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We examine the cost-effectiveness of treating epilepsy with anti-epileptic medicines in autistic children, looking at impacts on healthcare providers (in England, Ireland, Italy and Spain) and children's families (in Ireland). We find carbamazepine to be the most cost-effective drug to try first in children with newly diagnosed focal seizures. For England and Spain, oxcarbazepine is the most cost-effective treatment when taken as additional treatment for those children whose response to monotherapy is suboptimal. In Ireland and Italy, gabapentin is the most cost-effective option. Our additional scenario analysis presents the aggregate cost to families with autistic children who are being treated for epilepsy: this cost is considerably higher than healthcare provider expenditure. [ABSTRACT FROM AUTHOR]

Introduction: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections (ALRI) in children under one year of age. In high-income countries, RSV infections cause a significant overload of care every winter, imposing a significant burden to the healthcare system, which has made the development of prevention strategies a major global health priority. In this context, a new bivalent RSV prefusion F protein-based vaccine (RSVpreF) has recently been approved. The objective of this study was to evaluate the cost-effectiveness of vaccinating pregnant women with the RSVpreF vaccine to prevent RSV in infants from the Spanish National Healthcare System (NHS) perspective. Methods: A hypothetical cohort framework and a Markov-type process were used to estimate clinical outcomes, costs, quality-adjusted life years (QALY) and cost-per-QALY gained (willingness-to-pay threshold: €25,000/QALY) for newborn infants born to RSV-vaccinated versus unvaccinated mothers over an RSV season. The base case analysis was performed from the NHS perspective including direct costs (€2023) and applying a discount of 3% to future costs and outcomes. To evaluate the robustness of the model, several scenarios, and deterministic and probabilistic analyses were carried out. All the parameters and assumptions were validated by a panel of experts. Results: The results of the study showed that year-round maternal vaccination program with 70% coverage is a dominant option compared to no intervention, resulting in direct cost savings of €1.8 million each year, with an increase of 551 QALYs. Maternal vaccination could prevent 38% of hospital admissions, 23% of emergency room visits, 19% of primary care visits, and 34% of deaths due to RSV. All scenario analyses showed consistent results, and according to the probabilistic sensitivity analysis (PSA), the probability of maternal vaccination being cost-effective versus no intervention was 99%. Conclusions: From the Spanish NHS perspective, maternal vaccination with bivalent RSVpreF is a dominant alternative compared with a non-prevention strategy. [ABSTRACT FROM AUTHOR]

Background: The reimbursement of erenumab in Spain and other European countries is currently restricted because of the cost of this novel therapy to patients with migraine who have experienced previous failures to traditional preventive treatments. However, this reimbursement policy should be preferably based on cost-effectiveness studies, among other criteria. This study performed a cost-effectiveness analysis of erenumab versus topiramate for the prophylactic treatment of episodic migraine (EM) and versus placebo for chronic migraine (CM). Methods: A Markov model with a 10-year time horizon, from the perspective of the Spanish National Healthcare System, was constructed based on data from responder and non-responder patients. A responder was defined as having a minimum 50% reduction in the number of monthly migraine days (MMD). A hypothetical cohort of patients with EM with one or more prior preventive treatment failures and patients with CM with more than two treatment failures was considered. The effectiveness score was measured as an incremental cost per quality-adjusted life year (QALY) gained and cost per migraine day (MD) avoided. Data from clinical outcomes and patient characteristics were obtained from erenumab clinical trials (NCT02066415, STRIVE, ARISE, LIBERTY and HER-MES). Deterministic and probabilistic sensitivity analyses were performed to validate the robustness of the model. Results: After a 10-year follow-up, the estimated QALYs were 5.88 and 6.11 for patients with EM treated with topiramate and erenumab, respectively. Erenumab showed an incremental cost per patient of €4,420 vs topiramate. For CM patients, erenumab resulted in 0.756 QALYs gained vs placebo; and an incremental cost of €1,814. Patients treated with erenumab achieved reductions in MD for both EM and CM (172 and 568 MDs, respectively). The incremental cost per QALY gained with erenumab was below the Spanish threshold of €30,000/QALY for both health and societal perspectives (EM €19,122/QALY and CM €2,398/QALY). Conclusions: Erenumab is cost-effective versus topiramate as a preventive treatment for EM and versus placebo for patients with CM from the perspective of the Spanish National Health System. [ABSTRACT FROM AUTHOR]

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Background The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial enrolled patients with estimated glomerular filtration rate 25–75 mL/min/1.73 m2 and urine albumin-to-creatinine ratio >200 mg/g. The Dapagliflozin Effect on CardiovascuLAR Events-Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) trial enrolled patients with type 2 diabetes, a higher range of kidney function and no albuminuria criterion. The study objective was to estimate the cost-effectiveness of dapagliflozin in a broad chronic kidney disease population based on these two trials in the UK, Spain, Italy and Japan. Methods We adapted a published Markov model based on the DAPA-CKD trial but to a broader population, irrespective of urine albumin-to-creatinine ratio, using patient-level data from the DAPA-CKD and DECLARE-TIMI 58 trials. We sourced cost and utility inputs from literature and the DAPA-CKD trial. The analysis considered healthcare system perspectives over a lifetime horizon. Results Treatment with dapagliflozin was predicted to attenuate disease progression and extend projected life expectancy by 0.64 years (12.5 versus 11.9 years, undiscounted) in the UK, with similar estimates in other settings. Clinical benefits translated to mean quality-adjusted life year (QALY; discounted) gains between 0.45 and 0.68 years across countries. Incremental cost-effectiveness ratios in the UK, Spain, Italy and Japan ($10 676/QALY, $14 479/QALY, $7771/QALY and $13 723/QALY, respectively) were cost-effective at country-specific willingness-to-pay thresholds. Subgroup analyses suggest dapagliflozin is cost-effective irrespective of urinary albumin-to-creatine ratio and type 2 diabetes status. Conclusion Treatment with dapagliflozin may be cost-effective for patients across a wider spectrum of estimated glomerular filtration rates and albuminuria than previously demonstrated, with or without type 2 diabetes, in the UK, Spanish, Italian and Japanese healthcare systems. [ABSTRACT FROM AUTHOR]

Heart failure (HF) is a chronic condition with considerable clinical burden for patients and economic burden for healthcare systems. Treatment for HF is typically based on ejection fraction (EF) phenotype. The cost-effectiveness of empagliflozin + standard of care (SoC) compared to SoC has been examined for HF phenotypes below or above 40% EF separately, but not across the full spectrum of EF in Spain. The results of two preexisting, validated, and published phenotype-specific Markov cohort models were combined using a population-weighted approach, reflecting the incidence of each phenotype in the total HF population in Spain. A probabilistic sensitivity analysis was performed by sampling each model's probabilistic results. Empagliflozin + SoC compared to SoC resulted in increased life-years (LYs) (6.48 vs. 6.35), quality-adjusted LYs (QALYs) (4.80 vs. 4.63), and healthcare costs (€19,090 vs. €18,246), over a lifetime time horizon for the combined HF population in Spain. The incremental cost-effectiveness ratio (ICER) was €5,089/QALY. All subgroup, scenario, and probabilistic ICERs were consistently below €10,000/QALY. Empagliflozin is the first treatment with established efficacy and cost-effectiveness for HF patients across EF from the perspective of healthcare payers in Spain. Empagliflozin also proved to be cost-effective for all subgroups of patients included in the analysis. [ABSTRACT FROM AUTHOR]

Aims: Heart failure is a chronic progressive condition, with considerable burden on patients' quality of life and economic burden for the healthcare systems. Before the approval of empagliflozin, there were no proven effective treatments for patients with heart failure with left ventricular ejection fraction (HF LVEF) > 40%. The aim of this study was to evaluate the cost‐effectiveness of empagliflozin + standard of care (SoC) compared with SoC alone for patients with HF LVEF > 40%, from the perspective of the healthcare systems of the United Kingdom (UK), Spain, and France, and to quantify the healthcare costs for these patients. Methods and results: A lifetime Markov cohort state‐transition model was developed based on discrete health states defined by Kansas City Cardiomyopathy Questionnaire‐Clinical Summary Score quartiles to track disease severity. Model inputs relied primarily on the EMPEROR‐Preserved trial data or obtained from published literature or country‐specific databases, as well as local guidelines for the requirements for the conduct of the economic evaluation of healthcare technologies. The total lifetime cost of receiving SoC per patient was £10 092, €15 765, and €14 958 in the UK, Spain, and France, respectively, which increased by £1407, €1148, and €1485, respectively, with the addition of empagliflozin to the SoC. Empagliflozin + SoC was associated with significantly reduced number of hospitalization for HF or cardiovascular death compared with SoC alone, which was a key driver offsetting its drug acquisition costs. The incremental cost‐effectiveness ratio per quality‐adjusted life year (QALY) gained was consistently favourable at £14 851, €11 706, and €15 447 in the UK, Spain, and France, respectively. Scenario analysis using the New York Heart Association functional class showed similar results. Probabilistic sensitivity analyses showed more than 50% probability for cost‐effectiveness for a willingness‐to‐pay (WTP) threshold of £/€20 000/QALY for the three countries. Conclusions: Empagliflozin was found to be the first targeted treatment option that is clinically effective and cost‐effective for patients with HF LVEF > 40%. Prescribing empagliflozin with SoC to patients with HF LVEF > 40% is expected to improve clinical outcomes and patients' quality of life and substantially below accepted WTP threshold for the healthcare systems in the UK, Spain, and France. [ABSTRACT FROM AUTHOR]

Aims: When relying on clinical assessment alone, an estimated 22% of acute heart failure (AHF) patients are missed, so clinical guidelines recommend the use of N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) for AHF diagnosis. Since publication of these guidelines, there has been poor uptake of NT‐proBNP testing in part due to concerns over excessive false positive referrals resulting from the low specificity of a single 'rule‐out' threshold of <300 pg/mL. Low specificity can be mitigated by the addition of age‐specific 'rule‐in' NT‐proBNP thresholds. Methods and results: A theoretical hybrid decision tree/semi‐Markov model was developed, combining global trial and audit data to evaluate the cost‐effectiveness of NT‐proBNP testing using age‐specific rule‐in/rule‐out (RI/RO) thresholds, compared with NT‐proBNP RO only and with clinical decision alone (CDA). Cost‐effectiveness was measured as the incremental cost per quality‐adjusted life year (QALY) gained and incremental net health benefit. In the base case, using UK‐specific inputs, NT‐proBNP RI/RO was associated with both greater QALYs and lower costs than CDA. At a willingness‐to‐pay threshold of £20 000/QALY, NT‐proBNP RO was also cost‐effective compared with CDA [incremental cost‐effectiveness ratio (ICER) of £8322/QALY], but not cost‐effective vs. RI/RO (ICER of £64 518/QALY). Overall, NT‐proBNP RI/RO was the most cost‐effective strategy. Sensitivity and scenario analyses were undertaken; the conclusions were not impacted by plausible variations in parameters, and similar conclusions were obtained for the Netherlands and Spain. Conclusions: An NT‐proBNP strategy that combines an RO threshold with age‐specific RI thresholds provides a cost‐effective alternative to the currently recommended NT‐proBNP RO only strategy, achieving greater diagnostic specificity with minimal reduction in sensitivity and thus reducing unnecessary echocardiograms and hospital admissions. [ABSTRACT FROM AUTHOR]

Purpose: This research examined the cost-effectiveness of adding empagliflozin to standard of care (SoC) compared with SoC alone for treatment of heart failure with reduced ejection fraction (HFrEF) from the perspective of healthcare payers in the United Kingdom (UK), Spain and France. Methods: A lifetime Markov cohort model was developed to simulate patients' progression through health states based on Kansas City Cardiomyopathy Questionnaire Clinical Summary Score. The model predicted risk of death, hospitalisation for worsening heart failure (HHF), treatment-related adverse events, and treatment discontinuation each monthly cycle. Clinical inputs and utilities were derived from EMPEROR-Reduced trial data, supplemented by published literature and national costing databases. Costs (2021 pound sterling/euro) and quality-adjusted life-years (QALYs) were discounted annually for the UK (3.5%), Spain (3.0%) and France (2.5%). Results: In the UK, Spain and France, empagliflozin plus SoC yielded additional QALYs (0.19, 0.23 and 0.21) at higher cost (£1185, €1770 and €1183 per patient) than SoC alone, yielding incremental cost-effectiveness ratios of £6152/QALY, €7736/QALY and €5511/QALY, respectively. Reduced HHF incidence provided most cost offsets for empagliflozin plus SoC. Similar results were obtained for a range of subgroups and sensitivity analyses. Probabilistic sensitivity results indicated empagliflozin plus SoC remained cost-effective vs. SoC at willingness-to-pay thresholds of £20,000/QALY, €20,000/QALY and €30,000/QALY in 79.6%, 75.5% and 97.3% of model runs for the UK, Spain and France, respectively. Conclusions: Empagliflozin added to SoC leads to health benefits for patients with HFrEF and is a cost-effective treatment option for payers in multiple European countries (UK, Spain, France). [ABSTRACT FROM AUTHOR]

Background: The aim of this trial-based economic evaluation was to assess the incremental costs and cost-effectiveness of the modified diagnostic strategy combining the YEARS rule and age-adjusted D-dimer threshold compared with the control (which used the age-adjusted D-dimer threshold only) for the diagnosis of pulmonary embolism (PE) in the Emergency Department (ED). Methods: Economic evaluation from a healthcare system perspective alongside a non-inferiority, crossover, and cluster-randomized trial conducted in 16 EDs in France and two in Spain with three months of follow-up. The primary endpoint was the additional cost of a patient without failure of the diagnostic strategy, defined as venous thromboembolism (VTE) diagnosis at 3months after exclusion of PE during the initial ED visit. Mean differences in 3-month failure and costs were estimated using separate generalized linear-regression mixed models, adjusted for strategy type, period, and the interaction between strategy and period as fixed effects and the hospital as a random effect. The incremental cost-effectiveness ratio (ICER) was obtained by dividing the incremental costs by the incremental frequency of VTE. Results: Of the 1,414 included patients, 1,217 (86%) were analyzed in the per-protocol analysis (648 in the intervention group and 623 in the control group). At three months, there were no statistically significant differences in total costs (€-46; 95% CI: €-93 to €0.2), and the failure rate was non inferior in the intervention group (-0.64%, one-sided 97.5% CI: -∞ to 0.21%, non-inferiority margin 1.5%) between groups. The point estimate of the incremental cost-effectiveness ratio (ICER) indicating that each undetected VTE averted in the intervention group is associated with cost savings of €7,142 in comparison with the control group. There was a 93% probability that the intervention was dominant. Similar results were found in the as randomized population. Conclusions: Given the observed cost decrease of borderline significance, and according to the 95% confidence ellipses, the intervention strategy has a potential to lead to cost savings as a result of a reduction in the use of chest imaging and of the number of undetected VTE averted. Policy-makers should investigate how these monetary benefits can be distributed across stakeholders. Clinicaltrials: Trial registration number ClinicalTrials.gov Identifier: NCT04032769; July 25, 2019. [ABSTRACT FROM AUTHOR]

The objective of this article was to assess the cost-effectiveness of screening strategies for cardiovascular diseases (CVD). A decision analytic model was constructed to estimate the costs and benefits of one-off screening strategies differentiated by screening age, sex and the threshold for initiating statin therapy ("uniform" or "age-adjusted") from the Spanish NHS perspective. The age-adjusted thresholds were configured so that the same number of people at high risk would be treated as under the uniform threshold. Health benefit was measured in quality-adjusted life years (QALY). Transition rates were estimated from the European Prospective Investigation into Cancer and Nutrition (EPIC-CVD), a large multicentre nested case-cohort study with 12 years of follow-up. Unit costs of primary care, hospitalizations and CVD care were taken from the Spanish health system. Univariate and probabilistic sensitivity analyses were employed. The comparator was no systematic screening program. The base case model showed that the most efficient one-off strategy is to screen both men and women at 40 years old using a uniform risk threshold for initiating statin treatment (Incremental Cost-Effectiveness Ratio of €3,274/QALY and €6,085/QALY for men and women, respectively). Re-allocating statin treatment towards younger individuals at high risk for their age and sex would not offset the benefit obtained using those same resources to treat older individuals. Results are sensitive to assumptions about CVD incidence rates. To conclude, one-off screening for CVD using a uniform risk threshold appears cost-effective compared with no systematic screening. These results should be evaluated in clinical studies. [ABSTRACT FROM AUTHOR]

A cost-utility analysis was conducted to assess the efficiency of implementing a PCV20 vaccination strategy in the Spanish adult population older than 60 years, for the prevention of non-bacteremic pneumococcal pneumonia (NBP) and invasive pneumococcal disease (IPD). A Markov model, with annual cycles and a time horizon of 10 years was used. The analysis population was stratified by age and risk groups. The comparator was the sequential vaccination with the 15-valent pneumococcal conjugate vaccine (PCV15) followed by one dose of the pneumococcal polysaccharide vaccine (PPV23). The base case analysis was performed from the National Healthcare System (NHS) perspective including direct costs (€2018) and applying a discount of 3% to future costs and outcomes. Alternative scenarios explored a shorter time horizon (5 years), the societal perspective and other available vaccination strategies. All the parameters and assumptions were validated by a panel of experts. To evaluate the robustness of the model, deterministic and probabilistic sensitivity analyses (PSA) were carried out. The results of the study showed that the vaccination strategy with PCV20 is a dominant option compared to the sequential regimen (PCV15 + PPSV23), resulting in direct cost savings of €85.7 M over 10 years, with a small increase in quality-adjusted life years (QALYs). PCV20 vaccination avoided 2,161 cases of IPD, 19,470 of NBP and 3,396 deaths and according to the PSA, the probability of PCV20 being cost-effective compared to a sequential regimen (PCV15 + PPSV23) was 100%. In the Spanish adult population older than 60 years, the vaccination strategy with one dose of PCV20 is more effective and less expensive (dominant) than vaccination with a sequential schedule with PCV15 and PPSV23. [ABSTRACT FROM AUTHOR]

Aims: To determine the cost‐effectiveness of dapagliflozin, added to usual care, in patients with heart failure (HF) with mildly reduced or preserved ejection fraction for the UK, German and Spanish payers using detailed patient‐level data from the Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial. Methods and results: A lifetime Markov state‐transition cohort model was developed. Quartiles of the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ‐TSS) defined health states and monthly transition count data informed transition probabilities. Multivariable generalized estimating equations captured the incidence of HF hospitalizations and urgent HF visits, while cardiovascular deaths and all‐cause mortality were estimated using adjusted parametric survival models. Health state costs were assigned to KCCQ‐TSS quartiles (2021 British pound [GBP]/Euro) and patient‐reported outcomes were sourced from DELIVER. Future values of costs and effects were discounted according to country‐specific rates. In the UK, dapagliflozin treatment was predicted to increase quality‐adjusted life years (QALYs) and life‐years by 0.231 and 0.354, respectively, and extend the time spent in the best quartile of KCCQ‐TSS by 4.2 months. Comparable outcomes were projected for Germany and Spain. The incremental cost‐effectiveness ratios were £7761, €9540 and €5343/QALY in the UK, Germany and Spain, respectively. According to regional willingness‐to‐pay thresholds, 91%, 89% and 92% of simulations in the UK, Germany and Spain, respectively, were cost‐effective following probabilistic sensitivity analyses. Conclusion: Dapagliflozin, added to usual care, is very likely cost‐effective for HF with mildly reduced or preserved ejection fraction in several European countries. [ABSTRACT FROM AUTHOR]

Aim: Estimating the burden of obesity in five European countries (Germany, Greece, the Netherlands, Spain and the UK) and the potential health benefits and changes in health care costs associated with a reduction in body mass index (BMI). Materials and Methods: A Markov model was used to estimate the long‐term burden of obesity. Health states were based on the occurrence of diabetes, ischaemic heart disease and stroke. Multiple registries and literature sources were used to derive the demographic, epidemiological and cost input parameters. For the base‐case analyses, the model was run for a starting cohort of healthy obese people with a BMI of 30 and 35 kg/m2 aged 40 years to estimate the lifetime impact of obesity and the impact of a one‐unit decrease in BMI. Different scenario and sensitivity analyses were performed. Results: The base‐case analyses showed that total lifetime health care costs (for obese people aged 40 and BMI 35 kg/m2) ranged from €75 376 in Greece to €343 354 in the Netherlands, with life expectancies ranging from 37.9 years in Germany to 39.7 years in Spain. A one‐unit decrease in BMI showed gains in life expectancy ranging from 0.65 to 0.68 year and changes in total health care costs varying from −€1563 to +€4832. Conclusions: The economic burden of obesity is substantial in the five countries. Decreasing BMI results in health gains, reductions in obesity‐related health care costs, but an increase in non‐obesity related health care costs, which emphasizes the relevance of including all costs in decision making on implementation of preventive interventions. [ABSTRACT FROM AUTHOR]

Introduction: Current antiretroviral therapies (ARTs) have improved outcomes for people living with HIV. However, the requirement to adhere to lifelong daily oral dosing may be challenging for some people living with HIV, leading to suboptimal adherence and therefore reduced treatment effectiveness. Treatment with long-acting (LA) ART may improve adherence and health-related quality of life. The objective of this study was to evaluate the cost-effectiveness of cabotegravir + rilpivirine (CAB+RPV) LA administered every 2 months (Q2M) compared with current ART administered as daily oral single-tablet regimens (STRs) from a Spanish National Healthcare System perspective. Methods: A hybrid decision-tree and Markov state-transition model was used with pooled data from three phase III/IIIb trials (FLAIR, ATLAS, and ATLAS-2M) over a lifetime horizon, with health states defined by viral load and CD4+ cell count. Direct costs (in €) were taken from Spanish public sources from 2021 and several deterministic and probabilistic analyses were carried out. An annual 3% discount rate was applied to both costs and utilities. Results: Over the lifetime horizon, CAB+RPV LA Q2M was associated with an additional 0.27 quality-adjusted life years (QALYs) and slightly greater lifetime costs (€4003) versus daily oral ART, leading to an incremental cost-effectiveness ratio of €15,003/QALY, below the commonly accepted €30,000/QALY willingness-to-pay threshold in Spain. All scenario analyses showed consistent results, and the probabilistic sensitivity analysis showed cost-effectiveness compared with daily oral STRs in 62.4% of simulations, being dominant in 0.3%. Conclusion: From the Spanish National Health System perspective, CAB+RPV LA Q2M is a cost-effective alternative compared with the current options of daily oral STR regimens for HIV treatment. Clinical Trials Registration: ATLAS, NCT02951052; ATLAS-2M, NCT03299049; FLAIR, NCT02938520. Plain Language Summary: Over the past decades, treatments for HIV infection have improved outcomes for people living with HIV. However, most of the treatments available consist of daily oral administration, which may present challenges for some people. These challenges may lead to a less optimal intake of the medicines and, therefore, to a potential reduction of treatment effectiveness. A new long-acting treatment alternative for HIV with two drugs is now available: cabotegravir + rilpivirine long-acting is the first injectable treatment administered in the muscle every 2 months by a healthcare professional. Long-acting injectables may improve treatment administration and health-related quality of life of people living with HIV. This study estimated the cost-effectiveness of cabotegravir + rilpivirine long-acting in Spain compared with daily oral single-tablet treatment for HIV. An economic model using clinical data and Spanish inputs was used to estimate cost-effectiveness and health outcomes over a lifetime. Cabotegravir + rilpivirine long-acting compared with daily oral single-tablet treatment showed an increase in health-related quality of life, leading to a cost-effectiveness ratio of €15,003, below the Spanish willingness-to-pay threshold of €30,000. All different scenarios tested showed consistent results, with cabotegravir + rilpivirine long-acting being cost-effective in 62.4% of the simulations and less costly and more effective in 0.3%. This study demonstrated that, in Spain, cabotegravir + rilpivirine long-acting administered every 2 months is a cost-effective alternative to the current daily oral single-tablet treatment options for HIV. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: To assess the cost-effectiveness of the delayed-release device of dexamethasone compared with aflibercept in the treatment of patients with naïve diabetic macular edema (DME) from a societal perspective in the healthcare sector Zaragoza III in Spain. Methods: A Markov model with five states defined by visual acuity (VA) in the better-seeing eye (Snellen scale) and an additional death state were constructed. Two cohorts of patients were distributed along the VA states and treated during a year with either dexamethasone or aflibercept. One-year follow-up on each group was performed. Medical costs related to the DME treatment and follow-up, medical costs related to the DME comorbidities, and non-medical-related costs were taken into account. Costs (2020 €), health outcomes (Quality-Adjusted Life Years-QALYs), both discounted at a 3.5% annual rate, and incremental cost-effectiveness ratios (ICER: €/QALY) were determined for a lifetime horizon in the base case analysis. Results: Patients treated with dexamethasone were €77,349 more costly and provided 2.667 additional QALYs (€29,002/QALY) than those treated with aflibercept. The variable efficiency per patient was calculated dividing the improvement in quality of life (on the VFQ-25 scale) by the cost of the treatment. With the obtained results it can be concluded that the efficiency of treating the patients with dexamethasone is significantly superior than the efficiency of treating them with aflibercept. Conclusions: The cost per QALY gained with the delayed-release device of dexamethasone compared with the one obtained by aflibercept in the naïve DME population is just below the €30,000 threshold, below which, new drugs are sometimes regarded as cost-effective strategies in Spain. In this model, the key variables with greater impact on the cost-effectiveness results were the selected time horizon, the chosen extrapolation method and the number of aflibercept and dexamethasone injections. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) represents a sizable economic burden in Spain. Pharmacogenetic (PGx) screening to guide the choice of antidepressant medication (ADM) in MDD patients yields higher response and remission rates, which could reduce both healthcare and indirect costs., Methods: We built a cost-effectiveness probabilistic Markov model with microsimulation using Tree Age Pro 2022, simulating a patient cohort from the SNHS starting ADM for MDD, and comparing PGx screening before starting ADM versus no screening (No PGx). We carried out a probabilistic sensitivity analysis using the Monte Carlo simulation with microsimulation, set for 1000 iterations and 1000 microsimulation trials, both from societal and healthcare provider perspectives, for a time horizon of 3 years., Results: From a societal perspective, the model estimated a mean cost of 3172.85€ and effectiveness of 2.64 quality-adjusted life years (QALYs) for the No PGx strategy, and a mean cost of 1687.02€ and effectiveness of 2.84 QALYs for the PGx strategy. The mean ICER was -7820.56 €/QALY. From a healthcare provider perspective (no indirect costs considered), the mean cost was 662.62€ for the No PGx strategy, and 446.60€ for the PGx strategy. The mean ICER was -1130.16 €/QALY., Limitations: The heterogeneity of input data from the literature, the need for assumptions of homogeneous distribution of variables and events across population and time, and the inherent limitations of cost-effectiveness analysis should be considered. The model omits combined therapies (ADMs with mood stabilizers, antipsychotics, cognitive behavioral therapy…)., Conclusions: PGx screening in MDD prior to ADM start is a dominant strategy in the SNHS., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: F.A.-S. has been consultant or investigator in clinical trials sponsored by the following pharmaceutical companies: Abbott, Alter, Aptatargets, Chemo, Cinfa, FAES, Farmalíder, Ferrer, GlaxoSmithKline, Galenicum, Gilead, Italfarmaco, Janssen-Cilag, Kern, Moderna, MSD, Normon, Novartis, Servier, Silver Pharma, Teva, and Zambon. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Condoms and combined oral contraceptive pills are widely used in Spain with high failure rates. Long-Acting Reversible Contraceptive (LARC) methods offer better efficacy and adherence and reduce unintended pregnancies (UP) compared with short-acting reversible contraceptive (SARC) methods., Objective: To assess the cost-effectiveness of LNG-IUS 52 mg (Mirena ® ) versus other LARC for contraception in Spain., Materials and Methods: A Markov model with annual cycles and an eight-year time horizon was developed from the Spanish national healthcare system (NHS) perspective, considering costs for contraceptive method acquisition, health care resources (HCR) and UP. Effectiveness was based on failure and discontinuation rates. Sensitivity analyses were performed to test the model's robustness., Results: LNG-IUS 52 mg (Mirena ® ) resulted in lower costs and fewer UP versus LNG-IUS 13.5 mg (Jaydess ® ), Implant (Implanon ® ) and Copper IUD. LNG-IUS 52 mg (Levosert ® ) prevented the same UP events at a higher cost. LNG-IUS 19.5 mg (Kyleena ® ) was the most effective option, due to a lower discontinuation rate., Conclusions: LNG-IUS 52 mg (Mirena ® ) is the least costly LARC, driven by lower acquisition costs and reduced HCR utilisation. Increasing LNG-IUS 52 mg (Mirena ® ) uptake in contraception could generate further cost savings for the Spanish NHS and reduce economic burden of UP.

Background and Objective: Hyperkalemia (HK) is an electrolyte disturbance in the concentration of potassium ions (K + ), whose risk increases in patients with chronic kidney disease (CKD) or heart failure (HF) and/or in patients being treated with renin-angiotensin-aldosterone system inhibitors (RAASi). The new oral K + chelators offer a safe and effective treatment to maintain normokalemia in these patients. The objective of the analysis is to estimate the cost-effectiveness of sodium zirconium cyclosilicate (SZC) for the treatment of chronic HK in patients with CKD or HF versus standard treatment (calcium polystyrene sulfonate and lifestyle modifications) from the perspective of the Spanish National Health System., Materials and Methods: Two microsimulation models reflecting the natural history of CKD and HF were used. In both models, K + levels were simulated individually. Based on efficacy (reduction of K + levels), quality of life of patients (utilities according to health states, and disutilities of events derived from each pathology and adverse events [AEs] of treatment) and costs considered (cost of treatment for HK, of RAASi treatment and its modification, health states, management of events derived from each pathology, HK episodes, and AEs treatment) (, 2022), clinical benefit (quality-adjusted life years [QALYs]) and cost results were obtained. A time horizon of the patient's lifetime was used and a discount rate of 3% was applied for costs and outcomes., Results: SZC is a more effective option in both pathologies, with a difference in QALYs of 0.476 in CKD and 0.978 in HF compared to standard treatment, and it represents an incremental cost of 3,616 and 14,749, respectively, obtaining an incremental cost-utility ratio of 7,605/QALY in CKD and 15,078/QALY in HF., Conclusions: SZC is a cost-effective alternative for the treatment of HK in patients with CKD or HF, taking into account the reference efficiency values commonly used in Spain., (Copyright © 2024. Published by Elsevier España, S.L.U.)

Standard-dose quadrivalent influenza vaccines (QIV) are designed to provide protection against all four influenza strains. Adjuvanted QIV (aQIV), indicated for individuals aged 65+ years, combines MF59® adjuvant (an oil-in-water emulsion of squalene oil) with a standard dose of antigen, and is designed to produce stronger and longer immune response, especially in the elderly where immunosenescence reduces vaccine effectiveness. This study evaluated the cost-effectiveness of aQIV vs. egg-based standard-dose QIV (QIVe) in the elderly population, from the payer and societal perspective in Spain. A dynamic transmission model, which accounts for herd protection, was used to predict the number of medically attended infections in Spain. A decision tree structure was used to forecast influenza-related costs and benefits. Influenza-related probabilities of outpatient visit, hospitalization, work absenteeism, mortality, and associated utilities and costs were extracted from Spanish and European published literature. Relative vaccine effectiveness (rVE) was sourced from two different meta-analyses: the first meta-analysis was informed by laboratory-confirmed influenza studies only, resulting in a rVE = 34.6% (CI95% 2–66%) in favor of aQIV; the second meta-analysis included real world evidence influenza-related medical encounters outcomes, resulting in a rVE = 13.9% (CI95% 4.2–23.5%) in benefit of aQIV. All costs were expressed in 2021 euros. Results indicate that replacing QIVe with aQIV in the Spanish elderly population would prevent on average 43,664 influenza complicated cases, 1111 hospitalizations, and 569 deaths (with a rVE = 34.6%) or 19,104 influenza complicated cases, 486 hospitalizations, and 252 deaths (with a rVE = 13.9%). When the rVE of aQIV vs. QIVe is 34.6%, the incremental cost per quality adjusted life years (QALY) gained was €2240 from the payer; from the societal perspective, aQIV was cost saving compared with QIVe. If the rVE was 13.9%, the incremental cost per QALY was €6694 and €3936 from the payer and societal perspective, respectively. Sensitivity analyses validated the robustness of these findings. Results indicate that replacing QIVe with aQIV in the Spanish elderly population is a cost-effective strategy for the Spanish healthcare system. [ABSTRACT FROM AUTHOR]

Background: Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD) and can result in reduced quality of life and increased healthcare costs. IDA is treated with iron supplementation, commonly with intravenous iron formulations, such as ferric carboxymaltose (FCM), and iron sucrose (IS). Methods: This study assessed the cost-effectiveness of FCM compared with IS, in terms of additional cost per additional responder in patients with IDA subsequent to IBD in the Spanish setting. An economic model was developed to assess the additional cost per additional responder, defined as normalization or an increase of ⩾2 g/dl in hemoglobin levels, for FCM versus IS from a Spanish healthcare payer perspective. Efficacy inputs were taken from a randomized controlled trial comparing the two interventions (FERGIcor). Costs of treatment were calculated in 2021 Euros (EUR) using a microcosting approach and included the costs of intravenous iron, healthcare professional time, and consumables. Cost-effectiveness was assessed over one cycle of treatment, with a series of sensitivity analyses performed to test the robustness of the results. Results: FCM was more effective than IS, with 84% of patients achieving a response compared with 76%. When expressed as number needed to treat, 13 patients would need to switch treatment from IS to FCM in order to achieve one additional responder. Costs of treatment were EUR 323 with FCM compared with EUR 470 with IS, a cost saving of EUR 147 with FCM. Cost savings with FCM were driven by the reduced number of infusions required, resulting in a reduced requirement for healthcare professional time and use of consumables compared with the IS arm. Conclusion: The present analysis suggests that FCM is less costly and more effective than IS for the treatment of IDA subsequent to IBD in Spain and therefore was considered dominant. [ABSTRACT FROM AUTHOR]

Systems Training for Emotional Predictability and Problem Solving (STEPPS) is a group psychotherapy approach that is effective for patients with borderline personality disorder (BPD) in a public health care setting. The sample in this study comprised 118 outpatients with BPD who were asked to participate in a Spanish-adapted version of STEPPS for 18 months, a psychotherapy program that could be added to their usual psychiatric intervention. They were divided into an experimental group who participated in STEPPS, and a control group, who received treatment as usual. Several variables were collected and the Borderline Evaluation of Severity Over Time (BEST) scale was administered at pretest, Months 3 and 6, posttest (Month 18), and 2-year follow-up (Month 42), after which a post hoc data analysis was carried out. The STEPPS program improved the as-usual treatment provided previously, and the results were cost-effective. A higher educational level and good patient collaboration predicted better outcome. [ABSTRACT FROM AUTHOR]

Background: Mobile phone-based SMS text message reminders have the potential to improve colorectal cancer screening participation rates., Objective: This study assessed the effectiveness and acceptability of adding targeted SMS text message reminders to the standard procedure for those who picked up but did not return their screening kit at the pharmacy within 14 days in a colorectal cancer screening program in Catalonia, Spain., Methods: We performed a randomized control trial among individuals who picked up a fecal immunochemical test (FIT) kit for colorectal cancer screening at the pharmacy but did not return it within 14 days. The intervention group (n=4563) received an SMS text message reminder on the 14th day of kit pick up and the control group (n=4806) received no reminder. A 30-day reminder letter was sent to both groups if necessary. The main primary outcome was the FIT completion rate within 30, 60, and 126 days from FIT kit pick up (intention-to-treat analysis). A telephone survey assessed the acceptability and appropriateness of the intervention. The cost-effectiveness of adding an SMS text message reminder to FIT completion was also performed., Results: The intervention group had higher FIT completion rates than the control group at 30 (64.2% vs 53.7%; P<.001), 60 (78.6% vs 72.0%; P<.001), and 126 (82.6% vs 77.7%; P<.001) days. Participation rates were higher in the intervention arm independent of sex, age, socioeconomic level, and previous screening behavior. A total of 339 (89.2%) interviewees considered it important and useful to receive SMS text message reminders for FIT completion and 355 (93.4%) preferred SMS text messages to postal letters. We observed a reduction of US $2.4 per participant gained in the intervention arm for invitation costs compared to the control arm., Conclusions: Adding an SMS text message reminder to the standard procedure significantly increased FIT kit return rates and was a cost-effective strategy. SMS text messages also proved to be an acceptable and appropriate communication channel for cancer screening programs., Trial Registration: ClinicalTrials.gov NCT04343950; https://www.clinicaltrials.gov/study/NCT04343950., International Registered Report Identifier (irrid): RR2-10.1371/journal.pone.0245806., (©Nuria Vives, Noemie Travier, Albert Farre, Gemma Binefa, Carmen Vidal, Maria Jose Pérez Lacasta, Gemma Ibáñez-Sanz, Ena Pery Niño de Guzmán, Jon Aritz Panera, Montse Garcia, M-TICS Research Group. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 31.07.2024.)

Two vaccines against rotavirus diseases, Rotarix ® and RotaTeq ® , are being marketed in Spain; but rotavirus is not presently among the diseases covered by universal vaccination in Spain. The aim of this study was to assess the efficiency of extending Spain's current targeted rotavirus vaccination strategy including only preterm babies, to a policy of universal vaccination. A de novo cohort-based Markov model was built to evaluate the efficiency of three compared rotavirus vaccination strategies in Spain: targeted, universal, and no vaccination. Using Rotarix ® or RotaTeq ® , we compared the cost-utility of these strategies from both a societal perspective and Spanish National Health System (SNHS) perspective. The model represents the most important clinical events conceivably linked to rotavirus infection. Efficacy, effectiveness, safety, costs, and utilities were identified by systematic reviews. Incremental cost-utility ratio (ICUR) is EUR 23,638/QALY (Quality-Adjusted Life Year) for targeted vaccination with Rotarix ® compared with no vaccination. The ICUR for the rest of the strategies evaluated are above EUR 30,000/QALY. The sensitivity analysis shows price as the only parameter that could make the universal vaccination strategy efficient. Considering a threshold of EUR 25,000/QALY, only targeted vaccination with Rotarix ® would be efficient from societal perspective. Price drops of 36.9% for Rotarix ® and 44.6% for RotaTeq ® would make universal vaccination efficient.

Aim: To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective. Methods: A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (e2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results. Results: On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of e3,173.47 and e7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis. Conclusions: MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting. [ABSTRACT FROM AUTHOR]

• To our knowledge, this is the first cost-utility analysis comparing HD-QIV to aTIV. • Switching from aTIV to HD-QIV would prevent 36,476 cases of influenza annually. • Up to 9,193 hospitalisation episodes and 357 deaths would be avoided annually. • HD-QIV would be a cost-effective or even cost-saving strategy for ≥ 65 yo in Spain. • HD-QIV could save €28 million annually due to prevented cardiorespiratory events. The normal ageing process is accompanied by immunosenescence and a progressive weakening of the immune system. High-dose inactivated influenza quadrivalent vaccine (HD-QIV) has shown greater immunogenicity, relative efficacy, and effectiveness than the standard-dose inactivated quadrivalent vaccine (SD-QIV). The aim of the study was to assess the cost-utility of an HD-QIV strategy compared with an adjuvanted trivalent inactivated vaccine (aTIV) strategy in the population above 65 years of age in Spain. We evaluated the public health and economic benefits of alternatives by using a decision-tree model, which included influenza cases, visits to the general practitioner (GP), visits to the emergency department (ED), hospitalisations, and mortality related to influenza. We performed deterministic and probabilistic sensitivity analyses to account for both epidemiological and economical sources of uncertainty. Our results show that switching from aTIV strategy to HD-QIV would prevent 36,476 cases of influenza, 5,143 visits to GP, 1,054 visits to the ED, 9,193 episodes of hospitalisation due to influenza or pneumonia, and 357 deaths due to influenza – increasing 3,514 life-years and 3,167 quality–adjusted life–years (QALYs). Healthcare costs increase by €78,874,301, leading to an incremental cost-effectiveness ratio (ICER) of €24,353/QALY. The sensitivity analysis indicates that the results are rather robust. Our analysis shows that HD-QIV in people over 65 years of age is an influenza-prevention strategy that is at least cost-effective, if not dominant, in Spain. It reduces cases of influenza, GP visits, hospitalisations, deaths, and associated healthcare costs. [ABSTRACT FROM AUTHOR]

Objective: To determine the cost-effectiveness of 2 strategies for post-discharge suicide prevention, an Enhanced Contact intervention based on repeated in-person and telephone contacts, and an individual 2-month long problem-solving Psychotherapy program, in comparison to facilitated access to outpatient care following a suicide attempt. Methods: We conducted a cost-effectiveness analysis based on a decision tree between January and December 2019. Comparative effectiveness estimates were obtained from an observational study conducted between 2013 and 2017 in Madrid, Spain. Electronic health care records documented resource use (including extra-hospital emergency care, mortality, inpatient admission, and disability leave). Direct cost data were derived from Madrid's official list of public health care prices. Indirect cost data were derived from Spain's National Institute of Statistics. Results: Both augmentation strategies were more cost-effective than a single priority outpatient appointment considering reasonable thresholds of willingness to pay. Under the base-case scenario, Enhanced Contact and Psychotherapy incurred, respectively, €2,340 and 6,260 per averted attempt, compared to a single priority appointment. Deterministic and probabilistic sensitivity analyses showed both augmentation strategies to remain cost-effective under several scenarios. Enhanced Contact was slightly cost minimizing in comparison to Psychotherapy (base-case scenario: €−196 per averted attempt). Conclusions: Two post-discharge suicide prevention strategies based on Enhanced Contact and Psychotherapy were cost-effective in comparison to a single priority appointment. Increasing contacts between suicide attempters and mental health-care providers was slightly cost minimizing compared to psychotherapy. [ABSTRACT FROM AUTHOR]

To estimate the cost-effectiveness of two trabecular micro-bypass stent implants (iStent inject®) during cataract surgery, compared to cataract surgery alone, in patients with cataracts and mild-to-moderate primary Open Angle Glaucoma (OAG) in the Spanish National Health System (SNHS). A Markov model was used to simulate the progression of OAG patients, undergoing either cataract-iStent Inject® surgery or cataract surgery alone, over a lifetime horizon. Health states of glaucoma were based on the Hodapp-Parrish-Anderson criteria. Efficacy and resource use were obtained from published literature and validated by experts. Costs (€, 2020) were obtained from the Spanish database eSalud. The incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained was calculated. A societal perspective was also explored. Sensitivity analysis tested the robustness of results. Cataract-iStent Inject® surgery was more effective and costly than cataract surgery alone, with an ICER of 12,676.48/QALY. The probability of iStent Inject being cost-effective was 90.9% and 78.4%, at a willingness-to-pay of €30,000/QALY and €21,000/QALY, respectively. From a societal perspective, Cataract-iStent Inject® surgery was cost-saving compared to cataract surgery alone. Cataract-iStent Inject® surgery was cost-effective (SNHS perspective) or cost-saving (societal perspective) compared to cataract surgery alone in patients with mild-to-moderate OAG. [ABSTRACT FROM AUTHOR]

Background: ω‐3 Fatty acid (FA)–containing parenteral nutrition (PN) is associated with improvements in patient outcomes and with reductions in hospital length of stay (HLOS) vs standard PN regimens (containing non–ω‐3 FA lipid emulsions). We present a cost‐effectiveness analysis of ω‐3 FA–containing PN vs standard PN in 5 European countries (France, Germany, Italy, Spain, UK) and the US. Methods: This pharmacoeconomic model was based on estimates of ω‐3 efficacy reported in a recent meta‐analysis and data from country‐specific sources. It utilized a probabilistic discrete event simulation model to compare ω‐3 FA–containing PN with standard PN in a population of critically ill and general ward patients. The influence of model parameters was evaluated using probabilistic and deterministic sensitivity analyses. Results: Overall costs were reduced with ω‐3 FA–containing PN in all 6 countries compared with standard PN, ranging from €1741 (±€1284) in Italy to €5576 (±€4193) in the US. Expenses for infections and HLOS were lower in all countries for ω‐3 FA–containing PN vs standard PN, with the largest cost differences for both in the US (infection: €825 ± €4001; HLOS: €4879 ± €1208) and the smallest savings in the UK for infections and in Spain for HLOS (€63 ± €426 and €1636 ± €372, respectively). Conclusion: This cost‐effectiveness analysis in 6 countries demonstrates that the superior clinical efficacy of ω‐3 FA–containing PN translates into significant decreases in mean treatment cost, rendering it an attractive cost‐saving alternative to standard PN across different healthcare systems. [ABSTRACT FROM AUTHOR]

Background: Invasive mould diseases are associated with high morbidity, mortality and economic impact. Its treatment is often started prior to differential pathogen diagnosis. Isavuconazole is approved for treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) when amphotericin‐B is not indicated. Objectives: To estimate the cost‐effectiveness of isavuconazole vs voriconazole for the treatment of adult patients with possible IA prior to differential pathogen diagnosis, in Spain. Methods: A decision tree analysis was performed using the Spanish Healthcare System perspective. Among all patients with possible IA, it was considered that 7.81% actually had IM. Costs for laboratory analysis, management of adverse events, hospitalisation and drugs per patient, deaths and long‐term effects in life years (LYs) and quality‐adjusted LYs (QALYs) were considered. Efficacy data were obtained from clinical trials and utilities from the literature. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. Results: In patients with possible IA and when compared to voricanozole, isavuconazole showed an incremental cost of 4758.53€, besides an incremental effectiveness of +0.49 LYs and +0.41 QALYs per patient. The Incremental Cost Effectiveness Ratio was 9622.52€ per LY gained and 11,734.79€ per QALY gained. The higher cost of isavuconazole was due to drug acquisition. Main parameters influencing results were mortality, treatment duration and hospitalisation days. The PSA results showed that isavuconazole has a probability of being cost‐effective of 67.34%, being dominant in 24.00% of cases. Conclusions: Isavuconazole is a cost‐effective treatment compared to voriconazole for patients with possible IA for a willingness to pay threshold of 25,000€ per additional QALY. [ABSTRACT FROM AUTHOR]

The purpose of this manuscript was to illustrate the impact of the place in the treatment sequence on the cost and cost-effectiveness of different biologics for patients with moderate-to-severe plaque psoriasis. We developed a treatment sequence model and focused on seven different biological treatment options and 840 combinations of treatment sequences. The model converted cost of treatment to a cost per responder by dividing treatment cost by expected number of patients achieving PASI100 after 52 weeks of treatment. We used Spanish ex-factory price levels, dosing recommendations and real-world data on drug survival to calculate the treatment costs. The most cost-effective treatment sequence was brodalumab–risankizumab–guselkumab–ixekizumab, with a cost per responder of €139,281 during the first five years of treatment. In comparison, if brodalumab was not recommended as first-line therapy, total costs would increase by 7.4% to €149,616. If brodalumab was not recommended as any of the first four lines of treatment, total costs would increase by 13.1% to €157,527 relative to the most cost-effective treatment sequence. A sequential therapy model may improve efficiency in the treatment of psoriasis. According to our results, brodalumab as the first-line therapy in Spain leads to the most cost-effective treatment sequence. [ABSTRACT FROM AUTHOR]

To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective. A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (€2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results. On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of €3,173.47 and €7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis. MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting. [ABSTRACT FROM AUTHOR]

This study evaluated cost-effectiveness of defibrotide vs best supportive care (BSC) for the treatment of hepatic veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) with multiorgan dysfunction (MOD) post-hematopoietic cell transplantation (HCT) in Spain. A two-phase Markov model, comprising a 1-year acute phase with daily cycles and a lifetime long-term phase with annual cycles, was adapted to the Spanish setting. The model included a cohort of patients with severe VOD/SOS (defined as VOD/SOS with MOD) post-HCT. For the acute phase, efficacy and VOD/SOS-related length of stay were obtained from a phase 3 defibrotide study (NCT00358501). VOD/SOS-related hospital stays were 7.5 and 23.2 days in defibrotide-treated and BSC patients, respectively. Defibrotide-treated patients spent 30% of their stay in the intensive care unit vs 60% in BSC patients. Assumptions for the long-term phase and utility values were obtained from the literature. Costs were from the Spanish Health System perspective (€2019). Defibrotide cost was based on 25 mg/kg/day over 17.5 days, using local expert opinion. Life-years (LYs), quality-adjusted LYs (QALYs), and costs were estimated over a lifetime horizon, applying a 3% discount rate for costs and outcomes. Sensitivity analyses assessed the robustness of the results. Defibrotide produced an additional 1.214 QALYs and 1.348 LYs vs BSC, with a total cost of €33,708 more than BSC alone. However, defibrotide resulted in savings up to €16,644/patient for cost of hospital stay. Difference between costs and effective measures led to ratios of €27,757/QALY and €25,007/LY gained. Additional hospital stays had the greatest influence on base-case results. Probabilistic analysis confirmed the robustness of the deterministic results. Limitations include use of historical controls and assumptions extrapolated from the literature. This cost-effectiveness model, adapted to the Spanish setting, showed that defibrotide is a cost-effective alternative to BSC alone in patients with severe VOD/SOS post-HCT. [ABSTRACT FROM AUTHOR]

Objective: There is sufficient evidence on the feasibility of a vaccine to prevent Helicobacter pylori infection. Modeling studies in low prevalence environments report a very probable long-term cost-effectiveness. The objective of this study was to quantify its efficiency in a local context., Methods: The evolution of a cohort of newborns was simulated through a compartmental model representing a series of clinical situations regarding H. pylori infection and related diseases. The model was run under the assumption of both vaccination in the first year of life and no intervention. The time horizon was set as equivalent to the life expectancy and the perspective of the health system was taken into account., Results: Vaccination against H. pylori would cost an average of €2,168/person more than no intervention. This would yield an average additional 0.32 quality-adjusted life years gained (QALY), which would entail an incremental cost-effectiveness ratio (ICER) of €7,196/QALY. For a willingness to pay of €24,506/QALY, 99.96% of the simulations were cost-effective at eighty-four years old. This threshold was crossed thirty years after vaccination. The variables that carried the most weight in explaining the variability of the ICER were, in this order, vaccine effectiveness, the incidence of infection in young children, and the price of the vaccine. Vaccination would cease to be cost-effective with a price greater than €3,634/dose or with effective population coverage less than 11%., Conclusions: When implemented in an environment with the epidemiological and economic characteristics of Southern Europe, a prophylactic vaccination against H. pylori would be cost-effective in the long run.

Aim: To estimate the cost‐effectiveness of dapagliflozin added to standard therapy, vs. standard therapy only, in patients with heart failure (HF) with reduced ejection fraction (HFrEF), from the perspective of UK, German, and Spanish payers. Methods and results: A lifetime Markov model was built to estimate outcomes in patients with HFrEF. Health states were defined by Kansas City Cardiomyopathy Questionnaire total symptom score, type 2 diabetes and worsening HF events. The incidence of worsening HF and all‐cause mortality was estimated using negative binomial regression models and parametric survival analysis, respectively. Direct healthcare costs (2019 British pounds/Euro) and patient‐reported outcomes (EQ‐5D) were sourced from the existing literature and the Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure trial (DAPA‐HF), respectively; the median duration of follow‐up in DAPA‐HF was 18.2 months (range: 0–27.8). Future costs and effects were discounted at 3.0% for the Spanish and German analyses and 3.5% for the UK analysis. In the UK setting, treatment with dapagliflozin was estimated to increase life‐years and quality‐adjusted life‐years (QALYs) from 5.62 to 6.20 (+0.58) and 4.13 to 4.61 (+0.48), respectively, and reduce lifetime hospitalizations for HF (925 and 820 events per 1000 patients for placebo and dapagliflozin, respectively). Similar results were obtained for Germany and Spain. The incremental cost‐effectiveness ratios were £5822, €5379 and €9406/QALY in the UK, Germany and Spain, respectively. In probabilistic sensitivity analyses, more than 90% of simulations were cost‐effective at a willingness‐to‐pay threshold of £20 000/QALY in UK and €20 000/QALY in Germany and Spain. Conclusion: Dapagliflozin is likely to be a cost‐effective treatment for HFrEF in the UK, German and Spanish healthcare systems. [ABSTRACT FROM AUTHOR]

Aims: To assess the cost-effectiveness of pro-protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in cardiovascular disease.Methods and Results: We performed a comprehensive search strategy in electronic databases from January 2015 to January 2019. Out of 475 articles, 16 were entered into the study. Quality-adjusted life year, life years gained (LYG), annual cost, and the incremental cost-effectiveness ratio (ICER) regarding the use of PCSK9 inhibitors were considered as the key outcomes. The cost-effectiveness threshold varied from $45,000 in Spain to $150,000 in the USA. The annual cost of PCSK9 inhibitors for studies undertaken in the USA was in the range of $14,000 to $15,000, while it was about $7000 for other developed countries. The results showed that reduction in the price of PCSK9 inhibitors changed from 20 to 88%. The means of QALY were 0.65 and 0.67 in the Markov and Cardiovascular Disease Policy Modeling (CVDPM) models; also, the ICER means were $197,707 and $625,555 for the Markov and CVDPM model, respectively.Conclusion: According to the current study, the effectiveness of PCSK9 inhibitors is well documented, although all studies pointed out a higher cost of these inhibitors.Trial Registration: This study was registered within the International Prospective Register of Systematic Reviews (PROSPERO) database of the University of York (CRD42018088472). [ABSTRACT FROM AUTHOR]

Objective: To assess the cost-effectiveness of tofacitinib-containing treatment sequences versus sequences containing only standard biological therapies in patients with moderate-to-severe rheumatoid arthritis (RA) after the failure of conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR population) and in patients previously treated with methotrexate (MTX) who show an inadequate response to second-line therapy with any tumour necrosis factor inhibitor (TNFi-IR population). Methods: A patient-level microsimulation model estimated, from the perspective of the Spanish Public NHS, lifetime costs and quality-adjusted life years (QALY) for treatment sequences starting with tofacitinib (5 mg twice daily) followed by biological therapies versus sequences of biological treatments only. Concomitant treatment with MTX was considered. Model's parameters comprised demographic and clinical inputs (initial Health Assessment Questionnaire [HAQ] score and clinical response to short- and long-term treatment). Efficacy was measured by means of HAQ score changes using mixed treatment comparisons and data from long-term extension (LTE) trials. Serious adverse events (SAEs) data were derived from the literature. Total cost estimation (€, 2018) included drug acquisition, parenteral administration, disease progression and SAE management. Results: In the csDMARD-IR population, sequences starting with tofacitinib proved dominant options (more QALYs and lower costs) versus the corresponding sequences without tofacitinib. In the TNFi-IR population, first-line treatment with tofacitinib+MTX followed by scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX proved dominant versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX; and tofacitinib+MTX➔scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX was less effective but remained a cost-saving option. Conclusions: Inclusion of tofacitinib seems a dominant strategy in moderate-to-severe RA patients after csDMARDs failure. Tofacitinib, as initial third-line therapy, proved a cost-saving strategy (€− 337,489/QALY foregone) in moderate-to-severe TNFi-IR RA patients. Key points • Therapeutical approach in rheumatoid arthritis (RA) consisted in sequences of several therapies during patient lifetime. • Treatment sequences initiating with tofacitinib followed by biological drugs provided higher health effects in csDMARDs-IR population, compared with sequences containing only biological drugs. • In both csDMARD-IR and TNFi-IR RA populations, initiating treatment with tofacitinib was associated to lower treatment costs for the Spanish National Health System. [ABSTRACT FROM AUTHOR]

Objective: A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing. Method: Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model. Results: The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of €2482–3278 (sucrose octasulfate dressing) and €2768–3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of €3450 and €6054, respectively (CE=€3520, €6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor. Conclusion: Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates. [ABSTRACT FROM AUTHOR]

Background: Data from clinical trials comparing Helicobacter pylori (H. pylori) management strategies in patients with dyspepsia are limited. Cost‐effectiveness simulation models might help to identify the optimal strategy. Objective: To assess the cost‐effectiveness of the H. pylori "Test and Treat" (T&T) strategy including the use of urea breath test (UBT) vs symptomatic treatment (ST) and vs upper gastrointestinal endoscopy (UGE) as a first procedure in patients with dyspepsia. Methods: Three main strategies: "T&T" strategy including the use of UBT, "UGE" and "ST" have been compared using cost‐effectiveness models developed in accordance with the Spanish medical practice. For the model simulations, a time horizon of 4 weeks was considered for the endpoint "Dyspepsia symptoms relief" and 10 years when using "Peptic ulcer avoided" and "Gastric cancer avoided" endpoints. Results: For the endpoint "Dyspepsia symptoms relief", T&T strategy appears to be the most cost‐effective (883€/success) compared to UGE strategy and to ST strategy (respectively 1628€ and 990€/success). For the endpoint "Probability of peptic ulcer", the T&T strategy appears to be the most cost‐effective (421€/peptic ulcer avoided/y) compared to UGE strategy and ST strategy (respectively 728€ and 632€/peptic ulcer avoided/y). For the endpoint "Gastric cancer avoided", the T&T strategy appears to be the most cost‐effective (524€/gastric cancer avoided/y) compared to UGE strategy and "ST" strategy (respectively 716€ and 696€/gastric cancer avoided/y). Conclusions: T&T strategy including the use of UBT is the most cost‐effective medical approach for management of dyspepsia and for the prevention of ulcer and gastric cancer. [ABSTRACT FROM AUTHOR]

Campylobacter is a food safety hazard, which causes a substantial human disease burden. Infected broiler meat is a common source of campylobacteriosis. The use of probiotics, prebiotics, or synbiotics has been associated with controlling Campylobacter infections in broilers, although efficacy remains a contentiously debated issue. On-farm use of probiotics, prebiotics, or synbiotics is gaining momentum. Therefore, it is interesting to analyze the economic viability of this potential intervention to reduce Campylobacter prevalence in broilers. A normative cost-effectiveness analysis was conducted to estimate the cost-effectiveness ratio of using probiotics, prebiotics, or synbiotics in broiler production in Denmark, the Netherlands, Poland, and Spain. The cost-effectiveness ratio was defined as the estimated costs of probiotics, prebiotics, or synbiotics use divided by the estimated public health benefits expressed in euro (€) per avoided disability-adjusted life year (DALY). The model considered differences between the countries in zootechnical and economic farm performance, in import, export, and transit of live broilers, broiler meat and meat products, and in disease burden of Campylobacter-related human illness. Simulation results revealed that the costs per avoided DALY were lowest in Poland and Spain (€4,000–€30,000 per avoided DALY) and highest in the Netherlands and Denmark (€70,000–€340,000 per avoided DALY) at an efficacy ranging from 10 to 20%. In Poland and Spain, using probiotics can be classified as a moderately expensive intervention if efficacy is more than 10%, otherwise it is relatively expensive. In the Netherlands and Denmark, using probiotics is a relatively expensive intervention irrespective of efficacy. However, if probiotics, prebiotics, or synbiotics were assumed to enhance broiler performance, it would become a relatively cost-effective intervention for Campylobacter even at low efficacy levels of 1 to 10%. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-effectiveness of Cladribine Tablets in the treatment of relapsing multiple sclerosis (RMS) with high disease activity compared with fingolimod, from the perspective of the National Health System (NHS) in Spain.Methods: A Markov model was developed. The annual transition probabilities, were adjusted to patients with RMS with high disease activity. The effect of the treatments compared on the Expanded Disability Status Scale (EDSS) was modeled by hazard ratios for the confirmed progression of disability. The annual relapse rate and the probability of suffering adverse reactions were obtained from a meta-analysis and the literature. The derived costs were calculated from Spanish unit costs. The utilities were obtained from the CLARITY clinical trial and the literature. Deterministic and probabilistic sensitivity analyzes were performed.Results: Cladribine tablets was the dominant treatment: lower costs (-86,536 €) and more effective (+1.11 quality-adjusted life years - QALYs) compared to fingolimod. The probability that Cladribine Tablets was cost-effective compared to fingolimod ranged between 94.6% and 96.1% for willingness to pay from € 20,000 to € 30,000 per QALY gained.Conclusions: Cladribine Tablets is a cost-effective treatment, compared to fingolimod, for the treatment of RMS with high disease activity.Expert Opinion: According to the present study, compared to fingolimod, treatment with Cladribine Tablets of relapsing multiple sclerosis with high disease activity is an option that could generate savings for the Spanish National Health System, with a considerable gain in QALYs. Cladribine Tablets is considered cost-effective and dominant (less costs and more effectiveness) than fingolimod treatment option in this population. [ABSTRACT FROM AUTHOR]

Objectives: A centralised approach to health technology assessment (HTA) may facilitate optimal use of HTA resources. A regional approach may increase the chances of local implementation of recommendations. This study aimed to compare assessment procedures in England (centralised HTA approach) with Spain (regional HTA approach) discussing key challenges and opportunities from both approaches.Methods: We compared technology assessments of anticancer medicines in the two jurisdictions from 2008 to 2015. To assess the implementation of HTA recommendations, we assessed trends in medicine usage using regression methods. We used IQVIA data, from 2011 to 2016, for a sample of 11 medicines. We used CatSalut data from Catalonia to assess the implementation of local recommendations.Results: In England, 66 assessments were undertaken by the National Institute for Health and Care Excellence (NICE), using a standardised methodology. In Spain, there were 79 reports undertaken by a range of bodies using a shared process and coordinated through the GENESIS collaboration; the assessment methods used varied substantially. Overall, the recommendations in the two jurisdictions were similar. Regression analyses indicate that where there is a positive recommendation by HTA bodies, the usage of the medicine responds most strongly (p < 0.001) in Catalonia (4.892), followed by England (3.120) and Spain (1.693).Conclusions: This study suggests that medicine utilisation does respond to the positive recommendations of HTA bodies. However, if HTA capacity is organised primarily regionally, considerable effort may be required in coordination, to ensure consistent and rigorous assessments and adequate implementation of HTA findings. [ABSTRACT FROM AUTHOR]

Accurate HCV prevalence estimates are necessary for guiding elimination policies. Our aim was to determine the HCV prevalence and assess the cost‐effectiveness of a screen‐and‐treat strategy in the Spanish population. A population‐based, cross‐sectional study (PREVHEP‐ETHON Cohort, Epidemiological sTudy of Hepatic infectiONs; NCT02749864) was performed from July 2015‐April 2017. Participants from three Spanish regions were selected using two‐stage conglomerate sampling, and stratified by age, with randomized subject selection. Anthropometric and demographic data were collected, and blood samples were taken to detect anti‐HCV antibodies/quantify HCV RNA. The cost‐effectiveness of the screening strategies and treatment were analysed using a Markov model. Among 12 246 participants aged 20‐74 (58.4% females), the overall anti‐HCV prevalence was 1.2% (95% CI 1.0‐1.4), whereas the detectable HCV‐RNA prevalence was 0.3% (0.2‐0.4). Infection rates were highest in subjects aged 50‐74 years [anti‐HCV 1.6% (1.3‐1.9), HCV RNA 0.4% (0.3‐0.6]. Among the 147 anti‐HCV + subjects, 38 (25.9%) had active infections while 109 (74.1%) had been cleared of infection; 44 (40.4%) had cleared after antiviral treatment, whereas 65 (59.6%) had cleared spontaneously. Overall, 59.8% of the anti‐HCV + participants were aware of their serological status. Considering a cost of treatment of €7000/patient, implementing screening programmes is cost‐effective across all age cohorts, particularly in patients aged 50‐54 (negative incremental cost‐effectiveness ratio which indicates a cost‐saving strategy). The current HCV burden is lower than previously estimated, with approximately 25% of anti‐HCV + individuals having an active infection. A strategy of screening and treatment at current treatment prices in Spain is cost‐effective across all age cohorts. [ABSTRACT FROM AUTHOR]

Introduction: Once-weekly semaglutide has been associated with greater reductions in glycated hemoglobin (HbA1c) and body weight than sitagliptin and dulaglutide in the SUSTAIN 2 and 7 clinical trials, respectively. These trials also assessed the proportions of patients achieving treatment targets capturing glycemic control and avoidance of hypoglycemia and weight gain. This study assessed the cost of bringing patients with type 2 diabetes to three clinically relevant endpoints with semaglutide versus sitagliptin and dulaglutide in Spain. Methods: The proportions of patients achieving endpoints of HbA1c < 7.0%, HbA1c < 7.0% without hypoglycemia and without weight gain, and a ≥ 1.0% HbA1c reduction with ≥ 5.0% weight loss were taken from SUSTAIN 2 and 7. Cost of control was calculated as the annual per patient cost of each medication, expressed in 2019 euros (EUR), divided by the proportion of patients achieving each endpoint. Results: Based on SUSTAIN 2, cost of control was lower for sitagliptin for the HbA1c < 7.0% endpoint, results were comparable for the HbA1c < 7.0% without hypoglycemia and without weight gain endpoint, and both doses of semaglutide were associated with lower costs of control for the ≥ 1.0% HbA1c reduction with ≥ 5.0% weight loss endpoint. Based on SUSTAIN 7, both doses of semaglutide were associated with lower costs of control for all three endpoints. Conclusion: Both doses of semaglutide were associated with comparable or lower costs of control versus sitagliptin when considering endpoints incorporating hypoglycemia and weight loss alongside glycemic control, and lower costs of control versus dulaglutide 1.5 mg for all endpoints in Spain. Plain Language Summary: Plain language summary available for this article. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-effectiveness of second-line pharmacological treatments in patients with acromegaly resistant to first-generation somatostatin analogues (FG SSA) from the Spanish National Health System (NHS) perspective.Methods: A Markov model was developed to analyze the cost-effectiveness of pegvisomant and pasireotide in FG SSA-resistant acromegaly, simulating a cohort of patients from the treatment beginning to death. Treatment with pegvisomant or pasireotide was compared to FG SSA retreatment. Efficacy data were obtained from clinical trials and utilities from the literature. Direct health costs were obtained from Spanish sources (€2018).Results: The Incremental Cost Effectiveness Ratio (ICER) of pegvisomant vs. FG SSA was €85,869/Quality-adjusted life years (QALY). The ICER of pasireotide vs. FG SSA was €551,405/QALY. The ICER was mainly driven by the incremental efficacy (4.41 QALY for pegvisomant vs. FG SSA and 0.71 QALY for pasireotide vs. FG SSA), with a slightly lower increase in costs with pegvisomant (€378,597 vs. FG SSA) than with pasireotide (€393,151 vs. FG SSA).Conclusion: The ICER of pasireotide compared to FG SSA was six times higher than the ICER of pegvisomant vs. FG SSA. Pegvisomant is a more cost-effective alternative for the treatment of acromegaly in FG SSA-resistant patients in the Spanish NHS. [ABSTRACT FROM AUTHOR]

Introduction/objectives: Lesinurad, in combination with allopurinol, has been approved for treatment of patients with gout which do not reach therapeutic serum urate target with xanthine oxidase inhibitors monotherapy. The study aimed to assess the incremental cost-effectiveness ratio of adding lesinurad to allopurinol as second-line therapy, compared to febuxostat for patients with gout in Spain. Method: A Markov model representing disease evolution was used to estimate the lifetime accumulated cost and benefits in terms of quality-adjusted-life-year (QALY). Patients could either continue with second-line treatment with lesinurad (200 mg/daily) plus allopurinol (400 mg/daily) or febuxostat (80 mg/daily) switch to allopurinol monotherapy (271 mg/daily) in case of intolerance or discontinue treatment. The treatment's efficacy captured in the transition probabilities between health states were derived from CLEAR and EXCEL trials. Quality of life related to gout severity and flare frequency was considered by means of utilities. The total cost estimation (€, 2019) included drug acquisition cost, disease monitoring, and flare management cost. Unitary local costs derived from databases and literature. A 3% annual discount rate was applied for cost and outcomes. Results: Lesinurad plus allopurinol provided higher QALYs (14.79) than febuxostat (14.69). Total accrued cost/patient was lower with lesinurad and allopurinol (€50,631.51) versus febuxostat (€56,698.64). Lesinurad plus allopurinol resulted more effective and less costly (dominant option) versus febuxostat. Conclusions: Lesinurad plus allopurinol therapy compared with febuxostat seems an effective option for the management of hyperuricemia in patients who did not reach serum urate target to previous allopurinol monotherapy, associated to cost-savings for the Spanish Health System. Key Points • Lesinurad, in combination with allopurinol, has been recently authorized as second-line treatment of hyperuricemia in gout patients. • Lesinurad plus allopurinol provided higher effectiveness in terms of quality-adjusted-life-years (14.79) than febuxostat (14.69). • Lesinurad plus allopurinol resulted less costly (total cost/per patient) compared with febuxostat. • Lesinurad plus allopurinol resulted a dominant option compared with febuxostat. [ABSTRACT FROM AUTHOR]

Background: The efficacy of smoking cessation interventions can be quite diverse in day-to-day clinical practice.Objective: To analyse the effectiveness in smoking cessation of multicomponent interventions carried out in groups or individually in primary care practices.Methods: A quasi-experimental, multicentre study of 12-month follow-up of patients treated in multicomponent smoking cessation interventions was carried out in Urban health care centres in Sevilla, Spain. Two hundred and twenty smoking patients, ≥18 years of age, participated either in a multicomponent intervention group (n = 145; mean age 51.7 years; 53.1% women) or in individual interventions (n = 77; mean age 50.5 years; 61.0% women). The abstinence or relapse status was computed from patient self-reports, confirmed by relatives or companions when possible and supplemented by CO-oxymetry tests in 89 patients.Results: The overall percentage of smoking cessation was 36.9% (37.9% with group and 35.1% with individual intervention, P = 0.398). Patients who quit smoking were younger (48.7 versus 52.9 years old, P < 0.01), with fewer years of smoking (32.9 versus 36.8 years, P < 0.05), with higher education (39.0% versus 25.0%, P < 0.05) and had received pharmacological treatment (91.5% versus 67.9%, P < 0.001). In the multivariate analysis, level of education [odds ratio (OR): 1.995; 95% confidence interval (CI): 1.065-3.735, P < 0.01], group intervention (OR: 1.743; 95% CI: 1.006-3.287, P < 0.05) and drug prescription (OR: 2.368; 95% CI: 1.126-4.980, P < 0.05) were significantly associated with smoking cessation.Conclusions: Our study found that multicomponent group and individual interventions in primary care were associated with an overall quit rate of smoking of 36.9% at 12-month follow-up, with higher probability of success among patients with higher education and those who received the group intervention and drug treatment. [ABSTRACT FROM AUTHOR]

Summary: This study estimated the cost-effectiveness of pharmacological fracture prevention as prescribed in the five largest European countries (EU5) using the IOF reference cost-effectiveness model. Pharmacological fracture prevention as prescribed in clinical practice was cost-saving (provided more QALYs at lower costs) compared to no treatment in each of the EU5. Purpose: To estimate the real-world cost-effectiveness of pharmacological fracture prevention as prescribed in the five largest European countries by population size: France, Germany, Italy, Spain, and the United Kingdom (UK) (collectively EU5). Materials and methods: We analyzed sales data on osteoporosis drugs in each of the EU5 to derive a hypothetical intervention that corresponds to the mix of osteoporosis medication prescribed in clinical practice. The costs for this treatment mix were obtained directly from the sales data, and the efficacy of the treatment mix was estimated by weighing the treatment-specific fracture risk reductions from a published meta-analysis. Subsequently, we estimated the cost-effectiveness using costs per quality adjusted life year (QALY) of the intervention compared to no treatment in each of the EU5 using the International Osteoporosis Foundation (IOF) reference cost-effectiveness model. The model population comprised postmenopausal women, mean age 72 years with established osteoporosis (T-score ≤ − 2.5) among whom 23.6% had a prevalent vertebral fracture. The model was populated with country-specific data from the literature. Results: Pharmacological fracture prevention as prescribed in clinical practice was cost-saving (provided more QALYs at lower costs) compared to no treatment in each country. The findings were robust in scenario analyses. Conclusions: Pharmacological fracture prevention as prescribed in clinical practice is cost-saving in each of the EU5. Because of the under-diagnosis and under-treatment of post-menopausal osteoporosis, from a health economic perspective, further cost-savings may be reached by expanding treatment to those at increased risk of fracture currently not receiving any treatment. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the long‐term cost‐effectiveness of fixed‐ratio combination insulin degludec/liraglutide (IDegLira) versus comparator regimens for type 2 diabetes in Spain, based on real‐world evidence. Materials and methods: Clinical data were taken from the European Xultophy Treatment Retrospective Audit (EXTRA) real‐world evidence study in which patients failing to meet glycaemic targets were switched to IDegLira. Baseline regimens (prior to IDegLira treatment) were categorized as: multiple daily insulin injections (MDI; 28%); glucagon‐like peptide‐1 (GLP‐1) receptor agonists in combination with insulin (24%); basal insulin (19%); GLP‐1 receptor agonists (10%); and non‐injectable medications (19%). The IQVIA CORE Diabetes Model was used to project long‐term outcomes for patients switching to IDegLira or continuing their baseline regimens (excluding non‐injectable regimens). Costs were accounted from a Spanish National Health System perspective. Future costs and clinical benefits were discounted at 3% annually and sensitivity analyses were performed. Results: IDegLira was projected to reduce the incidence of diabetes‐related complications and improve quality‐adjusted life expectancy versus all four comparators. IDegLira reduced direct medical costs versus GLP‐1 receptor agonists in combination with insulin, and versus GLP‐1 receptor agonist therapy, and was therefore considered dominant (cost saving while improving outcomes). IDegLira was found to be cost‐effective versus MDI and basal insulin with incremental cost‐effectiveness ratios of EUR 3013 per quality‐adjusted life‐year (QALY) gained and EUR 6890 per QALY gained, respectively. Conclusions: Long‐term projections based on real‐world evidence indicated that IDegLira is likely to improve clinical outcomes and reduce costs or be cost‐effective compared with other injectable regimens in people with type 2 diabetes in Spain. [ABSTRACT FROM AUTHOR]