Health-related quality of life and glycaemic control among adults with type 1 and type 2 diabetes - a nationwide cross-sectional study.

BACKGROUND: Health-related quality of life and glycaemic control are some of the central outcomes in clinical diabetes care and research. The purpose of this study was to describe the health-related quality of life and assess its association with glycaemic control in adults with type 1 and type 2 diabetes in a nationwide setting. METHODS: In this cross-sectional survey, people with type 1 (n = 2479) and type 2 diabetes (n = 2469) were selected at random without replacement from the Swedish National Diabetes Register. Eligibility criteria were being aged 18-80 years with at least one registered test of glycated haemoglobin (HbA1c) the last 12 months. The generic 36-item Short Form version 2 (SF-36v2) was answered by 1373 (55.4%) people with type 1 diabetes and 1353 (54.8%) with type 2 diabetes. RESULTS: Correlation analyses showed weak correlations between scores on the SF-36v2 and glycaemic control for both diabetes types. After the participants were divided into three groups based on their levels of HbA1c, multivariate regression analyses adjusted for demographics, other risk factors and diabetes complications showed that among participants with type 1 diabetes, the high-risk group (≥70 mmol/mol/8.6%) had statistically significantly lower means in five out of eight domains of the SF-36v2 and the mental component summary measure, as compared with the well-controlled group (< 52 mmol/mol/6.9%). Among the participants with type 2 diabetes, the high-risk group had the lowest statistically significantly means in seven domains and both summary measures. CONCLUSIONS: Among people with type 1 and type 2 diabetes, adults with high-risk HbA1c levels have lower levels of health-related quality of life in most but not all domains of the SF-36v2. This finding was not explained by demographics, other risk factors, or diabetes complications. The weak individual-level correlations between HRQOL scores and levels of glycaemic control argues for the need to not focus exclusively on either HbA1c levels or HRQOL scores but rather on both because both are important parts of a complex, life-long, challenging condition.

Patient Heterogeneity in Health Economic Decision Models for Chronic Obstructive Pulmonary Disease: Are Current Models Suitable to Evaluate Personalized Medicine?

OBJECTIVES: To assess how suitable current chronic obstructive pulmonary disease (COPD) cost-effectiveness models are to evaluate personalized treatment options for COPD by exploring the type of heterogeneity included in current models and by validating outcomes for subgroups of patients. METHODS: A consortium of COPD modeling groups completed three tasks. First, they reported all patient characteristics included in the model and provided the level of detail in which the input parameters were specified. Second, groups simulated disease progression, mortality, quality-adjusted life-years (QALYs), and costs for hypothetical subgroups of patients that differed in terms of sex, age, smoking status, and lung function (forced expiratory volume in 1 second [FEV1] % predicted). Finally, model outcomes for exacerbations and mortality for subgroups of patients were validated against published subgroup results of two large COPD trials. RESULTS: Nine COPD modeling groups participated. Most models included sex (seven), age (nine), smoking status (six), and FEV1% predicted (nine), mainly to specify disease progression and mortality. Trial results showed higher exacerbation rates for women (found in one model), higher mortality rates for men (two models), lower mortality for younger patients (four models), and higher exacerbation and mortality rates in patients with severe COPD (four models). CONCLUSIONS: Most currently available COPD cost-effectiveness models are able to evaluate the cost-effectiveness of personalized treatment on the basis of sex, age, smoking, and FEV1% predicted. Treatment in COPD is, however, more likely to be personalized on the basis of clinical parameters. Two models include several clinical patient characteristics and are therefore most suitable to evaluate personalized treatment, although some important clinical parameters are still missing.

Cost effectiveness of pomalidomide in patients with relapsed and refractory multiple myeloma in Sweden.

BACKGROUND: Multiple myeloma (MM) patients who have progressed following treatment with both bortezomib and lenalidomide have a poor prognosis. In this late stage, other effective alternatives are limited, and patients in Sweden are often left with best supportive care. Pomalidomide is a new anti-angiogenic and immunomodulatory drug for the treatment of MM. Our objective was to evaluate the cost effectiveness of pomalidomide as an add-on to best supportive care in patients with relapsed and refractory MM in Sweden. MATERIAL AND METHODS: We developed a health-economic discrete event simulation model of a patient's course through stable disease and progressive disease, until death. It estimates life expectancy, quality-adjusted life years (QALYs) and costs from a societal perspective. Effectiveness data and utilities were taken from the MM-003 trial comparing pomalidomide plus low-dose dexamethasone with high-dose dexamethasone (HIDEX). Cost data were taken from official Swedish price lists, government sources and literature. RESULTS: The model estimates that, if a patient is treated with HIDEX, life expectancy is 1.12 years and the total cost is SEK 179 976 (€19 100), mainly indirect costs. With pomalidomide plus low-dose dexamethasone, life expectancy is 2.33 years, with a total cost of SEK 767 064 (€81 500), mainly in drug and indirect costs. Compared to HIDEX, pomalidomide treatment gives a QALY gain of 0.7351 and an incremental cost of SEK 587 088 (€62 400) consisting of increased drug costs (59%), incremental indirect costs (33%) and other healthcare costs (8%). The incremental cost-effectiveness ratio is SEK 798 613 (€84 900) per QALY gained. CONCLUSION: In a model of late-stage MM patients with a poor prognosis in the Swedish setting, pomalidomide is associated with a relatively high incremental cost per QALY gained. This model was accepted by the national Swedish reimbursement authority TLV, and pomalidomide was granted reimbursement in Sweden.

Cost-effectiveness models for chronic obstructive pulmonary disease: cross-model comparison of hypothetical treatment scenarios.

OBJECTIVES: To compare different chronic obstructive pulmonary disease (COPD) cost-effectiveness models with respect to structure and input parameters and to cross-validate the models by running the same hypothetical treatment scenarios. METHODS: COPD modeling groups simulated four hypothetical interventions with their model and compared the results with a reference scenario of no intervention. The four interventions modeled assumed 1) 20% reduction in decline in lung function, 2) 25% reduction in exacerbation frequency, 3) 10% reduction in all-cause mortality, and 4) all these effects combined. The interventions were simulated for a 5-year and lifetime horizon with standardization, if possible, for sex, age, COPD severity, smoking status, exacerbation frequencies, mortality due to other causes, utilities, costs, and discount rates. Furthermore, uncertainty around the outcomes of intervention four was compared. RESULTS: Seven out of nine contacted COPD modeling groups agreed to participate. The 5-year incremental cost-effectiveness ratios (ICERs) for the most comprehensive intervention, intervention four, was €17,000/quality-adjusted life-year (QALY) for two models, €25,000 to €28,000/QALY for three models, and €47,000/QALY for the remaining two models. Differences in the ICERs could mainly be explained by differences in input values for disease progression, exacerbation-related mortality, and all-cause mortality, with high input values resulting in low ICERs and vice versa. Lifetime results were mainly affected by the input values for mortality. The probability of intervention four to be cost-effective at a willingness-to-pay value of €50,000/QALY was 90% to 100% for five models and about 70% and 50% for the other two models, respectively. CONCLUSIONS: Mortality was the most important factor determining the differences in cost-effectiveness outcomes between models.

Implementation of the measure of case discussion complexity to guide selection of prostate cancer patients for multidisciplinary team meetings.

BACKGROUND: Multidisciplinary team meetings (MDTMs) provide an integrated team approach to ensure individualized and evidence-based treatment recommendations and best expert advice in cancer care. A growing number of patients and more complex treatment options challenge MDTM resources and evoke needs for case prioritization. In this process, decision aids could provide streamlining and standardize evaluation of case complexity. We applied the recently developed Measure of Case Discussion Complexity, MeDiC, instrument with the aim to validate its performance in another healthcare setting and diagnostic area as a means to provide cases for full MDTM discussions. METHODS: The 26-item MeDiC instrument evaluates case complexity and was applied to 364 men with newly diagnosed prostate cancer in Sweden. MeDiC scores were generated from individual-level health data and were correlated with clinicopathological parameters, healthcare setting, and the observed clinical case selection for MDTMs. RESULTS: Application of the MeDiC instrument was feasible with rapid scoring based on available clinical data. Patients with high-risk prostate cancers had significantly higher MeDiC scores than patients with low or intermediate-risk cancers. In the total study, population affected lymph nodes and metastatic disease significantly influenced MDTM referral, whereas comorbidities and age did not predict MDTM referral. When individual patient MeDiC scores were compared to the clinical MDTM case selection, advanced stage, T3/T4 tumors, involved lymph nodes, presence of metastases and significant physical comorbidity were identified as key MDTM predictive factors. CONCLUSIONS: Application of the MeDiC instrument in prostate cancer may be used to streamline case selection for MDTMs in cancer care and may complement clinical case selection.

Performance of standardized cancer patient pathways in Sweden visualized using observational data and a state-transition model.

Standardized Cancer Patient Pathways (CPPs) were introduced in Swedish healthcare starting in 2015 to improve diagnostics for patients with symptoms of cancer, patient satisfaction and equity of care between healthcare providers. An inclusion target and a time target were set. Our primary aim was to visualize the patient population going through CPPs, in terms of investigation time and indications of the various outcomes including cancer diagnoses. Our secondary aims were to examine if targets were met, and to examine frequencies of undetected cancer. We collected data from 19,204 patients starting in a CPP, and 7895 patients diagnosed with cancer in 2018 in a region of Sweden. A state transition model was developed and used as analytical framework, and patients were mapped over time in the states of the model. Visualization of the patient-flow through the model illustrates speed of investigation, time to treatment, frequencies of detected and undetected cancer. Twelve CPPs out of 28 met the inclusion target, five met the time target. After suspicion of cancer rejected, 0.8% of patients were diagnosed with the primarily suspected cancer, 1.0% with another cancer. In patients not meeting the criteria for well-founded suspicion less than 3% were later diagnosed with cancer. The visualization of the patient flow into and through standardized cancer patient pathways illustrates investigation time, events occurring and outcomes. The use of standardized cancer patient pathways detects cancer efficiently.

New Diabetes Questionnaire to add patients' perspectives to diabetes care for adults with type 1 and type 2 diabetes: nationwide cross-sectional study of construct validity assessing associations with generic health-related quality of life and clinical variables.

OBJECTIVES: To study evidence for construct validity, the aim was to describe the outcome from the recently developed Diabetes Questionnaire, assess the associations of that outcome with clinical variables and generic health-related quality of life, and study the sensitivity to differences between clinically relevant groups of glycaemic control in adults with type 1 and type 2 diabetes in a nation-wide setting. DESIGN: Cross-sectional survey. SETTING: Swedish diabetes care clinics connected to the National Diabetes Register (NDR). PARTICIPANTS: Among 2479 adults with type 1 diabetes and 2469 with type 2 diabetes selected at random from the NDR, 1373 (55.4%) with type 1 and 1353 (54.8%) with type 2 diabetes chose to participate. OUTCOME MEASURES: The Diabetes Questionnaire, the generic 36-item Short Form version 2 (SF-36v2) health survey and clinical variables. RESULTS: Related to the prespecified assumptions, supporting evidence for construct validity for the Diabetes Questionnaire was found. Supporting divergent validity, the statistically significant correlations with the clinical variables were few and weak. In relation to the SF-36v2 and in support of convergent validity, the strongest correlations were seen in the Diabetes Questionnaire scales General Well-being and Mood and Energy. In those scales, machine learning analyses showed that about 40%-45% of the variance was explained by the SF-36v2 results and clinical variables. In multiple regression analyses among three groups with differing levels of glycated haemoglobin adjusted for demographics, other risk factors, and diabetes complications, the high-risk group had, in support of sensitivity to clinically relevant groups, statistically significant lower scores than the well-controlled group in most Diabetes Questionnaire scales. CONCLUSIONS: This nation-wide study shows that the Diabetes Questionnaire captures some generic health-related quality-of-life dimensions, in addition to adding diabetes-specific information not covered by the SF-36v2 and clinical variables. The Diabetes Questionnaire is also sensitive to differences between clinically relevant groups of glycaemic control.

Factors affecting chronic obstructive pulmonary disease (COPD)-related costs: a multivariate analysis of a Swedish COPD cohort.

Chronic obstructive pulmonary disease (COPD) is an increasing public health problem, generating considerable costs. The objective of this study was to identify factors affecting COPD-related costs. A cohort of 179 subjects with COPD was interviewed over the telephone on four occasions about their annual use of COPD-related resources. The data set and explanatory variables were analysed by means of multivariate regression techniques for six different types of cost: societal (or total), direct (health care) and indirect (productivity), and three subcomponents of direct costs-hospitalisation, outpatient and medication. Poor lung function, dyspnoea and asthma were independently associated with higher costs. Poor lung function (severity of COPD) significantly increased all six examined cost types. Dyspnoea (breathing problems) also increased costs, though to a varying extent. The presence of reported asthma increased total, direct, outpatient and medication costs. Poor lung function and, to a lesser extent, extent of dyspnoea and concomitant asthma, were all strongly associated with higher COPD-related costs. Strong efforts should be made to prevent the progression of COPD and its symptoms.

Quality of life in chronic conditions using patient-reported measures and biomarkers: a DEA analysis in type 1 diabetes.

BACKGROUND: A chronic disease impacts a patient's daily life, with the burden of symptoms and managing the condition, and concerns of progression and disease complications. Such aspects are captured by Patient-Reported Outcomes Measures (PROM), assessments of e.g. wellbeing. Patient-Reported Experience Measures (PREM) assess patients' experiences of healthcare and address patient preferences. Biomarkers are useful for monitoring disease activity and treatment effect and determining risks of progression and complications, and they provide information on current and future health. Individuals may differ in which among these aspects they consider important. We aimed to develop a measure of quality of life using biomarkers, PROM and PREM, that would provide an unambiguous ranking of individuals, without presuming any specific set of importance weights. We anticipated it would be useful for studying needs and room for improvement, estimating the effects of interventions and comparing alternatives, and for developing healthcare with a broad focus on the individual. We wished to examine if efficiency analysis could be used for this purpose, in an application to individuals with type 1 diabetes. RESULTS: We used PROM and PREM data linked to registry data on risk factors, in a large sample selected from the National Diabetes Registry in Sweden. Efficiency analysis appears useful for evaluating the situation of individuals with type 1 diabetes. Quality of life was estimated as efficiency, which differed by age. The contribution of different components to quality of life was heterogeneous, and differed by gender, age and duration of diabetes. Observed quality of life shortfall was mainly due to inefficiency, and to some extent due to the level of available inputs. CONCLUSIONS: The efficiency analysis approach can use patient-reported outcomes measures, patient-reported experience measures and comorbidity risk factors to estimate quality of life with a broad focus on the individual, in individuals with type 1 diabetes. The approach enables ranking and comparisons using all these aspects in parallel, and allows each individual to express their own view of which aspects are important to them. The approach can be used for policy regarding interventions on inefficiency as well as healthcare resource allocation, although currently limited to type 1 diabetes.

Patient-reported outcome and experience measures for diabetes: development of scale models, differences between patient groups and relationships with cardiovascular and diabetes complication risk factors, in a combined registry and survey study in Sweden.

PURPOSE: The Swedish National Diabetes Register (NDR) has developed a diabetes-specific questionnaire to collect information on individuals' management of their diabetes, collaboration with healthcare providers and the disease's impact on daily life. Our main objective was to develop measures of well-being, abilities to manage diabetes and judgements of diabetes care, and to detect and quantify differences using the NDR questionnaire. DESIGN, SETTING AND PARTICIPANTS: The questionnaire was analysed with using responses from 3689 participants with type 1 and 2 diabetes, randomly sampled from the NDR population, combined with register data on patient characteristics and cardiovascular and diabetes complication risk factors. METHODS: We used item response theory to develop scales for measuring well-being, abilities to manage diabetes and judgements of diabetes care (scores). Test-retest reliability on the scale level was analysed with intraclass correlation. Associations between scores and risk factor levels were investigated with subgroup analyses and correlations. RESULTS: We obtained scales with satisfactory measurement properties, covering patient reported outcome measures such as general well-being and being free of worries, and patient reported experience measure, for example, access and continuity in diabetes care. All scales had acceptable test-retest reliability and could detect differences between diabetes types, age, gender and treatment subgroups. In several aspects, for example, freedom of worries, type 1 patients report lower than type 2, and younger patients lower than older. Associations were found between some scores and glycated haemoglobin, but none with systolic blood pressure or low-density lipoprotein cholesterol. Clinicians report positive experience of using scores, visually presented, in the patient dialogue. CONCLUSIONS: The questionnaire measures and detects differences in patient well-being, abilities and judgements of diabetes care, and identifies areas for improvement. To further improve diabetes care, we conclude that patient-reported measures are important supplements to cardiovascular and diabetes complication risk factors, reflecting patient experiences of living with diabetes and diabetes care.

The cost-effectiveness of treatment with erythropoietin compared to red blood cell transfusions for patients with chemotherapy induced anaemia: a Markov model.

BACKGROUND: Anaemia is a common complication of chemotherapy. As anaemia can lead to e.g. fatigue, depression, social isolation and chest pain it diminishes physical capacity and quality of life. It is generally accepted that symptomatic anaemia should be corrected. Treatment options include red blood cell transfusion (RBCT), erythropoietin (EPO) administration or a combination of both. OBJECTIVE: The objective of this study was to carry out a cost-effectiveness analysis of treatment with EPO (epoetin alfa), compared to treatment with RBCT for patients with chemotherapy-induced anaemia in Sweden from a health care perspective. METHOD: A model was developed for estimating incremental costs and QALY gains associated with EPO treatment compared to treatment with RBCTs, based on a model commissioned by the UK National Institute for Health and Clinical Excellence and adjusted to reflect Swedish treatment practice. Data regarding patient characteristics, response rates, and RBCT was derived from a Swedish observational study of EPO treatment in cancer patients with chemotherapy related anaemia. Swedish guidelines and unit costs were used throughout the study. A systematic review of EPO for treatment of anaemia associated with cancer was used to estimate QALY gains associated with changes in Hb-concentrations in our model. RESULTS: The model's results validate well to real world data from three major hospitals in Sweden. The cost per QALY gained from administration of EPO was estimated at EUR 24,700 in the base case analysis. Practicing an EPO treatment target Hb-level of 12 g/dl yields a cost per QALY about 40% lower than practicing a Hb-target level of 13 g/dl, which is in agreement with updated recommendations of using a 12 g/dl target. CONCLUSION: The estimated cost per QALY falls well within the range acceptable in Sweden when practicing a Hb-target level of 12 g/dl. The incremental cost of elevating Hb-levels above 13 g/dl is very high in relation to the incremental QALY gain achieved.

A disease-specific questionnaire for measuring patient-reported outcomes and experiences in the Swedish National Diabetes Register: Development and evaluation of content validity, face validity, and test-retest reliability.

OBJECTIVE: To describe the development and evaluation of the content and face validity and test-retest reliability of a disease-specific questionnaire that measures patient-reported outcomes and experiences for the Swedish National Diabetes Register for adult patients who have type 1 or type 2 diabetes. METHODS: In this methodological study, a questionnaire was developed over four phases using an iterative process. Expert reviews and cognitive interviews were conducted to evaluate content and face validity, and a postal survey was administered to evaluate test-retest reliability. RESULTS: The expert reviews and cognitive interviews found the disease-specific questionnaire to be understandable, with relevant content and value for diabetes care. An item-level content validity index ranged from 0.6-1.0 and a scale content validity/average ranged from 0.7-1.0. The fourth version, with 33 items, two main parts and seven dimensions, was answered by 972 adults with type 1 and type 2 diabetes (response rate 61%). Weighted Kappa values ranged from 0.31-0.78 for type 1 diabetes and 0.27-0.74 for type 2 diabetes. CONCLUSIONS: This study describes the initial development of a disease-specific questionnaire in conjunction with the NDR. Content and face validity were confirmed and test-retest reliability was satisfactory. PRACTICE IMPLICATIONS: With the development of this questionnaire, the NDR becomes a clinical tool that contributes to further understanding the perspectives of adult individuals with diabetes.

Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark.

BACKGROUND: It remains uncertain whether the increasing incidence of inflammatory bowel disease (IBD) during the last decades has been accompanied by an alteration in the presentation, course, and prognosis of the disease. To answer this question, 3 consecutive population-based IBD cohorts from Copenhagen, Denmark (1962-2005), were assessed and evaluated. METHODS: Phenotype, initial disease course, use of medications, cumulative surgery rate, standardized incidence ratio of colorectal cancer (CRC), and standardized mortality ratio (SMR) were compared in the 3 cohorts, which had a total of 641 patients with Crohn's disease (CD) and 1575 patients with ulcerative colitis (UC). RESULTS: From 1962 to 2005, the proportion of IBD patients suffering from CD increased (P < 0.001), time from onset of symptoms to diagnosis of CD decreased (P = 0.001), and median age at diagnosis of UC increased (P < 0.01). The prevalence of upper gastrointestinal involvement and pure colonic CD varied significantly between cohorts. UC patients diagnosed in the 1990s had a higher prevalence of proctitis, received more medications, and had a milder initial disease course than did previous patients. The surgery rate decreased significantly in CD but not in UC. The risk of CRC in IBD was close to expected over the entire period, whereas the mortality of patients with CD increased (overall SMR, 1.31; 95% CI, 1.07-1.60). CONCLUSIONS: Despite variations in the presentation and initial course of IBD during the last 5 decades, its long-term prognosis remained fairly stable. Treatment of IBD changed recently, and future studies should address the effect of these changes on long-term prognosis.

Retrospective incremental cost analysis of a hospital-based COPD Disease Management Programme in Sweden.

This paper reports on a retrospective analysis of hospital-based healthcare costs associated with the management of chronic obstructive pulmonary disease (COPD). During the second half of 2001, Simrishamn Hospital, Sweden, implemented a structured Disease Management Programme (DMP) for COPD and a total of 784 patients with COPD, enrolled in the DMP, were included in the analysis. The goal was to reduce the number of clinical events, such as severe exacerbations by early intervention, aggressive drug treatment, specialists easy available for advice, improved support for smoking cessation, increased number of scheduled follow-ups and closer tracking of high-risk COPD patients. The hospital administrative system provided data on resource consumption, such as outpatient care, inpatient care and drugs and unit cost, used in the economic analysis. The total cost of COPD drugs doubled (from euro 14,133 to euro 30,855 per year) as did the total number of outpatient visits (from 580 to 996 visits per year). The number of hospitalizations for acute COPD exacerbations and COPD with acute lower respiratory infection decreased from 67 to 25 per year. Total COPD-related healthcare costs decreased. The results presented here support the hypothesis that a COPD DMP can offer substantial overall direct cost savings.

Prediction models for exacerbations in different COPD patient populations: comparing results of five large data sources.

BACKGROUND AND OBJECTIVES: Exacerbations are important outcomes in COPD both from a clinical and an economic perspective. Most studies investigating predictors of exacerbations were performed in COPD patients participating in pharmacological clinical trials who usually have moderate to severe airflow obstruction. This study was aimed to investigate whether predictors of COPD exacerbations depend on the COPD population studied. METHODS: A network of COPD health economic modelers used data from five COPD data sources - two population-based studies (COPDGene® and The Obstructive Lung Disease in Norrbotten), one primary care study (RECODE), and two studies in secondary care (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoint and UPLIFT) - to estimate and validate several prediction models for total and severe exacerbations (= hospitalization). The models differed in terms of predictors (depending on availability) and type of model. RESULTS: FEV1% predicted and previous exacerbations were significant predictors of total exacerbations in all five data sources. Disease-specific quality of life and gender were predictors in four out of four and three out of five data sources, respectively. Age was significant only in the two studies including secondary care patients. Other significant predictors of total exacerbations available in one database were: presence of cough and wheeze, pack-years, 6-min walking distance, inhaled corticosteroid use, and oxygen saturation. Predictors of severe exacerbations were in general the same as for total exacerbations, but in addition low body mass index, cardiovascular disease, and emphysema were significant predictors of hospitalization for an exacerbation in secondary care patients. CONCLUSIONS: FEV1% predicted, previous exacerbations, and disease-specific quality of life were predictors of exacerbations in patients regardless of their COPD severity, while age, low body mass index, cardiovascular disease, and emphysema seem to be predictors in secondary care patients only.

Comparative cost-effectiveness of anticoagulation with bivalirudin or heparin with and without a glycoprotein IIb/IIIa-receptor inhibitor in patients undergoing percutaneous coronary intervention in Sweden: a decision-analytic model.

OBJECTIVE: This study modeled the comparative costs and effectiveness of anticoagulation with bivalirudin alone, heparin alone, and heparin combined with a glycoprotein IIb/IIIa-receptor inhibitor (GPI) in patients undergoing percutaneous coronary intervention (PCI) in Sweden. METHODS: GPIs are prescribed for -40% to 50% of patients undergoing PCI in Sweden. However, because treatment practices vary between hospitals, the model analyzed a cohort in which different proportions of patients (0%-100%) would receive a GPI in addition to heparin and the remaining patients would receive heparin monotherapy. This mixed cohort was compared with a cohort treated with bivalirudin. Abciximab was used as the GPI comparator, as this is the only GPI currently approved in Sweden for patients undergoing PCI. Pooled data from 3 studies (REPLACE-2 [second Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events], ESPRIT [European/Australasian Stroke Prevention in Reversible Ischaemia Trial], and EPISTENT [Evaluation of Platelet IIb/IIIa Inhibitor for Stenting]) were used as the source for the probabilities of myocardial infarction (MI), urgent revascularization (UR), major and minor bleeding (Thrombolysis in Myocardial Infarction study definitions), and death. Treatment costs associated with these complications were obtained from 4 Swedish hospitals, and official drug prices were obtained from the Swedish Pharmacopoeia. All costs were presented in 2006 Swedish kronor (SEK). The model was evaluated over a 30-day time frame from the perspective of a Swedish hospital. The modeled patient population was 63 years old, weighed 78 kg, and was 75% male. RESULTS: Compared with a pattern in which heparin plus a GPI was used in 50% of all PCIs and heparin alone was used in the remaining 50%, bivalirudin treatment was associated with a significant reduction in all complications in the model (P < 0.05), including a mean of 18.2 fewer MIs, 1.6 fewer URs, 15.3 fewer bleeding events, and 1.3 fewer deaths per 1000 treated patients. Bivalirudin therapy also was associated with a significant reduction in total drug and health care costs per patient (SEK -1301; 95% Cl, -1367 to -1229). The benefit of bivalirudin was sensitive to the rate of GPI use: additional reductions in rates of MI, UR, and death were seen at lower rates of GPI use, and additional reductions in rates of bleeding and costs of drugs and health care utilization were seen at higher rates of GPI use. CONCLUSIONS: In this model, anticoagulation with bivalirudin in patients undergoing PCI was cost-effective compared with heparin alone and heparin plus a GPI. In a hypothetical Swedish hospital unit using equal proportions of heparin alone and heparin plus a GPI, a switch to bivalirudin would reduce the risk of both ischemic events and bleeding events, resulting in savings in total drug and health care costs.

Epoetin alfa and darbepoetin alfa for the treatment of chemotherapy-related anemia in cancer patients in Sweden: comparative analysis of drug utilization, costs, and hematologic response.

A retrospective chart review was performed at 3 Swedish hospitals to evaluate the utilization, outcomes, and cost of using epoetin alfa or darbepoetin alfa to treat cancer patients with chemotherapy-related anemia. Data on dosage, duration of treatment, hematologic response, red blood cell transfusions, and healthcare resource consumption were collected and analyzed at various time points following the initiation of drug therapy. A significantly faster hematologic response and increase in hemoglobin were observed in patients treated with epoetin alfa. Dosages used in clinical practice appeared to be lower than those recommended by Swedish treatment guidelines. There were no significant differences in resource utilization or healthcare costs between the 2 treatment groups. By day 112, the mean treatment cost per patient, in Swedish kronors (SEK), was SEK74,701 (approximately US$9800 or approximately 8300) with epoetin alfa and SEK85,285 (approximately US$11,000 or approximately 9500) with darbepoetin alfa. Drug acquisition and administration accounted for 81% and 67% of the total cost of epoetin alfa and darbepoetin alfa therapy, respectively; the remainder of the total cost was for hospitalization and transfusions.

Cost-effectiveness analysis of ferric carboxymaltose in iron-deficient patients with chronic heart failure in Sweden.

OBJECTIVE: Iron deficiency is a common but treatable comorbidity in chronic heart failure (CHF) that is associated with impaired health-related quality-of-life (HRQoL). This study evaluates the cost-effectiveness of the intravenous iron preparation ferric carboxymaltose (FCM) for the treatment of iron deficiency in CHF from a Swedish healthcare perspective. METHODS: A cost-effectiveness analysis with a time horizon of 24 weeks was performed to compare FCM treatment with placebo. Data on health outcomes and medical resource use were mainly taken from the FAIR-HF trial and combined with Swedish cost data. An incremental cost-effectiveness ratio (ICER) was calculated as well as the change in per-patient costs for primary care and hospital care. RESULTS: In the FCM group compared with placebo, quality-adjusted life years (QALYs) are higher (difference = 0.037 QALYs), but so are per-patient costs [(difference = SEK 2789 (€303)]. Primary care and hospital care equally share the additional costs, but within hospitals there is a major shift of costs from inpatient care to outpatient care. The ICER is SEK 75,389 (€8194) per QALY. The robustness of the result is supported by sensitivity analyses. CONCLUSIONS: Treatment of iron deficiency in CHF with FCM compared with placebo is estimated to be cost-effective. The ICER in the base case scenario is twice as high as previously thought, but noticeably below SEK 500,000 (€54,300) per QALY, an informal average reference value used by the Swedish Dental and Pharmaceutical Benefits Agency. Increased HRQoL and fewer hospitalizations are the key drivers of this result.

Costs of COPD in Sweden according to disease severity.

OBJECTIVES: COPD is a common and disabling disease that entails high costs for society. The objectives of this study were to measure the societal costs of COPD in Sweden, and to examine the relationship between severity of illness and costs. METHODS: The costs of COPD were examined using a well-defined and representative cohort of subjects with mild, moderate, and severe COPD. Regular telephone interviews regarding resource utilization were made to a cohort of 212 subjects with COPD derived from studies of the general population in Northern Sweden. RESULTS: The annual per capita cost for COPD in Swedish crowns (SEK) was estimated at SEK 13,418 (1,284 US dollars (USD); 1,448 euros (EUR). The direct and indirect costs were SEK 5,592 (42%) and SEK 7,828 (58%), respectively. A highly significant relationship was found between severity of disease and costs. Costs for severe disease were 3 times as high as costs for moderate disease and > 10 times as high as for mild disease. Large individual variations in the level of costs were found. CONCLUSION: Assuming that the prevalence and treatment patterns are representative of Sweden as a whole, the total costs of COPD to society in 1999 were estimated at SEK 9.1 billion (USD 871 million; EUR 982 million). Subjects with mild disease (83%) accounted for 29%, while subjects with moderate disease (13%) accounted for 41% of the total costs. The subjects with severe disease (4%) accounted for the remainder (30%). Prevention, early diagnosis, and postponement of disease progression should have large monetary and policy implications.

Patient-reported outcome measures and risk factors in a quality registry: a basis for more patient-centered diabetes care in Sweden.

Diabetes is one of the chronic diseases that constitute the greatest disease burden in the world. The Swedish National Diabetes Register is an essential part of the diabetes care system. Currently it mainly records clinical outcomes, but here we describe how it has started to collect patient-reported outcome measures, complementing the standard registry data on clinical outcomes as a basis for evaluating diabetes care. Our aims were to develop a questionnaire to measure patient abilities and judgments of their experience of diabetes care, to describe a Swedish diabetes patient sample in terms of their abilities, judgments, and risk factors, and to characterize groups of patients with a need for improvement. Patient abilities and judgments were estimated using item response theory. Analyzing them together with standard risk factors for diabetes comorbidities showed that the different types of data describe different aspects of a patient's situation. These aspects occasionally overlap, but not in any particularly useful way. They both provide important information to decision makers, and neither is necessarily more relevant than the other. Both should therefore be considered, to achieve a more complete evaluation of diabetes care and to promote person-centered care.