Access in all areas? A round up of developments in market access and HTA: part 5.

In this latest update, we explore the recent announcement by Canada's Drug Agency (CDA-AMC, formerly CADTH) on their pilot to include the societal perspective in the evaluation of certain new medicines; a recent Office of Health Economics (OHE) report on the evaluation of HTA agency methods over time; and publications examining the impact of Project Orbis on patient access to oncology treatments.

Correlation of Pediatric Surgical Infrastructure With Clinical and Economic Outcomes: A Cohort Study.

INTRODUCTION: A significant burden of unmet pediatric surgical disease exists in low- and middle-income countries. We sought to assess the associations between the installation of a pediatric operating room (OR) and clinical and economic outcomes for families with children in Ethiopia. METHODS: A retrospective cohort study was performed of children who underwent elective surgery in a tertiary-level Ethiopian public hospital, comparing patient outcomes before and after OR installation in August 2019. Clinical data were collected via chart review, and an inpatient economic survey was administered to patient caregivers. Interrupted time series analysis investigated trends in surgical volume over time. The relative economic benefit was determined by comparing the patients' household income to the monetary health benefit gained using the value of statistical life method. RESULTS: One thousand one hundred and ninety-six patients were included from August 2018 to July 2022. Surgery averted 20,541 disability-adjusted life years (DALYs) cumulatively or 17 DALYs per patient. Monthly case volume and DALYs averted significantly increased postinstallation. The median annual household income of the economic survey responders (n = 339) was $1337 (IQR 669-2592). 27.7% (n = 94/339) lived in extreme poverty, and 41.3% (n = 140/339) experienced catastrophic healthcare expenditure. Net monetary health benefit was $29.3 million or $26,646 per patient. The ratio of net monetary health benefit to household annual income was 60:1. CONCLUSIONS: Installing a pediatric OR in a public Ethiopian hospital ensures increased access to surgery for those most impoverished in Ethiopia and improves equitable access to surgical care. Greater investment in expanding pediatric surgical infrastructure can help address global inequities in child health.

Cost-effectiveness of surgical interventions in low-income and middle-income countries: a systematic review and critical analysis of recent evidence.

BACKGROUND: Cost-effectiveness evidence is a critical tool to support resource allocation decisions. There is growing recognition that the development of benefit packages for surgical care should be guided by such evidence, particularly in resource-constraint settings. METHODS: We conducted a systematic review of evidence (Medline, Embase, Global Health, EconLit and grey literature) on the cost-effectiveness of surgery across low-income and middle-income countries published between January 2013 and January 2023. We included studies with minor and major therapeutic surgeries and minimally invasive intraluminal and endovascular interventions. We computed and compared the average cost-effectiveness ratios (ACERs) for different surgical interventions to the respective national gross domestic product per capita to determine cost-effectiveness and to common traditional public health interventions. RESULTS: We identified 87 unique studies out of 20 070 articles screened. Studies spanned 23 countries, with China (n=20), Thailand (n=12), Brazil (n=8) and Iran (n=8) accounting for about 55% of the evidence. Overall, the median ACERs across procedure groups ranged from I$17/disability-adjusted life year (DALY) for laparotomies to I$170 186/DALY for bariatric surgeries. Most of the ACER estimates were classified as cost-effective (89%) or very cost-effective (76%). Low-complexity surgical interventions compared favourably to common public health interventions. CONCLUSION: These findings reinforce the growing body of evidence that investments in surgery are economically smart. There remains however paucity of high-quality evidence that would allow decision-makers to assess the comparative cost-effectiveness of surgery and to determine best buys across a wide range of specialties and interventions. A concerted effort is needed to advance the generation and utilisation of economic evidence in the drive towards scale-up of surgical care across low-income and middle-income countries.

Self-Reported Financial Difficulties Among Patients with Multiple Myeloma and Chronic Lymphocytic Leukemia Treated at U.S. Community Oncology Clinics (Alliance A231602CD).

Objectives: To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL). Setting: 23 U.S. community and minority oncology practice sites affiliated with the National Cancer Institute Community Oncology Research Program (NCORP). Participants: 521 patients (≥18 years) with MM or CLL were consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%). Interventions: Observational, prospective, protocol-based survey administered in 2019-2020. Primary and secondary outcome measures: Financial difficulty was assessed using a single-item standard measure, the EORTC QLQC30: "Has your physical condition or medical treatment caused you financial difficulties in the past year?" and using an 'any-or-none' composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association between financial difficulty, diagnosis, and socioeconomic and treatment characteristics. Results: 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM versus CLL (adjusted odds ratio [aOR], 0.34; 95% CI, 0.13-0.84; P=.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37-4.66; P=.003), being non-White (aOR, 2.21; 95% CI, 1.04-4.72; P=.04), and having a high school education or below (aOR, 0.36; 95% CI, 0.21-0.64; P=.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41-0.94; P=.03). Conclusions: U.S. patients with blood cancer report financial difficulty, especially those with low socio-economic status. Evidence-based and targeted interventions are needed.

The epidemiology, treatments and outcomes of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node-positive early breast cancer in Taiwan.

Aim: Estimate patient counts, treatment patterns and outcomes of a subset of patients with early breast cancer (EBC) presenting with hormone receptor positive, human epidermal growth factor receptor 2 negative, node positive features, who are at high-risk of recurrence, in Taiwan.Materials & methods: Data from Taiwan's National Health Insurance Research Database and Taiwan Cancer Registry from 1 January 2011 to 31 December 2020 were analyzed.Results: There were 4500 patients with high-risk EBC (10.4% of all patients with EBC) from 2012 to 2018, with an annual average incidence of 643 that increased over time. Five-year progression was 24.8% in patients with high-risk EBC and 8-year survival was low (69.6%).Conclusion: Patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node positive high-risk EBC clinical features are an increasing high-risk subset of all patients with EBC.

[Box: see text].

Impact of X-linked hypophosphatemic rickets/osteomalacia on health and quality of life: baseline data from the SUNFLOWER longitudinal, observational cohort study.

The SUNFLOWER study was initiated in Japan and South Korea to clarify the course of X-linked hypophosphatemic rickets/osteomalacia (XLH); delineate its physical, mental, and financial burdens; and collect information on treatment. Here, we report cross-sectional data at the time of patient enrollment to better understand the real-world management and complications in patients with XLH and examine the effect of XLH on quality of life (QOL). This is an ongoing, longitudinal, observational cohort study of patients with a diagnosis of XLH. Data from 147 patients (118 in Japan and 29 in South Korea) were evaluated. In total, 77 children (mean age, 9.7 yr; 67.5% female) and 70 adults (mean age, 37.6 yr; 65.7% female) were enrolled. PHEX gene mutations were confirmed in 46/77 (59.7%) children and 37/70 (52.9%) adults. Most patients in both age groups were receiving a combination of phosphate and active vitamin D at baseline. The mean height Z-score was -2.21 among adults (male: -2.34; female: -2.14). The mean Rickets Severity Score in children was 1.62. Whereas children appeared to have low pain levels (mean revised faces pain scale score, 1.3), adults reported mild-to-moderate pain (mean Brief Pain Inventory pain severity, 2.02). Mean QOL in children (assessed using the 10-item short-form health survey for children) was low, with a score below normative level for physical functioning. In adults, results from the Western Ontario and McMaster Universities osteoarthritis index indicated the presence of pain, stiffness, and decreased physical function. The respective mean total days/year of work/school non-attendance due to symptoms/complications and management of XLH were 0.7 and 3.0 among adults, and 6.4 and 6.1 among children. Our findings reconfirmed a relationship between disease and QOL in patients with XLH. We anticipate that these data will be important in enabling clinicians to understand the daily reality of patients with XLH.

Economic effects of next-generation sequencing diagnostics in unspecific sepsis patients - a budget impact analysis from the healthcare providers' perspective in Germany.

PURPOSE: Next-generation sequencing (NGS) tools have clinical advantages over blood culture but are more expensive. This study assesses the budget impact and break-even point of NGS testing costs from a healthcare provider's perspective in Germany. METHODS: The budget impact was calculated based on aggregated data of German post-operative surgery cases. Simulated cost savings were calculated based on a simulated reduction in hospital length of stay (LOS) of four or eight days with a positivity rate of 71% and compared to the costs of one (scenario A) or two tests (scenario B) per case. Furthermore, the break-even point of the cost of two tests compared to saved costs through shortened LOS was conducted. RESULTS: For 9,450 cases, an average budget impact for scenario A and scenario B of €1,290.41 [95% CI €1,119.64 - €1,461.19] and - €208.59 [95% CI - €379.36 - - €37.81] was identified for gastrointestinal and kidney surgery cases, and €1,355.58 [95% CI €1,049.62 - €1,661.55] and €18.72 [95% CI - €324.69 - €287.24] for vascular artery surgery cases, respectively. The break-even analysis showed that using two tests per case could achieve a minimum positive contribution margin with an average of 1.9 tests per case across the study population. CONCLUSION: The results revealed a positive budget impact for one NGS test and a slightly negative budget impact for two NGS tests per case. Findings suggest that largest cost savings are generated for more severe cases and are highly dependent on the patient population.

Do tobacco regulatory and economic factors influence smoking cessation outcomes? A post-hoc analysis of the multinational EAGLES randomised controlled trial.

INTRODUCTION: We previously reported global regional differences in smoking cessation outcomes, with smokers of US origin having lower quit rates than smokers from some other countries. This post-hoc analysis examined global regional differences in individual-level and country-level epidemiological, economic and tobacco regulatory factors that may affect cessation outcomes. METHODS: EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) was a randomised controlled trial that evaluated first-line cessation medications and placebo in 8144 smokers with and without psychiatric disorders from 16 countries across seven regions. Generalised linear and stepwise logistic regression models that considered pharmacotherapy treatment, psychiatric diagnoses, traditional individual-level predictors (eg, demographic and smoking characteristics) and country-specific smoking prevalence rates, gross domestic product (GDP) per capita, relative cigarette cost and WHO-derived MPOWER scores were used to predict 7-day point prevalence abstinence at the end of treatment. RESULTS: In addition to several traditional predictors, three of four country-level variables predicted short-term abstinence: GDP (0.54 (95% CI 0.47, 0.63)), cigarette relative income price (0.62 (95% CI 0.53, 0.72)) and MPOWER score (1.03 (95% CI 1.01, 1.06)). Quit rates varied across regions (22.0% in Australasia to 55.9% in Mexico). With northern North America (USA and Canada) as the referent, the likelihood of achieving short-term abstinence was significantly higher in Western Europe (OR 1.4 (95% CI 1.14, 1.61)), but significantly lower in Eastern Europe (0.39 (95% CI 0.22, 0.69)) and South America (0.17 (95% CI 0.08, 0.35)). CONCLUSIONS: Increased tobacco regulation was associated with enhanced quitting among participants in the EAGLES trial. Paradoxically, lower GDP, and more affordable cigarette pricing relative to a country's GDP, were also associated with higher odds of quitting. Geographical region was also a significant independent predictor. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT01456936.

Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation.

INTRODUCTION: Diagnosing and treating lung cancer in early stages is essential for survival outcomes. The chest X-ray (CXR) remains the primary screening tool to identify lung cancers in the UK; however, there is a shortfall of radiologists, while demand continues to increase. Image analysis by machine-learning software has the potential to support radiology workflows with a focus on immediate triage of suspicious X-rays. The RADICAL study will evaluate Qure.ai's 'qXR' software in reducing reporting time for suspicious X-rays in NHS Greater Glasgow & Clyde. METHODS AND ANALYSIS: This is a stepped-wedge cluster-randomised study consisting of a retrospective technical evaluation and prospective clinical effectiveness study alongside the assessment of acceptability via qualitative work and evaluation of cost-effectiveness via a cost utility analysis. The primary objective is to assess the clinical effectiveness of qXR to prioritise patients suspected with lung cancer on CXR for follow-up CT. Secondary objectives will look at the utility, safety, technical performance, health economics and acceptability of the intervention. The study period is 24 months, consisting of an initial 12 month data collection period and a 12 month follow-up period. All the standard care CXRs from outpatient and primary care requests will be securely transmitted to Qure.ai software 'qXR' for interpretation. Images with features of cancer will be flagged as 'Urgent Suspicion of Cancer' and be prioritised for radiologist review within the existing reporting workflow. ETHICS AND DISSEMINATION: The study will follow the principles of Good Clinical Practice. The protocol was granted REC approval in August 2023 from North West-Greater Manchester West Research Ethics Committee (REC 23/NW/0211). This study was registered on clinicaltrials.gov (NCT06044454). An interim report will be produced for use by the Scottish Government. The results from this study will be presented at artificial intelligence, radiology and respiratory meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06044454.

Cost Analysis of Pelvic Exenteration Surgery for Advanced Pelvic Malignancy.

BACKGROUND: Pelvic exenteration (PE) is a radical procedure involving multi-visceral resection for locally advanced pelvic malignancies. Such radical surgery is associated with prolonged operating theater time and hospital stay, as well as a substantial risk of postoperative complications, and therefore significant financial cost. This study aimed to comprehensively detail the inpatient cost of PE at a specialist center in the Australian public sector. METHODS: A retrospective costing review of consecutive PE operations at Royal Prince Alfred Hospital in Sydney between March 2014 and June 2022 was performed. Clinical data were extracted from a prospectively maintained database, and in-hospital costing data were provided by the hospital Performance Unit. All statistical analyses were performed using SPSS. RESULTS: Pelvic exenteration was performed for 461 patients, of whom 283 (61 %) had primary or recurrent rectal cancer, 160 (35 %) had primary or recurrent non-rectal cancer, and 18 (4 %) had a benign indication. The median admission cost was $108,259.4 ($86,620.8-$144,429.3) (Australian dollars [AUD]), with the highest costs for staffing followed by the operating room. Overall, admission costs were higher for complete PE (p < 0.001), PE combined with cytoreductive surgery (CRS) (p < 0.001), and older patients (p = 0.006). DISCUSSION: The total admission cost for patients undergoing PE reflects the complexity of the procedure and the multidisciplinary requirement. Patients of advanced age undergoing complete PE and PE combined with CRS incurred greater costs, but the requirement of a sacrectomy, vertical rectus abdominal flap reconstruction, major nerve or vascular excision, or repair were not associated with higher overall cost in the multivariate analysis.

Financial toxicity of cancer care in sub-Saharan Africa: protocol for a systematic review.

INTRODUCTION: In sub-Saharan Africa (SSA), the number of cancer deaths is expected to double between 2020 and 2030; however, financial costs remain a barrier to accessing cancer treatment and care. There is an evidence gap on financial toxicity related to cancer care in SSA, both for the patient and for the family members providing care. Against this background, this review aims to analyse cancer care-related financial toxicity for the patient and family caregivers in SSA. METHODS AND ANALYSIS: A comprehensive search of peer-reviewed articles in the English language reporting the financial burden of cancer care on patients and family caregivers in SSA will be conducted using PubMed, Scopus and Web of Science from 1 January 2000 to 13 October 2023. Two researchers will independently review the titles, abstracts and full-text articles, and any disagreements will be resolved through consensus. A risk of bias assessment will be conducted using the assessment tools from the Joanna Briggs Institute Critical Appraisal Checklist. A quantitative and narrative synthesis of included studies, including the prevalence of financial toxicity of cancer care in SSA, will be developed. The review will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. ETHICS AND DISSEMINATION: Ethical review is not required because this review draws on published literature. The results will be presented at leading cancer and public health conferences, published in peer-reviewed journals and disseminated via website posts and social media channels to improve access to cancer care and to facilitate evidence-based policymaking in SSA. PROSPERO REGISTRATION NUMBER: CRD42023469011.

The impact of brain cancer care coordinators on healthcare utilization and outcomes in patients with glioblastoma.

Background: Cancer care coordinators (CCCs) are recognized as having an important role in patients' and carers' cancer journey. However, there are no studies investigating the impact of CCCs on quantitative outcomes. We performed a retrospective cohort study investigating the impact of brain cancer care coordinators (BCCCs) on health service resource use and survival in patients with glioblastoma. Methods: All patients diagnosed with glioblastoma between 2012 and 2019 in Hunter New England Local Health District, Australia (HNELHD) were included and the patients were divided into 2 cohorts: before and after the introduction of the BCCC. Any patient diagnosed in 2016, during the introduction of the BCCC, were excluded. The main outcomes assessed were overall survival, health service resource use, odds of being admitted to hospital after the emergency presentation, and cost-offset analysis to examine the economic implications of BCCCs. Results: A total of 187 patients were included. There were no significant differences in overall survival between the 2 groups (mOS 12.0 vs 11.16 months, HR 0.95). However, there was a reduction in the number of ED presentations and admissions. This was associated with a 24% reduction in aggregate length of stay with the BCCC. There was no statistically significant difference in mean patient costs, however our hospital may have saved over AUD$500 000 with BCCCs. Conclusions: The introduction of BCCC did not improve survival but appeared to be associated with reduced health resource utilization. This study provides economic justification, in addition to the established quality of life improvements, to support the presence of BCCCs.

Synthesized economic evidence on the cost-effectiveness of screening familial hypercholesterolemia.

BACKGROUND: Familial hypercholesterolemia (FH) is a prevalent genetic disorder with global implications for severe cardiovascular diseases. Motivated by the growing recognition of the need for early diagnosis and treatment of FH to mitigate its severe consequences, alongside the gaps in understanding the economic implications and equity impacts of FH screening, this study aims to synthesize the economic evidence on the cost-effectiveness of FH screening and to analyze the impact of FH screening on health inequality. METHODS: We conducted a systematic review on the economic evaluations of FH screening and extracted information from the included studies using a pre-determined form for evidence synthesis. We synthesized the cost-effectiveness components involving the calculation of synthesized incremental cost-effectiveness ratios (ICERs) and net health benefit (NHB) of different FH screening strategies. Additionally, we applied an aggregate distributional cost-effectiveness analysis (DCEA) to assess the impact of FH screening on health inequality. RESULTS: Among the 19 studies included, over half utilized Markov models, and 84% concluded that FH screening was potentially cost-effective. Based on the synthesized evidence, cascade screening was likely to be cost-effective, with an ICER of $49,630 per quality-adjusted life year (QALY). The ICER for universal screening was $20,860 per QALY as per evidence synthesis. The aggregate DCEA for six eligible studies presented that the incremental equally distributed equivalent health (EDEH) exceeded the NHB. The difference between EDEH and NHB across the six studies were 325, 137, 556, 36, 50, and 31 QALYs, respectively, with an average positive difference of 189 QALYs. CONCLUSIONS: Our research offered valuable insights into the economic evaluations of FH screening strategies, highlighting significant heterogeneity in methods and outcomes across different contexts. Most studies indicated that FH screening is cost-effective and contributes to improving overall population health while potentially reducing health inequality. These findings offer implications that policies should promote the implementation of FH screening programs, particularly among younger population. Optimizing screening strategies based on economic evidence can help identify the most effective measures for improving health outcomes and maximizing cost-effectiveness.

Analysis of factors associated with use of real-world data in single technology appraisals of cancer drugs by the National Institute for Health and Care Excellence.

OBJECTIVES: This study investigates factors associated with use of real-world data (RWD) in economic modelling for single technology appraisals (STAs) of cancer drugs by the National Institute for Health and Care Excellence (NICE) to improve systematic understanding of the use of RWD. METHODS: The data were extracted from STAs of cancer drugs, for which NICE issued guidance between January 2011 and December 2022 (n=267). Binary regression was used to test hypotheses concerning the greater or lesser use of RWD. Bonferroni-Holm correction was used to control error rates in multiple hypotheses tests. Several explanatory variables were considered in this analysis, including time (Time), incidence rate of disease (IR), availability of direct treatment comparison (AD), generalisability of trial data (GE), maturity of survival data in trial (MS) and previous technology recommendations by NICE (PR). The primary outcome variable was any use of RWD. Secondary outcome variables were specific uses of RWD in economic models. RESULTS: AD had a statistical negative association with any use of RWD whereas no associations with non-parametric and parametric use of RWD were found. Time had several statistical associations with use of RWD (validating survival distributions for the intervention, estimating progression-free survival for the intervention, estimating overall survival for comparators and transition probabilities). CONCLUSIONS: RWD were more likely to be used in economic modelling of cancer drugs when randomised controlled trials failed to provide relevant clinical information of the drug for appraisals, particularly in the absence of direct treatment comparisons. These results, based on analysis of data systematically collected from previous appraisals, suggest that uses of RWD were associated with data gaps in the economic modelling. While this result may support some of the claimed advantages of using RWD when evidence is absent, the question, the extent to which use of RWD in indirect treatment comparisons reduces uncertainty is still to be determined.

Interaction between economic status and healthy lifestyle in long COVID among Chinese older population: a cross-sectional study.

OBJECTIVES: To estimate the interaction between economic status (ES) and healthy lifestyle in long COVID among Chinese older people infected with SARS-CoV-2. DESIGN: A cross-sectional study based on the Peking University Health Cohort in Anning, Yunnan. SETTING: All primary health institutions in Anning, Yunnan Province, China, from April to May 2023. PARTICIPANTS: A total of 4804 people aged 60 and older infected with SARS-CoV-2 were included in this study. PRIMARY AND SECONDARY OUTCOME MEASURES: Long COVID was measured by participants' self-reported symptoms using structured questionnaires. ES was measured by last-month personal income, and participants' ES was defined as low if their income was below the per capita monthly income of local residents. Lifestyle score was equal to the number of healthy behaviours (including smoking, drinking, weight, exercise and diet) and grouped using the median score as the cut-off point. Univariate and multivariate logistic models were employed to estimate the association of ES with long COVID. Interaction between ES and lifestyle in long COVID was assessed by multiplicative interaction term. RESULTS: We enrolled a total of 4804 participants infected with SARS-CoV-2, of whom 57.3% (2754 of 4804) had at least one long COVID symptom. Fatigue (1546, 56.1%), cough (1263, 45.9%) and muscle pain (880, 32.0%) were the top three common symptoms. Patients with low ES had a 48% (adjusted OR: 1.48; 95% CI 1.22, 1.82) increased risk of long COVID. A significant interaction was observed between ES and lifestyle (p value for interaction <0.001) in long COVID. CONCLUSION: The interaction between ES and healthy lifestyle in long COVID was prominent. Comprehensive strengthened economic support for patients recovering from COVID-19, especially for those with low healthy lifestyle, should be implemented to prevent and manage long COVID symptoms.

Deep Inspiration Breath Hold in Left-Sided Breast Radiotherapy: A Balance Between Side Effects and Costs.

Background: Deep inspiration breath hold (DIBH) is an effective technique for reducing heart exposure during radiotherapy for left-sided breast cancer. Despite its benefits, cost considerations and its impact on workflow remain significant barriers to widespread adoption. Objectives: This study aimed to assess the cost-effectiveness of DIBH and compare its operational, financial, and clinical outcomes with free breathing (FB) in breast cancer treatment. Methods: Treatment plans for 100 patients with left-sided breast cancer were generated using both DIBH and FB techniques. Dosimetric data, including the average mean heart dose, were calculated for each technique and used to estimate the cardiotoxicity of radiotherapy. A state-transition microsimulation model based on SCORE2 (Systematic Coronary Risk Evaluation) algorithms projected the effects of DIBH on cardiovascular outcomes and quality-adjusted life-years (QALYs). Costs were calculated from a provider perspective using time-driven activity-based costing, applying a willingness-to-pay threshold of €40,000 for cost-effectiveness assessment. A discrete event simulation model assessed the impacts of DIBH vs FB on throughput and waiting times in the radiotherapy workflow. Results: In the base case scenario, DIBH was associated with an absolute risk reduction of 1.72% (95% CI: 1.67%-1.76%) in total cardiovascular events and 0.69% (95% CI: 0.67%-0.72%) in fatal cardiovascular events over 20 years. Additionally, DIBH was estimated to provide an incremental 0.04 QALYs (95% CI: 0.05-0.05) per left-sided breast cancer patient over the same time period. However, DIBH increased treatment times, reducing maximum achievable throughput by 12.48% (95% CI: 12.36%-12.75%) and increasing costs by €617 per left-sided breast cancer patient (95% CI: €615-€619). The incremental cost-effectiveness ratio was €14,023 per QALY. Conclusions: Despite time investments, DIBH is cost-effective in the Belgian population. The growing adoption of DIBH may benefit long-term cardiovascular health in breast cancer survivors.

Impact of perioperative diagnostic tools on clinical outcomes and cost-effectiveness in parathyroid surgery: a decision model-based analysis.

OBJECTIVES: Preoperative and intraoperative diagnostic tools influence the surgical management of primary hyperparathyroidism (PHPT), whereby their performance of classification varies considerably for the two common causes of PHPT: solitary adenomas and multiglandular disease. A consensus on the use of such diagnostic tools for optimal perioperative management of all PHPT patients has not been reached. DESIGN: A decision tree model was constructed to estimate and compare the clinical outcomes and the cost-effectiveness of preoperative imaging modalities and intraoperative parathyroid hormone (ioPTH) monitoring criteria in a 21-year time horizon with a 3% discount rate. The robustness of the model was assessed by conducting a one-way sensitivity analysis and probabilistic uncertainty analysis. SETTING: The US healthcare system. POPULATION: A hypothetical population consisting of 5000 patients with sporadic, symptomatic or asymptomatic PHPT. INTERVENTIONS: Preoperative and intraoperative diagnostic modalities for parathyroidectomy. MAIN OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs), net monetary benefits (NMBs) and clinical outcomes. RESULTS: In the base-case analysis, four-dimensional (4D) CT was the least expensive strategy with US$10 276 and 15.333 QALYs. Ultrasound and 99mTc-Sestamibi single-photon-emission CT/CT were both dominated strategies while 18F-fluorocholine positron emission tomography was cost-effective with an NMB of US$416 considering a willingness to pay a threshold of US$95 958. The application of ioPTH monitoring with the Vienna criterion decreased the rate of reoperations from 10.50 to 0.58 per 1000 patients compared to not using ioPTH monitoring. Due to an increased rate of bilateral neck explorations from 257.45 to 347.45 per 1000 patients, it was not cost-effective. CONCLUSIONS: 4D-CT is the most cost-effective modality for the preoperative localisation of solitary parathyroid adenomas and multiglandular disease. The use of ioPTH monitoring is not cost-effective, but to minimise clinical complications, the Miami criterion should be applied for suspected solitary adenomas and the Vienna criterion for multiglandular disease.

An international consensus panel on the potential value of Digital Surgery.

OBJECTIVES: The use of digital technology in surgery is increasing rapidly, with a wide array of new applications from presurgical planning to postsurgical performance assessment. Understanding the clinical and economic value of these technologies is vital for making appropriate health policy and purchasing decisions. We explore the potential value of digital technologies in surgery and produce expert consensus on how to assess this value. DESIGN: A modified Delphi and consensus conference approach was adopted. Delphi rounds were used to generate priority topics and consensus statements for discussion. SETTING AND PARTICIPANTS: An international panel of 14 experts was assembled, representing relevant stakeholder groups: clinicians, health economists, health technology assessment experts, policy-makers and industry. PRIMARY AND SECONDARY OUTCOME MEASURES: A scoping questionnaire was used to generate research questions to be answered. A second questionnaire was used to rate the importance of these research questions. A final questionnaire was used to generate statements for discussion during three consensus conferences. After discussion, the panel voted on their level of agreement from 1 to 9; where 1=strongly disagree and 9=strongly agree. Consensus was defined as a mean level of agreement of >7. RESULTS: Four priority topics were identified: (1) how data are used in digital surgery, (2) the existing evidence base for digital surgical technologies, (3) how digital technologies may assist surgical training and education and (4) methods for the assessment of these technologies. Seven consensus statements were generated and refined, with the final level of consensus ranging from 7.1 to 8.6. CONCLUSION: Potential benefits of digital technologies in surgery include reducing unwarranted variation in surgical practice, increasing access to surgery and reducing health inequalities. Assessments to consider the value of the entire surgical ecosystem holistically are critical, especially as many digital technologies are likely to interact simultaneously in the operating theatre.

Effectiveness of conversional metabolic and bariatric surgery on dyslipidemia and the cost of lipid-lowering medications over 4 years: a French nationwide study.

BACKGROUND: The need for conversional metabolic and bariatric surgery (CMBS) is still growing. No large-scale prospective cohort studies have assessed changes in lipid-lowering treatment (LLT) after CMBS. OBJECTIVES: This study assesses and compares the effectiveness of the 4 main CMBS sequences after sleeve gastrectomy (SG) and adjustable gastric banding (AGB) on reimbursement and cost of LLT. SETTING: France. METHODS: This nationwide observational population-based cohort study analyzed data from the French National Health Insurance database. It included all patients who had undergone primary SG and AGB in France between January 1, 2012, and December 31, 2014, and followed until December 31, 2020. The study assessed LLT reimbursement evolution and costs across 4 different CMBS sequences. RESULTS: During follow-up, 6396 patients underwent the 4 CMBS sequences: SG-RYGB (Roux-en-Y gastric bypass) (n = 2400), AGB-SG (n = 2277), AGB-RYGB (n = 1173), and SG-SG (n = 546), with a rate of LLT reimbursement of 9.8%, 3.6%, 6.6%, and 7.9%, respectively, in the year before CMBS. The rates of discontinuation of treatment at 2 and 4 years were 41.9%, 35.4%, 45.6%, 20.5% and 45.6%, 31.3%, 64.3%, 31.6%, respectively. At 4 years, the median [interquartile range] annual costs (euros) per patient were significantly lower (P < .01) than the costs in the year before CMBS for each sequence: 86.8 [57.3; 136.1] versus 38.0 [.0; 64.6], 79.1 [50.5; 120.1] versus 50.4 [15.6; 64.1], 89.0 [66.5; 139.6] versus .0 [.0; 58.8], and 89.8 [66.1; 121.4] versus 63.1 [.0; 93.4]. CONCLUSIONS: Our study underlines the effectiveness of CMBS in significantly reducing the need and associated costs of LLT for patients with dyslipidemia over a 4-year period.

Comparison of Costs, Re-Intervention Rates, and Length of Hospital Stay for Three Uterus Sparing Interventions for Uterine Fibroids: A 2-Year Retrospective Claims Analysis.

Purpose: To describe two-year post-operative outcomes, and healthcare utilization of three uterus-sparing interventions used to treat women with intramural and/or subserosal uterine fibroids. Subjects and Methods: This was a post-market, randomized, prospective, multi-center, longitudinal, interventional, and comparative clinical study to evaluate the costs and health outcomes of LAP-RFA vs the standard uterine conserving technologies (myomectomy and UAE) for the treatment of symptomatic uterine fibroids in women who desire uterine conservation. For this RCT study, 54 subjects were randomized on a 1:1 ratio across the three procedures and followed out to two years. Their results were compared to retrospective US insurance claims from the IBM MarketScan® Commercial Database from 2017-2020 for 96,854 women who underwent a uterus-sparing procedure for fibroids. Results: Mean ambulatory surgical center costs and the mean out-patient hospital costs were lowest for LAP-RFA ($13,134 and $14,428) and highest for UAE ($28,214 and $19,131). The total two-year re-intervention rate of any subsequent procedure (AM, LM, LAP-RFA, or UAE) was lowest in AM group (0%) followed by LM (4.2%), LAP-RFA (11%), and UAE (33%). Mean peri-operative reintervention costs and the mean reintervention total costs were $2429 and $5939 for LAP-RFA, $2122 and $8368 for LM, $4410 and $11,942 for AM, and $8113 and $46,692 for UAE subjects. In the RCT study, the average length of hospital stay was significantly less for the LAP-RFA group subjects (8.2 hours) in contrast to both the laparoscopic myomectomy group subjects (16.0 hours) and the abdominal myomectomy group subjects (33.6 hours). Despite the small numbers, two-year reintervention rates followed a similar pattern as the IBM MarketScan data. Conclusion: In comparing these three non-invasive approaches, LAP-RFA was associated with the lowest peri-operative cost, and UAE was associated with the highest peri-operative cost. Further studies are needed to assess the cost, effectiveness, and subject satisfaction with each procedure.