The Health Economics of Automated Insulin Delivery Systems and the Potential Use of Time in Range in Diabetes Modeling: A Narrative Review.

Intensive therapy with exogenous insulin is the treatment of choice for individuals living with type 1 diabetes (T1D) and some with type 2 diabetes, alongside regular glucose monitoring. The development of systems allowing (semi-)automated insulin delivery (AID), by connecting glucose sensors with insulin pumps and algorithms, has revolutionized insulin therapy. Indeed, AID systems have demonstrated a proven impact on overall glucose control, as indicated by effects on glycated hemoglobin (HbA1c), risk of severe hypoglycemia, and quality of life measures. An alternative endpoint for glucose control that has arisen from the use of sensor-based continuous glucose monitoring is the time in range (TIR) measure, which offers an indication of overall glucose control, while adding information on the quality of control with regard to blood glucose level stability. A review of literature on the health-economic value of AID systems was conducted, with a focus placed on the growing place of TIR as an endpoint in studies involving AID systems. Results showed that the majority of economic evaluations of AID systems focused on individuals with T1D and found AID systems to be cost-effective. Most studies incorporated HbA1c, rather than TIR, as a clinical endpoint to determine treatment effects on glucose control and subsequent quality-adjusted life year (QALY) gains. Likely reasons for the choice of HbA1c as the chosen endpoint is the use of this metric in most validated and established economic models, as well as the limited publicly available evidence on appropriate methodologies for TIR data incorporation within conventional economic evaluations. Future studies could include the novel TIR metric in health-economic evaluations as an additional measure of treatment effects and subsequent QALY gains, to facilitate a holistic representation of the impact of AID systems on glycemic control. This would provide decision makers with robust evidence to inform future recommendations for health care interventions.

A European Cost-Utility Analysis of the MiniMed™ 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes.

Background: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems are the most effective therapy in terms of assisting people with type 1 diabetes (T1D) to achieve glycemic targets; however, the cost can represent a barrier to uptake. In this study, a cost-utility analysis of the MiniMed™ 780G AHCL system (MM780G) versus intermittently scanned continuous glucose monitoring (is-CGM) plus multiple daily insulin injections (MDI) in people with T1D not achieving glycemic goals was performed across six European countries. Methods: Clinical input data were sourced from the ADAPT trial. Assuming a baseline HbA1c of 9.04%, HbA1c reductions of 1.54% for AHCL and 0.2% for is-CGM+MDI were modeled. The analyses were performed from a payer perspective over a time horizon of 40 years and an annual discount rate of 3% was applied. Results: Across all countries, the use of AHCL was projected to result in an incremental gain in quality-adjusted life expectancy of >2 quality-adjusted life years (QALYs) versus is-CGM+MDI. Lifetime direct costs were higher with AHCL resulting in incremental cost-utility ratios for AHCL versus is-CGM+MDI ranging from EUR 11,765 per QALY gained in Austria to EUR 43,963 per QALY gained in Italy. Conclusions: For people with T1D managed with is-CGM+MDI not achieving glycemic targets, initiation of the MM780G system was projected to improve long-term clinical outcomes; however, due to differences in health care costs between countries, the health economic outcomes differed. In all included countries, AHCL is likely to be cost-effective relative to is-CGM+MDI for people not achieving glycemic goals with is-CGM+MDI. The ADAPT trial is registered with ClinicalTrials.gov, NCT04235504.

Cost-Effectiveness of Hybrid Closed Loop Insulin Pumps Versus Multiple Daily Injections Plus Intermittently Scanned Glucose Monitoring in People With Type 1 Diabetes in The Netherlands.

INTRODUCTION: Hybrid closed loop (HCL) insulin pump systems and intermittently scanned continuous glucose monitoring (IS-CGM) are increasingly used by individuals with type 1 diabetes (T1D). The aim of the analysis was to compare the long-term cost-effectiveness of the MiniMed 670G HCL system versus IS-CGM plus multiple daily injections of insulin (MDI) or continuous subcutaneous insulin infusion (CSII) in adults with T1D in the Netherlands. METHODS: The analysis was performed using the IQVIA CORE Diabetes Model with clinical input data sourced from observational studies. Simulated patients were assumed to have a baseline HbA1c of 7.8%. Use of the MiniMed 670G system was assumed to reduce HbA1c by 0.4% and confer a quality-of-life (QoL) benefit through reduced fear of hypoglycemia (FoH). The analysis was performed from a societal perspective over a lifetime time horizon; future costs and clinical outcomes pertaining to the Netherlands were used and discounted at 4% and 1.5% per annum, respectively. RESULTS: Use of the MiniMed 670G HCL system was projected to improve mean quality-adjusted life expectancy by 2.231 quality-adjusted life years (QALYs) versus IS-CGM. Total mean lifetime costs were EUR 13,683 higher with the MiniMed 670G system resulting in an ICER of EUR 6133 per QALY gained. Sensitivity analyses revealed findings to be sensitive to changes in assumptions around severe hypoglycemic event rates and the (QoL) benefit associated with reduced FoH. CONCLUSIONS: Over patient lifetimes, for adults with long-standing T1D in the Netherlands, use of the MiniMed 670G system is projected to be cost-effective versus IS-CGM plus MDI or CSII.

Cost-Effectiveness Analysis of an Advanced Hybrid Closed-Loop Insulin Delivery System in People with Type 1 Diabetes in Greece.

AbstractIntroduction: Usage of automated insulin delivery systems is increasing for the treatment of people with type 1 diabetes (T1D). This study compared long-term cost-effectiveness of the Advanced Hybrid Closed Loop MiniMed 780G (AHCL) system versus sensor augmented pump (SAP) system with predictive low glucose management (PLGM) or multiple daily injections (MDI) plus intermittently scanned continuous glucose monitoring (isCGM) in people with T1D in Greece. Methods: Analyses were performed using the IQVIA CORE Diabetes Model, with clinical input data sourced from various studies. In the AHCL versus SAP plus PLGM analysis, patients were assumed to have 7.5% baseline glycated hemoglobin (HbA1c), when comparing AHCL with MDI plus isCGM baseline HbA1c was assumed to be 7.8%. HbA1c was reduced to 7.0% following AHCL treatment initiation but remained at baseline levels in the comparator arms. Analyses were performed from a societal perspective over a lifetime time horizon. Future costs and clinical outcomes were discounted at 1.5% per annum. Results: AHCL was associated with increased quality-adjusted life expectancy of 0.284 quality-adjusted life years (QALYs) and EUR 10,173 lower mean total lifetime costs with SAP plus PLGM. Compared with MDI plus isCGM, AHCL was associated with increased quality-adjusted life expectancy of 2.708 QALYs, EUR 76,396 higher mean total lifetime costs, and an incremental cost-effectiveness ratio of EUR 29,869 per QALY. Extensive sensitivity analysis confirmed the robustness of results. Conclusions: Over patient lifetime, the MiniMed 780G system is likely to be cost saving compared with the SAP plus PLGM system and cost-effective compared with MDI plus isCGM in people with T1D in Greece.

Cost-effectiveness of a novel hybrid closed-loop system compared with continuous subcutaneous insulin infusion in people with type 1 diabetes in the UK.

AIMS: The MiniMed 670 G insulin pump system is the first commercially available hybrid closed-loop (HCL) insulin delivery system and clinical studies have shown that this device is associated with incremental benefits in glycemic control relative to continuous subcutaneous insulin infusion (CSII) with or without continuous glucose monitoring (CGM). The aim was to evaluate the long-term cost-effectiveness of the MiniMed 670 G system versus CSII alone in people with type 1 diabetes (T1D) in the UK. MATERIALS AND METHODS: Cost-effectiveness analysis was performed using the IQVIA CORE Diabetes Model. Clinical input data were sourced from a clinical trial of the MiniMed 670 G system in 124 adults and adolescents with T1D. The analysis was performed over a lifetime time horizon and both future costs and clinical outcomes were discounted at 3.5% per annum. The analysis was performed from a healthcare payer perspective. RESULTS: The use of the MiniMed 670 G system led to an improvement in quality-adjusted life expectancy of 1.73 quality-adjusted life years (QALYs), relative to CSII. Total lifetime direct costs were GBP 35,425 higher with the MiniMed 670 G system than with CSII resulting in an incremental cost-effectiveness ratio (ICER) of GBP 20,421 per QALY gained. Sensitivity analyses revealed that the ICER was sensitive to assumptions around glycemic control and assumptions relating to the quality-of-life benefit associated with a reduction in fear of hypoglycemia. LIMITATIONS: Long-term projections from short-term data are inherently associated with uncertainty but represent arguably the best available evidence in lieu of long-term clinical trials. CONCLUSIONS: In the UK, over patient lifetimes, the incremental clinical benefits associated with the use of MiniMed 670 G system means that it is likely to be cost-effective relative to the continued use of CSII in people with T1D, particularly for those with a fear of hypoglycemia or poor baseline glycemic control.

Cost-Effectiveness of Sensor-Augmented Insulin Pump Therapy Versus Continuous Insulin Infusion in Patients with Type 1 Diabetes in Turkey.

Background and Aims: Sensor-augmented pump therapy (SAP) combines continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII). SAP is costlier than CSII but provides additional clinical benefits relative to CSII alone. A long-term cost-effectiveness analysis was performed to determine whether SAP is cost-effective relative to CSII in patients with type 1 diabetes (T1D) in Turkey. Methods: Analyses were performed in two different patient cohorts, one with poor glycemic control at baseline (mean glycated hemoglobin 9.0% [75 mmol/mol]) and a second cohort considered to be at increased risk of hypoglycemic events. Clinical input data and direct medical costs were sourced from published literature. The analysis was performed from a third-party payer perspective over patient lifetimes and future costs and clinical outcomes were discounted at 3.5% per annum. Results: In both patient cohorts, SAP was associated with a gain in quality-adjusted life expectancy but higher costs relative to CSII (incremental gain of 1.40 quality-adjusted life years [QALYs] in patients with poor baseline glycemic control and 1.73 QALYs in patients at increased risk of hypoglycemic events). Incremental cost-effectiveness ratios for SAP versus CSII were TRY 76,971 (EUR 11,612) per QALY gained for patients with poor baseline glycemic control and TRY 69,534 (EUR 10,490) per QALY gained for patients at increased risk for hypoglycemia. Conclusions: SAP is associated with improved long-term clinical outcomes versus CSII, and in Turkey, SAP is likely to represent good value for money compared with CSII in T1D patients with poor glycemic control and/or with frequent severe hypoglycemic events.

Cost-Effectiveness Analysis of the MiniMed 670G Hybrid Closed-Loop System Versus Continuous Subcutaneous Insulin Infusion for Treatment of Type 1 Diabetes.

BACKGROUND: Hybrid closed-loop (HCL) systems combine continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII) to continuously self-adjust basal insulin delivery. Relative to CSII, HCL improves glycemic control and reduces the risk of hypoglycemia but has higher acquisition costs. The aim of this analysis was to assess the cost-effectiveness of the MiniMed™ 670G HCL system versus CSII in people with type 1 diabetes (T1D) in Sweden. METHODS: Cost-effectiveness analysis, from a societal perspective, was performed over patient lifetimes using the IQVIA CORE Diabetes Model. Clinical data were sourced from a study comparing the MiniMed 670G system with CSII in people with T1D. Cost data, expressed in 2018 Swedish krona (SEK), were obtained from Swedish reference prices and published literature. RESULTS: The MiniMed 670G system was associated with a quality-adjusted life-year (QALY) gain of 1.90 but higher overall costs versus CSII, leading to an incremental cost-effectiveness ratio (ICER) of SEK 164,236 per QALY gained. Use of the HCL system resulted in a lower cumulative incidence of diabetes-related complications. Higher HCL system acquisition costs were partially offset by reduced complication costs and productivity losses. In people with T1D poorly controlled at baseline, the MiniMed 670G system was associated with 2.25 incremental QALYs versus CSII, yielding an ICER of SEK 15,830 per QALY gained. CONCLUSIONS: The MiniMed 670G system was associated with clinical benefits and quality-of-life improvements in people with T1D relative to CSII. At a willingness-to-pay threshold of SEK 300,000 per QALY gained, this HCL system likely represents a cost-effective treatment option for people with T1D in Sweden.

Cost-Effectiveness of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Patients with Poorly Controlled Type 2 Diabetes in Finland.

INTRODUCTION: Although primarily utilized in type 1 diabetes, continuous subcutaneous insulin infusion (CSII) represents a useful treatment alternative for patients with type 2 diabetes who are unable to achieve good glycemic control despite optimization of multiple daily injections (MDI). The aim of the analysis reported here was to investigate the long-term cost-effectiveness of CSII versus MDI in type 2 diabetes patients with poor glycemic control in Finland. METHODS: The IQVIA CORE Diabetes Model was used to make long-term projections of the clinical and economic outcomes associated with CSII use in type 2 diabetes, based on clinical input data from the OpT2mise trial, which showed that CSII was associated with a 1.1% decrease in glycated hemoglobin (HbA1c) in patients with poor glycemic control at baseline. The analysis was performed from a societal perspective and the time horizon was that of patient lifetimes. Future costs and clinical outcomes were discounted at 3% per annum. RESULTS: Continuous subcutaneous insulin infusion was associated with a gain in quality-adjusted life expectancy of 0.32 quality-adjusted life-years (QALYs) compared with MDI (8.15 vs. 7.83 QALYs, respectively), as well as higher mean lifetime costs, resulting in an incremental cost-effectiveness ratio of Euro (EUR) 47,834 per QALY gained for CSII versus MDI. The higher treatment costs in the CSII group were partly mitigated by a 15% reduction in diabetes-related complication costs. Sensitivity analyses demonstrated that CSII was most cost-effective in patients with the highest baseline HbA1c values. CONCLUSION: In Finland, CSII is likely to represent a cost-effective treatment alternative for patients with type 2 diabetes with poor glycemic control despite optimization of MDI. In such patients, CSII is associated with improved clinical outcomes relative to MDI, with the higher acquisition costs partly offset by a lower lifetime incidence and cost of diabetes-related complications. FUNDING: Medtronic International Sàrl.

Cost-effectiveness of sensor-augmented insulin pump therapy vs continuous subcutaneous insulin infusion in patients with type 1 diabetes in the Netherlands.

AIM: The aim of this study was to perform a cost-effectiveness analysis to establish the cost-effectiveness of sensor-augmented pump therapy (SAP) with automated insulin suspension vs continuous subcutaneous insulin infusion (CSII) alone in patients with type 1 diabetes in the Netherlands. PATIENTS AND METHODS: The analysis was performed using the IQVIA CORE Diabetes Model (CDM) in two different patient cohorts: one with suboptimal glycemic control at baseline (mean age 27 years, mean baseline HbA1c 8.0% [64 mmol/mol]) and the other at increased risk of hypoglycemic events (mean age 18.6 years, mean baseline HbA1c 7.5% [58 mmol/mol]). Clinical input data were sourced from published literature, and the analysis was performed from the societal perspective. RESULTS: In patients with suboptimal baseline glycemic control, SAP improved quality-adjusted life expectancy by 1.77 quality-adjusted life years (QALYs) vs CSII (15.54 QALYs vs 13.77 QALYs) with higher lifetime costs (EUR 189,855 vs EUR 150,366), resulting in an incremental cost-effectiveness ratio (ICER) of EUR 22,325 per QALY gained. In this cohort, sensitivity analyses showed that the influence of SAP on fear of hypoglycemia (FoH) and baseline HbA1c were key drivers of results. In patients at increased risk of hypoglycemia, the gain in quality-adjusted life expectancy with SAP vs CSII was 2.16 QALYs (16.70 QALYs vs 14.53 QALYs) with higher lifetime costs (EUR 204,013 vs EUR 171,032) leading to an ICER of EUR 15,243 per QALY gained. In this patient group, findings were most sensitive to changes in assumptions relating to the incidence of severe hypoglycemic events in the CSII arm. CONCLUSION: For type 1 diabetes patients in the Netherlands who do not achieve target HbA1c levels or who experience frequent severe hypoglycemic events on CSII, switching to SAP is likely to be cost-effective.

Cost-Effectiveness Analysis of Sensor-Augmented Insulin Pump Therapy with Automated Insulin Suspension Versus Standard Insulin Pump Therapy in Patients with Type 1 Diabetes in Sweden.

INTRODUCTION: In Sweden an estimated 10,000 people with type 1 diabetes use continuous subcutaneous insulin infusion (CSII). Sensor-augmented pump therapy (SAP) is associated with higher acquisition costs but provides additional clinical benefits (e.g. reduced rate of hypoglycemic events) over and above that of CSII alone. The aim of the analysis was to assess the cost-effectiveness of SAP with automated insulin suspension relative to CSII alone in two different groups of patients with type 1 diabetes in Sweden. METHODS: Cost-effectiveness analyses were performed using the QuintilesIMS CORE Diabetes Model, with clinical and economic input data derived from published literature. Separate analyses were performed for patients at increased risk of hypoglycemia and for patients with uncontrolled glycated hemoglobin (HbA1c) at baseline. Analyses were performed from a societal perspective over a lifetime time horizon. Future costs and clinical outcomes were discounted at 3% per annum. RESULTS: SAP with automated insulin suspension was associated with an incremental gain in quality-adjusted life expectancy versus the CSII of 1.88 quality-adjusted life years (QALYs) in patients at high risk of hypoglycemia and of 1.07 QALYs in patients with uncontrolled HbA1c at baseline. Higher lifetime costs for SAP with automated insulin suspension resulted in projected incremental cost-effectiveness ratios for the SAP with automated insulin suspension versus CSII of Swedish Krona (SEK) 139,795 [euros (EUR) 14,648] per QALY gained for patients at increased risk for hypoglycemia and SEK 251,896 (EUR 26,395) per QALY gained for patients with uncontrolled HbA1c. In both groups, SAP with automated insulin suspension also reduced the incidence of diabetes-related complications relative to CSII. CONCLUSIONS: In Sweden, SAP with automated insulin suspension likely represents a cost-effective treatment option relative to CSII for the management of patients with type 1 diabetes with a history of severe hypoglycemic events or patients who struggle to achieve good glycemic control despite the use of CSII. FUNDING: Medtronic International Trading Sàrl.

Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a U.K. perspective.

AIMS/HYPOTHESIS: Continuous subcutaneous insulin infusion (CSII) is an important treatment option for type 1 diabetes patients unable to achieve adequate glycemic control with multiple daily injections (MDI). Combining CSII with continuous glucose monitoring (CGM) in sensor-augmented pump therapy (SAP) with a low glucose-suspend (LGS) feature may further improve glycemic control and reduce the frequency of hypoglycemia. A cost-effectiveness analysis of SAP + LGS vs. CSII plus self-monitoring of blood glucose (SMBG) was performed to determine the health economic benefits of SAP + LGS in type 1 diabetes patients using CSII in the U.K. METHODS: Cost-effectiveness analysis was performed using the CORE diabetes model. Treatment effects were sourced from the literature, where SAP + LGS was associated with a projected HbA1c reduction of -1.49% vs. -0.62% for CSII, and a reduced frequency of severe hypoglycemia. The time horizon was that of patient lifetimes; future costs and clinical outcomes were discounted at 3.5% and 1.5% per annum, respectively. RESULTS: Projected outcomes showed that SAP + LGS was associated with higher mean quality-adjusted life expectancy (17.9 vs. 14.9 quality-adjusted life years [QALYs], SAP + LGS vs. CSII), and higher life expectancy (23.8 vs. 21.9 years), but higher mean lifetime direct costs (GBP 125,559 vs. GBP 88,991), leading to an incremental cost-effectiveness ratio (ICER) of GBP 12,233 per QALY gained for SAP + LGS vs. CSII. Findings of the base-case analysis remained robust in sensitivity analyses. CONCLUSIONS/INTERPRETATION: For UK-based type 1 diabetes patients with poor glycemic control, the use of SAP + LGS is likely to be cost-effective compared with CSII plus SMBG.

Short-term cost analysis of complications related to glycated hemoglobin in patients with type 1 diabetes in the Italian setting.

AIMS: The aim of this study is to assess the impact of the diabetes-related complications on costs and to shed light on the potential savings that could be obtained by the National Healthcare System if better glycemic control was to be achieved in the type 1 diabetes population. METHODS: Epidemiologic data were used to distribute diabetes type 1 patients into A1c levels, and the relative risk of diabetes-related complications associated with the level of A1c was extrapolated from published risk curves. The costs associated with all complications in the Italian settings, retrieved from published literature, were used to estimate the economic impact of complications in each A1c level from the NHS perspective and the potential savings that could be obtained should a treatment strategy allow to achieve better metabolic control. RESULTS: The reduction in the number of complications translates into consistent monetary savings compared to current scenario. Within 5 years, €29 and €33 million would be saved if all patients reduced their A1c level by 1 % and within the range 7-8 % (53-64 mmol/mol), respectively. CONCLUSIONS: This work allows focusing on the impact of managing the diabetes-related complications on the overall costs, not yet reported in the literature. It was shown that the potential savings for the National Healthcare Service associated with a more effective glycemic control are substantial.

Cost-Effectiveness of Sensor-Augmented Pump Therapy with Low Glucose Suspend Versus Standard Insulin Pump Therapy in Two Different Patient Populations with Type 1 Diabetes in France.

BACKGROUND: Sensor-augmented pump therapy (SAP) provides a useful adjunct relative to continuous subcutaneous insulin infusion (CSII) alone. It can provide early warning of the onset of hyperglycemia and hypoglycemia and has the functionality to suspend insulin delivery if sensor glucose levels fall below a predefined threshold. The aim was to assess the cost-effectiveness of SAP with low glucose suspend (LGS) versus CSII alone in type 1 diabetes. MATERIALS AND METHODS: Cost-effectiveness analysis was performed using the CORE Diabetes Model, using published clinical input data. The analysis was performed in two cohorts: one with uncontrolled glycated hemoglobin at baseline and one at elevated risk for hypoglycemic events. The analysis was conducted from a healthcare payer perspective over a lifetime time horizon; future costs and clinical outcomes were discounted at 4% per annum. RESULTS: In patients with uncontrolled glycated hemoglobin at baseline, SAP + LGS resulted in improved discounted quality-adjusted life expectancy (QALE) versus CSII (10.55 quality-adjusted life-years [QALYs] vs. 9.36 QALYs) but higher mean lifetime direct costs (€84,972 vs. €49,171) resulting in an incremental cost-effectiveness ratio (ICER) of €30,163 per QALY gained. In patients at elevated risk for hypoglycemia, the ICER was €22,005 per QALY gained for SAP + LGS versus CSII as lifetime costs were higher (€88,680 vs. €57,097), but QALE was also higher (18.46 QALYs vs. 18.30 QALYs). CONCLUSIONS: In France, projected improvements in outcomes with SAP + LGS versus CSII translated into an ICER generally considered as good value for money, particularly in patients who experience frequent and/or problematic hypoglycemic events.

Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study.

OBJECTIVES: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs). METHODS: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared. RESULTS: The majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years. CONCLUSIONS: The results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.

Pharmaco-economic consequences of losartan therapy in patients undergoing diabetic end stage renal disease in EU and USA.

Diabetic nephropathy is the most frequent cause of end stage renal disease (ESRD). As ESRD incidence increases continuously, more resources are needed for treatment. The objective was to evaluate the economic impact of losartan added to the standard care administered to diabetic subjects with ESRD. The analysis has involved more than 500 million inhabitants. Standard methods have been used in order to conduct an economic evaluation comparing the economic outcomes deriving from the administration of losartan added to standard care versus standard care alone in patients with type 2 diabetes mellitus (DM) and nephropathy over 3.4 years. The study was hence conducted from the perspective of the third-party payer. The clinical outcome data were based on the results from the Reduction of Endpoints in Non-Insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan (RENAAL) trial. Direct medical costs are referred to the purchase costs of losartan and to the costs of hospitalization. The costs were discounted back at an annual rate of 3%. Also sensitivity analysis was performed. The RENAAL study showed that losartan confers strong renal protection in patients with DM and nephropathy. Losartan results into cost saving in all countries considered: 3,602.98€/Italy, 4,531.35€/France, 3,019.66€/Germany, 3,949.50€/Switzer-land, and 3,855.50€/US per patient. Results are not sensitive to both clinical and economic variables. In addition to the medical benefits, this analysis demonstrates the economic relevance of the treatment with losartan in DM patients affected by nephropathy.

Cost-effectiveness analysis of TNF-alpha blockers for the treatment of chronic plaque psoriasis in the perspective of the Italian health-care system.

The cost-effectiveness of biological treatments for psoriasis is not well determined and may vary from country to country. The objectives of this study was to perform a cost-effectiveness analysis of infliximab compared with other anti-tumor necrosis factor-alpha agents for the treatment of psoriasis in Italy. The incremental cost-effectiveness ratio per patients achieving at least 75% improvement in the psoriasis area and severity index assessed over 24- and 48-50-week periods was calculated. Efficacy data were drawn from randomized controlled trials when available or from open label studies. Considering patients achieving psoriasis area and severity index at week 24 and 48-50, infliximab was dominant (more effective and less costly) over etanercept given at 50 mg twice weekly. In contrast, infliximab was not dominant over etanercept at other dosages or over adalimumab. When considering the impact of therapy on quality of life at Week 12 using the Dermatology Life Quality Index equal to zero, infliximab resulted more effective and less costly than etanercept. Therefore, infliximab seems to be cost-effective in the therapy of psoriasis. Further cost-efficacy evaluations based on head-to-head trials are necessary to address health economic considerations.

Psoriatic arthritis: pharmacoeconomic considerations.

Tumor necrosis factor (TNF) antagonists provide a clinically and economically efficient treatment option for psoriatic arthritis (PsA). PsA is a chronic inflammatory disease affecting the musculoskeletal system that, if untreated, can be disabling due to the progressive joint damage and the considerable impact on functional status and health-related quality of life. Therapies for PsA have been disappointing until recently. Traditional disease-modifying drugs are used to control symptoms, but there is no evidence that they slow the progression of the damage in peripheral joints. The introduction of the TNF-alpha-blocking agents has revolutionized the therapeutic management of PsA. These drugs lessen symptoms and signs of inflammation, enhance quality of life and functional capacity, and hinder the evolution of structural joint damage. TNF-alpha blockers are very expensive and not easily available to all patients, either depending on a national system or private insurance. Nevertheless, recent pharmacoeconomic studies have demonstrated that TNF-alpha blockers are cost-effective treatment options for the musculoskeletal and cutaneous manifestations of psoriatic disease.

Setting dialysis start at 6.0 ml/min/1.73 m2 eGFR--a study on safety, quality of life and economic impact.

BACKGROUND: End-stage renal disease care requires enormous economic resources. A timely dialysis start could reduce the costs of the renal replacement therapy (RRT). Our aim was to measure the time to dialysis in CKD patients, with an estimated glomerular filtration rate (eGFR)