AIMS:Non-cystic fibrosis bronchiectasis (NCFB) is a chronic progressive respiratory disorder occurring at a rate ranging from 4.2 to 278.1 cases per 100,000 persons, depending on age, in the United States. For many patients with NCFB, the presence of Pseudomonas aeruginosa (PA) makes treatment more complicated and typically has worse outcomes. Management of NCFB can be challenging, warranting a better understanding of the burden of illness for NCFB, treatments applied, healthcare resources used, and subsequent treatment costs. Comparing patients diagnosed with exacerbated NCFB, with or without PA on antibiotic utilization, treatments, and healthcare resources utilization and costs was the purpose of this study.MATERIALS AND METHODS:This was a retrospective cohort study of commercial claims from IQVIA's PharMetrics Plus database (January 1,2006-December 31, 2020). Study patients with a diagnosis of NCFB were stratified into two groups based on the presence or absence of PA, then followed to identify demographic characteristics, comorbid conditions, antibiotic treatment regimen prescribed, healthcare resources utilized, and costs of care.RESULTS:The results showed that patients with exacerbated NCFB who were PA+ had significantly more oral antibiotic fills per patient per year, more inpatient admissions with a longer length of stay, and more outpatient encounters than those who were PA-. For costs, PA+ patients also had significantly greater total healthcare costs per patient when compared to those who were PA-.CONCLUSION:Exacerbated NCFB with PA+ was associated with increased antibiotic usage, greater resource utilization, and increased costs. The major contributor to the cost differences was the use of inpatient services. Treatment strategies aimed at reducing the need for inpatient treatment could lessen the disparities observed in patients with NCFB.

Although possible effects of lipid parameters, and several important genetic factors, and cytokines on the development of coronary artery disease (CAD) have been demonstrated, there is still debate about how the lipid profile affects the sub-group of patients in a specific population. This study aimed to evaluate age- and gender-based effect of lipid profile in correlation with their IL-1 and IL-6 cytokine levels in South Indian population.Angiographically confirmed 150 CAD patients' with or without hypertension and 150 healthy control individuals of both the genders between 18 and 70 years of age were enrolled. Quantitative estimation of IL-1 and IL-6 protein in each serum sample was evaluated using ELISA. The plasma concentrations of cholesterol, HDL, LDL, VLDL and triglycerides were determined using different biochemical tests. Correlation was established between cytokines and lipid profile of patients in different sub-groups using Pearson's linear regression analysis.Sub-group analysis showed VLDL and triglyceride levels as significant risk factors for CAD, especially in women patients. Older men (>40 years) and younger women (<40 years) reported with the highest negative correlation of IL-1 with lipid parameters, while older women showed strong positive correlation. Both younger and older men (<40 years) showed the strongest negative correlation of IL-6 with lipid parameters. Younger women showed the strongest negative correlation, while older women had the strongest positive correlation of IL-6 with lipid parameters.Overall, this study indicates the importance of sub-group analysis in identifying comprehensive association of different parameters with the risk of CAD.

BACKGROUND:Chronic obstructive pulmonary disease (COPD) is a progressive debilitating condition with frequent exacerbations that have a high burden for patients and society. Digital tools may help to reduce the economic burden for patients and payers by improving outcomes. The Propeller platform is a digital self-management tool that facilitates passive monitoring of inhaler medication utilization, potentially assisting the healthcare team to identify patients at risk of a COPD exacerbation who may require further intervention. This study estimated the budget impact of Propeller from commercial payer and Medicare fee-for-service payer perspectives.METHODS:An Excel-based model was used to estimate the budget impact of Propeller for COPD patients in commercial and Medicare population sizes of 5 million members. Data on prevalence, baseline healthcare resource utilization (HCRU), and baseline use of rescue and controller inhaler medications with unit costs (adjusted to 2020 US dollars) were obtained from peer-reviewed literature. Data on reductions in HCRU during Propeller usage were based on direct evidence. Estimates for costs of remote monitoring were obtained from publicly available information. All patients were assumed to have insurance claims related to ongoing remote monitoring.RESULTS:The estimated number of annual eligible COPD patients for commercial and Medicare was 212,200 and 606,600, respectively. Propeller decreased costs by an estimated $2,475 (commercial) and $915 (Medicare) per enrolled patient. The greatest increase in expenditure was for remote monitoring related expenses. After accounting for estimated reductions in hospitalizations, emergency department visits and short-acting beta-agonist use, total net savings were approximately $1.60 and $1.70 per-member per-month for commercial and Medicare payers, respectively.CONCLUSION:Propeller is projected to be cost saving from both the commercial and Medicare payer perspectives.

This clinical cost offset analysis compared rtCGM vs. SMBG in people with type 1 diabetes (T1D) applying results from a 3-year, nonrandomized, prospective, real-world clinical trial (COMISAIR). Clinical effects for HbA1c reduction using rtCGM vs. SMBG combined with MDI (-0.96%) or CSII (-0.71%) after 3 years were converted directly into an economic benefit and inflated ($U.S. 2020). The MDI group showed reduced 3-year event rates for severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) of 68% and 100%, respectively. The CSII group showed 50% and nearly 0% fewer SH and DKA events, respectively, using rtCGM vs. SMBG. Estimated costs for HbA1c reduction (low/high) along with SH and DKA events were taken from published literature and inflated ($U.S. 2020). Switching from SMBG to rtCGM would result in an estimated 487 and 238 fewer SH and DKA events, respectively, for the MDI group and 208 and 8 fewer SH and DKA events in the CSII group. Table 1 describes the potential economic benefit. Sustained reduction in HbA1c for rtCGM vs. SMBG represents over 95% of the potential economic value and per person savings range from $3,555-$6,747 after 3 years. Our modelling study demonstrates compelling clinical and economic benefits of sustained HbA1c control using rtCGM over SMBG in T1D. Disclosure J. Soupal: Advisory Panel; Self; Abbott. Consultant; Self; Medtronic, Roche Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc. J.J. Isitt: Employee; Self; Dexcom, Inc. G. Grunberger: Research Support; Self; Medtronic. M. Prazny: Speaker’s Bureau; Self; Novartis Pharmaceuticals Corporation, Roche Diabetes Care. Other Relationship; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi, Teva Pharmaceutical Industries Ltd. C. Parkin: Consultant; Self; Abbott, CeQur Corporation, Dexcom, Inc., DreaMed Diabetes, Novo Nordisk Inc., Onduo, Roche Diabetes Care, Valeritas, Inc. M.E. Minshall: Consultant; Self; Dexcom, Inc. P.M. Lynch: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Dexcom, Inc. Funding Dexcom, Inc.

A BIA was performed comparing clinical cost offsets for rt-CGM compared with SMBG for U.S. Medicaid enrollees with type 1 diabetes (T1D) over one year. Clinical effects for HbA1c reduction using rt-CGM (-1.0%) and SMBG (-0.4%) were taken from the DIAMOND randomized controlled trial, converted into an economic benefit, and inflated ($U.S. 2019). Reduced hospitalization rates for severe hypoglycemia (SH; -73%) and diabetic ketoacidosis (DKA; -80%) were taken from the RESCUE trial, a Belgian observational cohort study, where SMBG was used in the year prior to countrywide rt-CGM reimbursement and outcomes tracked for one year. Estimated cost savings for HbA1c reduction (low and high), SH and DKA hospitalizations were taken from published literature and inflated ($U.S. 2019). We tested various ranges of pricing for rt-CGM and SMBG. Switching all U.S. Medicaid enrollees with T1D from SMBG to rt-CGM would result in an estimated 51,796 and 21,253 fewer SH and DKA hospitalizations, respectively, per year. Applying the clinical cost offsets against the added cost for rt-CGM over SMBG resulted in cost savings in most scenarios. Our modelling study demonstrates the substantial clinical and economic benefits using rt-CGM over SMBG in all U.S. Medicaid enrollees with T1D. Disclosure M.E. Minshall: Consultant; Self; Dexcom, Inc. J.J. Isitt: Employee; Self; Dexcom, Inc. C. Graham: Consultant; Self; Dexcom, Inc., DreaMed Diabetes. P.M. Lynch: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Dexcom, Inc. Funding Dexcom, Inc.

Background Several treatment options are available for patients with type 2 diabetes mellitus who are making the transition from oral antidiabetes drugs (OADs) to insulin. Two options currently recommended by the Canadian Diabetes Association for initiating insulin therapy in patients with type 2 diabetes who are no longer responsive to OADs alone are insulin glargine plus OADs, and premixed insulin therapy only. Because of differences in efficacy, adverse events (such as hypoglycaemia) and acquisition costs, these two treatment options may lead to different long-term clinical and economic outcomes. Objective To determine the cost effectiveness of insulin glargine plus OADs compared with premixed insulin without OADs in insulin-naive patients with type 2 diabetes in Canada. Methods Using treatment effects taken from a published clinical trial, the validated IMS-CORE Diabetes Model was used to simulate the long-term cost effectiveness of insulin glargine with OADs, versus premixed insulin. Input treatment effects for the two therapeutic approaches were based on changes in glycosylated haemoglobin A 1c (HbA 1c ) at clinical trial endpoint, and hypoglycaemia rates. The analysis was conducted from the perspective of the Canadian Provincial payer. Direct treatment and complication costs were obtained from published sources (primarily from Ontario) and reported in $Can, year 2008 values. All base-case costs and outcomes were discounted at 5% per year. Sensitivity analyses were conducted around key parameters and assumptions used in the study. Outcomes included direct medical costs associated with both treatment and diabetes-related complications. Cost-effectiveness outcomes included total average lifetime (35 years) costs, life expectancy (LE), QALYs and incremental cost-effectiveness ratios (ICERs). Results Base-case analyses showed that, compared with premixed insulin only, insulin glargine in combination with OADs was associated with a 0.051-year increase in LE and a 0.043 increase in QALYs. Insulin glargine plus OADs showed a very slight increase in total direct costs ($Can343 ± 2572), resulting in ICERs of $Can6750 per life-year gained (LYG) and $Can7923 per QALY gained. However, considerable uncertainty around the ICERs was demonstrated by insulin glargine having a 50% probability of being cost effective at a willingness-to-pay threshold of $Can10 000 per QALY, and a 54% probability at a $Can20 000 threshold. Base-case results were most sensitive to assumed disutilities for hypoglycaemic events, to the assumed effect of insulin glargine plus OADs on HbA 1c , and to its assumed acquisition costs. Conclusions These findings should be interpreted within the context of a large degree of uncertainty and of several study limitations that include a single clinical trial as the source for primary treatment assumptions and a single province as the source for most cost inputs. Under current study assumptions and limitations, insulin glargine plus OADs was projected to be a cost-effective option, compared with premixed insulin only, for the treatment of insulin-naive patients with type 2 diabetes unresponsive to OADs. Additional work is needed to examine the generalizability of the findings to individual jurisdictions of the Canadian healthcare system.

The establishment of a watertight closure of the dura mater following spinal surgery is critical as post operative cerebral spinal fluid (CSF) leaks may cause medical complications, increased length of hospital stay, reduced quality of life, and added costs.

OBJECTIVE:To assess the cost-effectiveness of Roux-en-Y gastric bypass for treating type 2 diabetes mellitus (T2DM) in the United States compared with standard medical management, using clinical data from a prospective observational study conducted at an academic medical center.STUDY DESIGN:Our study used a predictive health economic model (the CORE Diabetes Model) to project the long-term costs and clinical effectiveness of Roux-en-Y gastric bypass as a treatment for T2DM using the prospective observational study as the basis for our clinical effectiveness assumptions.METHODS:The CORE Diabetes Model used Monte Carlo simulation with tracker variables to estimate the lifetime costs and clinical outcomes of Roux-en-Y gastric bypass compared with standard medical management of obese T2DM patients. Sensitivity analyses were performed on key clinical assumptions, discount rates, and shorter time horizons.RESULTS:The base-case scenario yielded an incremental cost-effectiveness ratio (ICER) of $21,973 per quality-adjusted life-year (QALY) gained. In sensitivity analyses, shortening the time horizon to 5 and 10 years and excluding the negative impact of increased body mass index on the patient's quality of life had the greatest adverse impact on the ICERs (ie, higher cost per QALY).CONCLUSIONS:Under base-case assumptions, Roux-en-Y gastric bypass is cost-effective in the treatment of T2DM in the United States with an ICER below $50,000 per QALY gained. Sensitivity analyses indicated that bariatric surgery is not cost-effective over shorter time horizons, or if the negative quality-of-life impact of increased body mass index is ignored.

OBJECTIVE:The long-term cost-effectiveness of using pioglitazone plus metformin (Actoplusmet dagger) compared with rosiglitazone plus metformin (Avandamet double dagger) in treating type 2 diabetes (T2DM) was assessed from a US third-party payer perspective.RESEARCH DESIGN AND METHODS:Clinical efficacy (change in HbA(1c) and lipids) and baseline cohort parameters were extracted from a 12-month, randomized clinical trial (Derosa et al., 2006) evaluating the efficacy and tolerability of pioglitazone versus rosiglitazone, both in addition to metformin, in adult T2DM patients with insufficient glucose control (n = 96). A Markov-based model was used to project clinical and economic outcomes over 35 years, discounted at 3% per annum. Costs for complications were taken from published sources. Base-case assumptions were assessed through several sensitivity analyses.MAIN OUTCOME MEASURES:Outcomes included incremental life-years, quality-adjusted life-years (QALYs), total direct medical costs, cumulative incidence of complications and associated costs, and incremental cost-effectiveness ratios (ICERs).RESULTS:Compared to rosiglitazone plus metformin, pioglitazone plus metformin was projected to result in a modest improvement in 0.187 quality-adjusted life-years. Over patients' lifetimes, total direct medical costs were projected to be marginally lower with pioglitazone plus metformin (difference -$526.), largely due to reduced CVD complication costs. While costs were higher among renal, ulcer/amputation/neuropathy, and eye complications in the pioglitazone plus metformin group, the cost savings for CVD complications outweighed their economic impact. Pioglitazone plus metformin was found to be a dominant long-term treatment strategy in the US compared to rosiglitazone plus metformin. Sensitivity analyses showed findings to be robust under almost all scenarios, including short-term time horizons, 6% discounting, removal of individual lipid parameters, and modifications of patient cohort to more closely represent a US T2DM population. Pioglitazone plus metformin was no longer dominant with 0% discounting, with 25% reduction in its HbA(1c) effects, or with a 15% increase in its acquisition price.CONCLUSIONS:Under a range of assumptions and study limitations around cohorts, clinical effects, and treatment patterns, this long-term analysis showed that pioglitazone plus metformin, when compared to rosiglitazone plus metformin, was a dominant treatment strategy within the US payer setting. Results were driven by the combination of modest differences in QALYs and modest savings in total complication costs over 35 years.

Objective: This study was conducted to quantify the long-term cost-effectiveness of insulin detemir (Levemiry) versus intermediate-acting neutral protamine Hagedorn (NPH) insulin for the treatment of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in Canada, and to assess the sensitivity of results to dis-utilities for hypoglycemic events.Research design and methods: The web-based IMS- CORE diabetes model has a menu-driven interface programmed in hypertext markup language (HTML). It was used to project lifetime (60 years for T1DM and 35 years for T2DM) clinical and economic outcomes for patients on detemir vs. NPH. Cohort characteristics, utilities, and costs were derived from published literature. For T1DM, clinical trial data for HbA(1c) improvement (detemir -0.94% +/- 1.07; NPH -0.82% +/- 1.01) from baseline, and rates of hypoglycemic events (major events: 0.20 vs. 0.80 per patient-year for detemir vs. NPH, respectively) were modeled. For T2DM, observational study data for HbA(1c) improvement (detemir -0.18%) from baseline, and reductions in hypoglycemic events (major events: 0.0995 vs. 1.33 per patient-year for detemir vs. NPH, respectively) were modeled. Base-case hypoglycemia dis-utilities were -0.0118 for major and -0.0035 for minor events. Sensitivity analyses were conducted on discount rate and hypoglycemia dis-utility.Outcome measures: Outcomes included costs of treatment/management and costs (and incidence) of diabetes-related complications. Incremental cost-effectiveness ratios (ICERs) were calculated from differences in total costs and quality-adjusted life-years (QALYs).Results: Average total costs for T1DM were $CAN 83 622 +/- 4585 for detemir and $CAN 72 016 +/- 4593 for NPH. QALYs increased by 0.475 years with detemir, with an ICER of $ CAN 24 389/QALY. Average direct costs for T2DM were $CAN 74 919 +/- 6391 (detemir) and $CAN 69 230 +/- 6840 (NPH). QALYs increased by 0.305 years. The ICER was $CAN 18 677. Although detemir was associated with slightly lower costs for most complications, results were driven by the differences in rates and costs for hypoglycemic events, and their assumed dis-utility. Study limitations include the use of single trials for clinical assumptions and the lack of analyses for patient risk sub-groups.Conclusions: Findings provide evidence for the cost-effectiveness of detemir vs. NPH in treating T1 and T2DM in Canada, and support the key role of assumptions regarding the impact of hypoglycemic events. Additional work is needed to determine the extent to which results are robust for different sub-groups of patients and for variation in assumptions around HbA(1c) improvements and hypoglycemic event rates.

Background: Patients with type 1 diabetes mellitus (DM) may be treated with insulin via multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII).Objective: The purpose of this study was to evaluate the projected long-term cost-effectiveness of CSII compared with MDI by modeling a simulated sample of adult patients with type I DM in Canada.Methods: A health economic model was used to determine the incremental cost-effectiveness ratio (ICER) of CSII compared with MDI from the perspective of a Canadian provincial government. The primary input variable was change in glycosylated hemoglobin (HbA(1c)). A series of Markov constructs also simulated the progression of disease-related complications. Annual acquisition costs for CSII and MDI were year 2006 Can $6347.18 and Can $4649.69, respectively. A 60-year time horizon and a discount rate of 5.0% per annum on costs and clinical outcomes were used.Results: Mean direct lifetime costs were Can $15,591 higher with CSII treatment than MDI. Treatment with CSII was associated with an improvement in discounted life expectancy of 0.655 quality-adjusted life-years (QALYs) over a 60-year time horizon, compared with MDI (mean [SD], 10.029 [0.133] vs 9.374 [0.076] QALYs). ICERs were Can $27,264 per life-year gained and Can $23,797 per QALY for CSII compared with MDI. The results were most sensitive to HbA(1c) assumptions.Conclusion: Based on this analysis, CSII may be a cost-effective treatment option when compared with MDI in adult patients with type 1 DM in Canada. (Clin Ther. 2009;31:657-667) (C) 2009 Excerpta Medica Inc.

To estimate the long-term cost-effectiveness of adding pioglitazone versus placebo to standard treatment in high-risk patients with type 2 diabetes.The validated CORE Diabetes Model was modified to project long-term clinical and cost outcomes associated with pioglitazone versus placebo, based on results from PROactive. The model retained basic structure and functionality, with interdependent Markov submodels, Monte Carlo simulation and user interface. Adjustments to submodels were made to accommodate the PROactive primary end points. The analysis was from the perspective of a third party US health-care payer perspective, projected over a lifetime horizon using a 3% annual discount.Over a lifetime horizon, addition of pioglitazone was associated with increased life expectancy (0.237 life-years) and quality-adjusted life expectancy (QALE) [0.166 quality-adjusted life-years (QALYs)] versus placebo. Estimated long-term complication rates showed that pioglitazone reduced the number of events versus placebo for most outcomes. Lifetime total direct costs were marginally higher with pioglitazone versus placebo ($272,694 vs. $265,390, difference $7,305). The incremental cost-effectiveness ratio for pioglitazone versus placebo was $44,105 per QALY gained. Probabilistic sensitivity analysis indicated a 55% likelihood that pioglitazone would be considered cost-effective in the United States, with a willingness to pay of $50,000 per QALY gained.The addition of pioglitazone to existing therapy in high-risk patients with type 2 diabetes was projected to improve life expectancy, QALE and complication rates compared with placebo. Addition of pioglitazone was in the range generally considered acceptable.

OBJECTIVE To estimate the long-term cost-effectiveness of using continuous subcutaneous insulin infusion (CSII) compared with multiple daily injections (MDI) of insulin in adult and child/young adult type 1 diabetes mellitus (T1DM) patients from a third-party payer perspective in the United States. METHOD A previously validated health economic model was used to determine the incremental cost-effectiveness ratio (ICER) of CSII compared with MDI using published clinical and cost data. The primary input variable was change in HbA(1c), and was assumed to be an improvement of -0.9% to -1.2% for CSII compared with MDI for child/young adult and adults, respectively. A series of Markov constructs simulated the progression of diabetes-related complications. RESULTS CSII was associated with an improvement in quality-adjusted life-years (QALYs) gained of 1.061 versus MDI for adults and 0.799 versus MDI for children/young adults. ICERs were $16,992 and $27,195 per QALY gained for CSII versus MDI in adults and children/young adults, respectively. Improved glycemic control from CSII led to a lower incidence of diabetes complications, with the most significant reduction in proliferative diabetic retinopathy (PDR), end stage renal disease (ESRD), and peripheral vascular disease (PVD). The number needed to treat (NNT) for PDR was nine patients, suggesting that only nine patients need to be treated with CSII to avoid one case of PDR. The NNT for ESRD and PVD was 19 and 41, respectively. CONCLUSIONS Setting the willingness to pay at $50,000/QALY, the analysis demonstrated that CSII is a cost-effective option for patients with T1DM in the United States.