Design and implementation of a stakeholder consultation process for rapid health technology assessments in Argentina.

INTRODUCTION: Health technology assessment (HTA) is a standardized methodology that allows the assessment technologies' value. By incorporating the perspective of stakeholders in a public consultation process, transparency and quality of decisions can be improved. OBJECTIVE: To describe the active stakeholder consultation process for rapid HTAs in an Argentinean, independent, academic, non-profit HTA agency, assessing its initial five years. METHODS: Since 2017, we have been conducting an active public consultation process for rapid HTA documents, inviting producers, healthcare professionals, and patient organizations to provide comments, and their input may lead to changes in the HTA documents. Changes were classified as major (changes to the coverage recommendation), intermediate (changes in efficacy, net benefit, or cost-effectiveness that did not change coverage recommendations), and minor modifications (other changes). RESULTS: From May 2017-August 2022, 308 rapid HTA (rHTA) reports were published, and 3,438 invitations were sent. 140 rHTA (45.5%) received a total of 228 comments. Comments came from producers in 53% (n = 112) and healthcare professional organizations in 31.2% (n = 66). Technologies evaluated were drugs in 37% (n = 114), procedures in 35.5% (n = 109), diagnostic methods in 15.3% (n = 47), and devices in 12.2% (n = 38). Out of 308 rHTA documents, 120 (39%) were modified-mostly minor adjustments (n = 100; 80%), followed by major (n = 12; 10%) and intermediate modifications (n = 8; 6.4%). CONCLUSION: Implementing an active stakeholder involvement process in HTA is feasible in a low- to middle-income country context and strengthens and improves the HTA process.

Defining the acute care surgeon: American Association for the Surgery of Trauma (AAST) panel discussion on full-time employment, compensation and career trajectory.

Since its inception, the specialty of acute care surgery has evolved and now represents a field with a broad clinical scope and large variations in implementation and practice. These variations produce unique challenges and there is no consistent definition of the scope, intensity or value of the work performed by acute care surgeons. This lack of clarity regarding expectations extends to surgeons and non-surgeons outside of our specialty, compounding difficulties in advocacy at the local, regional and national levels. Coupled with a lack of clarity surrounding the definition of full-time employment, these challenges have prompted surgeons to develop initiatives within acute care surgery in collaboration with the American Association for the Surgery of Trauma (AAST). A panel session at the AAST 2023 annual meeting was held to discuss the need to define a full-time equivalent for an acute care surgeon and how to consider and incorporate non-clinical responsibilities. Experiences, perspectives and propositions for change were discussed and are presented here.

Improving Efficiency in Healthcare: Lessons from Successful Health Policies in Chile.

BACKGROUND: Chile has made significant progress in recent decades in implementing policies to improve the efficiency of its health system with an impact on population health. AIM: To present five case studies of successful policies whose impact has been documented. METHODS: Case study report. RESULTS: First, we present a summary of the evidence supporting the policy that is changing the Chilean care model from a problem-based to a patient-centered care model. Second, we show how tele-nephrology and advanced renal care units have demonstrated significant impact on chronic kidney disease in Chile. This internationally recognized successful Chilean policy is contributing to address one of the conditions that explains the highest financial burden on the health system. Third, we present recent evidence on the effectiveness of teleoncology care in Chile. Fourth, we highlight the most recent system of epidemiological surveillance implemented in Chile, the EPIVIGILA system, which was essential to support decisions throughout the pandemic. Finally, we underline the health benefit plans implemented in recent decades to improve access to services and financial protection. CONCLUSIONS: Chile has successfully implemented policies in its health system that have an impact on efficiency and population health. These experiences can be replicated in countries facing similar challenges, using the Chilean experience as a benchmark.

Cost of operating a human milk bank in the UK: a microcosting analysis.

ObjectiveGlobally, demand for donor human milk (DHM) is increasing with WHO guidelines recommending DHM as the first line nutrition for premature infants in the absence or shortfall of maternal milk. Policymakers and clinicians currently have limited knowledge regarding costs incurred by human milk banks (HMBs) making the planning and resourcing of these services challenging. This study aimed to evaluate costs in a national network of HMBs in the UK. DESIGN AND SETTING: All 14 UK HMBS were invited to complete a bottom-up microcosting survey from 1 April 2021 to 31 March 2022 covering four key areas: Staffing, equipment, donor screening and incidental costs. Total annual salary costs included on-costs (ie, national insurance, pensions), qualifications, overheads (ie, non-staff costs) and capital overheads. The annual equivalent costs for each equipment item were based on the total cost over its useful life and discounted at 3.5%. RESULTS: 10 out of 14 milk banks provided responses with more complete datasets returned by larger milk banks. Staffing costs ranged from £24 983 to £476 194 (n=9, mean: £159 798) and considerable expertise was provided voluntarily or from non-costed staffing. Other costs included equipment (n=7, range: £2600-£51 453, mean: £19 279), donor screening (n=6, range: £925-£38 057, mean: £18 570), incidentals (n=6, range: £650-£109 996, mean: £23 774). The total annual cost of operating a milk bank annually was £202 719 (range, £27 583-£675 699) to provide between 205 and 3495 litres of DHM. The cost per litre averaged £173.49 (range, £95.94-£274.88). CONCLUSIONS: The average cost of DHM is currently higher than current cost recovery tariffs and this study likely under-represents total costs. This study provides useful benchmarking data for future economic analyses, trial development and service planning.

Lifetime effects and cost-effectiveness of statin therapy for older people in the United Kingdom: a modelling study.

BACKGROUND: Cardiovascular disease (CVD) risk increases with age. Statins reduce cardiovascular risk but their effects are less certain at older ages. We assessed the long-term effects and cost-effectiveness of statin therapy for older people in the contemporary UK population using a recent meta-analysis of randomised evidence of statin effects in older people and a new validated CVD model. METHODS: The performance of the CVD microsimulation model, developed using the Cholesterol Treatment Trialists' Collaboration (CTTC) and UK Biobank cohort, was assessed among participants ≥70 years old at (re)surveys in UK Biobank and the Whitehall II studies. The model projected participants' cardiovascular risks, survival, quality-adjusted life years (QALYs) and healthcare costs (2021 UK£) with and without lifetime standard (35%-45% low-density lipoprotein cholesterol reduction) or higher intensity (≥45% reduction) statin therapy. CTTC individual participant data and other meta-analyses informed statins' effects on cardiovascular risks, incident diabetes, myopathy and rhabdomyolysis. Sensitivity of findings to smaller CVD risk reductions and to hypothetical further adverse effects with statins were assessed. RESULTS: In categories of men and women ≥70 years old without (15,019) and with (5,103) prior CVD, lifetime use of a standard statin increased QALYs by 0.24-0.70 and a higher intensity statin by a further 0.04-0.13 QALYs per person. Statin therapies were cost-effective with an incremental cost per QALY gained below £3502/QALY for standard and below £11778/QALY for higher intensity therapy and with high probability of being cost-effective. In sensitivity analyses, statins remained cost-effective although with larger uncertainty in cost-effectiveness among older people without prior CVD. CONCLUSIONS: Based on current evidence for the effects of statin therapy and modelling analysis, statin therapy improved health outcomes cost-effectively for men and women ≥70 years old.

Costs, challenges and opportunities of decentralised chimeric antigen receptor T-cell production: a literature review and clinical experts' interviews.

The objectives were to summarise the evidence and clinical experts' views comparing the use of decentralised produced chimeric antigen receptor (CAR) T-cell therapies versus commercially available products, regarding drug costs, time to finalised product and other reported advantages, disadvantages, challenges and facilitators. A literature review according to the PRISMA guidelines was conducted in Medline, Embase and Trip databases. Publications were included if they reported information on cost estimates, time to finalised products and other outcomes of interest of a decentralised CAR T-cell production strategy. A structured interview guide was developed and used for qualitative expert interviews. Five experts were purposively selected, and interviews were either conducted face-to-face or online, and recorded for the purpose of transcription. Transcripts were analysed and categories and codes extracted. Reporting is based on the COREQ checklist for reporting qualitative research. Costs of decentralised produced CAR T-cells appear to be lower by a factor two to 14, compared with commercial products. But there is high uncertainty about this estimate, because it is unclear whether cost components included are comparable and due to the heterogeneity of the studies. The most commonly reported advantages were proximity to patients and decreased product risks and costs, whereas the continuing dependency on centrally manufactured reagents and specific characteristics of 'fresh' CAR T-cells are reported as disadvantages. Compliance with regulatory requirements is mentioned as the biggest challenge. The availability of closed-system production devices is reported as one main facilitator, as are clear commitment, secured financing and knowledge transfer from already experienced centres. Apparent cost differences open a field for healthcare decision-makers to discuss and justify investment costs for implementation of a complementing decentralised production programme and to realise other associated benefits of such a strategy, such as flexibility, patient proximity and expanding patient access.

Changes in payer mix of new and established trauma centers: the new trauma center money grab?

Background: Although timely access to trauma center (TC) care for injured patients is essential, the proliferation of new TCs does not always improve outcomes. Hospitals may seek TC accreditation for financial reasons, rather than to address community or geographic need. Introducing new TCs risks degrading case and payer mix at established TCs. We hypothesized that newly accredited TCs would see a disproportionate share of commercially insured patients. Study design: We collected data from all accredited adult TCs in Pennsylvania using the state trauma registry from 1999 to 2018. As state policy regarding supplemental reimbursement for underinsured patients changed in 2004, we compared patient characteristics and payer mix between TCs established before and after 2004. We used multivariable logistic regression to assess the relationship between payer and presentation to a new versus established TC in recent years. Results: Over time, there was a 40% increase in the number of TCs from 23 to 38. Of 326 204 patients from 2010 to 2018, a total of 43 621 (13.4%) were treated at 15 new TCs. New TCs treated more blunt trauma and less severely injured patients (p<0.001). In multivariable analysis, patients presenting to new TCs were more likely to have Medicare (OR 2.0, 95% CI 1.9 to 2.1) and commercial insurance (OR 1.6, 95% CI 1.5 to 1.6) compared with Medicaid. Over time, fewer patients at established TCs and more patients at new TCs had private insurance. Conclusions: With the opening of new centers, payer mix changed unfavorably at established TCs. Trauma system development should consider community and regional needs, as well as impact on existing centers to ensure financial sustainability of TCs caring for vulnerable patients. Level of evidence: Level III, prognostic/epidemiological.

Budget impact analysis of implementing trauma registries in Argentina.

INTRODUCTION: In high-income countries, quality improvement interventions and research are usually guided by trauma registries. In low- and middle-income countries, the implementation of trauma registries has been limited mainly for cost reasons. OBJECTIVE: To analyze the budgetary impact of the implementation of trauma registries in Argentina. METHODS: We estimated direct costs of implementing trauma registries in public hospitals located in cities with a population over 50,000 inhabitants. In large urban areas, we selected hospitals by estimating a minimum volume of 240 severe trauma admissions/year and using the NBATS-2 instrument with geolocation techniques. We estimated costs based on a micro-costing approach of a trauma registry developed by Fundación Trauma. Scenario analysis was carried out restricting the population to hospitals from bigger cities and/or with higher concentration of trauma patients' care. For the high budget impact threshold, we used the total health spending estimation, and alternatively the health spending of the public sector. RESULTS: For the base case, 139 hospitals from 104 cities were included, comprising 175,605 injury-related discharges and 13,707 severely injured patients/year. The average cost for the initial three years was USD 3,753,085 (21.4 USD/per patient), falling below the high budget impact thresholds. The scenarios analysis showed a significantly costs reduction. CONCLUSIONS: The implementation of trauma registries in Argentina would be affordable, and in consequence, it would improve the coordination, management and quality of care for this great public health issue.

Applying current European periodontitis clinical practice guidelines is not feasible even for the richest countries in the world.

Clinical practice guidelines aim to enhance the quality, equality and consistency of care but often demand more time than is available, rendering adherence impractical and exceeding feasible resources. The 2017 introduction of a new periodontal classification system by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) sought to refine clinical and epidemiological practices by serving as the basis for clinical practice guidelines and epidemiological investigations around the world. Following this classification, the EFP recommends supportive periodontal care visits every 3-12 months for all periodontitis cases. Given that in Norway, approximately 72% of the adult population are identified as periodontitis cases under the current AAP/EFP case definition, this poses a significant demand on healthcare resources. We calculated that between 60% and 70% of all estimated available working hours available for adult dental care provided by dentists and dental hygienists in Norway in 2017 would be spent on supportive periodontal care visits alone if the recommendations were to be met. This situation calls for a reevaluation of disease definitions and clinical practice guidelines to ensure they are practical, financially feasible and patient-outcome relevant.

Quantifying societal burden of radiation-induced small bowel toxicity in patients with rectal cancer.

Introduction: Advancements in rectal cancer (RC) treatment not only led to an increase in lives saved but also improved quality of life (QoL). Notwithstanding these benefits, RC treatment comes at the price of gastrointestinal morbidity in many patients. Health economic modelling poses an opportunity to explore the societal burden of such side-effects. This study aims to quantify radiation-induced late small bowel (SB) toxicity in survivors of RC for Three-Dimensional Conformal Radiation Therapy (3D-CRT), Intensity Modulated Radiation Therapy (IMRT) and Intensity Modulated Radiation Therapy - Image Guided Radiation Therapy (IMRT/IGRT). Materials and methods: Materials and A model-based health economic evaluation was performed. The theoretical cohort consists of a case-mix of survivors of RC aged 25-99 years according to Belgian age-specific incidence rates. A societal perspective was adopted. The base case analysis was complemented with one-way deterministic analyses, deterministic scenario analyses and probabilistic sensitivity analysis (1,000 iterations). Results were presented as mean lifetime incremental cost (€) and utility (QALYs) per patient. Results: The analyses showed that the use of innovative radiotherapy (RT) improves lifetime QoL in survivors of RC by 0.11 QALYs and 0.05 QALYs by preferring IMRT/IGRT and IMRT over 3D-CRT, respectively. The use of IMRT/IGRT and IMRT results in an incremental cost-saving of €3,820 and €1,863 per patient, solely by radiation-induced SB toxicity, compared to 3D-CRT. Discussion and conclusion: It is important to consider late toxicity effects in decisions regarding investments and reimbursement as our analysis highlighted the potential long-term cost-savings and improved QoL of novel RT techniques in patients with rectal cancer.

Comparative Review of the Socioeconomic Burden of Lower Back Pain in the United States and Globally.

Internationally, the United States (U.S.) cites the highest cost burden of low back pain (LBP). The cost continues to rise, faster than the rate of inflation and overall growth of health expenditures. We performed a comprehensive literature review of peer-reviewed and non- peer-reviewed literature from PubMed, Scopus, and Google Scholar for contemporary data on prevalence, cost, and projected future costs. Policymakers in the U.S. have long attempted to address the high-cost burden of LBP through limiting low-value services and early imaging. Despite these efforts, costs (~$40 billion; ~$2,000/patient/yr) continue to rise with increasing rates of unindicated imaging, high rates of surgery, and subsequent revision surgery without proper trial of non-pharmacologic measures and no corresponding reduction in LBP prevalence. Globally, the overall prevalence of LBP continues to rise largely secondary to a growing aging population. Cost containment methods should focus on careful and comprehensive clinical assessment of patients to better understand when more resource-intensive interventions are indicated.

A global redistributive auction for vaccine allocation.

The global allocation of vaccines during the COVID-19 pandemic is widely perceived as unfair. Priority was given to countries that paid the most with little or no concern for who needed the vaccines the most. No satisfactory institutions have been established to allocate vaccines in a future pandemic. In this paper, we join reformers in proposing a new scheme for vaccine distribution: a global auction for vaccines where profits are distributed fairly to participating countries. Our proposal improves upon previous suggestions morally by taking countries' differing valuations of money and vaccines seriously. Since an auction is in the interest of both vaccine manufacturers and high-income countries, it is also politically feasible. A global redistributive auction for vaccines thus promises to be a robust and morally desirable way to allocate vaccines.

Equitable resource allocation in health emergencies: addressing racial disparities and ethical dilemmas.

This paper explores resource allocation complexities during health emergencies, focusing on pervasive racial disparities, notably affecting black communities. It aims to investigate alternatives to the Most Lives Saved approach, particularly its potential to exacerbate disparities. To analyse resource allocation strategies, the essay reviews the Dual-Principled System proposed by Bruce and Tallman (B+T) in 2021. B+T's proposal critiques previous methods like the Area Deprivation Index and First Come First Serve while seeking to balance equity and utility by adjusting triage scores based on diseases displaying racial disparities. However, the study identifies inherent challenges in subjectivity, complexity and fairness, necessitating a careful examination and potential innovative solutions. The examination of the Dual-Principled System uncovers challenges, leading to the identification of three main issues and potential solutions. Furthermore, to address subjectivity concerns, it is necessary to adopt objective disease selection criteria through data analysis. Moreover, proposed solutions for complexity include real-time data updates, adaptability and regional considerations. Fairness concerns can be mitigated through educational campaigns and a lottery system integrated with triage score adjustments. The study emphasises nuanced resource allocation with objective disease selection, adaptable strategies and educational initiatives, including a lottery system, aligning with fairness, equity and practicality. As healthcare evolves, resource allocation must align with justice, fostering inclusivity and responsiveness for all.

Direct and indirect costs of paediatric asthma in the UK: a cost analysis.

OBJECTIVE: To estimate the cost of paediatric asthma from a UK National Health Service (NHS) and societal perspective and explore determinants of these costs. DESIGN: Cost analysis based on data from a large clinical trial between 2017 and 2019. Case report forms recorded healthcare resource use and productivity losses attributable to asthma over a 12-month period. These were combined with national unit cost data to generate estimates of health service and indirect costs. SETTING: Asthma clinics in primary and secondary care in England and Scotland. MAIN OUTCOME MEASURES: Cost per asthma attack stratified by highest level of care received. Total annual health service and indirect costs. Modelled effect of sex, age, severity, number of attacks and adherence on total annual costs. RESULTS: Of 506 children included in the analysis, 252 experienced at least one attack. The mean (SD) cost per attack was £297 (806) (median £46, IQR 40-138) and the mean total annual cost to the NHS was £1086 (2504) (median £462, IQR 296-731). On average, children missed 6 days of school and their carers missed 13 hours of paid work, contributing to a mean annual indirect cost of £412 (879) (median £30, IQR 0-477). Health service costs increased significantly with number of attacks and participant age (>11 years). Indirect costs increased with asthma severity and number of attacks but were found to be lower in older children. CONCLUSIONS: Paediatric asthma imparts a significant economic burden on the health service, families and society. Efforts to improve asthma control may generate significant cost savings. TRIAL REGISTRATION NUMBER: ISRCTN 67875351.

Cost-effectiveness of emicizumab prophylaxis for haemophilia A with inhibitors: an adaptive health technology assessment for the Indian setting.

OBJECTIVE: To assess the cost-effectiveness of emicizumab prophylaxis for patients having haemophilia A with inhibitors in the Indian context using an adaptive health technology assessment (aHTA) methodology. DESIGN: Economic evaluation using multiple approaches aimed at adjusting previously generated cost-effectiveness results based on (1) price differences only ('simple') and (2) differences in cost and expected treatment duration ('moderate') and differences in cost, inflation and life expectancy ('complex'). SETTING: Typical haemophilia care in India. PARTICIPANTS: Patients with haemophilia A and inhibitors. INTERVENTION: Emicizumab prophylaxis using two vial strengths (30 or 150 mg/mL) in comparison to no prophylaxis. MAIN OUTCOME MEASURES: Adjusted incremental cost-effectiveness ratio (ICERa), incremental costs and incremental quality-adjusted life years associated with emicizumab prophylaxis from both the health system and societal perspectives. RESULTS: Using the simple ICER adjustment method, emicizumab prophylaxis resulted in potential cost savings from the payers' perspective for both vial strengths in patients aged ≥12 and <12 years. However, from a societal perspective, emicizumab prophylaxis was not cost-effective. Using the moderate adjustment method, emicizumab prophylaxis showed potential cost saving from the health system perspective. The complex adjustment method also revealed cost savings for emicizumab prophylaxis from the health system and societal perspectives across different age groups. CONCLUSION: We found that implementing emicizumab prophylaxis for patients with haemophilia A and inhibitors in India has the potential to result in cost savings. This study highlights the feasibility of using the expanded aHTA methodology for rapid evidence generation in the Indian context. However, it is crucial to address certain research gaps, including data limitations, challenges in translating international evidence to Indian context and associated uncertainties. Additionally, conducting a comprehensive budget impact analysis is necessary. These findings hold significant implications for decision-making regarding the potential provision of emicizumab prophylaxis through federal or/and state government-funded programmes and institutions in India.

Cost of childhood severe pneumonia management in selected public inpatient care facilities in Bangladesh: a provider perspective.

OBJECTIVE: To estimate inpatient care costs of childhood severe pneumonia and its urban-rural cost variation, and to predict cost drivers. DESIGN: The study was nested within a cluster randomised trial of childhood severe pneumonia management. Cost per episode of severe pneumonia was estimated from a healthcare provider perspective for children who received care from public inpatient facilities. A bottom-up micro-costing approach was applied and data collected using structured questionnaire and review of the patient record. Multivariate regression analysis determined cost predictors and sensitivity analysis explored robustness of cost parameters. SETTING: Eight public inpatient care facilities from two districts of Bangladesh covering urban and rural areas. PATIENTS: Children aged 2-59 months with WHO-classified severe pneumonia. RESULTS: Data on 1252 enrolled children were analysed; 795 (64%) were male, 787 (63%) were infants and 59% from urban areas. Average length of stay (LoS) was 4.8 days (SD ±2.5) and mean cost per patient was US$48 (95% CI: US$46, US$49). Mean cost per patient was significantly greater for urban tertiary-level facilities compared with rural primary-secondary facilities (mean difference US$43; 95% CI: US$40, US$45). No cost variation was found relative to age, sex, malnutrition or hypoxaemia. Type of facility was the most important cost predictor. LoS and personnel costs were the most sensitive cost parameters. CONCLUSION: Healthcare provider cost of childhood severe pneumonia was substantial for urban located public health facilities that provided tertiary-level care. Thus, treatment availability at a lower-level facility at a rural location may help to reduce overall treatment costs.

Surgical critical care: Is work-life expectancy increasing? An analysis of American Board of Surgery recertification rates across subspecialties.

The practice of surgical critical care (SCC) has traditionally necessitated additional in-house, extended night and weekend clinical commitments, which can be viewed as less desirable for many surgeons. Therefore, the authors have observed that some SCC surgeons elect to transition their practice to focus solely on general surgery (GS) rather than continuing practicing both SCC and GS. We hypothesized that surgeons with a practice focused on SCC are more likely to make the transition to a GS practice than those who have certification in other subspecialties that are certified through the American Board of Surgery.