Cost-Effectiveness Analysis of Fracture Liaison Services Compared with Standard of Care in the Secondary Prevention of Fragility Fractures in Spain.

Purpose: To assess the cost-effectiveness of a Fracture Liaison Service (FLS) compared with standard care for the secondary prevention of fragility fractures in Spain. Methods: Patients with osteoporosis and an initial fragility fracture who were candidates to initiate osteoporosis treatment (mean age 65 years, 90.7% female) were included in the model. Disease progression was simulated with a Markov model through seven health states (with and without osteoporosis treatment, subsequent hip, vertebral, forearm and humerus fracture, and death). A time horizon of 10 years and a 6-month duration per cycle was set. Clinical, economic, and quality of life parameters were estimated from the literature and Spanish clinical practice. Resource use and treatment patterns were validated by an expert panel. The Spanish National Health System (SNS) perspective was adopted, taking direct costs (€; 2020) into account. Effectiveness was measured in life-years gained (LYG) and quality-adjusted life years gained (QALYs). A discount rate of 3% was applied to costs and outcomes. The uncertainty of the parameters was assessed using deterministic, scenario and probabilistic sensitivity analyses (1000 iterations). Results: Setting up a FLS for the secondary prevention of fragility fractures in Spain would provide better osteoporosis treatment initiation and persistence. This would reduce subsequent fragility fractures, disutilities and deaths. FLS would have greater clinical benefits (0.008 and 0.082 LYG and QALY gained per patient, respectively) and higher costs (€563.69 per patient) compared with standard care, leading to an incremental cost-utility ratio of €6855.23 per QALY gained over the 10 years horizon. The sensitivity analyses showed limited dispersion of the base case results, corroborating their robustness. Conclusion: From the SNS perspective and considering Spanish willingness-to-pay thresholds, the introduction of FLS for the secondary prevention of fragility fractures would be a cost-effective strategy.

Cost of early-stage mycosis fungoides treatments in Spain.

AIM: To identify the most common therapeutic options for the treatment of early-stage mycosis fungoides in Spain, quantify their associated healthcare resource use and costs. METHODS: After reviewing the literature, a panel of 6 Spanish clinical dermatologists validated the treatments and healthcare resource use through a structured questionnaire. Individual responses were collected, analyzed and presented into a face-to-face meeting in order to reach a consensus. Cost categories considered were: drug acquisition and administration, photo/radiotherapy session and maintenance, clinical follow-up visits and laboratory tests. Costs were expressed in euros from 2018. The Spanish National Health System perspective was considered, taking into account direct health costs and time horizons of 1, 3 and 6 months. RESULTS: Costs for the skin-directed treatments (SDT) assessed at 1, 3 and 6 months, were: Topical carmustine [€6,593.36, €19,780.09 and €27,592.78]; Phototherapy with psoralens and ultraviolet A light (PUVA) [€1,098.68, €2,999.99 and €3,187.60]; Narrow-band ultraviolet B phototherapy [€1,657.47, €4,842.10 and €4,842.10]; Total skin electron beam therapy (TSEBT) [€6,796.45, €7,913.34 and €7,913.34]. Cost for topical corticosteroids, being considered an adjuvant option, were €17.16, €51.49 and €102.97. Costs for the assessed systemic treatments alone or in combination with SDT at 1, 3 and 6 months, were: Systemic retinoids [€2,026.03, €5,206.63 and €7,426.42]; Systemic retinoids + PUVA phototherapy [€3,066.50, €8,271.26 and €10,046.58]; Interferon alfa + PUVA phototherapy [€1,541.09, €5,167.57 and €6,404.55]. CONCLUSION: According to the Spanish clinical practice, phototherapies in monotherapy were the treatments with the lowest associated costs regardless of the time horizon considered. TSEBT turned out as the treatment with the highest associated costs when considering 1 month. However, while considering 3 and 6 months the treatment with the highest associated costs was topical carmustine. The results of this analysis may provide critical information to measure the disease burden, to detect unmet medical needs and to advocate towards better treatments for this rare disease.

Cost-effectiveness analysis of ribociclib versus palbociclib in the first-line treatment of HR+/HER2- advanced or metastatic breast cancer in Spain.

PURPOSE: The aim of this study was to evaluate the cost-effectiveness of ribociclib compared to palbociclib, both in combination with letrozole, in the first-line treatment of postmenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (ABC) from the perspective of the Spanish National Health System (NHS). PATIENTS AND METHODS: Disease progression was simulated with a partitioned survival model developed from the parameterization and extrapolation of survival curves of postmenopausal women with HR+/HER2- ABC from clinical trials with ribociclib or palbociclib, both in combination with letrozole. The model was structured on the basis of three health states (progression-free, progressed disease, and death), with a 1-month cycle length and inclusion of subsequent treatments administered for disease progression, over a time horizon of 15 years. Clinical, economic, and quality of life parameters were drawn from clinical trials and the literature. The use of resources and clinical practice in the Spanish setting was validated by a panel of experts. The Spanish NHS perspective was adopted, taking into account exclusively direct health costs from 2017 expressed in Euros. Drug prices used were the reported ex-factory prices. Uncertainty of the parameters and robustness of the results were evaluated using deterministic and probabilistic sensitivity analyses (2,000 iterations). RESULTS: This cost-effectiveness analysis showed a greater benefit (0.437 and 0.285 life-years gained [LYGs] and quality-adjusted life years [QALYs] gained, respectively) and a slightly higher cost (€439.86) for ribociclib+letrozole compared to palbociclib+letrozole. The resulting incremental cost-effectiveness and cost-utility ratios were €1,007.69 per LYG and €1,543.62 per QALY gained, respectively. The results of the multiple sensitivity analyses showed limited dispersion of the outcomes, thus corroborating their robustness. CONCLUSION: From the NHS perspective, considering the most commonly established willingness-to-pay thresholds in the Spanish setting, ribociclib+letrozole would represent a cost-effective therapeutic option compared to palbociclib+letrozole in the first-line treatment of HR+/HER2- ABC in postmenopausal women.

Impacto económico asociado a la implementación de las recomendaciones con grado de evidencia A-I del documento de consenso de GeSIDA/PNS (2015) relativas a la optimización del tratamiento antirretroviral en adultos infectados por virus de la inmunodeficiencia humana con carga viral suprimida en España / Economic impact of optimising antiretroviral treatment in human immunodeficiency virus-infected adults with suppressed viral load in Spain, by implementing the grade A-1 evidence recommendations of the 2015 GESIDA/National AIDS Plan

Introducción: El objetivo de este estudio es estimar el impacto económico en España de la optimización del tratamiento antirretroviral (TAR) triple en pacientes con carga viral suprimida según las recomendaciones GeSIDA/PNS (2015) y su aplicabilidad en la práctica clínica. Métodos: A partir de los datos de prescripción del TAR de la encuesta hospitalaria 2014, siguiendo las recomendaciones de GeSIDA/PNS de optimización de TAR con grado de evidencia A-I, se desarrolló un modelo farmacoeconómico. Las pautas de optimización, la voluntad de optimización y demás asunciones y resultados del modelo fueron validados por un panel de expertos en la infección por VIH (infectológos y farmacéuticos hospitalarios). El análisis se realizó desde la perspectiva del SNS, considerando el coste farmacológico anual, precio de venta del laboratorio notificado, deducción RD-Ley-8/2010 e IVA. Resultados: El panel seleccionó 6 estrategias de optimización y estimó que en España de los 80.859 pacientes actualmente en TAR triple, 10.863 (13,4%) serían candidatos a optimizar su TAR según estas estrategias, generando ahorros de 15,9M euros /año (2,4% del coste farmacológico del TAR triple). Las estrategias más factibles (>40% del total de pacientes candidatos a optimizar, n=4.556) y asociadas a mayores reducciones del gasto (ahorro entre 653 y 4.797 euros /paciente-año según el TAR triple de partida) serían las optimizaciones a ATV/r+3TC. Conclusión: La aplicación a la práctica clínica española de las principales estrategias de optimización recomendadas en el documento GeSIDA/PNS (2015) generaría ahorros sustanciales, especialmente aquellas basadas en biterapia con ATV+3TC, contribuyendo así al control del gasto farmacéutico y a la sostenibilidad del SNS (AU)

Introduction: The objective of this study is to estimate the economic impact associated with the optimisation of triple antiretroviral treatment (ART) in patients with undetectable viral load according to the recommendations from the GeSIDA/PNS (2015) Consensus and their applicability in the Spanish clinical practice. Methods: A pharmacoeconomic model was developed based on data from a National Hospital Prescription Survey on ART (2014) and the A-I evidence recommendations for the optimisation of ART from the GeSIDA/PNS (2015) consensus. The optimisation model took into account the willingness to optimise a particular regimen and other assumptions, and the results were validated by an expert panel in HIV infection (Infectious Disease Specialists and Hospital Pharmacists). The analysis was conducted from the NHS perspective, considering the annual wholesale price and accounting for deductions stated in the RD-Law 8/2010 and the VAT. Results: The expert panel selected six optimisation strategies, and estimated that 10,863 (13.4%) of the 80,859 patients in Spain currently on triple ART, would be candidates to optimise their ART, leading to savings of 15.9M euros /year (2.4% of total triple ART drug cost). The most feasible strategies (>40% of patients candidates for optimisation, n=4,556) would be optimisations to ATV/r+3TC therapy. These would produce savings between 653 euros and 4,797 euros per patient per year depending on baseline triple ART. Conclusion: Implementation of the main optimisation strategies recommended in the GeSIDA/PNS (2015) Consensus into Spanish clinical practice would lead to considerable savings, especially those based in dual therapy with ATV/r+3TC, thus contributing to the control of pharmaceutical expenditure and NHS sustainability (AU)

Economic evaluation of endoscopic radiofrequency ablation for the treatment of dysplastic Barrett’s esophagus in Spain

Background and study aims: To assess the cost-effectiveness of introducing endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection in selected patients into the standard of care of Barrett’s esophagus patients with high-grade dysplasia or low-grade dysplasia in Spain. Methods: The disease evolution was modeled via a semi-Markov model. The treatment strategies compared included endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection and the Standard of Care (esophagectomy or palliative chemoradiotherapy according to disease status for high-grade dysplasia and endoscopic surveillance for low-grade dysplasia). Efficacy rates, transition probabilities and utility values were obtained from the literature. Clinical management patterns and resource use were modeled according to Spanish clinical expert opinion. Costs were expressed in euros (Euros) from 2016 reflecting the Spanish National Health System perspective. Sensitivity analyses were performed to assess the robustness of the model. Results: With respect to the Spanish Standard of Care, endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection was a dominant strategy for high-grade dysplasia patients. When a willingness-to-pay threshold of Euros30,000 per quality-adjusted lifeyears gained was considered, this was cost-effective for low-grade dysplasia patients (€12,865 per quality-adjusted life-years gained). The sensitivity analyses supported the base case analysis results and pointed towards the main drivers of uncertainty in the model. Conclusions: From a health care decision-maker, endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection is the intervention of choice for dysplasic Barrett's esophagus patients in Spain (AU)

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Economic impact of optimising antiretroviral treatment in human immunodeficiency virus-infected adults with suppressed viral load in Spain, by implementing the grade A-1 evidence recommendations of the 2015 GESIDA/National AIDS Plan. / Impacto económico asociado a la implementación de las recomendaciones con grado de evidencia A-I del documento de consenso de GeSIDA/PNS (2015) relativas a la optimización del tratamiento antirretroviral en adultos infectados por virus de la inmunodeficiencia humana con carga viral suprimida en España.

INTRODUCTION: The objective of this study is to estimate the economic impact associated with the optimisation of triple antiretroviral treatment (ART) in patients with undetectable viral load according to the recommendations from the GeSIDA/PNS (2015) Consensus and their applicability in the Spanish clinical practice. METHODS: A pharmacoeconomic model was developed based on data from a National Hospital Prescription Survey on ART (2014) and the A-I evidence recommendations for the optimisation of ART from the GeSIDA/PNS (2015) consensus. The optimisation model took into account the willingness to optimise a particular regimen and other assumptions, and the results were validated by an expert panel in HIV infection (Infectious Disease Specialists and Hospital Pharmacists). The analysis was conducted from the NHS perspective, considering the annual wholesale price and accounting for deductions stated in the RD-Law 8/2010 and the VAT. RESULTS: The expert panel selected six optimisation strategies, and estimated that 10,863 (13.4%) of the 80,859 patients in Spain currently on triple ART, would be candidates to optimise their ART, leading to savings of €15.9M/year (2.4% of total triple ART drug cost). The most feasible strategies (>40% of patients candidates for optimisation, n=4,556) would be optimisations to ATV/r+3TC therapy. These would produce savings between €653 and €4,797 per patient per year depending on baseline triple ART. CONCLUSION: Implementation of the main optimisation strategies recommended in the GeSIDA/PNS (2015) Consensus into Spanish clinical practice would lead to considerable savings, especially those based in dual therapy with ATV/r+3TC, thus contributing to the control of pharmaceutical expenditure and NHS sustainability.

Economic evaluation of endoscopic radiofrequency ablation for the treatment of dysplastic Barrett's esophagus in Spain.

BACKGROUND AND STUDY AIMS: To assess the cost-effectiveness of introducing endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection in selected patients into the standard of care of Barrett's esophagus patients with high-grade dysplasia or low-grade dysplasia in Spain. METHODS: The disease evolution was modeled via a semi-Markov model. The treatment strategies compared included endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection and the Standard of Care (esophagectomy or palliative chemoradiotherapy according to disease status for high-grade dysplasia and endoscopic surveillance for low-grade dysplasia). Efficacy rates, transition probabilities and utility values were obtained from the literature. Clinical management patterns and resource use were modeled according to Spanish clinical expert opinion. Costs were expressed in euros (€) from 2016 reflecting the Spanish National Health System perspective. Sensitivity analyses were performed to assess the robustness of the model. RESULTS: With respect to the Spanish Standard of Care, endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection was a dominant strategy for high-grade dysplasia patients. When a willingness-to-pay threshold of €30,000 per quality-adjusted life-years gained was considered, this was cost-effective for low-grade dysplasia patients (€12,865 per quality-adjusted life-years gained). The sensitivity analyses supported the base case analysis results and pointed towards the main drivers of uncertainty in the model. CONCLUSIONS: From a health care decision-maker, endoscopic treatment based on radiofrequency ablation plus endoscopic mucosal resection is the intervention of choice for dysplasic Barrett's esophagus patients in Spain.