Diagnóstico en un solo paso de la hepatitis C en 2019: una realidad en España / Hepatitis C reflex testing in Spain in 2019: A story of success

Antecedentes: El diagnóstico en un solo paso (DUSP) es necesario para conseguir los objetivos de eliminación de la hepatitis C, pero en 2017 solo el 31% de los hospitales españoles hacía DUSP. Tras ese hallazgo, el DUSP fue recomendado por las sociedades científicas involucradas en el diagnóstico y tratamiento de la hepatitis C. Objetivos: Evaluar el grado de implementación del DUSP en 2019, y conocer la implantación de test de diagnóstico rápido y/o en gota seca (TDR y/o DBS) en los hospitales españoles. Métodos: Estudio transversal mediante encuesta realizada en octubre de 2019 dirigida a hospitales generales españoles con≥200 camas, públicos, o privados con acreditación docente. Resultados: Respondieron 129 (80%) hospitales. El DUSP lo hace el 89% de los centros vs. el 31% en 2017 (p<0,001). De 2017 a 2019 los centros que utilizan alertas para mejorar la continuidad asistencial aumentaron del 69 al 86% (p=0,002). En 2019, el 11% de los centros puede determinar anti-VHC en gota seca, el 15% viremia en gota seca, el 0,85% anti-VHC en saliva, y el 37% de anticuerpos y/o viremia con test point of care. El 43% de los hospitales disponen al menos de un método diagnóstico con TDR y/o DBS. Conclusiones: La implantación del DUSP ha aumentado significativamente, llegando al 89% de los hospitales en 2019. Las recomendaciones de las sociedades científicas podrían haber contribuido a la implantación del DUSP. Por otra parte, el acceso a los TDR y/o DBS es insuficiente y se necesitan medidas encaminadas a mejorar su implementación.(AU)

Background: Reflex testing is necessary to achieve the objectives of hepatitis C elimination. However, in 2017 only 31% of Spanish hospitals performed reflex test. As a consequence of that finding, reflex testing was recommended by scientific societies involved in the diagnosis and treatment of hepatitis C. Objective: To evaluate the degree of implementation of reflex testing in 2019 and to know the implementation of rapid diagnostic and/or dried blood spot testing (RDT and / or DBS) in Spanish hospitals. Methods: Cross-sectional study through a survey conducted in October 2019 to Spanish general hospitals with at least 200 beds, public or private with teaching accreditation. Results: 129 (80%) hospitals responded. Reflex testing is performed by 89% of the centers vs. 31% in 2017 (P<.001). From 2017 to 2019, centers using alerts to improve continuity of care increased from 69% to 86% (P=.002). In 2019, 11% of centers can determine anti-HCV in dried spot, 15% viremia in dried spot, 0.85% anti-HCV in saliva, and 37% of antibodies and/or viremia with point of care test. 43% of hospitals have at least one diagnostic method with RDT and/or DBS. Conclusion: The implementation of reflex testing has increased significantly, reaching 89% of hospitals in 2019. The recommendations of scientific societies could have contributed to the implementation of reflex testing. On the other hand, access to RDT and/or DBS is insufficient and initiatives are needed to improve their implementation.(AU)

Beyond visual acuity: Patient-relevant assessment measures of visual function in retinal diseases.

PURPOSE: To identify patient-reported outcomes (PROs) and other clinical outcome measures (contrast sensitivity (CS), low-luminance visual acuity (LLVA) and reading acuity or reading speed (RA-RS)), relevant to patients with age-related macular degeneration (AMD) or diabetic retinopathy (DR), which would be recommended for use in clinical practice. METHODS: The RAND/UCLA Appropriateness Method, based on the synthesis of the scientific evidence and the collective judgment of an expert panel using the two-round Delphi method, was applied. The evidence synthesis was performed by searching for articles on outcome measures for AMD and/or DR published between 2005 and 2018 in English or Spanish. The expert panel consisted of 14 Spanish ophthalmologists, who rated the recommendation degree for each outcome measure on a scale of 1 (extremely irrelevant) to 9 (maximum relevance). The recommended outcome measures were established according to the panel median score and the level of the panelists' agreement. RESULTS: Through the evidence search, 33 PRO-specific questionnaires (21 for visual function, six for AMD, three for DR, one for AMD and DR) and two treatment satisfaction questionnaires (one on AMD and one on DR) were identified. In addition, 21 methods were found for measuring CS, five for LLVA, and nine for RA-RS. According to the panel ratings, 11 of the 64 outcome measures evaluated for AMD, and seven of the 61 evaluated for DR were recommended. CONCLUSION: The AMD and DR outcome measures recommended will help ophthalmologists choose the outcome measure most appropriate for their patients. Furthermore, the use of PROs will contribute to shifting clinical practice towards patient-centered medicine.

Hepatitis C reflex testing in Spain in 2019: A story of success. / Diagnóstico en un solo paso de la hepatitis C en 2019: una realidad en España.

BACKGROUND: Reflex testing is necessary to achieve the objectives of hepatitis C elimination. However, in 2017 only 31% of Spanish hospitals performed reflex test. As a consequence of that finding, reflex testing was recommended by scientific societies involved in the diagnosis and treatment of hepatitis C. OBJECTIVE: To evaluate the degree of implementation of reflex testing in 2019 and to know the implementation of rapid diagnostic and/or dried blood spot testing (RDT and / or DBS) in Spanish hospitals. METHODS: Cross-sectional study through a survey conducted in October 2019 to Spanish general hospitals with at least 200 beds, public or private with teaching accreditation. RESULTS: 129 (80%) hospitals responded. Reflex testing is performed by 89% of the centers vs. 31% in 2017 (P<.001). From 2017 to 2019, centers using alerts to improve continuity of care increased from 69% to 86% (P=.002). In 2019, 11% of centers can determine anti-HCV in dried spot, 15% viremia in dried spot, 0.85% anti-HCV in saliva, and 37% of antibodies and/or viremia with point of care test. 43% of hospitals have at least one diagnostic method with RDT and/or DBS. CONCLUSION: The implementation of reflex testing has increased significantly, reaching 89% of hospitals in 2019. The recommendations of scientific societies could have contributed to the implementation of reflex testing. On the other hand, access to RDT and/or DBS is insufficient and initiatives are needed to improve their implementation.

Telemedicine efficiently improves access to hepatitis C management to achieve HCV elimination in the penitentiary setting.

INTRODUCTION: Linkage to care for hepatitis C includes a new tool: teleconsultation. Micro-elimination in prison is a recommendation and is feasible. An economic evaluation of telemedicine for hepatitis C virus (HCV) treatment in prisons has not yet been performed. This study aimed to provide a cost-minimization analysis comparing two strategies of HCV treatment in a prison: telemedicine clinical practice (TCP) and the usual clinical practice (UCP). METHODS: An observational cost-minimization study was carried out on a cohort of inmates who received anti-HCV treatment in El Dueso prison (May 2016-November 2017). A decision tree was constructed, incorporating different clinical profiles according to the severity of the disease, the results of diagnostic tests, and treatment outcomes as well as the costs of each profile. Satisfaction with telemedicine was evaluated through an 11-question questionnaire with a 5-point Likert scale. RESULTS: Seventy-five inmates were treated and underwent TCP with a follow-up of one year. The average cost per patient with the TCP strategy was €1,172 (€1,151 direct costs). Had UCP been carried out, the cost would have been €1,687 (€1,630 direct). Telemedicine consultation practice produced savings of €516 (30.6%) per patient, with total savings of €38,677. The transfer costs from prison to hospital represented the most important saving item, accounting for 99.3% of the TCP-related savings. The questionnaire revealed high levels of satisfaction with TCP, with a median score of 5 in each question. Sustained virological response rates were 94.7% after the first treatment and 100% after retreatment of the four relapses. CONCLUSION: Telemedicine consultation practice is a more efficient strategy than UCP, mainly due to the reduction of transfer costs while preserving effectiveness and user satisfaction.

Fundamentos para aplicar una estrategia de cribado poblacional de la hepatitis C en España / No disponible

ANTECEDENTES: la hepatitis C, además del impacto en la salud, produce una importante pérdida de productividad, disminuye la calidad de vida y contribuye notablemente al aumento del gasto sanitario. Por estas razones, el Ministerio de Sanidad, Consumo y Bienestar Social (MSCBS) de España implantó en 2015 el Plan Estratégico para el Abordaje de la Hepatitis C (PEAHC) en el Sistema Nacional de la salud. Sin embargo, el PEAHC no incluye ningún plan de cribado. El MSCBS desarrolló el "Documento marco sobre cribado poblacional", que define los criterios que debe reunir una enfermedad para considerar la implantación de un programa de cribado. En concreto, define 4 criterios relativos al problema de salud, 4 relativos a la prueba de cribado y 3 relativos al diagnóstico de confirmación y al tratamiento. OBJETIVO: identificar si existe evidencia científica que permita afirmar que la hepatitis C reúne los criterios para ser considerada una enfermedad para la que se debe desarrollar una estrategia de cribado poblacional en España. MÉTODOS: búsqueda bibliográfica de la evidencia científica sobre cada uno de los criterios requeridos para la implantación de un plan de cribado poblacional de la hepatitis C en España. RESULTADOS: se encontró evidencia científica suficiente que justifica que la hepatitis C reúne los criterios exigidos por el MSCBS para implantar un programa de cribado poblacional. CONCLUSIONES: según la evidencia científica disponible, la hepatitis C en España reúne los criterios necesarios para que se considere la implantación de un plan de cribado poblacional

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Principles for implementing a population screening strategy for hepatitis C in Spain.

BACKGROUND: hepatitis C, besides health impairment, results in significant loss of productivity and diminished quality of life, and noticeably contributes to health expenditure increases. Because of all this, the Spanish Ministry of Health (Ministerio de Sanidad, Consumo y Bienestar Social - MSCBS) implemented in 2015 a strategic plan for managing hepatitis C (Plan Estratégico para el Abordaje de la Hepatitis C - PEAHC) within the National Health System. However, the PEAHC includes no screening plan. The MSCBS developed a framework document on population screening (Documento Marco sobre Cribado Poblacional) that defines the criteria a disease must meet in order to consider implementing a screening program. Specifically, it defines 4 criteria related to the health issue, 4 related to the screening test, and 3 criteria dealing with diagnosis confirmation and treatment. OBJECTIVE: to identify whether there is scientific evidence to support hepatitis C meeting the criteria to be considered a disease qualifying for a population screening strategy in Spain. METHODS: a literature search for scientific evidence concerning each required criterion for implementing a population screening plan for hepatitis C in Spain. RESULTS: sufficient scientific evidence was found to support hepatitis C meeting the criteria required by the MSCBS for the implementation of a population screening program. CONCLUSIONS: according to the available scientific evidence, hepatitis C in Spain meets the required criteria to qualify for consideration of population screening plan.

Analysis of the costs and cost-effectiveness of the guidelines recommended by the 2018 GESIDA/Spanish National AIDS Plan for initial antiretroviral therapy in HIV-infected adults / Análisis de Costes y de Coste/Eficacia de las Pautas Recomendadas por GESIDA/Plan Nacional sobre el Sida en 2018 Para el Tratamiento Antirretroviral Inicial en Adultos Infectados Por el VIH

Background: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. Methods: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. Results: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC + RAL (PR). The effectiveness varies from 0.82 for TAF/FTC + DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC + RAL (PR), respectively. Conclusion: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR)

Introducción El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP), pautas alternativas (PA) y otras pautas (OP) para el tratamiento antirretroviral (TAR) como terapia de inicio en pacientes infectados por VIH para 2018. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con PP y PA. Métodos: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral <50 copias/ml en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del TAR y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando solo costes directos diferenciales: TAR (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA-B*5701. El ámbito es España, con costes de 2018. Se realizó un análisis de sensibilidad determinista construyendo 3 escenarios para cada pauta: basal, más favorable y más desfavorable. Resultados: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 6.788 para TAF/FTC/RPV (PA) y 10.649 para TAF/FTC+RAL (PP). La eficacia osciló entre 0,82 para TAF/FTC+DRV/r (PA) y 0,91 para TAF/FTC+DTG (PP). La eficiencia, en términos de coste/eficacia, osciló entre 7.814 y 12.412 por respondedor a las 48 semanas, para ABC/3TC/DTG (PP) y TAF/FTC+RAL (PP), respectivamente. Conclusión: Considerando el precio oficial del TAR, la pauta más eficiente fue ABC/3TC/DTG (PP), seguida de TAF/FTC/RPV (PA) y AF/FTC/EVG/COBI (PA)

Analysis of the costs and cost-effectiveness of the guidelines recommended by the 2018 GESIDA/Spanish National AIDS Plan for initial antiretroviral therapy in HIV-infected adults.

BACKGROUND: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC+RAL (PR). The effectiveness varies from 0.82 for TAF/FTC+DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR).

Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults / Análisis de costes y de coste/eficacia de las pautas recomendadas por GESIDA/Plan Nacional sobre el Sida en 2017 para el tratamiento antirretroviral inicial en adultos infectados por el VIH

INTRODUCTION: GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV-infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC + RAL (PR). The efficacy varied from 0.82 for TFV/FTC + DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC + RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR)

INTRODUCCIÓN: El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP), pautas alternativas (PA) y otras pautas (OP) para el tratamiento antirretroviral (TARV) como terapia de inicio en pacientes infectados por VIH para 2017. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con PP y PA. MÉTODOS: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral < 50 copias/mL en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del TARV y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando solo costes directos diferenciales: TARV (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA B*5701. El ámbito es España, con costes de 2017. Se realizó un análisis de sensibilidad determinista construyendo 3 escenarios para cada pauta: basal, más favorable y más desfavorable. RESULTADOS: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 6.882 euros para TFV/FTC/RPV (PA) y 10.904 euros para TFV/FTC + RAL (PP). La eficacia osciló entre 0,82 para TFV/FTC + DRV/p (PA) y 0,92 para TAF/FTC/EVG/COBI (PP). La eficiencia, en términos de coste/eficacia, osciló entre 7.923 y 12.765 euros por respondedor a las 48 semanas, para ABC/3TC/DTG (PP) y TFV/FTC + RAL (PP), respectivamente. CONCLUSIÓN: Considerando el precio oficial del TARV, la pauta más eficiente fue ABC/3TC/DTG (PP), seguida de TFV/FTC/RPV (PA) y TAF/FTC/EVG/COBI

Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

INTRODUCTION: GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV-infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC+RAL (PR). The efficacy varied from 0.82 for TFV/FTC+DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR).

REDOSER project: optimising biological therapy dose for rheumatoid arthritis and spondyloarthritis patients.

BACKGROUND: Reducing the dose of biological therapy (BT) when patients with immune-mediated arthritis achieve a sustained therapeutic goal may help to decrease costs for national health services and reduce the risk of serious infection. However, there is little information about whether such a decision can be applied universally. Therefore, the objective of this study was to develop appropriateness criteria for reducing the dose of BT in patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and peripheral spondyloarthritis (pSpA). METHODS: The RAND/UCLA appropriateness method was coordinated by experts in the methodology. Five rheumatologists with clinical research experience in RA and/or SpA selected and precisely defined the variables considered relevant when deciding to reduce the dose of BT in the 3 diseases, in order to define patient profiles. Ten rheumatologists with experience in prescribing BT anonymously rated each profile on a scale of 1 (completely inappropriate) to 9 (completely appropriate) after revising a summary of the evidence obtained from 4 systematic literature reviews carried out specifically for this project. FINDINGS: A total of 2,304 different profiles were obtained for RA, 768 for axSpA, and 3,072 for pSpA. Only 327 (14.2%) patient profiles in RA, 80 (10.4%) in axSpA, and 154 (5%) in pSpA were considered appropriate for reducing the dose of BT. By contrast, 749 (32.5%) patient profiles in RA, 270 (35.3%) in axSpA, and 1,243 (40.5%) in pSpA were considered inappropriate. The remaining profiles were considered uncertain. INTERPRETATION: Appropriateness criteria for reducing the dose of BT were developed in 3 inflammatory conditions. These criteria can help clinicians treating these disorders to optimize the BT dose. However, further research is needed, since more than 50% of the profiles were considered uncertain and the real prevalence of each profile in daily clinical practice remains unknown.

Cost-effectiveness of a cascade screening program for the early detection of familial hypercholesterolemia.

BACKGROUND: Although familial hypercholesterolemia (FH) confers a high risk of coronary artery disease, most patients are undiagnosed, and little is known about the efficiency of genetic cascade screening programs at national level. OBJECTIVE: The aim of the study was to estimate the cost-effectiveness of a national genetic cascade screening program in Spain. METHODS: An economic evaluation was performed using a decision tree analysis. The choice in the decision tree was between implementation of the national program for FH (NPFH) or keeping the usual clinical care. The NPFH detects FH patients through total cholesterol measurement at primary care level and use of genetic testing in index cases and relatives. The payer (National Health System) and social (including the productivity lost) perspectives were considered. The outcome variables were coronary events avoided, deaths avoided, and quality-adjusted life years (QALYs) gained. RESULTS: From the payer perspective, the application of the NPFH during 1 year prevents 847 coronary events and 203 deaths in the 9000 FH patients cohort during a 10-year follow-up, yielding an extra 767 QALYs, at a cost of €29,608 per QALY gained. From the social perspective, the NPFH is dominant over the control (the cost decreases and the effectiveness increases). The sensitivity analysis confirms the robustness of the findings. CONCLUSION: The NPFH based on molecular testing is a cost-effective diagnostic and management strategy that supports government expenditure aimed at preventing coronary artery disease in FH patients in Spain. Implementation of such a strategy is likely to be also cost-effective in countries with similar developed healthcare systems.

Eliminación de la hepatitis C en España: adaptación de un modelo matemático de salud pública partiendo del plan estratégico para el abordaje de la hepatitis C en el Sistema Nacional de Salud / Elimination of hepatitis C in Spain: Adaptation of a mathematical model based on the public health strategic plan for addressing hepatitis C in the National Health System

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Costs and cost-efficacy analysis of the 2016 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults / Análisis de costes y de coste/eficacia de las pautas recomendadas por GESIDA/Plan Nacional sobre el Sida en 2016 para el tratamiento antirretroviral inicial en adultos infectados por el VIH

INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. METHODS: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively. CONCLUSION: Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV

INTRODUCCIÓN: El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP), pautas alternativas (PA) y otras pautas (OP) para el tratamiento antirretroviral (TARV) como terapia de inicio en pacientes infectados por VIH para 2016. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con estas pautas. MÉTODOS: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral <50copias/ml en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del TARV y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando solo costes directos diferenciales: TARV (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA B*5701. El ámbito es España, con costes de 2016. Se realizó análisis de sensibilidad determinista construyendo 3 escenarios para cada pauta: basal, más favorable y más desfavorable. RESULTADOS: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 4.663euros para 3TC+LPV/r (OP) y 10.894euros para TDF/FTC+RAL (PP). La eficacia osciló entre 0,66 para ABC/3TC+ATV/r (PA) y ABC/3TC+LPV/r (OP), y 0,89 para TDF/FTC+DTG (PP) y TDF/FTC/EVG/COBI (PA). La eficiencia, en términos de coste/eficacia, osciló entre 5.280 y 12.836euros por respondedor a las 48 semanas, para 3TC+LPV/r (OP) y RAL+DRV/r (OP), respectivamente. CONCLUSIÓN: Aunque globalmente la pauta más eficiente fue 3TC+LPV/r (OP), considerando solamente las PP y las PA, la pauta más eficiente fue ABC/3TC/DTG (PP). De las PA, la más eficiente fue TDF/FTC/RPV

Costs and cost-efficacy analysis of the 2016 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. METHODS: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively. CONCLUSION: Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV.

Costs and cost-effectiveness analysis of 2015 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults / Análisis de costes y de coste/eficacia de las pautas recomendadas por GESIDA/Plan Nacional sobre el Sida en 2015 para el tratamiento antirretroviral inicial en adultos infectados por el VIH

INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest a preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2015. The objective of this study is to evaluate the costs and the effectiveness of initiating treatment with these regimens. METHODS: Economic assessment of costs and effectiveness (cost/effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2015. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC + LPV/r (OR) to 10,902 Euros for TDF/FTC + RAL (PR). The effectiveness varies from 0.66 for ABC/3TC + ATV/r (AR) and ABC/3TC + LPV/r (OR), to 0.89 for TDF/FTC + DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/effectiveness, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC + LPV/r (OR) and RAL + DRV/r (OR), respectively. CONCLUSION: The most efficient regimen was 3TC + LPV/r (OR). Among the PR and AR, the most efficient regimen was TDF/FTC/RPV (AR). Among the PR regimes, the most efficient was ABC/3TC + DTG

INTRODUCCIÓN: El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP), pautas alternativas (PA) y otras pautas (OP) para el tratamiento antirretroviral como terapia de inicio en pacientes infectados por VIH para 2015. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con estas pautas. MÉTODOS: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral <50 copias/mL en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del tratamiento antirretroviral y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando solo costes directos diferenciales: tratamiento antirretroviral (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA B*5701. El ámbito es España, con costes de 2015. Se realizó análisis de sensibilidad determinista construyendo 3 escenarios para cada pauta: basal, más favorable y más desfavorable. RESULTADOS: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 4.663 euros para 3TC + LPV/r (OP) y 10.902 euros para TDF/FTC + RAL (PP). La eficacia osciló entre 0,66 para ABC/3TC + ATV/r (PA) y ABC/3TC + LPV/r (OP), y 0,89 para TDF/FTC + DTG (PP) y TDF/FTC/EVG/COBI (PA). La eficiencia, en términos de coste/eficacia, osciló entre 5.280 y 12.836 euros por respondedor a las 48 semanas, para 3TC + LPV/r (OP) y RAL + DRV/r (OP), respectivamente. CONCLUSIÓN: La pauta más eficiente fue 3TC + LPV/r (OP). Entre las PP o PA, la pauta más eficiente fue TDF/FTC/RPV (PA). De las PP, la más eficiente fue ABC/3TC + DTG

Costs and cost-effectiveness analysis of 2015 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest a preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2015. The objective of this study is to evaluate the costs and the effectiveness of initiating treatment with these regimens. METHODS: Economic assessment of costs and effectiveness (cost/effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2015. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,902 Euros for TDF/FTC+RAL (PR). The effectiveness varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/effectiveness, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR) and RAL+DRV/r (OR), respectively. CONCLUSION: The most efficient regimen was 3TC+LPV/r (OR). Among the PR and AR, the most efficient regimen was TDF/FTC/RPV (AR). Among the PR regimes, the most efficient was ABC/3TC+DTG.

Análisis de costes y de coste/eficacia de las pautas recomendadas por GESIDA/Plan Nacional sobre el Sida en 2014 para el tratamiento antirretroviral inicial en adultos infectados por el VIH / Costs and cost-efficacy analysis of the 2014 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults

INTRODUCTION: GESIDA and the National AIDS Plan panel of experts suggest preferred (PR) and alternative (AR) regimens of antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2014. The objective of this study is to evaluate the costs and the efficiency of initiating treatment with these regimens. METHODS: An economic assessment was made of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied by considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and costs correspond to those of 2014. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranges from 5133 Euros for ABC/3TC + EFV to 11,949 Euros for TDF/FTC + RAL. The efficacy varies between 0.66 for ABC/3TC + LPV/r and ABC/3TC + ATV/r, and 0.89 for TDF/FTC/EVG/COBI. Efficiency, in terms of cost/efficacy, ranges from 7546 to 13,802 Euros per responder at 48 weeks, for ABC/3TC + EFV and TDF/FTC + RAL respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC + EFV (AR), followed by the non-nucleoside containing PR (TDF/FTC/RPV and TDF/FTC/EFV). The sensitivity analysis confirms the robustness of these findings

INTRODUCCIÓN: El panel de expertos de GESIDA/Plan Nacional del Sida ha recomendado pautas preferentes (PP) y alternativas (PA) de tratamiento antirretroviral (TARV) como terapia de inicio en pacientes infectados por VIH para 2014. El objetivo de este estudio es evaluar los costes y la eficiencia de iniciar tratamiento con estas pautas. MÉTODOS: Evaluación económica de costes y eficiencia (coste/eficacia) mediante construcción de árboles de decisión. Se definió eficacia como la probabilidad de tener carga viral <50 copias/mL en la semana 48 en análisis por intención de tratar. Se definió coste de iniciar tratamiento con una pauta como los costes del TARV y de todas sus consecuencias (efectos adversos, cambios de pauta y estudio de resistencias) que se producen en las siguientes 48 semanas. Se utilizó la perspectiva del Sistema Nacional de Salud, considerando sólo costes directos diferenciales: fármacos (a precio oficial), manejo de efectos adversos, estudios de resistencias y determinación de HLA B*5701. El ámbito es España, con costes de 2014. Se realizó análisis de sensibilidad determinista construyendo tres escenarios para cada pauta: basal, más favorable y más desfavorable. RESULTADOS: En el escenario basal, los costes de iniciar tratamiento oscilaron entre 5.133 euros para ABC/3TC + EFV y 11.949 euros para TDF/FTC + RAL. La eficacia osciló entre 0,66 para ABC/3TC + LPV/r y ABC/3TC + ATV/r, y 0,89 para TDF/FTC/EVG/COBI. La eficiencia, en términos de coste/eficacia, osciló entre 7.546 y 13.802 euros por respondedor a las 48 semanas, para ABC/3TC + EFV y TDF/FTC + RAL, respectivamente. CONCLUSIÓN: Considerando el precio oficial del TARV, la pauta más eficiente fue ABC/3TC + EFV (PA), seguida de las PP que contienen no nucleósidos (TDF/FTC/RPV y TDF/FTC/EFV). El análisis de sensibilidad confirmó la robustez de estos hallazgos