The public economic burden of suboptimal type 2 diabetes control upon taxpayers in Sweden: Looking beyond health costs.

AIM: To estimate the fiscal burden for taxpayers in Sweden associated with type 2 diabetes (T2D) attributed to diabetes-related complications in patients failing to meet HbA1c targets. MATERIAL AND METHODS: We developed a public economic framework to assess how changes in diabetes-related complications influenced projected tax contributions and government disability payments for people with T2D. The analysis applied accepted disease-modelling practices to estimate different rates of diabetes-related complications based on an HbA1c of 6.9% (52 mmol/mol) and of 6.0% (42 mmol/mol). We adjusted the employment activity rates for those experiencing T2D-related events, applying age-specific earnings to estimate lifetime tax losses. Furthermore, the likelihood of receiving payments for health-related employment inactivity was estimated. Direct healthcare costs are excluded from this analysis. RESULTS: The estimated per person earnings loss for immediate and delayed HbA1c control was Swedish krona (SEK) 42 299 and SEK 44 157, respectively, over 10 years. The lost employment activity of people with T2D translates to lost tax revenues of SEK 23 265 and SEK 24 287 for immediate and delayed control, respectively. The estimated difference in disability payments was SEK 538. Combining the tax revenue loss and excess disability payments defines the broader fiscal costs, where we observe combined fiscal losses that favour immediate and sustained control by SEK 1560 over 10 years. CONCLUSIONS: We show that conducting fiscal analysis of diabetes interventions offers an enriched perspective capturing a range of costs that fall on government in relation to lost tax revenue and disability payments. Tax-financed health systems may benefit from broadening the consideration of costs and benefits when evaluating new interventions and treatment practices.

Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting.

OBJECTIVE: The aim of this study was to assess the cost effectiveness of oral semaglutide versus other oral glucose-lowering drugs for the management of type 2 diabetes (T2D) in Sweden. METHODS: The Swedish Institute for Health Economics Diabetes Cohort Model was used to assess the cost effectiveness of oral semaglutide 14 mg versus empagliflozin 25 mg and oral semaglutide 14 mg versus sitagliptin 100 mg, using data from the head-to-head PIONEER 2 and 3 trials, respectively, in which these treatments were added to metformin (± sulphonylurea). Base-case and scenario analyses were conducted. Robustness was evaluated with deterministic and probabilistic sensitivity analyses. RESULTS: In the base-case analyses, greater initial lowering of glycated haemoglobin levels with oral semaglutide versus empagliflozin and oral semaglutide versus sitagliptin, respectively, resulted in reduced incidences of micro- and macrovascular complications and was associated with lower costs of complications and indirect costs. Treatment costs were higher for oral semaglutide, resulting in higher total lifetime costs than with empagliflozin (Swedish Krona [SEK] 1,245,570 vs. 1,210,172) and sitagliptin (SEK1,405,789 vs. 1,377,381). Oral semaglutide was shown to be cost effective, with an incremental cost-effectiveness ratio (ICER) of SEK239,001 per quality-adjusted life-year (QALY) compared with empagliflozin and SEK120,848 per QALY compared with sitagliptin, from a payer perspective. ICERs were lower at SEK191,721 per QALY compared with empagliflozin and SEK95,234 per QALY compared with sitagliptin from a societal perspective. Results were similar in scenario analyses that incorporated cardiovascular effects, and also in sensitivity analyses. CONCLUSIONS: In a Swedish setting, oral semaglutide was cost effective compared with empagliflozin and sitagliptin for patients with T2D inadequately controlled on oral glucose-lowering drugs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02863328 (PIONEER 2; registered 11 August 2016) and NCT02607865 (PIONEER 3; registered 18 November 2015).

For any disease, it is important to consider whether new treatments, which may be more effective but also more expensive, are worth paying for compared with treatments that are already being used. This is called a cost-effectiveness analysis and helps health authorities and other organisations (such as insurance companies) that pay for medications to decide whether or not to pay for the new treatment. Cost effectiveness differs between individual countries because each has its own health system, health costs and approved treatments. Semaglutide is a type of medication called a glucagon-like peptide-1 receptor agonist (or GLP-1RA) that is used by people with type 2 diabetes to help control their blood glucose (sugar). Semaglutide is administered by injection but has recently become the first GLP-1RA to be available in a once-daily oral (tablet) form. We used information from the Swedish Institute for Health Economics and two clinical trials of oral semaglutide that compared it with other oral glucose-lowering drugs­empagliflozin and sitagliptin­to work out whether oral semaglutide was a cost-effective treatment in Sweden. We found that oral semaglutide was more expensive than empagliflozin and sitagliptin over the entire time on treatment but also led to greater lowering of blood sugar. This means that patients had fewer other illnesses linked to diabetes and lower health costs as a result. Balancing the higher upfront cost of the drug versus savings from fewer illnesses linked to diabetes, we found that in Sweden, oral semaglutide was cost effective compared with empagliflozin and sitagliptin.

The burden of poor glycaemic control in people with newly diagnosed type 2 diabetes in Sweden: A health economic modelling analysis based on nationwide data.

AIM: To evaluate the economic and clinical burden associated with poor glycaemic control in Sweden, in people with type 2 diabetes (T2D) initiating first-line glucose-lowering therapy. MATERIALS AND METHODS: Population data were obtained from Swedish national registers. Immediate glycaemic control was compared with delays in achieving control of 1 and 3 years, with outcomes projected over 3, 10 and 50 years in the validated IQVIA CORE Diabetes Model. Glycaemic control was defined as glycated haemoglobin (HbA1c) targets of 52, 48 and 42 mmol/mol, as recommended in Swedish guidelines, according to age and disease duration. Costs (expressed in 2019 Swedish krona [SEK]) were accounted from a Swedish societal perspective. RESULTS: Immediate glycaemic control was associated with population-level cost savings of up to SEK 279 million and SEK 673 million versus delays of 1 and 3 years, respectively, as well as small population-level life expectancy benefits of up to 1305 and 2590 life years gained. Reduced levels of burden were a result of lower incidence and delayed time to onset of diabetes-related complications. CONCLUSIONS: Even in people with T2D initiating first-line glucose-lowering therapy, the economic burden of poor glycaemic control in Sweden is substantial, but could be reduced by early and effective treatment to achieve glycaemic targets.

Smart Insulin Pens are Associated with Improved Clinical Outcomes at Lower Cost Versus Standard-of-Care Treatment of Type 1 Diabetes in Sweden: A Cost-Effectiveness Analysis.

INTRODUCTION: Real-world evidence has demonstrated improved glycemic control and insulin management following introduction of smart insulin pens in a Swedish type 1 diabetes (T1D) population. To understand the implications for healthcare costs and expected health outcomes, this analysis evaluated the long-term cost-effectiveness of introducing smart insulin pens to standard-of-care T1D treatment (standard care) from a Swedish societal perspective. METHODS: Clinical outcomes and healthcare costs (in 2018 Swedish krona, SEK) were projected over patients' lifetimes using the IQVIA CORE Diabetes Model to estimate cost-effectiveness. Clinical data and baseline characteristics for the simulated cohort were informed by population data and a prospective, noninterventional study of a smart insulin pen in a Swedish T1D population. This analysis captured direct and indirect costs, mortality, and the impact of diabetes-related complications on quality of life. RESULTS: Over patients' lifetimes, smart insulin pen use was associated with per-patient improvements in mean discounted life expectancy (+ 0.90 years) and quality-adjusted life expectancy (+ 1.15 quality-adjusted life-years), in addition to mean cost savings (direct, SEK 124,270; indirect, SEK 373,725), versus standard care. A lower frequency and delayed onset of complications drove projected improvements in quality-adjusted life expectancy and lower costs with smart insulin pens versus standard care. Overall, smart insulin pens were a dominant treatment option relative to standard care across all base-case and sensitivity analyses. CONCLUSIONS: Use of smart insulin pens was projected to improve clinical outcomes at lower costs relative to standard care in a Swedish T1D population and represents a good use of healthcare resources in Sweden.

Costs of diabetes complications: hospital-based care and absence from work for 392,200 people with type 2 diabetes and matched control participants in Sweden.

AIMS/HYPOTHESIS: The risk of complications and medical consequences of type 2 diabetes are well known. Hospital costs have been identified as a key driver of total costs in studies of the economic burden of type 2 diabetes. Less evidence has been generated on the impact of individual diabetic complications on the overall societal burden. The objective of this study was to analyse costs of hospital-based healthcare (inpatient and outpatient care) and work absence related to individual macrovascular and microvascular complications of type 2 diabetes in Sweden in 2016. METHODS: Data for 2016 were retrieved from a Swedish national retrospective observational database cross-linking individual-level data for 1997-2016. The database contained information from population-based health, social insurance and socioeconomic registers for 392,200 people with type 2 diabetes and matched control participants (5:1). Presence of type 2 diabetes and of diabetes complications were derived using all years, 1997-2016. Costs of hospital-based care and of absence from work due to diabetes complications were estimated for the year 2016. Regression analysis was used for comparison with control participants to attribute absence from work to individual complications, and to account for joint presence of complications. RESULTS: Use of hospital care for complications was higher in type 2 diabetes compared with control participants in 2016: 26% vs 12% had ≥1 hospital contact; there were 86,104 vs 24,608 outpatient visits per 100,000 people; and there were 9894 vs 2546 inpatient admissions per 100,000 people (all p < 0.001). The corresponding total costs of hospital-based care for complications were €919 vs €232 per person (p < 0.001), and 74.7% of costs were then directly attributed to diabetes (€687 per person). Regression analyses distributed the costs of days absent from work across diabetes complications per se, basic type 2 diabetes effect and unattributed causes. Diabetes complications amounted to €1317 per person in 2016, accounting for possible complex interactions (25% of total costs of days absent). Key drivers of costs were the macrovascular complications angina pectoris, heart failure and stroke; and the microvascular complications eye diseases, including retinopathy, kidney disease and neuropathy. Early mortality in working ages cost an additional €579 per person and medications used in risk-factor treatment amounted to €418 per person. CONCLUSIONS/INTERPRETATION: The economic burden of complications in type 2 diabetes is substantial. Costs of absence from work in this study were found to be greater than of hospital-based care, highlighting the need for considering treatment consequences in a societal perspective in research and policy. Graphical abstract.

Real-world cost-effectiveness of insulin degludec in type 1 and type 2 diabetes mellitus from a Swedish 1-year and long-term perspective.

BACKGROUND AND AIMS: The ReFLeCT study demonstrated that switching to insulin degludec from other basal insulins was associated with reductions in glycated hemoglobin and hypoglycemic events in type 1 (T1D) and type 2 diabetes (T2D), and reductions in insulin doses in T1D. The aim of the present analysis was to assess the short- and long-term cost-effectiveness of switching to insulin degludec in Sweden. METHODS: Short-term outcomes were evaluated over 1 year in a Microsoft Excel model, while long-term outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Cohort characteristics and treatment effects were sourced from the ReFLeCT study. Costs (in 2018 Swedish krona [SEK]) encompassed direct medical expenditure and indirect costs from loss of workplace productivity. In the long-term analyses, patients were assumed to receive insulin degludec or continue prior insulin therapy (primarily insulin glargine U100) for 5 years, before all patients intensified to once-daily degludec and mealtime aspart. RESULTS: Switching to insulin degludec was associated with improved quality-adjusted life expectancy of 0.04 and 0.02 quality-adjusted life years (QALYs) over 1 year, and 0.16 and 0.08 QALYs over patient lifetimes, in T1D and T2D. Combined costs in T1D and T2D were estimated to be SEK 1,249 lower and SEK 1,181 higher over the short-term, and SEK 157,258 and SEK 2,114 lower over the long-term. Benefits were due to lower insulin doses in T1D, reduced rates of hypoglycemia, and lower incidences of diabetes-related complications. Insulin degludec was associated with an incremental cost-effectiveness ratio of SEK 64,298 per QALY gained for T2D over 1 year and considered dominant for T1D and T2D in all other comparisons. CONCLUSIONS: Insulin degludec was projected to be cost-effective or dominant versus other basal insulins for the treatment of T1D and T2D in Sweden.

Evaluation of the Cost Per Patient Achieving Treatment Targets with Oral Semaglutide: A Short-Term Cost-Effectiveness Analysis in the United States.

INTRODUCTION: Oral semaglutide is the first orally administered glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes, and has been evaluated in the PIONEER clinical trial program. These trials assessed the proportions of patients achieving single and composite endpoints, encompassing glycemic control [defined in terms of glycated hemoglobin (HbA1c)], weight loss, and hypoglycemia. The present study assessed the cost of control with oral semaglutide versus empagliflozin, sitagliptin, and liraglutide in the US. METHODS: Four endpoints were evaluated: (1) HbA1c ≤ 6.5%; (2) HbA1c < 7.0%; (3) ≥ 1.0%-point HbA1c reduction and weight loss ≥ 3.0%; and (4) HbA1c < 7.0% without hypoglycemia and without weight gain. The proportions of patients achieving each endpoint were sourced from the PIONEER 2, 3 and 4 trials. Treatment costs were accounted over an annual time-period in 2019 US dollars (USD), based on wholesale acquisition cost. Cost of control was calculated by dividing treatment costs by the proportion of patients achieving each target. RESULTS: Oral semaglutide was consistently associated with the lowest cost of control for all four endpoints. For the targets of HbA1c ≤ 6.5% and HbA1c < 7.0%, oral semaglutide 14 mg was associated with lower cost of control than empagliflozin 25 mg, sitagliptin 100 mg and liraglutide 1.8 mg by USD 15,036, 14,697, and 6996, respectively, and USD 931, 346 and 4497, respectively. For the double composite endpoint, cost of control was lower with oral semaglutide 14 mg by USD 525, 32,277 and 13,011, respectively versus empagliflozin 25 mg, sitagliptin 100 mg and liraglutide 1.8 mg. For the triple composite endpoint, cost of control was lower with oral semaglutide 14 mg by USD 1255, 7510 and 5774, respectively. CONCLUSION: Oral semaglutide was associated with lower cost of bringing patients with type 2 diabetes to four clinically-relevant treatment targets versus empagliflozin, sitagliptin, and liraglutide in the US. FUNDING: Novo Nordisk A/S.

Cost-effectiveness of once-weekly semaglutide versus dulaglutide and lixisenatide in patients with type 2 diabetes with inadequate glycemic control in Sweden.

Aims: This analysis evaluated the cost-effectiveness of once-weekly semaglutide vs glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes (T2D) uncontrolled on metformin or basal insulin in Sweden. Materials and methods: This cost-effectiveness analysis (CEA) was conducted using the Swedish Institute of Health Economics (IHE) Diabetes Cohort Model. Analyses were conducted from the Swedish societal perspective over a time horizon of 40 years. For patients uncontrolled on metformin, dulaglutide was the comparator, and data from the SUSTAIN 7 clinical trial was used. For patients uncontrolled on basal insulin, lixisenatide was chosen as the comparator and data was obtained from a network meta-analysis (NMA). Results: The results show that, in patients with inadequate control on metformin, semaglutide 1.0 mg dominated (i.e. provided greater clinical benefit, and was less costly) dulaglutide 1.5 mg. In patients with inadequate control on basal insulin, semaglutide 1.0 mg dominated lixisenatide. The reduction in costs is largely driven by the reduction in complications seen with once-weekly semaglutide. Limitations and conclusions: It is likely that this analysis is conservative in estimating the cardiovascular (CV) cost benefits associated with treatment with once-weekly semaglutide. In patients inadequately controlled on basal insulin, the analyses vs lixisenatide were based on results from an NMA, as no head-to-head clinical trial has been conducted for this comparison. These CEA results show that once-weekly semaglutide is a cost-effective GLP-1 RA therapy for the treatment of T2D in patients inadequately controlled on metformin or basal insulin, addressing many current clinician, patient, and payer unmet needs in Sweden.

Cost-effectiveness of liraglutide versus lixisenatide as add-on therapies to basal insulin in type 2 diabetes.

BACKGROUND: We assessed the cost-effectiveness of the glucagon-like peptide 1 receptor agonists liraglutide 1.8 mg and lixisenatide 20 µg (both added to basal insulin) in patients with type 2 diabetes (T2D) in Sweden. METHODS: The Swedish Institute for Health Economics cohort model for T2D was used to compare liraglutide and lixisenatide (both added to basal insulin), with a societal perspective and with comparative treatment effects derived by indirect treatment comparison (ITC). Drug prices were 2016 values, and all other costs 2015 values. The cost-effectiveness of IDegLira (fixed-ratio combination of insulin degludec and liraglutide) versus lixisenatide plus basal insulin was also assessed, under different sets of assumptions. RESULTS: From the ITC, decreases in HbA1c were -1.32% and -0.43% with liraglutide and lixisenatide, respectively; decreases in BMI were -1.29 and -0.65 kg/m2, respectively. An estimated 2348 cases of retinopathy, 265 of neuropathy and 991 of nephropathy would be avoided with liraglutide compared with lixisenatide in a cohort of 10,000 patients aged over 40 years. In the base-case analysis, total direct costs were higher with liraglutide than lixisenatide, but costs associated with complications were lower. The cost/quality-adjusted life-year (QALY) for liraglutide added to basal insulin was SEK30,802. Base-case findings were robust in sensitivity analyses, except when glycated haemoglobin (HbA1c) differences for liraglutide added to basal insulin were abolished, suggesting these benefits were driving the cost/QALY. With liraglutide 1.2 mg instead of liraglutide 1.8 mg (adjusted for efficacy and cost), liraglutide added to basal insulin was dominant over lixisenatide 20µg.IDegLira was dominant versus lixisenatide plus basal insulin when a defined daily dose was used in the model. CONCLUSIONS: The costs/QALY for liraglutide, 1.8 or 1.2 mg, added to basal insulin, and for IDegLira (all compared with lixisenatide 20 µg added to basal insulin) were below the threshold considered low by Swedish authorities. In some scenarios, liraglutide and IDegLira were cost-saving.

Achieving Good Glycemic Control Early After Onset of Diabetes: A Cost-Effectiveness Analysis in Patients with Type 1 Diabetes in Sweden.

INTRODUCTION: Sweden has amongst the highest incidence rates of type 1 diabetes (T1D) in Europe. The high incidence and chronic nature of T1D result in high prevalence and economic burden. Improving glycemic control reduces the incidence of microvascular complications, which in turn reduces medical costs. The present study aimed to quantify the reductions in cost and improvements in quality-adjusted life expectancy with varying reductions in HbA1c in the T1D population. METHODS: The IQVIA CORE Diabetes Model was used to simulate a typical Swedish population of patients with T1D experiencing HbA1c reductions from 0.1% to 0.8% (in 0.1% increments) from 7.9% at baseline. Analyses were conducted in simulated cohorts based on data from the Swedish National Diabetes Register (NDR) and in subgroups by sex, smoking status, and body mass index (BMI), with different sets of quality-of-life utilities included. Generalized least squares (GLS) models were used to test for significant differences between subgroups. Analyses were also performed to investigate the effect of the duration of HbA1c control. Analyses were run over 50 years and outcomes discounted at 3% per annum. RESULTS: In the reference case analysis, reducing HbA1c lowered the incidence of microvascular and macrovascular complications and improved quality-adjusted life expectancy. GLS models identified a significantly larger benefit of reducing HbA1c in women over men, but found no significant differences in the magnitude of quality of life improvements with decreasing HbA1c when segregating by smoking status or BMI. CONCLUSIONS: Reducing HbA1c in a population with T1D would reduce the incidence of microvascular complications, improve life expectancy and quality of life. Larger quality-of-life benefits were observed in younger and female adult patients, but no notable differences were observed in the benefits of glycemic control in smokers versus non-smokers or in patients with low or high BMI. FUNDING: Novo Nordisk Scandinavia AB, Malmö, Sweden.

Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden.

BACKGROUND: Patients with uncontrolled type 2 diabetes mellitus (T2DM) are a priority group for intensified therapy without weight gain and with low risk of hypoglycaemia. OBJECTIVE: This study evaluates the cost effectiveness of insulin degludec plus liraglutide (IDegLira, Xultophy®) compared with six potential intensification treatment options for patients with T2DM that is uncontrolled with basal insulin. METHODS: The Swedish Institute for Health Economics (IHE) Cohort Model of Type 2 Diabetes was used with Swedish input data, a 40-year time frame and a societal perspective. The comparators for treatment intensification included insulin glargine, neutral protamine Hagedorn (NPH) insulin, insulin aspart plus either glargine or NPH, and liraglutide plus either glargine or NPH. Clinical data for all comparators (except NPH insulin) were based on an indirect treatment comparison of several studies. Prices were obtained from the 2014 Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket [TLV]) database, and utility values were obtained from published studies. Sensitivity analyses were undertaken. RESULTS: Overall incremental cost-effectiveness ratios (ICER) were Swedish krona (SEK) 70,000 or lower per quality-adjusted life-year (QALY). IDegLira compared with intensified basal insulin showed an ICER of SEK 28,000 per QALY versus insulin glargine, SEK70,000 per QALY versus NPH insulin and SEK 60,000 per QALY versus NPH insulin plus liraglutide. IDegLira was dominant over insulin glargine plus liraglutide and insulin aspart plus insulin glargine or NPH insulin. Results were driven by the difference in glycated haemoglobin (HbA1c) reduction between treatments, as confirmed by sensitivity analyses. CONCLUSIONS: IDegLira is estimated to be a cost-effective treatment in Sweden compared with commonly used intensification treatments for patients with T2DM uncontrolled with basal insulin.

Cost-effectiveness of switching to insulin degludec from other basal insulins: evidence from Swedish real-world data.

OBJECTIVES: Health economic analysis from a healthcare and societal point of view was conducted to assess the cost-effectiveness of insulin degludec (IDeg) after switching from other basal insulins in people with type 1 diabetes. MATERIAL AND METHODS: This was a prospective, open-label, single arm, observational follow-up from August 2013 to October 2015 of 476 consecutive patients at Danderyd Hospital (Stockholm, Sweden) who switched to IDeg from other basal insulins (99% basal insulin analogs). The IMS CORE Diabetes Model (CDM) was used to predict the cost-effectiveness of life-long treatment with IDeg vs. other basal insulins, based on a Swedish setting. RESULTS: Mean (SD) duration of follow-up was 21.7 (6.0) weeks. Mean HbA1c decreased by 2.7 mmol/mol, mean basal insulin dose decreased by 13.1% (p < .0001), and mean bolus insulin dose decreased by 7.5% (p < .0001) after switching. Frequencies of non-severe daytime hypoglycemia and non-severe nocturnal hypoglycemia decreased by 12% (p = .0127) and 53% (p < .0001) respectively and severe hypoglycemia was reduced by 62% (p = .0225). The CDM predicted a gain in life expectancy of 0.33 years, a discounted gain in quality-adjusted life-years (QALYs) of 0.54, and lower estimated direct lifetime healthcare costs of SEK 22,757 for patients switching to IDeg. The incremental cost-effectiveness ratio (ICER) showed IDeg as dominant (i.e. higher effectiveness with a lower cost). Sensitivity analyses confirmed the results. CONCLUSION: Based on this prospective, real-world, follow-up and using the CDM, it was estimated that switching to IDeg from other basal insulins translated into QALY gains including improved life expectancy and health-related quality of life, as well as dominant ICER, meaning cost-savings for the healthcare system. However, the study is limited by its observational design. Extrapolation into the future is only estimated since the actual treatment effect cannot be projected with certainty.

Women's preferences toward attributes of local estrogen therapy for the treatment of vaginal atrophy.

OBJECTIVES: Decreased estrogen production due to menopause is often associated with vaginal atrophy, and estrogen therapy is the most effective treatment for the management of this condition. This study investigated women's preferences relating to various aspects of local estrogen therapy (LET) for the treatment of postmenopausal vaginal atrophy. STUDY DESIGN: The study involved 423 women aged >50 years who were resident in Sweden, had experienced menopausal changes in and around the vagina, and had used LET for these changes. The women completed an online questionnaire. MAIN OUTCOME MEASURES: The questionnaire involved a discrete choice experiment to determine women's willingness to pay for different characteristics of therapy. Time of LET appliance, use of disposable applicators with small tablets compared with both dosing syringes with vaginal cream and vagitories, and therapy that did/did not cause smudges/leakage were all considered. RESULTS: The women had no significant preference as to the time of day LET should be used. However, quantifying other preferences suggested that respondents were willing to pay € 66.58 or € 60.32 per month extra for using disposable applicators with small tablets rather than dosing syringes with vaginal cream or vagitories, respectively, and to avoid smudges/leakage. CONCLUSIONS: This survey suggests that women may prefer using disposable applicators with small tablets to deliver LET and value therapy that does not cause smudges/leakage. It is possible that if women are able to use their preferred form of LET, improved uptake or adherence of such medication may enhance the management of postmenopausal vaginal atrophy.

Evaluation of the long-term cost-effectiveness of insulin detemir compared with neutral protamine hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in Sweden.

AIMS: To evaluate the long-term clinical and economic outcomes associated with insulin detemir and neutral protamine hagedorn (NPH) insulin in combination with mealtime insulin aspart in patients with type 1 diabetes in Sweden, based on data from a two-year, multi-national, open-label, randomized, controlled trial. METHODS: Insulin detemir was associated with significant improvements in glycaemic control after 24 months (HbA1c 7.36% versus 7.58%, mean difference -0.22%, p = 0.022) and major hypoglycaemic events (69% risk reduction, p = 0.001) versus NPH. Patients treated with detemir gained less weight (1.7 versus 2.7 kg, P = 0.024). Based on these findings, a published and validated computer model (IMS CORE Diabetes Model) was used to estimate life-expectancy, quality-adjusted life expectancy and both direct medical costs and indirect costs. RESULTS: Basal-bolus therapy with insulin detemir was projected to improve life expectancy by 0.14 years (15.02 ± 0.19 versus 14.88 ± 0.18 years) and quality-adjusted life expectancy by 0.53 quality-adjusted life years (QALYs) versus NPH (8.35 ± 0.11 versus 7.82 ± 0.10 QALYs). Improvements in QALYs were driven by avoided or delayed diabetes-related complications and fewer hypoglycaemic events. Direct medical costs over patient lifetimes were SEK 26,144 higher in the insulin detemir arm (SEK 995,025 ± 19,580 versus 968,881 ± 19,769), leading to an incremental cost-effectiveness ratio of SEK 49,757 per QALY gained. Capturing indirect costs led to insulin detemir being cost saving over patient lifetimes, by SEK 80,113, compared to NPH (SEK 2,959,909 ± 64,727 versus 3,040,022 ± 62,317). CONCLUSIONS: Compared with NPH, insulin detemir is likely to be cost-effective from a healthcare payer perspective and dominant from a societal perspective in patients with type 1 diabetes in Sweden.

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.

Cost effectiveness of budesonide/formoterol in a single inhaler for COPD compared with each monocomponent used alone.

OBJECTIVE: To compare the healthcare costs and effects of budesonide/formoterol in a single inhaler with those of budesonide and formoterol monotherapies, and placebo, in a multinational study in patients with chronic obstructive pulmonary disease (COPD), National Heart, Lung and Blood Institute (NHLBI)/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III or IV. Previous analysis of the clinical data from the study had shown that budesonide/formoterol was associated with better lung function and improved health-related QOL compared with the monocomponents or placebo and lower frequency of exacerbations compared with formoterol and placebo. METHOD: Patients (n = 1022) were randomised to twice-daily treatment with two inhalations of budesonide/formoterol (160 microg/4.5 microg) in a single inhaler, budesonide 200 microg, formoterol 4.5 microg or placebo for 12 months. Data on medication and healthcare use were combined with Swedish unit cost data to estimate the total annual healthcare cost per patient from the Swedish healthcare payer perspective. Costs were valued in Swedish kronor (SEK) [2001 values] and converted to euros (SEK 1 = euro 0.11, 25th April 2003). RESULTS: This evaluation estimated the total annual healthcare costs per patient to be numerically lower for budesonide/formoterol (euro 2518) than for budesonide (euro 3194), formoterol (euro 3653) or placebo (euro 3213). Cost-effectiveness acceptability curves suggest that budesonide/formoterol may be cost effective compared with formoterol, even if the decision maker is not willing to pay anything for the additional clinical effects, and that budesonide/formoterol is cost effective compared with placebo if a decision maker is willing to pay about euro 2 per day, per avoided exacerbation. CONCLUSION: This economic analysis suggests that the clinical benefits of using budesonide/formoterol in a single inhaler are achieved at a numerically lower total healthcare cost than either monocomponent or placebo. Budesonide/formoterol in patients with severe COPD (GOLD stages III or IV) may be cost effective, from the healthcare provider perspective, compared with either monocomponent.

Cost differences for COPD with and without physician-diagnosis.

Previous studies have presented divergent estimates of the cost of illness of COPD due to differences in methodology. The objective of this study was to examine differences between register-based estimates versus population-based estimates on the burden of COPD. This study therefore examined differences in costs of COPD among physician-diagnosed and un-diagnosed subjects. During a one-year period, four telephone interviews were made with 212 randomly selected subjects with COPD derived from the Obstructive Lung Disease in Northern Sweden (OLIN) studies. Health care resource utilization and productivity losses were measured, and the costs were also transformed with the estimated COPD prevalence in Sweden. Average annual costs were SEK 18,252 (USD 2,207, EUR 2,072), and SEK 9,327 (USD 1,128, EUR 1,059) for subjects with and without a physician-diagnosis, respectively. Although lower per individual, the costs of undiagnosed subjects accounted for approximately 40% of the total costs in Sweden, since the majority of subjects with COPD in Sweden lack a physician-diagnosed disease. In conclusion, we found that the costs due to COPD differed considerably between those with and without physician-diagnosed disease. This study indicates that register-based studies result in underestimated costs of COPD.

A computer simulation model of the natural history and economic impact of chronic obstructive pulmonary disease.

OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is a major health problem with high societal costs. The Global Initiative for Chronic Lung Disease (GOLD) has identified a need for health economics data for COPD. For chronic diseases, such as COPD, where the natural history of disease is lifetime, a modeling approach for economic evaluation may be more realistic than prospective, piggy-backed clinical trials or specific COPD cohort studies. Simulation models can be used to extrapolate clinical data beyond the limited time frame of clinical trials, to analyze subgroups of patients or to explore uncertainty regarding the results by using sensitivity analysis techniques. Our purpose has been to develop a flexible computer simulation model for COPD that will represent disease progression and GOLD recommendations, useful for economic evaluations of new medicines to meet the needs of various payer requirements for reimbursement and resource allocation. METHODS: This article describes a two-dimensional Markov model, which uses data from multiple sources about disease progression, exacerbation frequency and duration, mortality, costs, burden of illness, and the relationships between those variables. The model is evaluated using stochastic uncertainty analysis, it allows comparison of treatments affecting different disease mechanisms, and it uses primary data validated against published sources. RESULTS: We have evaluated two hypothetical interventions treating different features of the disease (lung function decline and acute exacerbations). These analyses show that reducing lung function decline must be a long-term strategy compared to reducing the number of exacerbations. It was necessary to have a long term like 30 years, with 10,000 patients and 20% increase in price, or 20 years with equal prices to show cost-effectiveness with statistical significance for a treatment that reduces lung function decline. CONCLUSIONS: Our study shows the value of modeling as a tool for evaluating different scenarios and for combining several sources of data, to provide estimates that would otherwise be unavailable. Clinical trials of this size and duration would be unrealistic.

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.