IPECAD Modeling Workshop 2023 Cross Comparison Challenge on Cost-Effectiveness Models in Alzheimer's Disease.

OBJECTIVES: Decision-analytic models assessing the value of emerging Alzheimer's disease (AD) treatments are challenged by limited evidence on short-term trial outcomes and uncertainty in extrapolating long-term patient-relevant outcomes. To improve understanding and foster transparency and credibility in modeling methods, we cross-compared AD decision models in a hypothetical context of disease-modifying treatment for mild cognitive impairment (MCI) due to AD. METHODS: A benchmark scenario (US setting) was used with target population MCI due to AD and a set of synthetically generated hypothetical trial efficacy estimates. Treatment costs were excluded. Model predictions (10-year horizon) were assessed and discussed during a 2-day workshop. RESULTS: Nine modeling groups provided model predictions. Implementation of treatment effectiveness varied across models based on trial efficacy outcome selection (CDR-SB, CDR-global, MMSE, FAQ) and analysis method (observed severity transitions, change from baseline, progression hazard ratio, or calibration to these). Predicted mean time in MCI ranged from 2.6-5.2 years for control strategy, and from 0.1-1.0 years for difference between intervention and control strategies. Predicted quality-adjusted life-year gains ranged from 0.0-0.6 and incremental costs (excluding treatment costs) from -US$66,897 to US$11,896. CONCLUSIONS: Trial data can be implemented in different ways across health-economic models leading to large variation in model predictions. We recommend 1) addressing the choice of outcome measure and treatment effectiveness assumptions in sensitivity analysis, 2) a standardized reporting table for model predictions, and 3) exploring the use of registries for future AD treatments measuring long-term disease progression to reduce uncertainty of extrapolating short-term trial results by health economic models.

Comorbidity and household income as mediators of gender inequalities in dementia risk: a real-world data population study.

BACKGROUND: Low household income (HI), comorbidities and female sex are associated with an increased risk of dementia. The aim of this study was to measure the mediating effect of comorbidity and HI on the excess risk due to gender in relation to the incidence and prevalence of dementia in the general population. METHODS: A retrospective and observational study using real-world data analysed all people over 60 who were registered with the Basque Health Service in Gipuzkoa. The study measured HI level, the Charlson comorbidity index (CCI), age and sex. The prevalence and incidence of dementia were analysed using logistic regression and Poisson regression models, respectively, adjusted by HI, sex, comorbidity and age. We estimated the combined mediation effect of HI and comorbidity on the prevalence of dementia associated with gender. RESULTS: Of the 221,777 individuals, 3.85% (8,549) had a diagnosis of dementia as of 31 December 2021. Classification by the CCI showed a gradient with 2.90% in CCI 0-1, 10.60% in CCI 2-3 and 18.01% in CCI > 3. Both low HI and gender were associated with a higher crude prevalence of dementia. However, in the CCI-adjusted model, women had an increased risk of dementia, while HI was no longer statistically significant. The incidence analysis produced similar results, although HI was not significant in any model. The CCI was significantly higher for men and for people with low HI. The mediation was statistically significant, and the CCI and HI explained 79% of the gender effect. CONCLUSIONS: Comorbidity and low HI act as mediators in the increased risk of dementia associated with female sex. Given the difference in the prevalence of comorbidities by HI, individual interventions to control comorbidities could not only prevent dementia but also reduce inequalities, as the risk is greater in the most disadvantaged population.

Excess healthcare costs of mental disorders in children, adolescents and young adults in the Basque population registry adjusted for socioeconomic status and sex.

BACKGROUND: Mental illnesses account for a considerable proportion of the global burden of disease. Economic evaluation of public policies and interventions aimed at mental health is crucial to inform decisions and improve the provision of healthcare services, but experts highlight that nowadays the cost implications of mental illness are not properly quantified. The objective was to measure the costs of excess use of all healthcare services by 1- to 30-year-olds in the Basque population as a function of whether or not they had a mental disorder diagnosis. METHODS: A real-world data study was used to identify diagnoses of mental disorders and to measure resource use in the Basque Health Service Registry in 2018. Diagnoses were aggregated into eight diagnostic clusters: anxiety, attention deficit hyperactivity disorder, conduct disorders, mood disorders, substance use, psychosis and personality disorders, eating disorders, and self-harm. We calculated the costs incurred by each individual by multiplying the resource use by the unit costs. Annual costs for each cluster were compared with those for individuals with no diagnosed mental disorders through entropy balancing and two-part models which adjusted for socioeconomic status (SES). RESULTS: Of the 609,381 individuals included, 96,671 (15.9%) had ≥ 1 mental disorder diagnosis. The annual cost per person was two-fold higher in the group diagnosed with mental disorders (€699.7) than that with no diagnoses (€274.6). For all clusters, annual excess costs associated with mental disorders were significant. The adjustment also evidenced a social gradient in healthcare costs, individuals with lower SES consuming more resources than those with medium and higher SES across all clusters. Nonetheless, the effect of being diagnosed with a mental disorder had a greater impact on the mean and excess costs than SES. CONCLUSIONS: Results were consistent in showing that young people with mental disorders place a greater burden on healthcare services. Excess costs were higher for severe mental disorders like self-harm and psychoses, and lower SES individuals incurred, overall, more than twice the costs per person with no diagnoses. A socioeconomic gradient was notable, excess costs being higher in low SES individuals than those with a high-to-medium SES. Differences by sex were also statistically significant but their sizes were smaller than those related to SES.

Cost-utility analysis of the UPRIGHT intervention promoting resilience in adolescents.

BACKGROUND: As mental health in adulthood is related to mental status during adolescence, school-based interventions have been proposed to improve resilience. The objective of this study was to build a simulation model representing the natural history of mental disorders in childhood, adolescence and youth to estimate the cost-effectiveness of the UPRIGHT school-based intervention in promoting resilience and mental health in adolescence. METHODS: We built a discrete event simulation model fed with real-world data (cumulative incidence disaggregated into eight clusters) from the Basque Health Service database (609,381 individuals) to calculate utilities (quality-adjusted life years [QALYs]) and costs for the general population in two scenarios (base case and intervention). The model translated changes in the wellbeing of adolescents into different risks of mental illnesses for a time horizon of 30 years. RESULTS: The number of cases of anxiety was estimated to fall by 5,125 or 9,592 and those of depression by 1,269 and 2,165 if the effect of the intervention lasted 2 or 5 years respectively. From a healthcare system perspective, the intervention was cost-effective for all cases considered with incremental cost-utility ratios always lower than €10,000/QALY and dominant for some subgroups. The intervention was always dominant when including indirect and non-medical costs (societal perspective). CONCLUSIONS: Although the primary analysis of the trial did not did not detect significant differences, the UPRIGHT intervention promoting positive mental health was dominant in the economic evaluation from the societal perspective. Promoting resilience was more cost-effective in the most deprived group. Despite a lack of information about the spillover effect in some sectors, the economic evaluation framework developed principally for pharmacoeconomics can be applied to interventions to promote resilience in adolescents. As prevention of mental health disorders is even more necessary in the post-coronavirus disease-19 era, such evaluation is essential to assess whether investment in mental health promotion would be good value for money by avoiding costs for healthcare providers and other stakeholders.

Incidence of mental disorders in the general population aged 1-30 years disaggregated by gender and socioeconomic status.

PURPOSE: The objective of this study was to estimate the incidence and age of onset of mental disorders diagnosed by gender and socioeconomic status (SES) in children, adolescents, and young adults up to 30 years of age in the whole population of the Basque Country (Spain). METHODS: All mental health diagnoses documented in Basque Health Service records from 1 January 2003 to 31 December 2018, were classified into eight clusters: anxiety, attention deficit hyperactivity disorder (ADHD), conduct disorders, depression, psychosis/personality disorders, substance use, eating disorders, and self-harm. We calculated incidence and cumulative incidence for each cluster, disaggregated by gender, and socioeconomic status (SES). Poisson regression analyses were performed. RESULTS: Overall, 9,486,853 person-years of observation were available for the 609,281 individuals included. ADHD and conduct disorders were diagnosed in the first decade, anxiety and depression disorders in the second and third decades, and psychosis/personality and substance use in the third. The cumulative incidence at 18 years of age for any type of disorder was 15.5%. The group with low SES had a statistically significantly higher incidence of all eight clusters. The incidence of ADHD, conduct disorders, depression, psychosis/personality disorders, and substance use was higher in males and that of anxiety, eating disorders and self-harm was higher in females. CONCLUSIONS: The incidence of mental disorders is high among children, adolescents, and young adults in the Basque Country underlining the need for preventive interventions. Marked differences by gender and SES highlight mental health inequalities, especially for depression and psychosis in low SES males.

Cost-effectiveness models for Alzheimer's disease and related dementias: IPECAD modeling workshop cross-comparison challenge.

INTRODUCTION: The credibility of model-based economic evaluations of Alzheimer's disease (AD) interventions is central to appropriate decision-making in a policy context. We report on the International PharmacoEconomic Collaboration on Alzheimer's Disease (IPECAD) Modeling Workshop Challenge. METHODS: Two common benchmark scenarios, for the hypothetical treatment of AD mild cognitive impairment (MCI) and mild dementia, were developed jointly by 29 participants. Model outcomes were summarized, and cross-comparisons were discussed during a structured workshop. RESULTS: A broad concordance was established among participants. Mean 10-year restricted survival and time in MCI in the control group ranged across 10 MCI models from 6.7 to 9.5 years and 3.4 to 5.6 years, respectively; and across 4 mild dementia models from 5.4 to 7.9 years (survival) and 1.5 to 4.2 years (mild dementia). DISCUSSION: The model comparison increased our understanding of methods, data used, and disease progression. We established a collaboration framework to assess cost-effectiveness outcomes, an important step toward transparent and credible AD models.

Cost-effectiveness analysis of text messaging to support health advice for smoking cessation.

BACKGROUND: Smoking in one of the most serious public health problems. It is well known that it constitutes a major risk factor for chronic diseases and the leading cause of preventable death worldwide. Due to high prevalence of smokers, new cost-effective strategies seeking to increase smoking cessation rates are needed. METHODS: We performed a Markov model-based cost-effectiveness analysis comparing two treatments: health advice provided by general practitioners and nurses in primary care, and health advice reinforced by sending motivational text messages to smokers' mobile phones. A Markov model was used in which smokers transitioned between three mutually exclusive health states (smoker, former smoker and dead) after 6-month cycles. We calculated the cost-effectiveness ratio associated with the sending of motivational messages. Health care and society perspectives (separately) was adopted. Costs taken into account were direct health care costs and direct health care cost and costs for lost productivity, respectively. Additionally, deterministic sensitivity analysis was performed modifying the probability of smoking cessation with each option. RESULTS: Sending of text messages as a tool to support health advice was found to be cost-effective as it was associated with increases in costs of €7.4 and €1,327 per QALY gained (ICUR) for men and women respectively from a healthcare perspective, significantly far from the published cost-effectiveness threshold. From a societal perspective, the combined programmed was dominant. CONCLUSIONS: Sending text messages is a cost-effective approach. These findings support the implantation of the combined program across primary care health centres.

Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer.

BACKGROUND: It has been argued that laparoscopy should be a standard treatment in rectal cancer due to its greater technical complexity. The objective of this study was to conduct a cost-effectiveness analysis to compare laparoscopy with open surgery for rectal cancer adjusting for age and clinical stage. METHODS: A real-world prospective cost-effectiveness cohort study was conducted with data on costs and effectiveness at individual patient level. A "genetic matching" algorithm was used to correct for selection bias. After balancing the sample groups, combined multivariate analysis of total costs and quality-adjusted life years (QALYs) was performed using seemingly unrelated regression (SUR) models. These models were first constructed without interactions and, subsequently, effects of any age-stage interaction were analyzed. RESULTS: The sample included 601 patients (400 by laparoscopy and 201 by open surgery). Crude cost-effectiveness analysis indicated that overall laparoscopy was cheaper and associated with higher QALYs. The SUR models without interactions showed that while laparoscopy remained dominant, the incremental effectiveness decreased to the point that it offered no statistically significant benefits over open surgery. In the subgroup analysis, at advanced stages of the disease, although none of the coefficients were significant, the mean incremental effectiveness (QALYs value) for laparoscopy was positive in younger patients and negative in older patients. Further, for advanced stages, the mean cost of open surgery was lower in both age subgroups but differences did not reach statistical significance. In early stages, laparoscopy cost was significantly lower in the subgroup younger than 70 and higher in the older subgroup. CONCLUSIONS: The cost-effectiveness of laparoscopy in surgery for rectal cancer justifies this being the standard surgical procedure in young patients and those at initial stages. The choice of procedure should be discussed with patients who are older and/or in advanced stages of the disease. Trial registration ClinicalTrials.gov Identifier: NCT02488161.

Inequalities in health-related quality of life according to age, gender, educational level, social class, body mass index and chronic diseases using the Spanish value set for Euroquol 5D-5L questionnaire.

BACKGROUND: Reducing health inequalities on the basis of social factors has been a key driver in the development of Public Health policies. Health-related quality of life is a global indicator useful to assess health inequalities within a society. The objective of this study was to identify inequalities on health by analysing the interactive effects of gender, age, educational level, social class, body mass index and chronic diseases on health-related quality of life in a Spanish population sample. METHODS: We used data from the Spanish National Health Survey 2011-2012. Health-related quality of life was measured by the EQ-5D-5L instrument applying the Spanish value set. Probability of being in perfect health was ascertained by logistic regression models including gender, age, educational level, body mass index and social class and the corresponding terms of interaction. A two-part model combining logistic regression analysis and generalized linear models was applied to calculate the adjusted utility loss associated with chronic conditions (disutility values). RESULTS: The sample used for analysis contained 18,450 individuals. The mean age was 50 years, 51.3% were women, 55% were overweight or obese and 46.7% had low social status. The mean utility was 0.94 in men and 0.89 in women. Elderly women, obese people, those of low social class and those with chronic conditions had significant lower utility values. Within the regression analysis, interaction assessment revealed that the detrimental effect of obesity disappeared in higher social classes. Utility values for all chronic conditions considered were lower in women than in men and were on a gradient within social class, the lowest for individuals declaring stroke. The greatest decrease on health-related quality of life was determined by declaration of stroke (17.6%) or mental diseases (18.6%). CONCLUSIONS: The interactive effects of gender, age, educational level, social class, body mass index and chronic diseases on health-related quality of life in the Spanish population revealed important inequalities in health. Social class acted as a modulator of the stigma associated with obesity. Chronic conditions producing loss of autonomy had the greatest impact on reduction of health-related quality of life. This is the first study using the Spanish EQ-5D-5L value set to estimate utilities.

Gender and socioeconomic inequalities in the implementation of the Basque programme for multimorbid patients.

BACKGROUND: The aim of our study was to increase awareness of the relevance of the implemented programmes to inequity of access and inequality of health by analyzing the impact of a patient-centred strategy for multimorbid patients. METHODS: This retrospective study compared the 2014 multimorbid patient group (intervention group) with its 2012 analogue (control group), before the Department of Health of the Basque Country launched the strategy for managing disease chronicity. Inequalities in healthcare access were represented by differences in the inclusion of patients in the programme and in contacts with primary care (PC) services by gender and socioeconomic status (measured by deprivation index by census track). Likewise, differences in hospital care represented inequalities in health outcomes. Generalized linear models were used to analyze relationships among variables. A propensity score by a genetic matching approach was used to minimize possible selection bias. RESULTS: At baseline, women had less probability of being eligible for the programme. No clear patterns were seen in resource consumption in PC. The probability of hospitalization was higher for men and increased according to socioeconomic status. The implementation of the programme yielded more contacts with PC services in all groups and a reduction in hospitalizations, especially among men and the most socioeconomically deprived patients. CONCLUSION: The patient-centred, integrated-care intervention launched by the Department of Health of the Basque Country might have reduced some gender and socioeconomic inequalities in health outcomes, as it avoided more hospitalizations in subgroups that presented with more episodes of decompensation in the reference year.

[The impact of patient identification on an integrated program of palliative care in Basque Country]. / Impacto de la identificación de pacientes en un programa de cuidados paliativos del País Vasco.

OBJECTIVE: Evaluate the process and the economic impact of an integrated palliative care program. DESIGN: Comparative cross-sectional study. LOCATION: Integrated Healthcare Organizations of Alto Deba and Goierri Alto-Urola, Basque Country. PARTICIPANTS: Patients dead due to oncologic and non-oncologic causes in 2012 (control group) and 2015 (intervention group) liable to need palliative care according to McNamara criteria. INTERVENTIONS: Identification as palliative patients in primary care, use of common clinical pathways in primary and secondary care and arrange training courses for health professionals. MAIN MEASURES: Change in the resource use profile of patients in their last 3 months. Propensity score by genetic matching method was used to avoid non-randomization bias. The groups were compared by univariate analysis and the relationships between variables were analysed by logistic regressions and generalized linear models. RESULTS: One thousand and twenty-three patients were identified in 2012 and 1,142 patients in 2015. In 2015 doubled the probability of being identify as palliative patient in deaths due to oncologic (19-33%) and non-oncologic causes (7-16%). Prescriptions of opiates rise (25-68%) and deaths in hospital remained stable. Contacts per patient with primary care and home hospitalization increased, while contacts with hospital admissions decreased. Cost per patient rise 26%. CONCLUSIONS: The integrated palliative care model increased the identification of the target population. Relationships between variables showed that the identification had a positive impact on prescription of opiates, death outside the hospital and extension to non-oncologic diseases. Although the identification decreased admissions in hospital, costs per patient had a slight increase due to home hospitalizations.

Determinants of Informal Care, Burden, and Risk of Burnout in Caregivers of Stroke Survivors: The CONOCES Study.

BACKGROUND AND PURPOSE: The aim of this article was to analyze the likelihood of receiving informal care after a stroke and to study the burden and risk of burnout of primary caregivers in Spain. METHODS: The CONOCES study is an epidemiological, observational, prospective, multicenter study of patients diagnosed with stroke and admitted to a Stroke Unit in the Spanish healthcare system. At 3 and 12 months post-event, we estimated the time spent caring for the patient and the burden borne by primary caregivers. Several multivariate models were applied to estimate the likelihood of receiving informal caregiving, the burden, and the likelihood of caregivers being at a high risk of burnout. RESULTS: Eighty percent of those still alive at 3 and 12 months poststroke were receiving informal care. More than 40% of those receiving care needed a secondary caregiver at 3 months poststroke. The likelihood of receiving informal care was associated with stroke severity and the individual's health-related quality of life. When informal care was provided, both the burden borne by caregivers and the likelihood of caregivers being at a high risk of burnout was associated with (1) caregiving hours; (2) the patient's health-related quality of life; (3) the severity of the stroke measured at discharge; (4) the patient having atrial fibrillation; and (5) the degree of dependence. CONCLUSIONS: This study reveals the heavy burden borne by the caregivers of stroke survivors. Our analysis also identifies explanatory and predictive variables for the likelihood of receiving informal care, caregiver burden, and high risk of burnout.

Cost-effectiveness and budget impact analyses of a colorectal cancer screening programme in a high adenoma prevalence scenario using MISCAN-Colon microsimulation model.

BACKGROUND: The Basque Colorectal Cancer Screening Programme began in 2009 and the implementation has been complete since 2013. Faecal immunological testing was used for screening in individuals between 50 and 69 years old. Colorectal Cancer in Basque country is characterized by unusual epidemiological features given that Colorectal Cancer incidence is similar to other European countries while adenoma prevalence is higher. The object of our study was to economically evaluate the programme via cost-effectiveness and budget impact analyses with microsimulation models. METHODS: We applied the Microsimulation Screening Analysis (MISCAN)-Colon model to predict trends in Colorectal Cancer incidence and mortality and to quantify the short- and long-term effects and costs of the Basque Colorectal Cancer Screening Programme. The model was calibrated to the Basque demographics in 2008 and age-specific Colorectal Cancer incidence data in the Basque Cancer Registry from 2005 to 2008 before the screening begun. The model was also calibrated to the high adenoma prevalence observed for the Basque population in a previously published study. The multi-cohort approach used in the model included all the cohorts in the programme during 30 years of implementation, with lifetime follow-up. Unit costs were obtained from the Basque Health Service and both cost-effectiveness analysis and budget impact analysis were carried out. RESULTS: The goodness-of-fit of the model adaptation to observed programme data was evidence of validation. In the cost-effectiveness analysis, the savings from treatment were larger than the added costs due to screening. Thus, the Basque programme was dominant compared to no screening, as life expectancy increased by 29.3 days per person. The savings in the budget analysis appeared 10 years after the complete implementation of the programme. The average annual budget was €73.4 million from year 2023 onwards. CONCLUSIONS: This economic evaluation showed a screening intervention with a major health gain that also produced net savings when a long follow-up was used to capture the late economic benefit. The number of colonoscopies required was high but remain within the capacity of the Basque Health Service. So far in Europe, no other population Colorectal Cancer screening programme has been evaluated by budget impact analysis.

Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer.

BACKGROUND: Few economic evaluations have assessed laparoscopy for colon cancer. This study aimed to compare the cost-effectiveness of laparoscopic and open surgery for the treatment of colon cancer. METHOD: A cost-effectiveness analysis was performed comparing two groups of patients treated according to standard clinical practice (REDISSEC-CARESS/CCR cohort) by laparoscopic or open surgery. Data were collected from health records on clinical characteristics and resource use over 2 years after surgery. To calculate the incremental cost-effectiveness ratio, costs and quality-adjusted life years (QALYs) were obtained for each patient. Clinical heterogeneity was addressed using propensity score and joint multivariable analysis (seemingly unrelated regression) that included interactions between TNM stage, age, and surgical procedure to perform subgroup analysis. RESULTS: The sample was composed of 1591 patients, 963 who underwent laparoscopy and 628 open surgery. Using propensity score and regression analysis, we found that laparoscopy was associated with more QALYs and less resource use than open surgery (0.0163 QALYs, 95% CI 0.0114-0.0212; and - €3461, 95% CI - 3337 to - 3586). Costs were lower for laparoscopy in all subgroups. In the subgroups younger than 80 years old, utility was higher in patients who underwent laparoscopy. Nevertheless, open surgery had better outcomes in older patients in stages I-II (0.0618 QALYs) and IV (0.5090 QALYs). CONCLUSION: Overall, laparoscopy appears to be dominant, resulting in more QALYs and lower costs. Nevertheless, while laparoscopy required fewer resources in all subgroups, outcomes may be negatively affected in elderly patients, representing an opportunity for shared decision making between surgeons and patients. ClinicalTrials.gov Identifier: NCT02488161.

Economic evaluation of a population strategy for the treatment of chronic hepatitis C with direct-acting antivirals.

The high initial cost of antivirals against hepatitis C prompted development of the "Strategic Plan for Tackling Chronic Hepatitis C in the Spanish National Health System". The objective of this study was the economic evaluation of the first two years of its application in Navarre, Spain. The change in the natural history of hepatitis C produced by the sustained virological response (SVR) was compared to an alternative without treatment and modeled with patient-level data. By means of a discrete events simulation model, the cost-effectiveness and the budget impact analysis of the treatment program were measured from the perspective of the Navarre Health Service. Of 656 patients treated, 98% had SVR. The average cost of the treatments was 18,743 euros per patient. The incremental cost-effectiveness ratio (ICER) with discount was 5,346 euros per quality-adjusted life years, which became more efficient as the stage of fibrosis increased until it reached levels of dominance in stage 4 fibrosis. The associated costs for chronic liver disease decreased as the benefit of the treatment was expressed. The implementation of the Strategic Plan is cost-effective, with an ICER well below the threshold, since the cost of treatment is largely compensated by savings in long-term health expenditure. The budgetary impact foresees a net saving from the third year on. The two key parameters were the decrease in the price of the treatment and the SVR in nearly 100% of the patients.

Incorporating Budget Impact Analysis in the Implementation of Complex Interventions: A Case of an Integrated Intervention for Multimorbid Patients within the CareWell Study.

OBJECTIVES: To develop a framework for the management of complex health care interventions within the Deming continuous improvement cycle and to test the framework in the case of an integrated intervention for multimorbid patients in the Basque Country within the CareWell project. METHODS: Statistical analysis alone, although necessary, may not always represent the practical significance of the intervention. Thus, to ascertain the true economic impact of the intervention, the statistical results can be integrated into the budget impact analysis. The intervention of the case study consisted of a comprehensive approach that integrated new provider roles and new technological infrastructure for multimorbid patients, with the aim of reducing patient decompensations by 10% over 5 years. The study period was 2012 to 2020. RESULTS: Given the aging of the general population, the conventional scenario predicts an increase of 21% in the health care budget for care of multimorbid patients during the study period. With a successful intervention, this figure should drop to 18%. The statistical analysis, however, showed no significant differences in costs either in primary care or in hospital care between 2012 and 2014. The real costs in 2014 were by far closer to those in the conventional scenario than to the reductions expected in the objective scenario. The present implementation should be reappraised, because the present expenditure did not move closer to the objective budget. CONCLUSIONS: This work demonstrates the capacity of budget impact analysis to enhance the implementation of complex interventions. Its integration in the context of the continuous improvement cycle is transferable to other contexts in which implementation depth and time are important.

The cost of colorectal cancer according to the TNM stage. / Valoración del coste económico del cáncer colorrectal según estadio tumoral.

INTRODUCTION: The aim of this study was to measure the cost of treatment of colorectal cancer in the Basque public health system according to the clinical stage. METHODS: We retrospectively collected demographic data, clinical data and resource use of a sample of 529 patients. For stagesi toiii the initial and follow-up costs were measured. The calculation of cost for stageiv combined generalized linear models to relate the cost to the duration of follow-up based on parametric survival analysis. Unit costs were obtained from the analytical accounting system of the Basque Health Service. RESULTS: The sample included 110 patients with stagei, 171 with stageii, 158 with stageiii and 90 with stageiv colorectal cancer. The initial total cost per patient was 8,644€ for stagei, 12,675€ for stageii and 13,034€ for stageiii. The main component was hospitalization cost. Calculated by extrapolation for stageiv mean survival was 1.27years. Its average annual cost was 22,403€, and 24,509€ to death. The total annual cost for colorectal cancer extrapolated to the whole Spanish health system was 623.9million€. CONCLUSIONS: The economic burden of colorectal cancer is important and should be taken into account in decision-making. The combination of generalized linear models and survival analysis allows estimation of the cost of metastatic stage.

Economic evaluation of the breast cancer screening programme in the Basque Country: retrospective cost-effectiveness and budget impact analysis.

BACKGROUND: Breast cancer screening in the Basque Country has shown 20 % reduction of the number of BC deaths and an acceptable overdiagnosis level (4 % of screen detected BC). The aim of this study was to evaluate the breast cancer early detection programme in the Basque Country in terms of retrospective cost-effectiveness and budget impact from 1996 to 2011. METHODS: A discrete event simulation model was built to reproduce the natural history of breast cancer (BC). We estimated for lifetime follow-up the total cost of BC (screening, diagnosis and treatment), as well as quality-adjusted life years (QALY), for women invited to participate in the evaluated programme during the 15-year period in the actual screening scenario and in a hypothetical unscreened scenario. An incremental cost-effectiveness ratio was calculated with the use of aggregated costs. Besides, annual costs were considered for budget impact analysis. Both population level and single-cohort analysis were performed. A probabilistic sensitivity analysis was applied to assess the impact of parameters uncertainty. RESULTS: The actual screening programme involved a cost of 1,127 million euros and provided 6.7 million QALYs over the lifetime of the target population, resulting in a gain of 8,666 QALYs for an additional cost of 36.4 million euros, compared with the unscreened scenario. Thus, the incremental cost-effectiveness ratio was 4,214€/QALY. All the model runs in the probabilistic sensitivity analysis resulted in an incremental cost-effectiveness ratio lower than 10,000€/QALY. The screening programme involved an increase of the annual budget of the Basque Health Service by 5.2 million euros from year 2000 onwards. CONCLUSIONS: The BC screening programme in the Basque Country proved to be cost-effective during the evaluated period and determined an affordable budget impact. These results confirm the epidemiological benefits related to the centralised screening system and support the continuation of the programme.

Proposal to inform European institutions regarding the regulation of conscientious objection to abortion.

The aim of this paper is to define a set of proposals to inform European institutions in the regulation of Conscientious Objection to abortion. The board of the European Society of Contraception and Reproductive Health Care (ESC) was informed on the elements that should in the opinion of the authors be included in a future regulation of Conscientious Objection to abortion in Europe. These elements are outlined in this paper and the debate about them could form the basis for recommendations to the international scientific community and the European institutions. As current measures governing the principle of conscientious objection result in negative consequences regarding women's access to sexual and reproductive health services, they should be changed. Healthcare services should adopt measures to guarantee that a woman's right to voluntary abortion is not limited by the practitioner's stance on the principle of conscientious objection. In the countries where conscientious objection is allowed, the regulation must clearly delineate the extent of the duties and the exemptions of professionals based on the principles of established social consensus. The recommendations included in this document specify measures on the rights of women, the rights and duties of the practitioner, the role of institutions and the role of professional associations.

Cost-effectiveness analysis of sofosbuvir-based regimens for chronic hepatitis C.

BACKGROUND: A new scenario of therapy for chronic hepatitis C (CHC) is being established with the approval of sofosbuvir (SOF). OBJECTIVE: To estimate the cost-effectiveness of SOF-based regimens approved in the Summary of Product Characteristics (SmPC) versus the standard of care for different genotypes and patient populations (naive or pretreated). METHODS: A Markov model simulating CHC progression was used to estimate disease treatment costs and effects over patients' lifetimes, from the Spanish National Public Healthcare System perspective. Different therapeutic options were analysed for genotypes 1, 2 and 3 in naive population and for genotype 2 and 3 pretreated patients, according to data obtained from clinical trials. A one-way sensitivity analysis was performed to evaluate the uncertainty of certain parameters: treatment starting age, transition probabilities, drug costs and discount rate. A probabilistic sensitivity analysis was also carried out. RESULTS: For the naive population, the option SOF+pegylated-interferon-α (pIFN)+ribavirin (RBV) for 12 weeks recorded in SmPC for genotype 1 and 3 versus pIFN+RBV for 24 weeks estimated an incremental cost-effectiveness ratio (ICER) below the €40,000/quality-adjusted life-year (QALY) benchmark. For the pretreated population, SOF triple therapy reached an ICER on the threshold limit for genotype 3. Other options included in SmPC for different genotypes exceeded the accepted efficiency limit in our setting. CONCLUSIONS: The options that included SOF+RBV+pIFN in a 12-week course regimen fell below the efficiency threshold considered in our setting. IFN-free regimens administered for 24 weeks reached figures over the benchmark of €40,000/QALY.