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Background: Malnutrition among women of childbearing age is especially prevalent in Asia and sub-Saharan Africa and can be harmful to the fetus during pregnancy. In the most recently available Demographic and Health Survey (DHS), approximately 10% to 20% of pregnant women in India, Pakistan, Mali, and Tanzania were undernourished (body mass index [BMI] <18.5 kg/m2), and according to the Global Burden of Disease (GBD) 2017 study, approximately 20% of babies were born with low birth weight (LBW; <2,500 g) in India, Pakistan, and Mali and 8% in Tanzania. Supplementing pregnant women with micro and macronutrients during the antenatal period can improve birth outcomes. Recently, the World Health Organization (WHO) recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic acid (IFA) in the context of rigorous research. Additionally, WHO recommends balanced energy protein (BEP) for undernourished populations. However, few studies have compared the cost-effectiveness of different supplementation regimens. We compared the cost-effectiveness of MMS and BEP with IFA to quantify their benefits in 4 countries with considerable prevalence of maternal undernutrition., Methods and Findings: Using nationally representative estimates from the 2017 GBD study, we conducted an individual-based dynamic microsimulation of population cohorts from birth to 2 years of age in India, Pakistan, Mali, and Tanzania. We modeled the effect of maternal nutritional supplementation on infant birth weight, stunting and wasting using effect sizes from Cochrane systematic reviews and published literature. We used a payer's perspective and obtained costs of supplementation per pregnancy from the published literature. We compared disability-adjusted life years (DALYs) and incremental cost-effectiveness ratios (ICERs) in a baseline scenario with existing antenatal IFA coverage with scenarios where 90% of antenatal care (ANC) attendees receive either universal MMS, universal BEP, or MMS + targeted BEP (women with prepregnancy BMI <18.5 kg/m2 receive BEP containing MMS while women with BMI ≥18.5 kg/m2 receive MMS). We obtained 95% uncertainty intervals (UIs) for all outputs to represent parameter and stochastic uncertainty across 100 iterations of model runs. ICERs for all scenarios were lowest in Pakistan and greatest in Tanzania, in line with the baseline trend in prevalence of and attributable burden to LBW. MMS + targeted BEP averts more DALYs than universal MMS alone while remaining cost-effective. ICERs for universal MMS compared to baseline IFA were $52 (95% UI: $28 to $78) for Pakistan, $72 (95% UI: $37 to $118) for Mali, $70 (95% UI: $43 to $104) for India, and $253 (95% UI: $112 to $481) for Tanzania. ICERs for MMS + targeted BEP compared to baseline IFA were $54 (95% UI: $32 to $77) for Pakistan, $73 (95% UI: $40 to $104) for Mali, $83 (95% UI: $58 to $111) for India, and $245 (95% UI: $127 to $405) for Tanzania. Study limitations include generalizing experimental findings from the literature to our populations of interest and using population-level input parameters that may not reflect the heterogeneity of subpopulations. Additionally, our microsimulation fuses multiple sources of data and may be limited by data quality and availability., Conclusions: In this study, we observed that MMS + targeted BEP averts more DALYs and remains cost-effective compared to universal MMS. As countries consider using MMS in alignment with recent WHO guidelines, offering targeted BEP is a cost-effective strategy that can be considered concurrently to maximize benefits and synergize program implementation., Competing Interests: We have read the journal’s policy and the authors of this manuscript have the following competing interests: ADF has consulted recently for Janssen; SwissRe; Sanofi; Merck for Mothers; and Agathos, Ltd. Other authors have no conflicts of interest to disclose.

Importance: Increasingly, cost-effectiveness analyses are being done to determine the value of rapidly increasing oncology drugs; however, this assumes that these analyses are unbiased., Objective: To analyze the characteristics of cost-effectiveness studies and to determine characteristics associated with whether an oncology drug is found to be cost-effective., Design, Setting, and Participants: This retrospective cross-sectional study included 254 cost-effectiveness analyses for 116 oncology drugs that were approved by the US Food and Drug Administration from 2015 to 2020., Exposures: Each drug was analyzed for the incremental cost-effectiveness ratio per quality-adjusted life year, the funding of the study, the authors' conflict of interest, the threshold of willingness-to-pay, from what country's perspective the analysis was done, and whether a National Institute for Health and Care Excellence cost-effectiveness analysis had been done., Main Outcomes and Measures: The main outcome was the odds of a study concluding that a drug was cost-effective., Results: There were 116 drug approvals with 254 studies and country perspectives. Of the country perspectives, 132 (52%) were from the US. Forty-seven of 78 drugs with cost-effective studies had been shown to improve overall survival, whereas 15 of 38 of drugs without a cost-effectiveness study had been shown to improve overall survival. Having a study funded by a pharmaceutical company was associated with higher odds of a study concluding that a drug was cost-effective than studies without funding (odds ratio, 41.36; 95% CI, 11.86-262.23)., Conclusions and Relevance: In this cross-sectional study, pharmaceutical funding was associated with greater odds that an oncology drug would be found to be cost-effective. These findings suggest that simply disclosing potential conflict of interest is inadequate. We encourage cost-effectiveness analyses by independent groups.

Objectives: The COVID-19 pandemic has had a major impact on our society, with drastic policy restrictions being implemented to contain the spread of the severe acute respiratory syndrome coronavirus 2. This study aimed to provide an overview of the available evidence on the cost-effectiveness of various coronavirus disease 2019 policy measures., Methods: A systematic literature search was conducted in PubMed, Embase, and Web of Science. Health economic evaluations considering both costs and outcomes were included. Their quality was comprehensively assessed using the Consensus Health Economic Criteria checklist. Next, the quality of the epidemiological models was evaluated., Results: A total of 3688 articles were identified (March 2021), of which 23 were included. The studies were heterogeneous with regard to methodological quality, contextual factors, strategies' content, adopted perspective, applied models, and outcomes used. Overall, testing/screening, social distancing, personal protective equipment, quarantine/isolation, and hygienic measures were found to be cost-effective. Furthermore, the most optimal choice and combination of strategies depended on the reproduction number and context. With a rising reproduction number, extending the testing strategy and early implementation of combined multiple restriction measures are most efficient., Conclusions: The quality assessment highlighted numerous flaws and limitations in the study approaches; hence, their results should be interpreted with caution because the specific context (country, target group, etc) is a key driver for cost-effectiveness. Finally, including a societal perspective in future evaluations is key because this pandemic has an indirect impact on the onset and treatment of other conditions and on our global economy., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology . Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel., Results: Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups., Conclusions: There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed., Competing Interests: The authors have no relevant conflicts of interest to declare. However, a number of the coauthors work for health authorities or are advisers to them., (Copyright © 2021 Brian Godman et al.)

Background: Multiple Coronavirus Disease 2019 (COVID-19) vaccines appear to be safe and efficacious, but only high-income countries have the resources to procure sufficient vaccine doses for most of their eligible populations. The World Health Organization has published guidelines for vaccine prioritisation, but most vaccine impact projections have focused on high-income countries, and few incorporate economic considerations. To address this evidence gap, we projected the health and economic impact of different vaccination scenarios in Sindh Province, Pakistan (population: 48 million)., Methods and Findings: We fitted a compartmental transmission model to COVID-19 cases and deaths in Sindh from 30 April to 15 September 2020. We then projected cases, deaths, and hospitalisation outcomes over 10 years under different vaccine scenarios. Finally, we combined these projections with a detailed economic model to estimate incremental costs (from healthcare and partial societal perspectives), disability-adjusted life years (DALYs), and incremental cost-effectiveness ratio (ICER) for each scenario. We project that 1 year of vaccine distribution, at delivery rates consistent with COVAX projections, using an infection-blocking vaccine at $3/dose with 70% efficacy and 2.5-year duration of protection is likely to avert around 0.9 (95% credible interval (CrI): 0.9, 1.0) million cases, 10.1 (95% CrI: 10.1, 10.3) thousand deaths, and 70.1 (95% CrI: 69.9, 70.6) thousand DALYs, with an ICER of $27.9 per DALY averted from the health system perspective. Under a broad range of alternative scenarios, we find that initially prioritising the older (65+) population generally prevents more deaths. However, unprioritised distribution has almost the same cost-effectiveness when considering all outcomes, and both prioritised and unprioritised programmes can be cost-effective for low per-dose costs. High vaccine prices ($10/dose), however, may not be cost-effective, depending on the specifics of vaccine performance, distribution programme, and future pandemic trends. The principal drivers of the health outcomes are the fitted values for the overall transmission scaling parameter and disease natural history parameters from other studies, particularly age-specific probabilities of infection and symptomatic disease, as well as social contact rates. Other parameters are investigated in sensitivity analyses. This study is limited by model approximations, available data, and future uncertainty. Because the model is a single-population compartmental model, detailed impacts of nonpharmaceutical interventions (NPIs) such as household isolation cannot be practically represented or evaluated in combination with vaccine programmes. Similarly, the model cannot consider prioritising groups like healthcare or other essential workers. The model is only fitted to the reported case and death data, which are incomplete and not disaggregated by, e.g., age. Finally, because the future impact and implementation cost of NPIs are uncertain, how these would interact with vaccination remains an open question., Conclusions: COVID-19 vaccination can have a considerable health impact and is likely to be cost-effective if more optimistic vaccine scenarios apply. Preventing severe disease is an important contributor to this impact. However, the advantage of prioritising older, high-risk populations is smaller in generally younger populations. This reduction is especially true in populations with more past transmission, and if the vaccine is likely to further impede transmission rather than just disease. Those conditions are typical of many low- and middle-income countries., Competing Interests: The authors have declared that no competing interests exist.

Background: Stroke is a leading cause of death worldwide, with carotid atherosclerosis accounting for 10-20% of cases. In Brazil, the Public Health System provides care for roughly two-thirds of the population. No studies, however, have analysed large-scale results of carotid bifurcation surgery in Brazil., Methods: This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2019 in the country through web scraping of publicly available databases., Results: Between 2008 and 2019, 37,424 carotid bifurcation revascularization procedures were performed, of which 22,578 were CAS (60.34%) and 14,846 (39.66%) were CEA. There were 620 in-hospital deaths (1.66%), 336 after CAS (1.48%) and 284 after CEA (1.92%) (P = 0.032). Governmental reimbursement was US$ 77,216,298.85 (79.31% of all reimbursement) for CAS procedures and US$ 20,143,009.63 (20.69%) for CEA procedures. The average cost per procedure for CAS (US$ 3,062.98) was higher than that for CEA (US$ 1,430.33) (P = 0.008)., Conclusions: In Brazil, the frequency of CAS largely surpassed that of CEA. In-hospital mortality rates of CAS were significantly lower than those of CEA, although both had mortality rates within the acceptable rates as dictated by literature. The cost of CAS, however, was significantly higher. This is a pioneering analysis of carotid artery disease management in Brazil that provides, for the first time, preliminary insight into the fact that the low adoption of CEA in the country is in opposition to countries where utilization rates are higher for CEA than for CAS., (Copyright © 2021. Published by Elsevier Inc.)

Appropriate use of resources is a tenet of care transformation efforts, with a national campaign to reduce low-value imaging. The next level of performance improvement is to bolster evidence-based screening, imaging surveillance, and diagnostic innovation, which can avert more costly, higher-risk elements of unnecessary care like emergent interventions. Clinical scenarios in which underused advanced imaging can improve outcomes and reduce total cost of care are reviewed, including abdominal aortic aneurysm surveillance, coronary artery disease diagnosis, and renal mass characterization. Reliable abdominal aortic aneurysm surveillance imaging reduces emergency surgery and can be driven by radiologists incorporating best practice standardized recommendations in imaging interpretations. Coronary computed tomography angiography in patients with stable and unstable chest pain can reduce downstream resource use while improving outcomes. Preoperative 99m Tc-sestamibi single-photon emission computed tomography (SPECT) reliably distinguishes oncocytoma from renal cell carcinoma to obviate unnecessary nephrectomy. As technological advances in diagnostic, molecular, and interventional radiology improve our ability to detect and cure disease, analyses of cost effectiveness will be critical to radiology leadership and sustainability in the transition to a value-based reimbursement model., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Study Design: Retrospective review., Objective: Anterior cervical discectomy and fusion (ACDF) is a commonly performed procedure that may be complicated by airway compromise postoperatively. This life-threatening complication may necessitate reintubation and reoperation. We evaluated the cost utility of conventional postoperative x-ray., Summary of Background Data: Studies have demonstrated minimal benefit in obtaining an x-ray on postoperative day 1, but there is some utility of postanesthesia care unit (PACU) x-rays for predicting the likelihood of reoperation., Methods: We retrospectively reviewed the records of consecutive patients who underwent ACDF between September 2013 and February 2017. Patients were dichotomized into those who received PACU x-rays and those who did not (control group). Primary outcomes were reoperation, reintubation, mortality, and health care costs., Results: Eight-hundred and fifteen patients were included in our analysis: 558 had PACU x-rays; 257 did not. In those who received PACU x-rays, mean age was 53.7 ± 11.3 years, mean levels operated on were 2.0 ± 0.79, and mean body mass index (BMI) was 30.3 ± 6.9. In those who did not, mean age was 51.8 ± 10.9 years, mean levels operated on were 1.48 ± 0.65, and mean BMI was 29.9 ± 6.3. Complications in the PACU x-ray group were reintubation-0.4%, reoperation-0.7%, and death-0.3% (due to prevertebral swelling causing airway compromise). Complications in the control group were reintubation-0.4%, reoperation-0.8%, and death-0. There were no differences between groups with respect to reoperation (P = 0.92), reintubation (P = 0.94), or mortality (P = 0.49). The mean per-patient cost was significantly higher (P = 0.009) in those who received PACU x-rays, $1031.76 ± 948.67, versus those in the control group, $700.26 ± 634.48. Mean length of stay was significantly longer in those who had PACU x-rays (P = 0.01)., Conclusion: Although there were no differences in reoperation, reintubation, or mortality, there was a significantly higher cost for care and hospitalization in those who received PACU x-rays. Further studies are warranted to validate the results of the presented study.Level of Evidence: 3., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: Retrospective cohort., Objective: To determine surgery-free survival of patients receiving conservative management of lumbar disc herniation (LDH) in the military healthcare system (MHS) and risk factors for surgical intervention., Summary of Background Data: Radiculopathy from LDH is a major cause of morbidity and cost., Methods: The Military Data Repository was queried for all patients diagnosed with LDH from FY2011-2018; the earliest such diagnosis in a military treatment facility (MTF) was kept for each patient as the initial diagnosis. Follow-up time to surgical intervention was defined as the time from diagnosis to first encounter for lumbar microdiscectomy or lumbar decompression in either a MTF or in the civilian sector. The Military Data Repository was also queried for history of tobacco use at any time during MHS care, age at the time of diagnosis, sex, MHS beneficiary category, and diagnosing facility characteristics. Multivariable Cox proportional hazards models were used to evaluate the associations of patient and diagnosing facility characteristics with time to surgical intervention., Results: A total of 84,985 MHS beneficiaries including 62,771 active duty service members were diagnosed with LDH in a MTF during the 8-year study period. A total of 10,532 (12.4%) MHS beneficiaries, including 7650 (10.9%) active duty, failed conservative management onto surgical intervention with lumbar microdiscectomy or lumbar decompression. Median follow-up time of the cohort was 5.2 (interquartile range 2.6, 7.5) years. Among all healthcare beneficiaries, several patient-level (younger age, male sex, and history of tobacco use) and facility-level characteristics (hospital vs. clinic and surgical care vs. primary care clinic) were independently associated with higher risk of surgical intervention., Conclusion: LDH compromises military readiness and negatively impacts healthcare costs. MHS beneficiaries with LDH have a good prognosis with approximately 88% of patients successfully completing conservative management. However, strategies to improve outcomes of conservative management in LDH should address risks associated with both patient and facility characteristics.Level of Evidence: 4., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Adoption of artificial intelligence (AI) in clinical medicine is revolutionizing daily practice. In the field of colonoscopy, major endoscopy manufacturers have already launched their own AI products on the market with regulatory approval in Europe and Asia. This commercialization is strongly supported by positive evidence that has been recently established through rigorously designed prospective trials and randomized controlled trials. According to some of the trials, AI tools possibly increase the adenoma detection rate by roughly 50% and contribute to a 7-20% reduction of colonoscopy-related costs. Given that reliable evidence is emerging, together with active commercialization, this seems to be a good time for us to review and discuss the current status of AI in colonoscopy from a clinical perspective. In this review, we introduce the advantages and possible drawbacks of AI tools and explore their future potential including the possibility of obtaining reimbursement., (© 2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: Up to 31% of patients with relapsing-remitting multiple sclerosis (RRMS) discontinue treatment with disease-modifying drug (DMD) within the first year, and of the patients who do continue, about 40% are nonadherent. Shared decision making may decrease nonadherence and discontinuation rates, but evidence in the context of RRMS is limited. Shared decision making may, however, come at additional costs. This study aimed to explore the potential cost-effectiveness of shared decision making for RRMS in comparison with usual care, from a (limited) societal perspective over a lifetime., Methods: An exploratory economic evaluation was conducted by adapting a previously developed state transition model that evaluates the cost-effectiveness of a range of DMDs for RRMS in comparison with the best supportive care. Three potential effects of shared decision making were explored: 1) a change in the initial DMD chosen, 2) a decrease in the patient's discontinuation in using the DMD, and 3) an increase in adherence to the DMD. One-way and probabilistic sensitivity analyses of a scenario that combined the 3 effects were conducted., Results: Each effect separately and the 3 effects combined resulted in higher quality-adjusted life years (QALYs) and costs due to the increased utilization of DMD. A decrease in discontinuation of DMDs influenced the incremental cost-effectiveness ratio (ICER) most. The combined scenario resulted in an ICER of €17,875 per QALY gained. The ICER was sensitive to changes in several parameters., Conclusion: This study suggests that shared decision making for DMDs could potentially be cost-effective, especially if shared decision making would help to decrease treatment discontinuation. Our results, however, may depend on the assumed effects on treatment choice, persistence, and adherence, which are actually largely unknown.

Purpose: This study investigates the clinical and cost effectiveness of switching from traditional vagus nerve stimulation (VNS) to responsive VNS (rVNS), which has an additional ictal tachycardia detection and stimulation (AutoStim) mode., Methods: Retrospective chart review was used to collect data from patients with medically refractory epilepsy who underwent generator replacements. Patients with confounding factors such as medication changes were excluded. Vagus nerve stimulation parameters, seizure frequency, and healthcare costs were collected for the 1-year period following generator replacement with the rVNS device., Results: Documented seizure frequency was available for twenty-five patients. After implant with rVNS, 28% of patients had an additional ≥50% seizure reduction. There was a significant decrease in the average monthly seizure count (p = 0.039). In patients who were not already free of disabling seizures (n = 17), 41.2% had ≥50% additional seizure reduction. There was no difference in healthcare costs during the 1-year follow-up after the rVNS implant compared with one year prior., Conclusions: Ictal tachycardia detection and stimulation provided a significant clinical benefit in patients who were not free of disabling seizures with treatment from traditional VNS. There was no additional increase in healthcare costs during the first year after device replacement., Competing Interests: Declaration of competing interest Deepak Madhavan is a consultant for Neuropace and a speaker for Greenwich Pharmaceuticals. The remaining authors have no conflicts of interest. K.G.'s current address is Cleveland Clinic; K. S's current address is Thomas Jefferson University., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Health economic evaluation studies (e.g., cost-effectiveness analysis) can provide insight into which injury prevention interventions maximize available resources to improve health outcomes. A previous systematic review summarized 48 unintentional injury prevention economic evaluations published during 1998-2009, providing a valuable overview of that evidence for researchers and decisionmakers. The aim of this study was to summarize the content and quality of recent (2010-2019) economic evaluations of unintentional injury prevention interventions and compare to the previous publication period (1998-2009)., Methods: Peer-reviewed English-language journal articles describing public health unintentional injury prevention economic evaluations published January 1, 2010 to December 31, 2019 were identified using index terms in multiple databases. Injury causes, interventions, study methods, and results were summarized. Reporting on key methods elements (e.g., economic perspective, time horizon, discounting, currency year, etc.) was assessed. Reporting quality was compared between the recent and previous publication periods., Results: Sixty-eight recent economic evaluation studies were assessed. Consistent with the systematic review on this topic for the previous publication period, falls and motor vehicle traffic injury prevention were the most common study subjects. Just half of studies from the recent publication period reported all key methods elements, although this represents an improvement compared to the previous publication period (25 %)., Conclusion: Most economic evaluations of unintentional injury prevention interventions address just two injury causes. Better adherence to health economic evaluation reporting standards may enhance comparability across studies and increase the likelihood that this type of evidence is included in decision-making related to unintentional injury prevention., (Published by Elsevier Ltd.)

Importance: Genomic screening for hereditary breast and ovarian cancer (HBOC) in unselected women offers an opportunity to prevent cancer morbidity and mortality, but the potential clinical impact and cost-effectiveness of such screening have not been well studied., Objective: To estimate the lifetime incremental incidence of HBOC and the quality-adjusted life-years (QALYs), costs, and cost-effectiveness of HBOC genomic screening in an unselected population vs family history-based testing., Design, Setting, and Participants: In this study conducted from October 27, 2017, to May 3, 2020, a decision analytic Markov model was developed that included health states for precancer, for risk-reducing mastectomy (RRM) and risk-reducing salpingo-oophorectomy (RRSO), for earlier- and later-stage HBOC, after cancer, and for death. A complimentary cascade testing module was also developed to estimate outcomes in first-degree relatives. Age-specific RRM and RRSO uptake probabilities were estimated from the Geisinger MyCode Community Health Initiative and published sources. Parameters including RRM and RRSO effectiveness, variant-specific cancer risk, costs, and utilities were derived from published sources. Sensitivity and scenario analyses were conducted to evaluate model assumptions and uncertainty., Main Outcomes and Measures: Lifetime cancer incidence, QALYs, life-years, and direct medical costs for genomic screening in an unselected population vs family history-based testing only were calculated. The incremental cost-effectiveness ratio (ICER) was calculated as the difference in cost between strategies divided by the difference in QALYs between strategies. Earlier-stage and later-stage cancer cases prevented and total cancer cases prevented were also calculated., Results: The model found that population screening of 30-year-old women was associated with 75 (95% credible range [CR], 60-90) fewer overall cancer cases and 288 QALYs (95% CR, 212-373 QALYs) gained per 100 000 women screened, at an incremental cost of $25 million (95% CR, $21 millon to $30 million) vs family history-based testing; the ICER was $87 700 (78% probability of being cost-effective at a threshold of $100 000 per QALY). In contrast, population screening of 45-year-old women was associated with 24 (95% CR, 18-29) fewer cancer cases and 97 QALYs (95% CR, 66-130 QALYs) gained per 100 000 women screened, at an incremental cost of $26 million (95% CR, $22 million to $30 million); the ICER was $268 200 (0% probability of being cost-effective at a threshold of $100 000 per QALY). A scenario analysis without cascade testing increased the ICER to $92 600 for 30-year-old women and $354 500 for 45-year-old women. A scenario analysis assuming a 5% absolute decrease in mammography screening in women without a variant was associated with the potential for net harm (-90 QALYs per 100 000 women screened; 95% CR, -180 to 10 QALYs)., Conclusions and Relevance: The results of this study suggest that population HBOC screening may be cost-effective among younger women but not among older women. Cascade testing of first-degree relatives added a modest improvement in clinical and economic value. The potential for harm conferred by inappropriate reduction in mammography among noncarriers should be quantified.

Implementation science (IS) has developed as a field to assess effective ways to implement and disseminate evidence-based practices. Although the size and rigor of the field has improved, the economic evaluation of implementation strategies has lagged behind other areas of IS (Roberts, Healey, & Sevdalis, 2019). Beyond demonstrating the effectiveness of implementation strategies, there needs to be evidence that investments in these strategies are efficient or financially sustainable. In this editorial, we lay out conceptual challenges in applying economic evaluation to IS and the implications for conducting economic analyses in integrated primary care research. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Objective: Endoscopic full-thickness resection (EFTR) has shown efficacy and safety in the colorectum. The aim of this analysis was to investigate whether EFTR is cost-effective in comparison with surgical and endoscopic treatment alternatives., Design: Real data from the study cohort of the prospective, single-arm WALL RESECT study were used. A simulated comparison arm was created based on a survey that included suggested treatment alternatives to EFTR of the respective lesions. Treatment costs and reimbursement were calculated in euro according to the coding rules of 2017 and 2019 (EFTR). R0 resection rate was used as a measure of effectiveness. To assess cost-effectiveness, the average cost-effectiveness ratio (ACER) and the incremental cost-effectiveness ratio (ICER) were determined. Calculations were made both from the perspective of the care provider as well as of the payer., Results: The cost per case was €2852.20 for the EFTR group, €1712 for the standard endoscopic resection (SER) group, €8895 for the surgical resection group and €5828 for the pooled alternative treatment to EFTR. From the perspective of the care provider, the ACER (mean cost per R0 resection) was €3708.98 for EFTR, €3115.10 for SER, €8924.05 for surgical treatment and €7169.30 for all pooled and weighted alternatives to EFTR. The ICER (additional cost per R0 resection compared with EFTR) was €5196.47 for SER, €26 533.13 for surgical resection and €67 768.62 for the pooled rate of alternatives. Results from the perspective of the payer were similar., Conclusion: EFTR is cost-effective in comparison with surgical and endoscopic treatment alternatives in the colorectum., Competing Interests: Competing interests: AS and KC received lecture fees and study grants from Ovesco Endoscopy, Tübingen, Germany. AK, JB, TB, BS, AM, HM, HN, DA, MB, AP, MF, TF, MG and RT have no conflicts of interest or financial ties to disclose., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background . Threshold analysis is used to determine the threshold value of an input parameter at which a health care strategy becomes cost-effective. Typically, it is performed in a deterministic manner, in which inputs are varied one at a time while the remaining inputs are each fixed at their mean value. This approach will result in incorrect threshold values if the cost-effectiveness model is nonlinear or if inputs are correlated. Objective . To propose a probabilistic method for performing threshold analysis, which accounts for the joint uncertainty in all input parameters and makes no assumption about the linearity of the cost-effectiveness model. Methods . Three methods are compared: 1) deterministic threshold analysis (DTA); 2) a 2-level Monte Carlo approach, which is considered the gold standard; and 3) a regression-based method using a generalized additive model (GAM), which identifies threshold values directly from a probabilistic sensitivity analysis sample. Results . We applied the 3 methods to estimate the minimum probability of hospitalization for typhoid fever at which 3 different vaccination strategies become cost-effective in Uganda. The threshold probability of hospitalization at which routine vaccination at 9 months with catchup campaign to 5 years becomes cost-effective is estimated to be 0.060 and 0.061 (95% confidence interval [CI], 0.058-0.064), respectively, for 2-level and GAM. According to DTA, routine vaccination at 9 months with catchup campaign to 5 years would never become cost-effective. The threshold probability at which routine vaccination at 9 months with catchup campaign to 15 years becomes cost-effective is estimated to be 0.092 (DTA), 0.074 (2-level), and 0.072 (95% CI, 0.069-0.075) (GAM). GAM is 430 times faster than the 2-level approach. Conclusions . When the cost-effectiveness model is nonlinear, GAM provides similar threshold values to the 2-level Monte Carlo approach and is computationally more efficient. DTA provides incorrect results and should not be used.

Background . Intensive multidisciplinary intervention (IMI) represents a well-established treatment for pediatric feeding disorders (PFDs), but program availability represents an access care barrier. We develop an economic analysis of IMI for weaning from gastronomy tube (G-tube) treatment for children diagnosed with PFDs from the Medicaid programs' perspective, where Medicaid programs refer to both fee-for-service and managed care programs. Methods . The 2010-2012 Medicaid Analytic eXtract claims provided health care data for children aged 13 to 72 months. An IMI program provided data on average admission costs. We employed a finite-horizon Markov model to simulate PFD treatment progression assuming 2 treatment arms: G-tube only v. IMI targeting G-tube weaning. We compared the expenditure differential between the 2 arms under varying time horizons and treatment effectiveness. Results . Overall Medicaid expenditure per member per month was $6814, $2846, and $1550 for the study population of children with PFDs and G-tube treatment, the control population with PFDs without G-tube treatment, and the no-PFD control population, respectively. The PFD-diagnosed children with G-tube treatment only had the highest overall expenditures across all health care settings except psychological services. The expenditure at the end of the 8-year time horizon was $405,525 and $208,218 per child for the G-tube treatment only and IMI arms, respectively. Median Medicaid expenditure was between 1.7 and 2.2 times higher for the G-tube treatment arm than for the IMI treatment arm. Limitations . Data quality issues could cause overestimates or underestimates of Medicaid expenditure. Conclusions . This study demonstrated the economic benefits of IMI to treat complex PFDs from the perspective of Medicaid programs, indicating this model of care not only holds benefit in terms of improving overall quality of life but also brings significant expenditure savings in the short and long term.

Background: Cost-effectiveness evaluations for hepatitis C virus (HCV) treatments have been published frequently, but new products with significant cost and effectiveness differences make these analyses obsolete. How valuable are economic models for a fixed time period in a dynamic market?, Objective: To estimate the cost-effectiveness of the best available HCV treatment at different points in time, using the same comparator to demonstrate how rapid innovation in a disease area influences economic outcomes., Methods: A Markov model was used to calculate the cost-effectiveness of treatment in 2010, 2012, 2014, 2016, and 2018 compared with a standard comparator (no treatment) from the payer perspective. Expected drug costs and treatment effectiveness estimates for sustained virologic response (SVR) were calculated using recommended regimens for each of the 6 HCV genotypes at each time point and distribution of genotypes in the United States. Patients entered the model with different stages of fibrosis. Utility estimates for each health state were used to calculate quality-adjusted life-years (QALYs) earned at each cycle. Incremental cost-effectiveness ratios were reported for each year to compare the "treatment versus no treatment" decision at that time., Results: No HCV treatment resulted in a gain of 11.54 QALYs over a 20-year time horizon at a cost of $42,938. Costs for treated groups were $69,075, $123,267, $125,431, $86,782, and $56,470 for the 2010, 2012, 2014, 2016, and 2018 scenarios, respectively. QALYs gained for treated groups were 12.90, 12.97, 13.34, 13.39, and 13.46 for the 2010, 2012, 2014, 2016, and 2018 scenarios, respectively. The incremental cost-effectiveness ratios in each year compared with no treatment were $19,218 per QALY, $56,104 per QALY, $45,829 per QALY, $23,699 per QALY, and $7,048 per QALY., Conclusions: Treatment effectiveness for HCV has increased steadily, while treatment costs increased substantially from 2010-2014 before decreasing to its lowest point in 2018. Thus, the dynamic nature of innovation creates the need for iterative cost-effectiveness analyses., Disclosures: No outside funding supported this study. Mattingly reports unrelated consulting from the National Health Council, Bristol Myers Squibb, G&W Laboratories, Allergy and Asthma Foundation of American, and the Massachusetts Health Policy Commission. Love reports an unrelated research grant from the American Cancer Society.

Despite the achieved advancement in pharmacological cancer treatments, the majority of postmenopausal women with hormone receptor-positive metastatic breast cancer (mBC) will experience disease progression. Research into alternative therapies with improved efficacy and reduced side effects has led to the development of a new class of oral anticancer medications, the cyclin-dependent kinase (CDK) 4/6 inhibitors, which include palbociclib, ribociclib, and abemaciclib. Nonetheless, there is growing evidence that the effectiveness of oral anticancer medications is sub-optimal, being influenced by low adherence, sociodemographic factors, and adverse effect profiles. In addition, there is a disconnect between the high price tags of CDK 4/6 inhibitors and their observed effectiveness, raising questions about their value. Currently, the existing knowledge base on the effectiveness and cost-effectiveness of newer oral anticancer medications in understudied populations with possible health disparities is scant. This commentary discusses what is known about palbociclib's clinical effectiveness, safety, and adherence and suggests the need for further studies of real-world effectiveness and cost-effectiveness to help establish the value of newer oncologic drugs, such as palbociclib. DISCLOSURES: No funding supported the writing of this article. The authors have nothing to disclose.

This narrative review describes implementation, current status and perspectives of a pharmacogenomic (PGx) program at the Brazilian National Cancer Institute (INCA), targeting the cancer chemotherapeutic drugs - fluoropyrimidines, irinotecan and thiopurines. This initiative, designed as a research project, was supported by a grant from the Brazilian Ministry of Health. A dedicated task force developed standard operational procedures from recruitment of patients to creating PGx reports with dosing recommendations, which were successfully applied to test 100 gastrointestinal cancer INCA outpatients and 162 acute lymphoblastic leukemia pediatric patients from INCA and seven other hospitals. The program has been subsequently expanded to include gastrointestinal cancer patients from three additional cancer treatment centers. We anticipate implementation of routine pre-emptive PGx testing at INCA but acknowledge challenges associated with this transition, such as continuous financing support, availability of trained personnel, adoption of the PGx-informed prescription by the clinical staff and, ultimately, evidence of cost-effectiveness.

Introduction: There is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery., Primary Objectives: To compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis., Secondary Objectives: To compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost-utility analysis., Methods and Analysis: We will perform a systematic review of literature by updating the searches from MEDLINE, Embase, Cochrane library, Science Citation Index as well as trial registers. Two members of our team will independently screen the search results and identify randomised controlled trials comparing CRS+HIPEC versus SoC for inclusion based on full texts for articles shortlisted during screening. We will assess the risk of bias in the trials and obtain data related to baseline prognostic characteristics, details of intervention and control, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications and resource utilisation data. Using IPD, we will perform a two-step IPD, that is, calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses, meta-regression and sensitivity analyses. We will also perform a model-based cost-utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting., Ethics and Dissemination: This project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001). We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal., Prospero Registration Number: CRD42019130504., Competing Interests: Competing interests: The clinical practice of the clinicians in the project: TM, MM, MS, OA and SO may be altered by the findings of the review., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Background: Implementation of food taxes or subsidies may promote healthier and a more sustainable diet in a society. This study estimates the effects of a tax (15% or 30%) on meat and a subsidy (10%) on fruit and vegetables (F&V) consumption in the Netherlands using a social cost-benefit analysis with a 30-year time horizon., Methods: Calculations with the representative Dutch National Food Consumption Survey (2012-2014) served as the reference. Price elasticities were applied to calculate changes in consumption and consumer surplus. Future food consumption and health effects were estimated using the DYNAMO-HIA model and environmental impacts were estimated using Life Cycle Analysis. The time horizon of all calculations is 30 year. All effects were monetarized and discounted to 2018 euros., Results: Over 30-years, a 15% or 30% meat tax or 10% F&V subsidy could result in reduced healthcare costs, increased quality of life, and higher productivity levels. Benefits to the environment of a meat tax are an estimated €3400 million or €6300 million in the 15% or 30% scenario respectively, whereas the increased F&V consumption could result in €100 million costs for the environment. While consumers benefit from a subsidy, a consumer surplus of €10,000 million, the tax scenarios demonstrate large experienced costs of respectively €21,000 and €41,000 million. Overall, a 15% or 30% price increase in meat could lead to a net benefit for society between €3100-7400 million or €4100-12,300 million over 30 years respectively. A 10% F&V subsidy could lead to a net benefit to society of €1800-3300 million. Sensitivity analyses did not change the main findings., Conclusions: The studied meat taxes and F&V subsidy showed net total welfare benefits for the Dutch society over a 30-year time horizon.

Well-established methods of economic evaluation are used in many countries to inform decisions about the funding of new medical interventions. To guide such decisions, it is important to consider what health gains would be expected from the same level of investment elsewhere in the health care system. Recent research in the United Kingdom has evaluated the evidence available and the methods required to estimate the health effects of changes in health care expenditure within the National Health Service. Because of the absence of sufficiently broad-ranging data, assumptions were required in the previously mentioned work to estimate health effects in terms of a broader measure of health (quality-adjusted life-years), which is more relevant for policy. These assumptions constitute important sources of uncertainty. This work presents an application of the structured elicitation of the judgments of key individuals about these uncertain quantities. This article describes the design and conduct of the exercise, including the quantities elicited, the individual (rather than consensus) approach used, how uncertainty in knowledge was elicited (mode and bounds of an 80% credible interval), and methods to generate group estimates. It also reports on a successful application involving 28 clinical experts and 25 individuals with policy responsibilities. Although, as expected, most experts found replying to the questions challenging, they were able to express their beliefs quantitatively. Consistent across the uncertainties elicited, experts' judgments suggest that the quality-adjusted life-year (QALY) impacts of changes in expenditure from earlier work using assumptions are likely to have been underestimated and the "central" estimate of health opportunity cost from that work (£12,936 per QALY) to have been overestimated.

Objectives: The cost-effectiveness of screening adult patients for pulmonary tuberculosis is not clear. As such, this study aims to identify the cost-effectiveness between the Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear. Multi-outcomes were correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs)., Methods: A decision tree model was constructed to reveal a possible clinical pathway of tuberculosis diagnosis. The researchers used a clinical study to establish the probability of all clinical pathways for input into this model. The sample size was calculated following the correct diagnosis. Participants were randomly divided into 2 groups. A structural questionnaire and the Thai version of quality of life (EQ-5D-5L) were used for interviewing., Results: The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear. Both the correct diagnosis and QALYs of the base case analysis presented the Xpert MTB/RIF method as dominant. A Monte Carlo model, which analyzed the Xpert MTB/RIF method, revealed that the average number of patients who were correctly diagnosed was 673, the QALYs were 945.85 years, and the total cost was $143 110.64. For the sputum AFB smear method, the average number who received a correct diagnosis was 592, the QALYs were 940.40 years, and the total cost was $196 666.84. Probabilistic and one-way sensitivity analysis confirmed that the Xpert MTB/RIF remained dominant., Conclusions: These results provide useful information for the National Strategic Plan to screen all adult patients for pulmonary tuberculosis., (Copyright © 2020 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)

Background: Patients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life., Aims: We piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings., Methods: Scottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque., Results: We screened 1548/2613 (59%) admissions to four wards, recruiting n  = 325 patients and n  = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare ( P  = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42)., Conclusions: Our stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect., Trial Registration: NCT01954212.

Objective: For minority students from socioeconomically disadvantaged backgrounds, attending university and succeeding despite social and academic stressors is often considered the ultimate marker of resilience. However, a growing body of work suggests that there may be health costs to upward mobility for such students. This study investigated whether believing that the social system is fair simultaneously promotes psychological health while undermining the physical health of Latinx students experiencing frequent discrimination., Method: Two hundred thirty-three low-income and/or first-generation Latinx college students were followed through their first year at university. Discrimination experiences, psychological health, and physical health risk (a suite of inflammatory, biomorphic, and cardiovascular risk markers) were assessed upon entering university and at the end of the academic year., Results: Regardless of discrimination experiences, believing in system fairness predicted higher end-of-year psychological health (controlling for initial psychological health). However, for students who experienced substantial discrimination at university, believing in system fairness also led to higher end-of-year physical health risk (controlling for baseline levels of discrimination and physical health risk)., Conclusions: Beliefs that allow socioeconomically disadvantaged minority students to thrive psychologically may also put them at physical health risk when facing frequent discrimination. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

Background: In-hospital left ventricular (LV) thrombus following acute ST-elevation myocardial infarction (STEMI) has not been evaluated on a national scale and was the focus of this investigation., Methods: We used the 2003 to 2013 Nationwide Inpatient Sample database to identify adults ≥18 years old with a principal diagnosis code of ST-elevation myocardial infarction. Patients were divided into two groups defined by the presence or absence of LV thrombus. Clinical characteristics and in-hospital outcomes were studied using relevant statistics. Multiple linear and logistic regression models were conducted to identify factors associated with LV thrombus., Results: Of 1,035,888 STEMI patients hospitalized in the U. S from 2003 to 2013, 1982 (0.2%) developed acute in-hospital LV thrombus. Compared to no LV thrombus, patients with LV thrombus were more likely to have in-hospital complications; acute ischemic and hemorrhagic stroke, acute renal failure, gastrointestinal bleed, cardiogenic shock, in-hospital cardiac arrest and mortality. They also had longer mean length of stay and higher hospital charges. Factors associated with LV thrombus included: anterior/anterolateral STEMI, acute or chronic heart failure with reduced ejection fraction, atrial fibrillation, LV aneurysm, Left heart valvular disease, acute or chronic deep venous thrombosis/pulmonary embolism and alcohol abuse. Patients with LV thrombus were less likely to be female [AOR 0.66, 95% CI (0.51-0.84)]., Conclusion: The identification of factors associated with early development of LV thrombus following STEMI, will help direct resources for specific high-risk group and prompt cost-effective therapies. Gender variability in LV thrombus development warrants further investigations., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Lay health workers have been utilized to deliver health promotion programmes in a variety of settings. However, few studies have sought to determine whether these programmes represent value for money, particularly in a UK context. The present study involved an economic evaluation of Wellbeing for Life, an integrated health and wellbeing service in northern England. The service combined one-to-one interventions delivered by lay health workers (known as health trainers), group wellbeing interventions, volunteering opportunities and other community development activities. Value for money was assessed using an established economic model developed with input from a panel of commissioners and providers, and the main data source was the national health trainer data collection and reporting system. Between June 2015 and January 2017, behaviour change outcomes (i.e. whether client goals in relation to diet, physical activity, smoking or other behaviours, had been achieved) were recorded for 2433 of the 3179 individuals who accessed one-to-one interventions. The level of achievement observed gave an estimated total health gain of 287.7 quality-adjusted life years (QALYs). In addition, there were 4669 health-promoting events, five asset mapping projects and 1595 occurrences of signposting to other services. Combining the value of individual behaviour change with the value of these additional activities gave an overall net cost per QALY gained of £3900 and a total estimated societal value of at least £3.45 for every £1 spent on the service. These results suggest that the Wellbeing for Life service offered good value for money. Further research is needed to systematically and comprehensively determine the societal value of similar holistic, asset-based and lay-led approaches., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Endovascular treatment of basilar tip aneurysms is less invasive than microsurgical clipping, but requires closer follow-up., Objective: To characterize the additional costs associated with endovascular treatment of basilar tip aneurysms rather than microsurgical clipping., Materials and Methods: We obtained clinical records and billing information for 141 basilar tip aneurysms treated with clip ligation (n=48) or endovascular embolization (n=93). Costs included direct and indirect costs associated with index hospitalization, as well as re-treatments, follow-up visits, imaging studies, rehabilitation, and disability. Effectiveness of treatment was quantified by converting functional outcomes (modified Rankin Scale (mRS) score) into quality-adjusted life-years (QALYs). Cost-effectiveness was performed using cost/QALY ratios., Results: Average index hospitalization costs were significantly higher for patients with unruptured aneurysms treated with clip ligation ($71 400 ± $47 100) compared with coil embolization ($33 500 ± $22 600), balloon-assisted coiling ($26 200 ± $11 600), and stent-assisted coiling ($38 500 ± $20 900). Multivariate predictors for higher index hospitalization cost included vasospasm requiring endovascular intervention, placement of a ventriculoperitoneal shunt, longer length of stay, larger aneurysm neck and width, higher Hunt-Hess grade, and treatment-associated complications. At 1 year, endovascular treatment was associated with lower cost/QALY than clip ligation in unruptured aneurysms ($52 000/QALY vs $137 000/QALY, respectively, p=0.006), but comparable rates in ruptured aneurysms ($193 000/QALY vs $233 000/QALY, p=0.277). Multivariate predictors for higher cost/QALY included worse mRS score at discharge, procedural complications, and larger aneurysm width., Conclusions: Coil embolization of basilar tip aneurysms is associated with a lower cost/QALY. This effect is sustained during follow-up. Clinical condition at discharge is the most significant predictor of overall cost/QALY at 1 year., Competing Interests: Competing interests: BG: Viket Medical, Inc (equity interest), ML: National Institute of Neurological Disorders and Stroke, National Institutes of Health (grant), American Heart Association (grant), Stryker, Inc (unrestricted educational grant), Covidien (unrestricted educational grant), Medtronic (consulting), Minnetronix (consulting), Proprio (equity interest). LJK: National Institute of Neurological Disorders and Stroke, National Institutes of Health (grant), Microvention, Inc (consulting), Spi Surgical, Inc (equity interest). LNS: Spi Surgical, Inc (shareholder), Viket Medical, Inc (shareholder)., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Anterior cervical discectomy with fusion (ACDF) or posterior cervical foraminotomy (PCF) are the mainstay surgical treatment options for patients with degenerative cervical radiculopathy (DCR)., Objective: To compare 90-d bundled payments between ACDF and PCF for DCR in a cohort study., Methods: Data were extracted from MarketScan database (2000-2016) using ICD-9, ICD-10, and CPT-4 codes. The bundle payments were calculated as the payments accumulated from the index hospitalization admission to 90 d postsurgery. We also analyzed the index hospitalization (physician, hospital, and total) and the postdischarge payments (hospital readmission, outpatient services, medications, and total). Surgical groups were matched based on baseline characteristics (age, sex, insurance type, and Elixhauser score)., Results: A total of 100 041 patients met the inclusion criteria. 94.9% of patients (n = 95 031). Patients underwent ACDF with 5.1% (n = 5 010) treated via PCF. Overall, median 90-d costs were significantly higher for ACDF than for PCF ($31567 vs $18412; P < .0001). The median total index hospitalization ($27841 vs $15043), physician ($4572 vs $1920), and hospital payments ($14540 vs $7404) were higher for ACDF compared to PCF for both single- and multiple-level cohorts (P < .0001). There was no difference in overall 90-d postdischarge payments. Factors associated with higher 90-d payments for both cohorts included age and comorbidity scores., Conclusion: ACDF is associated with greater bundle payments in patients diagnosed with DCR. No difference was noted for the total postdischarge payments. PCF may be a cost-effective surgical option in appropriately selected patients with unilateral, paracentral, and foraminal soft herniated discs., (Copyright © 2019 by the Congress of Neurological Surgeons.)

In this series we address research topics in emergency medicine. While traditionally there was an almost exclusive focus on the efficacy and effectiveness of interventions in emergency research, analysis of the costs and the societal impact of different approaches and pathways have become increasingly important. In this paper we will address what health economics means and discuss the different types and key features of economic evaluation relevant for clinical researchers., (© 2019 Australasian College for Emergency Medicine.)

Study Design: Economic modelling analysis., Objectives: To determine lifetime direct and indirect costs from initial hospitalisation of all expected new traumatic and non-traumatic spinal cord injuries (SCI) over 12 months., Setting: United Kingdom (UK)., Methods: Incidence-based approach to assessing costs from a societal perspective, including immediate and ongoing health, rehabilitation and long-term care directly attributable to SCI, as well as aids and adaptations, unpaid informal care and participation in employment. The model accounts for differences in injury severity, gender, age at onset and life expectancy., Results: Lifetime costs for an expected 1270 new cases of SCI per annum conservatively estimated as £1.43 billion (2016 prices). This equates to a mean £1.12 million (median £0.72 million) per SCI case, ranging from £0.47 million (median £0.40 million) for an AIS grade D injury to £1.87 million (median £1.95 million) for tetraplegia AIS A-C grade injuries. Seventy-one percent of lifetime costs potentially are paid by the public purse with remaining costs due to reduced employment and carer time., Conclusions: Despite the magnitude of costs, and being comparable with international estimates, this first analysis of SCI costs in the UK is likely to be conservative. Findings are particularly sensitive to the level and costs of long-term home and residential care. The analysis demonstrates how modelling can be used to highlight economic impacts of SCI rapidly to policymakers, illustrate how changes in future patterns of injury influence costs and help inform future economic evaluations of actions to prevent and/or reduce the impact of SCIs.

Background: Given the complexity of providing dementia care in hospitals, integrating technology into practice is a high challenge and an important opportunity. Although there are a growing demand and interest in using social robots in a variety of care settings to support dementia care, little is known about the impacts of the robotics and their application in care settings, i.e., what worked, in which situations, and how., Methods: Scientific databases and Google Scholar were searched to identify publications published since 2000. The inclusion criteria consisted of older people with dementia, care setting, and social robot PARO., Results: A total of 29 papers were included in the review. Content analysis identified 3 key benefits of and 3 barriers to the use of PARO. Main benefits include: reducing negative emotion and behavioral symptoms, improving social engagement, and promoting positive mood and quality of care experience. Key barriers are: cost and workload, infection concerns, and stigma and ethical issues. This review reveals 3 research gaps: (a) the users' needs and experiences remain unexplored, (b) few studies investigate the process of how to use the robot effectively to meet clinical needs, and (c) theory should be used to guide implementation., Conclusions: Most interventions conducted have been primarily researcher-focused. Future research should pay more attention to the clinical needs of the patient population and develop strategies to overcome barriers to the adoption of PARO in order to maximize patient benefits.

Competing Interests: Competing interests: Peter Neumann received no funding for the submitted work. He has received research grants from Amgen, Lundbeck, the Bill & Melinda Gates Foundation, NPC, the Alzheimer’s Association, National Institutes of Health and the Pharmaceutical Research and Manufacturers of America for activities outside of the submitted work. He has also received financial support from AveXis as a member of the Forum for Gene Therapy Health Economics Group for research into the evaluation of gene therapies; one-time compensation as a member of the advisory boards of Bayer, Novo Nordisk, Amgen, Veritech, Sage, Sarepta Therapeutics, Biogen, Merck, DePuy Synthes, GlaxoSmithKline, Otsuka Pharmaceutical, ICON and Indivior; consultant fees from Vertex, Precision Health Economics, GlaxoSmith-Kline and Research Triangle Institute; and lecture or speaker fees from Celgene, Roche and Research Triangle Institute. No other competing interests were declared.

Objectives : Two studies in the early 1990s demonstrated that life narrative interviews conducted by age-peer volunteers strengthened the coping of older patients undergoing invasive medical procedures. The present article reports on the implementation of a similar life narrative interview program for medical inpatients and subsequent evaluation of the mood and coping effects of the intervention. Methods : Three volunteers (mean age = 69 years) were trained to administer 45- to 60-minute life narrative interviews. Fifty-three inpatients (mean age = 70 years) on various units of a Mid-Atlantic non-profit hospital agreed to participate. The Positive and Negative Affect Schedule and Coping Self-Efficacy Inventory (CSEI) were administered before and after the interviews. Results : T -tests indicated a significant increase in positive affect and decrease in negative affect following the interview but no changes in the CSEI. Patient satisfaction questions administered after the interview indicated that patients had a high level of satisfaction with the interview experience. Conclusions : The life narrative interview program appeared to improve the overall mood of participants while providing a satisfying activity to engage in while in the hospital. Clinical Implications : The project demonstrated a cost-effective method for employing volunteers to enhance the experience of patients at healthcare facilities.

The rising epidemic of non-communicable diseases (NCDs) poses substantial health and economic challenges to both individuals and society. Application of incentive-based strategies based on traditional and behavioural economic theory has emerged as a potential strategy to address rising rates of NCDs. Yet, whether or not incentives truly represent a promising strategy for addressing NCDs has not been systematically addressed nor is it clear whether certain behavioural economic strategies outperform others or simply offering a cash-based incentive for meeting a goal. In this systematic review we aim to determine whether there is an evidence base for any of these strategies. Forty-eight published randomized controlled trials (70 contrasts) evaluating the effectiveness of incentive-based strategies for improvements in NCD risk-factors were reviewed. Our primary conclusion is that there is a lack of compelling evidence that incentives of any form represent a compelling NCD reduction strategy. More evidence for long-term effectiveness and cost-effectiveness is needed to justify third party funding of any incentive based strategy., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Maintenance dialysis is a costly and resource intense activity. In Australia, inadequate health infrastructure and poor access to technically skilled staff can limit service provision in remote areas where many Aboriginal dialysis patients live. With most studies based on urban service provision, there is little evidence to guide service development. However permanent relocation to an urban area for treatment can have significant social and financial impacts that are poorly quantified. This study is part of a broader project to quantify the costs and benefits of dialysis service models in urban and remote locations in Australia's Northern Territory (NT)., Methods: We undertook a micro-costing analysis of dialysis service delivery costs in urban, rural and remote areas in the NT from the payer perspective. Recurrent maintenance costs (salaries, consumables, facility management and transportation) as well as capital costs were included. Missing and centralised costs were standardised; results were inflated to 2017 values and reported in Australian dollars., Results: There was little difference between the average annual cost for urban and rural services with respective median costs of $85,919 versus $84,629. However remote service costs were higher ($120,172 - $124,492), driven by higher staff costs. The inclusion of capital costs did not add substantially to annual costs. Annual home haemodialysis costs ($42,927) were similar to other jurisdictions despite the significant differences in program delivery and payment of expenses not traditionally borne by governments. Annual peritoneal dialysis costs ($58,489) were both higher than home and in-centre haemodialysis by recent national dialysis cost studies., Conclusion: The cost drivers for staffed services were staffing models and patient attendance rates. Staff salaries and transport costs were significantly higher in remote models of care. Opportunities to reduce expenditure exist by encouraging community supported services and employing local staff. Despite the delivery challenges of home haemodialysis including high patient attrition, the program still provides a cost benefit compared to urban staffed services. The next component of this study will examine patient health service utilisation and costs by model of care to provide a more comprehensive analysis of the overall cost of providing services in each location.

Objectives: To describe how post-market utilisation analysis in Australia informs cost-effectiveness assessment and pricing decisions, using aflibercept and ranibizumab as case studies., Methods: Pharmaceutical claims were used to identify initiators of aflibercept and ranibizumab in the year after aflibercept-listing (December 2012), and ranibizumab initiators in the year before aflibercept listing. The dispensing rates for each cohort were calculated, and their demographic and clinical characteristics compared using Kruskal-Wallis tests., Results: Aflibercept and ranibizumab each accounted for half the age-related macular degeneration market following aflibercept listing. Aflibercept initiators had similar dispensing rates to ranibizumab initiators in the pre- and post-aflibercept era (~ three scripts during the first 90 days, and eight to nine scripts during the following 12 months). All cohorts were similar in terms of their age, sex, residential aged-care status and geographic remoteness, and no differences were observed in their overall co-morbidity scores and history of thromboembolic events., Conclusions: Contrary to clinical trial protocols, post-market utilisation research for ranibizumab and aflibercept demonstrates equivalent use in practice in terms of dose frequency, and the demographic and clinical characteristics of initiators. This supports Australia's decision to pay the same price for each rather than giving a premium to aflibercept. Many other countries are likely overpaying for aflibercept if their utilization patterns are similar to Australia's, and could benefit from incorporating routine utilisation assessment.

Evaluating different approaches to assessing the clinical effectiveness and value of potential cures will be essential to arm the policymaker, payer, and manufacturer communities with a platform that can reward innovation while supporting a sustainable health insurance system. Potential cures will accentuate concerns about substantial uncertainty in long-term outcomes. They will also focus attention on whether broader elements of value need to be incorporated and whether specific social values have a special place in evaluations of potential cures. In addition, the large magnitudes of potential health gain and cost offsets may require new methods before translation into value-based price recommendations. This article analyzes the challenges and presents several options to modify the conduct and presentation of cost-effectiveness analyses to ensure they provide policy-relevant assessments of the value of potential cures., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objective: The West African Disaster Preparedness Initiative held a disaster preparedness tabletop exercise with representatives from the Economic Community of West African States (ECOWAS) in November 2015. The tabletop exercise was hosted by the Republic of Ghana's National Disaster Management Organization and partners in Accra, Ghana., Methods: ECOWAS Commission delegates and representatives from 10 member states were confronted with a series of simulated crises. Participants utilized existing national preparedness plans and web-based information technologies to research and communicate about internal disaster threats and those from neighboring countries. After each of the exercise's three phases, facilitators distributed participant surveys., Results: A total of 106 individuals participated in the tabletop exercise. During the exercise, national teams utilizing well-developed disaster contingency plans and emergency operations center (EOC) standard operating procedures (SOPs) reached out to help less-prepared national teams. Key issues identified in the survey were language and cultural issues as barriers, effectiveness of disaster management agencies linked to heads of state, and the need for data sharing and real-time communication for situational awareness and multisector coordination., Conclusion: This tabletop exercise helped improve and refine the ECOWAS regional and member states' national SOPs that teams will employ to prepare for, respond to, and recover from future disasters. (Disaster Med Public Health Preparedness. 2019;13:400-404).

Introduction: Daily phlebotomy is often a standard procedure in hospitalized patients. Recently, this practice has begun receiving attention as a potential target for efforts focused on eliminating overuse. Several organizations have published their efforts in this arena. Interventions have included education, feedback, and changes to computerized provider order entry (CPOE) but have yielded mixed results., Methods: A quality improvement initiative to reduce the utilization of daily phlebotomy was conducted at a 505-bed Academic Medical Center. This project involved a combination of educational interventions and changes to CPOE. The primary end point evaluated was the daily performance of complete blood counts (CBCs) and basic metabolic profiles (BMPs) on medical and surgery units relative to the corresponding hospital census., Results: Over the course of this project from August 1, 2013, to September 23, 2016, there was a 15.2% reduction in CBCs (p < .001 for linear trend) and 13.1% reduction in BMPs., Discussion: Our results suggest that layering multimodal interventions that involve both "hard-wired" changes to CPOE and education and performance feedback can result in decreased utilization of phlebotomy.

Background: Economic incentives through health insurance may promote healthier behaviors. Little is known about health and economic impacts of incentivizing diet, a leading risk factor for diabetes and cardiovascular disease (CVD), through Medicare and Medicaid., Methods and Findings: A validated microsimulation model (CVD-PREDICT) estimated CVD and diabetes cases prevented, quality-adjusted life years (QALYs), health-related costs (formal healthcare, informal healthcare, and lost-productivity costs), and incremental cost-effectiveness ratios (ICERs) of two policy scenarios for adults within Medicare and Medicaid, compared to a base case of no new intervention: (1) 30% subsidy on fruits and vegetables ("F&V incentive") and (2) 30% subsidy on broader healthful foods including F&V, whole grains, nuts/seeds, seafood, and plant oils ("healthy food incentive"). Inputs included national demographic and dietary data from the National Health and Nutrition Examination Survey (NHANES) 2009-2014, policy effects and diet-disease effects from meta-analyses, and policy and health-related costs from established sources. Overall, 82 million adults (35-80 years old) were on Medicare and/or Medicaid. The mean (SD) age was 68.1 (11.4) years, 56.2% were female, and 25.5% were non-whites. Health and cost impacts were simulated over the lifetime of current Medicare and Medicaid participants (average simulated years = 18.3 years). The F&V incentive was estimated to prevent 1.93 million CVD events, gain 4.64 million QALYs, and save $39.7 billion in formal healthcare costs. For the healthy food incentive, corresponding gains were 3.28 million CVD and 0.12 million diabetes cases prevented, 8.40 million QALYs gained, and $100.2 billion in formal healthcare costs saved, respectively. From a healthcare perspective, both scenarios were cost-effective at 5 years and beyond, with lifetime ICERs of $18,184/QALY (F&V incentive) and $13,194/QALY (healthy food incentive). From a societal perspective including informal healthcare costs and lost productivity, respective ICERs were $14,576/QALY and $9,497/QALY. Results were robust in probabilistic sensitivity analyses and a range of one-way sensitivity and subgroup analyses, including by different durations of the intervention (5, 10, and 20 years and lifetime), food subsidy levels (20%, 50%), insurance groups (Medicare, Medicaid, and dual-eligible), and beneficiary characteristics within each insurance group (age, race/ethnicity, education, income, and Supplemental Nutrition Assistant Program [SNAP] status). Simulation studies such as this one provide quantitative estimates of benefits and uncertainty but cannot directly prove health and economic impacts., Conclusions: Economic incentives for healthier foods through Medicare and Medicaid could generate substantial health gains and be highly cost-effective., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: RM reports research funding from NIH, Bill & Melinda Gates Foundation, and Unilever and personal fees from the World Bank and Bunge. DM reports research funding from the National Institutes of Health and the Gates Foundation; personal fees from GOED, Nutrition Impact, Pollock Communications, Bunge, Indigo Agriculture, Amarin, Acasti Pharma, Cleveland Clinic Foundation, America’s Test Kitchen, and Danone; scientific advisory board, Elysium Health (with stock options), Omada Health, and DayTwo; and chapter royalties from UpToDate, all outside the submitted work. TAG has also received research funds and/or consulting fees from Astra Zeneca, Novartis, United Health Group, Teva Pharmacueticals, and Takeda in the past five years, all of which were outside the submitted work.

Study Design: Retrospective cohort study., Objective: The purpose of this study is to characterize the utilization and costs of MNTs prior to spinal fusion surgery in patients with symptomatic lumbar stenosis or spondylolisthesis., Summary of Background Data: The costs and utilization of long-term maximal nonoperative therapy (MNT) can be substantial, and in the current era of bundled payments, the duration of conservative therapy trials should be reassessed., Methods: A large insurance database was queried for patients with symptomatic lumbar stenosis or spondylolisthesis undergoing index lumbar decompression and fusion procedures between 2007 and 2016. This database consists of 20.9 million covered lives and includes private/commercially insured and Medicare Advantage beneficiaries. Only patients with lumbar stenosis or spondylolisthesis and those continuously active within the insurance system for at least 5 years prior to the index operation were eligible., Results: A total of 4133 out of 497,822 (0.8%) eligible patients underwent 1, 2, or 3-level posterior lumbar instrumented fusion. 20.8% of patients were smokers, 44.5% had type II DM, and 38.2% were obese (body mass index [BMI] >30 kg/m). Patient MNT utilization was as follows: 66.7% used nonsteroidal anti-inflammatory drugs (NSAIDs), 84.4% used opioids, 58.6% used muscle relaxants, 65.5% received lumbar epidural steroid injections (LESI), 66.6% attended 21.1% presented to the emergency department (ED), and 24.9% received chiropractor treatments. The total direct cost associated with all MNT prior to index spinal fusion was $9,000,968; LESI comprised the largest portion of the total cost of MNT ($4,094,646, 45.5%), followed by NSAIDS ($1,624,217, 18.0%) and opioid costs ($1,279,219, 14.2%). At the patient level, when normalized per patient utilizing therapy, an average $4010 was spent on nonoperative treatments prior to index lumbar surgery., Conclusion: Assuming minimal improvement in pain and functional disability after maximum nonoperative therapies, the incremental cost-effectiveness ratio (ICER) for MNTs could be highly unfavorable., Level of Evidence: 3.

Objective: It is useful for reviewers of economic evaluations to assess quality in a manner that is consistent and comprehensive. Checklists can allow this, but there are concerns about their reliability and how they are used in practice. We aimed to describe how checklists have been used in systematic reviews of health economic evaluations., Methods: Meta-review with snowball sampling. We compiled a list of checklists for health economic evaluations and searched for the checklists' use in systematic reviews from January 2010 to February 2018. We extracted data regarding checklists used, stated checklist function, subject area, number of reviewers, and issues expressed about checklists., Results: We found 346 systematic reviews since 2010 that used checklists to assess economic evaluations. The most common checklist in use was developed in 1996 by Drummond and Jefferson, and the most common stated use of a checklist was quality assessment. Checklists and their use varied within subject areas; 223 reviews had more than one reviewer who used the checklist., Conclusions: Use of checklists is inconsistent. Eighteen individual checklists have been used since 2010, many of which have been used in ways different from those originally intended, often without justification. Different systematic reviews in the same subject areas would benefit from using one checklist exclusively, using checklists as intended, and having 2 reviewers complete the checklist. This would increase the likelihood that results are transparent and comparable over time., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: To develop a health economic model that included a great diversity of patient characteristics and outcomes for chronic obstructive pulmonary disease (COPD), which can be used to inform decisions about stratified medicine in COPD., Methods: The choice of patient characteristics and outcomes to include in the model was based on 3 literature reviews on multidimensional prognostic COPD indices, COPD phenotypes, and treatment effects in subgroups. A conceptual model was constructed including 14 patient characteristics, 7 intermediate outcomes (lung function, physical activity, exercise capacity, symptoms, disease-specific quality of life, exacerbations, and pneumonias), and 3 final outcomes (mortality, quality-adjusted life-years [QALYs], and costs). Regression equations describing the statistical associations between the patient characteristics and intermediate and final outcomes were estimated using the longitudinal data of 5 large COPD trials (19,378 patients). A patient-level simulation model was developed in which individual patients from the baseline population of the 5 trials are sampled and their outcomes over lifetime are predicted based on the regression equations., Results: The base-case analysis (single-arm simulation representing treatment with tiotropium) showed that patients had a mean lung function decline of 43 mL/year, 0.62 exacerbations/year, a worsening of their physical activity and quality of life with 1.48 and 1.10 points/year, a life expectancy of 11.2 years, 7.25 QALYs, and total lifetime costs of £24,891. Results for a selection of treatment scenarios and subgroups were shown to demonstrate the potential of the model., Conclusions: We developed a unique patient-level simulation model that can be used to evaluate COPD treatment options for a variety of subgroups., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources., Objectives: To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia., Methods: The study design included decision-analytic modeling combining data from various sources. Behavior before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies., Results: Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained., Conclusions: The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Healthcare consumerism, costs, and price transparency are garnering unprecedented attention from hospitals and health systems in the United States. To many observers of the US healthcare delivery system, the inability to provide accurate pricing information and the variability in prices for comparable services are utter failures of the administrative infrastructure that supports patient care processes.Price transparency and the affordability of healthcare have also become top concerns for professional and trade organizations, which are devoting significant resources to assist member institutions in facing these issues. In many states, elected officials have passed legislation requiring pricing support for consumers. When the value equation (cost divided by quality) is considered, comparisons of healthcare providers can become even more confusing.Price transparency and demonstration of cost-effective, high-quality service to patients have become strategic imperatives at Maricopa Integrated Health System (MIHS). A safety-net system and one of Arizona's largest providers of graduate medical education and other teaching programs, MIHS faced an operating deficit of more than $74 million in fiscal year 2014. In 2015, financial concerns prompted the CEO and board to hold weekly meetings to appraise cash availability and management interventions. Over the next four years, MIHS achieved a cumulative improvement in net income of more than $150 million. Today, MIHS is reinventing itself through a major capital campaign made possible in part by a $935 million public bond referendum passed by the voters of Maricopa County. Ultimately, our ability to better serve the community involves connecting with our patients and addressing their need for price transparency.