Palliative Care Costs in Different Ambulatory-Based Settings: A Systematic Review.

BACKGROUND: Cost-of-illness studies in palliative care are of growing interest in health economics. There is no standard methodology to capture direct and non-direct healthcare and non-healthcare expenses incurred by health services, patients and their caregivers in the course of the ambulatory palliative care process. OBJECTIVE: We aimed to describe the type of healthcare and non-healthcare expenses incurred by patients with cancer and non-cancer patients and their caregivers for palliative care in ambulatory-based settings and the methodology used to capture the data. METHODS: We conducted a systematic review of studies on the costs of ambulatory-based palliative care in patients with cancer (breast, lung, colorectal) and non-cancer conditions (chronic heart failure, chronic obstructive pulmonary disease, dementia) found in six bibliographic databases (PubMed, EMBASE [via Ovid], Cochrane Database of Systematic Reviews, EconLit, the National Institute for Health Research Health Technology Assessment Database and the National Health Service Economic Evaluation Database at the University of York, and Google Scholar). The studies were published between January 2000 and December 2022. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology for study selection and assessed study quality using the Quality of Health Economic Studies instrument. The study was registered in PROSPERO (CRD42021250086). RESULTS: Of 1434 identified references, 43 articles met the inclusion criteria. The primary data source was databases. More than half of the articles presented data from public healthcare systems (65.12%) were retrospective (60.47%), and entailed a bottom-up costing analysis (93.2%) made from a healthcare system perspective (53.49%). The sociodemographic characteristics of patients and families/caregivers were similar across the studies. Cost outcomes reports were heterogeneous; almost all of the studies collected data on direct healthcare costs (97.67%). The main driver of costs was inpatient care (55.81%), which increased during the end-of-life period. Nine studies (20.97%) recorded costs due to productivity losses for caregivers and three recorded such costs for patients. Caregiving costs were explored through an opportunity cost analysis in all cases, based on interviews conducted with and questionnaires administered to patients and caregivers, mainly via telephone calls (23.23%). CONCLUSIONS: This systematic review reveals that studies on the costs of ambulatory-based palliative care are increasing. These studies are mostly conducted from a healthcare system perspective, which leaves out costs related to patients'/caregivers' economic burden. There is a need for prospective studies to assess this financial burden and evaluate, with strong evidence, the interventions and actions designed to improve the quality of life of palliative care patients. Future studies should propose cost calculation approaches using a societal perspective to better estimate the economic burden imposed on patients in ambulatory-based palliative care.

Cost-effectiveness and cost-utility analyses of a web-based computer-tailored intervention for prevention of binge drinking among Spanish adolescents.

BACKGROUND: Binge drinking (BD) among adolescents is a public health concern worldwide. This study assessed the cost-effectiveness and cost-utility of a web-based computer-tailored intervention to prevent BD in adolescence. METHODS: The sample was drawn from a study evaluating the Alerta Alcohol program. The population consisted of adolescents 15 to 19 years of age. Data were recorded at baseline (January to February 2016) and after 4 months (May to June 2017) and were used to estimate costs and health outcomes, as measured by the number of BD occasions and quality-adjusted life years (QALYs). Incremental cost-effectiveness and cost-utility ratios were calculated from National Health Service (NHS) and societal perspectives and for a time horizon of 4 months. A multivariate deterministic sensitivity analysis of best/worst scenarios by subgroups was used to account for uncertainty. RESULTS: The cost of reducing BD occasions by one per month was €16.63 from the NHS perspective, which from the societal perspective resulted in savings of €7986.37. From the societal perspective, the intervention resulted in an incremental cost of €71.05 per QALY gained from the NHS perspective and this was dominant, resulting in savings of €34,126.64 per QALY gained in comparison with the control group. Subgroup analyses showed that the intervention was dominant for girls from both the perspectives and for individuals 17 years or older from the NHS perspective. CONCLUSIONS: Computer-tailored feedback is a cost-effective way to reduce BD and increase QALYs among adolescents. However, long-term follow-up is needed to evaluate more fully changes in both BD and health-related quality of life.

Cost-effectiveness of Alzheimer's disease CSF biomarkers and amyloid-PET in early-onset cognitive impairment diagnosis.

This study aimed at determining the cost-effectiveness of amyloid-positron emission tomography (PET) compared to Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers (amyloid-ß42, total-Tau and phosphorylated-Tau) for the diagnosis of AD in patients with early-onset cognitive impairment. A decision tree model using a national health care perspective was developed to compare the costs and effectiveness associated with Amyloid-PET and AD CSF biomarkers. Available evidence from the literature and primary data from Hospital Clínic de Barcelona were used to inform the model and calculate the efficiency of these diagnostic alternatives. Medical visits and diagnostic procedures were considered and reported in €2020. We calculated the incremental cost-effectiveness ratio to measure the cost per % of correct diagnoses detected and we perform one-way deterministic and probabilistic sensitivity analyses to assess the uncertainty of these results. Compared with AD CSF biomarkers, Amyloid-PET resulted in 7.40% more correctly diagnosed cases of AD, with an incremental total mean cost of €146,854.80 per 100 cases. We found a 50% of probability that Amyloid-PET was cost-effective for a willingness to pay (WTP) of €19,840.39 per correct case detected. Using a WTP of €75,000, the probability that it is cost-effective reached a maximum of 76.9%, thus leading to a conclusion that Amyloid-PET is not a cost-effective technique compared to AD CSF biomarkers, unless the funder is willing to pay a minimum of €19,840.39 to detect one more correct case. Furthermore, obtaining CSF provides simultaneous information on amyloid ß and tau biomarkers and allows other biomarkers to be analyzed at a relatively low cost.

Economic evaluations of interventions aimed at the prevention, treatment and/or rehabilitation of alcohol-related disorders: A systematic review. / Evaluaciones económicas de intervenciones dirigidas a la prevención, tratamiento y/o rehabilitación de trastornos por consumo de alcohol: Una revisión sistemática.

The aim of this systematic literature review is to identify economic evaluations of programmes or interventions aimed at the prevention, treatment and rehabilitation of alcohol use disorders, as well as to determine those types of programmes, treatments or interventions that are efficient. The systematic literature review was conducted by searching the following databases: National Health Service Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA), MEDLINE Ovid and PubMed. The search terms used were in English. No time restriction was applied. A data extraction form was used to draw information. The systematic review follows the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) on reporting systematic reviews. The interventions were classified into three categories: "A" treatments for people with alcohol use disorders (tertiary prevention); "B" treatments for people at risk for alcohol-related problems (secondary prevention); "C" policy legislation and enforcement interventions (primary prevention). Furthermore, the "A" interventions were subclassified into psychological, pharmacological and combined interventions. The review included 63 papers. In terms of treatments for people with alcohol use disorders, any psychosocial intervention compared to no intervention appeared to be a dominant strategy. In terms of treatments for people at risk of alcohol-related problems, brief intervention appears to be dominant or cost-effective when compared to no intervention. Advertising controls, tax increases, licensing, legal drinking age, and mass media campaigns seem to be dominant or cost-effective strategies compared to no intervention or random breath testing. Previous reviews have been extended by depicting alcohol programmes according to their efficiency. Despite this, the available studies in this regard have heterogeneous approaches and most do not adequately define the costs included in their analyses. Therefore, it is necessary to encourage the evaluation of the efficiency of these types of interventions to aid decision-making in public health.

El objetivo de esta revisión sistemática de la literatura es identificar evaluaciones económicas de programas o intervenciones dirigidas a la prevención, tratamiento y rehabilitación de trastornos por consumo de alcohol, así como determinar aquellos tipos de programas, tratamientos o intervenciones que son eficientes. Se realizó una revisión sistemática de la literatura mediante la búsqueda en las siguientes bases de datos: National Health Service Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA), MEDLINE Ovid and PubMed. Los términos de búsqueda utilizados fueron en inglés. No se aplicó ninguna restricción de tiempo. Se utilizó un formulario de extracción de datos para resumir la información. La revisión sistemática siguió las recomendaciones (PRISMA-P) sobre la presentación de informes de revisiones sistemáticas. Las intervenciones fueron clasificadas en tres categorías: «A¼ tratamientos para personas con trastornos por consumo de alcohol (prevención terciaria); «B¼ tratamientos para personas en riesgo de problemas relacionados con el alcohol (prevención secundaria); «C¼ legislación sobre políticas e intervenciones de aplicación (prevención terciaria). Además, las intervenciones «A¼ fueron subclasificadas en intervenciones psicológicas, farmacológicas y combinadas. Se incluyeron 63 documentos. En términos de tratamientos para personas con trastornos por uso de alcohol, cualquier intervención psicosocial en comparación con ninguna intervención parece ser una estrategia dominante. En términos de tratamientos para personas en riesgo de problemas relacionados con el alcohol, la intervención breve parece ser dominante o rentable en comparación con no hacer nada. Los controles publicitarios, las subidas de impuestos, las licencias, la edad legal para consumir alcohol y las campañas en los medios de comunicación parecen ser una estrategia dominante o rentable en comparación con ninguna intervención o prueba aleatoria de alcoholemia. Se han ampliado las revisiones anteriores al mostrar los programas de alcohol según criterios de eficiencia. A pesar de ello, los estudios disponibles al respecto tienen enfoques heterogéneos y la mayoría no define adecuadamente los costes incluidos en su análisis. Por tanto, es necesario continuar evaluando en términos de eficiencia este tipo de intervenciones para informar mejor la toma de decisiones en salud pública.

Posttransplant Hepatocellular Carcinoma Surveillance: A Cost-effectiveness and Cost-utility Analysis.

OBJECTIVE: Assess cost-effectiveness and -utility associated with posttransplant HCC surveillance compared to standard follow-up. SUMMARY OF BACKGROUND DATA: Despite lack of prospective clinical data, expert consensus recommends posttransplant surveillance to detect HCC recurrence in a latent phase, while it might be amenable to curative-intent therapy. METHODS: A Markov-based transition model was created to estimate life expectancy and quality-of-life among liver transplant patients undergoing HCC surveillance. Models were built for 2 cohorts: 1 undergoing HCC surveillance with contrast-enhanced computed tomography of chest and abdomen and serum alpha-fetoprotein analysis and the other receiving standard posttransplant follow-up. Primary model outputs included LY and QALY gains, incremental cost-effectiveness ratio, and incremental cost-utility ratio. Willingness-to-pay for a QALY gain (cost-effectiveness threshold) was used to estimate efficiency. RESULTS: Surveillance was marginally more effective versus no surveillance, resulting in means of 0.069 LYs and 0.026 QALYs gained. Costs for surveillance were increased by an average of 988.32€, resulting in incremental cost-effectiveness ratio 14,410.15€/LY and incremental cost-utility ratio 37,547.97€/QALY. Surveillance did not seem cost-effective in our setting, considering willingness-to-pay threshold of 25,000€/QALY. Probabilistic sensitivity analysis indicated surveillance might be cost-effective in 42% of cases, but degree of uncertainty in the analysis was high. CONCLUSIONS: Performing posttransplant HCC surveillance offers marginal clinical benefits and increases costs. Although expert consensus supports surveillance, results of this decision analysis raise doubt regarding the utility of such recommendations and support ongoing need for prospective clinical trials.

Estimating ambient air pollution mortality and disease burden and its economic cost in Barcelona.

BACKGROUND: The new WHO air quality guidelines indicate that the air pollution disease burden is greater than previously reported. We aimed to estimate the air pollution disease burden and its economic cost in Barcelona to inform local action. METHODS: We used a quantitative health impact assessment to estimate the non-accidental mortality and incidence of childhood asthma and lung cancer attributable to long-term air pollution exposure in the city of Barcelona (Spain) in 2018-2019. We used the population weighted mean of PM2.5 and NO2 assigned at the geocoded address during the study period and the 2021 WHO air quality guidelines as counterfactual scenario to estimate new annual cases attributable to each pollutant separately and combined. We estimated the social cost of attributable deaths and the health care cost of childhood asthma and lung cancer attributable cases. We also estimated attributable mortality by city district and the mortality avoidable by achieving the WHO air quality interim targets. RESULTS: Mean exposure was 17 µg/m3 for PM2.5 and 39 µg/m3 for NO2. Total combined air pollution attributable mortality was 13% (95%CI = 9%-17%), corresponding to 1,886 deaths (95%CI = 1,296-2,571) and a social cost of €1,292 million (95%CI = 888-1,762) annually. Fifty-one percent (95%CI = 21%-71%) and 17% (95%CI = 7%-29%) of new cases of childhood asthma and lung cancer were attributable to air pollution with a health care cost of €4.3 and €2.7 million, respectively. Achieving the first unmet WHO air quality interim targets for PM2.5 and for NO2 would avoid 410 deaths and €281 million annually. CONCLUSION: Air pollution in Barcelona represents a huge disease and economic burden, which is greater than previous estimates. Much stronger measures to reduce PM2.5 and NO2 levels are urgently needed. Until the WHO air quality guidelines are met in the city, achieving each WHO air quality interim targets would avoid hundreds of deaths each year.

Research can be integrated into public health policy-making: global lessons for and from Spanish economic evaluations.

WHO promotes the use of research in policy-making to drive improvements in health, including in achieving Sustainable Development Goals such as tobacco control. The European Union's new €95 billion Horizon Europe research framework programme parallels these aims, and also includes commitments to fund economic evaluations. However, researchers often express frustration at the perceived lack of attention to scientific evidence during policy-making. For example, some researchers claim that evidence regarding the return on investment from optimal implementation of evidence-based policies is frequently overlooked. An increasingly large body of literature acknowledges inevitable barriers to research use, but also analyses facilitators encouraging such use. This opinion piece describes how some research is integrated into policy-making. It highlights two recent reviews. One examines impact assessments of 36 multi-project research programmes and identifies three characteristics of projects more likely to influence policy-making. These include a focus on healthcare system needs, engagement of stakeholders, and research conducted for organizations supported by structures to receive and use evidence. The second review suggests that such characteristics are likely to occur as part of a comprehensive national health research system strategy, especially one integrated into the healthcare system. We also describe two policy-informing economic evaluations conducted in Spain. These examined the most cost-effective package of evidence-based tobacco control interventions and the cost-effectiveness of different strategies to increase screening coverage for cervical cancer. Both projects focused on issues of healthcare concern and involved considerable stakeholder engagement. The Spanish examples reinforce some lessons from the global literature and, therefore, could help demonstrate to authorities in Spain the value of developing comprehensive health research systems, possibly following the interfaces and receptor model. The aim of this would be to integrate needs assessment and stakeholder engagement with structures spanning the research and health systems. In such structures, economic evaluation evidence could be collated, analysed by experts in relation to healthcare needs, and fed into both policy-making as appropriate, and future research calls. The increasingly large local and global evidence base on research utilization could inform detailed implementation of this approach once accepted as politically desirable. Given the COVID-19 pandemic, increasing the cost-effectiveness of healthcare systems and return on investment of public health interventions becomes even more important.

A Social Return on Investment Analysis of Improving the Management of Chronic Obstructive Pulmonary Disease Within the Spanish National Healthcare System.

Purpose: To define a set of proposals that would improve the current management of chronic obstructive pulmonary disease (COPD) within the Spanish National Healthcare System (SNHS) from a comprehensive multidisciplinary perspective and to assess the impact of its implementation from clinical, healthcare, economic, and social perspectives. Patients and Methods: A group of 20 stakeholders related to COPD (healthcare professionals, patients, and informal caregivers, among others) participated in an online Delphi process to agree on a set of 15 proposals that would improve the current management of COPD within the SNHS in four areas: diagnosis, risk stratification, management of exacerbations, and management of stable COPD. A one-year forecast-type social return on investment (SROI) analysis was used to estimate the impact that implementing the set of proposals would have in relation to the investment required. A sensitivity analysis was used to test the strength of the model when varying assumption-based data-points. Results: The hypothetical implementation of the complete set of 15 proposals would require a €668 million investment and would generate a €2079 million social impact concerning savings for the SNHS and quality of life improvements for patients and their informal caregivers, among others. Accordingly, for every euro invested in the set of proposals, a social return of €3.11 would be generated (€2.71 in the worst-case scenario and €3.62 in the best-case scenario) of both tangible (32.56%) and intangible nature (67.44%). Conclusion: Altogether, implementing this set of 15 proposals would generate a positive social impact, threefold the required investment. The results may inform decisions relative to healthcare policy and practice regarding COPD management within the SNHS, further contributing to reduce the large burden of COPD.

Health and economic impact at a population level of both primary and secondary preventive lung cancer interventions: A model-based cost-effectiveness analysis.

OBJECTIVES: Robust economic evaluations are needed to identify efficient strategies for lung cancer prevention that combine brief and intensive smoking cessation intervention programmes with screening using low-dose computed tomography (LDCT) at different ages, frequencies, and coverages. We aimed to assess the cost-effectiveness of smoking cessation approaches combined with lung cancer screening in the European context at a population level from a societal perspective. MATERIALS AND METHODS: A microsimulation model that describes the natural history of lung cancer and incorporates several prevention strategies was developed. Discounted lifetime QALYs and costs at a rate of 3% were used to calculate incremental cost-effectiveness ratios, defined as additional costs in 2017 Euros per QALY gained. RESULTS: Smoking cessation interventions reduce the incidence of lung cancer by 8%-46% and are consistently more effective and cost-effective when starting at younger ages. Screening reduces lung cancer mortality by 1%-24% and is generally less effective and more costly than smoking cessation interventions. The most cost-effective strategy would be to implement intensive smoking cessation interventions at ages 35, 40 and 45, combined with screening every three years between the ages of 55 and 65. CONCLUSIONS: Combining smoking cessation interventions with LDCT screening is a very attractive prevention strategy that substantially diminishes the burden of lung cancer. These combined prevention strategies, especially when providing several intensive interventions for smoking cessation at early ages, are more cost-effective than both approaches separately and allow for a more intensified LDCT without losing efficiency.

Direct health care costs associated to neurological diseases and different degrees of malnutrition.

BACKGROUND AND AIMS: Home-based care and oral supplemental nutrition may be an efficient way of managing health resources, freeing up hospital resources and improving patient care and quality of life. For some conditions, such as neurodegenerative diseases and acute neurological conditions, adequate nutritional control of patients at the time of discharge, with home monitoring by a home hospitalization unit (HHU), coupled with the introduction of necessary and appropriate oral nutritional supplements for each patient, is a good strategy for ensuring the efficiency of health resources. The aim of this paper is to analyse the direct health costs, considering home care and oral nutritional supplement, of patients with newly diagnosed neurological diseases and at risk of nutritional problems. METHODS: A study was designed to measure direct health care costs of patients with neurological related diseases according to their different nutritional needs. The sample for this study consisted of all patients (n = 100) of the Elda University Hospital in Elda, Spain, with newly diagnosed neurological pathology and suspected malnutrition at hospital discharge during a six months period. These patients were included in a home base care program and given oral nutritional supplements afterwards. The nutritional intervention consisted in giving nutritional supplements according to nutritional patients' needs through a home-based care unit. Nutritional needs could comprise from protein-calorie malnutrition to at risk of malnutrition. Descriptive health care costs analysis was carried out accounting for the nutritional status. Costs are expressed in 2018 euros and for a total time horizon of one year, six months of classical inpatient care and six months of home care monitoring with a nutritional intervention. RESULTS: Mean direct health care cost for neurological patients in the six months of classical inpatient care was €8309.30 and, the direct healthcare cost of treating these patients according to their nutritional needs from a home care unit was €2970.18. The subgroup of patients that most benefited from the nutritional intervention and monitoring from the home care unit were those who were in a state of protein-calorie malnutrition or at risk of malnutrition. Under the log transformation of the variables, the Shapiro-Wilk test showed significant differences in mean costs at the 5% level for the two time periods for those suffering from protein-calorie malnutrition or at risk of malnutrition. CONCLUSIONS: It is important to measure and economically quantify the direct health care costs of patients with neurological diseases in order to be able to evaluate different hospital and home-care interventions according to different nutritional needs. Oral nutritional supplements and monitoring by the hospital home care unit could be associated with saving money when patients have protein-calorie malnutrition or at risk of malnutrition. Therefore, direct health costs information is needed to future evaluate these different management interventions.

Resource utilization and outcomes in emergency general surgery during the COVID19 pandemic: An observational cost analysis.

BACKGROUND: Over the course of the COVID19 pandemic, global healthcare delivery has declined. Surgery is one of the most resource-intensive area of medicine; loss of surgical care has had untold health and economic consequences. Herein, we evaluate resource utilization, outcomes, and healthcare costs associated with unplanned surgery admissions during the height of the pandemic in 2020 versus the same period in 2019. METHODS: Retrospective analysis on patients ≥18 years admitted from the emergency department to General & Digestive and Gastrointestinal Surgery Services between February and May 2019 and 2020 at our center; clinical outcomes and unadjusted and adjusted per-person healthcare costs were analyzed. RESULTS: Consults and admissions to surgery declined between February and May 2020 by 37% and 19%, respectively, relative to the same period in 2019, with even greater relative decline during late March and early April. Time between onset of symptoms to diagnosis increased from 2±3 days 2019 to 5±22 days 2020 (P = 0.01). Overall hospital stay was two days less in 2020 (P = 0.19). Complications (Comprehensive Complication Index 10.3±23.7 2019 vs. 13.9±25.5 2020, P = 0.10) and mortality rates (3% vs. 4%, respectively, P = 0.58) did not vary. Mean unadjusted per-person costs for patients in the 2019 and 2020 cohorts were 5,886.72€±12,576.33€ and 5,287.62±7,220.16€, respectively (P = 0.43). Following multivariate analysis, costs remained similar (4,656.89€±390.53€ 2019 vs. 4,938.54±406.55€ 2020, P = 0.28). CONCLUSIONS: Healthcare delivery and spending for unplanned general surgery admissions declined considerably due to COVID19. These results provide a small yet relevant illustration of clinical and economic ramifications of this healthcare crisis.

Who Smokes in Europe? Data From 12 European Countries in the TackSHS Survey (2017-2018).

BACKGROUND: Population data on tobacco use and its determinants require continuous monitoring and careful inter-country comparison. We aimed to provide the most up-to-date estimates on tobacco smoking from a large cross-sectional survey, conducted in selected European countries. METHODS: Within the TackSHS Project, a face-to-face survey on smoking was conducted in 2017-2018 in 12 countries: Bulgaria, England, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, and Spain, representing around 80% of the 432 million European Union (EU) adult population. In each country, a representative sample of around 1,000 subjects aged 15 years and older was interviewed, for a total of 11,902 participants. RESULTS: Overall, 25.9% of participants were current smokers (31.0% of men and 21.2% of women, P < 0.001), while 16.5% were former smokers. Smoking prevalence ranged from 18.9% in Italy to 37.0% in Bulgaria. It decreased with increasing age (compared to <45, multivariable odds ratio [OR] for ≥65 year, 0.31; 95% confidence interval [CI], 0.27-0.36), level of education (OR for low vs high, 1.32; 95% CI, 1.17-1.48) and self-rated household economic level (OR for low vs high, 2.05; 95% CI, 1.74-2.42). The same patterns were found in both sexes. CONCLUSIONS: These smoking prevalence estimates represent the most up-to-date evidence in Europe. From them, it can be derived that there are more than 112 million current smokers in the EU-28. Lower socio-economic status is a major determinant of smoking habit in both sexes.

Economic evaluation of a multimodal intervention in pre-frail and frail older people with diabetes mellitus: the MID-FRAIL project.

Background: The aim of this study was to estimate the incremental cost-utility ratio (ICUR) of a multi-modal intervention in frail and pre-frail subjects aged ≥70 years with type-2 diabetes versus usual care group focused on quality adjusted life years (QALYs) in different European countries. Methods: The MID-FRAIL study was a cluster randomized multicentre trial conducted in seven European countries. A cost-utility analysis was carried out based on this study, conducted from the perspective of the health care system with a time horizon of one year. Univariate and probabilistic analysis were carried out to test the robustness of the results. Results: The cost estimation showed the offsetting health effect of the intervention program on total health care costs. The mean annual health care costs were 25% higher among patients in usual care. The mean incremental QALY gained per patient by the intervention group were 0.053 QALY compared with usual care practice. Conclusions: The MID-FRAIL intervention program showed to be the dominant option in comparison with usual care practice. It saved costs to the health care system and achieved worthwhile health gains. This finding should encourage its implementation, at least, in the trial participant countries.

Social, economic and family factors associated with binge drinking in Spanish adolescents.

BACKGROUND: The main aim of this study was to determine the socioeconomic and family factors associated with binge drinking (BD) in Spanish adolescents who participated in a web-based computer intervention for the prevention of binge drinking known as Alerta Alcohol. METHODS: Longitudinal analyses were carried out in a sample of Andalusian adolescents aged 15 to 19 enrolled in public schools, which was part of a two-arm cluster randomized controlled trial with an intervention group (IG) who received the Alerta Alcohol programme and a control group (CG) who did not receive any active intervention. Panel count data and the following econometric procedures were used: negative binomial, a two-part model and a finite mixture model. The endogenous variable in all models was the number of BD occasions in the last 30 days. A total of 1247 subjects in the pre-intervention period, with an average age of 16.8 years, plus 612 adolescents in the follow-up period (4 months later), were included in the analysis. RESULTS: In relation to findings, being older (≥ 17 years old), having more pocket money and higher family alcohol consumption were associated with greater BD. By contrast, subjects who completed the questionnaire on Wednesday, Thursday or Friday, further from the previous weekend, indicated a lower number of BD occasions. CONCLUSIONS: Our results suggest the need to include families, especially parents and siblings, in interventions aimed at preventing alcohol use among adolescents, given the association shown between BD and both family alcohol consumption and weekly pocket money or availability of money to adolescents. Given the findings with regard to age, future research aimed at intervening in early adolescence to prevent BD would be justified. TRIAL REGISTRATION: (ClinicalTrials.gov): NCT03288896. Registration date: September 20, 2017. "Retrospectively registered".

Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?

BACKGROUND: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. OBJECTIVE: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. METHODS: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. RESULTS: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. CONCLUSIONS: Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.

Price Models for Multi-indication Drugs: A Systematic Review.

BACKGROUND: Marketing of new and existing drugs with new indications used alone or in combination is increasing. OBJECTIVE: To identify the advantages and disadvantages of indication-based pricing (IBP) systems for such drugs from the standpoint of economic theory, practical applications and international experiences. METHODS: We conducted a systematic review of published articles and reports using six bibliographic databases: PubMed, ASCO, Scopus, DARE, HTA and NHS EED. We also conducted a search of gray literature in Google Scholar. The same search terms were used as in Towse et al. (The debate on indication-based pricing in the U.S. and five major European countries. OHE Consulting Report, London, 2018). Articles and reports published from 1 January 2000 to 30 September 2018 were included. RESULTS: A total of 26 studies met the inclusion criteria. There are three main types of IBP: different brands with different prices for each indication, an averaged single price for all indications and a single price with differential discounts. The studies indicate that IBP systems are premised on the idea that charging a different price for different indications reflects the differences in their value and in social willingness to pay for each one and for the investment in R&D based on the indication's incremental clinical benefit. Some argue that a uniform price reduces access and increases the price for lower-value indications, while others contend that if IBP sets prices at the maximum threshold of social willingness to pay for each indication, all surplus is transferred to the producer and consumer surplus is reduced to zero. No practical applications of pure IBP were found. Single pricing for drugs is the most prevalent approach. The system that most closely approximates an IBP model consists of agreements that are generally confidential and linked to risk-sharing agreements. CONCLUSIONS: There are no applications of pure IBP systems and their practical consequences are therefore unknown. More economic theory-based assessments of the pros and cons of IBP and studies different from reviews are needed to capture their intricacies and specificities.

[Analysis of the evolution in the access to orphan medicines in Spain]. / Análisis de la evolución en el acceso a los medicamentos huérfanos en España.

OBJECTIVE: To assess the access to orphan medicines in Spain, focusing on those with an active "orphan" designation, as of 31st December 2017; and for those orphan medicines in the Spanish market, estimate the time between being assigned a National Code (NC) by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and being approved for launch. METHOD: We used the European Commission's Public Register of orphan medicines to identify the orphan medicines authorised by the European Medicines Agency (EMA), as of 31 December 2017, while we sourced expired orphan indications from the EMA's website. Dates when NCs were assigned were sourced from the AEMPS, and commercialisation dates from Bot PLUS. A descriptive analysis of the study variables was done. The quantitative variables were described using means and medians, as well as standard deviations and ranges. The qualitative variables were described according to absolute and relative frequencies. The comparison of results was performed by parametric and non-parametric contrasts according to the applicability, at a 5% significance level. RESULTS: The EMA has approved 100 orphan medicines (with designation as of 31/12/2017) between 2002-2017. Eighty-six have a NC assigned by the AEMPS. Fifty-four have been launched in Spain (representing 54% of the full sample; 63% with NC). For the 53 orphan drugs with launch date in Spain, the median time between receiving its NC and its launch is 13.4 months (standard deviation: 17.0; minimum: 2.1; maximum: 91,7). The median time is 12.4 months and 14.0 months for those medicines launched in Spain between 2002-2013 and 2014-2017 respectively (p = 0.46). This difference is not statistically significant, which is what could be expected given the low numbers of orphan medicines in the "population". CONCLUSION: Complex factors determine the access to orphan drugs in Europe. The centralised procedure to obtain marketing authorisation at European level is a success. However, access is more limited, given the complexities of the evaluation of the available evidence for pricing and reimbursement decisions. It is therefore necessary to implement new policies that reduce inequalities in access and help achieve sustainable healthcare systems. To achieve this, they will need to offer the possibility of allowing earlier access, and using payment by results when there is high uncertainty.

Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial.

BACKGROUND: Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres. METHODS/DESIGN: A cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out. DISCUSSION: The ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03931577.

[Health care costs of occupational disease: analysis of a patient series at a public hospital]. / Costes sanitarios de las enfermedades profesionales: análisis de una serie de pacientes de un hospital público.

The consistent under-recognition of occupational diseases (OD) in Spain leads to an exchange of patients and resources between the country's National Health System and the Social Security System. We examined the direct healthcare costs of a series of patients diagnosed with OD by the Clinical Occupational Diseases Unit in a Barcelona hospital. Information on all care associated with the diagnosis of PD was systematically reviewed. The economic value of each episode of care was obtained from the hospital cost accounting and billing system. Overall, we computed costs for 524 episodes in 33 patients. The average cost was 345.5€, being highest for hospital admissions (4,032.5€). The average cost per patient was € 5,486.2, and for cancer € 15,223.3. These results highlight the need for coordination between the National Health System and the Social Security System so that OD can be appropriately recognized.

El infra-reconocimiento secular de las enfermedades profesionales (EP) en España provoca un intercambio de pacientes y recursos entre el Sistema Nacional de Salud y el de Seguridad Social. Se estimaron los costes asistenciales directos de una serie de pacientes de un hospital de Barcelona diagnosticados de EP por su Unidad de Patología Laboral. La información sobre todas las asistencias asociadas al diagnóstico de EP fue revisada sistemáticamente. El valor económico de cada asistencia se obtuvo de la contabilidad de costes y sistema de facturación del hospital. En total, se computaron 524 asistencias de 33 pacientes, con un coste medio de 345,5€, siendo el más alto para las hospitalizaciones (4.032,5€). El coste medio por paciente fue de 5.486,2€, y para el cáncer de 15.223,3€. Estos resultados ponen de manifiesto la necesidad de coordinación entre el Sistema Nacional de Salud y el de Seguridad Social para un adecuado reconocimiento de EP.

What attributes should be included in a discrete choice experiment related to health technologies? A systematic literature review.

Discrete choice experiments (DCEs) are a way to assess priority-setting in health care provision. This approach allows for the evaluation of individuals' preferences as a means of adding criteria to traditional quality-adjusted life year analysis. The aim of this systematic literature review was to identify attributes for designing a DCE in order to then develop and validate a framework that supports decision-making on health technologies. Our systematic literature review replicated the methods and search terms used by de Bekker-Grob et al. 2012 and Clark et al. 2014. The Medline database was searched for articles dated between 2008 and 2015. The search was limited to studies in English that reflected general preferences and were choice-based, published as full-text articles and related to health technologies. This study included 72 papers, 52% of which focused on DCEs on drug treatments. The average number of attributes used in all included DCE studies was 5.74 (SD 1.98). The most frequently used attributes in these DCEs were improvements in health (78%), side effects (57%) and cost of treatment (53%). Other, less frequently used attributes included waiting time for treatment or duration of treatment (25%), severity of disease (7%) and value for money (4%). The attributes identified might inform future DCE surveys designed to study societal preferences regarding health technologies in order to better inform decisions in health technology assessment.