Agencia Espanola de Medicamentos y Productos Sanitarios

Madrid, Spain

Agencia Espanola de Medicamentos y Productos Sanitarios

Madrid, Spain
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Agency: European Commission | Branch: FP7 | Program: CP-CSA-Infra | Phase: INFRA-2007-2.2-01 | Award Amount: 8.06M | Year: 2008

European clinical research needs an integrated and distributed infrastructure able to provide efficient support to multinational clinical trials, taking advantage of the European population and competencies, unlocking latent expertise and patients scattered across the EU member states. ECRIN (European Clinical Research Infrastructures Network) is designed to bridge the fragmentation of clinical research in Europe through the connection of national networks of clinical research centres and clinical trial units. Participants are currently Austria, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, Switzerland, the United Kingdom, and the EORTC. It will provide integrated, one-stop shop services to investigators and sponsors in multinational studies (patient recruitment and investigation, data management, GMP manufacturing of biotherapy products, quality assurance, monitoring, ethics, regulatory affairs and adverse event reporting). With this objective, the preparation phase will consist of - WP2: selection of a legal status and of the governance structure - WP3: agreement on a financial plan leading to a long-term sustainability during the construction step and the operation phase - WP4: survey on needs in terms of GMP facilities for biopharmaceuticals and biotherapy, and their design. - WP5: education programme for multinational clinical studies - WP6: extension to other EU member states - WP7: capacity building to help national networks fulfil the sponsors tasks - WP8: update and upgrade of the quality assurance system - WP9: internal and external communication - WP10: accreditation of data centres - WP11: support to pilot projects Users will be investigators and sponsors in the academic and SME sector. Participants will be the national coordination of clinical research infrastructures, and national ministries and funding agencies in order to reach an agreement ensuring the long-term sustainability of the infrastructure.

Miguel R.S.,Complejo Hospitalario Of Navarra | Gimeno-Ballester V.,Hospital Universitario Miguel Servet | Blazquez A.,Agencia Espanola de Medicamentos y Productos Sanitarios | Mar J.,Hospital Alto Deba
Gut | Year: 2015

Background A new scenario of therapy for chronic hepatitis C (CHC) is being established with the approval of sofosbuvir (SOF). Objective To estimate the cost-effectiveness of SOF-based regimens approved in the Summary of Product Characteristics (SmPC) versus the standard of care for different genotypes and patient populations (naive or pretreated). Methods A Markov model simulating CHC progression was used to estimate disease treatment costs and effects over patients' lifetimes, from the Spanish National Public Healthcare System perspective. Different therapeutic options were analysed for genotypes 1, 2 and 3 in naive population and for genotype 2 and 3 pretreated patients, according to data obtained from clinical trials. A one-way sensitivity analysis was performed to evaluate the uncertainty of certain parameters: treatment starting age, transition probabilities, drug costs and discount rate. A probabilistic sensitivity analysis was also carried out. Results For the naive population, the option SOF+pegylated-interferon-α (pIFN)+ribavirin (RBV) for 12 weeks recorded in SmPC for genotype 1 and 3 versus pIFN+RBV for 24 weeks estimated an incremental cost-effectiveness ratio (ICER) below the □40 000/quality-adjusted life-year (QALY) benchmark. For the pretreated population, SOF triple therapy reached an ICER on the threshold limit for genotype 3. Other options included in SmPC for different genotypes exceeded the accepted efficiency limit in our setting. Conclusions The options that included SOF+RBV+pIFN in a 12-week course regimen fell below the efficiency threshold considered in our setting. IFN-free regimens administered for 24 weeks reached figures over the benchmark of □40 000/QALY.

Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.4.2-2 | Award Amount: 3.88M | Year: 2011

In 2010 a widely marketed drug for the treatment of type 2 diabetes (T2DM) (rosiglitazone) was taken from the market as it was associated with an increased risk of myocardial infarction, a T2DM complication it was actually supposed to prevent. This example shows several things. First, the approval requirements do not guarantee a longer term positive benefit risk profile. Second, large scale postmarketing studies are desperately needed to monitor the benefit risk profile throughout the lifecycle of T2DM drugs, and to achieve the required scale collaboration across countries is mandatory. Many novel T2DM drugs have come to the market, all on the basis of the same surrogate endpoints. New safety issues are constantly arising, such as potential associations with pancreatitis, pancreas cancer, bladder cancer, acute renal failure, etc. In the SAFEGUARD Consortium we have assembled an excellent multidisciplinary group of experts who collaboratively aim to quantify the cardiovascular, cerebrovascular and pancreatic safety risk of the T2DM drugs, in particular the more novel drugs by investigating 1) published clinical trials and observational studies; 2) spontaneously reported adverse event reports in national and international pharmacovigilance databases; 3) data from nine population-based health care databases in six countries capturing longitudinal drug exposure and event data on more than 1.7 million T2DM patients. Data elaboration will be distributed but standardized through common protocols, data models and scripts. To put the epidemiological results into perspective, intensive monitoring mechanistic studies in human will be conducted to further understand how and why these T2DM drugs may affect the cardiovascular, digestive or renal system. The SAFEGUARD consortium will yield a harmonized epidemiological data platform on a large T2DM population, which could easily be used to address newly occurring safety issues in the future.

Catala-Lopez F.,Agencia Espanola de Medicamentos y Productos Sanitarios | Garcia-Altes A.,Fundacion Institute Investigacion En Servicios Of Salud
Revista Espanola de Salud Publica | Year: 2010

Background: Economic evaluation has been promoted as a tool to guide decision-making processes regarding healthcare resources' allocation and in the adoption of healthcare technologies. We analyzed the evolution and the main characteristics of economic evaluations of healthcare interventions done during the period 1983-2008 in Spain. Methods: Observational descriptive study. We performed A systematic review in the main bibliographic databases (PubMed/MEDLINE, SCOPUS, ISI Web of Knowledge, CRD, IME, IBECS) and manually through Internet in journals and public reports. There were predefined inclusion and exclusion criteria, and a set of variables to analyze the characteristics of the selected reports. Results: In total, 477 studies fulfilled the inclusion criteria. Some of the studies characteristics were: cost-effectiveness analysis (62.5%), decision analysis techniques (34.0%), healthcare system perspective (42.1%), therapeutic interventions (70.0%) and non explicit financing (44.0%). The geographical distribution for Spanish regions of the first authors was: Catalonia (29.3%), Community of Madrid (23.7%), Andalusia (6.7%) and Region of Valencia (6.3%). A total of 50.9% of the principal authors were employed at hospital centers. The most common disease conditions were: cardiovascular diseases (15.7%), infectious and parasitic diseases (15.3%) and malignant neoplasms (13.2%). A total of 82.2 % of the reports provided recommendations for decision making. Conclusions: An increasing number of studies was observed. Identified reports combined heterogeneity in the quality of the information brought with regard to analysis methods, data sources, type of interventions, or disease conditions. It is suggested to do more efforts for improving the quantity and quality of reports in public health interventions.

Background and objective: We evaluated and quantified by meta-analysis techniques the incidence of contrast-induced nephropathy (CIN) in patients at risk undergoing computed tomography (CT). Material and methods: We conducted a systematic review of randomized controlled clinical trials designated to evaluate the nephrotoxicity related to iso-osmolar contrast media (IOCM) compared to low-osmolar contrast media (LOCM). Main electronic databases searched included PubMed/MEDLINE, EMBASE, ISI Web of Knowledge and Virtual Health Library (BVS-BIREME), as well as abstracts presented at related scientific societies meetings. Prior to data extraction, definitions of nephrotoxicity and risk population were established. Besides meta-analysis, the global agreement between CIN definitions was evaluated with Mantel-Haenszel stratified test. Results: Five studies were included with 716 randomized patients. When CIN was defined as increased serum creatinine (SCr) <25%, the relative risk (RR) was 0.71 (CI95%: 0.401.26)in favor of IOCMand when it was defined as SCr <0.5 mg/dL it showed a RR 1.48 (CI95%: 0.375.87)favoring LOCMin the four studies used this criterion. Mantel-Haenszel stratified test was χ2=2.51 (p=0.8). Conclusion: In patients with renal failure undergoing CT there is a similar risk of CIN with the administration of any contrast media studied. CIN incidence depends on the chosen criteria and is lower with the definition of SCr <0.5 mg/dL at 2472 h. No agreement was found between CIN definitions were adopted. © 2009 Elsevier España, S.L. All rights reserved.

Leon L.,Hospital Clinico San Carlos | Abasolo L.,Hospital Clinico San Carlos | Carmona L.,Camilo José Cela University | Rodriguez-Rodriguez L.,Hospital Clinico San Carlos | And 3 more authors.
Journal of Rheumatology | Year: 2013

Objective. To analyze sociodemographic and clinic-related factors associated with the use of orthopedic surgical procedures in rheumatoid arthritis (RA), focusing on the potential role of new biologic therapies. Methods. A retrospective medical record review was performed in a probability sample of 1272 patients with RA from 47 units distributed in 19 Spanish regions. Sociodemographic and clinical feature-rftxtDs, use of drugs, and arthritis-related joint surgeries were recorded following a standardized protocol. Results. A total of 94 patients (7.4%) underwent any orthopedic surgery during their disease course, with a total of 114 surgeries; 47 (41.2%) of these surgeries were total joint replacement (TJR). The median time to first orthopedic procedure was 7.9 years from the onset of RA symptoms, and the rate of orthopedic surgery (excluding TJR) was 4.5 procedures per 100 person-years from the beginning of RA, while the rate of TJR was 2.25 interventions per 100 person-years. A higher risk of undergoing an orthopedic surgical procedure was associated with taking nonsteroidal antiinflammatory drugs (NSAID) in the previous 2 years, female sex, longterm disease, and the presence of extraarticular complications. The risk factors for undergoing a TJR were being old, having a longterm disease, and taking biologic therapies. Conclusion. In the era of biologics, our national audit found a low percentage of patients who underwent orthopedic surgery, probably reflecting a thorough management of the RA. Sociodemographic factors, longterm RA, extraarticular complications, and NSAID were associated with orthopedic surgery. The Journal of Rheumatology Copyright © 2013. All rights reserved.

Lazaro-Bengoa E.,Agencia Espanola de Medicamentos y Productos Sanitarios | De Abajo Iglesias F.J.,Hospital Universitario Principe Of Asturias | Lopez-Navas A.,Agencia Espanola de Medicamentos y Productos Sanitarios | Fernandez-Cortizo M.J.,Agencia Espanola de Medicamentos y Productos Sanitarios
Enfermedades Infecciosas y Microbiologia Clinica | Year: 2010

The high use of antibiotics in the community is closely related to the increase in resistance to antibiotics. Monitoring antibiotic use is a key step to understanding whether trends are changing, and in this way efforts towards more prudent use can be implemented. Over the last 9 years, available active ingredients have decreased in Spain while at the same time the number of antibiotic offerings has increased. Presentations of generic pharmaceutical specialties account for almost 50% of the most frequently used subgroups. The use of antibiotics remains stable or shows a slight decrease depending on the unit of measure (DID or PIM) used. These differences are explained mainly by amoxicillin-clavulanate, since in recent years packages with greater concentrations and greater number of pharmaceutical formulationss per package have been used. Ten active ingredients constitute 80% of antibiotic use. Throughout the study period, more than 50% of total antibiotic use was due to amoxicillin-clavulanate and amoxicillin. There is significant seasonal variation in the use of antibiotics. Peaks in influenza incidence are correlated with the maximum consumption of antibiotics. The criteria on which the marketing authorisation for medication, including antibiotics, is based are quality, safety and effectiveness, regardless of the registration procedure used. The criteria that dictate the use of these antibiotics in clinical practice go beyond the purely regulatory framework. For this reason, it would be useful to have clinical practice guidelines based on broad consensus that incorporate criteria for a more rational use of antibiotics, such as the local prevalence of resistance. © 2010 Elsevier España, S.L. All rights reserved.

Blazquez-Perez A.,Agencia Espanola de Medicamentos y Productos Sanitarios | San Miguel R.,Complejo Hospitalario Of Navarra | Mar J.,Hospital Alto Deba
PharmacoEconomics | Year: 2013

Background: Chronic hepatitis C is the leading cause of chronic liver disease, representing a significant burden in terms of morbidity, mortality and costs. A new scenario of therapy for hepatitis C virus (HCV) genotype 1 infection is being established with the approval of two effective HCV protease inhibitors (PIs) in combination with the standard of care (SOC), peginterferon and ribavirin. Objective: Our objective was to estimate the cost effectiveness of combination therapy with new PIs (boceprevir and telaprevir) plus peginterferon and ribavirin versus SOC in treatment-naive patients with HCV genotype 1 according to data obtained from clinical trials (CTs). Methods: A Markov model simulating chronic HCV progression was used to estimate disease treatment costs and effects over patients' lifetimes, in the Spanish national public healthcare system. The target population was treatment-naive patients with chronic HCV genotype 1, demographic characteristics for whom were obtained from the published pivotal CTs SPRINT and ADVANCE. Three options were analysed for each PI based on results from the two CTs: universal triple therapy, interleukin (IL)-28B-guided therapy and dual therapy with peginterferon and ribavirin. A univariate sensitivity analysis was performed to evaluate the uncertainty of certain parameters: age at start of treatment, transition probabilities, drug costs, CT efficacy results and a higher hazard ratio for all-cause mortality for patients with chronic HCV. Probabilistic sensitivity analyses were also carried out. Results: Incremental cost-effectiveness ratios (ICERs) of €2012 per quality-adjusted life-year (QALY) gained were used as outcome measures. According to the base-case analysis, using dual therapy as the comparator, the alternative IL28B-guided therapy presents a more favorable ICER (€18,079/QALY for boceprevir and €25,914/QALY for telaprevir) than the universal triple therapy option (€27,594/QALY for boceprevir and €33,751/QALY for telaprevir), with an ICER clearly below the efficiency threshold for medical interventions in the Spanish setting. Sensitivity analysis showed that age at the beginning of treatment was an important factor that influenced the ICER. A potential reduction in PI costs would also clearly improve the ICER, and transition probabilities influenced the results, but to a lesser extent. Probabilistic sensitivity analyses showed that 95 % of the simulations presented an ICER below €40,000/QALY. Post hoc estimations of sustained virological responses of the IL28B-guided therapeutic option represented a limitation of the study. Conclusion: The therapeutic options analysed for the base-case cohort can be considered cost-effective interventions for the Spanish healthcare framework. Sensitivity analysis estimated an acceptability threshold of the IL28B-guided strategy of patients younger than 60 years. © 2013 Springer International Publishing Switzerland.

Tsume Y.,University of Michigan | Langguth P.,Johannes Gutenberg University Mainz | Garcia-Arieta A.,Agencia Espanola de Medicamentos y Productos Sanitarios | Amidon G.L.,University of Michigan
Biopharmaceutics and Drug Disposition | Year: 2012

The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE results and in vitro dissolution results for BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH of 6.0. Further the experimental dissolution of ibuprofen tablets in a low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol l -1/pH) was dramatically reduced compared with the dissolution in SIF (the average buffer capacity 12.6 mmol l -1/pH). Thus these predictions for the oral absorption of BCS class II acids indicate that the absorption patterns depend largely on the intestinal pH and buffer strength and must be considered carefully for a bioequivalence test. Simulation software may be a very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. Copyright © 2012 John Wiley & Sons, Ltd. Copyright © 2012 John Wiley & Sons, Ltd.

Sanchez M.P.V.,Agencia Espanola de Medicamentos y Productos Sanitarios | Saint-Gerons D.M.,Agencia Espanola de Medicamentos y Productos Sanitarios | De La Fuente Honrubia C.,Agencia Espanola de Medicamentos y Productos Sanitarios | Bermejo D.G.,Agencia Espanola de Medicamentos y Productos Sanitarios | And 2 more authors.
Revista Espanola de Salud Publica | Year: 2013

Background: For years, anxiolytics and hypnotics have been one of the most prescribed drug classes in most developed countries. The main aim of this study is to explore the pattern of use of anxiolytic and hypnotic drugs during the period 2000-2011, comparing their growth with that of five european countries. Method:We performed an ecological and descriptive study of anxiolytics and hypnotics consumption in Spain. Consumption data were obtained from the databases ofmedications dispensed in community pharmacies and charged through official prescriptions to the totality of the Spanish National Health System. Annual and total-period consumptions were expressed in defined daily doses (DDD) per 1000 inhabitants per day (DDD/1000 person/day) by each treatment subgroup, active substance and attending the plasma half-life of themedication.Approximate comparisons were alsomade with some European countries. Results: The use of anxiolytics and hypnotics drugs was 56.7 DDD/1000 person/day in 2000 and 82.9 DDD/1000 person/day in 2011 (a +46.1% increase across the period). Lorazepamand alprazolamwere themost used anxiolytics (20.5 and 15.6 DDD/1000 person/day in 2011, respectively), whereas lormetazepamwas among the hypnotics (18.3 DDD/1000 person/day in 2011). In relative terms, hypnotics' lormetazepam and zolpidem increased their use by 103.3%and 85.1%, respectively; while anxiolytics'lorazepamand hydroxyzine increased 75.1% and 72.8%, respectively. In Spain (period 2003-2010), the total increase in the consumption of anxiolytics and hypnotics was +34.3%, with 24.0% for Portugal, 4.0% for Italy, but a reduction of -6.1% for France. Conclusions: A considerable increase in anxiolytics and hypnotics' consumption has occurred in Spain during the last decade, being the growth higher than that reported in other European countries.

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