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BackgroundPreterm birth is the leading cause of death in children younger than 5 years worldwide. WHO recommends kangaroo mother care (KMC); however, its effects on mortality in sub-Saharan Africa and its relative costs remain unclear. We aimed to compare the effectiveness, safety, costs, and cost-effectiveness of KMC initiated before clinical stabilisation versus standard care in neonates weighing up to 2000 g.MethodsWe conducted a parallel-group, individually randomised controlled trial in five hospitals across Uganda. Singleton or twin neonates aged younger than 48 h weighing 700-2000 g without life-threatening clinical instability were eligible for inclusion. We randomly assigned (1:1) neonates to either KMC initiated before stabilisation (intervention group) or standard care (control group) via a computer-generated random allocation sequence with permuted blocks of varying sizes, stratified by birthweight and recruitment site. Parents, caregivers, and health-care workers were unmasked to treatment allocation; however, the independent statistician who conducted the analyses was masked. After randomisation, neonates in the intervention group were placed prone and skin-to-skin on the caregiver's chest, secured with a KMC wrap. Neonates in the control group were cared for in an incubator or radiant heater, as per hospital practice; KMC was not initiated until stability criteria were met. The primary outcome was all-cause neonatal mortality at 7 days, analysed by intention to treat. The economic evaluation assessed incremental costs and cost-effectiveness from a disaggregated societal perspective. This trial is registered with ClinicalTrials.gov, NCT02811432.FindingsBetween Oct 9, 2019, and July 31, 2022, 2221 neonates were randomly assigned: 1110 (50·0%) neonates to the intervention group and 1111 (50·0%) neonates to the control group. From randomisation to age 7 days, 81 (7·5%) of 1083 neonates in the intervention group and 83 (7·5%) of 1102 neonates in the contro

BackgroundRecently-updated global guidelines for cervical cancer screening incorporated new technologies-most significantly, the inclusion of HPV DNA detection as a primary screening test-but leave many implementation decisions at countries' discretion. We sought to develop recommendations for Malawi as a test case since it has the second-highest cervical cancer burden globally and high HIV prevalence. We incorporated updated epidemiologic data, the full range of ablation methods recommended, and a more nuanced representation of how HIV status intersects with cervical cancer risk and exposure to screening to model outcomes of different approaches to screening.MethodsUsing a Markov model, we estimate the relative health outcomes and costs of different approaches to cervical cancer screening among Malawian women. The model was parameterized using published data, and focused on comparing "triage" approaches-i.e., lesion treatment (cryotherapy or thermocoagulation) at differing frequencies and varying by HIV status. Health outcomes were quality-adjusted life years (QALYs) and deaths averted. The model was built using TreeAge Pro software.ResultsThermocoagulation was more cost-effective than cryotherapy at all screening frequencies. Screening women once per decade would avert substantially more deaths than screening only once per lifetime, at relatively little additional cost. Moreover, at this frequency, it would be advisable to ensure that all women who screen positive receive treatment (rather than investing in further increases in screening frequency): for a similar gain in QALYs, it would cost more than four times as much to implement once-per-5 years screening with only 50% of women treated versus once-per-decade screening with 100% of women treated. Stratified screening schedules by HIV status was found to be an optimal approach.ConclusionsThese results add new evidence about cost-effective approaches to cervical cancer screening in low-income countries. At relati

IntroductionIn 2015, the National Institute of Dental and Craniofacial Research (NIDCR) launched the Multidisciplinary Collaborative Research Consortium to Reduce Oral Health Disparities in Children, supporting four randomized trials testing strategies to improve preventive care. A Coordinating Center provides scientific expertise, data acquisition and quality assurance services, safety monitoring, and final analysis-ready datasets. This paper describes the trials' economic analysis strategies, placing these strategies within the broader context of contemporary economic analysis methods.MethodsThe Coordinating Center established a Cost Collaborative Working Group to share information from the four trials about the components of their economic analyses. Study teams indicated data sources for their economic analysis using a set of structured tables. The Group meets regularly to share progress, discuss challenges, and coordinate analytic approaches.ResultsAll four trials will calculate incremental cost-effectiveness ratios; two will also conduct cost-utility analyses using proxy diseases to estimate health state utilities. Each trial will consider at least two perspectives. Key process measures include dental services provided to child participants. The non-preference-weighted Early Childhood Oral Health Impact Scale (ECOHIS) will measure oral health-related quality of life. All trials are measuring training, implementation, personnel and supervision, service, supplies, and equipment costs.ConclusionsConsistent with best practices, all four trials have integrated economic analysis during their planning stages. This effort is critical since poor quality or absence of essential data can limit retrospective analysis. Integrating economic analysis into oral health preventive intervention research can provide guidance to clinicians and practices, payers, and policymakers.

BackgroundSmall incentives could improve engagement in HIV care. We evaluated the short-term and longer-term effects of financial incentives for visit attendance on viral suppression among adults initiating antiretroviral therapy (ART) in Tanzania.MethodsIn a type 1 hybrid effectiveness-implementation study, we randomised (1:1) 32 primary care HIV clinics in four Tanzanian regions to usual care (control group) or the intervention (usual care plus ≤6 monthly incentives [22 500 Tanzanian Shillings, about US$10, each], conditional on visit attendance). Adults (aged ≥18 years) initiating ART (<30 days) who owned a mobile phone and had no plans to transfer to another facility were eligible. The primary outcome was retention on ART with viral suppression (<1000 copies per mL) at 12 months. Secondary outcomes included retention on ART with viral suppression at 6 months and viral suppression at 6 months and 12 months using a lower threshold (<50 copies per mL). Intent-to-treat analysis and a cluster-based permutation test were used to evaluate the effect of financial incentives on outcomes. This trial is registered with ClinicalTrials.gov, NCT04201353, and is completed.FindingsBetween May 28, 2021, and March 8, 2022, 1990 participants (805 male and 1185 female) were enrolled in the study. 1059 participants were assigned to the intervention group and 931 participants were assigned to the control group. Overall, 1536 (88%) participants at 6 months and 1575 (83%) at 12 months were on ART with viral suppression. At 12 months, 6 months after the intervention ended, 866 (85%) participants in the intervention group compared with 709 (81%) in the control group had viral loads less than 1000 copies per mL (adjusted risk difference [aRD] 4·4 percentage points, 95% CI -1·4 to 10·1, permutation test p=0·35). At 6 months, 858 participants (90%) in the intervention group were on ART with viral loads less than 1000 copies per mL compared with 678 (86%) in the control group (aRD 5

HighlightsWe illustrate the steps involved in carrying out cost-effectiveness analysis using net benefit regressions with possibly censored demo data by providing step-by-step guidance and code applied to a data set.We demonstrate the importance of these new methods by illustrating how naïve methods for handling censoring can lead to biased cost-effectiveness results.

AimTo assess, from a United States (US) payer's perspective, the cost-effectiveness of gels designed to separate the endometrial surfaces (intrauterine spacers) placed following intrauterine surgery.Materials and methodsA decision tree model was developed to estimate the cost-effectiveness of intrauterine spacers used to facilitate endometrial repair and prevent the formation (primary prevention) and reformation (secondary prevention) of intrauterine adhesions (IUAs) and associated pregnancy- and birth-related adverse outcomes. Event rates and costs were extrapolated from data available in the existing literature. Sensitivity analyses were conducted to corroborate the base case results.ResultsIn this model, using intrauterine spacers for adhesion prevention led to net cost savings for US payers of $2,905 per patient over a 3.5-year time horizon. These savings were driven by the direct benefit of preventing procedures associated with IUA formation ($2,162 net savings) and the indirect benefit of preventing pregnancy-related complications often associated with IUA formation ($3,002). These factors offset the incremental cost of intrauterine spacer use of $1,539 based on an assumed price of $1,800 and the related increase in normal deliveries of $931. Model outcomes were sensitive to the probability of preterm and normal deliveries. Budget impact analyses show overall cost savings of $19.96 per initial member within a US healthcare plan, translating to $20 million over a 5-year time horizon for a one-million-member plan.LimitationsThere are no available data on the effects of intrauterine spacers or IUAs on patients' quality of life. Resultingly, the model could not evaluate patients' utility related to treatment with or without intrauterine spacers and instead focused on costs and events avoided.ConclusionThis analysis robustly demonstrated that intrauterine spacers would be cost-saving to healthcare payers, including both per-patient and per-plan member, through a re

IntroductionInfant HIV prophylaxis with broadly neutralizing anti-HIV antibodies (bNAbs) could provide long-acting protection against vertical transmission. We sought to estimate the potential clinical impact and cost-effectiveness of hypothetical bNAb prophylaxis programmes for children known to be HIV exposed at birth in three sub-Saharan African settings.MethodsWe conducted a cost-effectiveness analysis using the CEPAC-Pediatric model, simulating cohorts of infants from birth through death in Côte d'Ivoire, South Africa and Zimbabwe. These settings were selected to reflect a broad range of HIV care cascade characteristics, antenatal HIV prevalence and budgetary constraints. We modelled strategies targeting bNAbs to only WHO-designated "high-risk" HIV-exposed infants (HR-HIVE) or to all HIV-exposed infants (HIVE). We compared four prophylaxis approaches within each target population: standard of care oral antiretroviral prophylaxis (SOC), and SOC plus bNAbs at birth (1-dose), at birth and 3 months (2-doses), or every 3 months throughout breastfeeding (Extended). Base-case model inputs included bNAb efficacy (60%/dose), effect duration (3 months/dose) and costs ($60/dose), based on published literature. Outcomes included paediatric HIV incidence and incremental cost-effectiveness ratios (ICERs) calculated from discounted life expectancy and lifetime HIV-related costs.ResultsThe model projects that bNAbs would reduce absolute infant HIV incidence by 0.3-2.2% (9.6-34.9% relative reduction), varying by country, prophylaxis approach and target population. In all three settings, HR-HIVE-1-dose would be cost-saving compared to SOC. Using a 50% GDP per capita ICER threshold, HIVE-Extended would be cost-effective in all three settings with ICERs of $497/YLS in Côte d'Ivoire, $464/YLS in South Africa and $455/YLS in Zimbabwe. In all three settings, bNAb strategies would remain cost-effective at costs up to $200/dose if efficacy is ≥30%. If the bNAb effect duration were redu

BackgroundOsteoporosis is often considered to be a disease of women. Over the last few years, owing to the increasing clinical and economic burden, the awareness and imperative for identifying and managing osteoporosis in men have increased substantially. With the approval of agents to treat men with osteoporosis, more economic evaluations have been conducted to assess the potential economic benefits of these interventions. Despite this concern, there is no specific overview of cost-effectiveness analyses for the treatment of osteoporosis in men.ObjectivesThis study aims (1) to systematically review economic evaluations of interventions for osteoporosis in men; (2) to critically appraise the quality of included studies and the source of model input data; and (3) to investigate the comparability of results for studies including both men and women.MethodsA literature search mainly using MEDLINE (via Ovid) and Embase databases was undertaken to identify original articles published between 1 January, 2000 and 30 June, 2022. Studies that assessed the cost effectiveness of interventions for osteoporosis in men were included. The Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases and the International Osteoporosis Foundation osteoporosis-specific guideline was used to assess the quality of design, conduct, and reporting of included studies.ResultsOf 2973 articles identified, 25 studies fulfilled the inclusion criteria, classified into economic evaluations of active drugs (n = 8) or nutritional supplements (n = 4), intervention thresholds (n = 5), screening strategies (n = 6), and post-fracture care programs (n = 2). Most studies were conducted in European countries (n = 15), followed by North America (n = 9). Bisphosphonates (namely alendronate) and nutritional supplements were shown to be generally cost effective compared with no treatment in men over 60 years of age with osteoporosis or prior fractures. Two other studies suggested that denosuma

BackgroundRecent studies have shown a trend supporting endovascular revascularization (ER) in the treatment of chronic mesenteric ischemia (CMI). However, few studies have compared the cost effectiveness of ER and open revascularization (OR) for this indication. The purpose of this study is to conduct a cost-effectiveness analysis comparing open versus ER for CMI.MethodsWe built a Markov model with Monte Carlo microsimulation using transition probabilities and utilities from existing literature for CMI patients undergoing OR versus ER. Costs were derived from the hospital perspective using the 2020 Medicare Physician Fee Schedule. The model randomized 20,000 patients to either OR or ER and allowed for 1 subsequent reintervention with 3 other intervening health states: alive, alive with complications, and dead. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness.ResultsOR cost $4,532 for 1.03 QALYs while ER cost $5,092 for 1.21 QALYs, leading to an ICER of $3,037 per QALY gained in the ER arm. This ICER was less than our willingness to pay threshold of $100,000. Sensitivity analysis demonstrated that our model was most sensitive to costs, mortality, and patency rates after OR and ER. Probabilistic sensitivity analysis demonstrated ER would be considered cost effective 99% of iterations.ConclusionsThis study found that while 5-year costs for ER were greater than OR, ER afforded greater QALYs than OR. Although ER is associated with lower long-term patency and higher rates of reintervention, it appears to be more cost effective than OR for the treatment of CMI.

BackgroundDirect oral anticoagulants (DOACs) offer an alternative to low-molecular-weight heparin (LMWH) and warfarin for treating cancer-associated thrombosis (CAT).ObjectiveTo determine the cost and effectiveness of DOACs versus LMWH.DesignCohort-state transition decision analytic model.Data sourcesNetwork meta-analysis comparing DOACs versus LMWH.Target populationAdult patients with cancer at the time they develop thrombosis.Time horizonLifetime.PerspectiveHealth care sector.InterventionStrategies of 1) enoxaparin, 2) apixaban, 3) edoxaban, and 4) rivaroxaban for treatment of CAT.Outcome measuresIncremental cost-effectiveness ratio (ICER) in 2022 U.S. dollars per quality-adjusted life-year (QALY) gained.Results of base-case analysisIn the base-case scenario, using drug prices from the U.S. Department of Veterans Affairs Federal Supply Schedule, apixaban dominated enoxaparin and edoxaban by being less costly and more effective. Rivaroxaban was slightly more effective than apixaban, with an ICER of $493 246. In a scenario analysis using "real-world" drug prices from GoodRx, rivaroxaban was cost-effective with an ICER of $50 053 per QALY.Results of sensitivity analysisResults were highly sensitive to monthly drug costs. Probabilistic sensitivity analyses showed that at a willingness-to-pay threshold of $50 000 per QALY, apixaban was preferred in 80% of simulations. However, sensitivity analyses also demonstrated that apixaban only remained cost-effective if monthly medication costs were below $530. Above this, rivaroxaban became cost-effective.LimitationsAn assumption was made that patients would continue anticoagulation indefinitely unless they suffered a major bleed. Nonmedical costs such as patient and caregiver loss of productivity were not accounted for, and long-term thrombotic complications were not explicitly modeled.ConclusionThe 3 DOACs are more effective and more cost-effective than LMWH. The most cost-effective DOAC depends on the relative

Cost-effectiveness analyses of new cancer treatments in real-world settings (e.g., post-clinical trials) inform healthcare decision makers about their healthcare investments for patient populations. The results of these analyses are often, though not always, presented with statistical uncertainty. This paper identifies five ways to characterize statistical uncertainty: (1) a 95% confidence interval (CI) for the incremental cost-effectiveness ratio (ICER); (2) a 95% CI for the incremental net benefit (INB); (3) an INB by willingness-to-pay (WTP) plot; (4) a cost-effectiveness acceptability curve (CEAC); and (5) a cost-effectiveness scatterplot. It also explores their usage in 22 articles previously identified by a rapid review of real-world cost effectiveness of novel cancer treatments. Seventy-seven percent of these articles presented uncertainty results. The majority those papers (59%) used administrative data to inform their analyses while the remaining were conducted using models. Cost-effectiveness scatterplots were the most commonly used method (34.3%), with 40% indicating high levels of statistical uncertainty, suggesting the possibility of a qualitatively different result from the estimate given. Understanding the necessity for and the meaning of uncertainty in real-world cost-effectiveness analysis will strengthen knowledge translation efforts to improve patient outcomes in an efficient manner.

BackgroundGiven the increased attention to functional improvement in spine surgery as it relates to activities of daily living and cost, it is critical to fully understand the health care economic impact of enabling technologies. The use of intraoperative neuromonitoring (IOM) during spine surgery has long been controversial. Questions pertaining to utility, medico-legal considerations, and cost-effectiveness continue to be unresolved. The purpose of this study is to determine the cost-effectiveness by assessing quality-of-life due to adverse events averted, decreased postoperative pain, decreased revision rates, and improved patient reported outcomes (PROs).MethodsThe study patient population was extracted from a large multicenter database collected by a single, national IOM provider. Over 50,000 patient charts were abstracted and included in this analysis. The analysis was conducted in accordance with the second panel on cost-effectiveness health and medicine. Health-related utility was derived from questionnaire answers and expressed in quality-adjusted life years (QALYs). Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. Cost-effectiveness was calculated as the incremental cost-effectiveness ratio (ICER) for IOM. A value under the commonly accepted United States-based willingness-to-pay (WTP) threshold of $100,000 per QALY was considered cost-effective. Scenario (including litigation), probabilistic (PSA), and threshold sensitivity analyses were conducted to determine model discrimination and calibration.ResultsThe primary time horizon used to estimate cost and health utility was 2-years following index surgery. On average, index surgery for patients with IOM costs are approximately $1,547 greater than non-IOM cases. The base case assumed an inpatient Medicare population however multiple outpatient and payer scenarios were assessed in the sensitivity analysis. From a health system perspective IOM is

PurposeThe aim of this study was to assess the cost effectiveness of letermovir prophylaxis with the option for subsequent pre-emptive therapy (PET) for the prevention of cytomegalovirus (CMV) infection compared with a PET-only scenario in adult allogeneic hematopoietic stem cell transplant (allo-HCT) recipients in the United States over a 10-year time horizon.Materials and methodsA publicly available decision tree model was constructed using a commercial third-party payer perspective to simulate an allo-HCT recipient's clinical trajectory in the first-year post-transplant, followed by entry to a Markov model to simulate years 2 through 10. Clinical inputs and utility estimates were derived from published literature. Costs were derived from published literature and US Department of Veterans Affairs Federal Supply Schedule drug pricing. Outcomes assessed included life expectancy, quality-adjusted life-years (QALYs), direct medical costs, and the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses (PSA) were performed to test the robustness of the findings.ResultsCompared with PET alone, letermovir prophylaxis was projected to increase life-years per person (4.99 vs. 4.70 life-years), and increase QALYs (3.29 vs. 3.08) and costs (US$83.411 vs. US$70,698), yielding an ICER of US$59,356 per QALY gained. One-way sensitivity analyses indicated our model was sensitive to mortality (ICER: $164,771/QALY) and utility (letermovir ICER: $117,447/QALY; PET ICER: $107,290/QALY) in the first-year post-transplant. In 57.1% of the PSA simulations, letermovir was a cost-effective option using a willingness-to-pay threshold of US$100,000 per QALY.ConclusionsLetermovir prophylaxis is cost effective compared with PET alone with a willingness-to-pay threshold of US$100,000 per QALY gained. Sensitivity analysis results indicate future research is required to understand the impact of mortality and quality of life in the first-year post-transplant to

BackgroundWhile a 2021 federal commission recommended that the United States government levy a sugar-sweetened beverage (SSB) tax to improve diabetes prevention and control efforts, evidence is limited regarding the longer-term impacts of SSB taxes on SSB purchases, health outcomes, costs, and cost-effectiveness. This study estimates the impact and cost-effectiveness of an SSB tax levied in Oakland, California.Methods and findingsAn SSB tax ($0.01/oz) was implemented on July 1, 2017, in Oakland. The main sample of sales data included 11,627 beverage products, 316 stores, and 172,985,767 product-store-month observations. The main analysis, a longitudinal quasi-experimental difference-in-differences approach, compared changes in beverage purchases at stores in Oakland versus Richmond, California (a nontaxed comparator in the same market area) before and 30 months after tax implementation (through December 31, 2019). Additional estimates used synthetic control methods with comparator stores in Los Angeles, California. Estimates were inputted into a closed-cohort microsimulation model to estimate quality-adjusted life years (QALYs) and societal costs (in Oakland) from 6 SSB-associated disease outcomes. In the main analysis, SSB purchases declined by 26.8% (95% CI -39.0 to -14.7, p < 0.001) in Oakland after tax implementation, compared with Richmond. There were no detectable changes in purchases of untaxed beverages or sweet snacks or purchases in border areas surrounding cities. In the synthetic control analysis, declines in SSB purchases were similar to the main analysis (-22.4%, 95% CI -41.7% to -3.0%, p = 0.04). The estimated changes in SSB purchases, when translated into declines in consumption, would be expected to accrue QALYs (94 per 10,000 residents) and significant societal cost savings (>$100,000 per 10,000 residents) over 10 years, with greater gains over a lifetime horizon. Study limitations include a lack of SSB consumption data and use of sales data

BackgroundHeart failure with reduced ejection fraction (HFrEF) is one of the most costly and deadly chronic disease states. The cost effectiveness of a comprehensive quadruple therapy regimen for HFrEF has not been studied.ObjectivesThe authors sought to determine the cost-effectiveness of quadruple therapy comprised of beta-blockers, mineralocorticoid receptor antagonists, angiotensin receptor-neprilysin inhibitors, and sodium glucose cotransporter-2 inhibitors vs regimens composed of only beta-blockers, angiotensin-converting enzyme inhibitors, and mineralocorticoid receptor antagonists (triple therapy), and angiotensin-converting enzyme inhibitors and beta-blockers (double therapy).MethodsUsing a 2-state Markov model, the authors performed a cost-effectiveness study using simulated populations of 1,000 patients with HFrEF based on the participants in the PARADIGM-HF (Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure) trial and compared them by treatment strategy (quadruple therapy vs triple and double therapy) from a United States health care system perspective. The authors also performed 10,000 probabilistic simulations.ResultsTreatment with quadruple therapy resulted in an increase of 1.73 and 2.87 life-years compared with triple therapy and double therapy, respectively, and an increase in quality-adjusted life-years of 1.12 and 1.85 years, respectively. The incremental cost-effectiveness ratios of quadruple therapy vs triple therapy and double therapy were $81,000 and $51,081, respectively. In 91.7% and 99.9% of probabilistic simulations quadruple therapy had an incremental cost-effectiveness ratio of <$150,000 compared with triple therapy and double therapy, respectively.ConclusionsAt current pricing, the use of quadruple therapy in patients with HFrEF was cost effective compared with triple therapy and double therapy. These findings highlight the need for improved access and optimal i

BackgroundDecentralised molecular testing for tuberculosis could reduce missed diagnoses and losses to follow-up in high-burden settings. The aim of this study was to evaluate the cost and cost-effectiveness of the Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) study strategy, a multicomponent strategy including decentralised molecular testing for tuberculosis, in Uganda.MethodsWe conducted a costing and cost-effectiveness analysis nested in a pragmatic cluster-randomised trial of onsite (decentralised) versus hub-and-spoke (centralised) testing for tuberculosis with Xpert MTB/RIF Ultra (Xpert) in 20 community health centres in Uganda. We collected empirical data on the cost of the XPEL-TB strategy (decentralised Xpert testing, workflow redesign, and performance feedback) and routine tuberculosis testing (onsite smear microscopy with specimen transport for centralised Xpert testing) from the health system perspective. Time-and-motion studies were performed to estimate activity-based service costs. Cost-effectiveness was assessed as the incremental cost (2019 US$) per tuberculosis diagnosis and per 14-day treatment initiation.FindingsThe XPEL-TB study ran from Oct 22, 2018, to March 1, 2020. Effectiveness and cost-effectiveness outcomes were assessed from Dec 1, 2018, to Nov 30, 2019 and included 4867 women and 3139 men. On a per-test basis, the cost of decentralised ($20·46, range $17·85-25·72) and centralised ($18·20, range $16·58-24·25) Xpert testing was similar. However, decentralised testing resulted in more patients receiving appropriate Xpert testing, so the per-patient cost of decentralised testing was higher: $20·28 (range $17·68-25·48) versus $9·59 (range $7·62-14·34). The XPEL-TB strategy was estimated to cost $1332 (95% uncertainty range $763-5558) per incremental tuberculosis diagnosis and $687 ($501-1207) per incremental patient initiating tuberculosis treatment within 14 days. Cost-effectiveness was reduced in sites performing

ObjectiveTwin vaginal deliveries (VDs) are often performed in the operating room (OR) given the theoretical risk of conversion to cesarean delivery (CD) for the aftercoming twin. We aim to evaluate the cost-effectiveness of performing VDs for twin gestations in the labor and delivery room (LDR) versus OR.Study designWe conducted a cost-effectiveness analysis using a decision-analysis model that compared the costs and effectiveness of two strategies of twin deliveries undergoing a trial of labor: (1) intended delivery in the LDR and 2) delivery in the OR. Sensitivity analyses were performed to assess strength and validity of the model. Primary outcome was incremental cost-effectiveness ratio (ICER) defined as cost needed to gain 1 quality-adjusted life year (QALY).ResultsIn the base-case scenario, where 7% of deliveries resulted in conversion to CD for twin B, attempting to deliver twins in the LDR was the most cost-effective strategy. For every QALY gained by delivering in the OR, 243,335 USD would need to be spent (ICER). In univariate sensitivity analyses, the most cost-effective strategy shifted to delivering in the OR when the following was true: (1) probability of successful VD was less than 86%, (2) probability of neonatal morbidity after emergent CD exceeded 3.5%, (3) cost of VD in an LDR exceeded 10,500 USD, (4) cost of CD was less than 10,000 USD, or (5) probability of neonatal death from emergent CD exceeded 2.8%. Assuming a willingness to pay of 100,000 USD per neonatal QALY gained, attempted VD in the LDR was cost effective in 51% of simulations in the Monte Carlo analysis.ConclusionTwin VDs in the LDR are cost effective based on current neonatal outcome data, taking into account gestational age and associated morbidity. Further investigation is needed to elucidate impact of cost and outcomes on optimal utilization of resources.Key points· Cost effectiveness of twin VDs in the LDR versus OR was assessed.. · Twin VDs in the LDR are cost effective based on

ObjectiveTo perform a distributional cost-effectiveness analysis of liquid biopsy (LB) followed by, if needed, tissue biopsy (TB) (LB-first strategy) relative to a TB-only strategy to inform first-line treatment of advanced non-small-cell lung cancer (aNSCLC) from a US-payer perspective by which we quantify the impact of LB-first on population health inequality according to race and ethnicity.MethodsWith a health economic model, quality-adjusted life years (QALYs) and costs per patient were estimated for each subgroup. Given the lifetime risk of aNSCLC, and assuming equally-distributed opportunity costs, the incremental net health benefits of LB-first were calculated, which were used to estimate general population quality adjusted life expectancy at birth (QALE) by race and ethnicity with and without LB-first. The degree of QALYs and QALE differences with the strategies was expressed with inequality indices. Their differences were defined as the inequality impact of LB-first.ResultsLB-first resulted in an additional 0.17 (95%uncertainty interval 0.06;0.32) QALYs among treated patients, with the greatest gain observed among Asian patients (0.26 QALYs (0.08;0.52)). LB-first resulted in an increase in relative inequality in QALYs among patients, but a minor decrease in relative inequality in QALE.ConclusionLB-first to inform first-line aNSCLC therapy can improve health outcomes but with current diagnostic performance, the benefit is the greatest among Asian patients thereby potentially widening racial and ethnic differences in survival among aNSCLC patients. Assuming equally-distributed opportunity costs and access, LB-first does not worsen and, in fact, may reduce inequality in general population health according to race and ethnicity.

Background: The STRONG-HF trial demonstrated substantial reductions in the composite of mortality and morbidity over 6 months among hospitalized heart failure patients who were randomized to intensive guideline-directed medical therapy (GDMT) optimization compared to usual care. Whether an intensive GDMT optimization program would be cost-effective for patients with heart failure with reduced ejection fraction (HFrEF) is unknown. Methods: Using a 2-state Markov model we evaluated the effect of an intensive GDMT optimization program on hospitalized patients with HFrEF. Two population models were created to simulate this intervention, a "Clinical Trial" model, based off the participants in the STRONG-HF trial and a "Real-World" model, based off the Get With The Guidelines-HF Registry of patients admitted with worsening HF. We then modeled the effect of a 6-month intensive triple therapy GDMT optimization program comprised of cardiologists, clinical pharmacists, and registered nurses. Hazard ratios from the intervention arm of the STRONG-HF trial were applied to both populations models to simulate clinical and financial outcomes of an intensive GDMT optimization program from a United States healthcare sector perspective with a lifetime time horizon. Optimal quadruple GDMT use was also modeled. Results: An intensive GDMT optimization program was extremely cost-effective with incremental cost-effectiveness ratios <$10,000 per quality-adjusted life year in both models. Optimal quadruple GDMT implementation resulted in the most gains in life years with incremental cost-effectiveness ratios of $60,000 and $54,000 in the Clinical Trial and Real-World models, respectively. Conclusions: An intensive GDMT optimization program for patients hospitalized with HFrEF would be cost-effective and result in substantial gains in clinical outcomes especially with use of optimal quadruple GDMT. Clinicians, payers, and policy makers should prioritize creation of such programs.

BackgroundWHO promotes the SAFE strategy for the elimination of trachoma as a public health programme, which promotes surgery for trichiasis (ie, the S component), antibiotics to clear the ocular strains of chlamydia that cause trachoma (the A component), facial cleanliness to prevent transmission of secretions (the F component), and environmental improvements to provide water for washing and sanitation facilities (the E component). However, little evidence is available from randomised trials to support the efficacy of interventions targeting the F and E components of the strategy. We aimed to determine whether an integrated water, sanitation, and hygiene (WASH) intervention prevents the transmission of trachoma.MethodsThe WASH Upgrades for Health in Amhara (WUHA) was a two-arm, parallel-group, cluster-randomised trial in 40 rural communities in Wag Hemra Zone (Amhara Region, Ethiopia) that had been treated with 7 years of annual mass azithromycin distributions. The randomisation unit was the school catchment area. All households within a 1·5 km radius of a potential water point within the catchment area (as determined by the investigators) were eligible for inclusion. Clusters were randomly assigned (at a 1:1 ratio) to receive a WASH intervention either immediately (intervention) or delayed until the conclusion of the trial (control), in the absence of concurrent antibiotic distributions. Given the nature of the intervention, participants and field workers could not be masked, but laboratory personnel were masked to treatment allocation. The WASH intervention consisted of both hygiene infrastructure improvements (namely, construction of a community water point) and hygiene promotion by government, school, and community leaders, which were implemented at the household, school, and community levels. Hygiene promotion focused on two simple messages: to use soap and water to wash your or your child's face, and to always use a latrine for defecation. The primary outcome

BackgroundChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are common sexually transmitted infections (STIs) associated with adverse outcomes, yet most countries do not test and conduct syndromic management, which lacks sensitivity and specificity. Innovations allow for expanded STI testing; however, cost is a barrier.MethodsUsing inputs from a pilot program in Botswana, we developed a model among a hypothetical population of 50,000 pregnant women to compare 1-year costs and outcomes associated with 3 antenatal STI testing strategies: (1) point-of-care, (2) centralized laboratory, and (3) a mixed approach (point of care at high-volume sites, and hubs elsewhere), and syndromic management.ResultsSyndromic management had the lowest delivery cost but was associated with the most infections at delivery, uninfected women treated, CT/NG-related low-birth-weight infants, disability-adjusted life years, and low birth weight hospitalization costs. Point-of-care CT/NG testing would treat and cure the most infections but had the highest delivery cost. Among the testing scenarios, the mixed scenario had the most favorable cost per woman treated and cured ($534/cure). Compared with syndromic management, the mixed approach resulted in a mean incremental cost-effectiveness ratio of $953 per disability-adjusted life years averted, which is cost-effective under World Health Organization's one-time per-capita gross domestic product willingness-to-pay threshold.ConclusionsAs countries consider new technologies to strengthen health services, there is an opportunity to determine how to best deploy resources. Compared with point-of-care, centralized laboratory, and syndromic management, the mixed approach offered the lowest cost per infection averted and is cost-effective if policy makers' willingness to pay is informed by the World Health Organization's gross domestic product/capita threshold.

AimsTo assess the cost-effectiveness of proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab added to standard-of-care lipid-lowering treatment [maximum tolerated dose (MTD) of statin and ezetimibe] in Swedish patients with a history of myocardial infarction (MI).Methods and resultsCost-effectiveness was evaluated using a Markov model based on Swedish observational data on cardiovascular event rates and efficacy from the FOURIER trial. Three risk profiles were considered: recent MI in the previous year; history of MI with a risk factor; and history of MI with a second event within 2 years. For each population, three minimum baseline low-density lipoprotein cholesterol (LDL-C) levels were considered: 2.5 mmol/L (≈100 mg/dL), based on the current reimbursement recommendation in Sweden; 1.8 mmol/L (≈70 mg/dL), based on 2016 ESC/EAS guidelines; and 1.4 mmol/L (≈55 mg/dL), or 1.0 mmol/L (≈40 mg/dL) for MI with a second event, based on 2019 ESC/EAS guidelines. Proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab was associated with increased quality-adjusted life-years and costs vs. standard-of-care therapy. Incremental cost-effectiveness ratios (ICERs) were below SEK700 000 (∼€66 500), the generally accepted willingness-to-pay threshold in Sweden, for minimum LDL-C levels of 2.3 (recent MI), 1.7 (MI with a risk factor), and 1.7 mmol/L (MI with a second event). Sensitivity analyses demonstrated that base-case results were robust to changes in model parameters.ConclusionProprotein convertase subtilisin/kexin type 9 inhibition with evolocumab added to MTD of statin and ezetimibe may be considered cost-effective at its list price for minimum LDL-C levels of 1.7-2.3 mmol/L, depending on risk profile, with ICERs below the accepted willingness-to-pay threshold in Sweden.

BackgroundTransmission of SARS-CoV-2 in health care facilities poses a challenge against pandemic control. Health care workers (HCWs) have frequent and high-risk interactions with COVID-19 patients. We undertook a cost-effectiveness analysis to determine optimal testing strategies for screening HCWs to inform strategic decision-making in health care settings.MethodsWe modeled the number of new infections, quality-adjusted life years lost, and net costs related to six testing strategies including no test. We applied our model to four strata of HCWs, defined by the presence and timing of symptoms. We conducted sensitivity analyses to account for uncertainty in inputs.ResultsWhen screening recently symptomatic HCWs, conducting only a PCR test is preferable; it saves costs and improves health outcomes in the first week post-symptom onset, and costs $83,000 per quality-adjusted life year gained in the second week post-symptom onset. When screening HCWs in the late clinical disease stage, none of the testing approaches is cost-effective and thus no testing is preferable, yielding $11 and 0.003 new infections per 10 HCWs. For screening asymptomatic HCWs, antigen testing is preferable to PCR testing due to its lower cost.ConclusionsBoth PCR and antigen testing are beneficial strategies to identify infected HCWs and reduce transmission of SARS-CoV-2 in health care settings. IgG tests' value depends on test timing and immunity characteristics, however it is not cost-effective in a low prevalence setting. As the context of the pandemic evolves, our study provides insight to health-care decision makers to keep the health care workforce safe and transmissions low.

BackgroundPreoperative opioid is associated with poor postoperative outcomes for several surgical specialties, including neurosurgical, orthopedic, and general surgery. Patients with symptomatic adult spinal deformity (SASD) are among the highest patient populations reporting opioid use prior to surgery. Surgery for SASD has been demonstrated to improve patient reported quality of life, however, little medical economic data exists evaluating impact of preoperative opioid use upon surgical cost-effectiveness for SASD. The purpose of this study was to evaluate the impact that preoperative opioid use has upon SASD surgery including duration of intensive care unit (ICU) and hospital stay, postoperative complications, patient reported outcome measures (PROMs), and surgical cost-effectiveness using a propensity score matched analysis model.MethodsSurgically treated SASD patients enrolled into a prospective multi-center SASD study were assessed for preoperative opioid use, and divided into two cohorts; preoperative opioid users (OPIOID) and preoperative opioid non-users (NON). Propensity score matching (PSM) was used to control for patient age, medical comorbidities, spine deformity type and magnitude, and surgical procedures for OPIOID vs NON. Preoperative and minimum 2-year postoperative PROMs, duration of ICU and hospital stay, postoperative complications, and opioid use at one and two years postoperative were compared for OPIOID vs NON. Preoperative, one year, and minimum two-year postoperative SF6D values were calculated, and one- and two-year postoperative QALYs were calculated using SF6D change from baseline. Hospital costs at the time of index surgery were calculated and cost/QALY compared at one and two years postop for OPIOID vs NON.Results261/357 patients (mean follow-up 3.3 years) eligible for study were evaluated. Following the PSM control, OPIOID (n=97) had similar preoperative demographics, smoking and depression history, spine deformity magnitude, and surge

BackgroundWatch and wait (WW) protocols have gained increasing popularity for patients diagnosed with locally advanced rectal cancer and presumed complete clinical response after neoadjuvant chemoradiation. While studies have demonstrated comparable survival and recurrence rates between WW and radical surgery, the decision to undergo surgery has significant effects on patient quality of life. We sought to conduct a cost-effectiveness analysis comparing WW with abdominoperineal resection (APR) and low anterior resection (LAR) among patients with stage II/III rectal cancer.MethodsIn this comparative-effectiveness study, we built Markov microsimulation models to simulate disease progression, death, costs, and quality-adjusted life-years (QALYs) for WW or APR/LAR. We assessed cost effectiveness using the incremental cost-effectiveness ratio (ICER), with ICERs under $100,000/QALY considered cost effective. Probabilities of disease progression, death, and health utilities were extracted from published, peer-reviewed literature. We assessed costs from the payer perspective.ResultsWW dominated both LAR and APR at a willingness to pay (WTP) threshold of $100,000. Our model was most sensitive to rates of distant recurrence and regrowth after WW. Probabilistic sensitivity analysis demonstrated that WW was the dominant strategy over both APR and LAR over 100% of iterations across a range of WTP thresholds from $0-250,000.ConclusionsOur study suggests WW could reduce overall costs and increase effectiveness compared with either LAR or APR. Additional clinical research is needed to confirm the clinical efficacy and cost effectiveness of WW compared with surgery in rectal cancer.

BackgroundEarly experience with indocyanine green-based fluorescent cholangiography during laparoscopic cholecystectomy suggests the potential to improve outcomes. However, the cost-effectiveness of routine use has not been studied. Our objective was to evaluate the cost-effectiveness of fluorescent cholangiography versus standard bright light laparoscopic cholecystectomy for noncancerous gallbladder disease.MethodsA Markov model decision analysis was performed comparing fluorescent cholangiography versus standard bright light laparoscopic cholecystectomy alone. Probabilities of outcomes, survival, toxicities, quality-adjusted life-years, and associated costs were determined from literature review and pooled analysis of currently available studies on fluorescent cholangiography (n = 37). Uncertainty in the model parameters was evaluated with 1-way and probabilistic sensitivity analyses, varying parameters up to 40% of their means. Cost-effectiveness was measured with an incremental cost-effectiveness ratio expressed as the dollar amount per quality-adjusted life-year.ResultsThe model predicted that fluorescent cholangiography reduces lifetime costs by $1,235 per patient and improves effectiveness by 0.09 quality-adjusted life-years compared to standard bright light laparoscopic cholecystectomy. Reduced costs were due to a decreased operative duration (21.20 minutes, P < .0001) and rate of conversion to open (1.62% vs 6.70%, P < .0001) associated with fluorescent cholangiography. The model was not influenced by the rate of bile duct injury. Probabilistic sensitivity analysis found that fluorescent cholangiography was both more effective and less costly in 98.83% of model iterations at a willingness-to-pay threshold of $100,000/quality-adjusted life year.ConclusionThe current evidence favors routine use of fluorescent cholangiography during laparoscopic cholecystectomy as a cost-effective surgical strategy. Our model predicts that fluorescent cholangiograph

BackgroundMethamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions, and their implementation barriers in Vietnam.MethodDesign: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions.ParticipantsWe will recruit 600 participants in 20 methadone clinics.Eligibility criteria(1) age 16+; (2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores ≥ 10 for methamphetamine use or confirmed methamphetamine use with urine drug screening; (3) willing to provide three pieces of contact information; and (4) having a cell phone.OutcomesOutcomes are measured at 13, 26, and 49 weeks and throughout the interventions. Primary outcomes include the (1) increase in HIV viral suppression, (2) reduction in HIV risk behaviors, and (3) reduction in methamphetamine use. COVID-19 response: We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity.DiscussionThis study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness.Trial registrationClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624.

Crohn's disease (CD) is an inflammatory bowel disease with increasing incidence and prevalence worldwide. Perianal fistulas are seen in up to 26% of CD patients and are often refractory to medical therapy. Current treatments for CD perianal fistulas (pCD) include antibiotics, biologics, and for refractory cases, fecal diversion (FD) with ileostomy or colostomy. Mesenchymal stem/stromal cell therapy (MSCs) is a new modality that have shown efficacy in treating pCD. MSCs locally injected into pCD can lead to healing, and a phase III clinical trial (ADMIRE-CD) showed 66% clinical response, leading to approval of MSCs (Alofisel, Takeda) in the European Union. It is unclear if MSCs would be more cost-effective than the current standard of FD. We therefore developed a decision tree model to determine the cost-effectiveness of MSCs compared to FD for pCD. Our study showed that both autologous and allogeneic MSCs are more cost-effective than FD in an academic medical center and even in a worst-case scenario with 100% chance of all complications for MSCs treatment and 0% chance of complications for FD, both allogeneic and autologous MSCs are still cost saving compared to FD.

Cost-effectiveness analysis, the most common type of economic evaluation, estimates a new option's additional outcome in relation to its extra costs. This is crucial to study within the clinical setting because funding for new treatments and interventions is often linked to whether there is evidence showing they are a good use of resources. This article describes how to analyze a cost-effectiveness dataset using the framework of a net benefit regression. The process of creating estimates and characterizing uncertainty is demonstrated using a hypothetical dataset. The results are explained and illustrated using graphs commonly employed in cost-effectiveness analyses. We conclude with a call to action for researchers to do more person-level cost-effectiveness analysis to produce evidence of the value of new treatments and interventions. Researchers can utilize cost-effectiveness analysis to compare new and existing treatment mechanisms.

BackgroundThe COVID-19 pandemic led to important indirect health and social harms in addition to deaths and morbidity due to SARS-CoV-2 infection. These indirect impacts, such as increased depression and substance abuse, can have persistent effects over the life course. Estimated health and cost outcomes of such conditions and mitigation strategies may guide public health responses.MethodsWe developed a cost-effectiveness framework to evaluate societal costs and quality-adjusted life years (QALYs) lost due to six health-related indirect effects of COVID-19 in California. Short- and long-term outcomes were evaluated for the adult population. We identified one evidence-based mitigation strategy for each condition and estimated QALYs gained, intervention costs, and savings from averted health-related harms. Model data were derived from literature review, public data, and expert opinion.ResultsPandemic-associated increases in prevalence across these six conditions were estimated to lead to over 192,000 QALYs lost and to approach $7 billion in societal costs per million population over the life course of adults. The greatest costs and QALYs lost per million adults were due to adult depression. All mitigation strategies assessed saved both QALYs and costs, with five strategies achieving savings within one year. The greatest net savings over 10 years would be achieved by addressing depression ($242 million) and excessive alcohol use ($107 million).DiscussionThe COVID-19 pandemic is leading to significant human suffering and societal costs due to its indirect effects. Policymakers have an opportunity to reduce societal costs and health harms by implementing mitigation strategies.

Background and objectivesDurvalumab and atezolizumab are approved as first-line therapy in extensive-stage small-cell lung cancer. Although cost-effectiveness analyses compared these immunotherapy drugs with standard chemotherapy-alone regimens, no head-to-head cost-effectiveness comparisons for these treatments exist. The aim of the present analysis is to determine the cost-effectiveness of durvalumab and atezolizumab as first-line therapy for extensive-stage small-cell lung cancer from the US payers' perspective.MethodsThis study is based on two placebo-controlled, phase 3 clinical trials: CASPIAN and IMpower133. A Markov model was developed to simulate the three health states: progression-free survival, progressed disease, and death in patients with extensive-stage small-cell lung cancer. Transition probabilities were estimated from the clinical trial survival curves and extended with life-time modelling. Health utilities and direct costs of adverse event treatment were included. Main outcome was the incremental cost-effectiveness ratio (ICER) using quality-adjusted life-years saved (QALYS). Sensitivity analysis was performed to assess the impact of variables on the ICER.ResultsDurvalumab group has a cost of $187,503 with an effectiveness of 1.08 while atezolizumab has a cost of $160,219 and an effectiveness of 0.932. Durvalumab is not cost-effective compared to atezolizumab with an ICER of $165,182 QALYS, which is over the willingness-to-pay threshold of $150,000. The model was most sensitive to durvalumab cost and the cost of treating durvalumab adverse effects.ConclusionsWith the ICER of durvalumab treatment group being very close to $150,000, setting a higher willingness-to-pay threshold or decreasing the drug cost through contract pricing can increase the cost-effectiveness of durvalumab compared to atezolizumab.

IntroductionDespite the increased risk of cervical cancer among HIV-positive women, many HIV-care programs do not offer integrated cervical cancer screening. Incorporating self-collected Human Papillomavirus (HPV) testing into HIV programs is a potential strategy to identify women at higher risk for cervical cancer while leveraging the staffing, infrastructure and referral systems for existing services. Community-based HIV and HPV testing has been effective and efficient when offered in single-disease settings.MethodsThis cross-sectional study was conducted within a community outreach and multi-disease screening campaigns organized by the Family AIDS Care and Education Services in Kisumu County, Kenya. In addition to HIV testing, the campaigns provided screening for TB, malaria, hypertension, diabetes, and referrals for voluntary medical male circumcision. After these services, women aged 25-65 were offered self-collected HPV testing. Rates and predictors of cervical cancer screening uptake and of HPV positivity were analyzed using tabular analysis and Fisher's Exact Test. Logistic regression was performed to explore multivariate associations with screening uptake.ResultsAmong the 2016 women of screening age who attended the outreach campaigns, 749 women (35.6%) were screened, and 134 women (18.7%) were HPV-positive. In bivariate analysis, women who had no children (p < 0.01), who were not pregnant (p < 0.01), who were using contraceptives (p < 0.01), who had sex without using condoms (p < 0.05), and who were encouraged by a family member other than their spouse (p < 0.01), were more likely to undergo screening. On multivariable analysis, characteristics associated with higher screening uptake included: women aged 45-54 (OR 1.62, 95% CI 1.05-2.52) compared to women aged 25-34; no children (OR 1.65, 95% CI 1.06-2.56); and family support other than their spouse (OR 1.53, 95% CI 1.09-2.16). Women who were pregnant were 0.44 times (95% CI 0.25-0.76) less

BackgroundWatch and wait (WW) protocols have gained increasing popularity for patients diagnosed with locally advanced rectal cancer and presumed complete clinical response after neoadjuvant chemoradiation. While studies have demonstrated comparable survival and recurrence rates between WW and radical surgery, the decision to undergo surgery has significant effects on patient quality of life. We sought to conduct a cost-effectiveness analysis comparing WW with abdominoperineal resection (APR) and low anterior resection (LAR) among patients with stage II/III rectal cancer.MethodsIn this comparative-effectiveness study, we built Markov microsimulation models to simulate disease progression, death, costs, and quality-adjusted life-years (QALYs) for WW or APR/LAR. We assessed cost effectiveness using the incremental cost-effectiveness ratio (ICER), with ICERs under $100,000/QALY considered cost effective. Probabilities of disease progression, death, and health utilities were extracted from published, peer-reviewed literature. We assessed costs from the payer perspective.ResultsWW dominated both LAR and APR at a willingness to pay (WTP) threshold of $100,000. Our model was most sensitive to rates of distant recurrence and regrowth after WW. Probabilistic sensitivity analysis demonstrated that WW was the dominant strategy over both APR and LAR over 100% of iterations across a range of WTP thresholds from $0-250,000.ConclusionsOur study suggests WW could reduce overall costs and increase effectiveness compared with either LAR or APR. Additional clinical research is needed to confirm the clinical efficacy and cost effectiveness of WW compared with surgery in rectal cancer.

BackgroundThe COVID-19 pandemic led to important indirect health and social harms in addition to deaths and morbidity due to SARS-CoV-2 infection. These indirect impacts, such as increased depression and substance abuse, can have persistent effects over the life course. Estimated health and cost outcomes of such conditions and mitigation strategies may guide public health responses.MethodsWe developed a cost-effectiveness framework to evaluate societal costs and quality-adjusted life years (QALYs) lost due to six health-related indirect effects of COVID-19 in California. Short- and long-term outcomes were evaluated for the adult population. We identified one evidence-based mitigation strategy for each condition and estimated QALYs gained, intervention costs, and savings from averted health-related harms. Model data were derived from literature review, public data, and expert opinion.ResultsPandemic-associated increases in prevalence across these six conditions were estimated to lead to over 192,000 QALYs lost and to approach $7 billion in societal costs per million population over the life course of adults. The greatest costs and QALYs lost per million adults were due to adult depression. All mitigation strategies assessed saved both QALYs and costs, with five strategies achieving savings within one year. The greatest net savings over 10 years would be achieved by addressing depression ($242 million) and excessive alcohol use ($107 million).DiscussionThe COVID-19 pandemic is leading to significant human suffering and societal costs due to its indirect effects. Policymakers have an opportunity to reduce societal costs and health harms by implementing mitigation strategies.

Background and objectivesDurvalumab and atezolizumab are approved as first-line therapy in extensive-stage small-cell lung cancer. Although cost-effectiveness analyses compared these immunotherapy drugs with standard chemotherapy-alone regimens, no head-to-head cost-effectiveness comparisons for these treatments exist. The aim of the present analysis is to determine the cost-effectiveness of durvalumab and atezolizumab as first-line therapy for extensive-stage small-cell lung cancer from the US payers' perspective.MethodsThis study is based on two placebo-controlled, phase 3 clinical trials: CASPIAN and IMpower133. A Markov model was developed to simulate the three health states: progression-free survival, progressed disease, and death in patients with extensive-stage small-cell lung cancer. Transition probabilities were estimated from the clinical trial survival curves and extended with life-time modelling. Health utilities and direct costs of adverse event treatment were included. Main outcome was the incremental cost-effectiveness ratio (ICER) using quality-adjusted life-years saved (QALYS). Sensitivity analysis was performed to assess the impact of variables on the ICER.ResultsDurvalumab group has a cost of $187,503 with an effectiveness of 1.08 while atezolizumab has a cost of $160,219 and an effectiveness of 0.932. Durvalumab is not cost-effective compared to atezolizumab with an ICER of $165,182 QALYS, which is over the willingness-to-pay threshold of $150,000. The model was most sensitive to durvalumab cost and the cost of treating durvalumab adverse effects.ConclusionsWith the ICER of durvalumab treatment group being very close to $150,000, setting a higher willingness-to-pay threshold or decreasing the drug cost through contract pricing can increase the cost-effectiveness of durvalumab compared to atezolizumab.

Cost-effectiveness analysis, the most common type of economic evaluation, estimates a new option's additional outcome in relation to its extra costs. This is crucial to study within the clinical setting because funding for new treatments and interventions is often linked to whether there is evidence showing they are a good use of resources. This article describes how to analyze a cost-effectiveness dataset using the framework of a net benefit regression. The process of creating estimates and characterizing uncertainty is demonstrated using a hypothetical dataset. The results are explained and illustrated using graphs commonly employed in cost-effectiveness analyses. We conclude with a call to action for researchers to do more person-level cost-effectiveness analysis to produce evidence of the value of new treatments and interventions. Researchers can utilize cost-effectiveness analysis to compare new and existing treatment mechanisms.

ObjectiveThe objective was to (i) assess the long-term cost-effectiveness of acceptance and commitment therapy (ACT), a workplace dialog intervention (WDI), and ACT+WDI compared to treatment as usual (TAU) for common mental disorders and (ii) investigate any differences in cost-effectiveness between diagnostic groups.MethodsAn economic evaluation from the healthcare and limited welfare perspectives was conducted alongside a randomized clinical trial with a two-year follow-up period. Persons with common mental disorders receiving sickness benefits were invited to the trial. We used registry data for cost analysis alongside participant data collected during the trial and the reduction in sickness absence days as treatment effect. A total of 264 participants with a diagnosis of depression, anxiety, or stress-induced exhaustion disorder participated in a two-year follow-up of a four-arm trial: ACT (N=74), WDI (N=60), ACT+WDI (N=70), and TAU (N=60).ResultsFor all patients in general, there were no statistically significant differences between interventions in terms of costs or effect. The subgroup analyses suggested that from a healthcare perspective, ACT was a cost-effective option for depression or anxiety disorders and ACT+WDI for stress-induced exhaustion disorder. With a two-year time horizon, the probability of WDI to be cost-saving in terms of sickness benefits costs was 80% compared with TAU.ConclusionsACT had a high probability of cost-effectiveness from a healthcare perspective for employees on sick leave due to depression or anxiety disorders. For participants with stress-induced exhaustion disorder, adding WDI to ACT seems to reduce healthcare costs, while WDI as a stand-alone intervention seems to reduce welfare costs.

AimCombining preoperative spirometry with the Assess Respiratory Risk in Surgical Patients in Catalunia (ARISCAT) risk scale can reduce post-operative complications and improve patient survival. This study aimed to assess the cost-effectiveness of performing spirometry or not in conjunction with the ARISCAT scale, to reduce post-operative complications and improve survival among adult patients undergoing elective surgery in Mexico.MethodsA cost-effectiveness analysis (CEA) was performed to compare the specific cost and health outcomes associated with the combined use of the ARISCAT scale and preoperative spirometry (Group 1), and the use of the ARISCAT scale without preoperative spirometry (Group 2). The health outcomes evaluated were post-operative complications and survival. The perspective was from the health care provider (Hospital General de México) and direct medical costs were reported in 2019 US dollars. A decision tree with a time horizon of eight months was used for each health outcome and ARISCAT risk level.ResultsThe combined use of the ARISCAT scale and spirometry is more cost-effective for reducing post-operative complications in the low and moderate-risk levels and is cost-saving in the high-risk level, than use of the ARISCAT scale without spirometry. To improve patient survival, ARISCAT and spirometry are also more cost-effective at the moderate risk level, and cost-saving for high-risk patients, than using the ARISCAT scale alone.ConclusionsThe use of preoperative spirometry among patients with a high ARISCAT risk level was cost-saving, reduced post-operative complications, and improved survival. Our findings indicate an urgent need to implement spirometry as part of preoperative care in Mexico, which is already the standard of care in other countries.

BackgroundEarly experience with indocyanine green-based fluorescent cholangiography during laparoscopic cholecystectomy suggests the potential to improve outcomes. However, the cost-effectiveness of routine use has not been studied. Our objective was to evaluate the cost-effectiveness of fluorescent cholangiography versus standard bright light laparoscopic cholecystectomy for noncancerous gallbladder disease.MethodsA Markov model decision analysis was performed comparing fluorescent cholangiography versus standard bright light laparoscopic cholecystectomy alone. Probabilities of outcomes, survival, toxicities, quality-adjusted life-years, and associated costs were determined from literature review and pooled analysis of currently available studies on fluorescent cholangiography (n = 37). Uncertainty in the model parameters was evaluated with 1-way and probabilistic sensitivity analyses, varying parameters up to 40% of their means. Cost-effectiveness was measured with an incremental cost-effectiveness ratio expressed as the dollar amount per quality-adjusted life-year.ResultsThe model predicted that fluorescent cholangiography reduces lifetime costs by $1,235 per patient and improves effectiveness by 0.09 quality-adjusted life-years compared to standard bright light laparoscopic cholecystectomy. Reduced costs were due to a decreased operative duration (21.20 minutes, P < .0001) and rate of conversion to open (1.62% vs 6.70%, P < .0001) associated with fluorescent cholangiography. The model was not influenced by the rate of bile duct injury. Probabilistic sensitivity analysis found that fluorescent cholangiography was both more effective and less costly in 98.83% of model iterations at a willingness-to-pay threshold of $100,000/quality-adjusted life year.ConclusionThe current evidence favors routine use of fluorescent cholangiography during laparoscopic cholecystectomy as a cost-effective surgical strategy. Our model predicts that fluorescent cholangiograph

BackgroundTransmission of SARS-CoV-2 in health care facilities poses a challenge against pandemic control. Health care workers (HCWs) have frequent and high-risk interactions with COVID-19 patients. We undertook a cost-effectiveness analysis to determine optimal testing strategies for screening HCWs to inform strategic decision-making in health care settings.MethodsWe modeled the number of new infections, quality-adjusted life years lost, and net costs related to six testing strategies including no test. We applied our model to four strata of HCWs, defined by the presence and timing of symptoms. We conducted sensitivity analyses to account for uncertainty in inputs.ResultsWhen screening recently symptomatic HCWs, conducting only a PCR test is preferable; it saves costs and improves health outcomes in the first week post-symptom onset, and costs $83,000 per quality-adjusted life year gained in the second week post-symptom onset. When screening HCWs in the late clinical disease stage, none of the testing approaches is cost-effective and thus no testing is preferable, yielding $11 and 0.003 new infections per 10 HCWs. For screening asymptomatic HCWs, antigen testing is preferable to PCR testing due to its lower cost.ConclusionsBoth PCR and antigen testing are beneficial strategies to identify infected HCWs and reduce transmission of SARS-CoV-2 in health care settings. IgG tests' value depends on test timing and immunity characteristics, however it is not cost-effective in a low prevalence setting. As the context of the pandemic evolves, our study provides insight to health-care decision makers to keep the health care workforce safe and transmissions low.

AimsTo assess the cost-effectiveness of proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab added to standard-of-care lipid-lowering treatment [maximum tolerated dose (MTD) of statin and ezetimibe] in Swedish patients with a history of myocardial infarction (MI).Methods and resultsCost-effectiveness was evaluated using a Markov model based on Swedish observational data on cardiovascular event rates and efficacy from the FOURIER trial. Three risk profiles were considered: recent MI in the previous year; history of MI with a risk factor; and history of MI with a second event within 2 years. For each population, three minimum baseline low-density lipoprotein cholesterol (LDL-C) levels were considered: 2.5 mmol/L (≈100 mg/dL), based on the current reimbursement recommendation in Sweden; 1.8 mmol/L (≈70 mg/dL), based on 2016 ESC/EAS guidelines; and 1.4 mmol/L (≈55 mg/dL), or 1.0 mmol/L (≈40 mg/dL) for MI with a second event, based on 2019 ESC/EAS guidelines. Proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab was associated with increased quality-adjusted life-years and costs vs. standard-of-care therapy. Incremental cost-effectiveness ratios (ICERs) were below SEK700 000 (∼€66 500), the generally accepted willingness-to-pay threshold in Sweden, for minimum LDL-C levels of 2.3 (recent MI), 1.7 (MI with a risk factor), and 1.7 mmol/L (MI with a second event). Sensitivity analyses demonstrated that base-case results were robust to changes in model parameters.ConclusionProprotein convertase subtilisin/kexin type 9 inhibition with evolocumab added to MTD of statin and ezetimibe may be considered cost-effective at its list price for minimum LDL-C levels of 1.7-2.3 mmol/L, depending on risk profile, with ICERs below the accepted willingness-to-pay threshold in Sweden.

BackgroundChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are common sexually transmitted infections (STIs) associated with adverse outcomes, yet most countries do not test and conduct syndromic management, which lacks sensitivity and specificity. Innovations allow for expanded STI testing; however, cost is a barrier.MethodsUsing inputs from a pilot program in Botswana, we developed a model among a hypothetical population of 50,000 pregnant women to compare 1-year costs and outcomes associated with 3 antenatal STI testing strategies: (1) point-of-care, (2) centralized laboratory, and (3) a mixed approach (point of care at high-volume sites, and hubs elsewhere), and syndromic management.ResultsSyndromic management had the lowest delivery cost but was associated with the most infections at delivery, uninfected women treated, CT/NG-related low-birth-weight infants, disability-adjusted life years, and low birth weight hospitalization costs. Point-of-care CT/NG testing would treat and cure the most infections but had the highest delivery cost. Among the testing scenarios, the mixed scenario had the most favorable cost per woman treated and cured ($534/cure). Compared with syndromic management, the mixed approach resulted in a mean incremental cost-effectiveness ratio of $953 per disability-adjusted life years averted, which is cost-effective under World Health Organization's one-time per-capita gross domestic product willingness-to-pay threshold.ConclusionsAs countries consider new technologies to strengthen health services, there is an opportunity to determine how to best deploy resources. Compared with point-of-care, centralized laboratory, and syndromic management, the mixed approach offered the lowest cost per infection averted and is cost-effective if policy makers' willingness to pay is informed by the World Health Organization's gross domestic product/capita threshold.

BackgroundPreoperative opioid is associated with poor postoperative outcomes for several surgical specialties, including neurosurgical, orthopedic, and general surgery. Patients with symptomatic adult spinal deformity (SASD) are among the highest patient populations reporting opioid use prior to surgery. Surgery for SASD has been demonstrated to improve patient reported quality of life, however, little medical economic data exists evaluating impact of preoperative opioid use upon surgical cost-effectiveness for SASD. The purpose of this study was to evaluate the impact that preoperative opioid use has upon SASD surgery including duration of intensive care unit (ICU) and hospital stay, postoperative complications, patient reported outcome measures (PROMs), and surgical cost-effectiveness using a propensity score matched analysis model.MethodsSurgically treated SASD patients enrolled into a prospective multi-center SASD study were assessed for preoperative opioid use, and divided into two cohorts; preoperative opioid users (OPIOID) and preoperative opioid non-users (NON). Propensity score matching (PSM) was used to control for patient age, medical comorbidities, spine deformity type and magnitude, and surgical procedures for OPIOID vs NON. Preoperative and minimum 2-year postoperative PROMs, duration of ICU and hospital stay, postoperative complications, and opioid use at one and two years postoperative were compared for OPIOID vs NON. Preoperative, one year, and minimum two-year postoperative SF6D values were calculated, and one- and two-year postoperative QALYs were calculated using SF6D change from baseline. Hospital costs at the time of index surgery were calculated and cost/QALY compared at one and two years postop for OPIOID vs NON.Results261/357 patients (mean follow-up 3.3 years) eligible for study were evaluated. Following the PSM control, OPIOID (n=97) had similar preoperative demographics, smoking and depression history, spine deformity magnitude, and surge

IntroductionDespite the increased risk of cervical cancer among HIV-positive women, many HIV-care programs do not offer integrated cervical cancer screening. Incorporating self-collected Human Papillomavirus (HPV) testing into HIV programs is a potential strategy to identify women at higher risk for cervical cancer while leveraging the staffing, infrastructure and referral systems for existing services. Community-based HIV and HPV testing has been effective and efficient when offered in single-disease settings.MethodsThis cross-sectional study was conducted within a community outreach and multi-disease screening campaigns organized by the Family AIDS Care and Education Services in Kisumu County, Kenya. In addition to HIV testing, the campaigns provided screening for TB, malaria, hypertension, diabetes, and referrals for voluntary medical male circumcision. After these services, women aged 25-65 were offered self-collected HPV testing. Rates and predictors of cervical cancer screening uptake and of HPV positivity were analyzed using tabular analysis and Fisher's Exact Test. Logistic regression was performed to explore multivariate associations with screening uptake.ResultsAmong the 2016 women of screening age who attended the outreach campaigns, 749 women (35.6%) were screened, and 134 women (18.7%) were HPV-positive. In bivariate analysis, women who had no children (p < 0.01), who were not pregnant (p < 0.01), who were using contraceptives (p < 0.01), who had sex without using condoms (p < 0.05), and who were encouraged by a family member other than their spouse (p < 0.01), were more likely to undergo screening. On multivariable analysis, characteristics associated with higher screening uptake included: women aged 45-54 (OR 1.62, 95% CI 1.05-2.52) compared to women aged 25-34; no children (OR 1.65, 95% CI 1.06-2.56); and family support other than their spouse (OR 1.53, 95% CI 1.09-2.16). Women who were pregnant were 0.44 times (95% CI 0.25-0.76) less

BackgroundApproaches that allow easy access to pre-exposure prophylaxis (PrEP), such as over-the-counter provision at pharmacies, could facilitate risk-informed PrEP use and lead to lower HIV incidence, but their cost-effectiveness is unknown. We aimed to evaluate conditions under which risk-informed PrEP use is cost-effective.MethodsWe applied a mathematical model of HIV transmission to simulate 3000 setting-scenarios reflecting a range of epidemiological characteristics of communities in sub-Saharan Africa. The prevalence of HIV viral load greater than 1000 copies per mL among all adults (HIV positive and negative) varied from 1·1% to 7·4% (90% range). We hypothesised that if PrEP was made easily available without restriction and with education regarding its use, women and men would use PrEP, with sufficient daily adherence, during so-called seasons of risk (ie, periods in which individuals are at risk of acquiring infection). We refer to this as risk-informed PrEP. For each setting-scenario, we considered the situation in mid-2021 and performed a pairwise comparison of the outcomes of two policies: immediate PrEP scale-up and then continuation for 50 years, and no PrEP. We estimated the relationship between epidemic and programme characteristics and cost-effectiveness of PrEP availability to all during seasons of risk. For our base-case analysis, we assumed a 3-monthly PrEP cost of US$29 (drug $11, HIV test $4, and $14 for additional costs necessary to facilitate education and access), a cost-effectiveness threshold of $500 per disability-adjusted life-year (DALY) averted, an annual discount rate of 3%, and a time horizon of 50 years. In sensitivity analyses, we considered a cost-effectiveness threshold of $100 per DALY averted, a discount rate of 7% per annum, the use of PrEP outside of seasons of risk, and reduced uptake of risk-informed PrEP.FindingsIn the context of PrEP scale-up such that 66% (90% range across setting-scenarios 46-81) of HIV-negative people

Crohn's disease (CD) is an inflammatory bowel disease with increasing incidence and prevalence worldwide. Perianal fistulas are seen in up to 26% of CD patients and are often refractory to medical therapy. Current treatments for CD perianal fistulas (pCD) include antibiotics, biologics, and for refractory cases, fecal diversion (FD) with ileostomy or colostomy. Mesenchymal stem/stromal cell therapy (MSCs) is a new modality that have shown efficacy in treating pCD. MSCs locally injected into pCD can lead to healing, and a phase III clinical trial (ADMIRE-CD) showed 66% clinical response, leading to approval of MSCs (Alofisel, Takeda) in the European Union. It is unclear if MSCs would be more cost-effective than the current standard of FD. We therefore developed a decision tree model to determine the cost-effectiveness of MSCs compared to FD for pCD. Our study showed that both autologous and allogeneic MSCs are more cost-effective than FD in an academic medical center and even in a worst-case scenario with 100% chance of all complications for MSCs treatment and 0% chance of complications for FD, both allogeneic and autologous MSCs are still cost saving compared to FD.

Public health officials must provide guidance on operating schools safely during the COVID-19 pandemic. Using data from April-December 2021, we conducted a cost-effectiveness analysis to assess six screening strategies for schools using SARS-CoV-2 antigen and PCR tests and varying screening frequencies for 1000 individuals. We estimated secondary infections averted, quality-adjusted life years (QALYs), cost per QALY gained, and unnecessary school days missed per infection averted. We conducted sensitivity analyses for the more transmissible Omicron variant. Weekly antigen testing with PCR follow-up for positives was the most cost-effective option given moderate transmission, adding 0.035 QALYs at a cost of USD 320,000 per QALY gained in the base case (Reff = 1.1, prevalence = 0.2%). This strategy had the fewest needlessly missed school days (ten) per secondary infection averted. During widespread community transmission with Omicron (Reff = 1.5, prevalence = 5.8%), twice weekly antigen testing with PCR follow-up led to 2.02 QALYs gained compared to no test and cost the least (USD 187,300), with 0.5 needlessly missed schooldays per infection averted. In periods of moderate community transmission, weekly antigen testing with PCR follow up can help reduce transmission in schools with minimal unnecessary days of school missed. During widespread community transmission, twice weekly antigen screening with PCR confirmation is the most cost-effective and efficient strategy. Schools may benefit from resources to implement routine asymptomatic testing during surges; benefits decline as community transmission declines.

The global age standardized prevalence of type 2 diabetes (T2DM) has doubled (4.7% to 8.5%) over the last three decades and is increasing more rapidly in low and middle-income countries (LMICs). The global economic burden of diabetes affects individuals and health care systems and is estimated to cost $825 billion USD a year. Within Mexico, T2DM is the second leading cause of mortality and the leading cause of morbidity using disability associated life years (DALYs). A retrospective chart review and cost analysis, analyzing those at risk of diabetes, was conducted at a rural community health clinic in Jalisco, Mexico. The goal was to project the cost of providing an appropriate scope of care and plan prevention-based population health programs. The results demonstrated that out of 264 charts reviewed, 218 (83%) had one or more diabetic risk factor. The estimated per patient per visit cost is $127.22 MP (Mexican Peso, 2018) and as the number of diabetes risk factors increases for an individual patient, the mean cost of their care to the system increases (p < .001). Those with at least one risk factor comprise the majority in both males and females with a median age of 36 and median BMI of 28, and this group also has the highest percentage of borderline hypertension (46%). This data demonstrates an opportunity to intervene in a group of young adults (ages 27-46) with a cluster of high-risk borderline risk factors and preventing them from developing obesity, hypertension and diabetes later in life.

BackgroundMethamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions, and their implementation barriers in Vietnam.MethodDesign: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions.ParticipantsWe will recruit 600 participants in 20 methadone clinics.Eligibility criteria(1) age 16+; (2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores ≥ 10 for methamphetamine use or confirmed methamphetamine use with urine drug screening; (3) willing to provide three pieces of contact information; and (4) having a cell phone.OutcomesOutcomes are measured at 13, 26, and 49 weeks and throughout the interventions. Primary outcomes include the (1) increase in HIV viral suppression, (2) reduction in HIV risk behaviors, and (3) reduction in methamphetamine use. COVID-19 response: We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity.DiscussionThis study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness.Trial registrationClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624.

Background: Methamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a Type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions and their implementation barriers in Vietnam. Method: Design: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions. Participants We will recruit 600 participants in 20 methadone clinics. Eligibility criteria: 1) age 16+, 2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores 10 or more for methamphetamine use or confirmed methamphetamine use with urine drug screening; 3) willing to provide three pieces of contact information; 4) having a cell phone. Outcomes Outcomes are measured at 13-, 26- and 49-week and throughout the interventions. Primary outcomes include: (1) increase in HIV viral suppression; (2) reduction in HIV risk behaviors; and (3) reduction in methamphetamine use. COVID-19 response We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity. Discussion: This study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness. Trial registration NCT04706624. Registered 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624