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14. Los costes del ictus en España según su etiología. El protocolo del estudio CONOCES

Author

Mar, J., Álvarez-Sabín, J., Oliva, J., Becerra, V., Casado, M.Á., Yébenes, M., González-Rojas, N., Arenillas, J.F., Martínez-Zabaleta, M.T., Rebollo, M., Lago, A., Segura, T., Castillo, J., Gállego, J., Jiménez-Martínez, C., López-Gastón, J.I., Moniche, F., Casado-Naranjo, I., López-Fernández, J.C., González-Rodríguez, C., Escribano, B., and Masjuan, J.

Published
2013
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20. A multi-stakeholder multicriteria decision analysis for the reimbursement of orphan drugs (FinMHU-MCDA study)

Author

de Andrés-Nogales F., Cruz E., Calleja M.Á., Delgado O., Gorgas M.Q., Espín J., Mestre-Ferrándiz J., Palau F., Ancochea A., Arce R., Domínguez-Hernández R., Casado M.Á., Gómez Pajuelo P., Gorgas Torner M.Q., López Andrés A., López Rodríguez M., Marín Ballvé A., Martín Herranz M.I., Morell Baladrón A., Sánchez Martínez F.I., Antoñanzas F., Bonanad S., Caballero T., Cabasés J.M., Cruz J., García-Goñi M., Gil R., Pajuelo P.G., Torner M.Q.G., Andrés A.L., Rodríguez M.L., Ballvé A.M., Herranz M.I.M., Baladrón A.M., Mur C., Machado M.P., Martínez F.I.S., Santos A.R., Suárez M., Trillo J.L., the FinMHU-MCDA Group, Institut Català de la Salut, [de Andrés-Nogales F] Pharmacoeconomics & Outcomes Research Iberia (PORIB), 28224 Pozuelo de Alarcón, Spain. [Cruz E] Asociación Española de Medicamentos Biosimilares, Madrid, Spain. [Calleja MA] Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Delgado O] Servicio de Farmacia, Hospital Universitario Son Espases, Palma de Mallorca, Spain. [Gorgas MQ] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Espín J] Escuela Andaluza de Salud Pública, Granada, Spain. Instituto de Investigación Biosanitaria (IBS), Granada, Spain. CIBER de Epidemiología Y Salud Pública (CIBERESP), Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus, [de Andrés-Nogales,F, Domínguez-Hernández,R, Casado,MÁ] Pharmacoeconomics & Outcomes Research Iberia (PORIB), Pozuelo de Alarcón, Madrid, Spain. [Cruz,E] Asociación Española de Medicamentos Biosimilares, Madrid, Spain. [Calleja,MÁ] Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Delgado,O] Servicio de Farmacia, Hospital Universitario Son Espases, Palma de Mallorca, Spain. Servicio de Farmacia, Hospital Universitari Vall D’Hebron, Barcelona, Spain. [Espín,J] Escuela Andaluza de Salud Pública, Granada, Spain. [Espín,J] Instituto de Investigación Biosanitaria (IBS), Granada, Spain. [Espín,J] CIBER de Epidemiología Y Salud Pública (CIBERESP), Madrid, Spain. [Mestre-Ferrándiz,J] Consultor Económico Independiente, Madrid, Spain. [Mestre-Ferrándiz,J] Madrid, Spain. [Palau,F] Servicio de Medicina Genética y CIBERER, Hospital Universitari Sant Joan de Déu, Hospital Clínic y Universitat de Barcelona, Barcelona, Spain. [Ancochea,A] Federación Española de Enfermedades Raras (FEDER), Madrid, Spain. [Arce,R] Asociación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuérfanos (AELMHU), Barcelona, Spain., and This project was carried out with an unrestricted grant from AELMHU (Aso‑ciación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuér‑fanos). AELMHU was not involved in the design of the study and collection, analysis, and interpretation of data and writing the manuscript

Subjects
Orphan Drug Production, Cost-Benefit Analysis, España, Disease, Psychiatry and Psychology::Psychological Phenomena and Processes::Mental Processes::Thinking::Decision Making [Medical Subject Headings], Other subheadings::Other subheadings::/drug therapy [Other subheadings], fenómenos psicológicos::procesos mentales::pensamiento::toma de decisión [PSIQUIATRÍA Y PSICOLOGÍA], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, afecciones patológicas, signos y síntomas::procesos patológicos::atributos de la enfermedad::enfermedades raras [ENFERMEDADES], Medicine, Pharmacology (medical), 030212 general & internal medicine, Malalties rares - Tractament, Genetics (clinical), Reimbursement, Multinomial logistic regression, Técnicas de apoyo en la toma de decisiones, 030503 health policy & services, General Medicine, Multiple-criteria decision analysis, Rare diseases, tecnología, industria y agricultura::industria::industria fabril::industria farmacéutica::producción de medicamentos huérfanos [TECNOLOGÍA, INDUSTRIA Y AGRICULTURA], 0305 other medical science, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Decision Support Techniques [Medical Subject Headings], medicine.medical_specialty, Decision Making, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Psychological Phenomena::Mental Processes::Thinking::Decision Making [PSYCHIATRY AND PSYCHOLOGY], Medicaments orfes - Cost-eficàcia, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [Medical Subject Headings], Decision Support Techniques, Orphan drug, 03 medical and health sciences, Technology and Food and Beverages::Technology, Industry, and Agriculture::Industry::Drug Industry::Orphan Drug Production [Medical Subject Headings], Quality of life (healthcare), Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis [Medical Subject Headings], Rare Diseases, Orphan drugs, Humans, Humanities::Humanities::Philosophy::Life::Quality of Life [Medical Subject Headings], Technology, Industry, and Agriculture::Industry::Manufacturing Industry::Drug Industry::Orphan Drug Production [TECHNOLOGY, INDUSTRY, AND AGRICULTURE], Adverse effect, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], business.industry, Enfermedades raras, Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [DISEASES], Research, Multicriteria decision analysis, Medicamento huérfano, Mecanismo de reembolso, Spain, Family medicine, Economic evaluation, Quality of Life, business
Abstract

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 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.

Published
2021

25. PMU23 COST OF ILLNESS IN PATIENTS WITH PSORIASIS AND PSORIATIC ARTHRITIS DISEASE. COEPSO STUDY

Author

Llamas-Velasco, M.D.M., primary, Castañeda, S., additional, Sánchez-Pérez, J., additional, Vicente-Rabaneda, E.F., additional, Pardo, J., additional, Cabeza-Martínez, R., additional, Miranda Fontes, M., additional, Márquez, J., additional, Calvo-Alén, J., additional, Armesto, S., additional, Belinchón, I., additional, Gómez, A., additional, Miranda, M.D., additional, Martínez Pardo, S., additional, Merino, L., additional, Casado, M.Á., additional, Amaro, A., additional, Ordovás, M., additional, Yébenes, M., additional, and Casado, A., additional

Published
2019
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29. Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study

Author

Rodríguez, M., Pascasio, J.M., Fraga, E., Fuentes, J., Prieto, M., Sánchez-Antolín, G., Calleja, J.L., Molina, E., García-Buey, M.L., Blanco, M.Á., Salmerón, J., Bonet, M.L., Pons, J.A., González, J.M., Casado, M.Á., and Jorquera, F.

Subjects
virus diseases
Abstract

AIM To demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM. METHODS This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed. RESULTS Forty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (€4943 ± 1059 vs €5811 ± 1538, respectively, P < 0.001). CONCLUSION TDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.

Published
2018

45. Colaboradores

Author

Agrifoglio Rotaeche, Alexander, Aldabó Pallás, M.ª Teresa, Alonso Ovies, Ángela, Alted López, Emilio, Álvarez Fernández, Jesús Andrés, Amaya Villar, Rosario, Ansotegui Hernández, Aitor, Añón Elizalde, José Manuel, Arce Mendiburu, M.ª Antonia, Arias Martínez, Natividad, Arrascaeta Llanes, Abilio, Asensio Martín, M.ª José, Atutxa Bizkarguenaga, Lander, Ayuela Azcárate, José María, Azkárate Ayerdi, Begoña, Belda Hofheinz, Silvia, Bermejo Aznárez, Susana, Blanco Varela, Jesús, Blesa Malpica, Antonio Luis, Bordejé Laguna, M.ª Luisa, Bustelo Bueno, Pedro, Caballero Beltrán, José, Cabarcos Grávalos, Edurne, Cabré Pericas, Lluís, Cachafeiro Fuciños, Lucía, Calvo Herranz, Enrique, Cambronero Galache, José Andrés, Carbajal Guerrero, Jesús, Carvalho, Sulamita, Carrasco Gómez, Genís, Carreño Ponfil, Romina, Casado Flórez, Isabel, Casanueva Mateos, Lidia, Castaño Ávila, Sergio, Castillo Quintero, Manuel, Catalán González, Mercedes, Chico Fernández, Mario, Civantos Martín, Belén, Corchero Rodríguez, Eduardo, Corcía Palomo, Yael, Córcoles González, Virgilio, Corral Ansa, Luisa, Corral Torres, Ervigio, Custodio Sheen, Carlos Alberto, de Berrazueta Sánchez de Vega, Ana, de la Cerda Sainz de los Terreros, Gonzalo, Díaz Díaz, Juan José, Díaz Martín, Ana, Domínguez Roldán, José M.ª, Enamorado Enamorado, Judy, Escudero Augusto, Dolores, Paz Escuela Gericó, M.ª, Estébanez Montiel, Belén, Fernández Campos, María José, Fernández Ortega, Juan Francisco, Ferrándiz Millón, Carmen, Ferrándiz Sellés, Amparo, Figueira Iglesias, Juan Carlos, Flores Cabeza, Eva, Fontenla Cerezuela, Adolfo, Galeas López, Juan L., Galván Guijo, Beatriz, García Alfaro, Claudio, García de Lorenzo, Abelardo, Mateos, García Fuentes, Carlos, García Garmendia, José Luis, García Gigorro, Renata, García Hernández, Ricardo, García Urra, Francisco, García-Cosío Carmena, M.ª Dolores, Garijo Catalina, M.ª Ángeles, Garnacho Montero, José, Gómez Tello, Vicente, González Fernández, Camilo, González Gómez, Nagore, Gordo Vidal, Federico, Grau Carmona, Teodoro, Grill Díaz, Fabio, Guallar Espallargas, Camino, Güell Quintilla, Estel, Guerrero Pabón, Rafael, Gutiérrez Rodríguez, Julián, Hernández Bernal, Mónica, Hernández Caballero, Clara, Herrán Monge, Rubén, Herrera Carranza, Manuel, Concepción Herrera Melero, María, Herrero de Lucas, Eva, Herrero Meseguer, José Ignacio, Herruzo Avilés, Ángel, Hinojosa Pérez, Rafael, Huertas Alcázar, Pedro A., Igeño Cano, José Carlos, Jiménez Conde, Carlos, Jiménez Jiménez, Francisco Javier, Jiménez Urra, Isabel, Jiménez Vilches, Pedro Luis, Lázaro Martín, Noelia, Leal Noval, Santiago Ramón, León Vallés, Miguel, Llompart Pou, Juan Antonio, Llorente de la Fuente, Ana, López Díaz, Julia, Luque Lezcano, Oskar, Maestre Romero, Antonio, Manzanares Castro, William, Manzanares Gómez, Jesús Javier, Manzano Ramírez, Alberto, Marco Garde, Pilar, Marín Mateos, Helena, Márquez Vacaro, Juan Antonio, Marruecos Sant, Lluís, Marsé Milla, Pedro, Martín Asenjo, Roberto, Martín Bermúdez, Rafael, Martín Iglesias, Lorena, Martín Villén, Luis, Martínez Fernández, Carmen Eulalia, Martínez García, Pilar, Mateu Campos, María Lidón, Maynar Moliner, Javier, Millán Estañ, Pablo, Miñambres García, Eduardo, Molina Latorre, Ricard, Montejo González, Juan Carlos, Mora López, Diego, Morán Chorro, Indalecio, Morán García, Vicente, Moreno Gómez, José Luis, Morrondo Valdeolmillos, Pedro, Núñez Ruiz, Rafael, Olaechea Astigarraga, Pedro M.ª, Olmedilla Jódar, Marta, Oñoro Cañaveral, Juan José, Ortiz Leyba, Carlos, Ortiz Moyano, Carlos, Palacios Cuesta, Alba, Palomar Martínez, Mercedes, Parra Fuertes, Juan José, Peláez Fernández, Jesús, Pena de la Rosa, Maria, Perales Ferreira, Eva, Pérez Bernal, José Benito, Pérez Calvo, César, Pérez Vela, José Luis, Porras López, Manuel, Porres Aracama, José Manuel, Pozuelo Echegaray, I., Puerto García Martín, Elena, Puppo Moreno, Antonio Manuel, Quintana Díaz, Manuel, Ramos Casado, M.ª Victoria, Ramos Castro, José, Recuerda Núñez, María, Renes Carreño, Emilio, Rodríguez Carvajal, Manuel, Ruiz de Azúa López, Zaida, Ruiz Santana, Sergio, Sáez de la Fuente, Ignacio, Salguero Bodes, Rafael, Sánchez Álvarez, Carmen, Sánchez Díaz, Juan Ignacio, Sánchez Iniesta, Rafael, Sánchez Román, José Antonio, Sánchez Sánchez, Santos Manuel, Sánchez-Izquierdo Riera, José Ángel, Sancho Fernández, Helena, Serna Grande, Pablo, Serrano Hernández, Nicolás, Sirvent Calvera, José M.ª, Soriano Cuesta, Cruz, Suárez Álvarez, José Rafael, Terceros Almanza, Luis Juan, Tirapu León, Juan Pedro, Toboso Casado, José M.ª, Toral Vázquez, Darío, Torres Delgado, Eva, Valenzuela Sánchez, Francisco, Vallverdú Vidal, Montserrat, Vaquerizo Alonso, Clara Isabel, Vaquero Crespo, Concepción, Yébenes Reyes, Juan Carlos, Yus Teruel, Santiago, Zabarte Martínez de Aguirre, Mercedes, and Zubia Olaskoaga, Félix

Published
2017
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49. The costs of stroke in Spain by aetiology: The CONOCES study protocol

Author

Mar, J., primary, Álvarez-Sabín, J., additional, Oliva, J., additional, Becerra, V., additional, Casado, M.Á., additional, Yébenes, M., additional, González-Rojas, N., additional, Arenillas, J.F., additional, Martínez-Zabaleta, M.T., additional, Rebollo, M., additional, Lago, A., additional, Segura, T., additional, Castillo, J., additional, Gállego, J., additional, Jiménez-Martínez, C., additional, López-Gastón, J.I., additional, Moniche, F., additional, Casado-Naranjo, I., additional, López-Fernández, J.C., additional, González-Rodríguez, C., additional, Escribano, B., additional, and Masjuan, J., additional

Published
2013
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