Expression of Elafin and CD200 as Immune Checkpoint Molecules Involved in Celiac Disease.

We comprehensively evaluated the expression of therapeutically targetable immune checkpoint molecules involved in celiac disease (CD). We have focused on the alteration of the CD200/CD200R pathway and Elafin expression in celiac disease and discussed their roles in regulating the immune response. There are limited data related to the expression or function of these molecules in celiac disease. This finding could significantly contribute to the understanding of the clinical manifestation of CD. CD200, CD200R and Elafin distributions were determined by ELISA and immunohistochemistry analyses in serum and biopsies of CD patients. Analyses of Th1 and Th17 cytokines were determined. PCR amplification of a fragment of the PI3 gene was carried out using genomic DNA isolated from whole blood samples of the study subjects. Different aliquots of the PCR reaction product were subjected to RFLP analysis for SNP genotyping and detection. We characterized the expression and function of the CD200-CD200R axis and PI3 in celiac disease. A significantly higher level of soluble CD200 and CD200R and lower expression of PI3 in serum of CD patients was observed compared to healthy controls. Consistent with our results, CD200 expression is regulated by IFN-gamma. Interaction of CD200/CD200R leads to production of type-Th1 and -Th17 cytokines. Regarding the PI3 genotype, the CT genotype proportion SNP rs1733103 and the GG genotype SNP rs41282752 were predominant in CD patients. SNP rs1733103 showed a significant association between the SNP variables and CD. In celiac disease the immune checkpoint is compromised or dysregulated, which can contribute to inflammation and the autoimmunity process. The study of these checkpoint points will lead to the development of targeted therapies aimed at restoring immunological balance in CD. Specific coding regions of the PI3 gene-splice variants predispose the Elafin protein, both at the transcriptional and post-translational levels, to modify its expression and function, resulting in reduced differential functional protein levels in patients with active celiac disease.

Evaluation of the clinical and economic value of sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C in Spain during the last 5 years.

OBJECTIVE: Direct-acting antivirals for the treatment of hepatitis C virus (HCV) represented a paradigm shift. In 2017, sofosbuvir/velpatasvir (SOF/VEL-Epclusa®) was approved, which showed a high cure rate in all patient, contributing to HCV elimination. The analysis aimed to quantify the clinical and economic value of SOF/VEL in HCV chronic patients since its approval in Spain. METHODS: An economic evaluation was elaborated adapting a Markov model that simulated the lifetime disease progression in of all HCV chronic patients treated with SOF/VEL (30,488 patients) since its launch (5-years), compared to previous therapies. Patients entered the model and were distributed between the fibrosis states (F0-to-F4) in treated and untreated. All patients (100%) were treated with SOF/VEL regardless of their fibrosis, and 49% with previous therapies in ≥F2. The average sustained viral response (SVR) rates 98.9% SOF/VEL versus 61.0% previous therapies. All parameters for the analysis were obtained from real-life data and literature. Only direct healthcare costs associated with disease management were included. The SOF/VEL value was measured as the number of hepatic complications avoided and their associated cost, and hepatic mortality compared to previous therapies. National Health System perspective and a 3% discount rate was applied. RESULTS: SOF/VEL decreased the number of liver complications, avoiding 92% decompensated cirrhosis, 80% hepatocellular carcinomas, and 87% liver transplants, as well as 85% liver-related mortality. Their cost associated was reduced, amounting to savings of 197M€. CONCLUSION: SOF/VEL adds relevant value to the HCV treatment, reducing the clinical and economic disease burden and contributing to HCV elimination in Spain.

The Health Impacts of Better Access to Axicabtagene Ciloleucel: The Case of Spain.

In this study, the health impacts of improving access to treatment with axicabtagene ciloleucel (axi-cel) was assessed in patients with relapsed/refractory diffuse large B-cell lymphoma after ≥2 lines of therapy in Spain. A partitioned survival mixture cure model was used to estimate the lifetime accumulated life years gained (LYG) and quality-adjusted life years (QALYs) per patient treated with axi-cel versus chemotherapy. Efficacy data were extracted from the ZUMA-1 trial for axi-cel and from the SCHOLAR-1 study for chemotherapy. In the base case, the incremental outcomes of axi-cel versus chemotherapy were evaluated in a cohort of 187 patients treated with CAR T-cell therapies, as reported by the "Spanish National Health System Plan for Advanced Therapies", and in the alternative scenario in the full eligible population based on epidemiological estimates (n = 490). Taking those currently treated with axi-cel, compared with chemotherapy, axi-cel provided an additional 1341 LYGs and 1053 QALYs. However, when all eligible patients (n = 490) were treated, axi-cel provided an additional 3515 LYs and 2759 QALYs. Therefore, if all eligible patients were treated with axi-cel rather than those currently treated as per the registry (n = 187), there would have been an additional 303 patients treated, resulting in an additional 2173 LYGs and 1706 QALYs in total. The lack of access in Spain has led to a loss of a substantial number of LYGs and QALYs, and efforts should be made to improve access for all eligible patients.

National expert consensus on home-administered oncologic therapies in Spain.

The diagnosis and treatment of cancer impose a significant emotional and psychological burden on patients, families, and caregivers. Patients undergo several interventions in a hospital setting, and the increasing number of patients requiring extended care and follow-up is driving the demand for additional clinical resources to address their needs. Hospital at Home (HaH) teams have introduced home-administered oncologic therapies that represent a new model of patient-centered cancer care. This approach can be integrated with traditional models and offers benefits to both patients and healthcare professionals (HCPs). Home-administered treatment programs have been successfully piloted globally, demonstrated as a preferred option for most patients and a safe alternative that could reduce costs and hospital burden. The document aims to establish the minimum recommendations for the home administration of oncologic therapies (ODAH) based on a national expert agreement. The expert panel comprised seven leading members from diverse Spanish societies and three working areas: clinical and healthcare issues, logistical and administrative issues, and economic, social, and legal issues. The recommendations outlined in this article were obtained after a comprehensive literature review and thorough discussions. This document may serve as a basis for the future development of home-administered oncologic therapy programs in Spain. .

Economic and Humanistic Burden of Moderate and Severe Hemophilia A and B in Spain: Real-World Evidence Insights from the CHESS II Study.

Background: Hemophilia is a congenital disorder characterized by deficiency or absence of clotting factor VIII in hemophilia A (HA) or clotting factor IX in hemophilia B (HB), resulting in frequent, repeated, and prolonged spontaneous or traumatic bleeding into joints or soft tissue. Severity is classified by the patient's baseline level of clotting factor activity as mild (>5%-40%), moderate (1%-5%), or severe (<1%). In Spain, there is limited information on the societal economic burden of disease. Objective: To estimate the economic and humanistic burden of disease in adult patients with non-inhibitor moderate and severe HA and HB in Spain. Methods: Spanish data from the CHESS II study (2018-2020) on patients' clinical characteristics, health-related quality of life (HRQoL) and hemophilia-related healthcare resource utilization were analyzed. Economic burden was determined by estimating condition-related annual per-patient direct (medical and nonmedical) and indirect costs, stratified according to hemophilia type and severity and presented as 2022 Euros. HRQoL was assessed via the EQ-5D-5L. Results: Of 341 patients in the Spanish CHESS II cohort, 288 patients met the inclusion criteria: 181 had HA (37% [n = 66] moderate and 63% [n=115] severe) and 107 had HB (26% [n = 28] moderate and 74% [n = 79] severe). Mean annual direct cost was higher in HB than in HA, and higher in severe than in moderate patients, resulting in an annual cost/patient of €17 251 (moderate HA), €17 796 (moderate HB), €116 767 (severe HA) and €206 996 (severe HB). The main direct cost component in all groups except moderate HA was factor replacement therapy. Mean per-patient indirect cost was €4089 (moderate HA), €797 (moderate HB), €8633 (severe HA) and €8049 (severe HB). Finally, the mean total cost (direct and indirect) for moderate and severe patients were €91 017 (HA) and €163 924 (HB). EQ-5D-5L [SD] scores were lower in patients with severe HA (0.77 [0.18]) and severe HB (0.70 [0.22]) compared with patients with moderate HA (0.81 [0.15]) and moderate HB (0.86 [0.17]). Conclusions: Independently of the type of hemophilia, greater condition severity was associated with increased costs and a decrease in HRQoL.

The Era of DAAs: Assessing the Patients' Characteristics, Clinical Impact, and Emergence of Comorbidities in HIV/HCV-Coinfected versus HIV-Infected Individuals.

Objective: To determine whether HIV-infected individuals versus individuals with HIV/HCV coinfection, in the era of interferon-free therapies, exhibit an increased incidence of comorbidities and non-AIDS-related events. Methods: A retrospective analysis was conducted by collecting data from clinical records of Spanish patients at a tertiary hospital involving HIV/HCV-coinfected and HIV-infected patients, all with effectively controlled HIV. Coinfected patients underwent HCV clearance using direct-acting antivirals (DAAs) and had no history of interferon treatment. The incidences of hypertension, diabetes mellitus, cardiovascular disease, kidney disease, liver disease, non-AIDS cancer, and death were compared between the groups. Multivariate adjustments for all factors potentially impacting outcomes were used to assess the risk of clinical event onset. Propensity score (PS) analyses were also conducted to support the multivariate model results. Results: Data were available from 229 HIV/HCV-coinfected patients and 229 HIV-infected patients. Both cohorts were comparable in terms of age, gender distribution, follow-up, and HIV-related characteristics. Multivariate models and PS showed that previous exposure to HCV was not associated with the onset of any clinical events studied. Significant differences between HIV/HCV-coinfected and HIV-infected were not found for survival according to the log-rank test (p = 0.402). Conclusions: Successful HCV elimination using DAAs improved the outlook regarding comorbidities and survival across HIV/HCV-coinfected cohorts. Early HCV detection and DAA therapy could enhance clinical results. These findings provide an optimistic perspective for those living with HIV/HCV coinfection and underscore the importance of continuing efforts toward early detection and DAA treatment initiation.

Perceived quality of life by patients with immune-mediated inflammatory diseases treated with biological therapies. SACVINFA study.

OBJECTIVES: To evaluate health-related quality of life perceived by patients with the most prevalent immune-mediated inflammatory diseases in Spain: inflammatory bowel disease (IBD), psoriasis (Ps), psoriatic arthritis (AP), rheumatoid arthritis (RA), and spondyloarthropathies (SpAs), and to determine the factors that influence patient quality of life. METHODS: The SACVINFA study (SA=satisfaction, CV=quality of life, IN=immune-mediated, FA=pharmacy) consisted of an observational study conducted in 4 hospitals in the Community of Madrid. A cross-sectional analysis was made for adult patients diagnosed with an immune-mediated inflammatory disease who attended the Pharmacy Service. Quality of life was assessed using the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and specific questionnaires: SIBDQ-9, DLQI, PsAQoL, QoL-RA, and ASQoL. RESULTS: A total of 578 patients were analysed (inflammatory bowel disease=25.3%; psoriasis=19.7%; spondyloarthropathies=18.7%; rheumatoid arthritis=18.5%; psoriatic arthritis=17.8%). The mean age (standard deviation) was 49.8 (12.3) years and 50.7% were male. The average score (standard deviation) for the global EQ-5D-5L was 0.771 (0.2) and the mean (standard deviation) visual analogue scale score was 71.5 (20.0). Type of immune-mediated inflammatory diseases was associated with differences in quality of life showing psoriasis and inflammatory bowel disease higher values of EQ5D-5L than psoriatic arthritis, rheumatoid arthritis, and spondyloarthropathies, p<.05 in all comparisons. Patients with RA, IBD, and Ps achieved 70% of the maximum score, while patients with PsA and SpAs did not reach 50% of the maximum possible score. Female gender, a state of moderate/severe disease severity, an older age, and a higher number of previous treatments were correlated with worse quality of life. Conversely, persistence to current treatment correlated with better quality of life. CONCLUSIONS: Patients with immune-mediated inflammatory diseases have markedly affected quality of life, mainly in the pain/discomfort dimension, especially in those immune-mediated inflammatory diseases with a rheumatological component.

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.

Recommendations for the management of yttrium-90 radioembolization in the treatment of patients with colorectal cancer liver metastases: a multidisciplinary review / Recomendaciones para el manejo de la radioembolización con itrio-90 en el tratamiento de pacientes con metástasis hepáticas de cáncer colorrectal: una revisión multidisciplinaria

Purpose: Strategies for the treatment of liver metastases from colon cancer (lmCRC) are constantly evolving. Radioembolization with yttrium 90 (Y-90 TARE) has made significant advancements in treating liver tumors and is now considered a potential option allowing for future resection. This study reviewed the scientific evidence and developed recommendations for using Y-90 TARE as a treatment strategy for patients with unresectable lmCRC. Methods: A multidisciplinary scientific committee, consisting of experts in medical oncology, hepatobiliary surgery, radiology, and nuclear medicine, all with extensive experience in treating patients with ImCRC with Y-90 TARE, led this project. The committee established the criteria for conducting a comprehensive literature review on Y-90 TARE in the treatment of lmCRC. The data extraction process involved addressing initial preliminary inquiries, which were consolidated into a final set of questions. Results: This review offers recommendations for treating patients with lmCRC using Y-90 TARE, addressing four areas covering ten common questions: 1) General issues (multidisciplinary tumor committee, indications for treatment, contraindications); 2) Previous process (predictive biomarkers for patient selection, preintervention tests, published evidence); 3) Procedure (standard procedure); and 4) Post-intervention follow-up (potential toxicity and its management, parameters for evaluation, quality of life). Conclusions: Based on the insights of the multidisciplinary committee, this document offers a comprehensive overview of the technical aspects involved in the management of Y-90 TARE. It synthesizes recommendations for applying Y-90 TARE across various phases of the treatment process.(AU)

Satisfacción y experiencia de pacientes en tratamiento con sustitutivos opioides en España. Estudio PREDEPO / Patients’satisfaction and experience in treatment with opioid substitution therapy in Spain. The PREDEPO study

El objetivo es comparar la satisfacción, experiencia, objetivos y opinión de los pacientes con trastorno por consumo de opioides (TCO) en base a su tratamiento sustitutivo de opioides (TSO) actual (metadona o buprenorfina/naloxona (B/N)). El estudio PREDEPO es un estudio observacional, transversal, multicéntrico desarrollado en España que incluyó pacientes adultos, diagnosticados de TCO y en TSO, quienes contestaron una encuesta sobre su tratamiento actual. Se incluyeron 98 pacientes (B/N:50%, metadona:50%): edad media de 47 ± 8 años y el 80% varones. A nivel de la satisfacción con su tratamiento, los resultados fueron similares entre grupos. El factor “muy/bastante satisfactorio” que se reportó con mayor frecuencia fue “poder repartir las dosis en varios momentos del día” (44% B/N vs. 63% metadona; p = ,122). Se encontraron diferencias significativas en “tener que recoger la medicación diariamente” donde una menor proporción en el grupo B/N contestaron “muy/bastante molesto” versus el grupo metadona (19% vs. 52%, p = ,032). Los objetivos reportados por la mayoría de los pacientes fueron similares entre grupos (“no sentir más síndrome de abstinencia”, “disminuir o dejar definitivamente mi consumo de drogas”, “mejorar mi estado de salud” y “dejar de pensar en consumir todos los días”) excepto en “no tener más problemas de dinero” (72% B/N vs. 92% metadona; p = ,012). Estos resultados evidencian que existen expectativas no cubiertas con los TSO actuales y la necesidad de nuevos tratamientos que disminuyan la carga de la enfermedad, eviten la necesidad de una dosificación diaria y reduzcan el estigma, mejorando así el manejo del paciente, su adherencia y calidad de vida. (AU)

The aim of this study was to compare patients’ satisfaction, experience, objectives, and opinion based on their current opioid substitution therapy (OST) (buprenorphine/naloxone (B/N) or methadone). The PREDEPO study is an observational, cross-sectional, multicentric study performed in Spain. Adult patients diagnosed with opioid use disorder (OUD) receiving OST were included. They were asked to fill in a questionnaire regarding their current OST. A total of 98 patients were enrolled (B/N: 50%, methadone: 50%). Mean age was 47 ± 8 years old and 80% were male. Treatment satisfaction was similar between groups. The most frequently reported factor for being “very/quite satisfied” was “being able to distribute the dose at different times throughout the day” (44% B/N vs. 63% methadone; p = .122). A significantly lower proportion of patients in the B/N group versus the methadone group reported that having to collect the medication daily was “very/quite annoying” (19% vs. 52%, p = .032). Treatment objectives reported by the majority of patients were similar between groups (“not feeling in withdrawal anymore”, “reduce/definitely stop drug use”, “improve my health”, and “stop thinking about using daily”) except for “not having money problems anymore” (73% B/N vs. 92% methadone; p = .012). These results suggest there are several unmet expectations regarding current OST. There is a need for new treatments that reduce the burden of OUD, avoid the need for daily dosing, and are less stigmatizing which in turn could improve patient management, adherence and, quality of life. (AU)

Impacto económico asociado a eventos obstétricos en mujeres en edad fértil con artritis psoriásica, artritis reumatoide, espondiloartritis axial y psoriasis en España / Economic Impact of Obstetric Events on Women of Reproductive Age Living With Psoriatic Arthritis, Rheumatoid Arthritis, Axial Spondyloarthritis and Psoriasis in Spain

Objetivo: Estimar el coste anual asociado a eventos obstétricos que pueden experimentar mujeres en edad fértil con enfermedades inflamatorias inmunomediadas, desde la perspectiva del Sistema Nacional de Salud. Métodos: Se desarrolló un análisis de costes para estimar el impacto anual por paciente asociado a eventos obstétricos en mujeres en edad reproductiva con artritis psoriásica (APs), artritis reumatoide (AR), espondiloartritis axial (EspAax) y psoriasis (PsO). Se consideraron eventos durante la fertilidad, la concepción, el embarazo y el posparto. Todos los parámetros fueron validados y consensuados por un panel multidisciplinar de expertos. Los costes unitarios (€, 2019) se obtuvieron de bases de datos nacionales. Resultados: Durante la fertilidad y concepción, se estimó un coste anual/paciente de 229€ para una consulta preconcepcional en pacientes con PsO, de 3.642€ en pacientes con APs, AR y EspAax y de 4.339€ para reproducción asistida. En el embarazo, el coste anual/paciente fue de 1.214€ para un aborto espontáneo en el 1.er trimestre, 4.419€ para un aborto tardío en el 2.o trimestre, 11.260€ para preeclampsia, 3.188€ para crecimiento intrauterino retardado y 12.131€ para amenaza de parto prematuro. En el posparto, se estimó un coste anual/paciente de 120.364, 44.709 y 5.507€ para prematuridad de<28, 28-32 y 33-37 semanas, respectivamente. Conclusiones: Este análisis facilita información sobre la carga económica de los eventos en mujeres en edad reproductiva con APs, AR, EspAax y PsO. Una adecuada planificación junto con la individualización del manejo, el tratamiento y la monitorización adicional pueden reducir el riesgo y la carga de estos eventos.(AU)

Objective: To estimate the annual cost associated with obstetric events in women of reproductive age with immune-mediated inflammatory diseases, from the perspective of the National Healthcare System. Methods: A cost-analysis was developed to estimate the impact associated with obstetric events in women of reproductive age with psoriasis (PSO), psoriatic arthritis (PsA), rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). The analysis considered complications during fertility and conception, in pregnancy and in the postpartum. All parameters were validated and agreed by a multidisciplinary expert panel. Unitary costs (€, 2019) were obtained from national, local databases. Results: During fertility and conception, an annual cost per patient of €229 was estimated for a preconception consultation in a patient with PSO, of €3,642 for a preconception consultation in patients with PsA, RA and axSpA and €4,339 for assisted reproduction. Women with complications in pregnancy had an annual cost per patient of €1,214 for a miscarriage in the first trimester, €4,419 for a late miscarriage in the second trimester, €11,260 for preeclampsia €3,188 for restricted intrauterine growth and €12,131 for threat of premature delivery. In the postpartum, an annual cost per patient of €120,364, €44,709, and €5,507 were estimated associated with admissions to neonatology of premature infants of <28, 28-32 and 33-37 weeks, respectively. Conclusions: This analysis provides insight on the economic burden of complications associated with women of reproductive age for immune-mediated diseases (PSO, PsA, RA, axSpA). Individualization of treatment, additional and close monitoring may reduce the risk and burden of these complications.(AU)

La experiencia del paciente en el cáncer de pulmón y de mama a través del recorrido del paciente / Patient-reported experience in lung and breast cancer through a patient journey

Objetivo: Analizar la experiencia aportada por los pacientes concáncer de mama y pulmón utilizando la metodología del recorrido delpaciente en un hospital español.Método: Se empleó un diseño mixto, con entrevistas a 16 profesionalessanitarios y 25 pacientes (método cualitativo), y un cuestionario basadoen el indicador Net Promoter Score a 127 pacientes (método cuantitativo). Criterios de inclusión: pacientes oncológicos > 18 años tratados enel hospital entre febrero y mayo de 2019. Criterios de exclusión: pacientes pediátricos, en cuidados paliativos o que estaban hospitalizados enel momento del estudio.Resultados: Se identificaron seis fases a partir de los datos obtenidos enel método cualitativo: mi vida antes del diagnóstico, descubrir, comenzar,tratamiento, seguimiento y mi vida hoy. En la fase mi vida antes del diagnóstico se estableció un nivel de experiencia funcional, ya que la vida cumplía las expectativas de los pacientes. En la fase de descubrir se observóque las expectativas de los pacientes se cumplían, aunque se encontraronvarias experiencias satélite. En la fase comenzar, la experiencia tendió aser negativa debido a los largos tiempos de espera y al estrés emocionaly físico. La fase de tratamiento se consideró como una experiencia de nivelbásico-deficiente, debido a los tiempos de espera y a la falta de apoyoinstitucional. La experiencia en la fase de seguimiento fue positiva respectoa las pruebas y las visitas, pero se observaron puntos críticos en los tiemposde espera. En la fase mi vida hoy se mencionó el esfuerzo realizado polos profesionales sanitarios para garantizar el mejor tratamiento y atención posibles. En cuanto al análisis cuantitativo, se obtuvo una puntuaciónpositiva (46%) para el indicador Net Promoter Score, ya que el 60% delos pacientes pertenecían a la categoría de promotores, es decir, estabansatisfechos con el servicio ofrecido por el hospital. (AU)

Objective: To analyse a patient journey based on the experience reported by breast and lung cancer patients at Spanish hospital.Method: A mixed design was used, with interviews with 16 health professionals and 25 patients (qualitative method) and a Net Promoter Scorequestionnaire to 127 patients (quantitative method). Inclusion criteria:oncology patients > 18 years treated in hospital between February- May2019. Exclusion criteria: paediatric patients, in palliative care or whowere hospitalised at the time of the study.Results: Six phases were identified from the data obtained in the qualitative method: my life before diagnosis; discovery; initiation; treatment; followup; and my current life. In the my life before diagnosis phase, a functionallevel of experience was established, as patients’ lives met their expectations.In the discovery phase, patients’ expectations were observed to be met,although several satellite experiences were found. In the initiation phase, theexperience tended to be negative due to long waiting times and emotionaland physical stress. The treatment phase was defined as a basic-poor experience, due to waiting times and lack of institutional support. The experiencein the follow-up phase was positive in terms of tests and visits, but criticalpoints were observed in waiting times. In the current phase, the effort madeby health professionals to ensure the best possible treatment and care wasmentioned. In terms of quantitative analysis, a positive score (46%) wasobtained for the Net Promoter Score indicator, as 60% of patients werepromoters, i.e. they were satisfied with the service offered by the hospital. (AU)

Estudio para la determinación de medidas de resultados en salud relevantes en el trastorno por consumo de opiáceos. Análisis de decisión multicriterio / Study to determine relevant health outcome measures in opioid use disorder: Multicriteria decision análisis

El objetivo fue establecer los resultados en salud con mayor relevancia en la evaluación de programas de tratamiento de sustitución de opiáceos (PTSO) en pacientes con trastorno por consumo de opiáceos (TCO) en España. Se realizó un análisis de decisión multicriterio con 3 fases: 1) definición de conceptos y criterios a evaluar; 2) cribado y ponderación de criterios mediante un experimento de elecciones discretas; 3) proceso deliberativo. Los criterios de la fase 1 fueron: consumo de sustancias (opiáceos, alcohol, tabaco, estimulantes y cannabis), trastornos mentales (trastorno afectivo ansioso, psicosis, trastorno por déficit de atención e hiperactividad, trastorno límite de personalidad, trastornos de personalidad antisocial, trastorno por juego y otras alteraciones del control de los impulsos), nivel de discapacidad, adherencia, enfermedades médicas (comorbilidades, conductas de riesgo, enfermedades infecciosas y de transmisión sexual), aspectos psicosociales (conducta hostil y/o violenta, presencia de problemas laborales), discapacidad funcional (calidad de vida, satisfacción con el tratamiento y servicio, funcionamiento social). En la fase 2 se determinaron los factores fundamentales en la elección de un PTSO, revisados en el proceso deliberativo: remisión del consumo de sustancias (opiáceos, alcohol y estimulantes), mejoría en el manejo de otros trastornos mentales (psicosis y trastorno límite de la personalidad), mejoría en manejo de comorbilidades médicas y mejoría en el funcionamiento social, con un peso del 56,5%, 21,9%, 11,0% 10,7% respectivamente. Este análisis define los resultados sanitarios más relevantes en PTSO en pacientes con TCO en España, favoreciendo la toma de decisiones y la gestión socio-sanitaria de los recursos existentes

The aim of the current study was to establish the most relevant health outcomes to assess opioid substitution treatment programmes (OSP) in patients with opioid use disorder (OUD) in Spain. A multicriteria decision analysis was applied in 3 phases: 1) concepts and criteria definitions; 2) criteria screening and weighting by means of a discrete choice experiment; 3) deliberative process. Criteria established in phase 1 were: substance use (opioids, alcohol, tobacco, stimulants and cannabis), other mental disorders (affective/anxiety disorder, psychosis, attention deficit hyperactivity disorder, borderline personality disorder, antisocial personality disorder, gambling disorder and other impulse control disorders), level of disability, adherence, medical illnesses (medical comorbidities, risk behaviours, infectious and sexually transmitted diseases), psychosocial aspects (hostile and/ or violent behaviour and work problems), functional disability (quality of life, treatment and service satisfaction, social functionality). In phase 2, the most relevant factors in OSP were determined, and subsequently assessed in the deliberative process: remission of substance use (opioids, alcohol and stimulants), improvement of other mental disorders (psychosis and borderline personality disorder), improvement in comorbidity management, and improvement in social functionality, with a weighting of 56.5%, 21.9%, 11.0%, and 10.7%, respectively. The current analysis defines the main health outcomes in OSP in patients with OUD in Spain, supporting decision making and socio-health management of existing resources

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

Análisis de decisión multicriterio en programas de tratamiento de sustitución de opiáceos en trastornos por consumo de opiáceos / Multicriteria decision analysis in opioid substitution treatment programs in opioid use disorders

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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)

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)

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)

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Coste-efectividad de una estrategia de cribado del virus de la hepatitis B para prevenir la reactivación en pacientes con neoplasia hematológica / Cost-effectiveness of a hepatitis B virus screening strategy to prevent reactivation in patients with hematologic neoplasms

Introducción: se analizó la efectividad de una estrategia de cribado de la infección por el virus de la hepatitis B (VHB) con consiguiente profilaxis en pacientes con neoplasia hematológica para evitar la reactivación del VHB. Material y métodos: se utilizó un árbol de decisión para comparar costes y eficacia (reactivaciones evitadas), en 18 meses, de una estrategia con cribado previo a quimioterapia con R-CHOP (rituximab, ciclofosfamida, doxorrubicina, vincristina y prednisona) versus una estrategia sin cribado. Los pacientes HBsAg+ (antígeno de superficie de la hepatitis B) y/o antiHBc+ (anticuerpos del núcleo de la hepatitis B) y ADN-VHB+ recibieron profilaxis antiviral con tenofovir disoproxil desde el inicio de la quimioterapia hasta un año después de su finalización. Los pacientes sin cribado recibieron tenofovir en caso de reactivación. Las probabilidades del modelo se obtuvieron de la literatura. El coste total (Euros, 2015) incluyó: profilaxis antiviral, R-CHOP, pruebas de cribado (HBsAg, antiHBc y ADN-VHB) y función hepática. El coste farmacológico se calculó con el precio de venta al laboratorio aplicando la deducción obligatoria. Resultados: en una cohorte hipotética de 1.000 pacientes, el cribado evitó 7,36 reactivaciones frente a la estrategia sin cribado (14,9 versus 22,3). El coste total/paciente (incluyendo 8.282 Euros de coste de R-CHOP) fue de 8.584 Euros para la estrategia con cribado y 8.449 Euros para la estrategia sin cribado. La relación coste-efectividad incremental del cribado versus la estrategia sin cribado fue de 18.376 Euros/reactivación evitada. Conclusión: el cribado de la infección por el VHB permite implementar una profilaxis antiviral en pacientes con alto riesgo de reactivación, disminuyendo la frecuencia de dichas reactivaciones en pacientes con neoplasias hematológicas en tratamiento quimioterapia, con un coste incremental aceptable (AU)

Introduction: The effectiveness of a screening strategy for the detection of a hepatitis B virus (HBV) infection followed by prophylaxis in order to prevent HBV reactivation was assessed in patients with hematologic neoplasms. Material and methods: A decision tree was developed to compare the cost and effectiveness (prevented reactivations) over an 18 month period of a screening strategy prior to chemotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) with a non-screening approach. HBsAg+ (hepatitis B surface antigen) and/or anti-HBc+ (antibodies to hepatitis B core antigen) and HBV-DNA+ patients received oral antiviral prophylaxis with tenofovir disoproxil (245 mg once daily) from chemotherapy baseline until one year after chemotherapy completion. Non-screened patients received tenofovir in case of a reactivation. Model probabilities were obtained from the literature. The total cost (Euros, 2015) included: antiviral prophylaxis, R-CHOP, screening tests (HBsAg, anti-HBc, HBV-DNA) and liver function tests. Drug therapy costs were estimated using ex-factory prices with mandatory deductions. The incremental cost-effectiveness ratio (ICER) was calculated in order to assess the cost-effectiveness of this intervention in terms of cost per reactivation averted versus no screening. Results: In a hypothetical cohort of 1,000 patients, screening prevented 7.36 reactivations when compared to the non-screening approach (14.9 versus 22.3). Total cost/patient (including Euros 8,282 for R-CHOP) was Euros 8,584 for the screening strategy and Euros 8,449 for the non-screening approach. The ICER for screening versus non-screening was Euros18,376/prevented reactivation. Conclusion: HBV screening followed by oral antiviral prophylaxis yielded more health benefits than non-screening, reducing HBV reactivation in patients with hematologic neoplasms on chemotherapy (AU)