Checklist for clinical applicability of subgroup analysis.

WHAT IS KNOWN AND OBJECTIVE: Subgroup analysis plays an important role in clinical decision-making. Correct management of subgroup analysis is necessary to optimize effectiveness, safety and efficiency of treatments. No homogeneous criteria have been developed for interpretation of subgroup analysis. In this study, the researcher develops a checklist to evaluate the reliability and applicability of the results of subset analyses. METHODS: With a review of previous literature, three main criteria were included in the checklist: statistical association, biological plausibility and consistency among studies. Statistical association considered interaction probability, prespecification of analysis, number of subgroups analysed, sample size and positive/negative result in global analysis. Each item was given an indicative score. Total score was related to a level of applicability for the results in clinical practice. Checklist validation included interinvestigator concordance and assessment about utility. Three drug examples were used to validate the tool. RESULTS AND DISCUSSION: Twenty-six evaluators showed adequate interinvestigator concordance (kappa 0.79, 1 and 0.83 for each drug example regarding applicability). Kappa values increased to 0.94, 1 and 1 after group discussion. Checklist utility score was greater than 4.7/5 in three drug examples. In pre-analysis, inter-researcher agreement on global applicability recommendation of subgroup results to practice was 92.3% (ramucirumab), 96% (nivolumab) and 100% (mepolizumab). In post-analysis, inter-researcher agreement on applicability recommendation of subgroup results was 100%, 94.45% and 100%, respectively. The checklist validation shows a high interindividual agreement of the results, both with respect to the evaluation of the applicability of subgroup analysis and concerning clinical decision-making. WHAT IS NEW AND CONCLUSION: We have developed the first validated tool for interpretation of subgroup analyses. The checklist contributes to the adoption of homogeneous criteria for subgroup analyses, thereby allowing discussion and evaluation of the effects of a health intervention.

Systematic literature review of the methodology for developing pharmacotherapeutic interchange guidelines and their implementation in hospitals and ambulatory care settings.

PURPOSE: To summarize literature specific to therapeutic interchange (TI) focusing on methodological approaches in order to develop a list of steps that healthcare facilities can consult when developing pharmacotherapeutic interchange guidelines (PTIGs) in hospitals and primary care centers. METHODS: A search was conducted in PreMEDLINE, Medline, EMBASE, PsycINFO, and the Cochrane Library up to and including December 2015. PRISMA guidelines were used. The inclusion criteria were articles published on TI: methodology, implementation, guidelines, and position statements of scientific societies. Two authors independently reviewed all articles for eligibility and extracted the data. RESULTS: A total of 102 articles were selected for full-text review; we included three guidelines on how to effect TI, nine position papers of various scientific societies with regard to TI, two articles dealt exclusively about methodology, three articles consisted of recommendations and perspectives on TI, three articles dealt with legal aspects, four articles examined general implementation procedures, two articles were a post-discharge follow-up of patients who had TI, six were surveys referring to TI, and three were articles on the use of TI in ambulatory care The remaining 67 articles focused on therapeutic groups. Study quality was generally low. CONCLUSIONS: This review identified articles on TI as published guidelines, recommendations, and studies on TI carried out in hospital settings. As a result, eight fundamental steps were established for obtaining adequate results in the development of TI programs.

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines / Documento de posicionamiento de la Sociedad Española de Farmacia Hospitalaria sobre los medicamentos biosimilares

Biological medicines nowadays have a great impact, as they offer treatment for diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original biotechnological medicine, whose patent has expired, and they comply with the guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars’ authorization is carried out through a centralized procedure based on clinical, non-clinical and quality studies. These studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the interchangeability criteria in each center. Biosimilar drugs contribute to sustainability and to improvement of the accessibility to medicines. Faced with this situation, Spanish Society of Hospital Pharmacy considers interesting to express its position about biosimilar medicines’ strategies. Spanish Society of Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality, safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy and Therapeutic Committee of hospitals, where their knowledge for the selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals

Los medicamentos biológicos actualmente presentan un gran impacto, ya que ofrecen tratamiento para diversas enfermedades y suponen un elevado coste para el sistema sanitario. Los medicamentos biosimilares contienen una versión de una sustancia activa ya autorizada como medicamento biotecnológico original, cuya patente ha caducado, y cumplen con las guías publicadas por la European Medicines Agency, que establecen los criterios de biosimilitud para garantizar la comparabilidad entre el producto biosimilar y el de referencia. La autorización de los biosimilares se realiza mediante un procedimiento centralizado, a través de estudios comparativos clínicos, no-clínicos y de calidad, que permiten la extrapolación de indicaciones, frecuentemente sin realizar estudios adicionales. Algunos países europeos consideran seguro el intercambio entre medicamento original y biosimilar. En España, las Comisiones de Farmacia y Terapéutica hospitalarias, como órganos de consenso entre profesionales sanitarios, se consideran las más adecuadas para establecer los criterios de intercambiabilidad en cada centro. Los biosimilares contribuyen a la sostenibilidad y a la accesibilidad a los medicamentos. Ante esta situación, la Sociedad Española de Farmacia Hospitalaria considera de interés expresar su posicionamiento sobre las estrategias relacionadas con los medicamentos biosimilares. La Sociedad Española de Farmacia Hospitalaria, en septiembre de 2015, publicó una nota informativa sobre los medicamentos biosimilares, en la que destacó su similitud en calidad, seguridad y eficacia respecto a los originales, pero con menor coste. Igualmente, se recalcó el papel del farmacéutico hospitalario en las Comisiones de Farmacia y Terapéutica hospitalarias, donde sus conocimientos son útiles para la selección, evaluación y empleo de los medicamentos, en coordinación y colaboración permanente con los demás servicios clínicos del hospital

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines.

Biological medicines nowadays have a great impact, as they offer treatment for  diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original  biotechnological medicine, whose patent has expired, and they comply with the  guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars' authorization is carried out through a  centralized procedure based on clinical, non-clinical and quality studies. These  studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between  original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the  interchangeability criteria in each center. Biosimilar drugs contribute to  sustainability and to improvement of the accessibility to medicines. Faced with  this situation, Spanish Society of Hospital Pharmacy considers interesting to  express its position about biosimilar medicines' strategies. Spanish Society of  Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality,  safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy  and Therapeutic Committee of hospitals, where their knowledge for the  selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals.

Los medicamentos biológicos actualmente presentan un gran impacto, ya que ofrecen tratamiento para diversas enfermedades y suponen un elevado  coste para el sistema sanitario. Los medicamentos biosimilares contienen una  versión de una sustancia activa ya autorizada como medicamento biotecnológico original, cuya patente ha caducado, y cumplen con las guías publicadas por la European Medicines Agency, que establecen los criterios de biosimilitud para garantizar la comparabilidad entre el producto biosimilar y el de referencia.  La autorización de los biosimilares se realiza mediante un procedimiento  centralizado, a través de estudios comparativos clínicos, no-clínicos y de calidad, que permiten la extrapolación de indicaciones, frecuentemente sin realizar  estudios adicionales. Algunos países europeos consideran seguro el intercambio  entre medicamento original y biosimilar. En España, las Comisiones de Farmacia y Terapéutica hospitalarias, como órganos de consenso entre  profesionales sanitarios, se consideran las más adecuadas para establecer los  criterios de intercambiabilidad en cada centro. Los biosimilares contribuyen a la  sostenibilidad y a la accesibilidad a los medicamentos. Ante esta situación, la  Sociedad Española de Farmacia Hospitalaria considera de interés expresar su  posicionamiento sobre las estrategias relacionadas con los medicamentos  biosimilares. La Sociedad Española de Farmacia Hospitalaria, en septiembre de  2015, publicó una nota informativa sobre los medicamentos biosimilares, en la  que destacó su similitud en calidad, seguridad y eficacia respecto a los  originales, pero con menor coste. Igualmente, se recalcó el papel del  farmacéutico hospitalario en las Comisiones de Farmacia y Terapéutica  hospitalarias, donde sus conocimientos son útiles para la selección, evaluación y  empleo de los medicamentos, en coordinación y colaboración permanente con  los demás servicios clínicos del hospital.

Revisión crítica de la oritavancina en infecciones de la piel y tejidos blandos / Review of oritavancin for the treatment of acute bacterial skin and skin structure infections

Objetivo: Evaluar críticamente la oritavancina, lipoglicopéptido de segunda generación, para el tratamiento de la infección bacteriana aguda de la piel y tejidos blandos causada por bacterias Gram-positivas susceptibles, incluyendo Staphylococcus aureus resistente a meticilina. Método: Se realizó un informe de evaluación según la metodología del Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos de la Sociedad Española de Farmacia Hospitalaria, con el programa MADRE 4.0. Se llevó a cabo una búsqueda en PubMed, en www.clinicaltrials.gov, Embase y UptoDate. También se utilizaron informes publicados de agencias de evaluación. Resultados: La oritavancina en dosis única demostró no ser inferior a la vancomicina en Infección bacteriana aguda de la piel y tejidos blandos, con un perfil de seguridad similar. Sus ventajas potenciales frente a otras alternativas terapéuticas radicarían en su administración en dosis única y en la no necesidad de monitorización de los niveles plasmáticos (lo que posibilitaría su administración ambulatoria), y en la mejora de la adherencia. Aunque podría ser eficiente en determinados escenarios (tratamiento ambulatorio frente al hospitalario con las alternativas), no hay estudios convincentes en este sentido. Por otra parte, los fármacos alternativos por vía oral (linezolid, tedizolid) o IM (teicoplanina) pueden permitir también el tratamiento ambulatorio, reduciendo las ventajas de la oritavancina y agrandando las diferencias de coste. Dado que su eficacia es similar a las alternativas, cabría considerar un análisis de minimización de costes. Conclusiones: La oritavancina es de una eficacia y seguridad comparables a las alternativas existentes en Infección bacteriana aguda de la piel y tejidos blandos y no mejora la relación coste-efectividad, por lo que el posicionamiento propuesto sería el tratamiento de la infección por enterococo resistente a vancomicina en pacientes adultos cuando esté contraindicado el uso de linezolid o tedizolid (AU)

Objective: To assess critically oritavancin, a second-generation lipoglycopeptide, for the treatment of Acute Bacterial Skin and Skin Structure Infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. Method: An evaluation report of oritavancin in Acute Bacterial Skin and Skin Structure Infections was carried out according to the methodology of the Group for drug evaluation, standardization and research in drug selection of the Spanish Society of Hospital Pharmacy (SEFH)1 , with the MADRE 4.0 program. A search was made in PubMed, in the web www.clinicaltrials. gov, Embase, PubMed and UptoDate. The European Medication Agency and Food and Drug Administration evaluation reports were also used. Results: Single-dose oritavancin demonstrated its non-inferiority efficacy versus vancomycin in Acute Bacterial Skin and Skin Structure Infections, with a similar safety profile. Its potential advantage over other therapeutic alternatives lies in its administration in single dose and in its no need for plasma levels monitoring, which would allow its administration on an outpatient basis. Regarding to the other alternative possibilities of oral (linezolid, tedizolid) or IM (teicoplanin) treatment, oritavancin would improve the adherence to the treatment. Although oritavancin could be more efficient in certain scenarios (outpatient treatment versus inpatient treatment with alternatives), there are no convincing studies in this regard so far. On the other hand, alternative drugs above-mentioned, can also allow outpatient treatment, reducing advantages of oritavancin and further increasing cost differences. Therefore, given that the efficacy is similar to the alternatives, a cost minimization analysis could be considered. Conclusions: Oritavancin is comparable in terms of efficacy and safety to the existing alternatives in Acute Bacterial Skin and Skin Structure Infections, without improvements in the cost-effectiveness ratio, because of the proposed positioning is to consider it for the treatment of vancomycin resistant enterococcal infection in adult patients when the use of linezolid or tedizolid is contraindicated (AU)

Review of oritavancin for the treatment of acute bacterial skin and skin structure infections.

OBJECTIVE: To assess critically oritavancin, a second-generation  lipoglycopeptide, for the treatment of Acute Bacterial Skin and Skin Structure Infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. METHOD: An evaluation report of oritavancin in Acute Bacterial Skin and Skin  Structure Infections was carried out according to the methodology of the Group  for drug evaluation, standardization and research in drug selection of the  Spanish Society of Hospital Pharmacy (SEFH)1, with the MADRE 4.0 program. A  search was made in PubMed, in the web www.clinicaltrials. gov, Embase,  PubMed and UptoDate. The European Medication Agency and Food and Drug  Administration evaluation reports were also used. RESULTS: Single-dose oritavancin demonstrated its non-inferiority efficacy versus  vancomycin in Acute Bacterial Skin and Skin Structure  nfections, with a similar safety profile. Its potential advantage over other  therapeutic alternatives lies in its administration in single dose and in its no need for plasma levels monitoring, which would allow its administration on an outpatient basis. Regarding to the other alternative possibilities of oral  (linezolid, tedizolid) or IM (teicoplanin) treatment, oritavancin would improve the  adherence to the treatment. Although oritavancin could be more  efficient in certain scenarios (outpatient treatment versus inpatient treatment  with alternatives), there are no convincing studies in this regard so far. On the  other hand, alternative drugs above-mentioned, can also allow outpatient  treatment, reducing advantages of oritavancin and further increasing cost  differences. Therefore, given that the efficacy is similar to the alternatives, a  cost minimization analysis could be considered. CONCLUSIONS: Oritavancin is comparable in terms of efficacy and safety to the  existing alternatives in Acute Bacterial Skin and Skin Structure Infections,  without improvements in the cost-effectiveness ratio, because of the proposed  positioning is to consider it for the treatment of  vancomycinresistant enterococcal infection in adult patients when the use of  linezolid or tedizolid is contraindicated.

Objetivo: Evaluar críticamente la oritavancina, lipoglicopéptido de segunda generación, para el tratamiento de la infección bacteriana aguda de la  piel y tejidos blandos causada por bacterias Gram-positivas susceptibles,  incluyendo Staphylococcus aureus resistente a meticilina.Método: Se realizó un informe de evaluación según la metodología del Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de  Medicamentos de la Sociedad Española de Farmacia Hospitalaria, con el  programa MADRE 4.0. Se llevó a cabo una búsqueda en PubMed, en  www.clinicaltrials.gov, Embase y UptoDate. También se utilizaron informes  publicados de agencias de evaluación.Resultados: La oritavancina en dosis única demostró no ser inferior a la vancomicina en Infección bacteriana aguda de la piel y tejidos blandos, con un perfil de seguridad similar. Sus ventajas potenciales frente a otras alternativas  terapéuticas radicarían en su administración en dosis única y en la no necesidad  de monitorización de los niveles plasmáticos (lo que posibilitaría su  administración ambulatoria), y en la mejora de la adherencia. Aunque podría ser  eficiente en determinados escenarios (tratamiento ambulatorio frente al  hospitalario con las alternativas), no hay estudios convincentes en este sentido.  Por otra parte, los fármacos alternativos por vía oral (linezolid, tedizolid) o IM  (teicoplanina) pueden permitir también el tratamiento ambulatorio, reduciendo  las ventajas de la oritavancina y agrandando las diferencias de coste. Dado que  su eficacia es similar a las alternativas, cabría considerar un análisis de  minimización de costes.Conclusiones: La oritavancina es de una eficacia y seguridad comparables a las alternativas existentes en Infección bacteriana aguda de la piel y tejidos blandos y no mejora la relación coste-efectividad, por lo que el posicionamiento  propuesto sería el tratamiento de la infección por enterococo resistente a  vancomicina en pacientes adultos cuando esté contraindicado el uso de linezolid  o tedizolid.

Recommendations for the treatment of hepatitis C virus infection in chronic kidney disease: a position statement by the Spanish association of the liver and the kidney.

Hepatitis C virus (HCV) infection is one of the main causes of liver cirrhosis worldwide. The long-term impact of HCV infection is highly variable, ranging from minimal histological changes to extensive fibrosis with hepatocellular carcinoma. The development of HCV drugs has increased dramatically in recent years, even in special populations such as chronic kidney disease patients. Classical treatment of chronic hepatitis C was based on the administration of interferon and ribavirin for 24-48 weeks, which was associated with a poor viral response and a high rate of side effects, especially in patients with a lower estimated glomerular filtration rate. The current high availability of the new direct-acting antivirals renders the classification of these agents for this special population necessary. The Spanish Association of the Liver and the Kidney has produced a position statement on the treatment of HCV infection in chronic kidney disease patients since the evidence to guide this treatment is scant and what evidence does exist is weak. The recommendations are based on the results of clinical trials and controlled studies conducted to date, with data published hitherto by the authors of these studies. Since the indications for treatment have been evaluated by other societies or are dependent on internal clinical protocols, the main goal of this position statement is to assist in decision-making when choosing a therapeutic option.

[Off-label use of oncology drugs: national survey results]. / Uso de medicamentos fuera de ficha la técnica en oncohematología: resultado de una encuesta nacional.

PURPOSE: identify by means of a survey the off-label treatments more often used in the oncohaematology area, as well as to know the established procedures and criteria used to authorise those treatments. METHODS: a four-section survey was designed: 1) demographic data and hospital activity, 2) Off-label treatments protocol, 3) Approval criteria and 4) Off-label oncology treatments conducted during the last year. RESULTS: in 42.1% of the hospitals it's needed an authorisation before dispensing in more tan 80% of the treatments. The most influential factor in the approval-dispensation system is the available evidence. The consent of the hospital management with previous Pharmacy department's report was the most common authorisation procedure. 55.3% of the hospitals settled specific patient criteria to help the decision-making altogether with the available safety and efficacy data of the drug for the requested indication. In most centers a lower level of evidence is accepted if there are no therapeutic alternatives as well as in tumors of low prevalence. Most of the centers have not clearly established a criterion of effectiveness to consider a benefit as clinically relevant, nor the cost-effectiveness threshold for approving a FFT. CONCLUSIONS: there is a great variability in the off-label treatments use and also in the criteria used for its approval.

Objetivo: identificar mediante una encuesta los tratamientos fuera de la ficha tecnica (FFT) que mas frecuentemente se utilizan en el area de oncohematologia. Conocer los procedimientos y criterios que se han establecido para autorizar estos tratamientos. Método: se diseno una encuesta con cuatro secciones: 1) datos demograficos y de actividad del hospital, 2) procedimiento de utilizacion de medicamentos FFT, 3) criterios de aprobacion y 4) tratamientos oncologicos FFT tramitados durante el ano anterior. Resultados: en el 42,1% de los centros la proporcion en la que es necesaria autorizacion previa a la dispensacion es mayor del 80%. El factor mas importante que influye en el circuito de autorizacion-dispensacion de estos farmacos es la evidencia disponible. El procedimiento de autorizacion mas habitual es la autorizacion de la direccion del hospital previo informe del servicio de farmacia. En un 55,3% de los hospitales se han establecido criterios especificos del paciente que ayudan a la toma de decisiones, junto con los aspectos de eficacia y seguridad de los farmacos en la indicacion solicitada. En la mayoria de los centros se acepta un menor nivel de evidencia en el caso de que no existan alternativas terapeuticas, asi como en los tumores de baja prevalencia. La mayor parte de los centros no tienen claramente establecido un criterio de eficacia para considerar un beneficio como clinicamente relevante, y tampoco el umbral coste-eficacia para aprobar un FFT. Conclusiones: existe una gran variabilidad en el procedimiento de utilizacion de los FFT y en los criterios que se utilizan para su aprobacion.

Uso de medicamentos fuera de ficha la técnica en oncohematología: resultado de una encuesta nacional / Off-label use of oncology drugs: national survey results

Objetivo: identificar mediante una encuesta los tratamientos fuera de la ficha técnica (FFT) que más frecuentemente se utilizan en el área de oncohematología. Conocer los procedimientos y criterios que se han establecido para autorizar estos tratamientos. Método: se diseñó una encuesta con cuatro secciones: 1) datos demográficos y de actividad del hospital, 2) procedimiento de utilización de medicamentos FFT, 3) criterios de aprobación y 4) tratamientos oncológicos FFT tramitados durante el año anterior. Resultados: en el 42,1% de los centros la proporción en la que es necesaria autorización previa a la dispensación es mayor del 80%. El factor más importante que influye en el circuito de autorización-dispensación de estos fármacos es la evidencia disponible. El procedimiento de autorización más habitual es la autorización de la dirección del hospital previo informe del servicio de farmacia. En un 55,3% de los hospitales se han establecido criterios específicos del paciente que ayudan a la toma de decisiones, junto con los aspectos de eficacia y seguridad de los fármacos en la indicación solicitada. En la mayoría de los centros se acepta un menor nivel de evidencia en el caso de que no existan alternativas terapéuticas, así como en los tumores de baja prevalencia. La mayor parte de los centros no tienen claramente establecido un criterio de eficacia para considerar un beneficio como clínicamente relevante, y tampoco el umbral coste-eficacia para aprobar un FFT. Conclusiones: existe una gran variabilidad en el procedimiento de utilización de los FFT y en los criterios que se utilizan para su aprobación (AU)

Purpose: identify by means of a survey the off-label treatments more often used in the oncohaematology area, as well as to know the established procedures and criteria used to authorise those treatments. Methods: a four-section survey was designed: 1) demographic data and hospital activity, 2) Off-label treatments protocol, 3) Approval criteria and 4) Off-label oncology treatments conducted during the last year. Results: in 42.1% of the hospitals it’s needed an authorisation before dispensing in more tan 80% of the treatments. The most influential factor in the approval-dispensation system is the available evidence. The consent of the hospital management with previous Pharmacy department’s report was the most common authorisation procedure. 55.3% of the hospitals settled specific patient criteria to help the decision-making altogether with the available safety and efficacy data of the drug for the requested indication. In most centers a lower level of evidence is accepted if there are no therapeutic alternatives as well as in tumors of low prevalence. Most of the centers have not clearly established a criterion of effectiveness to consider a benefit as clinically relevant, nor the cost-effectiveness threshold for approving a FFT. Conclusions: there is a great variability in the off-label treatments use and also in the criteria used for its approval (AU)

Differences in cancer drug assessment between Spain and the United Kingdom.

OBJECTIVES: There is no Spanish Government agency resembling the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK) that carries out a centralised evaluation and makes decisions about funding. Therefore, we aim to assess the differences between NICE and the Spanish bodies in terms of their respective processes. We compare the decisions concerning cancer drugs in the assessments made by NICE/Single Technology Appraisal with assessments made by MADRE methodology. METHODS: We included all cancer drugs assessed by NICE and all MADRE reports made using a shared reports process (GENESIS) and reports from Catalonia (CAMDHA) and Andalucía (GFTHA). We compared the number of drugs assessed, the decisions taken by NICE and Spanish organizations and timelines. RESULTS: Between January 2011 and December 2013 NICE appraised 24 cancer drugs. In Spain, 44 reports were produced using MADRE methodology. For the 14 drugs assessed by both NICE and Spanish bodies, NICE rejected a high proportion of the drugs (50% versus 26%). GENESIS, with a median of 8 months, made decisions more quickly than NICE (13.5 months) and GFTHA (17 months). The slowest organisation was CAMDHA (24.5 months). CONCLUSIONS: More drugs are assessed in Spain than by NICE because there are more organisations in Spain doing this work and their processes are simpler. NICE rejects more drugs as it uses cost-effectiveness thresholds that lead to a 'not-recommended' decision, and Spanish bodies recommend cancer drugs for subgroups of patients where better results can be obtained. Timelines are better for Spanish Committees, probably because of the greater number of steps in the appraisal process by NICE.