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To estimate the cost-effectiveness of olaparib after being funded by the Spanish National Health Service (SNHS) as first-line monotherapy maintenance treatment in patients with advanced high-grade serous ovarian carcinoma (HGSOC) and BRCA mutations in Spain. A semi-Markov model with one-month cycles was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a time horizon of 50 years. Two scenarios were compared: receiving olaparib vs. no maintenance treatment. The model comprised four health states and included the clinical results of the SOLO1 study, along with the direct healthcare costs associated with the use of first-line and subsequent treatment resources (2020 €). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was also carried out and a cost-effectiveness threshold of €25,000 per quality adjusted life year (QALY) was considered. The introduction of olaparib as a first-line maintenance treatment for advanced HGSOC patients with BRCA mutations implied a cost of €131,614.98 compared to €102,369.54 without olaparib (difference: €29,245.44), with an improvement of 2.00 QALYs (5.56 and 3.57, respectively). Therefore, olaparib is cost-effective for advanced HGSOC patients with BRCA mutations, with an incremental cost-effectiveness ratio of €14,653.2/QALY. The results from the PSA showed that 92.1% of the simulations fell below the €25,000/QALY threshold. The model showed that olaparib could improve the overall survival by 2 years, vs. no maintenance treatment. Olaparib as first-line maintenance treatment is cost-effective in advanced HGSOC patients with BRCA mutations in Spain. • Our results suggest that olaparib could delay disease progression and improve OS by 2 years vs. no maintenance treatment. • Treatment with olaparib resulted in a gain of 2.00 QALYs vs. no maintenance treatment, at an ICER of €14,653,2/QALY. • First-line maintenance with olaparib is cost-effective in advanced HGSOC patients with BRCA mutations in Spain. [ABSTRACT FROM AUTHOR]

Introduction: In recent years, target therapies to specific molecular alterations in advanced non--small cell lung cancer (NSCLC) have been identified and have shown superior efficacy compared to non-targeted treatments. Anaplastic lymphoma kinase (ALK) is one of the therapeutic targets; nevertheless, ALK diagnosis is not performed in all NSCLC patients in Spain. The objective of this study is to estimate in monetary terms the benefit for the Spanish society of ALK diagnosis in advanced NSCLC patients. Methods: A cost-benefit analysis of ALK diagnosis vs. non-diagnosis in advanced NSCLC patients was carried out from the Spanish social perspective, with a time horizon of 5 years. Costs, benefits and the cost-benefit ratio were measured. The analysis has considered the overall survival in advanced NSCLC patients treated with the ALKtyrosine kinase inhibitor (TKI) alectinib. The natural history of NSCLC was simulated using a Markov model. A 3% discount rate was applied to both costs and benefits. The result was tested using a deterministic sensitivity analysis. Results: The cost of ALK diagnosis vs. non-diagnosis in the base case would be €10.19 million, generating benefits of €11.71 million. The cost-benefit ratio would be €1.15. In the sensitivity analysis, the cost-benefit ratio could range from €0.89 to €2.10. Conclusions: The results justify the universal application of ALK diagnosis in advanced NSCLC, which generates a benefit for Spanish society that outweighs its costs and allows optimal treatment with targeted therapies for these patients. [ABSTRACT FROM AUTHOR]

Invasive meningococcal disease (IMD) is a severe infectious disease, mainly affecting children under 5 years, associated with long-term physical, neurological and psychological sequelae. In Spain, most IMD cases are caused by meningococcal serogroup B (MenB). This study estimates its economic burden from a societal perspective in Spain. A previously published bottom-up, model-based incidence costing approach by Scholz et al. (2019) to estimate the economic burden of MenB in Germany was adapted to the Spanish setting. Diagnosis and age-related costs for a hypothetical Spanish cohort were calculated over a lifetime horizon. Official Spanish databases, literature and expert opinion were used as data sources. The costs were updated to 2019 prices, and a 3% discount rate was applied. Direct costs related to the acute IMD phase, long-term sequelae, rehabilitation and public health response were considered. Indirect costs included productivity losses and premature mortality and were calculated using the human-capital approach (HCA) and friction-cost approach (FCA). Deterministic and probabilistic sensitivity analyses were also performed. At base-case, the total cost for a cohort of 142 patients (2017–2018 period) was €4.74 million (€33,484/case) using the FCA and €13.14 million (€92,768/case) using the HCA. Direct costs amounted to €4.65 million (€32,765/case). Sequelae costs represented 62.46% of the total cost using the FCA and 77.63% using the HCA. Deterministic sensitivity analysis showed that variation of ± 20% in the input parameter values (population, epidemiology, productivity, costs) had the greatest influence on the base-case results, and the probabilistic sensitivity analysis showed the probability of fitting base-case estimates was > 99%, both for FCA and HCA. MenB IMD is an uncommon but severe disease, with a high economic burden for Spanish society. The elevated costs per IMD case reflect its severity in each patient suffering this disease, especially due to the development of sequelae. [ABSTRACT FROM AUTHOR]

Introduction: Emicizumab is a first-in-class monoclonal antibody, recently authorized for the treatment of hemophilia A with inhibitors. This study aims to estimate the direct and indirect costs of the management of hemophilia A with inhibitors, in adult and pediatric patients, including the prophylaxis with emicizumab. Methods: We calculated the costs of the on-demand and prophylactic treatments with bypassing agents (activated prothrombin complex concentrate and recombinant activated factor VII) and the emicizumab prophylaxis, from the societal perspective, over 1 year. The study considered direct healthcare costs (drugs, visits, tests, and hospitalizations), direct non-healthcare costs (informal caregivers), and indirect costs (productivity loss). Data were obtained from a literature review and were validated by an expert group. Costs were expressed in 2019 euros. Results: Our results showed that the annual costs of the prophylactic treatment per patient varied between €543,062.99 and €821,415.77 for adults, and €182,764.43 and €319,826.59 for children, while on-demand treatment was €532,706.84 and €789,341.91 in adults, and €167,523.05 and €238,304.71 in pediatric patients. In relation to other prophylactic therapies, emicizumab showed the lowest costs, with up to a 34% and 43% reduction in the management cost of adult and pediatric patients, respectively. It reduced the bleeding events and administration costs, as this drug is less frequently administered by subcutaneous route. Emicizumab prophylaxis also decreased the cost of other healthcare resources such as visits, tests, and hospitalizations, as well as indirect costs. Conclusion: In comparison to prophylaxis with bypassing agents, emicizumab reduced direct and indirect costs, resulting in cost savings for the National Health System and society. [ABSTRACT FROM AUTHOR]

Introduction: In March 2020, due to the pandemic caused by COVID-19, a pilot experience of pharmaceutical continuity of care received by hospital outpatients was launched in Cantabria, a Spanish autonomous community. Thanks to this experience, the medication was dispensed by the hospital pharmacy through the community pharmacy of the patient's choice. Our objective was to estimate the costs avoided by this practice during the months of April and May 2020. Methods: The analysis of the economic impact was carried out in terms of saved costs, from the hospital and from the social perspective. Savings associated with the avoided home delivery of medication and avoided labor productivity losses were calculated, as well as the time associated with avoided trips in monetary terms. Results: A total of 2,249 hospital-dispensed drugs were delivered through the community pharmacy in the analyzed period, with an average of 57.7 daily deliveries. The experience, which involved one hospital and 262 pharmacies of Cantabria, saved patients 93,305 km in trips to the hospital, associated with an average time saving of 1,374 hours. In terms of costs, the hospital saved on shipments by courier, estimated at €30,205, since it was the community pharmacy and the distribution warehouses that delivered the drugs. From a social perspective, this initiative saved €23,309 due to the trips (€8,907) and productivity losses (€14,402) that were avoided. Conclusions: This exceptional situation may be a good opportunity to improve the coordination between hospital pharmacies and community pharmacies in Spain, not only during the pandemic but also in the post-COVID-19 era. [ABSTRACT FROM AUTHOR]

The treatment of iron deficiency (ID) with ferric carboxymaltose (FCM) improves the functional class and quality of life of chronic heart failure (CHF) patients with reduced left ventricular ejection fraction (LVEF), and reduces the rate of hospitalization due to worsening CHF. This study aims to evaluate the budget impact for the Spanish National Health System (SNHS) of treating ID in reduced LVEF CHF with FCM compared to non-iron treatment. We simulated a hypothetical cohort of 1000 CHF patients with ID and reduced LVEF based on the Spanish population characteristics. A decision-analytic model was also built using the data from the largest FCM clinical trial (CONFIRM-HF) that lasted for a year. We considered the use of healthcare resources from a national prospective study. A deterministic sensitivity analysis was carried out varying the corresponding baseline data by ±25%. The cost of treating the simulated population with FCM was €2,570,914, while that of the non‐iron treatment was €3,105,711, which corresponds to a cost saving of €534,797 per 1,000 patients in one year. Cost savings were mainly due to a decrease in the number of hospitalizations. All sensitivity analysis showed cost savings for the SNHS. FCM results in an annual cost saving of €534.80 per patient, and would thus be expected to reduce the economic burden of CHF in Spain. [ABSTRACT FROM AUTHOR]

Aims: We aim to agree on a set of proposals to improve the current management of heart failure (HF) within the Spanish National Health System (SNHS) and apply the social return on investment (SROI) method to measure the social impact that these proposals would generate. Methods and results: A multidisciplinary working team of 16 experts was set up, with representation from the main stakeholders regarding HF: medical specialists (cardiologists, internal medicine physicians, general practitioners, and geriatric physicians), nursing professionals, health management professionals, patients, and informal caregivers. This team established a set of proposals to improve the management of HF according to the main areas of HF care: emergency and hospitalization, primary care, cardiology, and internal medicine. A forecast‐type SROI method, with a 1‐year time frame, was applied to measure the social impact resulting from the implementation of these proposals. The required investment and social return were estimated and summarized into a ratio indicating how much social return could be generated for each euro invested. Intangible returns were included and quantified through financial proxies. The approach to improve the management of HF consisted of 28 proposals, including the implementation of a case management nurse network, standardization of operational protocols, psychological support, availability of echocardiography machines at emergency departments, stationary units and primary care, early specialist visits after hospital discharge, and cardiac rehabilitation units, among others. These proposals would benefit not only patients and their informal caregivers but also the SNHS. Regarding patients, proposals would increase their autonomy in everyday activities, decrease anxiety, increase psychological and physical well‐being, improve pharmacological adherence and self‐care, enhance understanding of the disease, delay disease progression, expedite medical assessment, and prevent the decrease in work productivity associated with HF management. Regarding informal caregivers, proposals would increase their quality of life; improve their social, economic, and emotional well‐being; and reduce their care burden. The SNHS would benefit from shorter stays of HF patients at intensive care units and reduction of hospitalizations and admissions to emergency departments. The investment needed to implement these proposals would amount to €548m and yield a social return of €1932m, that is, €3.52 for each euro invested. Conclusions: The current management of HF could be improved by a set of proposals that resulted in an overall positive social return, varying between areas of analysis. This may guide the allocation of healthcare resources and improve the quality of life of patients with HF. [ABSTRACT FROM AUTHOR]

Introduction: Psoriasis is a chronic disease in which patients feel stigmatization, social rejection, and suffer from low self-esteem. There are still unmet needs that make it necessary to define a new multidisciplinary approach to provide benefits not only to patients and their families but also to the Spanish National Health System (SNHS) and society. The aim was to define a new approach to better address the unmet needs of patients with psoriasis within the SNHS and to measure its impact from a social perspective, that is, in clinical, health care, economic, and social terms. Methods: Multidisciplinary experts identified, agreed on, and selected several health care interventions that were feasible for implementation in the SNHS. This process was carried out in four different areas: diagnosis, mild psoriasis, moderate psoriasis, and severe psoriasis. To estimate investment and social return, the social return on investment (SROI) method was used. Results: The new approach to psoriasis management in the SNHS comprised 18 proposals. The investment needed for the implementation of this new approach would amount to €222.77 million and its return to €1,123.11 million. This would yield a SROI ratio of €5.04 for every euro invested. Conclusion: The new approach to psoriasis management would yield a positive social return. The results will allow optimal strategic planning adapted to each assistance situation, to achieve a comprehensive and multidisciplinary approach. [ABSTRACT FROM AUTHOR]

Background: Cerebrovascular diseases are the second leading cause of death worldwide and one of the health conditions which demand the highest level of social services. The aim of this study was to estimate the social cost of non-professional (informal) care provided to survivors of cerebrovascular accidents (CVA) with some type of disability in Spain.Methods: We obtained data from the 2008 Survey on Disability, Independent Living and Dependency (EDAD-08) on the main characteristics of individuals who provide informal care to survivors of CVAs in Spain. We estimated the cost of substituting informal care in favor of formal care provided by professional caregivers (proxy good method) and performed a statistical analysis of the relationship between degree of dependency and number of care hours provided using ordinary least squares regression.Results: The number of disabled people diagnosed with CVA totaled 1,975 (329,544 people when extrapolating to the national population using the elevation factor provided by EDAD-08). Of these, 1,221 individuals (192,611 people extrapolated to the national population) received at least one hour of informal care per week. The estimated hours of informal care provided in 2008 amounted to 852 million. The economic valuation of the time of informal care ranges from 6.53 billion euros (at 7.67 euros/hour) to 10.83 billion euros (when calculating each hour of care at 12.71 euros). The results of our statistical analysis highlight the importance of degree of dependency in explaining differences in the number of hours of informal care provided.Conclusions: The results of our study reveal the high social cost of cerebrovascular accidents in Spain. In addition, evidence is presented of a correlation between higher degree of dependency in CVA survivors and greater number of hours of care received. An integral approach to care for CVA survivors requires that the caregivers' role and needs be taken into account. [ABSTRACT FROM AUTHOR]

Objectives: Ankylosing spondylitis (AS) is a disease associated with a high number of comorbidities, chronic pain, functional disability, and resource consumption. The aim of this study was to estimate the burden of AS in Spain., Methods: A questionnaire, designed for the development of the "Atlas of Axial Spondyloarthritis in Spain 2017" cross-sectional study, was distributed to patients in 2016. This questionnaire was used to collect relevant sociodemographic and clinical information on patients with AS, as well as to identify resource consumption and patient work productivity losses related to AS within the previous 12 months of survey completion. Subsequently, direct costs were estimated with the bottom-up method and work productivity losses with the human capital method. Economic burden was estimated by subgroups, taking into account the degree of disease activity and the psychological status., Results: The study sample comprised 578 patients with AS: mean age was 46.0±11.0 years, 52.9% were males, and 35.8% had a university-level education. Mean disease duration and diagnostic delay were 13.4±11.3 and 8.4±7.6 years, respectively, and mean Bath Ankylosing Spondylitis Disease Activity Index was 5.4±2.1. The estimated median annual cost per patient with AS was 5,402.4, with an average annual cost per patient of 11,462.3 euros, of which 61.1% (6,999.8 euros) were attributed to direct health care costs, 5.3% (611.3 euros) to direct non-health care costs, and 33.6% (3,851.2 euros) to work productivity losses., Conclusions: AS poses a significant burden for the Spanish National Health System and society.

Background: Schizophrenia is a disease that causes strong societal rejection and requires a significant allocation of healthcare and social resources. The chronicity and characteristics of the disease require continued care, often provided by nonprofessionals close to the person diagnosed with schizophrenia., Aim of Study: To analyze the value of informal care associated with the loss of personal autonomy (dependency) caused by schizophrenia in Spain; to study the association between the level of dependency and the number of hours of informal care provided; and to examine the association between the level of dependency/hours of informal care and the burden borne by caregivers., Methods: We used the Survey on Disabilities, Autonomy and Dependency to obtain information on the characteristics of disabled individuals with schizophrenia and the individuals who provide them with personal care. Assessment of informal care time was performed using the proxy good method. Statistical multivariate analyses using ordered probit models were conducted to study the impact of the degree of dependency on the hours of care provided and probit models to study the burden placed on caregivers in terms of health, professional, and leisure/social dimensions., Results: The economic value of care varies between 523.06 and 866.7 euro per week censoring at 16 hours of care per day (667.22-1,105.66 when no time censored). A primary informal caregiver of a severe or greatly dependent individual with schizophrenia was between 20.5% and 23.8% more likely to provide a high level of informal care (over 70 hours per week), between 6.1% and 6.4% less likely to provide a medium level of informal care (between 31 and 70 hours per week), and between 14.4% and 17.6% less likely to provide low-level care (30 hours or less per week). Informal caregivers who provide care for severely/greatly dependent or moderately dependent people had a higher probability of suffering from health, professional, and family/socially related problems than caregivers who cared for non-dependent people., Discussion and Conclusions: The results show a part of the high social cost of schizophrenia in Spain. At the same time, the study provides evidence that more severe levels of dependency are positively associated with more hours of informal care and higher caregiver burden., Implications for Health Policy: The results show that health or social care programs targeted at persons with autonomy limitations cannot overlook the importance of informal care, since doing so would lead to inefficiencies or inequities and reduce the well-being of citizens., Implications for Further Research: Information on informal care should be incorporated in the design of health and social care policies geared toward improving equity and efficiency in the allocation of social resources. Longitudinal studies of patients diagnosed with schizophrenia would provide further information on the characteristics and impact of informal care.