence of selected CVD risk factors among a US OA and nonarthritic adult population. In additional analyses, we stratified the sample by gender and age (35-44, 45-64, and 65+ years) to further understand the CVD risk profile in an arthritic population and nonarthritic population. Relevant data on each survey participant's demographics, arthritis status, CVD risk factors, and sampling weights were obtained from the survey database. RESULTS: Of the 115.9 million US adults aged > or = 35 years, 24.3 million (21%) have OA. Hypertension is prevalent in approximately 40% of OA patients; 20% of the patients smoke and 11% have diabetes. Prevalence of high total cholesterol is estimated to be 32%, while prevalence of low high-density lipoprotein cholesterol is estimated at 13%. Approximately 37% of OA patients are estimated to have renal impairment, but less than 1% suffer from renal failure. CONCLUSION: National survey data suggest that, on average, US adults with OA have a high prevalence of cardiovascular risk factors. These findings highlight the need to consider patients' comorbidites when selecting the appropriate treatment options.

Outpatient treatment of venous thromboembolism with low-molecular-weight heparin: an economic evaluation.

BACKGROUND: The development of low-molecular-weight heparins (LMWHs) has made it possible to shift treatment of deep vein thrombosis (DVT) from inpatient to outpatient settings, thereby saving costs and improving patient quality of life. OBJECTIVE: To quantify the economic benefits of early discharge of patients treated for DVT with LMWH using data pooled from multiple healthcare plans. METHODS: Data sources were integrated medical and pharmacy claims paid by 37 US health plans (the PharMetrics Integrated Outcomes Database, PharMetrics, Inc., Watertown, MA). Hospitalized patients discharged with a diagnosis of DVT were selected and grouped according to the anticoagulation therapy they received after discharge. Outcomes and costs of DVT treatment were assessed over a 1-year period. RESULTS: Patients discharged on the LMWH enoxaparin and warfarin spent 2.6 fewer days in the hospital than those discharged on warfarin alone (P< .0001), resulting in cost savings of $1911 per patient. Mean costs of outpatient management of DVT, including pharmacy and medical services, were $901 higher in the enoxaparin/warfarin cohort, but rate of readmission was lower (6.7% versus 9.0%; P < .05) and hence subsequent inpatient costs were reduced by $140 per patient. Total cost savings in the enoxaparin/warfarin cohort, net of higher outpatient costs, were $1151 per patient. CONCLUSIONS: Outpatient anticoagulation therapy for DVT with enoxaparin and warfarin is associated with earlier hospital discharge, fewer readmissions, and lower total DVT-related costs compared with warfarin monotherapy.

Use of managed care claims data in the risk assessment of venous thromboembolism in outpatients.

BACKGROUND: Deep vein thrombosis (DVT) is a complication of immobilizing illness in both inpatient and outpatient settings and can lead to serious complications such as pulmonary embolism (PE). DVT and PE are collectively referred to as venous thromboembolism. OBJECTIVE: To develop DVT and PE risk assessment models that can be used in office-based practice and for population-based disease management efforts. METHODS: Data were culled from integrated medical and pharmacy claims paid by 37 health plans in the United States (the PharMetrics Integrated Outcomes Database, PharMetrics Inc., Watertown, MA), and included information on adult plan members enrolled during 1998 and 1999. Patients hospitalized for DVT or PE in 1999 were identified, and potential risk factors were assessed by reviewing claims for the entire study population in 1998 to document prior DVT or immobilizing illness. The contribution of each potential risk factor to the probability of the occurrence of DVT or PE was determined by means of multiple logistic regression analysis. A risk-scoring algorithm based on regression coefficients was then developed. RESULTS: Fifty-two percent of the study population of 2.8 million plan members were women. DVT or PE occurred in 1330 of those 2.8 million individuals (47 per 100,000). Logistic regression results confirmed the role of risk factors previously reported in the literature and revealed additional risk factors that have not been reported previously, including diabetes, renal failure, rheumatoid arthritis, cellulitis, use of warfarin, use of systemic corticosteroids, and use of potassium chloride. When risk scores were applied to the study population, the 1% identified as being at highest risk had a probability for the development of venous thromboembolism that was 10 times greater than that of the population average. CONCLUSIONS: This study confirms the feasibility of using managed care claims data to develop a risk assessment tool for venous thromboembolism that can be used in office-based practice and for population-based disease management.

Outcomes of dalteparin use following total knee arthroplasty: a retrospective analysis.

In this study, we assessed the clinical and economic consequences of using dalteparin as first-line prophylaxis for deep-vein thrombosis and pulmonary embolism in patients undergoing inpatient rehabilitation following total knee arthroplasty. The objective of the study was to demonstrate that dalteparin can be used effectively and safely in this indication. Using data abstracted from medical records of patients admitted to an Oklahoma rehabilitation center following total knee arthroplasty, we found the occurrence of thromboembolic and bleeding events in patients receiving dalteparin to be low. Results of this study also suggest that use of dalteparin in this indication could offer rehabilitation hospitals a valuable source of cost savings, without compromising patient care.