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Item A Cost-Effectiveness Analysis: Personal Systems Approach in Improving Medication Adherence in Adult Kidney Transplant Patients(Wolters Kluwer, 2022) Whittington, Melanie; Goggin, Kathy; Glasscock, Ernest L.; Noel-MacDonnell, Janelle; Hathaway, Donna; Remy, Laura; Aholt, Dana; Clark, Debra; Miller, Courtney; Ashbaugh, Catherine; Wakefield, Mark; Bartlett Ellis, Rebecca; Russell, Cynthia; School of NursingInterventions to improve medication non-adherence in transplantation have recently moved from a focus on motivation and intention, to a focus on person-level quality improvement strategies. These strategies link adherence to established daily routines, environmental cues and supportive people. The objective of this evaluation was to estimate the cost of implementation and the cost-effectiveness of a person-level intervention shown to increase medication adherence. To estimate the intervention costs, a direct measure micro-costing approach was used following key informant interviews with project champions and a review of implementation expenditures. Cost-effectiveness was calculated by comparing the incremental implementation costs and healthcare costs associated with non-adherence to the incremental percent adherent, defined as the percent of patients who took greater or equal to 85% of their medication doses, for each pairwise comparison. The intervention was low-resource to implement, costing approximately $520 to implement per patient, and was associated with significant improvements in medication adherence. These implementation costs were more than outweighed by the expected healthcare savings associated with improvements in adherence. This person-level intervention is a low cost, efficacious intervention associated with significant statistical and clinical improvements in medication adherence in adult kidney transplant recipients.Item A targeted systematic review of cost analyses for implementation of simulation-based education in healthcare(Sage, 2020-03-19) Hippe, Daniel S.; Umoren, Rachel A.; McGee, Alex; Bucher, Sherri L.; Bresnahan, Brian W.; Pediatrics, School of MedicineOver the past two decades, there has been an increase in the use of simulation-based education for training healthcare providers in technical and non-technical skills. Simulation education and research programs have mostly focused on the impact on clinical knowledge and improvement of technical skills rather than on cost. To study and characterize existing evidence to inform multi-stakeholder investment decisions, we performed a systematic review of the literature on costs in simulation-based education in medicine in general and in neonatal resuscitation as a particular focus. We conducted a systematic literature search of the PubMed database using two targeted queries. The first searched for cost analyses of healthcare simulation-based education more broadly, and the second was more narrowly focused on cost analyses of neonatal resuscitation training. The more general query identified 47 qualified articles. The most common specialties for education interventions were surgery (51%); obstetrics, gynecology, or pediatrics (11%); medicine, nursing, or medical school (11%); and urology (9%), accounting for over 80% of articles. The neonatal resuscitation query identified five qualified articles. The two queries identified seven large-scale training implementation studies, one in the United States and six in low-income countries. There were two articles each from Tanzania and India and one article each from Zambia and Ghana. Methods, definitions, and reported estimates varied across articles, implying interpretation, comparison, and generalization of program effects are challenging. More work is needed to understand the costs, processes, and outcomes likely to make simulation-based education programs cost-effective and scalable. To optimize return on investments in training, assessing resource requirements, associated costs, and subsequent outcomes can inform stakeholders about the potential sustainability of SBE programs. Healthcare stakeholders and decision makers will benefit from more transparent, consistent, rigorous, and explicit assessments of simulation-based education program development and implementation costs in low- and high-income countries.Item Analyzing the Clinical Outcomes of a Rapid Mass Conversion From Rosuvastatin to Atorvastatin in a VA Medical Center Outpatient Setting(SAGE, 2017-10) Naville-Cook, Chad; Rhea, Leroy; Triboletti, Mark; White, Christina; Pharmacology and Toxicology, School of MedicineBackground: Medication conversions occur frequently within the Veterans Health Administration. This manual process involves several pharmacists over an extended period of time. Macros can automate the process of converting a list of patients from one medication to a therapeutic alternative. Objectives: To develop a macro that would convert active rosuvastatin prescriptions to atorvastatin and to create an electronic dashboard to evaluate clinical outcomes. Methods: A conversion protocol was approved by the Pharmacy & Therapeutics Committee. A macro was developed using Microsoft Visual Basic. Outpatients with active prescriptions for rosuvastatin were reviewed and excluded if they had a documented allergy to atorvastatin or a significant drug-drug interaction. An electronic dashboard was created to compare safety and efficacy endpoints pre- and postconversion. Primary endpoints included low-density lipoprotein (LDL), creatine phosphokinase (CPK), aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase. Secondary endpoints evaluated cardiovascular events, including the incidences of myocardial infarction, stroke, and stent placement. Results: The macro was used to convert 1520 patients from rosuvastatin to atorvastatin over a period of 20 hours saving $5760 in pharmacist labor. There were no significant changes in LDL, AST, ALT, or secondary endpoints (P > .05). There was a significant increase in alkaline phosphatase (P = .0035). Conclusions: A rapid mass medication conversion from rosuvastatin to atorvastatin saved time and money and resulted in no clinically significant changes in safety or efficacy endpoints. Macros and clinical dashboards can be applied to any Veterans Health Administration facility.Item Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis(Taylor & Francis, 2021) Nikolaou, Andreas; Ambavane, Apoorva; Shah, Anshul; Ma, Wenkang; Tosh, Jon; Kapetanakis, Venediktos; Willson, Jenny; Wang, Feng; Hogea, Cosmina; Gorsh, Boris; Gutierrez, Ben; Sapra, Sandhya; Suvannasankha, Attaya; Samyshkin, Yevgeniy; Medicine, School of MedicineBackground: Patients with relapsed/refractory multiple myeloma (RRMM) require several lines of therapy, with typically shorter remission duration with each additional line. Research design and methods: The cost-effectiveness of belantamab mafodotin (belamaf; DREAMM-2; NCT03525678) was compared with selinexor plus dexamethasone (SEL+DEX; STORM Part 2; NCT02336815) among patients with RRMM who have received at least four prior therapies. The base case used a US commercial payer's perspective over a 10-year time horizon. Efficacy data were based on parametric survival analysis of DREAMM-2 and matching-adjusted indirect treatment comparison between DREAMM-2 and STORM Part 2, which assessed relative treatment effects between belamaf and SEL+DEX. Cost inputs included drug treatment, concomitant medications, adverse event management, subsequent treatments, and disease management. Results: Belamaf decreased total treatment costs per patient by $14,267 and increased patient life years by 0.74 and quality-adjusted life years (QALYs) by 0.49 versus SEL+DEX. Patients receiving belamaf accrued 0.12 fewer progression-free life years versus patients on SEL+DEX. Conclusions: From a US commercial payer's perspective, belamaf had lower costs, and increased QALYs and life-year gain, compared with SEL+DEX. Belamaf is therefore likely to be a cost-effective treatment option for patients with RRMM who have received four or more prior lines of therapy.Item Cost-Effectiveness of Closed-Loop Automated Insulin Delivery Using the Cambridge Hybrid Algorithm in Children and Adolescents with Type 1 Diabetes: Results from a Multicenter 6-Month Randomized Trial(Sage, 2024-03-17) Fox, D. Steven; Ware, Julia; Boughton, Charlotte K.; Allen, Janet M.; Wilinska, Malgorzata E.; Tauschmann, Martin; Denvir, Louise; Thankamony, Ajay; Campbell, Fiona; Wadwa, R. Paul; Buckingham, Bruce A.; Davis, Nikki; DiMeglio, Linda A.; Mauras, Nelly; Besser, Rachel E. J.; Ghatak, Atrayee; Weinzimer, Stuart A.; Kanapka, Lauren; Kollman, Craig; Sibayan, Judy; Beck, Roy W.; Hood, Korey K.; Hovorka, Roman; DAN05 Consortium; Pediatrics, School of MedicineBackground/objective: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D). Methods: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed. Analysis focused on the treatment subgroup (n = 21) who received the much more reliable CamAPS FX hardware iteration and their contemporaneous control group (n = 24). Lifetime complications and costs were simulated via an updated Sheffield T1D policy model. Results: Within-trial, both groups had indistinguishable and statistically unchanged health-related quality of life, and statistically similar hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis (DKA) event rates. Total health care utilization was higher in the treatment group. Both the overall treatment group and CamAPS FX subgroup exhibited improved HbA1C (-0.32%, 95% CI: -0.59 to -0.04; P = .02, and -1.05%, 95% CI: -1.43 to -0.67; P < .001, respectively). Modeling projected increased expected lifespan of 5.36 years and discounted quality-adjusted life years (QALYs) of 1.16 (U.K. tariffs) and 1.52 (U.S. tariffs) in the CamAPS FX subgroup. Estimated ICERs for the subgroup were £19 324/QALY (United Kingdom) and -$3917/QALY (United States). For subgroup patients already using continuous glucose monitors (CGM), ICERs were £10 096/QALY (United Kingdom) and -$33 616/QALY (United States). Probabilistic sensitivity analysis generated mean ICERs of £19 342/QALY (95% CI: £15 903/QALY to £22 929/QALY) (United Kingdom) and -$28 283/QALY (95% CI: -$59 607/QALY to $1858/QALY) (United States). Conclusions: For children and adolescents with T1D on insulin pump therapy, AID using the Cambridge algorithm appears cost-effective below a £20 000/QALY threshold (United Kingdom) and cost saving (United States).Item Economic Evaluation of Web- versus Telephone-based Interventions to Simultaneously Increase Colorectal and Breast Cancer Screening Among Women(American Association for Cancer Research, 2021) Huang, Danmeng; Lairson, David R.; Chung, Tong Han; Monahan, Patrick O.; Rawl, Susan M.; Champion, Victoria L.; Biostatistics, School of Public HealthScreening for colorectal and breast cancer is considered cost effective, but limited evidence exists on cost-effectiveness of screening promotion interventions that simultaneously target both cancers. Increasing Colorectal and Breast Cancer Screening (Project COBRA), a randomized controlled trial conducted in the community, examined the cost-effectiveness of an innovative tailored web-based intervention compared with tailored telephone counseling and usual care. Screening status at 6 months was obtained by participant surveys plus medical record reviews. Cost was prospectively measured from the patient and provider perspectives using time logs and project invoices. Relative efficiency of the interventions was quantified by the incremental cost-effectiveness ratios. Nonparametric bootstrapping and net benefit regression analysis were used to assess statistical uncertainty of the results. The average cost per participant to implement the Phone counseling, Web-based, and Web + Phone counseling interventions were $277, $314, and $337, respectively. Comparing Phone counseling with usual care resulted in an additional cost of $300 (95% confidence interval [CI]: $283-$320) per cancer screening test and $421 (95% CI: $400-$441) per additional person screened in the target population. Phone counseling alone was more cost-effective than the Web + Phone intervention. Web-based intervention alone was more costly but less effective than the Phone counseling. When simultaneously promoting screening for both colorectal and breast cancer the Web-based intervention was less cost-effective compared with Phone and Web + Phone strategies. The results suggest that targeting multiple cancer screening may improve the cost-effectiveness of cancer screening interventions. PREVENTION RELEVANCE: This study informs researchers, decision makers, healthcare providers, and payers about the improved cost-effectiveness of targeting multiple cancer screenings for cancer early detection programs.Item Estimating the Economically Justifiable Price of Limited-Duration Treatment with Donanemab for Early Symptomatic Alzheimer's Disease in the United States(Springer, 2024) Boustani, Malaz; Doty, Erin G.; Garrison, Louis P., Jr.; Smolen, Lee J.; Klein, Timothy M.; Murphy, Daniel R.; Spargo, Andrew W.; Belger, Mark; Johnston, Joseph A.; Medicine, School of MedicineIntroduction: The goal of this economic model is to estimate an economically justifiable price (EJP) for using donanemab for the treatment of early symptomatic Alzheimer's disease (AD) in the United States based on clinical data from the phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511). Methods: We adapted an AD Markov state-transition model developed by the Institute for Clinical and Economic Review to estimate the EJP for donanemab at different willingness-to-pay (WTP) thresholds from the health care system perspective and the societal perspective as co-base cases. Results: Assuming a WTP threshold of $150,000 per quality-adjusted life-year (QALY) gained, the model estimates a 1-year (13-dose) EJP for donanemab of $80,538 from the health care system perspective and $91,126 from the societal perspective; at a WTP threshold of $100,000 per QALY gained, the model estimates a 1-year (13-dose) EJP for donanemab of $44,691 from the health care system perspective and $55,419 from the societal perspective. Mean total treatment costs per patient at the $150,000 per QALY gained EJP derived from the health care system perspective were estimated at $77,812 based on the average number of doses of donanemab patients received in the co-base case analysis. One-way sensitivity analysis (OWSA) indicated that treatment efficacy, disease severity at the time of treatment initiation, and duration of treatment effect were the main drivers of the potential EJP. Conclusions: Results from this modeling simulation informed by the TRAILBLAZER-ALZ 2 study support an EJP for limited-duration treatment with donanemab that exceeds per-dose list prices for currently available amyloid-targeting therapies, implying potentially lower lifetime costs and better value for money.Item Evidence-based cardiovascular magnetic resonance cost-effectiveness calculator for the detection of significant coronary artery disease(BMC, 2022) Pandya, Ankur; Yu, Yuan‑Jui; Ge, Yin; Nagel, Eike; Kwong, Raymond Y.; Bakar, Rafidah Abu; Grizzard, John D.; Merkler, Alexander E.; Ntusi, Ntobeko; Petersen, Steffen E.; Rashedi, Nina; Schwitter, Juerg; Selvanayagam, Joseph B.; White, James A.; Carr, James; Raman, Subha V.; Simonetti, Orlando P.; Bucciarelli‑Ducci, Chiara; Sierra‑Galan, Lilia M.; Ferrari, Victor A.; Bhatia, Mona; Kelle, Sebastian; Medicine, School of MedicineBackground: Although prior reports have evaluated the clinical and cost impacts of cardiovascular magnetic resonance (CMR) for low-to-intermediate-risk patients with suspected significant coronary artery disease (CAD), the cost-effectiveness of CMR compared to relevant comparators remains poorly understood. We aimed to summarize the cost-effectiveness literature on CMR for CAD and create a cost-effectiveness calculator, useable worldwide, to approximate the cost-per-quality-adjusted-life-year (QALY) of CMR and relevant comparators with context-specific patient-level and system-level inputs. Methods: We searched the Tufts Cost-Effectiveness Analysis Registry and PubMed for cost-per-QALY or cost-per-life-year-saved studies of CMR to detect significant CAD. We also developed a linear regression meta-model (CMR Cost-Effectiveness Calculator) based on a larger CMR cost-effectiveness simulation model that can approximate CMR lifetime discount cost, QALY, and cost effectiveness compared to relevant comparators [such as single-photon emission computed tomography (SPECT), coronary computed tomography angiography (CCTA)] or invasive coronary angiography. Results: CMR was cost-effective for evaluation of significant CAD (either health-improving and cost saving or having a cost-per-QALY or cost-per-life-year result lower than the cost-effectiveness threshold) versus its relevant comparator in 10 out of 15 studies, with 3 studies reporting uncertain cost effectiveness, and 2 studies showing CCTA was optimal. Our cost-effectiveness calculator showed that CCTA was not cost-effective in the US compared to CMR when the most recent publications on imaging performance were included in the model. Conclusions: Based on current world-wide evidence in the literature, CMR usually represents a cost-effective option compared to relevant comparators to assess for significant CAD.Item Malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: study protocol for a multi-centre, two-arm, randomised, placebo-controlled, superiority trial(BMC, 2018-11-06) Kwambai, Titus K.; Dhabangi, Aggrey; Idro, Richard; Opoka, Robert; Kariuki, Simon; Samuels, Aaron M.; Desai, Meghna; van Hensbroek, Michael Boele; John, Chandy C.; Robberstad, Bjarne; Wang, Duolao; Phiri, Kamija; Ter Kuile, Feiko O.; Pediatrics, School of MedicineBACKGROUND: Children hospitalised with severe anaemia in malaria endemic areas in Africa are at high risk of readmission or death within 6 months post-discharge. Currently, no strategy specifically addresses this period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly treatment courses of artemether-lumefantrine given at discharge and at 1 and 2 months prevented 30% of all-cause readmissions by 6 months post-discharge. Another efficacy trial is needed before a policy of malaria chemoprevention can be considered for the post-discharge management of severe anaemia in children under 5 years of age living in malaria endemic areas. OBJECTIVE: We aim to determine if 3 months of PMC with monthly 3-day treatment courses of dihydroartemisinin-piperaquine is safe and superior to a single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths (composite primary endpoint) by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia of any or undetermined cause. METHODS/DESIGN: This is a multi-centre, two-arm, placebo-controlled, individually randomised trial in children under 5 years of age recently discharged following management for severe anaemia. Children in both arms will receive standard in-hospital care for severe anaemia and a 3-day course of artemether-lumefantrine at discharge. At 2 weeks after discharge, surviving children will be randomised to receive either 3-day courses of dihydroartemisinin-piperaquine at 2, 6 and 10 weeks or an identical placebo and followed for 26 weeks through passive case detection. The trial will be conducted in hospitals in malaria endemic areas in Kenya and Uganda. The study is designed to detect a 25% reduction in the incidence of all-cause readmissions or death (composite primary outcome) from 1152 to 864 per 1000 child years (power 80%, α = 0.05) and requires 520 children per arm (1040 total children). RESULTS: Participant recruitment started in May 2016 and is ongoing.