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Background and objective: This study aimed to determine the cost-effectiveness of Tocilizumab (TCZ) compared with Adalimumab (ADA) in patients with Rheumatoid Arthritis (RA), who had not responded to methotrexate (MTX), from a societal perspective in Iran. Method: To conduct the cost-utility analysis, using an individual microsimulation Markov model, a hypothetical cohort of 1,000 patients was evaluated over a lifetime horizon. The efficacy and safety of each treatment were estimated using the American College of Rheumatology (ACR) criteria to determine the continuation or switching of treatment every six months. Treatment responses were captured based on Health Assessment Questionnaire (HAQ) scores and mapped into utility values to determine QALY gained for each treatment. All direct and indirect costs associated with the disease and perspective were included according to societal perspective. Deterministic and Probabilistic sensitivity analyses were performed to assess the robustness of the model. Results: The result of the study estimated that TCZ is a more cost-effective treatment option, with a probability of 76%. TCZ was associated with a higher cost ($6,990 versus $6,608) and higher QALYs gained (4.24 versus 3.95) compared to ADA with an incremental cost-effectiveness ratio (ICER) of USD 1,301, which is below the willingness-to-pay threshold of 1,448 USD in Iran. Conclusion: This study provides convincing evidence of the cost-effectiveness of TCZ compared to ADA in the treatment of active severe RA in Iran. [ABSTRACT FROM AUTHOR]

Background: Following the COVID-19 pandemic, millions of people continue to experience ongoing physical and mental health sequelae after recovery from acute infection. There is currently no specific treatment for the diverse symptoms associated with post-COVID-19 condition. Physical and mental health rehabilitation may help improve quality of life in such patients. This study reports the cost-effectiveness of a programme of physical and mental health rehabilitation compared to best practice usual care in people with post-COVID-19 condition who were previously hospitalised. Methods: We conducted an economic evaluation within a randomised controlled trial from the perspective of the UK national health service (NHS) and personnel social services perspective (PSS). Resource used and health-related quality of life were collected using bespoke questionnaire and the EQ-5D-5 L questionnaire at three, six, and 12 months. Incremental costs and quality adjusted life years accrued over the follow-up period were estimated and reported as the incremental cost-effectiveness ratio. Estimate uncertainty was managed by multiple imputation and bootstrapping cost-effectiveness estimates; and displayed graphically on the cost-effectiveness plane. Results: Over a 12-month time horizon, incremental costs and QALYs were £305 (95% CI: -123 to 732) and 0.026 (95% CI: -0.005 to 0.052) respectively. The ICER was £11,941 per QALY indicating cost-effective care. Sensitivity analyses supported the base case findings. The probability of the intervention being cost-effective at a £30,000 per QALY willingness-to-pay threshold was 84%. Conclusion: The within-trial economic evaluation suggested that people with post-COVID-19 condition after hospitalisation should be offered a programme of physical and mental health rehabilitation as it likely reflects a cost-effective use of NHS resources. Hospitalisation for COVID-19 has become less commonplace: further evaluation in non-hospitalised patients may be worthwhile. Trial registration: ISRCTN registry ISRCTN11466448 23rd November 2020. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion The purpose of this study is to explore the rational pricing range for the once‐weekly administration of insulin icodec in the treatment of type 2 diabetes patients in China who have already received basal insulin therapy.The data foundation of this study originates from the ONWARDS 4 clinical trial and research materials on Chinese type 2 diabetes patients. By comprehensively applying cost‐utility analysis methods and binary search techniques, the appropriate price positioning of insulin icodec was determined from the perspective of China's healthcare system.In the long‐term treatment simulation, we found that insulin icodec and insulin glargine performed similarly in terms of quality‐adjusted life years (QALYs), with 10.15 and 10.07 years, respectively. Although the annual cost of insulin icodec was initially assumed to be equivalent to that of insulin glargine, in‐depth analysis revealed that insulin icodec may have higher cost‐effectiveness potential. Further price sensitivity analysis indicated that the reasonable cost range of insulin icodec lies between $851.95 and $1358.25. After fine‐tuning through univariate sensitivity analysis, this cost range was revised to $784.90 to $1145.96, a conclusion that was robustly validated in subsequent probabilistic sensitivity analysis and scenario simulations.The conclusion drawn from this study is that, with insulin glargine as the cost reference, the economic cost of insulin icodec for Chinese type 2 diabetes patients is expected to range from $784.90 to $1145.96, providing a reference basis for clinical decision‐making and healthcare policy formulation. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective Methods Results Conclusions To perform an economic evaluation to determine whether or not teledermatology (TD) units in primary care (PC) centers offer an alternative in terms of cost‐utility and cost per quality‐adjusted life years (QALYs) to conventional dermatology consultations (face‐to‐face dermatology [F‐F/D]) at the hospital from the perspective of the Public Health System (PHS) and the patients.This is a randomized, controlled, nonblinded, and multicenter study. During 6 months, data from 450 patients (TD: 225 vs. F‐F/D: 225) were collected. From both perspectives, costs, quality of life, and costs per QALYs were analyzed. The QALY scores were estimated from the EuroQol‐5D‐5L (EQ5D‐5L) questionnaire responses.From the perspective of the PHS, the cost per patient was 53.04% lower in the TD group (p < 0.001). Hospital visits decreased by 72.43% in the TD group (p < 0.001). From the patients’ perspective, TD reduced costs per patient by 77.59% (p < 0.001). The cost per QALY was 63.34% higher in the F‐F/D group (p < 0.001). The TD group's total costs were 56.34% lower (p < 0.001). Furthermore, patients in the TD group gained 0.05 QALYs more than those in the F‐F/D group (p = 0.004).This study shows that TD units in PC represent a significant cost‐effective alternative to conventional hospital follow‐up. To enhance TD in PC, it is important to introduce remote consultation platforms incorporating artificial intelligence for prediagnosis. This will enable general practitioners and nurses to make more accurate initial assessments. It is also crucial to provide thorough training to healthcare personnel using these technologies to ensure more efficient and personalized care. Public health nurses will benefit from gaining new skills in managing digital tools, which will help in the early identification of dermatological diseases and reduce unnecessary referrals to specialists. This will optimize resources and improve response times for patients. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Highlights In Thailand, an upper‐middle‐income country, managing haemophilia A (HA) with inhibitors poses significant challenges, often necessitating bypassing agents (BPAs) for bleeding control. This study evaluates the cost‐effectiveness and budget impact of emicizumab, a novel prophylactic agent, as an alternative to both episodic and prophylactic BPA treatments from a societal perspective.A Markov model was employed to estimate the lifetime societal costs and outcomes of emicizumab prophylaxis for HA patients with inhibitors. Treatment efficacy, cost, and epidemiological data were obtained through a comprehensive literature review and incorporated into the model. A 5‐year budget impact analysis complemented the cost‐utility analysis, with a 3% annual discount rate applied to future costs and outcomes.In the base‐case scenario, emicizumab prophylaxis in HA patients aged 2 years and above demonstrated superior cost‐effectiveness, yielding 18.1 quality‐adjusted life years (QALYs) per patient over a lifetime and resulting in cost savings of 138 million Thai Baht (THB) compared to BPA prophylaxis. Compared to episodic BPA treatment, emicizumab yielded 30.5 QALYs and saved 25 million THB per patient. The 5‐year budget impact was projected at 1775 million THB.Emicizumab offers a cost‐saving approach for HA treatment with inhibitors in Thailand, promising significant health benefits and budgetary savings. This supports its potential inclusion in Thailand's National List of Essential Medicines to enhance haemophilia care access. Managing haemophilia A (HA) with inhibitors in Thailand, an upper‐middle‐income country, faces challenges due to limited access to effective treatments or newer drugs for bleeding management. Emicizumab prophylaxis found to as a cost‐effective and viable alternative to traditional treatments, effectively preventing bleeding in Thai HA patients over 2 years old with inhibitors. Demonstrating improved clinical outcomes and reduced costs, emicizumab prophylaxis outperforms episodic BPA treatments, positioning it as a superior treatment option for HA patients with inhibitors in Thailand. [ABSTRACT FROM AUTHOR]

Sirolimus is being increasingly employed to manage specific vascular anomalies. We performed an exploratory cost‐utility analysis to evaluate sirolimus as a treatment for vascular malformations from the Australian healthcare system perspective. Over a one‐year time horizon, sirolimus treatment was associated with an increased expenditure of AU$2832.80 and a gain of 0.08 quality‐adjusted life years (QALYs) when compared to supportive care, resulting in an incremental cost‐effectiveness ratio of AU$35,410/QALY. By most metrics, sirolimus would be considered a cost‐effective treatment for vascular malformations. [ABSTRACT FROM AUTHOR]

Background: Nowadays, minimally invasive lateral lumbar interbody fusion (LLIF) is used to treat degenerative lumbar spine disease. Many studies have proven that LLIF results in less soft tissue destruction and rapid recovery compared with open posterior lumbar interbody fusion (PLIF). Our recent cost-utility study demonstrated that LLIF was not cost-effective according to the Thai willingness-to-pay threshold, primarily due to the utilization of an expensive bone substitute: bone morphogenetic protein 2. Therefore, this study was designed to use less expensive tricalcium phosphate combined with iliac bone graft (TCP + IBG) as a bone substitute and compare cost-utility analysis and clinical outcomes of PLIF in Thailand. Methods: All clinical and radiographic outcomes of patients who underwent single-level LLIF using TCP + IBG and PLIF were retrospectively collected. Preoperative and 2-year follow-up quality of life from EuroQol-5 Dimensions-5 Levels and health care cost were reviewed. A cost-utility analysis was conducted using a Markov model with a lifetime horizon and a societal perspective. Results: All enrolled patients were categorized into an LLIF group (n = 30) and a PLIF group (n = 50). All radiographic results (lumbar lordosis, foraminal height, and disc height) were improved at 2 years of follow-up in both groups (P < 0.001); however, the LLIF group had a dramatic significant improvement in all radiographic parameters compared with the PLIF group (P < 0.05). The fusion rate for LLIF (83.3%) and PLIF (84%) was similar and had no statistical significance. All health-related quality of life (Oswestry Disability Index, utility, and EuroQol Visual Analog Scale) significantly improved compared with preoperative scores (P < 0.001), but there were no significant differences between the LLIF and PLIF groups (P > 0.05). The total lifetime cost of LLIF was less than that of PLIF (15,355 vs 16,500 USD). Compared with PLIF, LLIF was cost-effective according to the Thai willingness-to-pay threshold, with a net monetary benefit of 539.76 USD. Conclusion: LLIF with TCP + IBG demonstrated excellent radiographic and comparable clinical health-related outcomes compared with PLIF. In economic evaluation, the total lifetime cost was lower in LLIF with TCP + IBG than in PLIF. Furthermore, LLIF with TCP + IBG was cost-effective compared with PLIF according to the context of Thailand. Clinical Relevance: LLIF with less expensive TCP + IBG as bone graft results in better clinical and radiographic outcomes, less lifetime cost, and cost-effectiveness compared with PLIF. This suggests that LLIF with TCP + IBG could be utilized in lower- and middle-income countries for treating patients with degenerative disc disease. Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

The primary objective of this study was to conduct a cost–utility analysis of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in real-world, comparing their use with standard care for managing cardiovascular disease. A multicenter prospective study was conducted across 12 Spanish hospitals from May 2020 to April 2022, involving 158 patients with hypercholesterolemia or atherosclerotic cardiovascular disease. This study assessed health-related quality of life (QoL) using the EQ-5D-3L questionnaire. The cost–utility analysis evaluated the economic impact of PCSK9 inhibitors when used with standard care compared to standard care alone, calculating the incremental cost–effectiveness ratio (ICER). This study included 158 patients with an average age of 61 years, male (66.5%). For patients initiating PCSK9 inhibitors, the treatment cost was EUR 13,633.39, while standard therapy cost EUR 3638.25 over two years. QoL for PCSK9 inhibitors stood at 1.6489 over two years, compared to 1.4548 for standard therapy. The results revealed favorable cost–utility outcomes, with an ICER of EUR 51,427.72. Significant improvements were observed in the domains of mobility, self-care, daily activities, pain/discomfort, and anxiety/depression (p < 0.001). This study presents the first real-world cost–utility analysis of PCSK9 inhibitors, supporting their economic rationale and highlighting their benefits in clinical practice. Healthcare decision-makers can use these results to inform their decisions and reimbursement policies concerning PCSK9 inhibitors. Trial Registration clinicaltrials.gov Identifier: NCT04319081. [ABSTRACT FROM AUTHOR]

Objective: Medical interventions used in pregnancy can affect the length and quality of life of both the pregnant person and fetus. The aim of this systematic review was to identify and describe the theoretical frameworks that underpin outcome measurement in cost-utility analyses of pregnancy interventions. Methods: Searches were conducted in the Paediatric Economic Database Evaluation (PEDE) database (up to 2017), as well as Medline, Embase and EconLit (2017–2019). We included all cost-utility analyses of any intervention given during pregnancy, published in English. We conducted a narrative synthesis of: study design; outcome construction (life expectancy, quality adjustment, discount rate); and whether the Incremental Cost-Effectiveness Ratio (ICER) was constructed using maternal or fetal outcomes. Where both outcomes were included, methods for combining them were extracted. Results: We identified 127 cost-utility analyses in pregnancy, of which 89 reported QALYs and 38 DALYs. Outcomes were considered solely for the fetus in 59 studies (47%), solely for the pregnant person in 13 studies (10%), and for both in 49 studies (39%). The choice to include or exclude one or both sets of outcomes was not consistent within particular clinical areas. Where outcomes for both mother and baby were included, methods for combining these outcomes varied. Twenty-nine studies summed QALYs/DALYs for maternal and fetal outcomes, with no adjustment. The remaining 20 took a variety of approaches designed to weigh maternal and fetal outcomes differently. These include (1) treating fetal outcomes as a component of maternal quality of life, rather than (or in addition to) an independent individual health outcome; (2) treating the maternal-fetal dyad as a single entity and applying a single utility value to each combination of outcomes; and (3) assigning a shorter time horizon to fetal outcomes to reduce the weight of lifetime fetal outcomes. Each approach made different assumptions about the relative value of maternal and fetal health outcomes, demonstrating a lack of consistency and the need for guidance. Conclusion: Methods for capturing QALY/DALY outcomes in cost-utility analysis in pregnancy vary widely. This lack of consistency indicates a need for new methods to support the valuation of maternal and fetal health outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Recent evidence indicates that Maternal Supplementation with Long-Chain n-3 Fatty Acids During Pregnancy Substantially Mitigates Offspring's Asthma. Adding information regarding its cost-utility will undoubtedly allow its adoption, or not, in clinical practice guidelines. This research aimed to determine the cost-utility of LCPUFA supplementation in the third trimester of pregnancy to reduce the risk of wheezing and asthma in infants in Colombia. Methods: A Markov model was formulated to estimate the cost and quality-adjusted life-years (QALYs) attributed to individuals with severe asthma in Colombia, with a time horizon of five years and a cycle length of two weeks. Probabilistic sensitivity analysis and a value of information (VOI) analysis were conducted to evaluate the uncertainties in the case base. Cost-utility was assessed at a willingness-to-pay (WTP) value of US$5180. All costs were adjusted to 2021 with a 5% annual discounting rate for cost and QALYs. Results: The mean incremental cost of LCPUFA supplementation versus no supplementation was US-43.65. The mean incremental benefit of LCPUFA supplementation versus no supplementation was 0.074 QALY. The incremental cost-utility ratio was estimated at US$590.68 per QALY. The outcomes derived from our primary analysis remained robust when subjected to variations in all underlying assumptions and parameter values. Conclusion: Supplementation strategy supplementation with long-chain n-3 fatty acids during pregnancy is cost-effective in reducing the risk of developing asthma during childhood in Colombia. [ABSTRACT FROM AUTHOR]

Osteoporotic vertebral compression fractures (OVCFs) are a highly prevalent source of morbidity and mortality, and preventive treatment has been demonstrated to be both effective and cost effective. To take advantage of the information available on existing chest and abdominal radiographs, the authors' study group has developed software to access these radiographs for OVCFs with high sensitivity and specificity using an established artificial intelligence deep learning algorithm. The aim of this analysis was to assess the potential cost-effectiveness of implementing this software. A deterministic expected-value cost-utility model was created, combining a tree model and a Markov model, to compare the strategies of opportunistic screening for OVCFs against usual care. Total costs and total quality-adjusted life-years were calculated for each strategy. Screening and treatment costs were considered from a limited societal perspective, at 2022 prices. In the base case, assuming a cost of software implantation of $10 per patient screened, the screening strategy dominated the nonscreening strategy: it resulted in lower cost and increased quality-adjusted life-years. The lower cost was due primarily to the decreased costs associated with fracture treatment and decreased probability of requiring long-term care in patients who received preventive treatment. The screening strategy was dominant up to a cost of $46 per patient screened. Artificial intelligence–based opportunistic screening for OVCFs on existing radiographs can be cost effective from a societal perspective. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Mammography (MG) has demonstrated its effectiveness in diminishing mortality and advanced-stage breast cancer incidences in breast screening initiatives. Notably, research has accentuated the superior diagnostic efficacy and cost-effectiveness of digital breast tomosynthesis (DBT). However, the scope of evidence validating the cost-effectiveness of DBT remains limited, prompting a requisite for more comprehensive investigation. The present study aimed to rigorously evaluate the cost-effectiveness of DBT plus MG (DBT-MG) compared to MG alone within the framework of Taiwan's National Health Insurance program. Methods: All parameters for the Markov decision tree model, encompassing event probabilities, costs, and utilities (quality-adjusted life years, QALYs), were sourced from reputable literature, expert opinions, and official records. With 10,000 iterations, a 2-year cycle length, a 30-year time horizon, and a 2% annual discount rate, the analysis determined the incremental cost-effectiveness ratio (ICER) to compare the cost-effectiveness of the two screening methods. Probabilistic and one-way sensitivity analyses were also conducted to demonstrate the robustness of findings. Results: The ICER of DBT-MG compared to MG was US$5971.5764/QALYs. At a willingness-to-pay (WTP) threshold of US$33,004 (Gross Domestic Product of Taiwan in 2021) per QALY, more than 98% of the probabilistic simulations favored adopting DBT-MG versus MG. The one-way sensitivity analysis also shows that the ICER depended heavily on recall rates, biopsy rates, and positive predictive value (PPV2). Conclusion: DBT-MG shows enhanced diagnostic efficacy, potentially diminishing recall costs. While exhibiting a higher biopsy rate, DBT-MG aids in the detection of early-stage breast cancers, reduces recall rates, and exhibits notably superior cost-effectiveness. [ABSTRACT FROM AUTHOR]

Abstract Background and objective This study aimed to determine the cost-effectiveness of Tocilizumab (TCZ) compared with Adalimumab (ADA) in patients with Rheumatoid Arthritis (RA), who had not responded to methotrexate (MTX), from a societal perspective in Iran. Method To conduct the cost-utility analysis, using an individual microsimulation Markov model, a hypothetical cohort of 1,000 patients was evaluated over a lifetime horizon. The efficacy and safety of each treatment were estimated using the American College of Rheumatology (ACR) criteria to determine the continuation or switching of treatment every six months. Treatment responses were captured based on Health Assessment Questionnaire (HAQ) scores and mapped into utility values to determine QALY gained for each treatment. All direct and indirect costs associated with the disease and perspective were included according to societal perspective. Deterministic and Probabilistic sensitivity analyses were performed to assess the robustness of the model. Results The result of the study estimated that TCZ is a more cost-effective treatment option, with a probability of 76%. TCZ was associated with a higher cost ($6,990 versus $6,608) and higher QALYs gained (4.24 versus 3.95) compared to ADA with an incremental cost-effectiveness ratio (ICER) of USD 1,301, which is below the willingness-to-pay threshold of 1,448 USD in Iran. Conclusion This study provides convincing evidence of the cost-effectiveness of TCZ compared to ADA in the treatment of active severe RA in Iran.

Abstract Objective This study aimed to compare the efficacy and cost-utility of unilateral biportal endoscopy (UBE) versus percutaneous endoscopic interlaminar discectomy (PEID) for the treatment of single-level lumbar disc herniation (LDH). Methods A retrospective analysis was conducted on 99 patients who underwent either UBE (n = 33) or PEID (n = 66) between July 2022 and December 2023 at the Second Xiangya Hospital. Patients were matched 1:2 based on age, sex, and surgery level to ensure comparability. Clinical outcomes were assessed using Visual Analog Scale (VAS), European Quality of Life-5 Dimensions (EQ-5D), and Oswestry Disability Index (ODI) scores, with quality-adjusted life years (QALYs) calculated for cost-utility analysis. Hospitalization costs were analyzed, and the incremental cost-utility ratio (ICER) was determined. Results Both UBE and PEID groups demonstrated significant postoperative improvements in VAS, EQ-5D, and ODI scores (p

Abstract Background Edaravone has been widely used in amyotrophic lateral sclerosis (ALS) treatment, and a sublingual (SL) tablet has been developed to offer a more convenient alternative for injection. We present a cost-utility analysis to comprehensively evaluate the costs and health outcomes of oral and intravenous edaravone for the treatment of ALS in Chinese medical context. Methods Cost-utility analysis of SL tablets of edaravone versus intravenous edaravone at home was performed by constructing a 20-year Markov model of ALS stage 1–4 and death. The data were extracted from the literature with model assumptions. Typical sensitivity analysis and scenario analysis for administering SL tablets at home versus intravenous tablets at the hospital were performed. Results In the base case analysis, with SL tablets and intravenous injections both at home, the model estimated an additional cost of ¥12,670.04 and an additional 0.034 QALYs over 20 years (life time) of modeling analysis, and the ICER was ¥372,648.24 per QALY. However, in the scenario of intravenous administration at the hospital, SL tablet was demonstrated dominance to intravenous injection. Conclusions Using 3 times the GDP per capita of China in 2023 as the threshold, the SL tablet edaravone was not cost-effective in the context of home treatment for both formulationst, but was dominance to intravenous injection in hospital treatment. The results highlighted the importance of treatment context for health economic analysis.

Álvaro J Rallo-López,1 Rafael Martínez-Costa Pérez2 1Department of Ophthalmology, Clínica Baviera, Valencia, Spain; 2Department of Ophthalmology – Retina and Vitreous, Hospital Universitario y Politécnico La Fe, Valencia, SpainCorrespondence: Álvaro J Rallo-López, Email rallo.1c@gmail.comBackground and Objective: To compare the cost and utility of scleral buckle (SB) and pars plana vitrectomy (PPV) techniques for repairing moderately complex rhegmatogenous retinal detachment (RRD).Patients, Materials, and Methods: A cost-utility analysis was conducted using data from the Primary Retinal Detachment Outcomes Study (PRO) and a study conducted by the author. Total costs, patient utility over a lifetime, and cost per quality-adjusted life year (QALY) were calculated for each surgical procedure.Results: The cost of scleral buckle surgery was € 287.93, with an estimated lifetime QALY of 7.49. Costs per QALY were € 38.44. According to the PRO study and Belin et al, total costs were &dollar;5975, with a lifetime QALY of 5.4 and costs per QALY of &dollar;1106. The cost of pars plana vitrectomy (PPV) was € 1468.26, with an estimated lifetime QALY of 6.84 and costs per QALY of € 214.65. Based on the PRO study and Belin et al, total costs were &dollar;8125, with a lifetime QALY of 4.7 and costs per QALY of &dollar;2196.Conclusion: Repairing moderately complex RRD presents a highly cost-effective profile for both SB and PPV techniques, well below recommended QALY thresholds. SB demonstrated a slightly more favorable profile compared to PPV.Keywords: retinal detachment, pars plana vitrectomy, scleral buckle, cost-utility analysis, QALY

Abstract Objective Medical interventions used in pregnancy can affect the length and quality of life of both the pregnant person and fetus. The aim of this systematic review was to identify and describe the theoretical frameworks that underpin outcome measurement in cost-utility analyses of pregnancy interventions. Methods Searches were conducted in the Paediatric Economic Database Evaluation (PEDE) database (up to 2017), as well as Medline, Embase and EconLit (2017–2019). We included all cost-utility analyses of any intervention given during pregnancy, published in English. We conducted a narrative synthesis of: study design; outcome construction (life expectancy, quality adjustment, discount rate); and whether the Incremental Cost-Effectiveness Ratio (ICER) was constructed using maternal or fetal outcomes. Where both outcomes were included, methods for combining them were extracted. Results We identified 127 cost-utility analyses in pregnancy, of which 89 reported QALYs and 38 DALYs. Outcomes were considered solely for the fetus in 59 studies (47%), solely for the pregnant person in 13 studies (10%), and for both in 49 studies (39%). The choice to include or exclude one or both sets of outcomes was not consistent within particular clinical areas. Where outcomes for both mother and baby were included, methods for combining these outcomes varied. Twenty-nine studies summed QALYs/DALYs for maternal and fetal outcomes, with no adjustment. The remaining 20 took a variety of approaches designed to weigh maternal and fetal outcomes differently. These include (1) treating fetal outcomes as a component of maternal quality of life, rather than (or in addition to) an independent individual health outcome; (2) treating the maternal-fetal dyad as a single entity and applying a single utility value to each combination of outcomes; and (3) assigning a shorter time horizon to fetal outcomes to reduce the weight of lifetime fetal outcomes. Each approach made different assumptions about the relative value of maternal and fetal health outcomes, demonstrating a lack of consistency and the need for guidance. Conclusion Methods for capturing QALY/DALY outcomes in cost-utility analysis in pregnancy vary widely. This lack of consistency indicates a need for new methods to support the valuation of maternal and fetal health outcomes.

Aim: Insulin icodec is a first once‐weekly administration basal insulin analogue for type 2 diabetes. This study aimed to investigate the price range of icodec for type 2 diabetes in the Chinese market, taking insulin degludec as reference. Materials and Methods: Long‐term health outcomes and costs for icodec and degludec were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model (version 2.1) over 40 years from the Chinese healthcare provider's perspective. The efficacy and safety data were obtained from the ONWARDS 2 trial (Switching to once‐weekly insulin icodec versus once‐daily insulin degludec in individuals with basal insulin‐treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat‐to‐target trial). Cost–utility analysis and a binary search were used to investigate the price range of icodec. Sensitivity analyses were performed to verify the robustness of the base‐case analysis results. Results: After a 40‐year simulation, the quality‐adjusted life years (QALY) of icodec and degludec were 10.32 and 10.28 years, respectively. At the initial assumption of the same annual costs of icodec and degludec of $455.40, icodec was the dominant therapy compared with degludec, with higher QALYs and lower total cost. After the binary search, we observed that the annual cost range of icodec was $625.17–$855.25. This cost range was finally adjusted to be $597.66–$736.34 using one‐way sensitivity analysis and confirmed using probabilistic sensitivity analysis and scenario analysis. The scenario analysis revealed that the annual cost range of icodec could be $506.70–$736.34 if the price of degludec decreased by 20% in the future. Conclusion: Insulin icodec appears to be more cost effective than degludec if the annual cost of icodec ranges from $597.66 to $736.34 for patients with type 2 diabetes in China. [ABSTRACT FROM AUTHOR]

Introduction: Utility values offer a quantitative means to evaluate the impact of novel cancer treatments on patients' quality of life (QoL). However, the multiple methods available for valuing QoL present challenges in selecting the most appropriate method across different contexts. Areas covered: This review provides cancer clinicians and researchers with an overview of methods to value QoL for economic evaluations, including standalone and derived preference-based measures (PBMs) and direct preference elicitation methods. Recent developments are described, including the comparative performance of cancer-specific PBMs versus generic PBMs, measurement of outcomes beyond health-related QoL, and increased use of discrete choice experiments to elicit preferences. Recommendations and considerations are provided to guide the choice of method for cancer research. Expert opinion: We foresee continued adoption of the QLU-C10D and FACT-8D in cancer clinical trials given the extensive use of the EORTC QLQ-C30 and FACT-G in cancer research. While these cancer-specific PBMs offer the convenience of eliciting utility values without needing a standalone PBM, researchers should consider potential limitations if they intend to substitute them for generic PBMs. As the field advances, there is a greater need for consensus on the approach to selection and integration of various methods in cancer clinical trials. [ABSTRACT FROM AUTHOR]

Abstract Background The 13‐MD is a new generic instrument developed to measure general health‐related quality of life (GHRQoL). This instrument considers all aspects of health (i.e., physical, mental, and social) in a balanced way. A previous study led to minor changes in the original version of the 13‐MD. The objective of this study was to confirm the validity of the modified 13‐MD. Methods Validity was assessed with recent data from the general population of Quebec, Canada. The meta‐dimensions and items composing the 13‐MD were also subjected to a ranking procedure, which allowed to determine the most important aspects for respondents. Results A total of 1337 French‐speaking participants were recruited with 1099 completing the 13‐MD for validation purposes and 1084 completing the ranking procedure. The 13‐MD showed very satisfactory results and confirmed to be a valid instrument. The ranking of the meta‐dimensions revealed that “Well‐being” received the most points, followed by “Sleep and energy” and “Body functioning.” Conclusion These results will be very useful in the continuous improvement of the 13‐MD, ultimately leading to the valuation stage (i.e., development of a value set).

Abstract This study aimed to assess the cost-utility and budget impact of dual to single HER2 targeted neoadjuvant therapy for HER2-positive breast cancer in Sri Lanka. A five-health state Markov model with lifetime horizon was used to assess the cost-utility of neoadjuvant trastuzumab (T) plus pertuzumab (P) or lapatinib (L) compared to single therapy of T with chemotherapy (C), in public healthcare system and societal perspectives. Input parameters were estimated using local data, network meta-analysis, published reports and literature. Costs were adjusted to year 2021 (1USD = LKR194.78). Five-year budget impact for public healthcare system was assessed. Incremental cost-effectiveness ratios in societal perspective for neoadjuvantLTC plus adjuvantT (strategy 3), neoadjuvantPTC plus adjuvantT (strategy 2), neoadjuvantLTC plus adjuvantLT (strategy 5), and neoadjuvantPTC plus adjuvantPT (strategy 4) compared to neoadjuvantTC plus adjuvantT (strategy 1) were USD2716, USD5600, USD6878, and USD12127 per QALY gained, respectively. One GDP per-capita (USD3815) was considered as the cost-effectiveness threshold for the analysis. Even though only the ICER for strategy 3 was cost-effective, uncertainty of efficacy parameter was revealed. For strategy 2 neoadjuvant PTC plus adjuvant T, a 25% reduction of neoadjuvant regimen cost was required to be cost effective for use in early HER2 positive breast cancer.

Abstract Background The potential for artificial intelligence (AI) to transform healthcare cannot be ignored, and the development of AI technologies has increased significantly over the past decade. Furthermore, healthcare systems are under tremendous pressure, and efficient allocation of scarce healthcare resources is vital to ensure value for money. Health economic evaluations (HEEs) can be used to obtain information about cost-effectiveness. The literature acknowledges that the conduct of such evaluations differs between medical technologies (MedTechs) and pharmaceuticals, and poor quality evaluations can provide misleading results. This systematic review seeks to map the evidence on the general methodological quality of HEEs for AI technologies to identify potential areas which can be subject to quality improvements. We used the 35-item checklist by Drummond and Jefferson and four additional checklist domains proposed by Terricone et al. to assess the methodological quality of full HEEs of interventions that include AI. Results We identified 29 studies for analysis. The included studies had higher completion scores for items related to study design than for items related to data collection and analysis and interpretation of results. However, none of the studies addressed MedTech-specific items. Conclusions There was a concerningly low number of full HEEs relative to the number of AI publications, however the trend is that the number of studies per year is increasing. Mapping the evidence of the methodological quality of HEEs of AI shows a need to improve the quality in particular the use of proxy measures as outcome, reporting, and interpretation of the ICER.

Abstract Background The economic assessment of health care models in palliative care promotes their global development. The purpose of the study is to assess the cost-effectiveness of a palliative care program (named Contigo) with that of conventional care from the perspective of a health benefit plan administrator company, Sanitas, in Colombia. Methods The incremental cost-utility ratio (ICUR) and the incremental net monetary benefit (INMB) were estimated using micro-costing in a retrospective, analytical cross-sectional study on the care of terminally ill patients enrolled in a palliative care program. A 6-month time horizon prior to death was used. The EQ-5D-3 L questionnaire (EQ-5D-3 L) and the McGill Quality of Life Questionnaire (MQOL) were used to measure the quality of life. Results The study included 43 patients managed within the program and 16 patients who received conventional medical management. The program was less expensive than the conventional practice (difference of 1,924.35 US dollars (USD), P = 0.18). When compared to the last 15 days, there is a higher perception of quality of life, which yielded 0.25 in the EQ-5D-3 L (p

Abstract Background Road traffic injuries are a major concern worldwide, with Thailand facing high accident mortality rates. Drunk driving is a key factor that requires countermeasures. Random breath testing (RBT) and mass media campaigns recommended by the World Health Organisation intend to deter such behaviour. This study aimed to evaluate the cost-effectiveness of implementing RBT in combination with mass media campaigns in Thailand. Methods A Markov simulation model estimated the lifetime cost and health benefits of RBT with mass media campaigns compared to mass media campaigns only. Direct medical and non-medical care costs were evaluated from a societal perspective. The health outcomes were quality-adjusted life years (QALY). Costs and outcomes were discounted by 3% per year. Subgroup analyses were conducted for both sexes, different age groups, and different drinking levels. Probabilistic sensitivity analyses were conducted over 5,000 independent iterations using a predetermined distribution for each parameter. Results This study suggested that RBT with mass media campaigns compared with mass media campaigns increases the lifetime cost by 24,486 THB per male binge drinker and 10,475 THB per female binge drinker (1 USD = 35 THB) and results in a QALY gain of 0.43 years per male binge drinker and 0.10 years per female binge drinker. The intervention yielded incremental cost-effectiveness ratios (ICERs) of 57,391 and 103,850 THB per QALY for male and female drinkers, respectively. Moreover, the intervention was cost-effective for all age groups and drinking levels. The intervention yielded the lowest ICER among male-dependent drinkers. Sensitivity analyses showed that at a willingness-to-pay (WTP) threshold of 160,000 per QALY gained, the RBT combined with mass media campaigns had a 99% probability of being optimal for male drinkers, whereas the probability for females was 91%. Conclusions RBT and mass media campaigns in Thailand are cost-effective for all ages and drinking levels in both sexes. The intervention yielded the lowest ICER among male-dependent drinkers. Given the current Thai WTP threshold, sensitivity analyses showed that the intervention was more cost-effective for males than females.

Abstract Background Relapsed or refractory classic Hodgkin lymphoma (RRcHL) associates with poor prognosis and heavy disease burden to patients. This study evaluated the cost-effectiveness of brentuximab vedotin (BV) in comparison to conventional chemotherapy in patients with RRcHL, from a Chinese healthcare perspective. Methods The lifetime cost and quality adjusted life years (QALYs) were estimated through a partitioned survival model with three health states (progression free, post progression, and death). Two cohorts for each BV arm and chemotherapy arm were built, representing patients with and without transplant after BV or chemotherapy, respectively. Clinical parameters were retrieved from BV trials and the literature. Resource utilization data were mainly collected from local expert surveys and cost parameters were reflecting local unit prices. Utility values were sourced from the literature. A discount rate of 5% was employed according to the Chinese guideline. A series of deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness and uncertainty associated with the model. Results Results of the base case analysis showed that the incremental cost-effectiveness ratio (ICER) for BV versus chemotherapy was $2,867 (¥19,774). The main model driver was the superior progression-free and overall survival benefits of BV. The ICERs were relatively robust in a series of sensitivity analyses, all under a conventional decision threshold (1 time of Chinese per capita GDP). With this conventional threshold, the probability of BV being cost-effective was 100%. Conclusions Brentuximab vedotin can be considered a cost-effective treatment versus conventional chemotherapy in treating relapsed or refractory classic Hodgkin lymphoma in China.

Background: The World Health Organization (WHO) has set hepatitis C (HCV) elimination targets for 2030. Understanding existing gaps in the "HCV care-cascade" is essential for meeting these targets. We aimed to identify the level of service scale-up needed along the "HCV care-cascade" to achieve the WHO's HCV elimination targets in Ontario, Canada. Methods: By employing a decision analytic model, we projected the quality-adjusted life years (QALYs) and healthcare costs for individuals with HCV in Ontario. We increased RNA testing and treatment rates to 98%, followed by increasing antibody testing uptake until we achieved the WHO's mortality target (i.e., a 65% reduction in liver-related mortality by 2030 vs. 2015). Results: Without scaling up by 2030, the expected QALYs and costs per person were 9.156 and CAD 48,996, respectively. Improved RNA testing and treatment rates reduced liver-related deaths to 3.3/100,000, a 57% reduction from 2015. Further doubling the antibody testing rates can achieve the WHO's mortality target in 2035, but not in 2030. Compared to the status quo, such program would be cost-effective considering a 50,000 CAD/QALY gained threshold if annual implementation costs stayed under 2.3 M CAD/100,000 people. Conclusions: Doubling the antibody testing rates, along with increased RNA testing and treatment rates, showed promise in meeting the WHO's goals by 2035. [ABSTRACT FROM AUTHOR]

Aim: To investigate the most matchable price of tirzepatide (TIRZ) compared with semaglutide (SEMA) in the treatment of type 2 diabetes in China. Methods: The patient cohort and clinical efficacy data were derived from the SURPASS‐2 trial. Cost‐utility analysis and a binary search were performed to identify the most matchable price of TIRZ from a Chinese healthcare provider's perspective. Results: After lifetime simulation, the quality‐adjusted life years of TIRZ 5, 10, 15 mg and SEMA 1 mg were 11.17, 11.21, 11.27 and 11.12 years, respectively. Despite an initial assumption that the annual cost of TIRZ equals that of SEMA, our analysis revealed that TIRZ is probably more cost‐effective than SEMA. A thorough evaluation of pricing showed that the cost ranges for TIRZ at doses of 5, 10 and 15 mg were $1628.61‐$1846.23, $1738.40‐$2140.95 and $1800.30‐$2430.81, respectively. After adjustment in the univariate sensitivity analysis, the cost ranges for TIRZ 5, 10 and 15 mg were $1542.68‐$1757.57, $1573.00‐$1967.16 and $1576.54‐$2133.96, respectively. These cost intervals were validated through robust probabilistic sensitivity analysis and scenario analysis, except for the cost range for TIRZ 5 mg. Conclusions: This study shows that, using SEMA as a reference, the annual costs for TIRZ 10 and 15 mg are $1573.00‐$1967.16 and $1576.54‐$2133.96, respectively, for patients with type 2 diabetes in China. [ABSTRACT FROM AUTHOR]

Background: The economic assessment of health care models in palliative care promotes their global development. The purpose of the study is to assess the cost-effectiveness of a palliative care program (named Contigo) with that of conventional care from the perspective of a health benefit plan administrator company, Sanitas, in Colombia. Methods: The incremental cost-utility ratio (ICUR) and the incremental net monetary benefit (INMB) were estimated using micro-costing in a retrospective, analytical cross-sectional study on the care of terminally ill patients enrolled in a palliative care program. A 6-month time horizon prior to death was used. The EQ-5D-3 L questionnaire (EQ-5D-3 L) and the McGill Quality of Life Questionnaire (MQOL) were used to measure the quality of life. Results: The study included 43 patients managed within the program and 16 patients who received conventional medical management. The program was less expensive than the conventional practice (difference of 1,924.35 US dollars (USD), P = 0.18). When compared to the last 15 days, there is a higher perception of quality of life, which yielded 0.25 in the EQ-5D-3 L (p < 0.01) and 1.55 in the MQOL (P < 0.01). The ICUR was negative and the INMB was positive. Conclusion: Because the Contigo program reduces costs while improving quality of life, it is considered to be net cost-saving and a model with value in health care. Greater availability of palliative care programs, such as Contigo, in Colombia can help reduce existing gaps in access to universal palliative care health coverage, resulting in more cost-effective care. [ABSTRACT FROM AUTHOR]

Background: The potential for artificial intelligence (AI) to transform healthcare cannot be ignored, and the development of AI technologies has increased significantly over the past decade. Furthermore, healthcare systems are under tremendous pressure, and efficient allocation of scarce healthcare resources is vital to ensure value for money. Health economic evaluations (HEEs) can be used to obtain information about cost-effectiveness. The literature acknowledges that the conduct of such evaluations differs between medical technologies (MedTechs) and pharmaceuticals, and poor quality evaluations can provide misleading results. This systematic review seeks to map the evidence on the general methodological quality of HEEs for AI technologies to identify potential areas which can be subject to quality improvements. We used the 35-item checklist by Drummond and Jefferson and four additional checklist domains proposed by Terricone et al. to assess the methodological quality of full HEEs of interventions that include AI. Results: We identified 29 studies for analysis. The included studies had higher completion scores for items related to study design than for items related to data collection and analysis and interpretation of results. However, none of the studies addressed MedTech-specific items. Conclusions: There was a concerningly low number of full HEEs relative to the number of AI publications, however the trend is that the number of studies per year is increasing. Mapping the evidence of the methodological quality of HEEs of AI shows a need to improve the quality in particular the use of proxy measures as outcome, reporting, and interpretation of the ICER. [ABSTRACT FROM AUTHOR]

Objective: There is an economic evaluation on the family‐based Helicobacter pylori screen‐and‐treat strategy (FBHS) in China. This study aimed to compare the cost‐effectiveness of the FBHS with the traditional H. pylori screen‐and‐treat strategy (TBHS). Materials and Methods: A seven‐state microsimulation model, including H. pylori infection and gastric cancer states, was constructed on the basis of the target family samples from 29 provinces in China. Taking a lifetime horizon from a healthcare system perspective, the long‐term costs and health outcomes of the FBHS and TBHS screening strategies were simulated separately, and economic evaluations were performed. The model parameters were primarily derived from real‐world data, published literature, and expert opinions. The primary outcome was the incremental cost‐effectiveness ratio (ICER) expressed as cost/quality‐adjusted life‐year (QALY) gained. One‐way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis were performed to assess the uncertainty of the results. Results: The base‐case analysis revealed that the average costs for FBHS and TBHS were 563.67 CNY and 574.08 CNY, respectively, with corresponding average QALYs of 14.83 and 14.79. The ICER for the comparison between the two strategies was −214.07, indicating that FBHS was an absolutely dominant strategy with better cost‐effectiveness. The results of both one‐way sensitivity analysis and probabilistic sensitivity analysis were robust. When taking into account the added benefit of the higher H. pylori eradication rate in FBHS, the average costs were further reduced, and the average QALYs were increased, solidifying its position as an unequivocally dominant strategy. Conclusion: The FBHS is an absolutely dominant and cost‐effective strategy that enables an optimized allocation of screening resources. Decision‐makers should prioritize FBHS when developing H. pylori prevention and control strategies. [ABSTRACT FROM AUTHOR]

Background and Aims: Cardiovascular diseases (CVDs) are one of the major diseases in developing and developed countries and have high prevalence and mortality rates. Pharmacological interventions, especially the use of combination medications, can have preventive effects in patients with CVDs. Recently, in the PolyIran trial, a combination of atorvastatin, hydrochlorothiazide, aspirin, and valsartan or enalapril (Polypill) was shown to be effective in providing survival benefits as a primary prevention strategy. In the present study, we examine the cost‐effectiveness of the use of polypill compared to its individual components (named as medication monotherapy) in the prevention of CVDs in Iran. Methods: This was an economic evaluation study conducted to compare the cost‐utility of polypill with that of medication monotherapy for 10,000 hypothetical cohorts of people over 35 years of age using the Markov model and with a lifetime horizon. The study perspective was patient perspective and direct medical costs, quality‐adjusted life‐years (QALYs), and incremental cost‐effectiveness ratio were estimated. To deal with uncertaintysensitivity analyses were used. Results: The results showed that polypill, with the lowest costs (871 USD) and highest QALYs (14.55), had the most cost‐utility than medication monotherapy. Also, the results showed that the highest sensitivities were related to the utilities of angina and stroke states. At the 21,768 USD threshold, polypill had a 92% probability of being cost‐effective versus other medications. Conclusion: Considering that polypill had the most cost‐utility, it is suggested that health system policymakers pay special attention to polypill in designing clinical guidelines. Also, through covering this medication by health insurance organizations, it is possible to complete the country's medicine pharmacopeia in preventing CVDs. [ABSTRACT FROM AUTHOR]

Heart failure (HF) is a common clinical syndrome in which the cardiac systolic and/or diastolic functions are significantly insufficient, resulting in an inadequate pump function. Currently, it is one of the leading causes of human death and/or hospitalization, and it has become a serious global public health problem. Approximately 1.2 million people in Poland suffer from HF, and approximately 140,000 of them die every year. In this article, we present the result of telemedicine intervention and its cost-effectiveness in a group of patients from a pilot program on telemedicine and e-health solutions reducing social inequalities in the field of cardiology. Based on the EQ-5D-5L questionnaire administered in the beginning of the project and after approximately 3 months, used for the health state utility values calculation, cost estimates of the project, and inclusion of supplementary data, the economic rationale behind telemedical intervention in HF patients using a cost–utility analysis was corroborated. The choice of a 3-month project duration was due to the top-down project assumptions approved by the bioethics committee. The average improvement in health state utility values was statistically significant, implying a 0.01 QALY improvement per patient. The cost of the telemedical intervention per QALY was well within the official limit adopted as a cost-effective therapy measure in Poland. [ABSTRACT FROM AUTHOR]

Background: Road traffic injuries are a major concern worldwide, with Thailand facing high accident mortality rates. Drunk driving is a key factor that requires countermeasures. Random breath testing (RBT) and mass media campaigns recommended by the World Health Organisation intend to deter such behaviour. This study aimed to evaluate the cost-effectiveness of implementing RBT in combination with mass media campaigns in Thailand. Methods: A Markov simulation model estimated the lifetime cost and health benefits of RBT with mass media campaigns compared to mass media campaigns only. Direct medical and non-medical care costs were evaluated from a societal perspective. The health outcomes were quality-adjusted life years (QALY). Costs and outcomes were discounted by 3% per year. Subgroup analyses were conducted for both sexes, different age groups, and different drinking levels. Probabilistic sensitivity analyses were conducted over 5,000 independent iterations using a predetermined distribution for each parameter. Results: This study suggested that RBT with mass media campaigns compared with mass media campaigns increases the lifetime cost by 24,486 THB per male binge drinker and 10,475 THB per female binge drinker (1 USD = 35 THB) and results in a QALY gain of 0.43 years per male binge drinker and 0.10 years per female binge drinker. The intervention yielded incremental cost-effectiveness ratios (ICERs) of 57,391 and 103,850 THB per QALY for male and female drinkers, respectively. Moreover, the intervention was cost-effective for all age groups and drinking levels. The intervention yielded the lowest ICER among male-dependent drinkers. Sensitivity analyses showed that at a willingness-to-pay (WTP) threshold of 160,000 per QALY gained, the RBT combined with mass media campaigns had a 99% probability of being optimal for male drinkers, whereas the probability for females was 91%. Conclusions: RBT and mass media campaigns in Thailand are cost-effective for all ages and drinking levels in both sexes. The intervention yielded the lowest ICER among male-dependent drinkers. Given the current Thai WTP threshold, sensitivity analyses showed that the intervention was more cost-effective for males than females. [ABSTRACT FROM AUTHOR]

Background: Relapsed or refractory classic Hodgkin lymphoma (RRcHL) associates with poor prognosis and heavy disease burden to patients. This study evaluated the cost-effectiveness of brentuximab vedotin (BV) in comparison to conventional chemotherapy in patients with RRcHL, from a Chinese healthcare perspective. Methods: The lifetime cost and quality adjusted life years (QALYs) were estimated through a partitioned survival model with three health states (progression free, post progression, and death). Two cohorts for each BV arm and chemotherapy arm were built, representing patients with and without transplant after BV or chemotherapy, respectively. Clinical parameters were retrieved from BV trials and the literature. Resource utilization data were mainly collected from local expert surveys and cost parameters were reflecting local unit prices. Utility values were sourced from the literature. A discount rate of 5% was employed according to the Chinese guideline. A series of deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness and uncertainty associated with the model. Results: Results of the base case analysis showed that the incremental cost-effectiveness ratio (ICER) for BV versus chemotherapy was $2,867 (¥19,774). The main model driver was the superior progression-free and overall survival benefits of BV. The ICERs were relatively robust in a series of sensitivity analyses, all under a conventional decision threshold (1 time of Chinese per capita GDP). With this conventional threshold, the probability of BV being cost-effective was 100%. Conclusions: Brentuximab vedotin can be considered a cost-effective treatment versus conventional chemotherapy in treating relapsed or refractory classic Hodgkin lymphoma in China. Highlights: In China, BV was approved in 2020 for the treatment of adult patients with CD30-positive RRcHL. However, the economic value of BV compared with conventional therapy remains unknown. This study evaluated the cost-effectiveness of brentuximab vedotin (BV) in comparison to conventional chemotherapy in patients with RRcHL, from a Chinese healthcare perspective. Brentuximab vedotin can be considered a cost-effective treatment versus conventional chemotherapy in treating relapsed or refractory classic Hodgkin lymphoma in China, with the ICER under a conventional decision threshold (1 time of Chinese per capita GDP). [ABSTRACT FROM AUTHOR]

Aim: Depressive disorders in adolescents are common and impairing. Evidence‐based treatments are available; however, at a cost. In the context of the COVID‐19 pandemic, we anticipate increased demand for treatment services for adolescents with depression. We also anticipate that economic resources will be strained. Identifying cost‐effective strategies to optimally treat depression in adolescents is imperative. This protocol for a scoping review aims to describe the literature with respect to economic evaluations of treatments for depression in adolescents. Methods: We will conduct a scoping review using established methods and reporting guidelines. MEDLINE, Embase, PsyclNFO, Econlit, and the International HTA Database will be searched from inception to June 13, 2023, with an update closer to time of manuscript submission, while the NHS Economic Evaluation Database archives will be searched from inception to December 2014. Publications that contain economic evaluations, in the context of a clinical trial or a model‐based study, testing a treatment of depression in adolescents will be selected for inclusion. Extracted data items will include: economic evaluation perspectives, health outcome variables and costs used in economic evaluations, types of analyses performed, as well as quality of reporting and methodology. Result: A narrative synthesis with summary tables will be used to describe our findings. Conclusion: Our findings will help identify gaps in the literature with respect to economic analyses for the treatment of depression such that these gaps can be filled with future research. Policy‐makers, funders and administrators may also use our findings to inform their decisions around provision of various treatments for depression in adolescents. Registration: osf.io/5fteb (note that information on this link will be updated upon acceptance for publication based on reviewer comments). [ABSTRACT FROM AUTHOR]

Background: There is uncertainty in the relative benefits and harms of hyperthermic intraoperative peritoneal chemotherapy (HIPEC) when added to cytoreductive surgery (CRS) +/− systemic chemotherapy or systemic chemotherapy alone in people with peritoneal metastases from colorectal, gastric, or ovarian cancers. Methods: We searched randomized controlled trials (RCTs) in the medical literature until April 14, 2022 and applied methods used for high‐quality systematic reviews. Findings: We included a total of eight RCTs (seven RCTs included in quantitative analysis as one RCT did not provide data in an analyzable format). All comparisons other than ovarian cancer contained only one trial. For gastric cancer, there is high uncertainty about the effect of CRS + HIPEC + systemic chemotherapy. For stage III or greater epithelial ovarian cancer undergoing interval cytoreductive surgery, CRS + HIPEC + systemic chemotherapy probably decreases all‐cause mortality compared to CRS + systemic chemotherapy. For colorectal cancer, CRS + HIPEC + systemic chemotherapy probably results in little to no difference in all‐cause mortality and may increase the serious adverse events proportions compared to CRS +/− systemic chemotherapy, but probably decreases all‐cause mortality compared to fluorouracil‐based systemic chemotherapy alone. Interpretation: The role of CRS + HIPEC in gastric peritoneal metastases is uncertain. CRS + HIPEC should be standard of care in women with stage III or greater epithelial ovarian cancer undergoing interval CRS. CRS + systemic chemotherapy should be standard of care for people with colorectal peritoneal metastases, with HIPEC given only as part of a RCT focusing on subgroups and regimes. PROSPERO Registration: CRD42019130504. [ABSTRACT FROM AUTHOR]

Since 2013, Flanders has introduced a screening programme for colorectal cancer for all citizens aged between 50 and 74 years. The objective of this study was to assess the cost-utility of an expansion of the colorectal cancer screening policy in Flanders (Belgium) and to place these findings in the international context. Cost-utility analysis using high-detail data about screening participation, screening results, and epidemiological data, a Markov cohort model has been constructed to study long-term costs and effects. A cost-utility analysis was performed as a three-way comparison between current, expanded (from age 45 years), and no screening scenarios, from a societal and healthcare perspective. Robustness was assessed by both one-way and probabilistic sensitivity analyses. Analyses show that both current and expanded screening result in quality-adjusted life years (QALY) gains and are mostly cost-saving. Overall, 97.5% of Incremental Cost-Effectiveness Ratios (ICERs) remained well below € 2000 per QALY for all comparisons. Parameters related to the colonoscopy that follows a positive test result such as compliance and cost are especially impactful on the cost-effectiveness. Screening participation and screening costs have remained comparatively stable, making colorectal cancer screening a cost-effective (dominant) policy. Expanding the screen age to 45 years is also cost-effective (dominant) compared with current screening, albeit with a slimmer margin. [ABSTRACT FROM AUTHOR]

Purpose: This study measured the health‐related quality of life (HRQoL) and costs and conducted a cost–utility analysis and budget impact analysis of ambulatory knee arthroscopic surgery compared with inpatient knee arthroscopic surgery in Thailand from a societal perspective. Methods: Health outcomes were measured in units of quality‐adjusted life year (QALY) based on the Thai version of the EQ‐5D‐5L Health Questionnaire, and costs were obtained from an electronic database at a tertiary care hospital (Ramathibodi Hospital). A cost–utility analysis was performed to evaluate ambulatory and inpatient surgery using the societal perspective and a 2‐week time horizon. The incremental cost‐effectiveness ratio was applied to examine the costs and QALYs. One‐way sensitivity analysis was used to investigate the robustness of the model. Budget impact analysis was performed considering over 5 years. Results: A total of 161 knee arthroscopic patients were included and divided into two groups: ambulatory surgery (58 patients) and inpatient surgery (103 patients). The total cost of the inpatient surgery was 2235 United States dollars (USD), while the ambulatory surgery cost was 2002 USD. The QALYs of inpatient surgery and ambulatory surgery were 0.79 and 0.81, respectively, resulting in the ambulatory surgery becoming a dominant strategy (cost reduction of 233 USD with an increase of 0.02 QALY) over the inpatient surgery. The ambulatory surgery led to net savings of 4.5 million USD over 5 years. Medical supply costs are one of the most influential factors affecting the change in results. Conclusion: Ambulatory knee arthroscopic surgery emerged as a cost‐saving strategy over inpatient surgery, driven by lower treatment costs and enhanced HRQoL. Budget impact analysis indicated net savings over 5 years, supporting the feasibility of adopting ambulatory knee arthroscopic surgery. Our findings were advocated for its application across diverse hospitals and informed policymakers to improve reimbursement systems in low‐ to middle‐income countries and Thailand. Level of Evidence: Level IV. [ABSTRACT FROM AUTHOR]

ORIENT-16, a phase III clinical trial conducted at 62 hospitals in China, reported that add-on sintilimab (Sin) to chemotherapy (Chemo) had favorable efficacy (p < 0.05) for patients with advanced HER2-negative gastric or gastroesophageal junction cancer (GC/GEJC). This study aimed to evaluate the cost-utility of the Sin+Chemo based on results of ORIENT-16 from the perspective of Chinese healthcare payers. A three-state partitioned survival model was developed to simulate the 10-year life expectancy and total healthcare costs for patients with advanced HER2-negative GC/GEJC. Primary measure outcomes were: cost, quality-adjusted life-years (QALYs), and incremental cost-utility ratios (ICURs). Sensitivity/scenario analyses were conducted to assess the model robustness. In all patients, Sin+Chemo vs Chemo increased costs by $6,472, additionally providing 0.61 QALYs, resulting in an ICUR of $10,610/QALY. While, in PD-L1 combined positive score ≥ 5 cohort, the ICUR was $9,738/QALYs. The ICUR was most sensitive to the utility of progression-free survival. The probabilistic sensitivity analysis showed that add-on Sin had a 100% probability of being cost-effective at a willingness-to-pay threshold of $18,625/QALY gained. Sin+Chemo is a cost-effective first-line treatment option for advanced HER2-negative GC/GEJC in China. ORIENT-16, , identifier is NCT03745170. [ABSTRACT FROM AUTHOR]

Background Pioglitazone significantly reduces the risk of stroke in people with diabetes, and in those with prediabetes, it markedly reduces the risk of stroke/myocardial infarction and new‐onset diabetes. Low‐dose pioglitazone provides most of the clinical benefits of high‐dose pioglitazone, with fewer adverse effects. We report an economic evaluation of the cost‐effectiveness of low‐dose pioglitazone versus placebo from a Canadian public payer perspective in 2023 Canadian dollars. Methods and Results A Markov model was developed at a lifetime horizon with an annual cycle length and 5 health states (event‐free, myocardial infarction, stroke, new‐onset diabetes, and death). Transition probabilities were extracted from the IRIS (Insulin Resistance Intervention in Stroke) trial. Health state costs and utilities were based on public sources. Annual discount rates of 1.5% were applied in the reference‐case analysis. Probabilistic analyses were conducted to deal with parameter uncertainty through 5000 simulations. The costs were estimated as $24 887 (interquartile range [IQR], $14 632–$41507) for low‐dose pioglitazone and $57 301 (IQR, $48 730–$67368) for placebo, resulting in a cost saving of −$30 287 (IQR, −$43 374 to −$14 587) in favor of low‐dose pioglitazone. Quality‐adjusted life years were estimated as 25.99 (IQR, 24.56–26.81) for the low‐dose pioglitazone and 19.44 (IQR, 18.68–20.13) for placebo, resulting in a difference of 6.37 (IQR, 5.07−7.36) in favor of low‐dose pioglitazone. Consistent findings were observed from scenario analyses and 1‐way probability sensitivity analyses. Conclusions Holding across a wide range of values in modeling parameters, low‐dose pioglitazone is found as the dominant strategy versus a placebo.

Background The BioImpedance Spectroscopy to maintain Renal Output randomised controlled trial investigated the effect of bioimpedance spectroscopy added to a standardised fluid management protocol on the risk of anuria and preservation of residual kidney function (primary trial outcomes) in incident haemodialysis patients. Despite the economic burden of kidney disease, the cost-effectiveness of using bioimpedance measurements to guide fluid management in haemodialysis is not known. Objectives To assess the cost-effectiveness of bioimpedance-guided fluid management against current fluid management without bioimpedance. Design Within-trial economic evaluation (cost–utility analysis) carried out alongside the open-label, multicentre BioImpedance Spectroscopy to maintain Renal Output randomised controlled trial. Setting Thirty-four United Kingdom outpatient haemodialysis centres, both main and satellite units, and their associated inpatient hospitals. Participants Four hundred and thirty-nine adult haemodialysis patients with > 500 ml urine/day or residual glomerular filtration rate > 3 ml/minute/1.73 m2. Intervention The study intervention was the incorporation of bioimpedance technology-derived information about body composition into the clinical assessment of fluid status in patients with residual kidney function undergoing haemodialysis. Bioimpedance measurements were used in conjunction with usual clinical judgement to set a target weight that would avoid excessive fluid depletion at the end of a dialysis session. Main outcome measures The primary outcome measure of the BioImpedance Spectroscopy to maintain Renal Output economic evaluation was incremental cost per additional quality-adjusted life-year gained over 24 months following randomisation. In the main (base-case) analysis, this was calculated from the perspective of the National Health Service and Personal Social Services. Sensitivity analyses explored the impact of different scenarios, sources of resource use data and value sets. Results The bioimpedance-guided fluid management group was associated with £382 lower average cost per patient (95% CI −£3319 to £2556) and 0.043 more quality-adjusted life-years (95% CI −0.019 to 0.105) compared with the current fluid management group, with neither values being statistically significant. The probability of bioimpedance-guided fluid management being cost-effective was 76% and 83% at commonly cited willingness-to-pay threshold of £20,000 and £30,000 per quality-adjusted life-year gained, respectively. The results remained robust to a series of sensitivity analyses. Limitations The missing data level was high for some resource use categories collected through case report forms, due to COVID-19 disruptions and a significant dropout rate in the informing BioImpedance Spectroscopy to maintain Renal Output trial. Conclusions Compared with current fluid management, bioimpedance-guided fluid management produced a marginal reduction in costs and a small improvement in quality-adjusted life-years. Results from both the base-case and sensitivity analyses suggested that use of bioimpedance is likely to be cost-effective. Future work Future work exploring the association between primary outcomes and longer-term survival would be useful. Should an important link be established, and relevant evidence becomes available, it would be informative to determine whether and how this might affect longer-term costs and benefits associated with bioimpedance-guided fluid management. Funding details This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number HTA 14/216/01 (NIHR136142). Plain language summary ‘Bioimpedance’ is a measure of how difficult it is for an electric current to pass through a biological object. Bioimpedance is used in devices that assess fluid status (over- or under-hydration) because it is very sensitive to the amount of water in tissue. Bioimpedance can be used in addition to clinical judgement when deciding how much water should be removed from someone with kidney failure during a dialysis treatment session. This is the first study to examine whether using this treatment represents a cost-effective use of National Health Service resources. We carried out an economic evaluation within a large randomised controlled trial in patients with kidney disease undergoing haemodialysis. We calculated the additional costs and quality-adjusted life-years (a measure that combines quality and quantity of life) using established methods. Over 2 years, our study showed that taking into account bioimpedance measurements about target weight resulted in slightly lower costs and marginally more quality-adjusted life-years, although there is uncertainty around these findings.

Background The presence of dental caries impacts on children’s daily lives, particularly among those living in deprived areas. There are successful interventions across the United Kingdom for young children based on toothbrushing with fluoride toothpaste. However, evidence is lacking for oral health improvement programmes in secondary-school pupils to reduce dental caries and its sequelae. Objectives To determine the clinical and cost effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in secondary-school pupils. Design A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot and embedded health economic and process evaluations. Setting Secondary schools in Scotland, England and Wales with above-average proportion of pupils eligible for free school meals. Randomisation occurred within schools (year-group level), using block randomisation stratified by school. Participants Pupils aged 11–13 years at recruitment, who have their own mobile telephone. Interventions Two-component intervention based on behaviour change theory: (1) 50-minute lesson delivered by teachers, and (2) twice-daily text messages to pupils’ mobile phones about toothbrushing, compared with routine education. Main outcome measures Primary outcome: presence of at least one treated or untreated carious lesion using DICDAS4–6MFT (Decayed, Missing and Filled Teeth) in any permanent tooth, measured at pupil level at 2.5 years. Secondary outcomes included: number of DICDAS4–6MFT; presence and number of DICDAS1–6MFT; plaque; bleeding; twice-daily toothbrushing; health-related quality of life (Child Health Utility 9D); and oral health-related quality of life (Caries Impacts and Experiences Questionnaire for Children). Results Four thousand six hundred and eighty pupils (intervention, n = 2262; control, n = 2418) from 42 schools were randomised. The primary analysis on 2383 pupils (50.9%; intervention 1153, 51.0%; control 1230, 50.9%) with valid data at baseline and 2.5 years found 44.6% in the intervention group and 43.0% in control had obvious decay experience in at least one permanent tooth. There was no evidence of a difference (odds ratio 1.04, 95% confidence interval 0.85 to 1.26, p = 0.72) and no statistically significant differences in secondary outcomes except for twice-daily toothbrushing at 6 months (odds ratio 1.30, 95% confidence interval 1.03 to 1.63, p = 0.03) and gingival bleeding score (borderline) at 2.5 years (geometric mean difference 0.92, 95% confidence interval 0.85 to 1.00, p = 0.05). The intervention had higher incremental mean costs (£1.02, 95% confidence interval −1.29 to 3.23) and lower incremental mean quality-adjusted life-years (−0.003, 95% confidence interval −0.009 to 0.002). The probability of the intervention being cost-effective was 7% at 2.5 years. However, in two subgroups, pilot trial schools and schools with higher proportions of pupils eligible for free school meals, there was an 84% and 60% chance of cost effectiveness, respectively, although their incremental costs and quality-adjusted life-years remained small and not statistically significant. The process evaluation revealed that the intervention was generally acceptable, although the implementation of text messages proved challenging. The COVID-19 pandemic hampered data collection. High rates of missing economic data mean findings should be interpreted with caution. Conclusions Engagement with the intervention and evidence of 6-month change in toothbrushing behaviour was positive but did not translate into a reduction of caries. Future work should include work with secondary-school pupils to develop an understanding of the determinants of oral health behaviours, including toothbrushing and sugar consumption, particularly according to free school meal eligibility. Trial registration This trial is registered as ISRCTN12139369. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/166/08) and is published in full in Health Technology Assessment; Vol. 28, No. 52. See the NIHR Funding and Awards website for further award information. Plain language summary What was the problem? Tooth decay has an impact on children and young people’s daily lives, particularly those living in deprived areas. For young children, programmes to improve toothbrushing with fluoride toothpaste help prevent tooth decay. The Brushing RemInder 4 Good oral HealTh trial (BRIGHT) investigated whether a secondary-school-based toothbrushing programme would work. What did we do? We developed a new programme which included a lesson and twice-daily text messages sent to pupils’ phones. In total, 4680 pupils, aged 11–13 years, from 42 secondary schools in the United Kingdom took part in the trial. At each school, one year group was randomly selected to receive the programme, while the other year group did not receive it. All pupils were followed up for 2.5 years to see whether there were any differences in levels of tooth decay, frequency of toothbrushing, plaque or quality of life. We also considered the programme’s value for money and the views of pupils and school staff. What did we find? We followed up 2383 pupils and found no difference in tooth decay, plaque or quality of life. We found those who had the programme were more likely to brush their teeth twice daily after 6 months than those who did not. The programme was not good value for money overall. However, the programme appeared to be of more benefit at preventing tooth decay in pupils eligible for free school meals compared to those not eligible. In the schools with more pupils eligible for free school meals, the chance of the programme representing good value for money increased. The programme was generally liked by the pupils and school staff. Some pupils found the text messages useful, although others said they were annoying. What does this mean? The programme helped pupils brush their teeth more frequently in the short term, but this did not lead to less tooth decay. Further research is needed to understand how to prevent tooth decay in secondary-school pupils. Scientific summary Background Reducing the high prevalence and severity of dental caries in the UK is a public health priority. Dental caries is largely preventable with several evidence-based child oral health promotion interventions including toothbrushing with fluoride toothpaste. However, evidence is lacking for interventions targeting toothbrushing practices to reduce dental caries and its sequelae (pain, infection and tooth loss) in secondary-school pupils. The Brushing RemInder 4 Good oral HealTh (BRIGHT) trial investigated a two-component behaviour change intervention (lesson and text messages) to prevent dental caries in secondary-school pupils. Objectives Conduct an internal pilot phase with feasibility components to: Tailor the intervention to young people. Test trial processes. Assess feasibility of within-school cluster randomisation (by year group). Investigate the intervention’s effect on caries prevalence, twice-daily toothbrushing, oral health-related quality of life and oral health behaviours. Investigate the intervention’s cost effectiveness. Explore implementation, mechanisms of impact and context through process evaluation. Methods Design A multicentre, school-based, assessor-blinded, two-arm cluster randomised controlled trial with an internal pilot phase, and embedded health economic and process evaluations. Criteria determining progression to the main phase were pre-specified and reviewed within the internal pilot phase. Setting Secondary schools in Scotland, England and Wales with above national average percentage of pupils eligible for free school meals (FSM) were recruited. Schools had to have pupils aged 11–16 years and at least 60 pupils per year group. Participant recruitment Pupils aged 11–13 years (Years 7 and 8 in England and Wales; S1 and S2 in Scotland) in participating schools were eligible to take part and received an information session about BRIGHT. Parents/carers had 2 weeks to decline their child’s participation. Pupils who had not been opted out were invited to participate by completing a consent form and providing their mobile telephone number. If they did not own a mobile telephone or could not provide their number, they were ineligible. Sample size We proposed to recruit 5040 pupils from 42 schools (84 year groups) to give 90% power to detect a reduction in the proportion of pupils with obvious decay experience from 34% to 26%, assuming: within-school (year-group level) randomisation, partial contamination effects (i.e. those contaminated gain half the treatment benefits) for 27% of the control group, recruiting an average of 60 pupils per year group, an intracluster correlation coefficient of 0.02% and 20% attrition at follow-up. A sample size of 10 schools was considered sufficient to test internal pilot objectives. Randomisation Year groups within schools were randomised 1 : 1 to the intervention or control arm. An allocation sequence, stratified by school using blocks of size two, was generated by an independent statistician. Once each school’s baseline assessments were completed, the year groups were randomised by allocation to the next available block. Trial interventions The intervention consisted of two components: (1) a 50-minute classroom-based session (CBS) about dental health delivered by teachers using a lesson plan and pupil-facing materials followed by (2) a series of twice-daily text messages to participants’ mobile phones about toothbrushing. Year groups allocated to the control arm received routine education only. Follow-up Assessment time points were baseline, after the lesson (internal pilot only), 12 weeks (internal pilot only), 6 months, 1, 2 (internal pilot only) and 2.5 years following lesson delivery. Pupils completed self-report questionnaires at all these time points. Dental examinations at baseline, 2 and 2.5 years included assessment of caries, plaque and gingival bleeding. Parents/carers were sent a resource use questionnaire at baseline, and 1, 2 and 2.5 years. Note, the descriptors of the time points for the assessments (e.g. 2.5 years) reflect the planned follow-up schedule and are used throughout the report; however, some of the actual average time intervals of follow-up varied from that planned (e.g. the actual average length of follow-up at the 2.5-year assessment was closer to 3 years as this was delayed due to disruptions caused by the COVID-19 pandemic). Primary outcome The primary outcome was the presence of at least one treated or untreated carious lesion in any permanent tooth, measured at the pupil level during the 2.5-year dental assessment using DICDAS4–6MFT (Decayed, Missing and Filled Teeth). Secondary outcomes Secondary outcomes assessed during the dental assessments were DICDAS4–6MFT at 2 years, and the following at 2 and 2.5 years: the presence of at least one treated or untreated carious lesion in any permanent tooth measured using DICDAS1–6MFT, the number of permanent DICDAS4–6MFT and DICDAS1–6MFT, plaque score (modified gingival index of Löe), bleeding score (gingival index) and number of teeth with bleeding gingivae. Participant-reported secondary outcome measures were: twice-daily toothbrushing, health-related quality of life measured by the Child Health Utility 9D (CHU9D) and oral health-related quality of life assessed using Caries Impacts and Experiences Questionnaire for Children (CARIES-QC). Statistical methods Both the clinical effectiveness and economic analyses were conducted to pre-specified and externally endorsed analysis plans. Analyses were conducted in STATA v17 (StataCorp LP, College Station, TX, USA) following the principles of intention to treat using two-sided statistical tests assessed at the 5% significance level. Baseline data were summarised descriptively overall and by randomised arm. The primary outcome was analysed using mixed-effect logistic regression, adjusting for the number of DICDAS4–6MFT and school year at baseline as fixed effects, and school as a random effect. Sensitivity analyses were conducted in which year group, nested within school, was additionally included as a random effect, and including additional covariates that were significantly associated with missing primary outcome data. A further sensitivity analysis excluded pupils whose dental assessments were completed outside of 3 months either side of the average length of follow-up for the 2.5-year time point. A complier-average causal effect (CACE) analysis, using a two-stage instrumental variable regression approach with the randomised group as the instrumental variable, was implemented to assess the impact of: attending the lesson; attending the lesson and receiving at least seven text messages a week for the first 12 weeks; and number of text messages sent. Subgroup analyses considered whether or not the intervention effect differed by FSM status, number of carious teeth at baseline and whether the school was recruited during the pilot or main trial phase. The secondary outcome of presence of at least one DICDAS1–6MFT was analysed as described for the primary outcome. The number of permanent DICDAS4–6MFT and DICDAS1–6MFT and number of teeth with bleeding gingivae were analysed using mixed-effect negative binomial regression, self-reported twice-daily toothbrushing via mixed-effect logistic regression and plaque, bleeding and CARIES-QC scores via mixed-effect linear regression. Models were adjusted for school year and associated baseline value of the outcome as fixed effects and school as a random effect. Attendance data, adverse events and safeguarding issues are summarised descriptively. Economic analysis The economic evaluation was undertaken using individual-level trial data, took the NHS perspective and generated quality-adjusted life-years (QALYs) using the CHU9D. The time horizon of the analysis was set to cover all relevant costs and outcomes. Parental questionnaires were used to collect data on dental treatments and child health-related quality of life. Other sources of cost data were used in relation to the text messages and the lesson. Results Clinical effectiveness results Of the 14,083 pupils approached in the 42 recruited schools, 4699 (33.4%) were eligible and consented and were asked to complete baseline data collection; however, 19 withdrew pre randomisation leaving 4680 pupils (92.9% of our target of 5040) included in the randomised sample (intervention, n = 2262; control, n = 2418). The average number of pupils recruited per school was 111.4 [standard deviation (SD) 35.9, median 107, range 46–189] and per year group was 55.7 (SD 21.6, median 53, range 13–119). The average age of pupils at recruitment was 12.7 years (SD 0.6), 54.2% were female and 21.9% were eligible for FSM. Over three-quarters (77.6%) reported brushing their teeth at least twice a day. There was a valid baseline dental assessment for 4625 pupils; 1603 (34.7%) had evidence of obvious decay experience (presence of DICDAS4–6MFT in at least one permanent tooth) and 2929 (63.3%) had at least one treated or untreated carious lesion in any permanent tooth (DICDAS1–6MFT). Baseline data were similar between the intervention and control groups. Confirmation of lesson delivery was received from 39 of the 42 schools, with an estimated 2016 (89.1%) of 2262 pupils randomised to the intervention group attending. Text messages were sent to 2258 (99.8%) intervention pupils. The other four withdrew shortly after receiving the lesson and so their messages were not commenced. Participants were sent text messages until they requested them to stop or until 12 July 2020 (when a technical error occurred with the text provider that meant texts stopped being sent). A total of 962 intervention participants (42.5%) withdrew from receiving the text messages, a median of 2.8 months after they commenced (range 1 day to 30 months). Participants were sent messages for between 0 and 127 weeks (approximately 30 months, mean 53.4 weeks, SD 35.4, median 62). This equated to between 1 and 1708 text messages (mean 694.5, SD 468.9, median 789). On average, 71.4% of the text messages sent to a participant were successfully delivered. At 2.5 years, 1043 out of 2383 pupils (43.8%; intervention 514, 44.6%; control 529, 43.0%) had obvious decay experience in at least one permanent tooth. There was no evidence of a difference between the intervention and control groups [odds ratio (OR) 1.04, 95% confidence interval (CI) 0.85 to 1.26, p = 0.72]. The sensitivity analyses produced similar results to the primary analysis. The CACE estimates of the treatment effect based on attending the CBS session and on attending the CBS session and receiving at least 50% of their messages per week for the first 12 weeks were similar to the intention to treat estimate (OR 1.05, 95% CI 0.85 to 1.31, p = 0.64, and 1.07, 95% CI 0.72 to 1.59, p = 0.74, respectively). The CACE estimate associated with the number of texts sent was OR 1.00 (95% CI 0.999 to 1.001, p = 0.93), which indicates that for every additional text message sent, there was no evidence of a decrease in likelihood of having a carious lesion. There was no significant interaction between treatment allocation and either number of carious teeth at baseline or pilot/main trial schools, but there was evidence of a qualitative interaction for FSM status, with a benefit of the intervention seen among FSM pupils (OR 0.69, 95% CI 0.44 to 1.08, p = 0.10) but not among non-FSM pupils (OR 1.17, 95% CI 0.93 to 1.46, p = 0.18). There was evidence of a statistically significant difference for twice-daily toothbrushing at 6 months (OR 1.30, 95% CI 1.03 to 1.63, p = 0.03) and borderline evidence of a difference in gingival index score between the two groups (geometric mean difference 0.92, 95% CI 0.85 to 1.00, p = 0.05) at 2.5 years. One non-serious adverse event was recorded during the trial, which was deemed possibly related and unexpected, for a pupil in the control group. No suspected serious pathologies were identified during dental assessments. Fifteen safeguarding issues arose during the course of the trial. All were dealt with according to the trial safeguarding procedure. Cost-effectiveness results Clinical results suggested that there was unlikely to be effects beyond 2.5 years, which was therefore set as the time horizon. Due to high rates of missing data, treatment costs were estimated from dental assessment data using multiple imputation. Text messages cost £32.53 per pupil on average, while mean dental costs over the 2.5-year follow-up were £20.73 and £21.02 for control and intervention groups, respectively. QALYs were similar in the control and intervention groups (2.196 and 2.193, respectively). Regression analysis estimated incremental costs and QALYs of the intervention, relative to the control group, to be £1.02 (95% CI −1.29 to 3.23) and −0.003 (95% CI −0.009 to 0.002), respectively, with a 7% chance that the intervention is cost-effective using a £20,000 per QALY gained threshold. The results were robust to the changes explored in the sensitivity analyses, except for an alternative approach to estimating QALYs using the CARIES-QC. While this only had a very small impact on incremental costs and QALYs, it was enough to generate an incremental QALY gain, which, in combination with a very small incremental cost, generates an incremental cost-effectiveness ratio (ICER) of £79 per QALY gained and an associated probability of the intervention being cost-effective of 96%. The subgroup analyses suggest that there is no evidence of a difference in the probability of the intervention being cost-effective within schools in Scotland versus England/Wales (6% in both cases). A positive QALY gain is observed in those schools with higher levels of pupils eligible for FSM than schools with lower levels of FSM eligibility. This produces an ICER of £2254 per QALY gained and a probability of the intervention being cost-effective of 60%. We also observed a QALY gain for pilot schools which leads to the intervention having an ICER of £3049 per QALY gained (and an 84% chance of it being cost-effective). Process evaluation The process evaluation showed that the BRIGHT intervention was generally implemented as intended, although there were challenges establishing the dose delivered and received for both components and technical difficulties delivering the text messages. Overall, pupils, staff members and stakeholders felt the intervention was acceptable. Conclusions At the 2.5-year follow-up, there was no evidence of a difference between the control and intervention groups in the prevalence of caries extending to dentine (primary outcome) or including enamel and dentine lesions. The proportion of participants with caries into dentine was high (intervention group 34.4% at baseline and 44.7% at the 2.5-year follow-up, and control group 34.9% at baseline and 43.1% at follow-up). There was an indication of a positive effect on short-term toothbrushing behaviour at 6 months. The subgroup analysis of participants eligible for FSM suggests a significant, qualitative interaction effect whereby the intervention appeared to be beneficial in terms of caries prevalence within pupils eligible for FSM but not for those not eligible for FSM. The process evaluation found the intervention to be broadly acceptable with some technical issues of text message delivery. The primary economic analysis shows that the intervention is not likely to be cost-effective. Further research is needed to understand how to prevent dental caries in secondary-school pupils. Trial registration This trial is registered as ISRCTN12139369. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/166/08) and is published in full in Health Technology Assessment; Vol. 28, No. 52. See the NIHR Funding and Awards website for further award information.

Background We compared the relative benefits, harms and cost-effectiveness of hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery ± systemic chemotherapy versus cytoreductive surgery ± systemic chemotherapy or systemic chemotherapy alone in people with peritoneal metastases from colorectal, gastric or ovarian cancers by a systematic review, meta-analysis and model-based cost–utility analysis. Methods We searched MEDLINE, EMBASE, Cochrane Library and the Science Citation Index, ClinicalTrials.gov and WHO ICTRP trial registers until 14 April 2022. We included only randomised controlled trials addressing the research objectives. We used the Cochrane risk of bias tool version 2 to assess the risk of bias in randomised controlled trials. We used the random-effects model for data synthesis when applicable. For the cost-effectiveness analysis, we performed a model-based cost–utility analysis using methods recommended by The National Institute for Health and Care Excellence. Results The systematic review included a total of eight randomised controlled trials (seven randomised controlled trials, 955 participants included in the quantitative analysis). All comparisons other than those for stage III or greater epithelial ovarian cancer contained only one trial, indicating the paucity of randomised controlled trials that provided data. For colorectal cancer, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably results in little to no difference in all-cause mortality (60.6% vs. 60.6%; hazard ratio 1.00, 95% confidence interval 0.63 to 1.58) and may increase the serious adverse event proportions compared to cytoreductive surgery ± systemic chemotherapy (25.6% vs. 15.2%; risk ratio 1.69, 95% confidence interval 1.03 to 2.77). Hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably decreases all-cause mortality compared to fluorouracil-based systemic chemotherapy alone (40.8% vs. 60.8%; hazard ratio 0.55, 95% confidence interval 0.32 to 0.95). For gastric cancer, there is high uncertainty about the effects of hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy versus cytoreductive surgery + systemic chemotherapy or systemic chemotherapy alone on all-cause mortality. For stage III or greater epithelial ovarian cancer undergoing interval cytoreductive surgery, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably decreases all-cause mortality compared to cytoreductive surgery + systemic chemotherapy (46.3% vs. 57.4%; hazard ratio 0.73, 95% confidence interval 0.57 to 0.93). Hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy may not be cost-effective versus cytoreductive surgery + systemic chemotherapy for colorectal cancer but may be cost-effective for the remaining comparisons. Limitations We were unable to obtain individual participant data as planned. The limited number of randomised controlled trials for each comparison and the paucity of data on health-related quality of life mean that the recommendations may change as new evidence (from trials with a low risk of bias) emerges. Conclusions In people with peritoneal metastases from colorectal cancer with limited peritoneal metastases and who are likely to withstand major surgery, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy should not be used in routine clinical practice (strong recommendation). There is considerable uncertainty as to whether hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy or cytoreductive surgery + systemic chemotherapy should be offered to patients with gastric cancer and peritoneal metastases (no recommendation). Hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy should be offered routinely to women with stage III or greater epithelial ovarian cancer and metastases confined to the abdomen requiring and likely to withstand interval cytoreductive surgery after chemotherapy (strong recommendation). Future work More randomised controlled trials are necessary. Study registration This study is registered as PROSPERO CRD42019130504. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/135/02) and is published in full in Health Technology Assessment; Vol. 28, No. 51. See the NIHR Funding and Awards website for further award information. Plain language summary What was the question? Cancers of the bowel, ovary or stomach can spread to the lining of the abdomen (‘peritoneal metastases’). Chemotherapy (the use of drugs that aim to kill cancer cells) given by injection or tablets (‘systemic chemotherapy’) is one of the main treatment options. There is uncertainty about whether adding cytoreductive surgery (cytoreductive surgery; an operation to remove the cancer) and ‘hyperthermic intraoperative peritoneal chemotherapy’ (warm chemotherapy delivered into the lining of the abdomen during cytoreductive surgery) are beneficial. What did we do? We reviewed all the information from medical literature published until 14 April 2022, to answer the above uncertainty. What did we find? We found the following from eight trials, including about 1000 participants. In people with peritoneal metastases from bowel cancer, hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably does not provide any benefits and increases harm compared to cytoreductive surgery + systemic chemotherapy, while cytoreductive surgery + systemic chemotherapy appears to increase survival compared to systemic chemotherapy alone. There is uncertainty about the best treatment for people with peritoneal metastases from stomach cancer. In women with peritoneal metastases from ovarian cancer who require systemic chemotherapy before cytoreductive surgery to shrink the cancer to allow surgery (‘advanced ovarian cancer’), hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy probably increases survival compared to cytoreductive surgery + systemic chemotherapy. What does this mean? In people who can withstand a major operation and in whom cancer can be removed, cytoreductive surgery + systemic chemotherapy should be offered to people with peritoneal metastases from bowel cancer, while hyperthermic intraoperative peritoneal chemotherapy + cytoreductive surgery + systemic chemotherapy should be offered to women with peritoneal metastases from ‘advanced ovarian cancer’. Uncertainty in treatment continues for gastric cancer. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/135/02) and is published in full in Health Technology Assessment; Vol. 28, No. 51. See the NIHR Funding and Awards website for further award information. Scientific summary Background There is uncertainty about whether hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with cytoreductive surgery (CRS) improves survival and/or quality of life (QoL) compared to CRS or no treatment in addition to systemic chemotherapy in people with peritoneal metastases who can withstand major surgery. Objectives Primary objectives To compare the relative benefits and harms of HIPEC + CRS ± systemic chemotherapy versus CRS ± systemic chemotherapy or systemic chemotherapy alone in people with peritoneal metastases from colorectal, gastric or stage III or greater epithelial ovarian cancers eligible to undergo HIPEC + CRS by a systematic review and meta-analysis. Secondary objectives To compare the cost-effectiveness of HIPEC + CRS ± systemic chemotherapy versus CRS ± systemic chemotherapy or systemic chemotherapy alone from the NHS and personal social services (PSS) perspective using a model-based cost–utility analysis. Methods We performed a systematic review of literature by searching MEDLINE, EMBASE, Cochrane Library, Science Citation Index, Conference Proceedings Citation Index, as well as trial registers until 14 April 2022. We followed the standard guidance for performing a high-quality systematic review and meta-analysis. We included only randomised controlled trials (RCTs) and assessed the risk of bias using Risk of Bias version 2.0 (ROB 2.0). We were unable to perform an individual participant data (IPD) meta-analysis as planned because of unforeseen circumstances related to coronavirus disease 2019 (COVID-19). This led to trialists who were also clinical researchers being unable to engage for transfer of IPD. We did not foresee that study authors (surgeons) would be sufficiently engaged with providing IPD soon because of the backlog with surgeries and the fatigue induced by COVID-19. Therefore, we performed a meta-analysis based on aggregate data. We calculated the hazard ratio (HR), risk ratio (RR), rate ratio or mean difference (MD) with 95% confidence intervals (CIs) as appropriate. When applicable, we performed meta-analysis using the random-effects model using Review Manager 5.4. We used GRADE guidance to assess the certainty of evidence and determine the strength of recommendations. For the cost-effectiveness analysis, we performed a model-based cost–utility analysis using methods recommended by The National Institute for Health and Care Excellence (NICE). We estimated the costs and quality-adjusted life-years (QALYs) per patient using lifetime horizon. We calculated the incremental net monetary benefit (incremental NMB) for each comparison based on deterministic analysis and probabilistic sensitivity analysis (PSA). We also performed univariate sensitivity analysis and value of information analysis. Results The systematic review included a total of eight RCTs. A total of 955 participants in seven RCTs were included in the quantitative analysis. All comparisons other than those of ovarian cancer contained only one trial. For colorectal cancer, HIPEC + CRS + systemic chemotherapy probably results in little to no difference in all-cause mortality (60.6% in HIPEC + CRS + systemic chemotherapy vs. 60.6% in CRS + systemic chemotherapy; median follow-up 64 months; HR 1.00, 95% CI 0.63 to 1.58; one trial; 265 participants; moderate-certainty evidence) and may increase the number of people who developed serious adverse events compared to CRS +/– systemic chemotherapy (25.6% in HIPEC + CRS + systemic chemotherapy vs. 15.2% in CRS + systemic chemotherapy; RR 1.69, 95% CI 1.03 to 2.77; one trial; 265 participants; low-certainty evidence). HIPEC + CRS + systemic chemotherapy probably decreases all-cause mortality compared to fluorouracil-based systemic chemotherapy alone (40.8% in HIPEC + CRS + systemic chemotherapy vs. 60.8% in systemic chemotherapy alone; median follow-up 22 months; HR 0.55, 95% CI 0.32 to 0.95; one trial; 105 participants; moderate-certainty evidence). For gastric cancer, there is high uncertainty about the effect of HIPEC + CRS + systemic chemotherapy versus CRS + systemic chemotherapy on all-cause mortality (effect estimates not presented because of very low-certainty evidence). HIPEC + CRS + systemic chemotherapy probably decreases all-cause mortality compared to systemic chemotherapy (40.8% in HIPEC + CRS + systemic chemotherapy vs. 100% in systemic chemotherapy alone; minimum follow-up 24 months; HR 0.40, 95% CI 0.30 to 0.52; one trial; 17 participants; moderate-certainty evidence). For stage III or greater epithelial ovarian cancer requiring interval CRS, HIPEC + CRS + systemic chemotherapy probably decreases all-cause mortality compared to CRS + systemic chemotherapy (46.3% in HIPEC + CRS + systemic chemotherapy vs. 57.4% in CRS + systemic chemotherapy; median follow-up 32–70 months; HR 0.73, 95% CI 0.57 to 0.93; three trials; 500 participants; moderate-certainty evidence). It may result in little to no difference in health-related quality of life (HRQoL) (MD 4.85, 95% CI −7.74 to 17.44; one trial; 71 participants; moderate-certainty evidence) or number of people who developed serious adverse events compared to CRS + systemic chemotherapy (26.7% in HIPEC + CRS + systemic chemotherapy vs. 25.2% in CRS + systemic chemotherapy; RR 1.06, 95% CI 0.73 to 1.54; two trials; 316 participants; moderate-certainty evidence), although it probably increases the number of serious adverse events per participant compared to CRS + systemic chemotherapy (41.4 events per 100 participants in HIPEC + CRS + systemic chemotherapy vs. 32.6 events per 100 participants in CRS + systemic chemotherapy; rate ratio 1.27, 95% CI 1.09 to 1.49; one trial; 184 participants; moderate-certainty evidence). The cost-effectiveness analysis included the five comparisons described above: HIPEC + CRS + systemic chemotherapy versus CRS + systemic chemotherapy for each of the colorectal, gastric and ovarian cancers and HIPEC + CRS + systemic chemotherapy versus systemic chemotherapy alone for each of the colorectal and gastric cancers. In people with colorectal peritoneal metastases, the incremental NMBs at willingness to pay (WTP) of £20,000 and £30,000 were −£6162.83 and −£6164.19, respectively, indicating that HIPEC + CRS + systemic chemotherapy was not cost-effective compared to CRS + systemic chemotherapy in NHS. The likelihood of HIPEC + CRS + systemic chemotherapy being cost-effective compared to CRS + systemic chemotherapy was 46.5% and 47.6% at WTP of £20,000 and £30,000, respectively. In the same group of people, the incremental NMBs at WTP of £20,000 and £30,000 were £107,909.46 and £167,621.58, respectively, indicating that HIPEC + CRS + systemic chemotherapy may be cost-effective compared to systemic chemotherapy alone in NHS. The likelihood of HIPEC + CRS + systemic chemotherapy being cost-effective compared to systemic chemotherapy alone was 89.3% and 90.3% at WTP of £20,000 and £30,000, respectively. In people with gastric peritoneal metastases, the incremental NMBs at WTP of £20,000 and £30,000 were £14,174.73 and £22,955.89, respectively, for HIPEC + CRS + systemic chemotherapy versus CRS + systemic chemotherapy and £81,796.38 and £127,768.23, respectively, for HIPEC + CRS + systemic chemotherapy versus systemic chemotherapy, indicating that HIPEC + CRS + systemic chemotherapy may be cost-effective compared to CRS + systemic chemotherapy or systemic chemotherapy alone in NHS. The likelihood of HIPEC + CRS + systemic chemotherapy being cost-effective ranged between 60% and 70% for the different comparisons and different thresholds. In women with grade III or greater epithelial ovarian cancer requiring interval CRS, the incremental NMBs at WTP of £20,000 and £30,000 were £46,761.81 and £71,938.23, respectively, indicating that HIPEC + CRS + systemic chemotherapy was cost-effective compared to CRS +systemic chemotherapy in NHS. The likelihood of HIPEC + CRS + systemic chemotherapy being cost-effective compared to CRS + systemic chemotherapy was 71.9% and 72.4% at WTP of £20,000 and £30,000, respectively. The value of information analysis indicated that the expected value of perfect information (EVPI) ranged between £3 and £53 million for the different cancer types (when estimation was possible) for WTP of £20,000 and £30,000. Discussion and conclusions Limitations of the review We were unable to obtain IPD as planned. IPD would have allowed us to refine our effect estimates for subgroups of people with peritoneal metastases from colorectal, gastric or stage III or greater epithelial ovarian cancer. It is difficult to estimate whether our conclusions would have changed if we had IPD; however, our systematic review and meta-analysis support similar conclusions as the trial authors, suggesting that the impact of IPD may not be major enough to warrant an IPD once the health services have recovered from the impact of COVID-19. We estimated the HR for survival for gastric cancer trials from Kaplan–Meier curves. This might have introduced bias. However, because of the small number of participants and the estimations that we have performed to calculate the effect estimates, we have concluded that there is uncertainty in the benefit of HIPEC + CRS + systemic chemotherapy in gastric cancers. Because of the paucity of trials under each comparison, evidence from new RCTs of low risk of bias may change our recommendations. There are concerns regarding the clinical recommendations for people with colorectal peritoneal metastases based on the PRODIGE-7 trial. We have discussed in detail the different concerns raised and why these concerns should not be used as a justification for not basing clinical practice on PRODIGE-7 trial (in the full article). In summary, we based our clinical practice recommendations for colorectal peritoneal metastases on PRODIGE-7 trial because the trial was a low risk of bias trial for the comparison of HIPEC + CRS + systemic chemotherapy versus CRS + systemic chemotherapy. An appropriate analysis was used to analyse trial data, and there was no other trial of low of bias comparing HIPEC + CRS + systemic chemotherapy versus CRS + systemic chemotherapy. While the CRS + systemic chemotherapy was not directly compared with systemic chemotherapy alone, we recommended CRS + systemic chemotherapy in people with colorectal peritoneal metastases because of the lack of any ‘systemic chemotherapy alone’ treatments that provide equivalent median survival as that observed in the control arm (CRS + systemic chemotherapy) in the PRODIGE-7 trial. Because of the difficulties in estimating the Peritoneal Cancer Index (PCI) during surgery, we have not recommended HIPEC + CRS + systemic chemotherapy even for the subset of patients with PCI 11–15, but this exploratory subgroup analysis can guide future research. We have not based our recommendations on non-randomised studies, as we did not find any non-randomised study in which similar participants with colorectal peritoneal metastases underwent HIPEC + CRS + systemic chemotherapy versus CRS + systemic chemotherapy or systemic chemotherapy alone. CRS + systemic chemotherapy provides equivalent median survival of 41 months as HIPEC + CRS + systemic chemotherapy. When there is an existing, less invasive treatment that provides equivalent survival, it can hardly be considered life-threatening to warrant recommendations based on low-or very low-certainty evidence. Recommendations for clinical practice In people with peritoneal metastases from colorectal cancer, based on the results of PRODIGE-7 trial, HIPEC + CRS + systemic chemotherapy probably results in little to no difference in all-cause mortality or progression-free survival and results in increased complications compared to CRS + systemic chemotherapy. Therefore, HIPEC based on oxaliplatin regimen used in PRODIGE-7 trial + CRS + systemic chemotherapy should not be used in routine clinical practice (strong recommendation). Because of the lack of reliability of preoperative or perioperative PCI, the lack of pre-PRODIGE-7 trial standard classification of PCI into PCI 15 and pre-defined subgroup analysis based on the PCI classification, HIPEC based on oxaliplatin regimen used in PRODIGE-7 trial + CRS + systemic chemotherapy cannot be recommended for any subgroups. Because of the median survival observed in the CRS + systemic chemotherapy arm of PRODIGE-7 trial (41 months) and the poor survival observed in people with disseminated colorectal peritoneal metastases (

Abstract Background Mammography (MG) has demonstrated its effectiveness in diminishing mortality and advanced-stage breast cancer incidences in breast screening initiatives. Notably, research has accentuated the superior diagnostic efficacy and cost-effectiveness of digital breast tomosynthesis (DBT). However, the scope of evidence validating the cost-effectiveness of DBT remains limited, prompting a requisite for more comprehensive investigation. The present study aimed to rigorously evaluate the cost-effectiveness of DBT plus MG (DBT-MG) compared to MG alone within the framework of Taiwan’s National Health Insurance program. Methods All parameters for the Markov decision tree model, encompassing event probabilities, costs, and utilities (quality-adjusted life years, QALYs), were sourced from reputable literature, expert opinions, and official records. With 10,000 iterations, a 2-year cycle length, a 30-year time horizon, and a 2% annual discount rate, the analysis determined the incremental cost-effectiveness ratio (ICER) to compare the cost-effectiveness of the two screening methods. Probabilistic and one-way sensitivity analyses were also conducted to demonstrate the robustness of findings. Results The ICER of DBT-MG compared to MG was US$5971.5764/QALYs. At a willingness-to-pay (WTP) threshold of US$33,004 (Gross Domestic Product of Taiwan in 2021) per QALY, more than 98% of the probabilistic simulations favored adopting DBT-MG versus MG. The one-way sensitivity analysis also shows that the ICER depended heavily on recall rates, biopsy rates, and positive predictive value (PPV2). Conclusion DBT-MG shows enhanced diagnostic efficacy, potentially diminishing recall costs. While exhibiting a higher biopsy rate, DBT-MG aids in the detection of early-stage breast cancers, reduces recall rates, and exhibits notably superior cost-effectiveness.

Abstract Background Deep learning (DL) is a new technology that can assist prenatal ultrasound (US) in the detection of congenital heart disease (CHD) at the prenatal stage. Hence, an economic-epidemiologic evaluation (aka Cost-Utility Analysis) is required to assist policymakers in deciding whether to adopt the new technology. Methods The incremental cost-utility ratios (CUR), of adding DL assisted ultrasound (DL-US) to the current provision of US plus pulse oximetry (POX), was calculated by building a spreadsheet model that integrated demographic, economic epidemiological, health service utilization, screening performance, survival and lifetime quality of life data based on the standard formula: $${\rm CUR} = \frac{{\text{Increase in Intervention Costs}} - {\text{Decrease in Treatment costs}}}{{\text{Averted QALY losses of adding DL to US}} \ \& \ {\rm POX}}$$ CUR = Increase in Intervention Costs - Decrease in Treatment costs Averted QALY losses of adding DL to US & POX US screening data were based on real-world operational routine reports (as opposed to research studies). The DL screening cost of 145 USD was based on Israeli US costs plus 20.54 USD for reading and recording screens. Results The addition of DL assisted US, which is associated with increased sensitivity (95% vs 58.1%), resulted in far fewer undiagnosed infants (16 vs 102 [or 2.9% vs 15.4%] of the 560 and 659 births, respectively). Adoption of DL-US will add 1,204 QALYs. with increased screening costs 22.5 million USD largely offset by decreased treatment costs (20.4 million USD). Therefore, the new DL-US technology is considered “very cost-effective”, costing only 1,720 USD per QALY. For most performance combinations (sensitivity > 80%, specificity > 90%), the adoption of DL-US is either cost effective or very cost effective. For specificities greater than 98% (with sensitivities above 94%), DL-US (& POX) is said to “dominate” US (& POX) by providing more QALYs at a lower cost. Conclusion Our exploratory CUA calculations indicate the feasibility of DL-US as being at least cost-effective.