Integrating viral hepatitis management into the emergency department: A further step towards viral hepatitis elimination.

Background & Aims: Many people with HCV and HBV infection are unaware of their condition, particularly at-risk and vulnerable populations who face barriers for screening and linkage to care. Emergency departments are often their only point of contact with the health system. Methods: This is a prospective study investigating HBsAg and HCV antibody testing, with reflex testing for HDV antibodies and HCV RNA, in adults attending an emergency department and requiring a blood test. Positive cases were linked to care. A cost-effectiveness analysis was performed. Results: From February 2020 to February 2022, a total of 17,560 individuals were screened. HBsAg was detected in 91 (0.5%), HCV RNA in 128 (0.7%), and HDV antibodies in two (0.01%) individuals. Nearly 40% of positive cases were unaware of their condition. Linkage to care was achieved in 42 of 56 HBsAg-positive and 45 of 69 HCV RNA-positive participants who were candidates for referral. HCV and HBV screening vs. no screening yielded 1.06 and 0.42 additional quality-adjusted life-years, respectively, with incremental cost-utility ratios of €7,629 and -€147 per quality-adjusted life-year gained, respectively, and proved even more cost-effective in patients with hepatitis C aged 40-70 years. Conclusions: On emergency department screening for hepatitis B, C, and D in Barcelona, the prevalence of HBsAg was 0.5% and HCV RNA 0.7%, approximately threefold higher than that observed in the general population. This strategy diagnosed patients with active HCV infection and no risk factors, who would not have been screened according to the current recommendations. Screening and linkage to care of viral hepatitis is cost-effective in this setting. Impact and implications: We evaluated the performance and cost-effectiveness of a viral hepatitis screening programme implemented in an emergency department, which aimed to identify and link to care people living with hepatitis B and C. Our findings reveal a threefold higher prevalence of hepatitis B and C than in the general Spanish population, possibly attributable to the role of the emergency department as the main healthcare gateway for vulnerable populations, who have a higher prevalence of viral hepatitis. Risk factors for viral hepatitis could not be identified in most people living with hepatitis B and C attending the emergency department; hence, screening beyond risk factors should be considered in hepatitis detection strategies. Emergency department screening is cost-effective for hepatitis C and is a cost-saving strategy for hepatitis B in our setting. These data should inform future updates to clinical guidelines.

Achieving the UNAIDS goals by 2030 in people living with HIV: A simulation model to support the prioritization of health care interventions / Alcanzar los objetivos de ONUSIDA para 2030 en personas con VIH: un modelo de simulación para respaldar la priorización de las intervenciones sanitarias

Objective: We simulated the impact of implementing different health interventions to improve the HIV continuum of care for people diagnosed, on treatment, and virologically suppressed in Spain for the 2020–2030 period. Methods: The model was carried out in four phases involving a multidisciplinary expert panel: (1) literature review; (2) selection/definition of the interventions and their effectiveness; (3) consensus meeting; and (4) development of an analytical decision model to project the impact of implementing/strengthening these interventions to improve the HIV continuum of care, corresponding to 2017–2019 (87% diagnosed, 97% on treatment, 90% with viral suppression), through the creation of different scenarios for 2020–2030. A total of 19 interventions were selected based on expanding the offer of HIV rapid tests and implementing training/peer programmes, electronic alerts, multidisciplinary care, and mHealth, among others. The effectiveness of the interventions was defined by the percentage increases in diagnosis, treatment, and viral suppression after their implementation, targeting the entire population and specific groups at high-risk (men who have sex with men, migrants, female sex workers, transgender people, and people who inject drugs). Results: Implementing eight interventions for diagnosis, three for treatment, and eight for viral suppression for the target populations during 2020–2030 would increase the continuum of care to approximately 100% diagnosed (remaining residual undetectable cases), 98% treated, and 96% virologically suppressed. Conclusions: Planification, prioritization, and implementation of selected interventions based on the current HIV continuum of care could allow achievement of the 95-95-95 UNAIDS goals in Spain by 2030.(AU)

Objetivo: Simulamos el impacto de la implementación de diferentes intervenciones sanitarias para mejorar la atención continua de las personas diagnosticadas, en tratamiento y con supresión vírica del VIH en España para el período 2020-2030. Métodos: El modelo se llevó a cabo en 4 fases con la participación de un panel de expertos multidisciplinario: (1) revisión de la literatura médica publicada; (2) selección/definición de las intervenciones y su eficacia; (3) reunión de consenso, y (4) desarrollo de un modelo de toma de decisiones analítico para proyectar el impacto de la implementación/refuerzo de estas intervenciones para mejorar la atención continua de las personas con VIH, correspondiente al período 2017-2019 (87% diagnosticados, 97% en tratamiento y 90% con supresión vírica), a través de la creación de diferentes escenarios para el período 2020-2030. Se seleccionaron un total de 19 intervenciones sobre la base de ampliar la oferta de pruebas rápidas de VIH, y la implementación de programas de formación/entre pares, alertas electrónicas, atención multidisciplinaria y mHealth, entre otras. La efectividad de las intervenciones se definió a partir del porcentaje de incremento en el diagnóstico, tratamiento y supresión vírica tras la implementación, dirigida a toda la población y a grupos específicos de alto riesgo (hombres que mantienen relaciones sexuales con otros hombres, migrantes, trabajadoras sexuales, personas transgénero y personas que consumen drogas inyectables). Resultados: La implementación de 8 intervenciones para el diagnóstico, 3 para el tratamiento y 8 para la supresión vírica dirigidas a las poblaciones objetivo durante el período 2020-2030 debería mejorar la atención continua recibida en aproximadamente un 100% de personas diagnosticadas (con un remanente de casos residuales indetectables), un 98% de personas tratadas y un 96% de personas con supresión vírica...(AU)

Impact of hepatitis D reflex testing on the future disease burden: A modelling analysis.

Chronic hepatitis D (CHD) is a severe form of viral hepatitis that leads to liver cirrhosis and hepatocellular carcinoma. CHD is underdiagnosed, and this study aimed to assess the impact of hepatitis D reflex testing in HBsAg-positive individuals in Spain over the next 8 years. Two scenarios were compared: the current situation (7.6% of HBsAg-positive patients tested for anti-HDV) and reflex testing for all positive samples. A decision tree model was designed to simulate the CHD care cascade. Implementing reflex testing would increase anti-HDV detection to 5498 cases and HDV-RNA to 3225 cases. Additionally, 2128 more patients would receive treatment, with 213 achieving undetectable HDV-RNA levels. The cost per anti-HDV case detected would be €132. In the median time of the analysis, liver complications (decompensated cirrhosis, HCC and liver-related deaths) would be reduced by 35%-38%, implying an estimated cost savings of 36 million euros associated with the management of such complications. By 2030, implementing anti-HDV reflex testing would reduce the clinical and economic burden of CHD by 35%-38%.

Achieving the UNAIDS goals by 2030 in people living with HIV: A simulation model to support the prioritization of health care interventions.

OBJECTIVE: We simulated the impact of implementing different health interventions to improve the HIV continuum of care for people diagnosed, on treatment, and virologically suppressed in Spain for the 2020-2030 period. METHODS: The model was carried out in four phases involving a multidisciplinary expert panel: (1) literature review; (2) selection/definition of the interventions and their effectiveness; (3) consensus meeting; and (4) development of an analytical decision model to project the impact of implementing/strengthening these interventions to improve the HIV continuum of care, corresponding to 2017-2019 (87% diagnosed, 97% on treatment, 90% with viral suppression), through the creation of different scenarios for 2020-2030. A total of 19 interventions were selected based on expanding the offer of HIV rapid tests and implementing training/peer programmes, electronic alerts, multidisciplinary care, and mHealth, among others. The effectiveness of the interventions was defined by the percentage increases in diagnosis, treatment, and viral suppression after their implementation, targeting the entire population and specific groups at high-risk (men who have sex with men, migrants, female sex workers, transgender people, and people who inject drugs). RESULTS: Implementing eight interventions for diagnosis, three for treatment, and eight for viral suppression for the target populations during 2020-2030 would increase the continuum of care to approximately 100% diagnosed (remaining residual undetectable cases), 98% treated, and 96% virologically suppressed. CONCLUSIONS: Planification, prioritization, and implementation of selected interventions based on the current HIV continuum of care could allow achievement of the 95-95-95 UNAIDS goals in Spain by 2030.

Recommendations for the integral diagnosis of chronic viral hepatitis in a single analytical extraction. / Recomendaciones para el diagnóstico integral de las hepatitis virales crónicas en una única extracción analítica.

The Spanish Society of Digestive Pathology (SEPD), the Spanish Association for the Study of the Liver (AEEH), the Spanish Society of Infections and Clinical Microbiology (SEIMC) and its Viral Hepatitis Study Group (GEHEP), and with the endorsement of the Alliance for the Elimination of Viral Hepatitis in Spain (AEHVE), have agreed on a document to carry out a comprehensive diagnosis of viral hepatitis (B, C and D), from a single blood sample; that is, a comprehensive diagnosis, in the hospital and/or at the point of care of the patient. We propose an algorithm, so that the positive result in a viral hepatitis serology (B, C and D), as well as human immunodeficiency virus (HIV), would trigger the analysis of the rest of the virus, including the viral load when necessary, in the same blood draw. In addition, we make two additional recommendations. First, the need to rule out a previous hepatitis A virus (VHA) infection, to proceed with its vaccination in cases where IgG-type studies against this virus are negative and the vaccine is indicated. Second, the determination of the HIV serology. Finally, in case of a positive result for any of the viruses analyzed, there must be an automated alerts and initiate epidemiological monitoring.

Clinical and economic value of sofosbuvir-based regimens in the treatment of chronic hepatitis C in Spain.

BACKGROUND: The treatment of chronic hepatitis C virus (HCV) with direct-acting antivirals has undergone a spectacular revolution and added significant value to healthcare systems and patients. The aim of the study was to evaluate the efficiency and value of Sofosbuvir (SOF)-based regimens for a target population of 85,959 chronic HCV patients treated in Spain during 2015-2019, compared to previous therapeutic strategies (peginterferon/ and ribavirin in double/triple therapy with telaprevir or boceprevir). METHODS: A previously developed lifetime Markov model was adapted to simulate the disease HCV evolution. In SOF-based regimens, all patients (100%) were treated regardless with sustained virological response (SVR) of 93-98%, obtained from real-world data. In previous therapeutic, only ≥F2 patients were treated according to clinical practice (38%) with an average SVR of 61% taken from published literature. The value was measured as clinical and economic impact in terms of avoided HCV-related mortality and liver complications; total costs and quality-adjusted life years (QALYs) applying an annual 3% discount rate. RESULTS: Compared to previous therapeutic, during lifetime, SOF-based regimens reduced decompensated cirrhosis by 89%, hepatocellular carcinoma by 77% and liver transplant by 84%, decreasing the cost associated to liver complications management in €770 million. SOF-based regimens also decreased liver-related mortality by 82%. Besides, SOF-based regimens gained 310,765/QALYs, saving €274 million (considering drugs, monitoring, and HCV management). CONCLUSION: For Spain, SOF-based regimens offer value for HCV patients in terms of lowering HCV-related liver disease burden and generating significant cost savings for the health system, contributing to the WHO goal.

Point-of-care hepatitis C testing and treatment strategy for people attending harm reduction and addiction centres for hepatitis C elimination.

According to WHO goals, the elimination of Hepatitis C Virus (HCV) by 2030 requires enhancing and simplifying HCV testing. Our aim was to create a model to assess and compare different strategies for HCV testing, linkage to care and treatment among people who access harm reduction centres (HRC) and Addiction Centres in Catalonia. A decision tree model was designed to evaluate two strategies: Hepatitis C Point-of-care (POC) "test and treat", at the community versus standard-of-care (SOC), in which HCV testing was performed at community and therapy at the hospital. Both strategies were assessed separately in HRCs (6,878 users) and Addiction Centres (13,778 users). with a time horizon of 18 months. Healthcare outcomes were HCV testing, linkage to care, treatment outcomes and reinfection rate. HCV testing was performed in 3,178 (46%) of the HRC users. Compared with SOC, POC increased access to treatment by 57% (63% vs. 6%). SVR rates were 64% in POC vs. 23% in SOC. Reinfection rates were 21% with POC compared to 24% with SOC. With POC, losses to follow-up were reduced by 41%. In the Addiction Centres, 12,566 users (91%) were screened using the two strategies. Compared to the SOC, POC increased access to treatment and linkage to care by 19% along with SVR at the same rate. Reinfection rates decreased by 6%. Thus, the implementation of a POC "test and treat" strategy at HRCs and Addiction Centres has shown to be an effective public health strategy to help eliminating HCV in accordance with WHO goal.

Clinical and economic impact of an alert system in primary care for the detection of patients with chronic hepatitis C.

INTRODUCTION: Prevalence of chronic hepatitis C (CHC) is higher in patients born between 1955-1975. The aim was to perform an economic evaluation of an age-based electronic health record (EHR) alert in primary care to detect patients with undiagnosed CHC and its treatment in comparison with non-use of the alert system, in Valencian Community, Spain. MATERIALS AND METHODS: Decision trees and Markov model were used to evaluate the diagnosis and progression of the disease, respectively. CHC was diagnosed by serology and viral load in seropositive subjects. Epidemiological data and diagnostic costs were extracted from public sources of the Valencian Community. Probabilities, utilities and costs of model states were obtained from the literature. The impact on mortality and hepatic complications avoided by the implementation of the alert were estimated, and efficiency was measured as an incremental cost-utility ratio (ICUR) based on quality-adjusted life years (QALYs) and the costs of both alternatives. RESULTS: The EHR alert detected 269,548 patients, of whom 1,331 had CHC (vs. 23 patients with non-alert). Over the patients' lifetime, the alert would prevent 93% of decompensated cirrhosis cases, 87% of hepatocellular carcinomas, 90% of liver transplants, and 89% of liver related deaths compared to non-use of the alert system. In addition, it would obtain an additional 3.3 QALY per patient, with an incremental cost of €10,880 and an ICUR of €3,321. CONCLUSIONS: The implementation of an age-based EHR alert in primary care to detect patients with CHC reduces hepatic complications and mortality and is an efficient strategy.

A multi-stakeholder multicriteria decision analysis for the reimbursement of orphan drugs (FinMHU-MCDA study).

BACKGROUND: Patient access to orphan medicinal products (OMPs) is limited and varies between countries, reimbursement decisions on OMPs are complex, and there is a need for more transparent processes to know which criteria should be considered to inform these decisions. This study aimed to determine the most relevant criteria for the reimbursement of OMPs in Spain, from a multi-stakeholder perspective, and using multicriteria decision analysis (MCDA). METHODS: An MCDA was developed in 3 phases and included 28 stakeholders closely related to the field of rare diseases (6 physicians, 5 hospital pharmacists, 7 health economists, 4 patient representatives and 6 members from national and regional health authorities). Initially [phase A], a bibliographic review was conducted to identify the potential reimbursement criteria. Then, a reduced advisory board (8 members) proposed, selected, and defined the final list of criteria that could be relevant for reimbursement. A discrete choice experiment (DCE) [phase B] was developed to determine the relevance and relative importance weight of such criteria according to the stakeholders' preferences by choosing between pairs of hypothetical financing scenarios. A multinomial logit model was fitted to analyze the DCE responses. Finally [phase C], the advisory board review the results using a deliberative process. RESULTS: Thirteen criteria were selected, related to 4 dimensions: patient population, disease, treatment, and economic evaluation. Nine criteria were deemed relevant for decision-making and associated with a higher relative importance: Health-related quality of life (HRQL) (23.53%), treatment efficacy (14.64%), availability of treatment alternatives (13.51%), disease severity (12.62%), avoided costs (11.21%), age of target population (7.75%), safety (seriousness of adverse events) (4.72%), quality of evidence (3.82%) and size of target population (3.12%). The remaining criteria had a < 3% relative importance: economic burden of disease (2.50%), cost of treatment (1.73%), cost-effectiveness (0.83%) and safety (frequency of adverse events) (0.03%). CONCLUSION: The reimbursement of OMPs in Spain should be determined by its effect on patient's HRQL, the extent of its therapeutic benefit from efficacy and the availability of other therapeutic options. Furthermore, the severity of the rare disease should also influence the decision along with the potential of the treatment to avoid associated costs.

Is the universal population Hepatitis C virus screening a cost-effective strategy? A systematic review of the economic evidence / ¿Es coste-efectivo realizar el cribado poblacional para la hepatitis C? Revisión sistemática de la evidencia farmacoeconómica

BACKGROUND: Efficient strategies are needed in order to achieve the objective of the WHO of eradicating Hepatitis C virus (HCV). Hepatitis C infection can be eliminated by a combination of direct acting antiviral (DAA). The problem is that many individuals remain undiagnosed. The objective is to conduct a systematic review of the evidence on economic evaluations that analyze the screening of HCV followed by treatment with DAAs. METHODS: Eleven databases were performed in a 2015-2018-systematic review. Inclusion criteria were economic evaluations that included incremental cost-effectiveness ratio (ICER) in terms of cost per life year gained or quality-adjusted life year. RESULTS: A total of 843 references were screened. Sixteen papers/posters meet the inclusion criteria. Ten of them included a general population screening. Other populations included were baby-boomer, people who inject drugs, prisoners or immigrants. Comparator was "standard of care", other high-risk populations or no-screening. Most of the studies are based on Markov model simulations and they mostly adopted a healthcare payer's perspective. ICER for general population screening plus treatment versus high-risk populations or versus routinely performed screening showed to be below the accepted willingness to pay thresholds in most studies and therefore screening plus DAAs strategy is highly cost-effective. CONCLUSION: This systematic review shows that screening programmes followed by DAAs treatment is cost-effective not only for high risk population but for general population too. Because today HCV can be easily cured and its long-term consequences avoided, a universal HCV screening plus DAAs therapies should be the recommended strategy to achieve the WHO objectives for HCV eradication by 2030

ANTECEDENTES: Para conseguir el objetivo de la Organización Mundial de la Salud (OMS) de erradicar la hepatitis C (VHC) se necesita estrategias eficientes. La infección por VHC puede ser eliminada por combinaciones de antivirales de acción directa (DAA). El problema es que muchos individuos permanecen sin diagnosticar. El objetivo es realizar una revisión sistemática de la evidencia de evaluaciones económicas que analicen el cribado del VHC (screening) seguido de tratamiento con DDA. MÉTODO: Realizamos una revisión sistemática de once bases de datos incluyendo 2015-2018. Los criterios de inclusión fueron evaluación económica que incluyera ratio de coste-efectividad incremental (ICER) en coste por año de vida ganado o año de vida ajustado por calidad. RESULTADOS: Extrajimos 843 referencias. Dieciséis pósters/artículos cumplieron criterio de inclusión. Diez de ellos valoraban cribado de población general. Otras poblaciones analizadas fueron "baby-boomer", usuarios de drogas parenterales, prisiones o inmigrantes. El comparador fue "práctica clínica habitual", otras poblaciones de alto riesgo o no hacer cribado. La mayoría de los estudios utilizaron simulaciones por modelo de Markov y la perspectiva del pagador. El ICER para cribado de población general + tratamiento DDA frente a poblaciones de alto riesgo o práctica rutinaria mostraron que está por debajo del umbral de la disponibilidad a pagar en la mayoría de los estudios y concluyen que la estrategia es altamente coste-eficaz y que está por debajo de los umbrales habituales de disposición a pagar. CONCLUSIÓN: Esta revisión sistemática muestra que los programas de detección seguidos de tratamiento con DDAs son coste-efectivos no sólo para poblaciones de alto riesgo sino también para población general. Dado que hoy el VHC puede ser fácilmente curado y evitadas sus consecuencias a largo plazo, el cribado universal seguido de tratamiento con combinaciones de DDA debería ser la estrategia recomendada para alcanzar el objetivo de la OMS de erradicar el VHC para 2030

La simplificación del proceso de diagnóstico de la hepatitis C crónica es una estrategia coste-efectiva / The simplification of the diagnosis process of chronic hepatitis C is cost-effective strategy

INTRODUCCIÓN: Los circuitos de diagnóstico de la hepatitis C son complejos. El diagnóstico de infección activa en la misma muestra simplificaría el proceso estableciendo un acceso rápido al tratamiento. Nuestro objetivo fue estimar el impacto sanitario y económico del diagnóstico de la infección crónica en un solo paso (D1P) comparado con el diagnóstico tradicional (DTRA) en Andalucía (8,39 millones de personas). MÉTODOS: Se realizó un árbol de decisión para estimar la derivación de los pacientes con infección crónica, pérdidas de seguimiento, acceso al tratamiento y costes del diagnóstico de la infección, para ambos procesos. Los costes unitarios, en euros (€) de 2018, de los recursos sanitarios (visitas médicas, anticuerpos, carga viral y genotipo), sin considerar el coste farmacológico, se obtuvieron de fuentes públicas de Andalucía. RESULTADOS: del total de la población estimada (269.526 pacientes), 1.389 pacientes serían derivados al especialista en el D1P y 1.063 en el DTRA, siendo tratados 1.320 y 1.009, respectivamente. Con el D1P ningún paciente con carga viral negativa sería remitido al especialista, frente a los 540 con el DTRA. El D1P generaría un ahorro de costes de 184.928 € frente al DTRA (15.671.493 vs 15.856.421 €). Al comparar el D1P frente a DTRA, el ahorro por paciente con carga viral positiva derivado al especialista sería de 3.644 € (11.279 vs 14.923 €). CONCLUSIONES: El diagnóstico en un solo paso conseguirá un aumento de pacientes diagnosticados, aumentará el acceso de los pacientes crónicos al tratamiento y generará un ahorro de costes, demostrando su eficiencia en el sistema sanitario en Andalucía

BACKGROUND: The cascade of care of the hepatitisC are complex. The diagnosis of active infection in the same serum sample would simplify the process establishing a rapid access for patients to treatment. Our objective was to estimate the impact on healthcare and economic outcomes of the diagnosis of chronic infection in one-step diagnosis compared to standard diagnosis in Andalusia (8.39 million people). METHODS: A decision tree was developed to estimate the referral of patients with chronic infection, loss of follow-up, access to treatment and costs of the diagnosis of the infection, for both processes. The unit costs (€, 2018) of the health resources (medical visits, antibodies, viral load and genotype), without considering the pharmacological cost, were obtained form public sources in Andalusia. RESULTS: Of the total estimated population (269,526 patients), 1,389 patients would be referred to the specialised care in the one-step diagnosis and 1,063 in de standard diagnosis, being treated 1,320 and 1,009, respectively. In one-step diagnosis, no negative viral loud patient would be referred to specialist versus 540 with standard diagnosis. One-step diagnosis would generate a cost saving of €184,928 versus standard diagnosis (€15,671,493 vs €15,856,421). When compared one-step diagnosis to standard diagnosis, the savings per patient with positive viral load referred to specialist would be € 3,634 (€ 11,279 vs € 14,923). CONCLUSION: The one-step diagnosis will achieve an increase in diagnosed patients, will increase the access of chronic patient to treatment and will generate cost savings, demonstrating its efficiency in the system in Andalusia

The simplification of the diagnosis process of chronic hepatitis C is cost-effective strategy. / La simplificación del proceso de diagnóstico de la hepatitis C crónica es una estrategia coste-efectiva.

BACKGROUND: The cascade of care of the hepatitisC are complex. The diagnosis of active infection in the same serum sample would simplify the process establishing a rapid access for patients to treatment. Our objective was to estimate the impact on healthcare and economic outcomes of the diagnosis of chronic infection in one-step diagnosis compared to standard diagnosis in Andalusia (8.39 million people). METHODS: A decision tree was developed to estimate the referral of patients with chronic infection, loss of follow-up, access to treatment and costs of the diagnosis of the infection, for both processes. The unit costs (€, 2018) of the health resources (medical visits, antibodies, viral load and genotype), without considering the pharmacological cost, were obtained form public sources in Andalusia. RESULTS: Of the total estimated population (269,526 patients), 1,389 patients would be referred to the specialised care in the one-step diagnosis and 1,063 in de standard diagnosis, being treated 1,320 and 1,009, respectively. In one-step diagnosis, no negative viral loud patient would be referred to specialist versus 540 with standard diagnosis. One-step diagnosis would generate a cost saving of €184,928 versus standard diagnosis (€15,671,493 vs €15,856,421). When compared one-step diagnosis to standard diagnosis, the savings per patient with positive viral load referred to specialist would be €3,634 (€11,279 vs €14,923). CONCLUSION: The one-step diagnosis will achieve an increase in diagnosed patients, will increase the access of chronic patient to treatment and will generate cost savings, demonstrating its efficiency in the system in Andalusia.

Healthcare value of implementing hepatitis C screening in the adult general population in Spain.

BACKGROUND: Elimination of hepatitis C virus (HCV) infection requires high diagnostic rates and universal access to treatment. Around 40% of infected individuals are unaware of their infection, which indicates that effective screening strategies are needed. We analyzed the efficiency (incremental cost-utility ratio, ICUR) of 3 HCV screening strategies: a) general population of adults, b) high-risk groups, and c) population with the highest anti-HCV prevalence plus high-risk groups. METHODS: An analytical decision model, projecting progression of the disease over a lifetime, was used to establish the candidate population for HCV screening. HCV data were obtained from the literature: anti-HCV prevalence (0.56%-1.54%), viremic patients (31.5%), and percentage of undiagnosed persons among those with viremia (35%). It was assumed that most patients would be treated and have HCV therapy response (98% SVR); transition probabilities, utilities, and disease management annual costs were obtained from the literature. Efficiency over the life of patients under the National Health System perspective was measured as quality-adjusted life years (QALY) and total cost (screening, diagnosis, pharmacological and disease management). A discount rate of 3% was applied to costs and outcomes. RESULTS: Screening of the adult population would identify a larger number of additional chronic hepatitis C cases (N = 52,694) than screening the highest anti-HCV prevalence population plus high-risk groups (N = 42,027) or screening high-risk groups (N = 26,128). ICUR for the general population vs. high-risk groups was €8914/QALY gained per patient (€18,157 incremental cost and 2.037 QALY). ICUR for the general population vs. population with highest anti-HCV prevalence plus high-risk groups was €7,448/QALY gained per patient (€7,733 incremental cost and 1.038 QALY). These ICUR values are below the accepted efficiency threshold (€22,000-€30,000). CONCLUSION: HCV screening and treatment of the general adult population is cost-effective compared to screening of high-risk groups or the population with the highest anti-HCV prevalence plus high-risk groups.

Value and innovation of direct-acting antivirals: long-term health outcomes of the strategic plan for the management of hepatitis C in Spain

Objective: To assess the long-term healthcare costs and health outcomes in association with the access to new direct-acting antivirals (DAAs), during the first year of the National Strategic Plan for Chronic Hepatitis C (SPCHC) in patients with chronic hepatitis C (CHC) in Spain. Methods: A decision tree and a lifetime Markov model were developed to simulate the natural history, morbidity, and mortality of a cohort of 51,900 patients with CHC before (pre-DAA strategy) and after (post-DAA strategy) access to DAAs, following SPCHC approval. The percentage of patients treated, transition probabilities, disease management costs, health state utility values, sustained virologic response rates and treatment costs were obtained from the literature and published data from Spain. The results were expressed in terms of costs (Euros, 2016), quality-adjusted life years (QALYs) and prevention of clinical events, with an annual discount rate of 3%. Results: The post-DAA strategy would prevent 8,667 cases of decompensated cirrhosis, 5,471 cases of hepatocellular carcinoma, 1,137 liver transplants and 9,608 liver-related deaths. The cohort of 51,900 patients would require investments of 1,606 and 1,230 million euros with the post-DAA and pre-DAA strategies, respectively. This would produce 819,674 and 665,703 QALYs. Conclusions: The use of new DAA-based treatments in CHC patients during the first year after the implementation of the SPCHC significantly reduced long-term morbidity and mortality and increased quality of life; demonstrating that this plan is an efficient use of public health resources (AU)

No disponible

Value and innovation of direct-acting antivirals: long-term health outcomes of the strategic plan for the management of hepatitis C in Spain.

OBJECTIVE: To assess the long-term healthcare costs and health outcomes in association with the access to new direct-acting antivirals (DAAs), during the first year of the National Strategic Plan for Chronic Hepatitis C (SPCHC) in patients with chronic hepatitis C (CHC) in Spain. METHODS: A decision tree and a lifetime Markov model were developed to simulate the natural history, morbidity, and mortality of a cohort of 51,900 patients with CHC before (pre-DAA strategy) and after (post-DAA strategy) access to DAAs, following SPCHC approval. The percentage of patients treated, transition probabilities, disease management costs, health state utility values, sustained virologic response rates and treatment costs were obtained from the literature and published data from Spain. The results were expressed in terms of costs (€, 2016), quality-adjusted life years (QALYs) and prevention of clinical events, with an annual discount rate of 3%. RESULTS: The post-DAA strategy would prevent 8,667 cases of decompensated cirrhosis, 5,471 cases of hepatocellular carcinoma, 1,137 liver transplants and 9,608 liver-related deaths. The cohort of 51,900 patients would require investments of 1,606 and 1,230 million euros with the post-DAA and pre-DAA strategies, respectively. This would produce 819,674 and 665,703 QALYs. CONCLUSIONS: The use of new DAA-based treatments in CHC patients during the first year after the implementation of the SPCHC significantly reduced long-term morbidity and mortality and increased quality of life; demonstrating that this plan is an efficient use of public health resources.

Análisis coste-efectividad de dos estrategias de tratamiento para la hepatitis C crónica: antes y después del acceso a los agentes antivirales de acción directa en España / Cost-effectiveness analysis of two treatment strategies for chronic hepatitis C before and after access to direct-acting antivirals in Spain

Objetivo: Análisis coste-efectividad de una estrategia basada en antivirales de acción directa (AAD) a partir de la comercialización de simeprevir y sofosbuvir (post-AAD) frente a otra previa (pre-AAD), en pacientes con hepatitis C crónica, desde la perspectiva del Sistema Nacional de Salud. Métodos: Se realizó un árbol de decisión combinado con un modelo de Markov para estimar los costes directos sanitarios (€, 2016) y resultados en salud (años de vida ajustados por calidad, AVAC), a lo largo de toda la vida del paciente, con una tasa de descuento anual del 3%. La respuesta virológica sostenida, el porcentaje de pacientes tratados o no en cada estrategia, las características clínicas de los pacientes, las probabilidades anuales de transición, los costes del tratamiento y manejo de la enfermedad, y las utilidades se obtuvieron de la literatura. El análisis coste-efectividad se expresó como relación coste-efectividad incremental (coste incremental por AVAC ganado). Se realizaron análisis de sensibilidad determinísticos y probabilístico. Resultados: La estrategia post-AAD mostró mayores costes sanitarios por paciente (30.944€ vs. 23.707€) que la estrategia pre-AAD. Sin embargo, se asoció con un aumento de la ganancia de AVAC (15,79 vs. 12,83), mostrando una relación coste-efectividad incremental de 2.439€ por AVAC. Los análisis de sensibilidad mostraron la consistencia de los resultados siendo la estrategia post-AAD, frente a pre-AAD, coste-efectiva en el 99% de los casos. Conclusiones: La estrategia post-AAD, en comparación con la pre-AAD, es eficiente para el tratamiento de la hepatitis C crónica en España, obteniéndose un coste por AVAC muy inferior al umbral de eficiencia utilizado en España (30.000€ por AVAC) (AU)

Objective: To evaluate the cost-effectiveness of a strategy based on direct-acting antivirals (DAAs) following the marketing of simeprevir and sofosbuvir (post-DAA) versus a pre-direct-acting antiviral strategy (pre-DAA) in patients with chronic hepatitis C, from the perspective of the Spanish National Health System. Methods: A decision tree combined with a Markov model was used to estimate the direct health costs (€, 2016) and health outcomes (quality-adjusted life years, QALYs) throughout the patient's life, with an annual discount rate of 3%. The sustained virological response, percentage of patients treated or not treated in each strategy, clinical characteristics of the patients, annual likelihood of transition, costs of treating and managing the disease, and utilities were obtained from the literature. The cost-effectiveness analysis was expressed as an incremental cost-effectiveness ratio (incremental cost per QALY gained). A deterministic sensitivity analysis and a probabilistic sensitivity analysis were performed. Results: The post-DAA strategy showed higher health costs per patient (€30,944 vs. €23,707) than the pre-DAA strategy. However, it was associated with an increase of QALYs gained (15.79 vs. 12.83), showing an incremental cost-effectiveness ratio of €2,439 per QALY. The deterministic sensitivity analysis and the probabilistic sensitivity analysis showed the robustness of the results, with the post-DAA strategy being cost-effective in 99% of cases compared to the pre-DAA strategy. Conclusions: Compared to the pre-DAA strategy, the post-DAA strategy is efficient for the treatment of chronic hepatitis C in Spain, resulting in a much lower cost per QALY than the efficiency threshold used in Spain (€30,000 per QALY) (AU)

Cost-effectiveness analysis of two treatment strategies for chronic hepatitis C before and after access to direct-acting antivirals in Spain. / Análisis coste-efectividad de dos estrategias de tratamiento para la hepatitis C crónica: antes y después del acceso a los agentes antivirales de acción directa en España.

OBJECTIVE: To evaluate the cost-effectiveness of a strategy based on direct-acting antivirals (DAAs) following the marketing of simeprevir and sofosbuvir (post-DAA) versus a pre-direct-acting antiviral strategy (pre-DAA) in patients with chronic hepatitis C, from the perspective of the Spanish National Health System. METHODS: A decision tree combined with a Markov model was used to estimate the direct health costs (€, 2016) and health outcomes (quality-adjusted life years, QALYs) throughout the patient's life, with an annual discount rate of 3%. The sustained virological response, percentage of patients treated or not treated in each strategy, clinical characteristics of the patients, annual likelihood of transition, costs of treating and managing the disease, and utilities were obtained from the literature. The cost-effectiveness analysis was expressed as an incremental cost-effectiveness ratio (incremental cost per QALY gained). A deterministic sensitivity analysis and a probabilistic sensitivity analysis were performed. RESULTS: The post-DAA strategy showed higher health costs per patient (€30,944 vs. €23,707) than the pre-DAA strategy. However, it was associated with an increase of QALYs gained (15.79 vs. 12.83), showing an incremental cost-effectiveness ratio of €2,439 per QALY. The deterministic sensitivity analysis and the probabilistic sensitivity analysis showed the robustness of the results, with the post-DAA strategy being cost-effective in 99% of cases compared to the pre-DAA strategy. CONCLUSIONS: Compared to the pre-DAA strategy, the post-DAA strategy is efficient for the treatment of chronic hepatitis C in Spain, resulting in a much lower cost per QALY than the efficiency threshold used in Spain (€30,000 per QALY).

Análisis coste-efectividad de sofosbuvir, interferón pegilado y ribavirina en pacientes con hepatitis crónica por virus C: tratamiento precoz en fases iniciales de fibrosis vs. tratamiento tardío en fases avanzadas / Cost-effectiveness analysis of sofosbuvir, peginterferon and ribavirin in patients with chronic hepatitis C: Early treatment in the initial stage of fibrosis vs. delayed treatment in advanced fibrosis

OBJETIVO: Análisis coste-efectividad de sofosbuvir con peginterferón/ribavirina (SOF/PEG-IFN/RBV) en pacientes con hepatitis C crónica genotipo 1 (HCC-GT1) no tratados previamente con diferentes grados de fibrosis, desde la perspectiva del Sistema Nacional de Salud (SNS). MÉTODOS: Modelo de Markov para estimar costes y resultados en salud (años de vida ganados [AVG] y años de vida ajustados por calidad [AVAC]), con una tasa de descuento del 3% anual de dos estrategias: SOF/PEG-IFN/RBV en fases precoces (fibrosis leve-moderada, F2-F3) o tardías (cirrosis compensada, F4). La eficacia (respuesta virológica sostenida), probabilidades anuales de transición, costes del manejo de la enfermedad y utilidades se obtuvieron de la literatura. Se consideraron costes directos expresados en € 2014. Se realizó un análisis de sensibilidad probabilístico (ASP). RESULTADOS: SOF/PEG-IFN/RBV en F2-F3 fue más efectiva (19,12 AVG y 14,14 AVAC) que en F4 (16,36 AVG y 9,27 AVAC). En 1.000 pacientes, SOF/PEG-IFN/RBV en F2-F3 podría evitar 66 casos de cirrosis descompensada, 60 de carcinoma hepatocelular y 4 trasplantes, en comparación con F4. El coste total de la terapia con SOF/PEG-IFN/RBV en F2-F3 (43.263 €) fue menor que en F4 (49.018 €). Administrar el tratamiento en F2-F3 frente a F4 representó una estrategia dominante (más efectiva y con menor coste). En el ASP, la administración de SOF/PEG-IFN/RBV en F2-F3 permaneció dominante en el 100% de las simulaciones. CONCLUSIONES: La administración de SOF/PEG-IFN/RBV en F2-F3, comparada con la terapia en F4, disminuyó la incidencia de complicaciones de la enfermedad hepática y se asoció con un ahorro en costes para el SNS en pacientes HCC-GT1

AIMS: Cost-effectiveness analysis of sofosbuvir combined with peginterferon alpha-2a and ribavirin (SOF/Peg-IFN/RBV) in early versus advanced fibrosis in previously untreated patients with chronic hepatitis C genotype 1 (CHC-GT1), from the perspective of the Spanish National Health System (NHS). METHODS: A Markov model was developed to compare lifetime costs and outcomes (life years gained [LYGs] and quality-adjusted life years [QALYs]) of 2 treatment strategies: SOF/Peg-IFN/RBV administered during early fibrosis (mild-moderate fibrosis; F2-F3) or advanced fibrosis (cirrhosis; F4). Efficacy (sustained virologic response), annual transition probabilities, disease management costs and utilities were obtained from the literature. Costs and outcomes were discounted annually at 3%. Direct costs were considered, expressed in Euros (€, 2014). Probabilistic sensitivity analysis (PSA) was also performed. RESULTS: SOF/Peg-IFN/RBV therapy at F2-F3 was more effective (19.12 LYGs and 14.14 QALYs) compared to F4. In a cohort of 1,000 patients, SOF/Peg-IFN/RBV prevented 66 cases of decompensated cirrhosis, 60 hepatocellular carcinomas and 4 liver transplantations compared with therapy in advanced fibrosis. The total lifetime cost of early therapy (€43,263) was less than the cost of treatment in the advanced stage (€49,018). Early therapy was a dominant strategy, more effective and less costly in all simulations. In the PSA analysis, administration of SOF/PEG-IFN/RBV at F2-F3 was dominant in all simulations. CONCLUSIONS: Starting SOF/Peg-IFN/RBV therapy at F2-F3, compared with therapy at F4, reduced the incidence of liver disease complications and was associated with cost savings for the Spanish NHS in CHC-GT1 patients