Coste-efectividad de la polipíldora CNIC frente a los monocomponentes separados en prevención secundaria cardiovascular en España / Cost-effectiveness of the CNIC-Polypill versus separate monocomponents in cardiovascular secondary prevention in Spain

Introducción y objetivos A pesar de los avances en el tratamiento, la enfermedad cardiovascular es la segunda causa de muerte en España. El objetivo de este estudio fue determinar el coste-efectividad de la estrategia polipíldora CNIC (ácido acetilsalicílico 100mg, atorvastatina 20/40mg, ramipril 2,5/5/10mg) comparada con los mismos monocomponentes por separado para la prevención secundaria de eventos cardiovasculares recurrentes en adultos en España. Materiales y métodos Se adaptó un modelo Markov considerando 4 estados de salud (estable, evento cardiovascular adverso mayor posterior, ictus isquémico posterior y muerte) y la ecuación de riesgo SMART con un horizonte temporal de toda la vida desde la perspectiva del Sistema Nacional de Salud español. La estrategia polipíldora CNIC se comparó con monocomponentes en una cohorte hipotética de 1.000 pacientes en prevención secundaria.Los datos de efectividad, epidemiológicos, de costes y de utilidades se obtuvieron del estudio NEPTUNO, de bases de datos oficiales y de la literatura. Los resultados fueron los costes (en euros de 2021) por año de vida (AV) ganados y por años de vida ajustados por calidad (AVAC) ganados. Se aplicó una tasa de descuento del 3%. Se realizaron análisis de sensibilidad determinísticos univariantes y probabilísticos para evaluar la solidez del modelo. Resultados La estrategia polipíldora CNIC, en prevención secundaria, produce más ganancias de AV (13,22) y AVAC (11,64) a un coste inferior que los monocomponentes. La polipíldora CNIC es dominante y ahorra 280,68euros por paciente en comparación con los monocomponentes por separado. El análisis de sensibilidad probabilístico muestra que el 82,4% de las simulaciones están por debajo del umbral de 25.000euros por AVAC ganado (AU)

Introduction and objectives Despite advances in treatment, cardiovascular disease is the second leading cause of death in Spain. The objective of this study was to determine the cost-effectiveness of the CNIC-Polypill strategy (acetylsalicylic acid 100mg, atorvastatin 20/40mg, ramipril 2.5/5/10mg) compared with the same separate monocomponents for the secondary prevention of recurrent cardiovascular events in adults in Spain. Materials and methods A Markov cost-utility model was adapted considering four health states (stable, subsequent major adverse cardiovascular event, subsequent ischemic stroke and death) and the SMART risk equation over a lifetime horizon from the perspective of the Spanish National Healthcare System. The CNIC-Polypill strategy was compared with monocomponents in a hypothetical cohort of 1000 secondary prevention patients. Effectiveness, epidemiological, cost and utilities data were obtained from the NEPTUNO study, official databases and literature. Outcomes were costs (in 2021euros) per life-year (LY) and quality-adjusted LY (QALY) gained. A 3% discount rate was applied. Deterministic one-way and probabilistic sensitivity analyses evaluated the robustness of the model. Results The CNIC-Polypill strategy in secondary prevention results in more LY (13.22) and QALY (11.64) gains at a lower cost than monocomponents. The CNIC-Polypill is dominant and saves €280.68 per patient compared with monocomponents. The probabilistic sensitivity analysis shows that 82.4% of the simulations are below the threshold of €25,000 per QALY gained. Conclusions The CNIC-Polypill strategy in secondary cardiovascular prevention is cost-effective compared with the same separate monocomponents, resulting in a cost-saving strategy to the Spanish National Healthcare System (AU)

Cost-effectiveness of the CNIC-Polypill versus separate monocomponents in cardiovascular secondary prevention in Spain.

INTRODUCTION AND OBJECTIVES: Despite advances in treatment, cardiovascular disease is the second leading cause of death in Spain. The objective of this study was to determine the cost-effectiveness of the CNIC-Polypill strategy (acetylsalicylic acid 100 mg, atorvastatin 20/40 mg, ramipril 2.5/5/10 mg) compared with the same separate monocomponents for the secondary prevention of recurrent cardiovascular events in adults in Spain. MATERIALS AND METHODS: A Markov cost-utility model was adapted considering 4 health states (stable, subsequent major adverse cardiovascular event, subsequent ischemic stroke and death) and the SMART risk equation over a lifetime horizon from the perspective of the Spanish National Healthcare System. The CNIC-Polypill strategy was compared with monocomponents in a hypothetical cohort of 1000 secondary prevention patients. Effectiveness, epidemiological, cost and utilities data were obtained from the NEPTUNO study, official databases and literature. Outcomes were costs (in 2021 euros) per life-year (LY) and quality-adjusted LY (QALY) gained. A 3% discount rate was applied. Deterministic one-way and probabilistic sensitivity analyses evaluated the robustness of the model. RESULTS: The CNIC-Polypill strategy in secondary prevention results in more LY (13.22) and QALY (11.64) gains at a lower cost than monocomponents. The CNIC-Polypill is dominant and saves є280.68 per patient compared with monocomponents. The probabilistic sensitivity analysis shows that 82.4% of the simulations are below the threshold of є25,000 per QALY gained. CONCLUSIONS: The CNIC-Polypill strategy in secondary cardiovascular prevention is cost-effective compared with the same separate monocomponents, resulting in a cost-saving strategy to the Spanish National Healthcare System.

Strategic discussion on funding and access to therapies targeting rare diseases in Spain: an expert consensus paper.

BACKGROUND: In recent years, significant advances have been made in the field of rare diseases (RDs). However, there is a large number of RDs without specific treatment and half of these treatments have public funding in Spain. The aim of the FINEERR project was to carry out a multidisciplinary strategic discussion on the challenge of funding and access to RD-targeted drugs in Spain, in order to agree on specific proposals for medium-term improvement and hence support decision-making in the Spanish National Healthcare System (SNHS). RESULTS: The FINEERR Project was organized around a CORE Advisory Committee, which provided an overview, agreed on the design and scope of the project, and selected the members within each of four working groups (WG). Overall, 40 experts discussed and reached a consensus on different relevant aspects, such as conditioning factors for initial funding and access, evaluation and access to RD-targeted therapies, funding of these therapies, and implementation of a new funding and access model. From these meetings, 50 proposals were defined and classified by their level of relevance according to the experts. A descriptive analysis of responses was performed for each proposal. Thereafter, experts completed another questionnaire where they ranked the 25 most relevant proposals according to their level of feasibility of being implemented in the SNHS. The most relevant and feasible proposals were to improve: process of referral of patients with RDs, control over monitoring mechanisms, and communication between healthcare professionals and patients. CONCLUSIONS: The FINEERR project may provide a starting point for stakeholders involved in the process of funding and access to RD-targeted therapies in Spain to provide the necessary resources and implement measures to improve both the quality of life and life expectancy of patients with RDs.

A strategic reflection for the management and implementation of CAR-T therapy in Spain: an expert consensus paper.

CAR-T cell therapy represents a therapeutic revolution in the prognosis and treatment of patients with certain types of hematological cancer. However, they also pose new challenges in the healthcare, regulatory and financial fields. The aim of the RET-A project was to undertake a strategic reflection on the management of CAR-T therapies within the Spanish National Health System, to agree on recommendations that will help to better deal with the new context introduced by these cell therapies in the present and in the future. This think tank involved 40 key agents and opinion leaders. The experts identified three great challenges for implementing advanced therapies in Spain: therapeutic individualisation, with a multidisciplinary approach; acceleration of access times, by minimizing bureaucracy; and increase in the number of centers qualified to manage the CAR-T therapies in the NHS. The experts agreed on the ideal criteria for designating those qualified centers. They also agreed on a comprehensive CAR-T care pathway with the timings and roles which would ideally be involved in each part of the process.

Pathway towards an ideal and sustainable framework agreement for the public procurement of vaccines in Spain: a multi-criteria decision analysis.

Objective: To advance the development of an ideal and sustainable framework agreement for the public procurement of vaccines in Spain, and to agree on the desirable award criteria and their relative weight. Methods: A multidisciplinary committee of seven health-care professionals and managers developed a partial multi-criteria decision analysis to determine the award criteria that should be considered and their specific weights for the public procurement of routine vaccines and seasonal influenza vaccines, considering their legal viability. A re-test of the results was carried out. The current situation was analyzed through 118 tender specifications and compared to the ideal framework. Results: Price is the prevailing award criterion for the public procurement of both routine (weighting of 60% versus 40% for all other criteria) and influenza (36% versus 64%) vaccines. Ideally, 22 criteria should be considered for routine vaccines, grouped and weighted into five domains: efficacy (weighting of 29%), economic aspects (27%), vaccine characteristics (22%), presentation form and packaging (13%), and others (9%). Per criteria set, price was the most important criterion (22%), followed by effectiveness (9%), and composition/formulation (7%). Regarding influenza vaccines, 20 criteria were selected, grouped, and weighted: efficacy (29%), economic aspects (25%), vaccine characteristics (20%), presentation form and packaging (16%), and others (11%). Per criteria set, price was also the most relevant criterion (19%), followed by composition/formulation (8%), and effectiveness (8%). Conclusions: Contrary to the current approach, technical award criteria should prevail over economic criteria in an ideal and sustainable framework agreement for the public procurement of vaccines.

Herramienta para mejorar la eficiencia en el manejo clínico de pacientes hipertensos / Tools to improve efficiency in the clinical management of hypertensive patients

Objetivo: Crear una herramienta que permita evaluar la eficiencia de la gestión clínica de los pacientes hipertensos en atención primaria. Material y métodos: Se creó un cuestionario dirigido a los centros de atención primaria, con acceso vía Web, para la autoevaluación del manejo de la hipertensión, respecto a 5 áreas de gestión: sistemas de información; pruebas diagnósticas y analíticas; aspectos organizativos; demanda asistencial y consumo de recursos; y programas de atención continuada para profesionales y para pacientes. Previamente, un comité de expertos definió estas preguntas, así como su respuesta ideal o «control», basándose en la literatura científica o, en caso de no haber referencias publicadas, de manera consensuada por dicho comité. Se realizó un análisis descriptivo de los datos y se creó un índice de adherencia de sus resultados con respecto al «control», que oscila entre 0 (ninguna adherencia) y 1 (total adherencia). Resultados: Un total de 35 centros de salud introdujeron sus datos de gestión de pacientes hipertensos en la Web de gestión clínica. Se observó la mayor adherencia en el área «Pruebas diagnósticas y analíticas» (0,69±0,10) y la menor en el área «Programas de formación continuada para pacientes y profesionales» (0,42±0,21). Conclusiones: La eficiencia de la gestión clínica en pacientes hipertensos puede analizarse mediante la herramienta web creada para este fin. Su uso permite realizar una auditoría interna para detectar las áreas que necesitan mejoras y también sirve para hacer evaluaciones comparativas en las distintas áreas de gestión a lo largo del tiempo

Objective: To create a tool to evaluate the efficiency of the clinical management of hypertensive patients in Primary Care. Material and methods: A web-based questionnaire was designed for Primary Care centres to self-evaluate the management of hypertension in five specific areas: information systems, diagnostic and analytical tests, organisational aspects, use of resources, and continuous training programmes for patients and healthcare professionals. A committee of experts previously defined these questions and their ideal responses or "control", based on the scientific literature or, if there were no published references, by consensus of the committee. A descriptive analysis was performed on the data, and an adherence score was created that ranged from 0 (no adherence) to 1 (total adherence). Results: A total of 35 Primary Care centres entered their data into the website for the clinical management of hypertensive patients. The highest adherence to the ideal algorithm was observed in the area "Diagnostic and analytical tests" (0.69±0.10), and the lowest in "Continuous training programmes for patients and professionals" (0.42±0.21). Conclusions: The efficiency of clinical management in hypertensive patients can be analysed using the website tool created for this purpose. Its use allows an internal audit to detect the areas that need improvement, and also serves to make comparative evaluations in the different areas of management over time

[Tools to improve efficiency in the clinical management of hypertensive patients]. / Herramienta para mejorar la eficiencia en el manejo clínico de pacientes hipertensos.

OBJECTIVE: To create a tool to evaluate the efficiency of the clinical management of hypertensive patients in Primary Care. MATERIAL AND METHODS: A web-based questionnaire was designed for Primary Care centres to self-evaluate the management of hypertension in five specific areas: information systems, diagnostic and analytical tests, organisational aspects, use of resources, and continuous training programmes for patients and healthcare professionals. A committee of experts previously defined these questions and their ideal responses or "control", based on the scientific literature or, if there were no published references, by consensus of the committee. A descriptive analysis was performed on the data, and an adherence score was created that ranged from 0 (no adherence) to 1 (total adherence). RESULTS: A total of 35 Primary Care centres entered their data into the website for the clinical management of hypertensive patients. The highest adherence to the ideal algorithm was observed in the area "Diagnostic and analytical tests" (0.69±0.10), and the lowest in "Continuous training programmes for patients and professionals" (0.42±0.21). CONCLUSIONS: The efficiency of clinical management in hypertensive patients can be analysed using the website tool created for this purpose. Its use allows an internal audit to detect the areas that need improvement, and also serves to make comparative evaluations in the different areas of management over time.

Estado de salud, calidad de vida y utilización de recursos sanitarios de los pacientes con diabetes mellitus en España / Health status, quality of life, and use of healthcare resources by patients with diabetes mellitus in Spain

Introducción. Este estudio analiza el estado de salud de los pacientes con diabetes mellitus (DM), su calidad de vida relacionada con la salud (CVRS) y la utilización de recursos sanitarios. Material y métodos. Se utilizó la Encuesta Nacional de Salud (2012), identificando a aquellas personas de 15 años o más diagnosticadas de DM. Se realizó un análisis descriptivo de su estado de salud, CVRS y utilización de recursos sanitarios, y se compararon sistemáticamente con pacientes con otras enfermedades crónicas (OEC) y con población sin DM (no DM). Resultados. De los 21.007 sujetos participantes, el 7,4% tenían DM y el 59% OEC (edad media 65,6±14,2 años para DM; 51,3±18,1 años para OEC y 45,7±18,2 años para no DM). En comparación con no DM y OEC, la DM se asoció, de forma estadísticamente significativa, con una mayor frecuencia de hipertensión, hipercolesterolemia, obesidad, infarto de miocardio, hospitalización en el último año y consumo de medicamentos, pero con un menor número de visitas a atención secundaria. La media anual de años de vida ajustados por calidad (AVAC) en DM fue 0,75, significativamente inferior (p<0,05) a la de las personas con OEC (0,89) y a la de la población no DM (0,92). La diferencia con respecto a no DM se mantuvo estadísticamente significativa cuando se ajustó por edad, sexo y número de comorbilidades (p<0,001). Conclusiones. En España, la DM está asociada a una elevada comorbilidad, conlleva una pérdida de AVAC mayor a la del conjunto de personas con OEC y genera una carga significativa sobre el sistema sanitario (AU)

Introduction. This study analyses the health status of patients diagnosed with diabetes mellitus (DM), their health related quality of life (HRQoL) and their use of healthcare resources in Spain. Materials and methods. A descriptive analysis was conducted using the Spanish Health National Survey (ENSE, 2012), gathering data on those patients aged 15 and over diagnosed with DM. Their health status, their HRQoL, and their use of healthcare resources were systematically compared with those of patients diagnosed with other chronic conditions (OCC), as well as a population without DM (non-DM). Results. Out of 21,007 subjects that took part, 7.4% were diagnosed with DM and 59% with OCC conditions (mean age 65.6±14.2 years with DM, 51.3±18.1 years with OCC, and 45.7±18.2 years with non-DM). When compared to non-DM and OCC, DM was statistically significantly associated with higher frequencies of hypertension, hypercholesterolaemia, obesity, myocardial infraction, hospital admissions in the last year, and drug consumption, but with a lower number of visits to secondary healthcare. The mean quality adjusted life years (QALY) of patients with DM was 0.75 per year, significantly lower (P<.05) to that of individuals with OCC (0.89), and those without DM (0.92). The difference vs. non-DM remained statistically significant after adjusting for age, gender, and number of comorbidities (P<.001). Conclusions. In Spain, DM is associated with a high comorbidity, involves a greater loss in HRQoL than those diagnosed with other chronic conditions as a whole, and generates a significant burden on the healthcare system (AU)

[Health status, quality of life, and use of healthcare resources by patients with diabetes mellitus in Spain]. / Estado de salud, calidad de vida y utilización de recursos sanitarios de los pacientes con diabetes mellitus en España.

INTRODUCTION: This study analyses the health status of patients diagnosed with diabetes mellitus (DM), their health related quality of life (HRQoL) and their use of healthcare resources in Spain. MATERIALS AND METHODS: A descriptive analysis was conducted using the Spanish Health National Survey (ENSE, 2012), gathering data on those patients aged 15 and over diagnosed with DM. Their health status, their HRQoL, and their use of healthcare resources were systematically compared with those of patients diagnosed with other chronic conditions (OCC), as well as a population without DM (non-DM). RESULTS: Out of 21,007 subjects that took part, 7.4% were diagnosed with DM and 59% with OCC conditions (mean age 65.6±14.2 years with DM, 51.3±18.1 years with OCC, and 45.7±18.2 years with non-DM). When compared to non-DM and OCC, DM was statistically significantly associated with higher frequencies of hypertension, hypercholesterolaemia, obesity, myocardial infraction, hospital admissions in the last year, and drug consumption, but with a lower number of visits to secondary healthcare. The mean quality adjusted life years (QALY) of patients with DM was 0.75 per year, significantly lower (P<.05) to that of individuals with OCC (0.89), and those without DM (0.92). The difference vs. non-DM remained statistically significant after adjusting for age, gender, and number of comorbidities (P<.001). CONCLUSIONS: In Spain, DM is associated with a high comorbidity, involves a greater loss in HRQoL than those diagnosed with other chronic conditions as a whole, and generates a significant burden on the healthcare system.

Long-term fiscal implications of funding assisted reproduction: a generational accounting model for Spain.

The aim of this study was to assess the lifetime economic benefits of assisted reproduction in Spain by calculating the return on this investment. We developed a generational accounting model that simulates the flow of taxes paid by the individual, minus direct government transfers received over the individual's lifetime. The difference between discounted transfers and taxes minus the cost of either IVF or artificial insemination (AI) equals the net fiscal contribution (NFC) of a child conceived through assisted reproduction. We conducted sensitivity analysis to test the robustness of our results under various macroeconomic scenarios. A child conceived through assisted reproduction would contribute €370,482 in net taxes to the Spanish Treasury and would receive €275,972 in transfers over their lifetime. Taking into account that only 75% of assisted reproduction pregnancies are successful, the NFC was estimated at €66,709 for IVF-conceived children and €67,253 for AI-conceived children. The return on investment for each euro invested was €15.98 for IVF and €18.53 for AI. The long-term NFC of a child conceived through assisted reproduction could range from €466,379 to €-9,529 (IVF) and from €466,923 to €-8,985 (AI). The return on investment would vary between €-2.28 and €111.75 (IVF), and €-2.48 and €128.66 (AI) for each euro invested. The break-even point at which the financial position would begin to favour the Spanish Treasury ranges between 29 and 41 years of age. Investment in assisted reproductive techniques may lead to positive discounted future fiscal revenue, notwithstanding its beneficial psychological effect for infertile couples in Spain.