Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma.

INTRODUCTION: Teclistamab is the first approved B cell maturation antigen × CD3 bispecific antibody with precision dosing for the treatment of triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). We compared the effectiveness of teclistamab in MajesTEC-1 versus real-world physician's choice of therapy (RWPC) in patients from the prospective, non-interventional LocoMMotion and MoMMent studies. METHODS: Patients treated with teclistamab from MajesTEC-1 (N = 165) were compared with an external control arm from LocoMMotion (N = 248) or LocoMMotion + MoMMent pooled (N = 302). Inverse probability of treatment weighting adjusted for imbalances in prognostic baseline characteristics. The relative effect of teclistamab versus RWPC for overall response rate (ORR), very good partial response or better (≥ VGPR) rate, and complete response or better (≥ CR) rate was estimated with an odds ratio using weighted logistic regression transformed into a response-rate ratio (RR) and 95% confidence interval (CI). Weighted proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs for duration of response (DOR), progression-free survival (PFS), and overall survival (OS). RESULTS: Baseline characteristics were well balanced between treatment cohorts after reweighting. Patients treated with teclistamab had significantly improved outcomes versus RWPC in LocoMMotion: ORR (RR [95% CI], 2.44 [1.79-3.33]; p < 0.0001), ≥ VGPR (RR 5.78 [3.74-8.93]; p < 0.0001), ≥ CR (RR 113.73 [15.68-825.13]; p < 0.0001), DOR (HR 0.39 [0.24-0.64]; p = 0.0002), PFS (HR 0.48 [0.35-0.64]; p < 0.0001), and OS (HR 0.64 [0.46-0.88]; p = 0.0055). Teclistamab versus RWPC in LocoMMotion + MoMMent also had significantly improved outcomes: ORR (RR 2.41 [1.80-3.23]; p < 0.0001), ≥ VGPR (RR 5.91 [3.93-8.88]; p < 0.0001), ≥ CR (RR 132.32 [19.06-918.47]; p < 0.0001), DOR (HR 0.43 [0.26-0.71]; p = 0.0011), PFS (HR 0.49 [0.37-0.66]; p < 0.0001), and OS (HR 0.69 [0.50-0.95]; p = 0.0247). CONCLUSION: Teclistamab demonstrated significantly improved effectiveness over RWPC in LocoMMotion ± MoMMent, emphasizing its clinical benefit as a highly effective treatment for patients with TCE RRMM. TRIAL REGISTRATION: MajesTEC-1, ClinicalTrials.gov NCT03145181 (phase 1) and NCT04557098 (phase 2); LocoMMotion, ClinicalTrials.gov NCT04035226; MoMMent, ClinicalTrials.gov NCT05160584.

Comparative Efficacy of Teclistamab Versus Current Treatments in Real-World Clinical Practice in the Prospective LocoMMotion Study in Patients with Triple-Class-Exposed Relapsed and/or Refractory Multiple Myeloma.

INTRODUCTION: Patients with triple-class-exposed relapsed/refractory multiple myeloma (TCE-RRMM) have a poor prognosis and limited treatment options. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, was studied in patients with TCE-RRMM in the single-arm MajesTEC-1 study. To assess the relative effectiveness of teclistamab versus real-world physician's choice of therapy (RWPC), adjusted comparisons were performed using individual patient data from MajesTEC-1 and LocoMMotion, a prospective study of patients with TCE-RRMM. METHODS: An external control arm for MajesTEC-1 was created from patients in LocoMMotion (n = 248; clinical cut-off: November 2, 2021) and compared with treated patients (n = 165) from MajesTEC-1 (teclistamab 1.5 mg/kg weekly; clinical cut-off: March 16, 2022). Inverse probability weighting was used to adjust for imbalances in baseline covariates. For binary endpoints [overall response rate (ORR), very good partial response or better (≥ VGPR) rate, complete response or better (≥ CR)], relative effect of teclistamab versus RWPC was estimated with an odds ratio and relative response rate and 95% confidence interval (CI), derived from weighted logistic regression. Weighted Cox proportional hazards model was used to estimate hazard ratios (HR) and 95% CIs for time-to-event endpoints [duration of response (DOR), progression-free survival (PFS), and overall survival (OS)]. RESULTS: After weighting, baseline characteristics were balanced across cohorts. In adjusted comparisons, teclistamab-treated patients were 2.3-fold, 5.2-fold and 148.3-fold, more likely to reach ORR [response-rate ratio (RR) = 2.31, 95% CI 1.77-2.85, p < 0.0001], ≥ VGPR (RR = 5.19, 95% CI 3.26-7.12, p < 0.0001) and ≥ CR (RR = 148.25, 95% CI 20.63-1065.40, p < 0.0001), respectively, versus patients receiving RWPC. Following adjustment, DOR (HR 0.32, 95% CI 0.19-0.54, p < 0.0001) and PFS (HR 0.48, 95% CI 0.35-0.65, p < 0.0001) were significantly longer with teclistamab versus RWPC. OS was numerically better with teclistamab versus RWPC [HR 0.77 (0.55-1.09), p = 0.1419]. CONCLUSION: Teclistamab demonstrated improved effectiveness versus RWPC, highlighting its clinical benefit as a novel and effective treatment for patients with TCE-RRMM. TRIAL REGISTRATION: Majest TEC-1, ClinicalTrials.gov NCT04557098; LocoMMotion, ClinicalTrials.gov NCT04035226.

Patient Preferences for Attributes of Type 2 Diabetes Mellitus Medications in Germany and Spain: An Online Discrete-Choice Experiment Survey.

INTRODUCTION: Understanding patient preferences for attributes of type 2 diabetes mellitus (T2DM) medications may help explain how the attributes differentially affect patient perceptions and behaviors. In this survey, we quantified the relative preferences among patients in Germany and Spain in separate analyses. METHODS: A stated-preference, discrete-choice experiment (DCE) survey was designed to elicit preferences for T2DM treatment attributes among patients with self-reported T2DM and who reported being prescribed T2DM medication for > 2 years. Patients recruited from an online national consumer panel completed an online survey. The survey presented choices between eight pairs of hypothetical T2DM treatments defined by seven attributes: chance of reaching target hemoglobin A1c (HbA1c) level; reduced risk of serious heart attack or stroke; frequency of hypoglycemia; risk of gastrointestinal (GI) problems; weight change; mode of administration (oral or injectable); dosing frequency. Data were analyzed using random-parameters logit. Minimum acceptable benefit (MAB) was defined as the minimum increase in the probability of reaching target HbA1c for which respondents would accept less desirable levels of other attributes. RESULTS: In Germany and Spain, 474 and 401 respondents completed the survey, respectively. DCE analysis showed that risk of GI problems was most important to German respondents. MAB analysis found that respondents would require a 56 percentage point increase in the probability of reaching their HbA1c target to offset a change from 0% to 30% risk of GI problems. For Spanish respondents, mode of administration was the most important attribute. These respondents would require a 59 percentage point increase in the probability of reaching their HbA1c target to offset moving from oral to injectable medications. CONCLUSIONS: Respondents in Germany and Spain were willing to trade efficacy for improvements in side effects and mode of administration. Given the variety of T2DM medications currently available, the results suggest that careful discussion about patient preferences could help improve patient satisfaction with T2DM treatment.

Consumo de recursos sanitarios y costes asociados al inicio del tratamiento con fármacos inyectables en pacientes con diabetes mellitus tipo 2 / Use of healthcare resources and costs associated to the start of treatment with injectable drugs in patients with type 2 diabetes mellitus

Objetivos: El objetivo principal fue evaluar el uso de recursos y costes de los pacientes con diabetes mellitus tipo 2 que inician tratamiento con insulina o análogos del receptor de GLP-1 (AR GLP-1) inyectables en un ámbito poblacional español. Por otro lado, se determinó la adherencia y persistencia al tratamiento en ambos grupos de tratamiento. Pacientes y métodos: Diseño observacional, no-intervencionista, de carácter retrospectivo. Se incluyeron pacientes ≥20 años que iniciaron tratamiento con insulina o AR GLP-1 durante 2010-2012. Se determinó el consumo de recursos sanitarios relacionados con la actividad asistencial (visitas médicas, días de hospitalización, visitas a urgencias, solicitudes diagnósticas o terapéuticas, medicación) para evaluar el coste sanitario en estos 2 grupos de pacientes. Se recogió información clínica como índice de masa corporal (kg/m2) control metabólico (HbA1c), adherencia, persistencia y complicaciones (hipoglucemias y eventos cardiovasculares). El seguimiento se realizó durante 12 meses. Solo se tuvo en cuenta los costes sanitarios directos. Resultados: Se reclutaron 1.301 pacientes, con una edad media de 67,6 años, el 51,6% varones. El 71,9% en tratamiento con insulina y el 28,1% con AR GLP-1. Al año de seguimiento los pacientes tratados con AR GLP-1 tuvieron menos consultas a atención primaria (8 vs 11; p < 0,001), a especializada (1,0 vs 1,8; p < 0,001), hospitalizaciones (0,3 vs 0,7; p = 0,030) y visitas a urgencias (0,8 vs 1,6; p < 0,001). Los pacientes tratados con GLP-1 mostraron una mayor adherencia (88,1% vs 82,7%; p < 0,001), persistencia (62,0% vs 55,9%; p=0,046) y menor proporción de hipoglucemias (13,4% vs 18,7%; p = 0,022) con similar control metabólico (HbA1c: 7,2% vs 7,4%; p = 0,049), índice de masa corporal (29,1 vs 30,9kg/m2) y tasa de eventos cardiovasculares (9,1% vs 11,5%; p = 0,330), respectivamente. El promedio/unitario de los costes sanitarios directos corregidos fue de 1.787€ vs 2.005€; p=0,046. Conclusiones: Los pacientes en tratamiento con AR GLP-1 ocasionaron menores costes sanitarios directos para el Sistema Nacional de Salud que los pacientes en tratamiento con insulinas. Los resultados obtenidos podrían explicarse por una mayor adherencia al tratamiento y menores tasas de hipoglucemias en los pacientes tratados con AR GLP-1. Se necesitan más estudios para poder confirmar estas posibles razones (AU)

Objectives: The main objective was to assess resource use and costs of starting treatment with insulin or injectable GLP-1 receptor analogues (GLP-1 RAs) in a Spanish population of patients with type 2 diabetes mellitus. Treatment adherence and persistence were also determined for both treatment groups. Patients and methods: A retrospective, non-interventional, observational study was conducted. Patients aged ≥20 years who started treatment with insulin or GLP-1 RAs in the 2010-2012 period were recruited. Use of healthcare resources was estimated to evaluate healthcare costs in these two groups of patients (medical visits, hospital stay, emergency visits, diagnostic or treatment requests, medication). Clinical information including body mass index (BMI, kg/m2), metabolic control (HbA1c), adherence, persistence, and complications (hypoglycemia, and cardiovascular events (CVE) was collected. The follow-up period was 12 months. Only direct healthcare costs were considered. Results: A total of 1301 patients with a mean age of 67.6 years (51.6% males) were recruited. Of these, 71.9% and 28.1% were on treatment with insulin and GLP-1 RA respectively. After one year of follow-up, patients treated with GLP-1 RAs were found less visits to primary care (8 vs. 11; P<.001) and specialized care (1.0 vs. 1.8; P<.001), hospital stays (0.3 vs. 0.7; P=.030) and less visits to the emergency room (0.8 vs. 1.6; P<.001). Patients treated with GLP-1 showed greater adherence (88.1% vs. 82.7%; P<.001) and persistence (62.0% vs. 55.9%; P=.046), and had less hypoglycemia episodes (13.4% vs. 18.7%; P=.022), with similar metabolic control (HbA1c: 7.2% vs. 7.4%; P=.049), BMI (29.1 vs. 30.9kg/m2), and CVE rate (9.1% vs. 11.5%; P=.330) respectively. The mean corrected direct healthcare cost per patient was €1787 vs. €2005 (P=.046.) Conclusions: Patients treated with GLP-1 RAs caused lower direct healthcare costs for the National Health System than patients treated with insulin. The results may be explained by greater treatment adherence and lower hypoglycemia rates in patients treated with GLP-1 RAs. Additional studies are needed to confirm these possibilities (AU)

Use of healthcare resources and costs associated to the start of treatment with injectable drugs in patients with type 2 diabetes mellitus. / Consumo de recursos sanitarios y costes asociados al inicio del tratamiento con fármacos inyectables en pacientes con diabetes mellitus tipo 2.

OBJECTIVES: The main objective was to assess resource use and costs of starting treatment with insulin or injectable GLP-1 receptor analogues (GLP-1 RAs) in a Spanish population of patients with type 2 diabetes mellitus. Treatment adherence and persistence were also determined for both treatment groups. PATIENTS AND METHODS: A retrospective, non-interventional, observational study was conducted. Patients aged ≥20 years who started treatment with insulin or GLP-1 RAs in the 2010-2012 period were recruited. Use of healthcare resources was estimated to evaluate healthcare costs in these two groups of patients (medical visits, hospital stay, emergency visits, diagnostic or treatment requests, medication). Clinical information including body mass index (BMI, kg/m2), metabolic control (HbA1c), adherence, persistence, and complications (hypoglycemia, and cardiovascular events (CVE) was collected. The follow-up period was 12 months. Only direct healthcare costs were considered. RESULTS: A total of 1301 patients with a mean age of 67.6 years (51.6% males) were recruited. Of these, 71.9% and 28.1% were on treatment with insulin and GLP-1 RA respectively. After one year of follow-up, patients treated with GLP-1 RAs were found less visits to primary care (8 vs. 11; P<.001) and specialized care (1.0 vs. 1.8; P<.001), hospital stays (0.3 vs. 0.7; P=.030) and less visits to the emergency room (0.8 vs. 1.6; P<.001). Patients treated with GLP-1 showed greater adherence (88.1% vs. 82.7%; P<.001) and persistence (62.0% vs. 55.9%; P=.046), and had less hypoglycemia episodes (13.4% vs. 18.7%; P=.022), with similar metabolic control (HbA1c: 7.2% vs. 7.4%; P=.049), BMI (29.1 vs. 30.9kg/m2), and CVE rate (9.1% vs. 11.5%; P=.330) respectively. The mean corrected direct healthcare cost per patient was €1787 vs. €2005 (P=.046.) CONCLUSIONS: Patients treated with GLP-1 RAs caused lower direct healthcare costs for the National Health System than patients treated with insulin. The results may be explained by greater treatment adherence and lower hypoglycemia rates in patients treated with GLP-1 RAs. Additional studies are needed to confirm these possibilities.

[Efficiency of initiation with ambrisentan versus bosentan in the treatment of pulmonary arterial hypertension]. / Eficiencia del inicio con ambrisentan frente a bosentan en el tratamiento de la hipertensión arterial pulmonar.

OBJECTIVE: To evaluate the efficiency of initiation with endothelin receptor antagonists, ambrisentan or bosentan, followed by sequential combination with phosphodiesterase-5 inhibitors and prostanoids in the treatment of pulmonary arterial hypertension, from the Spanish National Health System perspective. METHODS: A Markov model was developed based on the four New York Heart Association functional classes. A panel of three experts reached a consensus on patient management based on clinical practice. Patients revised their treatment every 12 weeks, based on their health status and previous medication records. Pharmacological treatment costs and costs associated with very frequent adverse events (AE) were considered in a horizon of 60 weeks. Outcomes were measured in qualityadjusted life years (QALY). A probabilistic sensitivity analysis was performed. RESULTS: No clinically relevant differences in QALY per-patient and year were found for initiation with ambrisentan and bosentan: 0.6853 and 0.6902, respectively. Initiation with ambrisentan resulted in lower pharmacological treatment and AE management costs: ?35,550 and ?117 versus ?40,224 and ?171. In the sensitivity analysis, initiation with ambrisentan resulted in a negative significant cost difference: ?-4,982; CI95%[?- 8,014; ?-2,500]; while no significant differences in QALY were found: -0.0044; CI95%[-0.0189; 0.0101]. CONCLUSIONS: Initiation with ambrisentan followed by sequential combination with phosphodiesterase-5 inhibitors and prostanoids yields comparable outcomes at lower costs than initiation with bosentan.

Objetivo: Se pretende evaluar la eficiencia del tratamiento secuencial de combinación de la hipertensión arterial pulmonar iniciado con antagonistas del receptor de la endotelina, ambrisentan o bosentan, seguido de inhibidores de la fosfodiesterasa- 5 y prostanoides, desde la perspectiva del Sistema Nacional de Salud. Métodos: Se desarrolló un modelo de Markov basado en las cuatro clases funcionales de la New York Heart Association. Un panel de tres expertos alcanzó un consenso sobre el manejo del paciente basado en la práctica clínica. Los pacientes revisaron su tratamiento cada 12 semanas, en función de su estado de salud y de la medicación recibida previamente. Se incluyeron costes farmacológicos y costes asociados al manejo de eventos adversos (EA) muy frecuentes, en un horizonte de 60 semanas. Los resultados se expresaron en términos de los años de vida ajustados por calidad (AVAC). Se realizó un análisis de sensibilidad probabilístico. Resultados: No se encontraron diferencias clínicamente relevantes en los AVAC por paciente y año para el inicio con ambrisentan y bosentan: 0,6853 y 0,6902, respectivamente. El inicio con ambrisentan resultó en un coste farmacológico y asociado al manejo de EA menor: 35.550 ??y 117 ??frente a 40.224 ??y 171 ?. En el análisis de sensibilidad, el inicio con ambrisentan presentó una diferencia de costes totales negativa y significativa: -4.982 ?; IC95%[-8.014 ?; -2.500 ?]; mientras que no se detectaron diferencias significativas en los AVAC: -0,0044; IC95%[-0,0189; 0,0101]. Conclusiones: El tratamiento secuencial de combinación de la HAP iniciado con ambrisentan, seguido de inhibidores de la fosfodiesterasa- 5 y prostanoides, proporciona resultados en salud comparables y menores costes que el tratamiento iniciado con bosentan.

Eficiencia del inicio con ambrisentan frente a bosentan en el tratamiento de la hipertensión arterial pulmonar / Efficiency of initiation with ambrisentan versus bosentan in the treatment of pulmonary arterial hypertension

OBJETIVO: Se pretende evaluar la eiciencia del tratamiento secuencial de combinación de la hipertensión arterial pulmonar iniciado con antagonistas del receptor de la endotelina, ambrisentan o bosentan, seguido de inhibidores de la fosfodiesterasa-5 y prostanoides, desde la perspectiva del Sistema Nacional de Salud. MÉTODOS: Se desarrolló un modelo de Markov basado en las cuatro clases funcionales de la New York Heart Association. Un panel de tres expertos alcanzó un consenso sobre el manejo del paciente basado en la práctica clínica. Los pacientes revisaron su tratamiento cada 12 semanas, en función de su estado de salud y de la medicación recibida previamente. Se incluyeron costes farmacológicos y costes asociados al manejo de eventos adversos (EA) muy frecuentes, en un horizonte de 60 semanas. Los resultados se expresaron en términos de los años de vida ajustados por calidad (AVAC). Se realizó un análisis de sensibilidad probabilístico.RESULTADOS: No se encontraron diferencias clínicamente relevantes en los AVAC por paciente y año para el inicio con ambrisentan y bosentan: 0,6853 y 0,6902, respectivamente. El inicio con ambrisentan resultó en un coste farmacológico y asociado al manejo de EA menor: 35.550 € y 117 € frente a 40.224 € y 171 €. En el análisis de sensibilidad, el inicio con ambrisentan presentó una diferencia de costes totales negativa y significativa: -4.982 €; IC95%[-8.014 €; -2.500 €]; mientras que no se detectaron diferencias signiicativas en los AVAC: -0,0044; IC95%[-0,0189; 0,0101].CONCLUSIONES: El tratamiento secuencial de combinación de la HAP iniciado con ambrisentan, seguido de inhibidores de la fosfodiesterasa-5 y prostanoides, proporciona resultados en salud comparables y menores costes que el tratamiento iniciado con bosentan

OBJECTIVE: To evaluate the efficiency of initiation with endothelin receptor antagonists, ambrisentan or bosentan, followed by sequential combination with phosphodiesterase-5 inhibitors and prostanoids in the treatment of pulmonary arterial hypertension, from the Spanish National Health System perspective.METHODS: A Markov model was developed based on the four New York Heart Association functional classes. A panel of three experts reached a consensus on patient management based on clinical practice. Patients revised their treatment every 12 weeks, based on their health status and previous medication records. Pharmacological treatment costs and costs associated with very frequent adverse events (AE) were considered in a horizon of 60 weeks. Outcomes were measured in quality-adjusted life years (QALY). A probabilistic sensitivity analysis was performed.RESULTS: No clinically relevant differences in QALY per-patient and year were found for initiation with ambrisentan and bosentan: 0.6853 and 0.6902, respectively. Initiation with ambrisentan resulted in lower pharmacological treatment and AE management costs: €35,550 and € 117 versus €40,224 and € 171. In the sensitivity analysis, initiation with ambrisentan resulted in a negative significant cost difference: €-4,982; CI95%[€-8,014; €-2,500]; while no significant differences in QALY were found: -0.0044; CI95%[-0.0189; 0.0101].CONCLUSIONS: Initiation with ambrisentan followed by sequential combination with phosphodiesterase-5 inhibitors and prostanoids yields comparable outcomes at lower costs than initiation with bosentan

Impacto sanitario y económico de la vacunación frente al cáncer de cérvix y lesiones precursoras en España / Healthcare and economic impact of vaccination against cervical cancer and precursor lesions in Spain

Objetivo. Analizar el impacto sanitario y económico de la vacunación frente al cáncer de cérvix en España con la vacuna VPH 16/18 adyuvada AS04 (Cervarix®) desde la perspectiva del Sistema Nacional de Salud. Material y métodos. Adaptación al entorno español de un modelo farmacoeconómico que simula el impacto que podría esperarse de los actuales programas de vacunación infantil sobre la carga de las lesiones precursoras y cáncer de cérvix. El modelo emplea datos epidemiológicos nacionales y la eficacia demostrada por la vacuna en ensayos clínicos. Resultados. Considerando la cobertura vacunal media en España, el modelo estima que actualmente la vacunación con Cervarix® podría evitar anualmente 45.060 ASCUS, 35.166 lesiones CIN1, 29.549 lesiones CIN2/3 y 1.053 casos de cáncer de cérvix, lo que supondría evitar unos costes sanitarios totales de 89.271.085 euros. Conclusiones. La vacunación con Cervarix® en España disminuiría los casos de cáncer de cérvix y lesiones precursoras y los consecuentes costes sanitarios asociados a su tratamiento (AU)

Objective. To evaluate the healthcare and economic impact of vaccination against cervical cancer with the HPV 16/18 AS04-adjuvanted vaccine (Cervarix®) in Spain from the perspective of the national health system. Material and methods. A health economics model was adapted to the Spanish environment. The model simulated the impact of current vaccination programs on the burden of precancerous lesions and cervical cancer. National epidemiological data and the vaccine efficacy shown in clinical trials were used. Results. Considering the average vaccination coverage in Spain, the model estimated that vaccination with Cervarix® would prevent 45,060 cases of atypical squamous cells of undetermined significance (ASCUS), 35,166 cases of low-grade squamous intraepithelial lesions (LSIL), 29,549 cases of high-grade squamous intraepithelial lesions (HSIL) and 1,053 cases of cervical cancer. Thus, vaccination would save 89,271,085 € in direct medical costs. Conclusions. Vaccination with Cervarix® in Spain would significantly reduce the number of cases of cervical cancer and precancerous lesions and the associated medical costs (AU)

Análisis de coste-efectividad de la vacunación antineumocócica en España / Cost-effectiveness analysis of pneumococcal vaccination in Spain

Objetivo: Análisis de coste-efectividad de la vacunación antineumocócica pediátrica en Espa˜na.Métodos: Se utilizó un modelo determinístico poblacional en forma de árbol de decisión con un horizontetemporal de 1 a˜no para estimar el impacto de la vacunación con Synflorix® o Prevenar13® sobre lapoblación menor de 2 a˜nos en Espa˜na, bajo la perspectiva del Sistema Nacional de Salud. Los datos epidemiológicosse obtuvieron del Conjunto Mínimo Básico de Datos al alta hospitalaria y de la literatura.Los datos sobre costes se obtuvieron de bases de datos nacionales de costes sanitarios. Los principalesresultados en salud medidos fueron los casos evitados de enfermedad neumocócica invasora, otitis mediaaguda (OMA), miringotomías y hospitalizaciones por neumonía. Todos los costes se expresaron en eurosde 2010. La efectividad se midió en a˜nos de vida ajustados por calidad (AVAC).Resultados: El potencial demostrado por Synflorix® para prevenir episodios de OMA causados por Haemophilusinfluenzae no tipificable podría traducirse en la prevención adicional de 41.513 episodios deOMA, 36.324 prescripciones de antibióticos y 382 miringotomías, y supondrían la ganancia de 143 AVACfrente a Prevenar13®. El coste total de la vacunación con Synflorix® resultaría unos 22 millones de eurosmenor.Conclusiones: La vacunación antineumocócica de la población menor de 2 a˜nos en Espa˜na con Synflorix®,en comparación con la vacunación con Prevenar13®, podría resultar en un mayor número de AVAC, asícomo en una reducción sustancial del coste total, resultando una estrategia dominante en términos decoste-efectividad (AU)

Objective: To perform a cost-effectiveness analysis of pediatric pneumococcal vaccination in Spain.Methods: A deterministic population-based model in the form of a decision-tree with a 1-year timehorizon was used to estimate the impact of vaccination with Synflorix® or Prevenar13® in children agedless than 2 years in Spain from the perspective of the National Health System. Epidemiological data wereobtained from the hospital discharge minimum data set (MDS) and the literature. Data on costs wereobtained from national health costs databases. The main outcomes measured were the number of casesavoided of invasive pneumococcal disease, acute otitis media (AOM) and myringotomies, and hospitaladmissions for pneumonia. All costs were expressed in 2010 euros. Effectiveness was measured as thenumber of quality-adjusted life years (QALYs) gained.Results: The efficacy of Synflorix® in preventing episodes of AOM caused by non-typeable Haemophilusinfluenzae could lead to additional prevention of 41,513 episodes of AOM, 36,324 antibiotic prescriptionsand 382 myringotomy procedures and 143 QALYs gained compared with Prevenar13®. The totalvaccination cost with Synflorix® would result in savings of 22 million euros.Conclusions: Pneumococcal vaccination with Synflorix® in comparison with Prevenar13® in children agedless than 2 years old in Spain could achieve a higher number of QALYs and a substantial cost offset.Vaccination with Synflorix® would be a dominant strategy in terms of cost-effectiveness (AU)

[Cost-effectiveness analysis of pneumococcal vaccination in Spain]. / Análisis de coste-efectividad de la vacunación antineumocócica en España.

OBJECTIVE: To perform a cost-effectiveness analysis of pediatric pneumococcal vaccination in Spain. METHODS: A deterministic population-based model in the form of a decision-tree with a 1-year time horizon was used to estimate the impact of vaccination with Synflorix® or Prevenar13® in children aged less than 2 years in Spain from the perspective of the National Health System. Epidemiological data were obtained from the hospital discharge minimum data set (MDS) and the literature. Data on costs were obtained from national health costs databases. The main outcomes measured were the number of cases avoided of invasive pneumococcal disease, acute otitis media (AOM) and myringotomies, and hospital admissions for pneumonia. All costs were expressed in 2010 euros. Effectiveness was measured as the number of quality-adjusted life years (QALYs) gained. RESULTS: The efficacy of Synflorix® in preventing episodes of AOM caused by non-typeable Haemophilus influenzae could lead to additional prevention of 41,513 episodes of AOM, 36,324 antibiotic prescriptions and 382 myringotomy procedures and 143 QALYs gained compared with Prevenar13®. The total vaccination cost with Synflorix® would result in savings of 22 million euros. CONCLUSIONS: Pneumococcal vaccination with Synflorix® in comparison with Prevenar13® in children aged less than 2 years old in Spain could achieve a higher number of QALYs and a substantial cost offset. Vaccination with Synflorix® would be a dominant strategy in terms of cost-effectiveness.