Study Design: The cost-effectiveness analysis was performed with the validated IQVIA Core Diabetes Model. Am J Manag Care. 2021;27(8):e269-e277. https://doi.org/10.37765/ajmc.2021.88728 _____ ...Takeaway Points Treatment intensification with sodium-glucose co-transporter 2 (SGLT2) inhibitors demonstrated slightly better efficacy and cost savings compared with switching to glucagon-like peptide 1 receptor agonists (GLP-1 RAs): * The SGLT2 inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor pathway showed slightly better quality-adjusted life-years; cost savings were driven by lower medication costs with SGLT2 inhibitor therapy compared with GLP-1 RAs. * Scenarios that tested differences in drug costs, clinical parameters, and cardiovascular effects confirmed the cost savings with the DPP-4 inhibitor + SGLT2 inhibitor pathway. * For patients who fail to achieve glycemic control on metformin plus a DPP-4 inhibitor, intensification by adding an SGLT2 inhibitor to the combination before moving to insulin could be a cost-saving strategy compared with switching from a DPP-4 inhibitor to a GLP-1 RA. _____ Type 2 diabetes (T2D) is a chronic condition in which the body becomes resistant to insulin, causing glucose to build up in the blood.1 High blood glucose results in complications in a variety of organs, including the eyes, kidneys, nerves, and heart.1 T2D is among the most prevalent chronic diseases in the world today and accounts for 90% to 95% of all diabetes cases.2 Twenty-one million Americans (8.6%) received a diagnosis of T2D in 2016.3 T2D is a multifactorial condition characterized by increasing chronic disability and higher risk of related conditions that contribute to increased patient morbidity and risk of mortality, such as cardiovascular disease (CVD) and obesity.1 It was the seventh leading cause of death in the United States in 2015, listed as the underlying cause for 79,535 deaths (2.9% of 2015 total mortality) and mentioned as a cause for 252,806 deaths (9.3%).2,4 Beyond exacting a large burden on individual patients, T2D imposes a substantial economic burden on health systems and the US population. In 2017, the total estimated cost of diagnosed diabetes was $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity.5 The high cost of diabetes is driven by the substantial health care resource use in managing acute events and long-term complications.5 More than 21% of the 7.2 million hospital discharges with diabetes in 2014 were for major CVD, with another 4% associated with diabetic ketoacidosis and lower-extremity amputation.2 Emergency department visits totaled 14.2 million for hypo- and hyperglycemic events as well as other conditions for which diabetes was listed among the diagnoses.2 The goal of diabetes treatment is to manage blood glucose, which subsequently prevents or slows the progress of complications and their impact on quality of life.6 The 2018 guidelines from the American Diabetes Association (ADA) recommend a glycated hemoglobin A1c (HbA1c) target of 6.5% to 8%, depending on patient characteristics and history of hypoglycemia and adverse events.7 A threshold of 8% may be appropriate for patients with a history of severe hypoglycemia or advanced CVD complications who have not had success with previous glucose-lowering agents.7 Patients with T2D are first treated with metformin monotherapy.7 Although the ADA guidelines do not denote a specific preference for add-on therapies, sulfonylurea has been frequently prescribed after metformin because of its low cost and availability of long-term safety data.8 However, a 2010 meta-analysis revealed significant risk of hypoglycemia with sulfonylurea compared with placebo.9 Dipeptidyl peptidase-4 (DPP-4) inhibitors have been demonstrated to be at least as effective as sulfonylurea in glycemic control without increased risk of hypoglycemia and have become a commonly used add-on therapy among patients with T2D whose HbA1c is not at goal levels with metformin monotherapy.7,10 Evidence has also indicated lower all-cause mortality and fewer CVD events with DPP-4 inhibitors.11 For patients who fail to reach target HbA1c on metformin plus a DPP-4 inhibitor, there are many treatment options for intensification, which could include adding an oral therapy such as a sodium-glucose co-transporter 2 (SGLT2) inhibitor or switching to other products such as a glucagon-like peptide 1 receptor agonist (GLP-1 RA).7 Whereas GLP-1 RAs are not recommended for concurrent use with DPP-4 inhibitors,7 recent clinical trials of third-line therapy have demonstrated a clinical benefit of combinations with DPP-4 inhibitors and SGLT2 inhibitors that is significantly greater than the use of each individual component with metformin.12-18 With emerging evidence on the clinical benefits and cardioprotective effects of SGLT2 inhibitors, it is expected that treatment pathways for patients who fail on metformin with DPP-4 inhibitors may increasingly consider triple-therapy combinations.19-21 With the variety of treatment options that could be recommended by physicians along the treatment pathway in real-world practice, it may be difficult for clinical trials to capture the complete picture of every possible combination and sequence of treatments. ...it is vital to understand the comparative performance and the associated economic outcomes for treatment options to ensure that key health care decision makers can support the use of products that bring the most value to patients and health care systems.
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CEKLJ, NUK, UL, UM, UPUK, VSZLJ
Abstract
Introduction
Value is a prominent issue in healthcare measured by the clinical outcomes of good medical practices relative to the literal or figurative costs of care. As a result, cost ...effectiveness has become an essential measure when assessing new technologies in burn care. To help providers evaluate cost-effectiveness, the BEACON model was developed in 2018 using National Burn Repository (NBR) data. While the NBR data has tremendous value portraying a cumulative picture of burn care, it lacks resolution for new innovations such as autologous skin cell suspension (ASCS). In BEACON, ASCS was shown to reduce costs associated with the current treatment of severe burns, where this cost-saving was attributed to reductions in length of stay (LOS), the number of operations, the donor site size, and associated wound care. Our study examines the efficacy of the BEACON model by performing a multicenter real-world data (RWD) analysis of primary cost-savings measures of reduced LOS for patients treated with ASCS vs. standard of care (SOC).
Methods
De-identified electronic medical record data was collected over a 20-month period (1/2019 to 8/2020) from 43 burn centers in 14 states. Patients with burn injuries treated with ASCS were matched by age, gender, TBSA, and comorbidities to patients treated by current SOC treatment. Injury severity was calculated as categorical data with intervals: < 10%, 10–19%, 20–29%, 30–39%, and 40–49% TBSA. Co-morbidities were also assessed to facilitate a 1:1 comparison of patients across the two cohorts. Cost analysis was determined prior peer-reviewed literature in burn care.
Results
A total of 2,438 patients were reviewed, and 162 were used in the matched cohort analysis (n=81 in each cohort). In these patients, 68% had < 20% TBSA. When comparing patients matched on co-morbidities, burn %TBSA/extent, age, and gender, ASCS patients had a shorter LOS by 4.1 days. At an assumed cost of $6,795 per day, these differences in LOS produced a savings of over $28,000 in hospital bed costs alone per ASCS patient versus SOC. LOS was the same or shorter for ASCS patients in 63% of cases with an average reduction of 4.1 days resulting in an overall savings of $2,269,530 for ASCS-treated patients compared to SOC.
Conclusions
Our study is the largest RWD cost-effectiveness analysis of ASCS vs SOC. This analysis confirms the BEACON model with savings primarily originating from reducing LOS, even for small burns with 68% of patients having burns less than 20% TBSA.
Maintaining glycemic control limits costly health risks in patients with type 2 diabetes (T2D), but accomplishing this may require individualized strategies. Generic medications (eg, sulfonylureas ...SU, insulin) are common in T2D management due to their efficacy and costs; however, relatively new drug classes (eg, dipeptidyl peptidase 4 DPP-4 inhibitors, sodium-glucose cotransporter 2 SGLT2 inhibitors) have demonstrated clinical benefits in combination therapy. The objective of this study was to evaluate the long-term cost-effectiveness of a strategy involving branded combination therapy with DPP-4 inhibitors and SGLT2 inhibitors (pathway 1) compared with a generic alternative with SU and insulin (pathway 2) on a background of metformin.
Cost-effectiveness analysis using the validated IQVIA CORE Diabetes Model from the US payer perspective.
Cost-effectiveness analysis. Lifetime clinical and economic outcomes (discounted 3%/year) were modeled for a T2D cohort failing to achieve glycemic goal on metformin monotherapy. Patient baseline data and treatment effects reflect results of clinical trials. Direct medical cost inputs are from multiple published sources. Scenario analyses on key intervention effects and assumptions tested robustness of results.
Pathway 1 had higher direct medical costs compared with pathway 2, yet also increased total quality-adjusted life-years (QALYs) by 0.24. Increased costs were partially offset by a reduction in diabetes-related complications and delayed insulin initiation. The incremental cost-effectiveness ratio (ICER) for pathway 1 is favorable at $64,784/QALY. Scenario analyses showed limited impact; nearly all ICERs were less than $100,000/QALY.
In the United States, sequential addition of SGLT2 inhibitors to DPP-4 inhibitors may be considered cost-effective compared with traditional treatment with generic medications for patients who fail to achieve glycemic goal on metformin.
Objectives
A drug that improves survival and/or disease progression can create real option value (ROV)—the additional health gain from future innovations enabled by a longer survival. ROV can be a ...relevant consideration for both clinical and payer decision-makers. We aimed to estimate the
ex ante
ROV for first-line (1L) alectinib in anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC).
Methods
We developed a Markov model to estimate life-years (LYs) and quality-adjusted life-years (QALYs) gained with 1L alectinib versus 1L crizotinib due to potential future second-line (2L) drugs. Transition probabilities were derived from the phase 3 trial of 1L alectinib and phase 2 trial of 2L brigatinib. We identified drugs being studied in phase 2 and 3 trials in ALK-positive NSCLC at the time of alectinib’s 1L approval and projected the likelihood and timing of their arrival and their potential efficacy based on publicly available data.
Results
The discounted incremental LYs and QALYs for alectinib increased by 12.9% (95% CR − 2.96%, 34.82%; 1.25 vs. 1.11) and 11.2% (95% CR − 2.14%, 29.29%; 1.03 vs. 0.92), respectively, after accounting for ROV. The incremental ROV of alectinib was sensitive to the projected efficacy of future drugs, uptake level, and the hazard ratio of progression-free survival of alectinib (vs. crizotinib).
Conclusions
Ex ante
ROV can be a significant value consideration in therapeutic areas with high levels of expected innovation. The potential efficacy of future drugs and incremental survival with alectinib at the projected time of arrival are important considerations in assessing ROV.
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CEKLJ, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
A drug that improves survival and/or disease progression can create real option value (ROV)-the additional health gain from future innovations enabled by a longer survival. ROV can be a relevant ...consideration for both clinical and payer decision-makers. We aimed to estimate the ex ante ROV for first-line (1L) alectinib in anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC).
We developed a Markov model to estimate life-years (LYs) and quality-adjusted life-years (QALYs) gained with 1L alectinib versus 1L crizotinib due to potential future second-line (2L) drugs. Transition probabilities were derived from the phase 3 trial of 1L alectinib and phase 2 trial of 2L brigatinib. We identified drugs being studied in phase 2 and 3 trials in ALK-positive NSCLC at the time of alectinib's 1L approval and projected the likelihood and timing of their arrival and their potential efficacy based on publicly available data.
The discounted incremental LYs and QALYs for alectinib increased by 12.9% (95% CR - 2.96%, 34.82%; 1.25 vs. 1.11) and 11.2% (95% CR - 2.14%, 29.29%; 1.03 vs. 0.92), respectively, after accounting for ROV. The incremental ROV of alectinib was sensitive to the projected efficacy of future drugs, uptake level, and the hazard ratio of progression-free survival of alectinib (vs. crizotinib).
Ex ante ROV can be a significant value consideration in therapeutic areas with high levels of expected innovation. The potential efficacy of future drugs and incremental survival with alectinib at the projected time of arrival are important considerations in assessing ROV.
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CEKLJ, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Aim
To evaluate the long‐term cost‐effectiveness of an intensification strategy with sodium‐glucose co‐transporter‐2 (SGLT2) inhibitors (pathway 1) compared with NPH insulin (pathway 2) in patients ...with type 2 diabetes (T2D) in the United Kingdom who were not at goal on metformin and sitagliptin.
Methods
Cost‐effectiveness analysis was performed using the well‐established, validated IQVIA CORE Diabetes Model from the payer perspective over a patient's lifetime. Randomized clinical trials informed treatment effect measures, while public or published sources informed economic inputs. Scenario analyses of glycated haemoglobin (HbA1c), hypoglycaemia rate, body mass index effects, SGLT2 inhibitor cardiovascular protective effects, and population characteristics were conducted to assess the robustness of results.
Results
Pathway 1 increased life‐years and quality‐adjusted life‐years (QALYs) compared with pathway 2 (13.49 vs. 13.37, and 9.40 vs. 9.22, respectively). Additional drug costs in pathway 1 were offset by diabetes‐related complication decreases, leading to slightly lower direct medical costs for pathway 1 (£25747 vs £26095). Pathway 1 was therefore cost‐neutral (no interpretable incremental cost‐effectiveness ratio), while improving clinical outcomes. Scenario analyses consistently showed cost‐neutrality or cost‐effectiveness of pathway 1. The highest result remained less than £3000/QALY, reflecting older patients (≥65 years) with lower baseline HbA1c (7%).
Conclusions
For UK patients with T2D not at goal on metformin and sitagliptin therapy, treatment intensification with SGLT2 inhibitors prior to NPH insulin is cost‐neutral or cost‐effective compared with immediate NPH insulin intensification.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Abstract
Introduction
Published information on the relationship between patient characteristics such as total body surface area (TBSA) of burn on number of procedures and length of stay (LOS) is not ...widely available in the United States. Clinical expertise assumes a “rule of thumb” of 1 day stay per percentage TBSA, but deviations based on burn and patient characteristics is rarely explored. The American Burn Association NBR version 8.0 (2002–2011) was analyzed to understand the relationship between key patient and burn characteristics for surviving, severe (TBSA 10–60%) burn patients and number of procedures or LOS.
Methods
Outcomes include the number of procedures autograft, debridement, and excision procedures and LOS. Independent variables considered were TBSA, TBSA of partial-thickness and full-thickness (FT) burn, age (linear, squared and cubed to account for non-linearity), hospital-acquired infection (HAI), other infection, inhalation injury, female gender and diabetes status. Statistical regression models were developed to control for the independent variables and predict the number of procedures and LOS based on such characteristics.
Results
Among 21,175 surviving burn patients (TBSA 10–60%), the mean age was 33 years old, and the mean TBSA was 19.9%. Number of excision and autografting procedures increased with TBSA. All independent variables were retained in the LOS model. After adjusting for gender, age and comorbidities, predicted LOS for adults (18+) was 16.4, 29.5, 42.7 and 56.0 days for 10%, 20%, 30% and 40% TBSA respectively. Similarly, predicted LOS for pediatrics (age< 18) was 12.9, 26.0, 28.6 and 55.4 days for each TBSA group, respectively.
Conclusions
When considering all independent variables, the LOS per percent TBSA is estimated at approximately 1.12 days for adults and 1.01 for pediatrics. However, when considering patient (age, comorbidity status) and burn (burn depth, TBSA) characteristics, the observed LOS could vary by 66% more, as seen with detailed investigations into trends for patients with TBSA 20%. Using the predictive equations from this study, burn centers can generate tailored rule-of-thumb estimates for LOS/%TBSA that better reflect the influence of factors beyond burn center practice patterns.
Applicability of Research to Practice
By identifying patients with characteristics that lead to excess resource use, burn centers can examine more closely why these patients need more care, creating opportunities for more tailored care practices based on patient and burn characteristics
These estimates can indicate whether a given burn center achieves definitive closure with shorter LOS and fewer procedures, relative to national NBR estimates
Introduction
When introducing a new intervention into burn care, it is important to consider both clinical and economic impacts, as the financial burden of burns in the USA is significant. This study ...utilizes a health economic modeling approach to estimate cost-effectiveness and burn center budget-impact for the use of the RECELL
®
Autologous Cell Harvesting Device to prepare autologous skin cell suspension (ASCS) compared to standard of care (SOC) split-thickness skin graft (STSG) for the treatment of severe burn injuries requiring surgical intervention for definitive closure.
Methods
A hospital-perspective model using sequential decision trees depicts the acute burn care pathway (wound assessment, debridement/excision, temporary coverage, definitive closure) and predicts the relative differences between use of ASCS compared to SOC. Clinical inputs and ASCS impact on length of stay (LOS) were derived from clinical trials and real-world use data, American Burn Association National Burn Repository database analyses, and burn surgeon interviews. Hospital resource use and unit costs were derived from three US burn centers. A budget impact calculation leverages Monte Carlo simulation to estimate the overall impact to a burn center.
Results
ASCS treatment is cost-saving or cost-neutral (< 2% difference) and results in lower LOS compared to SOC across expected patient profiles and scenarios. In aggregate, ASCS treatment saves a burn center 14–17.3% annually. Results are sensitive to, but remain robust across, changing assumptions for relative impact of ASCS use on LOS, procedure time, and number of procedures.
Conclusions
Use of ASCS compared to SOC reduces hospital costs and LOS of severe burns in the USA.
Funding
AVITA Medical.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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