Health Economic Implications Research Articles

Burden and Associated Factors of Tuberculosis Among Household Contacts of Sputum Positive Tuberculosis Patients of Aligarh

Background: Engaging patients in healthcare for diagnosis and treatment through active case-finding, which is initiated by healthcare providers, involves methodically searching for tuberculosis in individuals who may not seek medical attention otherwise. Active case finding provides a promising opportunity to identify additional undetected cases of tuberculosis within the community. The current study aimed at evaluating household contact tracing of Tuberculosis among the household contacts of pulmonary TB cases who were recently diagnosed, as well as to identify risk factors in both household contacts and index cases that contribute to the transmission of TB within households. Materials and Method: This cross-sectional study, which was conducted within the community, focused on the household contacts of recently diagnosed patients of Pulmonary Tuberculosis (TB) who were confirmed through microbiological testing. These patients were registered at Tuberculosis Units (TUs) of JNMC and Jawan of Aligarh district, West U.P. The investigator conducted visits to each household and met with both the index case and their corresponding household contacts to establish rapport and gather necessary information. Results: Within this investigation, a total of 103 individuals who tested positive for sputum smear were identified as index cases, alongside 405 household contacts of these index cases. The predominant symptom observed in household contacts who tested positive during the screening process was a cough, with fever following closely behind. Among the 405 household contacts examined, 54 individuals (13.3%) exhibited symptoms associated with Tuberculosis. Further investigation revealed that 11 of these individuals (20.37%) tested positive for tuberculosis. The total prevalence of tuberculosis cases among household contacts was determined to be 2.72%. Conclusion: The present research affirms that conducting contact screening for households of active TB cases is a comparatively feasible and beneficial strategy that could result in prompt diagnosis and initiation of treatment for active TB, thereby diminishing the severity of the disease and lowering the rate of transmission. Also, it can help to improve TB-related health effects, social and economic implications, and treatment outcomes in the index cases.

Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment

BackgroundUse of electronic health records (EHR) to provide real-world data for research is established, but using EHR to deliver randomised controlled trials (RCTs) more efficiently is less developed. The Allergy AntiBiotics And Microbial resistAnce (ALABAMA) RCT evaluated a penicillin allergy assessment pathway versus usual clinical care in a UK primary care setting. The aim of this paper is to describe how EHRs were used to facilitate efficient delivery of a large-scale randomised trial of a complex intervention embracing efficient participant identification, supporting minimising GP workload, providing accurate post-intervention EHR updates of allergy status, and facilitating participant follow up and outcome data collection. The generalisability of the EHR approach and health economic implications of EHR in clinical trials will be reported in the main ALABAMA trial cost-effectiveness analysis.MethodsA descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection.ResultsAn ALABAMA organisation group within SystmOne was established which allowed sharing of trial functions/materials developed centrally by the research team. The ‘ALABAMA unit’ within SystmOne was also created and provided a secure efficient environment to access participants’ EHR data. Processes of referring consented participants, allocating them to a trial arm, and assigning specific functions to the intervention arm were developed by adapting tools such as templates, reports, and protocols which were already available in SystmOne as well as pathways to facilitate allergy de-labelling processes and data retrieval for trial outcome analysis.ConclusionsALABAMA is one of the first RCTs to utilise SystmOne EHR functionality and data across the RCT delivery, demonstrating feasibility and applicability to other primary care RCTs.Trial registrationClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216.

Cost-Effectiveness of Baloxavir Marboxil Versus Oseltamivir or no Treatment for the Management of Influenza in the United States.

This study sought to evaluate the cost-effectiveness of baloxavir marboxil compared with oseltamivir or no antiviral treatment from a US payer perspective using data from a real-world US administrative claims study. Given baloxavir's ability to rapidly stop viral shedding, the potential health economic implications of a baloxavir-induced population-level reduction in viral transmission was also explored. A decision tree cost-effectiveness model was developed for seasonal influenza (2018-2020) using a lifetime time horizon with 3.0% discounting for costs and quality-adjusted life-years (QALYs). Patients aged≥12years could receive baloxavir, oseltamivir or no antiviral treatment. Patient characteristics, complications, and costs were derived from the Merative™ MarketScan® Research Databases including US commercial claims and Medicare and Medicaid Supplemental databases. A scenario analysis explored the impact of reduced viral transmission with baloxavir. In the base case analysis, baloxavir was cost-effective within a willingness-to-pay threshold of US$100,000/QALY compared with oseltamivir [incremental cost-effectiveness ratio (ICER), $6813/QALY gained] or no antiviral treatment (ICER, $669/QALY gained). The net monetary benefit (NMB) of baloxavir was $1180 and $6208 compared with oseltamivir and no treatment, respectively. The NMB of baloxavir increased linearly with reductions in viral transmission, where a 5% transmission reduction yielded an NMB of $2592 versus oseltamivir and $7621 versus no treatment. Baloxavir became dominant (more effective and less costly, with ICERs<0) starting with a 12.0% reduction in viral transmission versus oseltamivir and 6.0% versus no antiviral treatment. Baloxavir was cost-effective compared with oseltamivir or no antiviral treatment. The potential of baloxavir to reduce viral transmission offers a substantial economic benefit from a US payer perspective.

Robotic surgery reduces the consumption of medical consumables: cost analysis of robotic pancreatic surgery from a tertiary hospital in China.

Robotic surgery has been increasingly adopted in various surgical fields, but the cost-effectiveness of this technology remains controversial due to its high cost and limited improvements in clinical outcomes. This study aims to explore the health economic implications of robotic pancreatic surgery, to investigate its impact on hospitalization costs and consumption of various medical resources. Data of patients who underwent pancreatic surgery at our institution were collected and divided into robotic and traditional groups. Statistical analyses of hospitalization costs, length of stay, costs across different service categories, and subgroup cost analyses based on age, BMI class, and procedure received were performed using t tests and linear regression. Although the total hospitalization cost for the robotic group was significantly higher than that for the traditional group, there was a notable reduction in the cost of medical consumables. The reduction was more prominentamong elderly patients, obese patients, and those undergoing pancreaticoduodenectomy, which could be attributed to the technological advantages of the robotic surgery platform that largely facilitate blood control, tissue protection, and suturing. The study concluded that despite higher overall costs, robotic pancreatic surgery offers significant savings in medical consumables, particularly benefiting certain patient subgroups. The findings provide valuable insights into the economic viability of robotic surgery, supporting its adoption from a health economics perspective.

Taking a health economic perspective in monitoring health inequalities: A focus on excess weight

BackgroundTraditional approaches to monitoring health inequalities predominantly rely on headcount methods. However, these methods fail to reflect the non-linear health economic implications of changes in disease severity. Alternative, distribution-sensitive metrics are available which could more adequately inform financial planning and policy decision making. MethodsWe describe the design of the Foster-Greer-Thorbecke (FGT) index, and discuss its relative merits as a summary monitoring metric of health inequalities in the population, compared to the Erreygers concentration index. We illustrate the FGT index by conducting a comparative longitudinal analysis of adult excess inequalities in England using Health Survey for England data from 2009 to 2019. FindingsExcess weight inequalities have steadily increased in the English adult population, especially over the last five years. Going beyond headcount, the FGT index analyses revealed that, unlike the rest of the population, the average overweight adult from the most socio-economically deprived group is either obese (30.3 BMI for females) or at the brink of obesity (29.1 BMI for males). These results underscore a deepening divide in obesity severity between communities, with the most socioeconomically deprived groups being increasingly and disproportionally affected. Conclusions: The FGT index can address some shortcomings of traditional approaches to inequality measurement and local governments should consider adopting it as an alternative population health metric. Future research should apply and develop more refined distribution-sensitive measures of health inequality.

Estimates of the excess cost burden of Ehlers-Danlos syndromes: a United States MarketScan® claims database analysis.

Patients with Ehlers-Danlos syndromes (EDS) and hypermobility spectrum disorders (HSD) have significant health challenges that are well-documented, however their impact in terms of cost is not known. Our research objective was to examine the cost burden of EDS and HSD in the United States. We focused this analysis on those with commercial insurance plans. We queried the MarketScan® database for year 2021 for claims that contained an ICD-10 diagnosis code for EDS or hypermobility. Excess costs for patients in the EDS and HSD cohorts were determined by matching each patient to one patient in the database that did not have a claim for EDS or HSD and comparing total costs for the calendar year. We determined whether patients had claims for selected comorbid conditions likely to impact costs during the calendar year. Sample sizes were 5,113 for adult (age ≥ 18) patients with EDS, 4,880 for adult patients with HSD, 1,059 for child (age 5-17) patients with EDS, and 2,427 for child patients with HSD. The mean excess costs were $21,100 for adult EDS patients, $11,600 for adult HSD patients, $17,000 for child EDS patients, and $11,000 for child HSD patients. EDS and HSD cohorts, both adults and children, with any of the comorbidities had greater healthcare costs. The largest difference was found in the EDS cohort with gastrointestinal comorbid conditions, with more than double the costs for adults. We found that patients in the MarketScan database, adults and children, who had EDS or HSD had substantially higher associated excess healthcare costs than patients without EDS or HSD when considering age, sex, geographic location, and comorbidities. These disproportionate healthcare costs in this population have health policy and economic implications, including the need for rapid diagnosis, access to treatment, and accelerated research to advance treatments.

Epidemiological and health economic implications of symptom propagation in respiratory pathogens: A mathematical modelling investigation.

Respiratory pathogens inflict a substantial burden on public health and the economy. Although the severity of symptoms caused by these pathogens can vary from asymptomatic to fatal, the factors that determine symptom severity are not fully understood. Correlations in symptoms between infector-infectee pairs, for which evidence is accumulating, can generate large-scale clusters of severe infections that could be devastating to those most at risk, whilst also conceivably leading to chains of mild or asymptomatic infections that generate widespread immunity with minimal cost to public health. Although this effect could be harnessed to amplify the impact of interventions that reduce symptom severity, the mechanistic representation of symptom propagation within mathematical and health economic modelling of respiratory diseases is understudied. We propose a novel framework for incorporating different levels of symptom propagation into models of infectious disease transmission via a single parameter, α. Varying α tunes the model from having no symptom propagation (α = 0, as typically assumed) to one where symptoms always propagate (α = 1). For parameters corresponding to three respiratory pathogens-seasonal influenza, pandemic influenza and SARS-CoV-2-we explored how symptom propagation impacted the relative epidemiological and health-economic performance of three interventions, conceptualised as vaccines with different actions: symptom-attenuating (labelled SA), infection-blocking (IB) and infection-blocking admitting only mild breakthrough infections (IB_MB). In the absence of interventions, with fixed underlying epidemiological parameters, stronger symptom propagation increased the proportion of cases that were severe. For SA and IB_MB, interventions were more effective at reducing prevalence (all infections and severe cases) for higher strengths of symptom propagation. For IB, symptom propagation had no impact on effectiveness, and for seasonal influenza this intervention type was more effective than SA at reducing severe infections for all strengths of symptom propagation. For pandemic influenza and SARS-CoV-2, at low intervention uptake, SA was more effective than IB for all levels of symptom propagation; for high uptake, SA only became more effective under strong symptom propagation. Health economic assessments found that, for SA-type interventions, the amount one could spend on control whilst maintaining a cost-effective intervention (termed threshold unit intervention cost) was very sensitive to the strength of symptom propagation. Overall, the preferred intervention type depended on the combination of the strength of symptom propagation and uptake. Given the importance of determining robust public health responses, we highlight the need to gather further data on symptom propagation, with our modelling framework acting as a template for future analysis.

Cost-effectiveness of adding quizartinib to induction chemotherapy for patients with FLT3-mutant acute myeloid leukemia

The FLT3 inhibitor quizartinib has been shown to improve overall survival when added to intensive induction chemotherapy (“7 + 3”) in patients 18-75 years old with newly diagnosed AML harboring a FLT3-ITD mutation. However, the health economic implications of this approval are unknown. We evaluated the cost-effectiveness of quizartinib using a partitioned survival analysis model. One-way and probabilistic sensitivity analyses were conducted. In the base case scenario, the addition of quizartinib to 7 + 3 resulted in incremental costs of $289,932 compared with 7 + 3 alone. With an incremental gain of 0.84 quality-adjusted life years (QALYs) with quizartinib + 7 + 3 induction vs. 7 + 3 alone, the incremental cost-effectiveness ratio for the addition of quizartinib to standard 7 + 3 was $344,039/QALY. Only an 87% reduction in the average wholesale price of quizartinib or omitting quizartinib continuation therapy after completion of consolidation therapy and allogeneic hematopoietic cell transplant would make quizartinib a cost-effective option.

Enhancing the SUSTAINable uptake of evidence to minimise harms from alcohol and other drugs in New South Wales, Australia.

Although alcohol and other drug use is increasingly the focus of policy and research efforts, there are challenges identifying and applying evidence-based strategies to minimise harms for alcohol and other drugs in health care and community settings. These challenges include limited available research, variability across settings, and lack of 'fit' between research evidence and their intended settings. In this commentary, we describe a novel approach to develop and evaluate tailored, sustainable strategies to enhance the uptake of evidence-based activities into health services and community settings. Our approach involves four key principles: (i) identifying evidence-based alcohol and other drug harm minimisation strategies; (ii) partnering with local experts to identify and tailor strategies; (iii) implementing strategies into existing practice/infrastructure to build in sustainability; and (iv) using sustainable co-designed outcome measures including value-based health-care principles to measure uptake, feasibility and acceptability, health outcomes and economic implications. We propose that this approach offers a way forward to enhance the relevance and suitability of research in health services and community settings and has potential to be applied in other sectors.

From Acute Infection to Prolonged Health Consequences: Understanding Health Disparities and Economic Implications in Long COVID Worldwide.

The COVID-19 pandemic has resulted in a growing number of patients experiencing persistent symptoms and physiological changes after recovering from acute SARS-CoV-2 infection, known as Long COVID. Long COVID is characterized by recurring symptoms and inflammation across multiple organ systems. Diagnosis can be challenging, influenced by factors like demographics, comorbidities, and immune responses. Long COVID impacts various organ systems and can have neuropsychological effects. Health disparities, particularly related to race, contribute to a higher burden of infection and ongoing symptoms in minority populations. Managing Long COVID entails addressing a spectrum of symptoms that encompass physical, cognitive, and psychological aspects. The recovery period for patients with Long COVID can vary significantly, influenced by factors like the severity of the disease, hospitalization, comorbidities, and age. Currently, there are no universally effective treatments, although certain interventions show promise, necessitating further research. Self-management and rehabilitation programs can provide relief, but more research is needed to establish their effectiveness. Preventive measures such as vaccination and the use of antiviral medications and metformin. It is imperative to conduct further research to develop evidence-based guidelines and gain a better understanding of the long-term implications of COVID-19. Long COVID could have substantial economic impact on the labor market, productivity, healthcare expenditures, and overall economic growth. To address the challenges patients with long-term complications face, there is a focus on strategies like promoting telework and flexible work arrangements to accommodate diverse symptoms, particularly chronic fatigue and other Long COVID effects. In conclusion, this review emphasizes the multifaceted complexity of Long COVID and the ongoing need to address its potential long-term health and economic impacts.

A cost-effectiveness analysis assessing systemic treatments in metastatic castration-sensitive prostate cancer (mCSPC) by volume of disease.

93 Background: The treatment paradigm for mCSPC patients has rapidly evolved over the last few years with the emergence of triplet therapy and prognostication by volume of disease. However, the health economic implications of triplet therapy by disease volume remain unclear. Methods: A Markov model where patients transitioned between the progression-free, progression and death states was developed. State utilities were derived from the LATITUDE trial. Point probabilities for overall survival, progression-free survival, grade ≥ 3 and 5 toxicities were obtained from the eligible mCSPC phase III clinical trials. Medicare Advantage and commercial total paid amounts (2022 US$) of treatments were obtained from OptumLabs Data Warehouse. Costs and disutilities of adverse events were derived from published literature. Half-cycle corrected costs and utilities were accrued monthly over a 20-year lifetime horizon and were discounted at 3%. Monte Carlo simulation was used to calculate incremental cost-effectiveness ratios (ICERs). A willingness-to-pay (WTP) threshold of US$100,000 was used. Results: In terms of Medicare Advantage payer’s perspective (Table), docetaxel (D)+ADT was observed to provide additional 0.068 QALYs compared to ADT at an ICER of US$16,544 per QALY in high volume disease. Compared to D+ADT, abiraterone (AAP) triplet provided additional 1.03 QALYs at US$56,641 per QALY. Compared to AAP triplet, apalutamide (APA)+ADT provided additional 0.048 QALYs at US$5,846,248 per QALY in high volume disease. In low volume disease, D+ADT provided 0.45 more QALYs at US$20,690 per QALY compared to ADT alone. Compared to D+ADT, AAP triplet provided an additional 1.51 QALYS at US$44,267 per QALY. In terms of total paid commercial costs, AAP triplet provided an additional 1.19 QALYs compared to ADT at US$91,952 per QALY in high volume disease. In low volume, D+ADT provided additional 0.38 QALYs at US$22,058 per QALY compared to ADT. Compared to D+ADT, AAP triplet provided a 0.97 QALY gain at US$105,958 per QALY. Compared to AAP triplet, darolutamide (DARO) triplet provided a 0.47 QALY at US$689,196 per QALY. Compared to DARO triplet, APA+ADT provided an additional 0.49 QALYs at an ICER of US$971,389 per QALY. All other treatments (not reported here) were dominated. Conclusions: At the selected WTP of US$100,000 per QALY, AAP triplet therapy was most likely the cost-effective strategy in overall mCSPC population particularly in patients with high volume disease. However, these results should be interpreted with careful accounting for timing of metastases. [Table: see text]

Pocket pain following spinal cord stimulator generator implantation: A narrative review of this under-reported risk.

Spinal cord stimulation (SCS) is a well-established treatment option for chronic pain. Pain over the implantable pulse generator, or pocket pain, is an incompletely understood risk of SCS implantation which may limit the efficacy of treatment and patient quality of life. The goal of this narrative review is to analyze the literature to gain a more thorough understanding of the incidence and risk factors for the development of pocket pain to help guide treatment options and minimize its occurrence in the future. A literature review was conducted investigating the development of pocket pain in patients with SCS for the management of a variety of pain conditions. In total, 305 articles were included in the original database search and 50 met the criteria for inclusion. The highest level of evidence for papers that specifically investigated pocket pain was level III. Four retrospective, observational analyses included pocket pain as a primary outcome. The remainder of the included studies listed pocket pain as an adverse event of SCS implantation. There is a relative dearth of primary literature that examines the incidence, characteristics, and health economic implications of pocket pain in patients with SCS. This highlights the need for large-scale, high-quality prospective or randomized controlled trials examining pocket pain. This may ultimately help prevent and reduce pocket pain leading to improved efficacy of treatment and greater patient quality of life.

The Burden of Self-Reported Antibiotic Allergies in Health Care and How to Address It: A Systematic Review of the Evidence.

Antibiotics are the first-line treatment for bacterial infections; however, overuse and inappropriate prescribing have made antibiotics less effective with increased antimicrobial resistance. Unconfirmed reported antibiotic allergy labels create a significant barrier to optimal antimicrobial stewardship in health care, with clinical and economic implications. A systematic review was conducted to summarize the impact of patient-reported antibiotic allergy on clinical outcomes and various strategies that have been employed to effectively assess and remove these allergy labels, improving patient care. The review was undertaken using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A critical appraisal was conducted on all studies and a narrative synthesis was performed to identify themes. Four themes emerged: the prevalence of antibiotic allergy, impact of antibiotic allergy on antimicrobial prescribing, impact of antibiotic allergy on clinical outcomes, and delabeling strategies to improve clinical outcomes. Of the 32 studies, including 1,089,675 participants, the prevalence of reported antibiotic allergy was between 5% and 35%. Patients with a reported antibiotic allergy had poorer concordance with prescribing guidelines in 30% to 60% of cases, with a higher use of alternatives such as quinolone, tetracycline, macrolide, lincosamide, and carbapenem and lower use of beta-lactam antibiotics. Antibiotic allergy delabeling was identified as an intervention and recommendation to advance the state of the science. There is substantial evidence within the literature that antibiotic allergy labels significantly impact patient clinical outcomes and a consensus that systematic assessment of reported antibiotic allergies, commonly referred to as delabeling, improves the clinical management of patients.

Health Care Resource, Economic, and Readmission Implications After Acute Decompensated Aortic Stenosis–A Nationwide Study

Acute decompensated aortic stenosis (ADAS) is common. The cumulative burden of ADAS from a clinical, health care resource, and financial perspective is unknown. This study sought to assess the national impact of ADAS compared with electively treated, stable patients with aortic stenosis (non-ADAS). Using the National Readmissions Database between 2016 and 2019, patients with ADAS and non-ADAS were identified using International Classification of Diseases, Tenth Revision codes. Patients with ADAS were propensity-matched to non-ADAS patients (1:2) using age, gender, and Charlson co-morbidity index. We compared in-hospital mortality, length of stay (LOS), health care-associated costs, and 90-day readmission data between the 2 cohorts. A total of 51,498 propensity-matched patients were included in this study: median age 75years, 64% men. The in-hospital mortality for ADAS was higher than non-ADAS (2.8% vs 1.5%, p <0.0001). The LOS during the index admission was longer for ADAS (9 [5 to 13] vs 4 [2 to 6] days, p <0.0001). The health care-associated costs per patient was greater for ADAS ($55,450.0 [41,860.4 to 74,500.7] vs $43,405.7 [34,218.5 to 56,034.8], p <0.0001). Readmission to hospital within 90days was more frequent in ADAS (21.1 vs 16.8%, p <0.001). The in-hospital mortality during readmission was higher with ADAS (3.9% vs 2.8%, p=0.004). The readmission LOS was longer with ADAS (4 [2 to 7] vs 3 [2 to 6] days, p <0.0001). In conclusion, ADAS imposes a significant burden clinically and financially and on health care resources compared with non-ADAS during the index admission and 90-day follow-up. There is an urgent need to predict ADAS and optimize the timing of aortic valve replacement to reduce the incidence and the burden associated with ADAS.

Cost-Effectiveness of Hydroxyurea for Sickle Cell Anemia in a Low-Income African Setting: A Model-Based Evaluation of Two Dosing Regimens.

The disease burden of sickle cell anemia (SCA) in sub-Saharan African (SSA) countries is substantial, with many children dying without an established diagnosis or proper treatment. The global burden of SCA is increasing each year, making therapeutic intervention a high priority. Hydroxyurea is the only disease-modifying therapy with proven feasibility and efficacy suitable for SSA; however, no one has quantified the health economic implications of its use. Therefore, from the perspective of the health care provider, we estimated the incremental cost-effectiveness of hydroxyurea as a fixed-dose regimen or maximumtolerated dose (MTD) regimen, versus SCA care without hydroxyurea. We estimated the cost of providing outpatient treatment at a pediatric sickle cell clinic in Kampala, Uganda. These estimates were used in a discrete-event simulation model to project mean costs (2021 US$), disability-adjusted life years (DALYs), and consumption of blood products per patient (450mL units), for patients between 9months and 18years of age. We calculated cost-effectiveness as the ratio of incremental costs over incremental DALYs averted, discounted at 3% annually. To test the robustness of our findings, and the impact of uncertainty, we conducted probabilistic and one-way sensitivity analyses, scenario analysis, and price threshold analyses. Hydroxyurea treatment averted an expected 1.37 DALYs and saved US$ 191 per patient if administered at the MTD, compared with SCA care without hydroxyurea. In comparison, hydroxyurea at a fixed dose averted 0.80 DALYs per patient at an incremental cost of US$ 2. The MTD strategy saved 11.2 (95% CI 11.1-11.4) units of blood per patient, compared with 9.1 (95% CI 9.0-9.2) units of blood per patient at the fixed-dose alternative. Hydroxyurea at MTD is likely to improve quality of life and reduce the consumption of blood products for children with SCA living in Uganda. Compared with a fixed dose regimen, treatment dosing at MTD is likely to be a cost-effective treatment for SCA, using realistic ranges of hydroxyurea costs that are relevant across SSA. Compared with no use of the drug, hydroxyurea could lead to substantial net savings per patient, while reducing the disease morbidity and mortality and increasing quality of life.

Real-world evidence on the economic implications of CGRP-mAbs as preventive treatment of migraine

BackgroundCalcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) are approved in Europe as preventive treatment of migraine in patients with at least four monthly migraine days. Migraine gives rise to direct healthcare expenditures, but most of the economic burden of migraine is socioeconomic. Evidence on the socioeconomic implications of CGRP-mAbs is, however, limited. There is an increasing interest in supplementing evidence from randomised controlled trials (RCTs) with real-world evidence (RWE) to aid clinical decision making and inform decision making for migraine management. The objective of this study was to generate RWE on the health economic and socioeconomic implications of administering CGRP-mAbs to patients with chronic migraine (CM) and episodic migraine (high-frequency episodic migraine (HFEM), and low-frequency episodic migraine (LFEM)).MethodsReal-world data (RWD) on Danish patients with CM, HFEM, and LFEM were collected via two Danish patient organisations and two informal patient networks and used in a tailored economic model. Treatment effects of CGRP-mAbs on health economic and socioeconomic outcomes were estimated using a sub-sample of patients with CM who receive CGRP-mAb treatment.ResultsA total of 362 patients (CM: 199 [55.0%], HFEM: 80 [22.1%], LFEM: 83 [22.9%]) were included in the health economic model (mean age 44.1 ± 11.5, 97.5% female, 16.3% received treatment with CGRP-mAbs), and 303 patients were included in the socioeconomic model (15.2% received treatment with CGRP-mAbs). Health economic savings from initiating CGRP-mAb treatment totalled €1,179 per patient with CM per year on average (HFEM: €264, LFEM: €175). Socioeconomic gains from initiating CGRP-mAb treatment totalled an average gross domestic product (GDP) gain of €13,329 per patient with CM per year (HFEM: €10,449, LFEM: €9,947).ConclusionOur results indicate that CGRP-mAbs have the potential to reduce both health economic expenditures and the socioeconomic burden of migraine. Health economic savings are used as a basis for health technology assessments (HTAs) of the cost-effectiveness of new treatments, which implies that important socioeconomic gains may not be given enough importance in decision making for migraine management.

#5431 THE VALUE OF MANAGING DIABETIC KIDNEY DISEASE: CONTRASTING FINDINGS FROM THE INDIVIDUAL PATIENT AND POPULATION LEVEL PERSPECTIVES

Abstract Background and Aims The management of diabetic kidney disease (DKD) is associated with considerable resource utilisation. Within the context of the broader healthcare system, understanding the health economic implications of adopting strategies to ameliorate the progression of DKD is imperative for fully informed decision-making. The objective of this study was to estimate the UK whole healthcare system economic value, from the individual patient and population perspectives, associated with modifying the progression of DKD through attenuating the decline in eGFR by values consistent with those observed in recent randomised clinical outcome trials. Method Since type 2 diabetes (T2D) is the commonest single cause of chronic kidney disease (CKD), we developed a deterministic model utilising published estimates of disease progression stratified by stages: stage 1/2, stage 3a, stage 3b and stage 4/5. Patient characteristics and mean annual decline in eGFR were aligned to the placebo arm of DECLARE-TIMI 58 (-2.44 ml/min/1.732). We explored scenarios where a sustained attenuation in the rate of eGFR decline by 1 and 2ml/min/1.732 per year was realised. T2D specific and all-cause mortality were captured using UKPDS risk equations. CKD stage specific costs and changes in health utility were drawn from NICE guidelines (NG203). Per-patient and population level costs (indexed to 2022) and quality adjusted life years (QALYs) were estimated, and both discounted at 3.5%. Results We estimated there were 3.2M, 0.6M, 0.2M and 0.04M DKD patients in stages 1/2, 3a, 3b and 4/5 respectively. Declining kidney function was associated with increasing per-patient lifetime costs and decreasing QALYs: stage 1/2 £36,714, 8.1 QALYs; stage 3a £90,666, 6.5 QALYs; stage 3b £126,931, 5.2 QALYs; stage 4/5 £168,604, 3.7 QALYs. A sustained attenuation in the rate of eGFR decline by 1 and 2ml/min/1.732 per year had the greatest impact in those in stage 3b: with cost savings of £23,690 and £47,463 and gains in QALYs of 0.68 and 1.46 for 1 and 2ml/min/1.732 respectively. At the population level, however, total lifetime cost for DKD was greatest in those in stage 1/2 £30.3Bn; followed by stage 3a, £19.2Bn; stage 3b £9.5Bn; stage 4/5 £146M. A sustained attenuation in eGFR resulted in the largest cost savings in those in stage 1/2: £16.9 Bn and £22.3Bn for 1 and 2ml/min/1.732 respectively, and the greatest gains in QALYs of 0.8M and 1.1M for 1 and 2ml/min/1.732 respectively. In contrast, population level stage 4 cost savings and QALY gains were modest at £70.7M and £281.6M and 0.02M and 0.4M for 1 and 2ml/min/1.732 respectively. Conclusion The notion of value in healthcare is influenced by stakeholder perspective. From the clinician's and patient's perspective the greatest value in attenuating the progression of DKD is in those with more advanced disease. However, from the health care provider perspective, at the population level, modest cost-savings and QALY gains are realised in such patients. By contrast, those at an earlier disease stage deliver much greater population level return on investment consequent upon larger numbers of such individuals. This study illustrates that attenuating DKD progression provides value at both the individual and public health levels, irrespective of disease stage.

0711 Health-Economic Implications of Tonic Motor Activation (TOMAC) therapy for RLS: An Exploratory Analysis based on the RESTFUL study

Abstract Introduction Restless legs syndrome (RLS) is a debilitating condition associated with reduced health-related quality of life (HRQoL) and increased resource utilization. Recently, the RESTFUL study demonstrated significant improvement in RLS severity following treatment with a novel non-invasive neuromodulation treatment (Tonic Motor Activation; TOMAC). Our objective was to provide model-based estimates of quality-adjusted life year (QALY) gain and reduction in healthcare utilization that might be expected for the observed changes in symptom severity. Methods The RESTFUL study randomized n=133 subjects 1:1 to active TOMAC treatment and sham control, with change in International Restless Legs Scale (IRLS) scores reported at four weeks at the end of the randomization period. Functional relationships between IRLS and HRQoL and resource utilization were derived from two prior health-economic studies (Happe et al. 2009 and Durgin et al. 2015). Model-projected quality-adjusted life year (QALY) gain and events avoided at a five-year analysis horizon were calculated based on assumption of maintained treatment effect. Results From baseline of 25.2, change in IRLS at four weeks was -7.2 for the active and -3.8 for the sham group (between group difference -3.4, p&amp;lt; 0.01). Based on this effect size, TOMAC was projected to add 0.16 QALYs over 5 years (0.39 when considering reduction from baseline). Based on lower symptom severity, TOMAC was projected to avoid 3.80 (8.05) health care provider visits, 0.29 (0.62) ER visits, and 0.12 (0.26) hospitalizations over 5 years, resulting in a relative risk (RR) of composite healthcare utilization of 0.94 (0.88). Conclusion The findings of this exploratory analysis suggest TOMAC-associated improvements in RLS severity as observed in the RESTFUL study may lead to meaningful improvements in patient quality-of-life and concurrent reductions in healthcare utilization. Further investigation is warranted. Support (if any) Wing Tech Inc. (AMR, KNC, JBP) received consulting fees from Noctrix Health. AR is an investigator in the RESTFUL study.

Modeling a traffic light warning system for acute respiratory infections

The high morbidity of acute respiratory infections constitutes a crucial global health burden. In particular, for SARS-CoV-2, non-pharmaceutical intervention geared to enforce social distancing policies, vaccination, and treatments will remain an essential part of public health policies to mitigate and control disease outbreaks. However, the implementation of mitigation measures directed to increase social distancing when the risk of contagion is a complex enterprise because of the impact of NPI on beliefs, political views, economic issues, and, in general, public perception. The way of implementing these mitigation policies studied in this work is the so-called traffic-light monitoring system that attempts to regulate the application of measures that include restrictions on mobility and the size of meetings, among other non-pharmaceutical strategies. Balanced enforcement and relaxation of measures guided through a traffic-light system that considers public risk perception and economic costs may improve the public health benefit of the policies while reducing their cost. We derive a model for the epidemiological traffic-light policies based on the best response for trigger measures driven by the risk perception of people, instantaneous reproduction number, and the prevalence of a hypothetical acute respiratory infection. With numerical experiments, we evaluate and identify the role of appreciation from a hypothetical controller that could opt for protocols aligned with the cost due to the burden of the underlying disease and the economic cost of implementing measures. As the world faces new acute respiratory outbreaks, our results provide a methodology to evaluate and develop traffic light policies resulting from a delicate balance between health benefits and economic implications.

Analysis and Comparison of Hazardous Location Identification Practices in Croatia: Lessons from International Approaches

Road safety is a crucial aspect of transportation systems around the globe, with significant implications for public health economics, and overall quality of life. Reactive road safety assessment methods, which focus on identifying and rectifying hazardous locations within road networks, play a key role in maintaining and improving the safety of these systems. The purpose of this paper is to delve into the methodologies currently in use for reactive road safety assessment, with a particular focus on practices in Croatia. By comparing these methods with international approaches, the study aims to not only illuminate the strengths and weaknesses of existing practices, but also to provide valuable recommendations for enhancing road safety assessment in Croatia. Through a detailed analysis of safety performance metrics, network screening methods, and specific methodological elements, the paper offers insights into this critical area of transportation safety.