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Sensitivity analysis in a health economic model of a cohort of IMSS T1D adult patients to determine the ICER of CSII therapy compared to MDI therapy

Sensitivity analysis in a health economic model of a cohort of IMSS T1D adult patients to determine the ICER of CSII therapy compared to MDI therapy

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Background: To estimate the incremental cost-effectiveness ratio (ICER) of the use of continuous subcutaneous insulin infusion (CSII) therapy versus multiple daily injections (MDI) therapy in adult patients with type 1 diabetes (T1D) at the Mexican Institute of Social Security (IMSS). Methods: An analysis was developed using the internationally...

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... (5) unit cost of $2.12 per IU of lispro insulin b Calculated considering (1) insulin types, daily doses obtained from the clinical records of the baseline cohort and (2) unit cost according to the type of insulin c Weighted cost of AMI of patients with discharge due to improvement (56%) and mortality (44%), weight based on patient distribution of GRDs d Weighted cost of stroke of patients with (14%) and without (86%) infarction, weight based on patient distribution of GRDs e Hemodialysis procedure plus anastomosis artery-vein required f Weighted average of manual (54%) and automated (46%) procedures based on Méndez-Duran [28], plus cost of peritoneal dialysis performed in operating room g Transplant plus post-transplant short-term care according to the transplant protocol at the Mexican National Institute of Medical Sciences and Nutrition "Salvador Zubiran" (INCMNSZ) [29] h Follow-up healthcare, according to Mexico´s INCMNSZ transplant protocol No. work days/year cPage 7 of 12 Doubova et al. Cost Eff Resour Alloc (2019) 17:19 One-way deterministic sensitivity analysis and subgroup analysis Table 7 presents the outcomes of the sensitivity analysis, indicating that the results are most sensitive to modifications in the baseline HbA1c. Specifically, the ICER ranged from MXN$262,237/QALY for patients with uncontrolled HbA1c (> 9%) at baseline, to MXN$1,334,460/ QALY for patients with controlled HbA1c (≤ 9%). ...

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... This study conducted the first cost-effectiveness analysis of CSII and MDI using health economics model and CORE mode, based on a cohort of T1DM pediatric patients treated in a public Our study shows that the usage of CSII is an more effective therapy, although it has a higher overall cost of treating children with T1DM, and confirms similar results reported in the literature on improving metabolic control, reducing the incidence of complications and improving quality of life (32)(33)(34)(35). Under the scenarios of 60 years of time horizon simulation, the long-term direct medical cost of the CSII group is only 67,137 yuan higher than that of the MDI group, because CSII treatment significantly reduces the treatment cost of diabetes-related complications, especially renal complications and severe hypoglycemia events. ...
... Under the scenarios of 30, 40, 50, and 60 years of time horizon simulation, ICER is lower than 3 times of Qingdao's per capita GDP in 2019,however,under the scenarios of 30 and 40 years, ICER is more than 1.5 times of per capita GDP. The results of this study are consistent with other studies that evaluated the efficacy and ICER of insulin pump therapy in developed countries (34,36,37). The findings show that compared with MDI, long-term or even life-long CSII treatment has cost-effective advantages. ...
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Objectives To evaluate the clinical and economic consequences of continuous subcutaneous insulin infusion (CSII) vs. multiple daily injections (MDI) in children and adolescents with type 1 diabetes mellitus (T1DM) from a public health care system in developed areas of developing country, considering changes in glycemic Control, daily insulin requirements, lipid profile, body mass index (BMI), frequency of severe hypoglycemia and Diabetic Ketoacidosis (DKA) and diabetic complications. Methods This was a retrospective cohort study of children and adolescents with T1DM. Data were collected at baseline and the end of every year including glycated hemoglobin (HbA1c), insulin dose, lipid profile, blood pressure, and adverse events (severe hypoglycemia and DKA). The Cost-effectiveness analysis was performed using the IQVIA CORE Diabetes Model (CDM) to simulate diabetes progression by utilizing the clinical data obtained from the two groups. The main outcome measures were Life Expectancy, Quality adjusted life years (QALYs), Total Costs and Incremental Costs and Effectiveness Ratio (ICER) of CSII compared with MDI in Chinese pediatric patients with T1DM in Qingdao City (60 years). Results Mean HbA1c values and daily insulin doses were significantly lower in those receiving CSII therapy throughout follow-up. Mean direct lifetime costs were ¥ 67,137 higher with CSII treatment than with MDI for pediatric patients. Treatment with CSII was associated with an improvement in life expectancy of 0.41 years for pediatric patients compared with MDI based on CORE diabetes model simulation. The corresponding gains in QALYs were 0.42. These data produced corresponding ICER is ¥ 161,815 per QALY for pediatric T1DM patients in Qingdao. Sensitivity analyses suggested that our base-case assumptions were mostly robust. Conclusions CSII is associated with improved long‐term clinical outcomes compared with MDI. Based on this model analysis, CSII appears to be more cost-effective for the Qingdao TIDM pediatric population and health care system.
... The better glycemic control associated with insulin pumps reduces the chance of becoming hypoglycaemic, or suffering keto-acidosis, (blood glucose becoming too high) (Karges et al., 2017). Even though insulin can be administered using a simple injection pen, there will be an increasing need for insulin pumps, which are considered the gold standard for outpatient insulin delivery and control, despite their high cost (Hirsch et al., 2005;Doubova et al., 2019). ...
Article
Insulin pumps are the most consistent and accurate means of regulating blood glucose levels in Types 1 and 2 diabetes. However, the technology is underutilised due to very high costs. A typical insulin pump costs US$6500, which makes this gold standard of care inaccessible to many, reducing equity of access to care. Since insulin pumps were first introduced, the simple hardware has not changed significantly. Pump manufacturers couple the low-cost and simple hardware with their own software, removing consumer choice and locking value into the product. Using both a traditional motor-driven and novel spring-loaded approach, insulin pump hardware can be replicated for US$100. Initial testing of the traditional motor-driven prototype proves the low-cost approach has comparable accuracy to commercially available pumps, with 85.1% of basal doses delivered within 5% of target. The results obtained indicate pump hardware and software can be separated with no significant loss in accuracy. If a separate market for pump software is established, costs can be driven down through market pressure given the increasing access to relatively extensive mobile and cloud computing. If open-source software is made accessible, a complete pump could be offered for US$100. A 98.5% cost reduction would drastically improve pump accessibility, particularly in developing nations, and could lead to a global improvement in diabetes treatment, outcomes and costs.
... The effectiveness and advantages of continuous subcutaneous insulin infusion (CSII) are well-established [20][21][22][23] . Studies performed on the economic value of CSIIs compared to multiple daily injections (MDI) have demonstrated cost-effectiveness at varying willingness-to-pay thresholds across a broad set of geographies [24][25][26][27] . ...
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Aims The purpose of this article is to compare the insulin cost-savings of the Medtronic Extended Infusion Set (or EIS, a.k.a. Extended Wear Infusion Set) designed and labeled for up to 7-day use with rapid-acting insulins to the current standard of care, 2- to 3-day infusion sets. Methods There are three major improvements (reducing insulin waste, plastic waste, and adverse events) with the extended duration of infusion set wear. This analysis focuses on cost savings from reduced insulin wastage during set changes. Studies published on insulin infusion set survival and EIS clinical trial data (NCT04113694) were used to estimate device lifetime performance using a Markov chain Monte Carlo model, including the assessment of adverse effects and device failure. Total costs associated with infusion set change or failure were systematically found in published literature or estimated based on physical usage, and the direct impact on insulin costs was calculated. Results Based on the model and clinical data, EIS users can expect to change their infusion sets about 75 fewer times than standard set users each year. The costs related to unrecoverable insulin during an infusion set and reservoir change in the US were estimated to range from $19.79 to $22.48, resulting in approximately $1324 to $1677 in annual cost-savings for the typical user from minimizing insulin wastage. Limitations The study only assessed devices used within a monitored setting, that is, clinical trials. In addition, the variability associated with healthcare standards and costs and individual treatment variability including insulin dosages, contribute to the uncertainties with the calculations. Conclusions Our analysis demonstrates that by extending the duration of infusion set wear, there may be substantial cost savings by reducing insulin wastage.
... Furthermore, 40 of the 118 subjects (33.8%) reported having either no significant change in frequency of hypoglyacaemic attacks or more hypoglycaemic attacks after CSII therapy. CSII has been highlighted in several health economic studies as being more cost effective than MDI, at least in adults [18,19], but not in children [20]. In the present study, the common issues encountered by the subjects regarding their medical devices should be reported to the Saudi Food and Drug Administration (SFDA) where approval of such devices takes place. ...
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Introduction: Type 1 diabetes mellitus (T1DM) is on the rise in Saudi Arabia. Management of T1DM is crucial in curbing the economic burden of this disease. Studies on insulin pump issues are scarce in the region. The present study aims to fill this gap. Methods: In this single-centre, retrospective study done in King Abdulaziz Medical City (KAMC) from March 2018 to March 2019, a total of 118 known Saudi T1DM adults (34 males and 84 females) were included. Data on demographics, glycated haemoglobin (HbA1c) and CSII use were collected. Results: The most common problem encountered by the patients on CSII was breaking down of the pump (30.0%), relocation of the cannula or tubing (22%) and air bubbles affecting delivery (16.1%). Eighty-one subjects (68.6%) claimed to have been admitted for DM management while on CSII. The use of CSII led to a significant reduction in HbA1c in all subjects (p < 0.001), but levels remain suboptimal. Only 53 subjects (44.9%) reported no significant problems in their CSII experience. Conclusion: There is a high prevalence of T1DM adult patients experiencing device malfunctions and other issues while on CSII therapy. This may account for suboptimal improvement in the glycaemic control among T1DM Saudi patients. Issues on adherence and device malfunctions should be investigated further.
Article
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BACKGROUND: A tubeless, on-body automated insulin delivery (AID) system (Omnipod 5 Automated Insulin Delivery System) demonstrated improved glycated hemoglobin A1c levels and increased time in range (70 mg/dL to 180 mg/dL) for both adults and children with type 1 diabetes in a 13-week multicenter, single-arm study. OBJECTIVE: To assess the cost-effectiveness of the tubeless AID system compared with standard of care (SoC) in the management of type 1 diabetes (T1D) in the United States. METHODS: Cost-effectiveness analyses were conducted from a US payer's perspective, using the IQVIA Core Diabetes Model (version 9.5), with a time horizon of 60 years and an annual discount of 3.0% on both costs and effects. Simulated patients received either tubeless AID or SoC, the latter being defined as either continuous subcutaneous insulin infusion (86% of patients) or multiple daily injections. Two cohorts (children: <18 years; adults: ≥18 years) of patients with T1D and 2 thresholds for nonsevere hypoglycemia (nonsevere hypoglycemia event [NSHE] <54 mg/dL and <70 mg/dL) were considered. Baseline cohort characteristics and treatment effects of different risk factors for tubeless AID were sourced from the clinical trial. Utilities and cost of diabetes-related complications were obtained from published sources. Treatment costs were derived from US national database sources. Scenario analyses and probabilistic sensitivity analyses were performed to test the robustness of the results. RESULTS: Treating children with T1D with tubeless AID, considering an NSHE threshold of less than 54 mg/dL, brings incremental life-years (1.375) and quality-adjusted life-years (QALYs) (1.521) at an incremental cost of $15,099 compared with SoC, resulting in an incremental cost-effectiveness ratio of $9,927 per QALY gained. Similar results were obtained for adults with T1D assuming an NSHE threshold of less than 54 mg/dL (incremental cost-effectiveness ratio = $10,310 per QALY gained). Furthermore, tubeless AID is a dominant treatment option for children and adults with T1D assuming an NSHE threshold of less than 70 mg/dL compared with SoC. The probabilistic sensitivity analyses results showed that compared with SoC, in both children and adults with T1D, tubeless AID was cost-effective in more than 90% of simulations, assuming a willingness-to-pay threshold of $100,000 per QALY gained. The key drivers of the model were the cost of ketoacidosis, duration of treatment effect, threshold of NSHE, and definition of severe hypoglycemia. CONCLUSIONS: The current analyses suggest that the tubeless AID system can be considered a cost-effective treatment compared with SoC in people with T1D from a US payer's perspective. DISCLOSURES: This research was funded by Insulet. Mr Hopley, Ms Boyd, and Mr Swift are full-time Insulet employees and own stock in Insulet Corporation. IQVIA, the employer of Ms Ramos and Dr Lamotte, received consulting fees for this work. Dr Biskupiak is receiving research support and consulting fees from Insulet. Dr Brixner has received consulting fees from Insulet. The University of Utah has received research funding from Insulet. Dr Levy is a consultant with Dexcom and Eli Lilly and has received grant/research support from Insulet, Tandem, Dexcom, and Abbott Diabetes. Dr Forlenza conducted research sponsored by Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly. He has been speaker/consultant/advisory board member for Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly.
Article
Objective: To evaluate the health economics of using continuous subcutaneous insulin infusion (CSII) therapy versus multiple daily injections (MDI) therapy in children and adolescent patients with type 1 diabetes (T1D) in Qingdao, China. Methods: A long-term cost-effectiveness analysis was conducted using the IQVIA Core Diabetes Model (CDM). The baseline characteristics of the simulated cohorts were obtained from 213 pediatric T1D patients who received care with CSII(104 cases) or MDI(109 cases) in Qingdao from January 1, 2015 to March 31, 2019. In the essential case, the expenditure of the complications and treatment of the disease with both therapies were evaluated in Chinese currency from the perspective of healthcare system. In a secondary analysis, the model used a 70-year time horizon, and a discount rate of 5% was applied to all future health outcomes and costs. A one-way sensitivity analysis was conducted on delta HbA1c, different price of insulin pump, price of each upgrade cycle rates and different discount rates. Uncertainty was also evaluated by the probability sensitivity analysis and scenario analysis. Results: In the base-case analysis, the lifetime total costs were lower for CSII group at ¥630,871 per patient compared with ¥672,672 for MDI group. The quality-adjusted life years (QALYs) gained were 11.612 and 11.197 for patients treated with CSII group and MDI group, respectively. The CSII group was cost-saving compared to MDI group. The feasibility of CSII group being cost-effective was 100% under the threshold of 3 times per capita GDP of China in 2019 (¥212,676) which was indicated from the probabilistic sensitivity analysis. Regarding scenario analysis, the ICER of the CSII group compared to MDI was between -151,583 and 153,366 RMB/QALYs, which is cost-effect. Conclusions: This economic evaluation compared CSII therapy versus MDI therapy for T1D children and adolescent patients in China and findings indicate that CSII should be considered a preferred treatment modality to MDI.