Incidence of cardiovascular diseases and type-2-diabetes mellitus in patients with psychiatric disorders.

OBJECTIVE: To assess the incidence of cardiovascular diseases (CVD) and type-2-diabetes in patients with psychiatric disorders. METHODS: A population-based study was conducted using the Swedish national health registries. Patients were identified from the Electronic Medical Records (EMR) in 20 primary care centers and were categorized in four diagnosis cohorts according to their first psychiatric diagnosis: bipolar disorder, schizophrenia, major depressive disorder, or other mood disorder. A control cohort of patients with no psychiatric disorders followed in the same primary care centers was also identified. Incident CVD and type-2-diabetes were defined as the presence of a diagnosis of CVD or diabetes during the follow-up period in patients without prior event. RESULTS: The age and sex standardized incidence rate of CVD was 13.5 per 1000 patient-year in the patients with any psychiatric disorder versus 6.3 per 1000 patient-year in the controls. A similar trend was observed for incident diabetes (5.7 versus 3.4 per 1000 patient-year, respectively). The bipolar disorder and the schizophrenia cohorts showed the highest standardized incidence rates. CONCLUSION: Incidence of CVD and to a lesser extent type-2-diabetes was particularly high in patients with psychiatric disorders. This carries strong clinical implications for the prevention of CVD and type-2-diabetes in these patients.

Population-based study of giant cell tumor of bone in Sweden (1983-2011).

INTRODUCTION: Giant-cell tumor of bone (GCTB) is a locally aggressive histologically benign neoplasm with a less common malignant counterpart. Longitudinal data sources on GCTB are sparse, limited to single institution case series or surgical outcomes studies. The Swedish Cancer Registry is one of the few national population-based databases recording GCTB, representing a unique source to study GCTB epidemiology. We estimated incidence rate (IR) and overall mortality rates based on registry data. MATERIALS AND METHODS: We identified patients with a GCTB diagnosis in the Swedish Cancer Registry from 1983 to 2011: benign (ICD-7 196.0-196.9; PAD 741) and malignant (PAD 746). Results were stratified by age at diagnosis, gender, and anatomical lesion location. RESULTS: The cohort included 337 GCTB cases (IR of 1.3 per million persons per year). The majority (n=310) had primary benign GCTB (IR of 1.2 per million per year). Median age at diagnosis was 34 years (range 10-88) with 54% (n=183) females. Malignant to benign ratio for women was 0.095 (16/167) and for men 0.077 (11/143). Incidence was highest in the 20-39 years age group (IR of 2.1 per million per year). The most common lesion sites were distal femur and proximal tibia. Mortality at 20 years from diagnosis was 14% (n=48) and was slightly higher for axial (17%; n=6) and pelvic (17%; n=4) lesions. Recurrence occurred in 39% of primary benign cases and 75% of primary malignant cases. CONCLUSIONS: In our modern population-based series primary malignant cases were uncommon (8%), peak incidence 20-39 years with slight predominance in women. Recurrence rates remain significant with overall 39% occurring in benign GCTB, and 75% in malignant form. The linkage between databases allowed the first population based estimates of the proportion of patients who received surgery at initial GCTB diagnosis, and those who also received subsequent surgeries.

Incidence Trends in the Diagnosis of Giant Cell Tumor of Bone in Sweden Since 1958.

BACKGROUND: The Swedish Cancer Registry (founded in 1958) constitutes a unique resource for epidemiological studies of giant cell tumor of bone with potential for use for population-based studies of incidence over time. The aim of this study was to provide what we believe is the first modern population-based assessment of the incidence trends of giant cell tumor, a unique osteoclastogenic lytic stromal tumor with both benign and malignant histological forms, and to compare the findings with data from the same registry on osteosarcoma, a tumor that may display similar histological characteristics. METHODS: Cases were identified with use of codes for pathological bone tumor (International Classification of Diseases [ICD]-7 196). Specific morphological coding distinguishes benign (PAD 741) from malignant giant cell tumor (PAD 746) and osteosarcoma (PAD 766). RESULTS: During the period of 1958 to 2011, 4625 bone tumors were reported, including 505 giant cell tumors (383 benign and 122 malignant) and 1152 osteosarcomas. From 1958 to 1982 the ratio of malignant to benign giant cell tumors was 1.3, whereas from 1983 to 2011 the ratio inverted to 0.09, suggesting a change in the reporting or diagnosis of malignant or benign cases. Cases of giant cell tumor diagnosed from 1983 to 2011 displayed an age and sex distribution (median age at diagnosis, 34.0 years; 54% female) that were consistent with those in large published case series but differed from those in 1958 to 1982 (median age at diagnosis, 31.5 years; 48% female). The most current data (1983 to 2011) showed the giant cell tumor incidence in Sweden to be 1.3 per million per year, while the osteosarcoma incidence was 2.3 per million per year. CONCLUSIONS: Early Swedish Cancer Registry data (1958 to 1982) revealed a higher proportion of malignant giant cell tumors than seen in large sequential case series and a distinct age and sex profile compared with more recent data (1983 to 2011). This likely represents changes in the diagnostic workup and introduction of multidisciplinary review of giant-cell-containing tumors around 1982. Recent data may reflect the impact of expert centralized biopsy and multidisciplinary case review and more comprehensive reporting of benign giant cell tumors.

Regional variation and challenges in estimating the incidence of giant cell tumor of bone.

BACKGROUND: Estimating the incidence of giant cell tumor of bone is challenging because few population-based cancer registries record benign bone tumors. We compared two approaches, the indirect (relative index) estimation approach used in The Burden of Musculoskeletal Diseases in the United States (BMUS) and a direct incidence rate approach (from registries that record giant cell tumor), to estimate giant cell tumor incidence in France, Germany, Italy, Spain, the U.K., Sweden, Australia, Canada, Japan, and the U.S. METHODS: Giant cell tumor of bone incidence was calculated with use of the BMUS relative index of giant cell tumor to osteosarcoma in three scenarios (low, base case, and high) from case series. We compared the BMUS approach with the latest data from tumor registries in Australia (1972 to 1996), Japan (2006 to 2008), and Sweden (1993 to 2011) that record giant cell tumors. United Nations population estimates were used to project results to 2013. RESULTS: The low scenario in the BMUS approach reflects data from Unni and Inwards; the incidence of giant cell tumor of bone is 0.34 relative to osteosarcoma. As the incidence of osteosarcoma is 31.4% of the total incidence of bone and joint cancers, the incidence of giant cell tumor is 0.11 times that of all bone and joint cancers. The base scenario reflects the series by Mirra et al., with a giant cell tumor incidence of 0.47 relative to osteosarcoma (0.15 to all bone and joint cancers). The high scenario reflects the series by Ward, with an incidence of 0.84 relative to osteosarcoma (0.26 to all bone and joint cancers). Differences among the three series reflect referral to a national center of excellence compared with referral to a local oncology practice. Registry data indicated a giant cell tumor incidence rate per million per year of 1.33 in Australia, 1.03 in Japan, and 1.11 in Sweden in 2013. The estimated incidence rate per million in the ten countries in 2013 ranged from 1.03 (Japan) to 1.17 (Canada) with use of the registry-based approach and from 0.73 (Japan) for the low scenario) to 2.20 (Germany) for the base case with use of the BMUS approach. CONCLUSIONS: Giant cell tumor of bone affects approximately one person per million per year in the ten countries studied. Estimates derived with use of age-specific incidences from tumor registries were typically within the range of the low and base case BMUS scenarios. We recommend the registry-derived method for estimating the incidence of giant cell tumor.

Comparing health outcomes and costs of general vaccination with pneumococcal conjugate vaccines in Sweden: a Markov model.

BACKGROUND: Two new pneumococcal conjugate vaccines were licensed to immunize infants and young children against pneumococcal disease. OBJECTIVES: The objective of this study was to estimate the expected health benefits, costs, and incremental cost-effectiveness of routine vaccination with the 10-valent pneumococcal nontypeable hemophilus influenza protein-D conjugate vaccine (PHiD-CV) compared with the 13-valent pneumococcal conjugate vaccine (PCV13) in Sweden. METHODS: A Markov cohort model was used to estimate the effect of vaccination at vaccine steady state, taking a societal perspective and using a 2+1 vaccination schedule. Price parity was assumed between the vaccines. Outcomes were measured by reduction in disease burden, costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio. RESULTS: The results predicted that PCV13 would prevent 3 additional cases of invasive pneumococcal disease and 34 additional cases of pneumonia, whereas PHiD-CV would avoid 3 additional cases of mastoiditis, 1010 tube insertions, and 10,420 cases of ambulatory acute otitis media compared with PCV13. By combining morbidity and mortality benefits of all clinical outcomes, PHiD-CV would generate 45.3 additional QALYs compared with PCV13 and generate savings of an estimated 62 million Swedish kronors. CONCLUSION: The present study predicted lower costs and better health outcome (QALYs) gained by introducing PHiD-CV compared with PCV13 in routine vaccination. Our results indicated that PHiD-CV is cost-effective compared with PCV13 in Sweden.

Use of medical resources and indirect costs of otitis media in Sweden.

AIMS: To estimate the use of medical resources and the societal impact of otitis media (OM) in children less than five years of age in Sweden. METHODS: An internet survey questionnaire was administered to a sample of parents with children <5 years of age. The survey covered socio-demographic data, characteristics of the OM episode, use of medical resources, productivity loss by the caregivers, and travel-related costs. Medical doctor confirmed OM (MD-OM) was defined as symptoms of earache or ''running'' ear, and/or a diagnosis of OM provided by a medical doctor. RESULTS: Of all MD-OM episodes (n = 91), in 47% a general practitioner had been consulted, in 21% a paediatrician, and in 23% an emergency department had been visited. Hospital admission occurred in one case. The MD prescribed antibiotics in 85% and over the counter drugs were bought in 69% of the episodes. In 57% of the MD-OM episodes the caregivers lost days from a paid job (mean 30.3 hours per episode, SD 19.6). In 30% of the episodes, parents reported productivity loss at work during their child's illness (mean 9.0 hours per episode, SD 12.4). The mean costs were estimated to be 6,385 SEK (575) per episode of MD-OM resulting in an economic burden to Sweden of 743,570,000 SEK (66,920,866). Fifty eight per cent of the costs were indirect non-medical costs. CONCLUSIONS: The medical and economic burden of OM is considerable to individual families as well as to society in Sweden. This study has filled a gap in the knowledge base on the impact of OM on society.

The burden of ankylosing spondylitis in Spain.

OBJECTIVE: To investigate the burden of ankylosing spondylitis (AS) in Spain, as baseline for economic evaluation of the use of biological agents. METHODS: A cross-sectional retrospective observational study was performed in 601 patients with AS in Spain, using a methodology developed in studies in the United Kingdom and Canada. Patients were mailed a questionnaire asking about their health-care consumption, out-of-pocket expenses, work capacity, need for informal care during the past 3 months, as well as quality of life. Patient's current functional status and disease activity level was assessed using the Bath functional and disease activity indexes (BASFI and BASDAI). RESULTS: The mean age (median) was 47.8 (12.4) years, and the mean disease duration was 18.8 years. Eighty percent of patients were male, and slightly more than half of patients below 65 years of age were working. The mean (median) BASDAI and BASFI scores were 4.3 (2.5) and 3.8 (2.9),respectively, and all levels of disease severity were represented. The mean (median) total annual cost per patient is estimated at euro 20,328 (euro 7920). Direct health care represented 22.8%, investments (adaptations of house and devices) and informal care 43.5%, and productivity losses 33.7%. Costs increased significantly with worsening disease, in particular diminishing physical function, covering a range between euro 5000 and euro 75,000 per patient and year. The mean (median) utility was 0.59 (0.30). Utility showed a significant inverse relation with BASFI and BASDAI, covering a range from 0.80 for patients with BASFI/BASDAI below 3 to 0.25 for patients with BASFI/BASDAI greater than 7. CONCLUSIONS: As in studies in other countries, all types of costs accelerate steeply with worsening disease while utility decreases significantly, indicating the need to prevent disease progression.

Cost of disorders of the brain in Italy.

The aim of this study was to estimate the cost of "brain" disorders in Italy. Country-specific prevalence and health-economic data on addiction, affective, anxiety and psychotic disorders, tumours, dementia, epilepsy, migraine/other headaches, multiple sclerosis, Parkinson's disease, stroke and head trauma were reviewed. Direct medical/non-medical and indirect costs were computed. Population-based samples and national or regional registries were used. The Italian population expected with a brain disorder was 12.4 million in 2004. The highest cost per case was for tumours and multiple sclerosis; the lowest was for anxiety disorders and migraine. Dementia (8.6 billion euros), psychotic and affective disorders (18.7 billion euros), migraine (3.5 billion euros) and stroke (3.4 billion euros) represented the highest total costs. Direct medical costs were predominant for psychiatric and neurosurgical disorders, direct non-medical costs for dementia, and indirect costs for neurological disorders. The total cost of brain disorders in Italy was 40.8 billion euros, 3% of the gross national product, and 706 euros per Italian citizen/year. This figure is however likely to be underestimated as it is based on retrospective methodology and samples of brain disorders, and does not include intangible costs.

Cost of disorders of the brain in Switzerland with a focus on mental disorders.

QUESTIONS UNDER STUDY: This study aims at estimating the costs of disorders of the brain in Switzerland based on the published epidemiological and economic evidence. METHODS: the data presented for Switzerland are derived from the "cost of disorders of the brain in Europe" study of the European Brain Counsil (EBC). Available Swiss data were integrated. RESULTS: There are an estimated 2 million people currently living with a brain disorder in Switzerland. This number amounts to about 25% of all people living in Switzerland. The total annual costs are estimated to amount to 8.9 billion Euros corresponding to 1200 Euros per inhabitant and per year. Direct medical expenditure accounts for 33% of all expenditure, while indirect costs add up to 49%. Mental disorders account for approximately 2/3 of the total costs of brain disorders, ie, 5.6 billion Euros. This cost estimate comes very close to the current expenses for mental health in Switzerland with 5.3 billion Euros constituting 16% of total health care costs. : The present study probably underestimates the full economic burden of brain and especially mental disorders in Switzerland. In order to better understand the impact of brain disorders on Swiss society prospective field studies are needed in all disorders of the brain.

Estimating the cost of epilepsy in Europe: a review with economic modeling.

PURPOSE: Based on available epidemiologic, health economic, and international population statistics literature, the cost of epilepsy in Europe was estimated. METHODS: Europe was defined as the 25 European Union member countries, Iceland, Norway, and Switzerland. Guidelines for epidemiological studies on epilepsy were used for a case definition. A bottom-up prevalence-based cost-of-illness approach, the societal perspective for including the cost items, and the human capital approach as valuation principle for indirect costs were used. The cost estimates were based on selected studies with common methodology and valuation principles. RESULTS: The estimated prevalence of epilepsy in Europe in 2004 was 4.3-7.8 per 1,000. The estimated total cost of the disease in Europe was euro15.5 billion in 2004, indirect cost being the single most dominant cost category (euro8.6 billion). Direct health care costs were euro2.8 billion, outpatient care comprising the largest part (euro1.3 billion). Direct nonmedical cost was euro4.2 billion. That of antiepileptic drugs was euro400 million. The total cost per case was euro2,000-11,500 and the estimated cost per European inhabitant was euro33. CONCLUSIONS: Epilepsy is a relevant socioeconomic burden at individual, family, health services, and societal level in Europe. The greater proportion of such burden is outside the formal health care sector, antiepileptic drugs representing a smaller proportion. Lack of economic data from several European countries and other methodological limitations make this report an initial estimate of the cost of epilepsy in Europe. Prospective incidence cost-of-illness studies from well-defined populations and common methodology are encouraged.

Comparison of the cost-effectiveness of infliximab in the treatment of ankylosing spondylitis in the United Kingdom based on two different clinical trials.

OBJECTIVES: To compare the cost-effectiveness of the treatment of ankylosing spondylitis (AS) with infliximab in the United Kingdom over lifetime estimated from two different clinical trials and adjusted for clinical practice guidelines. METHODS: A cost-effectiveness model was developed to incorporate clinical, epidemiological, and economic data and allow extrapolation of trial results and incorporation of long-term treatment. Assumptions regarding treatment beyond the trials were based on open extensions from the trials and treatment guidelines by the British Society for Rheumatology. Results are presented for both the societal perspective and the perspective of the National Health Service (UK pound, discounted 3.5 percent). RESULTS: Under the assumption that disease activity would be controlled and functional capacity would remain stable while on drug, treatment with infliximab (5 mg/kg every 6 weeks) dominates standard treatment in the societal perspective. In the National Health Service perspective, the cost per quality-adjusted life-year (QALY) gained over lifetime was pound28,300 and pound26,800 for the two trials. If functional capacity were to deteriorate at half the rate of untreated patients, the cost per QALY gained would be pound35,300 and pound34,100, respectively. The results are sensitive to the dosing regimen adopted, the discontinuation rate, and assumptions concerning disease progression while on treatment. CONCLUSIONS: The two clinical trials yield the same cost-effectiveness results and the cost per QALY gained with treatment was found to be in the acceptable range.

The societal burden of osteoporosis in Sweden.

In osteoporosis, the bone mass is decreased, thereby increasing the risk of fractures. Common osteoporotic fractures include those at the hip, the spine and the forearm. Fractures are a burden to society; in terms of costs, morbidity and mortality. The main objective of this study was to estimate the burden of osteoporosis in Sweden. The study used a prevalence-based bottom-up approach to estimate the total annual burden of osteoporosis in Sweden. The burden was assessed from a societal perspective including medical care costs, non-medical care costs, informal care and indirect costs. Moreover, the value of quality-adjusted life-years (QALYs) lost because of fractures was included in the total burden estimations. The total annual fracture cost was estimated at MSEK 5639, which is about 3.2% of the total health care costs in Sweden. Community care was the most important cost category accounting for 66% of the total annual cost followed by medical care costs (31%), informal care (2%) and indirect costs (1%). By combining the annual value of QALYs lost (MSEK 10354) and the annual fracture costs, the total annual societal burden of osteoporosis in Sweden was estimated at MSEK 15183. Assuming no changes in the age-differentiated fracture risk, the annual burden of osteoporosis was projected to increase to MSEK 26301 in the year 2050. The present study shows the societal burden of osteoporosis in Sweden to be higher than previously perceived. This burden is substantial and must be acknowledged as an important health problem. Osteoporosis-related fractures do not only lead to high medical care costs but also to high community care costs.

Health-related quality of life measured with EQ-5D in patients treated for depression in primary care.

OBJECTIVE: The objective of the present study was to assess the impact of depression on patients' health-related quality of life (HRQL) with the EQ-5D instrument over 6 months while on antidepressant treatment. METHODS: A total of 447 patients were recruited at 56 primary care centers to this naturalistic longitudinal observational study. Patients older than 18 years with depressive symptoms, and who initiated an antidepressant therapy because of depression were included in the study. Data on patients' sociodemographics, daily activity, and quality of life (EQ-5D) were collected using questionnaires completed during outpatient general practitioner visits for a follow-up period of 6 months. RESULTS: The mean EQ-5D utility score at baseline was 0.47 (0.44-0.49). Milder cases of depression reported a health utility of 0.60, whereas moderately and severely depressed patients reported utility values of 0.46 and 0.27, respectively (P < 0.01). At end of follow up the average utility was 0.69 (0.67-0.72), corresponding to an increase of 0.23 over 6 months (P < 0.01). Regression analyses showed that, all else equal, patients who were on sick leave were associated with 10% lower utility. CONCLUSIONS: Depression has a substantial impact on HRQL. Our results indicate that treatments for depression are associated with significant improvement in EQ-5D index score over a course of 6 months. Self-reported patient valuations are important outcomes for cost-utility analysis of new treatments for depression and the present study provides important evidence for future economic evaluations.

Economic evaluations of leukemia: a review of the literature.

OBJECTIVES: Leukemia, together with lymphoma and multiple myeloma, are hematological malignancies, malignancies of the blood-forming organs. There are four major types of leukemia: acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). There is a growing amount of literature of the health economic aspects of leukemia. However, no comprehensive review is yet performed on the health economic evidence for the disease. Hence, our aim was to review and analyze the existing literature on economic evaluations of the different types of leukemia. METHODS: A systematic literature search used electronic databases to identify published cost analyses and economic evaluations of leukemia treatments. After reviewing all identified studies, sixty studies were considered relevant for the purpose of the review. RESULTS: The identified studies were published after 1990, with a few exceptions. Many of the identified economic evaluations in leukemia, particularly for ALL and AML, may be defined as cost-minimization analyses, where only the costs of different treatment strategies are compared. In CML, a new treatment, imatinib, was introduced in 2001 and several cost-effectiveness analyses have since then been conducted comparing imatinib with previous first line treatments. CONCLUSIONS: This review indicates that there is a shortage of cost-effectiveness information in leukemia. The introduction of new therapies will stress the need for new economic evaluations in this group of diseases. More information about the total costs, that is, including indirect costs, and quality of life effects would be valuable in future evaluations in leukemia.

The economic burden of depression in Sweden from 1997 to 2005.

BACKGROUND: Depression is one of the most common causes of disability and is associated with substantial reductions in the individual's quality of life. The aim of this study was to estimate the economic burden of depression to Swedish society from 1997 to 2005. MATERIALS AND METHODS: The study was conducted in a cost-of-illness framework, measuring both the direct cost of providing health care to depressive patients, and the indirect costs as the value of production that is lost due to morbidity or mortality. The costs were estimated by a prevalence and top-down approach. RESULTS: The cost of depression increased from a total of 1.7 billion euros in 1997 to 3.5 billion euros in 2005, representing a doubling of the burden of depression to society. The main reason for the cost increase is found in the significant increase in indirect costs due to sick leave and early retirement during the past decade, whereas direct costs were relatively stable over time. In 2005, indirect costs were estimated at 3 billion euros (86% of total costs) and direct costs at 500 million euros (16%). Cost of drugs was estimated at 100 million euros (3% of total cost). CONCLUSION: The cost of depression is substantial to society and the main cost driver is indirect costs due to sick leave and early retirement. The cost of depression has doubled during the past eight years making it a major public health concern for the individuals afflicted, carers and decision makers.

Cost of depression in Europe.

BACKGROUND: Depression is one of the most disabling diseases, and causes a significant burden both to the individual and to society. WHO data suggests that depression causes 6% of the burden of all diseases in Europe in terms of disability adjusted life years (DALYs). Yet, the knowledge of the economic impact of depression has been relatively little researched in Europe. AIMS OF THE STUDY: The present study aims at estimating the total cost of depression in Europe based on published epidemiologic and economic evidence. METHODS: A model was developed to combine epidemiological and economic data on depression in Europe to estimate the cost. The model was populated with data collected from extensive literature reviews of the epidemiology and economic burden of depression in Europe. The cost data was calculated as annual cost per patient, and epidemiologic data was reported as 12-month prevalence estimates. National and international statistics for the model were retrieved from the OECD and Eurostat databases. The aggregated annual cost estimates were presented in Euro for 2004. RESULTS: In 28 countries with a population of 466 million, at least 21 million were affected by depression. The total annual cost of depression in Europe was estimated at Euro 118 billion in 2004, which corresponds to a cost of Euro 253 per inhabitant. Direct costs alone totalled dollar 42 billion, comprised of outpatient care (Euro 22 billion), drug cost (Euro 9 billion) and hospitalization (Euro 10 billion). Indirect costs due to morbidity and mortality were estimated at Euro 76 billion. This makes depression the most costly brain disorder in Europe, accounting for 33% of the total cost. The cost of depression corresponds to 1% of the total economy of Europe (GDP). DISCUSSION: Our cost results are in good agreement with previous research findings. The cost estimates in the present study are based on model simulations for countries where no data was available. The predictability of our model is limited to the accuracy of the input data employed. As there is no earlier cost-of-illness study conducted on depression in Europe, it is, however, difficult to evaluate the validity of our results for individual countries and thus further research is needed. CONCLUSION: The cost of depression poses a significant economic burden to European society. The simulation model employed shows good predictability of the cost of depression in Europe and is a novel approach to estimate the cost-of-illness in Europe. IMPLICATIONS FOR HEALTH CARE PROVISION AND POLICIES: Health and social care policy and commissioning must be evidence-based. The empirical results from this study confirm previous findings, that depression is a major concern to the economic welfare in Europe which has consequences to both healthcare providers and policy makers. One important way to stop this explosion in cost is through increased research efforts in the field. Moreover, better detection, prevention, treatment and patient management are imperatives to reduce the burden of depression and its costs. Mental healthcare policies and better access to healthcare for mentally ill are other challenges to improve for Europe. IMPLICATIONS FOR FURTHER RESEARCH: This study has identified several research gaps which are of interest for future research. In order to better understand the impact of depression to European society long-term prospective epidemiology and cost-of-illness studies are needed. In particular data is lacking for Central European countries. On the basis of our findings, further economic evaluations of treatments for depression are necessary in order to ensure a cost-effective use of European healthcare budgets.

Model to assess the cost-effectiveness of new treatments for depression.

OBJECTIVES: The objective of this study was to develop a model to assess the cost-effectiveness of a new treatment for patients with depression. METHODS: A Markov simulation model was constructed to evaluate standard care for depression as performed in clinical practice compared with a new treatment for depression. Costs and effects were estimated for time horizons of 6 months to 5 years. A naturalistic longitudinal observational study provided data on costs, quality of life, and transition probabilities. Data on long-term consequences of depression and mortality risks were collected from the literature. Cost-effectiveness was quantified as quality-adjusted life-years (QALYs) gained from the new treatment compared with standard care, and the societal perspective was taken. Probabilistic analyses were conducted to present the uncertainty in the results, and sensitivity analyses were conducted on key parameters used in the model. RESULTS: Compared with standard care, the new hypothetical therapy was predicted to substantially decrease costs and was also associated with gains in QALYs. With an improved treatment effect of 50 percent on achieving full remission, the net cost savings were 20,000 Swedish kronor over a 5-year follow-up time, given equal costs of treatments. Patients gained .073 QALYs over 5 years. The results are sensitive to changes in assigned treatment effects. CONCLUSIONS: The present study provides a new model for assessing the cost-effectiveness of treatments for depression by incorporating full remission as the treatment goal and QALYs as the primary outcome measure. Moreover, we show the usefulness of naturalistic real-life data on costs and quality of life and transition probabilities when modeling the disease over time.

The cost-effectiveness of infliximab (Remicade) in the treatment of ankylosing spondylitis in Canada.

OBJECTIVE: To estimate the cost-effectiveness of the treatment of ankylosing spondylitis (AS) with infliximab (Remicade) in Canada over the long term, with both international and Canadian treatment regimens. METHODS: A previously published disease model based on functional capacity and disease activity was adapted to the Canadian setting. Current resource consumption from a cross-sectional bottom-up burden-of-illness study in 545 patients at different levels of severity of AS in 4 Canadian provinces was incorporated into the model. Cost-effectiveness estimates were based on a 3-month placebo-controlled clinical trial with 2-year open extension as well as a 4-year followup study of clinical practice in Canada. In the cost-effectiveness model, patients with insufficient response to treatment at 12 weeks (> or = 50% reduction in Bath Ankylosing Spondylitis Disease Activity Index) discontinue treatment. In view of the long disease duration, simulations over a 30-year timeframe were performed, incorporating disease progression from cohort studies and assumptions about treatment continuation beyond the clinical trial from the trial extension period. Results are presented in Canadian dollars, from the societal and healthcare payer perspectives, with both costs and effects discounted at 5%. RESULTS: Over a 30-year timeframe, with the assumption that patients' disease would remain stable while on treatment, the cost per quality-adjusted life-year (QALY) gained in the societal perspective is $37,491, using the treatment regimen in the clinical trial (5 mg/kg every 6 weeks). Using the dosing regimen of the Canadian study (75% at 3 mg/kg every 8 weeks, 15% at 3 mg/kg every 6 weeks, and 10% at 5 mg/kg every 8 weeks) the cost per QALY is dollar 10,264. Assuming that patients on treatment progress at half the rate of untreated patients, the cost-effectiveness ratios are dollar 45,121 and dollar 13,883, respectively, while the most conservative assumption that progression is the same in both arms, the ratios are dollar 54,137 and dollar 18,712, respectively. The results are sensitive to the dosing regimen adopted, the discontinuation rate, and assumptions concerning disease progression while on treatment. CONCLUSION: Our results indicate that infliximab therapy for patients with active AS would be cost-effective (ranges dollar 10,264-dollar 54,137 per QALY) in a Canadian setting.

Costs and quality of life of patients with ankylosing spondylitis in Canada.

OBJECTIVE: The use of biological agents in the treatment of ankylosing spondylitis (AS) has emphasized the need for information about the current burden of the disease to estimate the cost-effectiveness of these drugs. We investigated resource utilization and utility of patients with AS in Canada. METHODS: A cross-sectional retrospective observational study was performed in a cohort of 545 patients with AS in Alberta, Ontario, British Columbia, and Manitoba. Patients completed a questionnaire asking about their healthcare consumption, out of pocket expenses, work capacity, and need for informal care during the past 3 months. Patients' current functional status and disease activity level was assessed using the Bath AS functional and disease activity indexes (BASFI and BASDAI), and utility was determined using the EQ-5D 5-dimensional health status classification. Descriptive analysis was performed to estimate costs and utility for the sample and by level of disease severity. RESULTS: Patients' mean age was 49.6 years and the mean disease duration was 22.3 years; 64% were male, and 63% of patients in the sample were working. The mean BASDAI score was 4.3 and BASFI 3.6, although 13% of patients in the sample had a BASFI score > or = 7. The mean annual cost per patient is estimated at 9,008 Canadian dollars (SD 17,724 Canadian dollars), and direct healthcare represented 28.9% of these costs. Patients' out of pocket costs represented 33.1%, and lost work capacity accounted for 38%. Costs increased significantly with diminishing physical function and high disease activity, covering a range of 4,000 Canadian dollars to 30,000 Canadian dollars per patient and year. The estimated cost-increase per unit-increase in the BASFI score at values < 5 was around 1,000 Canadian dollars, and more than 5,000 Canadian dollars at values > 7. The mean utility was 0.65 (SD 0.23). Utility was significantly correlated with age, sex, BASFI, and BASDAI, covering a range from 0.87 for patients with BASFI/BASDAI < or = 2 to 0.20 for patients with BASFI/BASDAI > or = 8. On average, utility decreased by 0.075 for each unit-increase in the BASFI. CONCLUSION: All types of costs accelerate steeply with increasing loss of function (BASFI) and disease activity (BASDAI) in patients with AS, while utility decreases significantly. Treatments that control disease activity and maintain patients' function are likely to offset the high cost and low quality of life of severe disease. Our findings provide information on the burden of AS and a baseline for assessing the cost-effectiveness of the new biological agents in this indication.