Prevention and management of hyperphosphatemia with sevelamer in Canada: health and economic consequences.

BACKGROUND: Sevelamer hydrochloride (Renagel) binds phosphate in patients with end-stage renal disease without the use of exogenous calcium and may reduce the progression of coronary vascular calcification. This intervention was shown to be cost-effective in the United States. This paper presents the Canadian adaptation. METHODS: A discrete event simulation of the long-term cardiovascular implications of 1 year of phosphate binding in a prevalent hemodialysis population was used to estimate the cost-effectiveness of sevelamer use in Canada based on the demographics, comorbidities, physiological and renal characteristics. Initial calcification score and expected changes over 1 year were derived using regression equations developed from a clinical trial and translated to cardiovascular disease risk based on equations developed from a long-term cohort study. Direct medical costs from a Canadian Medicare perspective were taken from Ontario data. Ten replications of 10,000 patients over 13 years (discounting at 3%) were done for the base case and extensive sensitivity analyses were conducted. RESULTS: The cardioprotective effect of sevelamer over 1 year is estimated to prevent 10 cardiovascular events and gain 18 life-years compared with calcium carbonate in 100 patients over a lifetime. These benefits are obtained at a net cost of CAD$2,096; an incremental cost-effectiveness ratio of CAD$12,384 per discounted life-year gained. Sensitivity analyses showed that the time horizon and efficacy were the most important factors. CONCLUSION: The results of this study provide evidence that use of sevelamer in Canada would be economically sound.

Economic evaluation of atorvastatin for prevention of recurrent stroke based on the SPARCL trial.

OBJECTIVES: This study evaluated the economic implications of results obtained by the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. METHODS: To enable long-term projection of the trial results, a discrete event simulation of the course of clinical care after a recent stroke or transient ischemic attack (TIA) was developed. It generates pairs of identical patients; both receive usual care, one receives atorvastatin in addition. Their clinical course is simulated based on their risk of stroke, cardiovascular events, and case fatality rates taken from SPARCL, life expectancy from Saskatchewan Health data, and utility weights from literature. Costs, from a US health-care payer perspective in 2005 US dollars, were estimated for a within-trial 5-year period; survival and quality-adjusted life-years (QALYs) were extrapolated over a patient's lifetime; all discounted at 3%/year. RESULTS: The prevention of stroke, coronary, and other cardiovascular events expected with atorvastatin translates to mean gains of 0.155 life-years gained and 0.172 QALYs per patient over their lifetime. Reducing associated medical costs ($8405 vs. $11,237) but increasing drug costs ($13,984 vs. $8752) results in net $2400/patient, or $13,916/QALY gained. Probabilistic sensitivity analysis indicates no simulations yield ratios above $50,000/QALY. CONCLUSION: Prescribing atorvastatin for patients with prior stroke or TIA is expected to provide health benefits at an acceptable cost in the United States.

Treating relapsing multiple sclerosis with subcutaneous versus intramuscular interferon-beta-1a: modelling the clinical and economic implications.

The EVIDENCE trial concluded that administering high-dose/high-frequency subcutaneous (SC) interferon-beta-1a (IFNb1a) was more effective in preventing relapses among patients with relapsing multiple sclerosis (MS) than low-dose weekly intramuscular (IM) IFNb1a after 64 weeks. This analysis utilized discrete-event simulation (DES) to model the potential longer-term clinical and economic implications of this trial. A DES predicting the course of relapsing MS and incorporating the effect of IFNb1a therapy was developed. The model began by randomly reading in actual patient data from the trial to create 1000 patients. Each simulated patient was replicated - one was assigned to receive SC IFNb1a three times a week and the other to receive IM IFNb1a once a week. During the simulation, patients may (i) experience relapses, with associated short- and long-term impacts on costs and disability; (ii) develop new T2 lesions detected by a magnetic resonance imaging scan; (iii) discontinue treatment because of adverse events or lack of response; (iv) advance to secondary progressive MS; or (v) die. Model inputs were mainly obtained from the EVIDENCE trial, but were taken from published literature if they could not be obtained from the trial. Direct medical costs ($US, year 2006 values) to the US payers were primarily obtained by updating a published cost analysis. Costs and benefits were discounted at 3% per annum. Extensive sensitivity analyses were conducted to test the robustness of the model results. Based on 100 replications of 1000 patient pairs over 4 years, SC IFNb1a was predicted to enable more patients to avoid relapse (216 vs 147). Total mean costs per patient (discounted) were $US79 890 with SC IFNb1a versus $US74 485 with IM administration, a net increase of $US5405 per patient. However, SC IFNb1a was estimated to prevent 0.50 relapses and save 23 relapse-free days per patient, yielding incremental cost-effectiveness ratios of $US10 755 per relapse prevented and $US232 per relapse-free day gained. Sensitivity analyses revealed that the result was most sensitive to the treatment efficacy, model time horizon and cost of IFNb1a treatment. Based on the results observed in the EVIDENCE trial, the model predicted that SC IFNb1a would yield greater health benefits over 4 years than IM IFNb1a, at a cost that would seem to be a reasonable trade-off.

Structural determinants of rotavirus subgroup specificity mapped by cryo-electron microscopy.

The rotavirus double-layered particle (DLP) is a molecular machine that transcribes 11 genomic segments of double-stranded RNA into full-length mRNA segments during viral replication. DLPs from the human Wa strain of virus, belonging to subgroup II (SG II), possess a significantly reduced level of transcriptase activity compared to bovine UK DLPs that belong to subgroup I (SG I). Cryo-electron microscopy and icosahedral image analysis was used to define the structural basis for this difference in transcriptase activity and to derive three-dimensional density maps of bovine UK and human Wa DLPs at 26 angstroms and 28 angstroms resolution, respectively. The two rotavirus strains had the same diameter, T = 13 l icosahedral lattice symmetry and size of the VP6 trimers on the surface of the DLPs. However, the Wa particles displayed a remarkable absence of VP6 trimers surrounding each 5-fold vertex position. To further explore these structural differences, three-dimensional reconstructions were generated of DLPs decorated with Fab fragments derived from subgroup-specific monoclonal antibodies. The X-ray structures of VP6 and a generic Fab fragment were then docked into the cryo-electron microscopy density maps, which allowed us to propose at "pseudo-atomic" resolution the locations of the amino acid residues defining the subgroup-specific epitopes. Our results demonstrate a correlation between the structure of the VP6 layer and the transcriptase activity of the particles, and suggest that the stability of VP6 trimers, specifically those at the icosahedral 5-fold axes, may be critical for mRNA synthesis. Thus, subgroup specificity of rotavirus may reflect differences in the architecture of the double-layered particle, with resultant consequences for viral mRNA synthesis.

The emerging infectious challenge of clostridium difficile-associated disease in Massachusetts hospitals: clinical and economic consequences.

OBJECTIVE: To estimate the clinical and economic burden of Clostridium difficile-associated disease (CDAD) in Massachusetts over 2 years. DESIGN: A retrospective analysis of Massachusetts hospital discharge data from 1999-2003 was conducted. Cases of CDAD in 2000 were identified using code 008.45 from the International Classification of Diseases, Ninth Revision, Clinical Modification; patients were excluded if they had a hospitalization in the prior year during which a diagnosis of CDAD was recorded. Hospitalizations for CDAD during 2001 and 2002 were examined. For primary case patients (ie, those for which CDAD was the principal diagnosis), all inpatient costs were deemed to be related, whereas for secondary case patients, all-patient refined diagnosis-related group assignment, case severity level, and length of stay (LOS) were used to calculate incremental costs attributable to CDAD. Costs were adjusted to the national level and reported in 2005 US dollars. RESULTS: The CDAD cohort consisted of 3,692 patients; 59% were women, and the mean age was 70 years. This group represented 1% of all patients hospitalized in Massachusetts in 2000 (96% of hospitals treated at least 1 case; range, 1-257 cases). Of patients who received a first hospital diagnosis of CDAD in 2000, a total of 28% were primary case patients; their mean LOS was 6.4 days, and the mean cost per stay was $10,212. For secondary case patients, the mean CDAD-related incremental LOS was 2.95 days, and the mean incremental cost per stay was $13,675 per patient. Of patients with CDAD who survived their index stay in 2000, a total of 455 (14%) had at least 1 readmission for CDAD within the subsequent 2 years (mean number of readmissions, 1.4 per patient; range, 1-7 readmissions), with a mean time to first readmission of 3 months. Over 2 years, a total of 55,380 inpatient-days and $51.2 million were consumed by CDAD management. CONCLUSION: CDAD is widespread in Massachusetts hospitals. Rehospitalization with CDAD, if it occurs, generally happens within a few months and happens multiple times for some patients. Based on this study's findings, a conservative estimate of the annual US cost for CDAD management is $3.2 billion dollars.

Cost-effectiveness of clopidogrel in acute coronary syndromes in Canada: a long-term analysis based on the CURE trial.

BACKGROUND: Cardiovascular diseases account for nearly 20% of all hospitalizations in Canada and consume 12% of the total cost of all illnesses. With increasing trends of cardiovascular disease and increasing costs of care, development of cost-effective strategies is vital. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial demonstrated the effectiveness of clopidogrel plus acetylsalicylic acid (ASA) compared with ASA alone in reducing cardiovascular events in patients with acute coronary syndromes and, in addition, patients undergoing percutaneous coronary intervention in the Percutaneous Coronary Intervention in CURE (PCI-CURE) trial. OBJECTIVE: To assess the cost-effectiveness of clopidogrel in the Canadian health care system. METHODS: Estimates of hospitalization costs were based on the 2003 cost schedules released by the Health Funding and Costing Branch of the Alberta Health and Wellness, as well as on the Case Mix Group classification system. Life expectancy beyond the trial was estimated from the Saskatchewan Health Database. Cost-effectiveness was expressed as the incremental cost-effectiveness ratio, and bootstrap methods were used to estimate the joint distribution of costs and effectiveness. RESULTS: Clopidogrel was shown to be cost-effective, with incremental cost-effectiveness ratios less than $10,000 per event prevented and less than $4,000 per life-year gained. The probability of clopidogrel resulting in cost per life-year gained of less than $20,000 was 0.975 for CURE patients and 0.904 for PCI-CURE patients. CONCLUSIONS: The economic analysis demonstrated that clopidogrel combination therapy is not only cost-effective as antiplatelet therapy compared with ASA alone, but it is also cost-effective compared with other commonly used and openly reimbursed cardiovascular therapies in the Canadian health care system.

The time course of subsequent hospitalizations and associated costs in survivors of an ischemic stroke in Canada.

BACKGROUND: Documentation of the hospitalizations rates following a stroke provides the inputs required for planning health services and to evaluate the economic efficiency of any new therapies. METHODS: Hospitalization rates by cause were examined using administrative data on 18,695 patients diagnosed with ischemic stroke (first or subsequent, excluding transient ischemic attack) in Saskatchewan, Canada between 1990 and 1995. Medical history was available retrospectively to January 1980 and follow-up was complete to March 2000. Analyses evaluated the rate and timing of all-cause and cardiovascular hospitalizations within discrete periods in the five years following the index stroke. Cardiovascular hospitalizations included patients with a primary diagnosis of ischemic stroke, transient ischemic attack, myocardial infarction, stable or unstable angina, heart failure or peripheral arterial disease. RESULTS: One-third (36%) of patients were identified by a hospitalized stroke. Mean age was 70.5 years, 48.0% were male, half had a history of stroke or a transient ischemic attack at the time of their index stroke. Three-quarters of the patients (72.7%) were hospitalized at least once during a mean follow-up of 4.6 years, accruing CAD $24 million in the first year alone. Of all hospitalizations, 20.4% were related to cardiovascular disease and 1.6% to bleeds. In the month following index stroke, 12.5% were admitted, an average of 1.04 times per patient hospitalized. Strokes accounted for 33% of all hospitalizations in the first month. The rate diminished steadily throughout the year and stabilized in the second year when approximately one-third of patients required hospitalization, at a rate of about one hospitalization for every two patient-years. Mean lengths of stay ranged from nine days to nearly 40 days. Close-fitting Weibull functions allow highly specific probability estimates. Other cardiovascular risk factors significantly increased hospitalization rates. CONCLUSION: After stroke, there are frequent hospitalizations accounting for substantial additional costs. Though these rates drop after one year, they remain high over time. The number of other cardiovascular causes of hospitalization confirms that stroke is a manifestation of disseminated atherothrombotic disease.

Setting up annual OSHA training--bloodborne pathogen standard.

While monitoring actual performance will always be of paramount importance, laboratory managers must also be vigilant about protecting their employees. In Part One of this two-part series discussing OSHA training procedures, columnist Judith O'Brien examines the necessary precautions related to bloodborne pathogens.

Pertussis immunization of adolescents in the United States: an economic evaluation.

The incidence of reported pertussis has increased during the past decade and poses a growing health and economic burden in developed countries, despite high rates of primary vaccination. Administration of a booster dose of acellular pertussis vaccine to adolescents may help reduce this burden, not only by reducing infections in vaccinated individuals but also by reducing transmission of Bordetella pertussis to other individuals, particularly infants. An epidemiologic model was created to assess the health and economic impact of implementing a program of routine acellular pertussis immunization in adolescents 11-18 years of age in the United States, considering both the reduction in cases in those vaccinated and among the unvaccinated population (due to herd immunity). Inputs for the base case were defined according to information derived from published literature and were supplemented by estimates provided by members of the Global Pertussis Initiative. Both direct and indirect costs were included (in 2002 US dollars) using U.S. data. Outcomes were evaluated over the lifetime of a cohort of potential adolescent vaccine candidates. Because of uncertainty in many of the inputs, extensive sensitivity analyses were conducted. With 80% vaccination coverage of adolescents and a 20% reduction of other cases because of herd immunity, >68,000 cases and 41 pertussis-related deaths would be avoided in the subsequent 10 years by routine administration of acellular pertussis boosters to a single cohort of adolescents in the United States. This strategy would be cost-effective, incurring from 6000 US dollars to 22,000 US dollars per life-year gained. The level of herd immunity attained and the true incidence of pertussis are critical determinants of cost effectiveness, as is the duration of immunity resulting from immunization. The cost of immunization and the discount rate also play a role. Although there is considerable uncertainty surrounding key inputs, the results indicate that the conditions required for adolescent immunization to be economically warranted are realistic.

Health and economic consequences of an outbreak of pertussis among healthcare workers in a hospital in France.

BACKGROUND: Bordetella pertussis is highly contagious, and because immunity wanes after vaccination, it continues to be a cause of cough among adults. OBJECTIVE: To describe the healthcare services used and productivity losses accrued by healthcare workers (HCWs) missing work due to pertussis. METHODS: After 3 pertussis cases were confirmed among HCWs, all hospital employees and patients with a cough were screened between November 2000 and March 2001. Each potential case underwent diagnostic tests and received antibiotics (spiramycin or azithromycin) when appropriate. Symptomatic employees were not allowed to return to work until they received an antibiotic for at least 5 days. Services used (physician visits and calls, antibiotics, diagnostic tests, hospitalization, and treatment provided to their contacts) were combined with cost estimates (in 2002 euros) for these services in France. RESULTS: Ninety-one potential cases were identified (77 HCWs, 12 patients, and 2 family members). Of them, 89% received antibiotics and 22% had at least one contact who was also treated. Approximately half (55%) of the HCWs who were cases missed 5 days of work. Four patients were admitted to the hospital as a result of the infection. The average medical cost was 297 euros per potential case: diagnostic tests accounted for 32% and hospitalization for 31%. Total cost (medical and productivity) was 46,661 euros for 91 cases, 42% from productivity losses. An investigation to identify these potential cases also accrued additional costs. CONCLUSION: Serious adverse health and economic consequences arose from transmission of pertussis among HCWs, their families, and patients.

Hospitalization for pertussis: profiles and case costs by age.

BACKGROUND: Pertussis, a highly contagious respiratory illness, affects people of all ages and can have serious clinical consequences. It has been reported that from 1997-2000, 20% of all pertussis cases required hospitalization in the US. This analysis examined demographics, case fatality rate, resource use and costs of hospital care related to pertussis by age. METHODS: ICD-9 codes (033.0, 033.9) were used to identify cases of pertussis in hospital discharge databases from roughly 1,000 US hospitals in 4 states (California, Florida, Maryland, Massachusetts). Data from 1996-1999 were examined by age group. Separate analyses were done for infants (< 1 year) and children (1-11 years); however, adolescent and adult cases were combined into one group (12+ years), due to the small number of cases. Databases were used to determine demographics, health service utilization and care costs. Cost estimates include accommodations, ancillary and physician services, reported in 2002 USD. RESULTS: Of the 2,518 cases identified, 90% were infants. The inpatient case fatality rate was < 1%. Of survivors, 99% were discharged home (6% with home health care); 1% required further sub-acute inpatient care. For the 2,266 infants, the mean LOS was 6 days at a cost of 9,586 dollars per stay. Children (n = 191) had a mean LOS of 3.7 and cost of 4,729 dollars; adolescents/adults (n = 61, mean age 40 years) stayed on average 3.4 days with a cost of 5,683 dollars per hospitalization. CONCLUSION: Infants are responsible for the bulk of hospitalizations and generate higher inpatient costs. Costly hospital care occurs, however, in patients with pertussis at all ages.

Costs and medical care consequences associated with the diagnosis of peripheral arterial disease.

BACKGROUND: Peripheral arterial disease (PAD) is increasingly recognised as an indicator of disseminated atherothrombosis, but its impact on use of healthcare resources is not well understood. OBJECTIVE: To provide a quantitative description of the resource utilisation and costs incurred following PAD. METHODS: Hospitalisations, physician visits and the corresponding direct medical costs were examined in 16,440 patients with a diagnosis of PAD (1985--1995) in Saskatchewan, Canada, and compared with 15,590 reference patients with a diagnosis of myocardial infarction (MI) [1990--1995]. Medical history and patient characteristics were available retrospectively to January 1980 and follow-up to December 2000. Rates and timing of all-cause and cardiovascular hospitalisations and physician visits within discrete periods in the 10 years following PAD diagnosis, and 5 years following MI, were evaluated, as were lengths of stay and predictors of hospitalisation. RESULTS: Average follow-up was 5.9 years among patients with PAD and 3.6 years for MI. Half (55%) of patients with PAD were male versus 64% of reference patients. The mean ages were 67.3 and 66.9 years, respectively. Patients with PAD were hospitalised most frequently soon after diagnosis, with rates subsequently decreasing to 0.14 per month. These rates were similar in the reference group except for the period immediately following MI. The average 5-year cost post-diagnosis (2002 Can dollars) per patient was 41,968 Can dollars vs 48,578 Can dollars for the reference population. CONCLUSIONS: A diagnosis of PAD not only imposes a severe burden on patients and their families, but it also significantly increases the use of healthcare resources and the associated costs. By the end of year 1, this burden is comparable with a diagnosis of MI.

Lifetime costs of complications resulting from type 2 diabetes in the U.S.

OBJECTIVE: To model the lifetime costs associated with complications of type 2 diabetes. RESEARCH DESIGN AND METHODS: A cohort of 10,000 patients with diabetes was simulated using a model based on existing epidemiological studies. Complication rates were estimated for various stages of macrovascular disease, nephropathy, retinopathy, neuropathy, and hypoglycemia. At the beginning of the simulation, patients were assumed to have been treated for 5 years and have a mean HbA1c of 8.4. From the U.K. Prospective Diabetes Study, it was estimated that on current therapies, the HbA1c would drift upward on average 0.15% per year. Direct medical costs of managing each complication were estimated (in 2000 U.S. dollars) from all-payor databases, surveys, and literature. RESULTS: Macrovascular disease was estimated to be the largest cost component, accounting for 85% of cumulative costs of complications over the first 5 years. The costs of complications were estimated to be $47,240 per patient over 30 years, on average. The management of macrovascular disease is estimated to be the largest cost component, accounting for 52% of the costs; nephropathy accounts for 21%, neuropathy accounts for 17%, and retinopathy accounts for 10% of the costs of complications. CONCLUSIONS: The complications of diabetes account for substantial costs, with management of macrovascular disease being the largest and earliest. If improving glycemic control prevents complications, it will reduce these costs.

Estimates of direct medical costs for microvascular and macrovascular complications resulting from type 2 diabetes mellitus in the United States in 2000.

BACKGROUND: Diabetes mellitus is a chronic condition that affects the health of Americans and the US health care system on many levels. According to the American Diabetes Association, approximately 16 million Americans have diabetes mellitus. The onset of type 2 diabetes mellitus, which accounts for the vast majority (90%-95%) of cases, precedes diagnosis by a mean 7 years, with the disease typically manifesting during adulthood. It is not uncommon for people to first realize they have diabetes mellitus due to the appearance of a related complication. OBJECTIVE: The goal of this analysis was to estimate the direct medical costs of managing microvascular and macrovascular complications of type 2 diabetes mellitus in the United States in the year 2000. METHODS: Complication costs were estimated by applying unit costs to typical resource-use profiles. A combination of direct data analysis and cost modeling was used. For each complication, the event costs referred to those associated with the acute episode and subsequent care in the first year. State costs were the annual costs of continued management. Data were obtained from many sources, including inpatient, ambulatory, and emergency department care databases from several states; national physician and laboratory fee schedules; government reports; and literature. All costs were expressed in 2000 US dollars. RESULTS: Major events (eg, acute myocardial infarction--30,364 dollars event cost, 1678 dollars state cost) generated a greater financial burden than early-stage complica- tions (eg, microalbuminuria--63 dollars event cost, 15 dollars state cost). However, complications that were initially relatively low in cost (eg, microalbuminuria) can progress to more costly advanced stages (eg, end-stage renal disease--37,022 dollars state cost). CONCLUSIONS: Given the scope of diabetes mellitus in the United States and its impact on health care and budgets, it is important for policy makers to have up-to-date information about treatment outcomes and costs. The costs presented here provide essential components for any analysis examining the economic burden of the complications of diabetes mellitus.

Economic evaluation of galantamine in the treatment of mild to moderate Alzheimer's disease in the United States.

BACKGROUND: Alzheimer's disease (AD) is estimated to affect up to 11% of those aged > or =65 years in the United States, and the number of patients with AD is predicted to increase over the next few decades as the population ages. The substantial social and economic burden associated with AD is well established, with the cost of management increasing as the disease progresses. OBJECTIVE: The aim of this study was to evaluate the economic impact of galantamine 16 and 24 mg/d relative to no pharmacologic treatment in the management of mild to moderate AD in the United States based on the concept of need for full-time care (FTC). METHODS: Calculations were made using the Assessment of Health Economics in Alzheimer's Disease model, which applies predictive equations to estimate the need for FTC and the associated costs. The predictive equations were developed from longitudinal data on patients with AD. Inputs to the equations were derived by analyzing the data from 2 randomized, placebo-controlled, galantamine clinical trials. Resource use (from a payer perspective) was estimated from US clinical trial data, and costs were estimated from several US databases. Analyses were carried out over 10 years, and costs and benefits were discounted at 3%. RESULTS: In the base case, 3.9 to 4.6 patients need to start treatment with galantamine to avoid 1 year of FTC, depending on dose. Treated patients spent 7% to 8% more time pre-FTC and 12% to 14% less time requiring FTC, resulting in savings of 2408 to 3601 US dollars. Time horizons below 3 years, very high discontinuation rates, or increased survival with galantamine reversed the savings. Conversely, limiting treatment to responders delayed FTC by 6 to 7 months, with savings of approximately 9097 to 11,578 US dollars. CONCLUSIONS: These results suggest that use of galantamine in patients with AD in the United States could reduce the use of costly resources such as formal home care and nursing homes, leading to cost savings over time.

Direct medical cost of managing deep vein thrombosis according to the occurrence of complications.

BACKGROUND: Management of deep vein thrombosis (DVT) has evolved from hospitalisation for intravenous heparin therapy to treatment options that include acute management as an outpatient. While efficacy and safety remain the principal basis for choosing a therapy, the economic consequences of that choice should be considered as well. OBJECTIVE: To estimate the average cost of various DVT management options from the perspective of US health payers. DESIGN: Inpatient and outpatient management strategies were examined. Inpatient cases were identified by International Classification of Diseases, 9(th) Edition, Clinical Modification codes and were classified into subgroups according to complication status. A cost estimate was developed by applying unit costs to the corresponding course of treatment. Cost estimates included initial acute care and that occurring in the following 6 months. Resource use profiles and unit costs were derived from several statewide inpatient, emergency room and ambulatory care databases supplemented by national fee schedules, published reports and peer-reviewed literature. All costs are reported in 1999 US dollars. RESULTS: The mean 6-month treatment costs for inpatient management ranged from US dollars 3906 to US dollars 17,168, depending on complication status. For outpatient management, the cost ranged from US dollars 2394 to US dollars 3369, depending on frequency of low molecular weight heparin (LMWH) injection and need for professional assistance. CONCLUSIONS: The management strategy selected for DVT has an important economic impact. Self-administered LMWH in a homecare setting results in the lowest cost. However, as some patients either cannot, or will not, be treated this way, it is important for decision makers to consider the costs of other strategies.

Cost effectiveness of tinzaparin sodium versus unfractionated heparin in the treatment of proximal deep vein thrombosis.

OBJECTIVE: To evaluate economic and health implications of tinzaparin sodium, a once a day low-molecular-weight heparin (LMWH), versus unfractionated heparin (UFH) in the treatment of acute deep vein thrombosis (DVT) from a US healthcare payer perspective. STUDY DESIGN: An economic model, composed of two submodules, was created: A short-term module based on clinical trial data covering the first 3 months and a long-term module that projects trial results based on published data for up to 50 years. METHODS: Clinical trial results were combined with data from long-term follow-up studies of DVT in a model that estimates the health and economic consequences of treatment. Both short- and long-term costs with tinzaparin sodium were compared with UFH, as were health outcomes and quality-adjusted life-years (QALYs). RESULTS: Patients treated with tinzaparin sodium are estimated to live a mean of 0.9 years longer on average (0.6 discounted), resulting in an increase of 0.8 QALYs (0.5 discounted). At the same time, lifetime savings are US dollars 621 per patient (1999 values), even when all patients receiving tinzapirin sodium are treated as inpatients. Early discharge of patients receiving tinzaparin sodium, or outpatient treatment, would save between US dollars 3000 and US dollars 5000 per patient. CONCLUSION: Tinzaparin sodium leads to better health outcomes and substantial economic savings compared with UFH treatment when all management costs are considered.

Cost of managing complications resulting from type 2 diabetes mellitus in Canada.

BACKGROUND: Decision makers need to have Canadian-specific cost information in order to develop an accurate picture of diabetes management. The objective of this study is to estimate direct medical costs of managing complications of diabetes. Complication costs were estimated by applying unit costs to typical resource use profiles. For each complication, the event costs refer to those associated with the acute episode and subsequent care in the first year. State costs are the annual costs of continued management. Data were obtained from many Canadian sources, including the Ontario Case Cost Project, physician and laboratory fee schedules, formularies, reports, and literature. All costs are expressed in 2000 Canadian dollars. RESULTS: Major events (e.g., acute myocardial infarction: 18,635 dollars event cost; 1,193 dollars state cost), generate a greater financial burden than early stage complications (e.g., microalbuminuria: 62 dollars event cost; 10 dollars state cost). Yet, complications that are initially relatively low in cost (e.g., microalbuminuria) can progress to more costly advanced stages (e.g., end-stage renal disease, 63,045 dollars state cost). CONCLUSIONS: Macrovascular and microvascular complication costs should be included in any economic analysis of diabetes. This paper provides Canadian-based cost information needed to inform critical decisions about spending limited health care dollars on emerging new therapies and public health initiatives.

Cost of managing an episode of relapse in multiple sclerosis in the United States.

BACKGROUND: The purpose of this study was to determine the direct medical US cost of managing multiple sclerosis relapses. METHODS: Direct data analysis and cost modeling were employed to derive typical resource use profiles and costs in 2002 US dollars, from the perspective of a third-party payer responsible for comprehensive health-care. The location and scope of health care services provided over a 90-day period were used to define three levels of relapse management. Hospitalization and resulting subsequent care was defined as high intensity management. A medium level of intervention was defined as either use of the emergency room, an observational unit, or administration of acute treatments, such as intravenous methylprednisolone in an outpatient or home setting. The lowest intensity of care comprised physician office visits and symptom-related medications. Data were obtained from many sources including all payer inpatient, ambulatory and emergency room databases from several states, fee schedules, government reports, and literature. All charges were adjusted using cost-to-charge ratios. RESULTS: Average cost per person for high management level was 12,870 dollars, based on analysis of 4,634 hospital cases (mean age 48 years, 73% female). Hospital care comprised 71% of that cost. At discharge, 36% required inpatient sub-acute care, rehabilitation or home care. The typical cost per moderate episode was 1,847 dollars and mild episode 243 dollars. CONCLUSIONS: Management strategies leading to a reduction in the frequency and severity of a relapse, less reliance on inpatient care, or increased access to steroid infusions in the home, would have a substantial impact on the economic consequences of managing relapses.