La Línea de la Concepción, Spain
La Línea de la Concepción, Spain

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Gonzalez-Juanatey J.R.,Hospital Clinico Universitario Of Santiago | Alvarez-Sabin J.,Autonomous University of Barcelona | Martinez-Rubio A.,Hospital Universitario La Paz | Reverter J.C.,Hospital Clinic | And 3 more authors.
Revista Espanola de Cardiologia | Year: 2012

Introduction and objectives: Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System. Methods: Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10 000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed. Results: Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17 581 euros/quality-adjusted life year gained and 14 118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust. Conclusions: From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30 000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives. Full English text available from: ©2012 Sociedad Espanola de Cardiolog?a. Publicado por Elsevier Espana, S.L. Todos los derechos reservados.

Villarrubia R.,Pharmacoeconomics and Outcomes Research Iberia | Oyaguez I.,Pharmacoeconomics and Outcomes Research Iberia | Alvarez-Roman M.T.,Hospital Universitario La Paz | Mingot-Castellano M.E.,University of Malaga | And 2 more authors.
Haemophilia | Year: 2015

Objective A cost analysis model was developed to compare annual cost of prophylaxis with activated prothrombin complex concentrate (aPCC) vs. on-demand therapy with activated recombinant factor VII (rFVIIa) in severe haemophilia A patients with inhibitors for the Spanish National Health System (NHS). Methods:: Model inputs were drug cost for prophylaxis (aPCC) and for on-demand treatment (rFVIIa or aPCC); bleeding episodes management (excluding bypassing agent cost); surgical costs and disease management (excluding bleeding episodes). Annual bleeding episodes treated on-demand was assumed to be 25, whereas breakthrough bleeds on prophylaxis was 8. Dose for prophylaxis was 75.72 U kg-1, three times per week. The total on-demand dose/bleeding episode was 679.66 μg kg-1 (rFVIIa) and 235.28 U kg-1 (aPCC). The average bleeding cost (€2998) considered different bleeding sites (62.5% joints, 28.6% muscles and soft tissues, 3.6% mucocutaneous tissues and 5.4% other areas). A 7.5% deduction was applied to ex-factory drug prices. Unitary costs (€2013) derived from local databases. Sensitivity analyses (SA) were performed. Results:: Annual cost of aPCC prophylaxis (€524 358) was 16% lower than on-demand treatment with rFVIIa (€627 876). Yearly drug costs were €497 017 for aPCC (€73 166 for on-demand treatment and €423 850 for prophylaxis), and €548 870 for rFVIIa. Disease management cost (€2645 per year) and surgical procedures (€708 per year) were common for both strategies. In the SA prophylactic treatment led to savings between €26 225 and €-1 008 960. Conclusion:: Prophylaxis with aPCC reduces number of bleeding episodes in severe haemophilia A patients with inhibitors. aPCC prophylaxis resulted in savings in excess of €100 000 per-patient per year, being 16% less costly than on-demand treatment with rFVIIa, for the Spanish NHS. © 2015 John Wiley & Sons Ltd213 May 2015 10.1111/hae.12681 Original Article Original Articles Clinical haemophilia © 2015 John Wiley & Sons Ltd.

Grau S.,Hospital del Mar | de la Camara R.,Hospital Of La Princesa | Sabater F.J.,IMS Health | Jarque I.,Hospital Universitario La Paz | And 3 more authors.
BMC Infectious Diseases | Year: 2012

Background: We evaluated the cost-effectiveness of posaconazole compared with standard azole therapy (SAT; fluconazole or itraconazole) for the prevention of invasive fungal infections (IFI) and the reduction of overall mortality in high-risk neutropenic patients with acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS). The perspective was that of the Spanish National Health Service (NHS).Methods: A decision-analytic model, based on a randomised phase III trial, was used to predict IFI avoided, life-years saved (LYS), total costs, and incremental cost-effectiveness ratio (ICER; incremental cost per LYS) over patients' lifetime horizon. Data for the analyses included life expectancy, procedures, and costs associated with IFI and the drugs (in euros at November 2009 values) which were obtained from the published literature and opinions of an expert committee. A probabilistic sensitivity analysis (PAS) was performed.Results: Posaconazole was associated with fewer IFI (0.05 versus 0.11), increased LYS (2.52 versus 2.43), and significantly lower costs excluding costs of the underlying condition (€6,121 versus €7,928) per patient relative to SAT. There is an 85% probability that posaconazole is a cost-saving strategy compared to SAT and a 97% probability that the ICER for posaconazole relative to SAT is below the cost per LYS threshold of €30,000 currently accepted in Spain.Conclusions: Posaconazole is a cost-saving prophylactic strategy (lower costs and greater efficacy) compared with fluconazole or itraconazole in high-risk neutropenic patients. © 2012 Grau et al; licensee BioMed Central Ltd.

De La Camara R.,Hospital Of La Princesa | Jarque I.,Hospital Universitario La Paz | Sanz M.A.,Hospital Universitario La Paz | Grau S.,Hospital Del Mar | And 3 more authors.
Bone Marrow Transplantation | Year: 2010

Posaconazole has been proven to be as effective as fluconazole in the prevention of invasive fungal infections (IFI) in allogeneic haematopoietic SCT patients with GVHD. We assessed, from the perspective of the Spanish National Health Service, the cost-effectiveness of posaconazole vs fluconazole in preventing IFI. A decision-analytic model was developed to assess the average per patient treatment costs, IFIs avoided, life-years gained (LYG) and incremental cost per LYG for each prophylactic treatment used (in euros at 2007 prices). Patients are assumed to have received either posaconazole or fluconazole. The probabilities of IFI, IFI-related death and death from other causes were obtained from a single clinical trial. Long-term mortality and costs were estimated from secondary sources. Posaconazole was associated with fewer IFIs (5.3 vs 9%), increased LYG (8.01 vs 7.78) and higher IFI-related costs (\[euro]11 585 vs \[euro]6 959) per patient compared with fluconazole. The incremental cost-effectiveness of posaconazole vs fluconazole was estimated at \[euro]20 246 per LYG. There was a 70% probability that posaconazole is cost-effective at a \[euro]30 000 per LYG threshold. In conclusion, compared with fluconazole, posaconazole prophylaxis is a cost-effective strategy for the prevention of IFI in patients with GVHD. © 2010 Macmillan Publishers Limited.

Sanchez-De La Rosa R.,Teva Pharmaceutical Industries | Sabater E.,Pharmacoeconomics and Outcomes Research Iberia | Casado M.A.,Pharmacoeconomics and Outcomes Research Iberia | Arroyo R.,Hospital Clnico San Carlos
Journal of Medical Economics | Year: 2012

Objective: The aim of this study was to assess cost-effectiveness of the different Disease Modifying Drugs (DMD) used as first-line treatments (interferons IM IFNβ-1a, SC IFNβ-1a, SC IFNβ-1b, and glatiramer acetate, GA) in Remitting-Relapsing Multiple Sclerosis (RRMS) in Spain. Methods: A Markov model was developed to simulate the progression of a cohort of patients with RRMS, during a period of 10 years. Seven health states, defined by the Expanded Disability Status Scale (EDSS), were considered in the model. Patients with an EDSS score less than 6.0 were assumed to be treated with one of the DMD. In addition, all patients were assumed to receive symptomatic treatment. The monthly transition probabilities of the model were obtained from the literature. The analysis was performed from the societal perspective, in which both direct and indirect (losses in productivity) healthcare costs (€, 2010) were included. A discount rate of 3% was applied to both costs and efficacy results. Results: GA was the less costly strategy (€322,510), followed by IM IFNβ-1a (€329,595), SC IFNβ-1b (€ 333,925), and SC IFNβ-1a (€348,208). IM IFNβ-1a has shown the best efficacy results, with 4.176 quality-adjusted life years (QALY), followed by SC IFNβ-1a (4.158 QALY), SC IFNβ-1b (4.157 QALY), and GA (4.117 QALY). Incremental costs per QALY gained with IM IFNβ-1a were €-1,005,194/ QALY, €-223,397/QALY, and €117,914/QALY in comparison to SC IFNβ-1a, SC IFNβ-1b, and GA, respectively. Conclusions: First-line treatment with GA is the less costly strategy for the treatment of patients with RRMS. Treatment with IM IFNβ-1a is a dominant strategy (lower cost and higher QALY) compared with SC IFNβ-1a and SC IFNβ-1b. However, IM IFNβ-1a is not a cost-effective strategy vs GA, because incremental cost per QALY gained with IM IFNβ-1a exceeds the €30,000 per QALY threshold commonly used in Spain. Limitations: The highly-restrictive inclusion criteria of clinical trials limits generalization of the results on efficacy to all patients with multiple sclerosis. Availability of data for head-to-head comparisons is associated with the use of information from clinical trials. © 2012 Informa UK Ltd All rights reserved.

Martinez-Raga J.,CEU Cardenal Herrera University | Gonzalez Saiz F.,Fundacion Andaluza Para la Atencion e Incorporacion Social | Pascual C.,Hospital Infanta Leonor | Casado M.A.,Pharmacoeconomics and Outcomes Research Iberia | Sabater Torres F.J.,Schering
European Addiction Research | Year: 2010

Objective: To evaluate the economic impact of buprenorphine/naloxone (B/N) as an agonist opioid treatment for opiate dependence. Methods: A budgetary impact analysis model was designed to calculate the annual costs (drugs and associated costs) to the Spanish National Healthcare System of methadone versus B/N. Data for the model were obtained from official databases and expert panel opinion. Results: It was estimated that 86,017 patients would be in an agonist opioid treatment program each of the 3 years of the study. No increase in the number of patients is expected with the introduction of B/N combination. The budgetary impact (drugs and associated costs) for agonist opiate treatment in the first year of the study would be 89.53 million EUR. In the first year of B/N use, the budgetary impact would rise by 4.39 million EUR (4.6% of the total impact), with an incremental cost of 0.79 million EUR (0.9% of the total impact). The budgetary increase would be 0.6% (0.48 million EUR increase) and 0.6% (0.49 million EUR increase) in the second and third years of use, respectively. The mean cost per patient in the first year with and without B/N would be EUR 1,050 and 1,041, respectively. The most influential variables in the sensitivity analysis were logistics and production costs of methadone and the percentage use of B/N. Conclusion: With an additional cost of only EUR 9 per patient, B/N is an efficient addition to the therapeutic arsenal in the drug treatment of opiate dependence, particularly when considering clinical aspects of novel pharmacotherapy. © 2009 S. Karger AG, Basel.

Buti M.,Hospital General Universitario | Oyaguez I.,Pharmacoeconomics and Outcomes Research Iberia | Lozano V.,Pharmacoeconomics and Outcomes Research Iberia | Casado M.A.,Pharmacoeconomics and Outcomes Research Iberia
PharmacoEconomics | Year: 2013

Background: Chronic hepatitis B is a common, progressive disease, particularly when viral replication is detected. Oral antivirals can suppress viral replication and prevent or delay the development of cirrhosis and liver-related complications. Objective: The aim of this study was to systematically review the quality of cost-effectiveness evidence on first-line treatment with entecavir (ETV) or tenofovir difumarate (TDF) for patients with chronic hepatitis B. Methods: We searched electronic databases and retrieved articles published up to October 2011, in which the cost effectiveness of ETV or TDF was compared with that of other oral antivirals. The quality of the studies identified was assessed with a standard checklist for critical appraisal. Results: We selected 16 original papers, all published in the last 5 years. There was a conflict of interest in 12 of the 16 studies due to sponsorship by the corresponding pharmaceutical companies. According to the validity assessment, ten studies were classified as high quality. Five studies performed a cost-effectiveness analysis comparing ETV with TDF; they concluded that TDF dominates ETV. The other 11 studies compared ETV or TDF with other strategies; all concluded that ETV and TDF are both cost-effective interventions. Conclusions: This systematic review shows that there is valid evidence suggesting that ETV and TDF are cost-effective interventions for the treatment of patients with chronic hepatitis B in many health systems. In countries where both alternatives are available, it appears that TDF dominates ETV. These results could help decision makers and clinicians to understand economic issues regarding the available drugs for first-line treatment of hepatitis B. © 2012 Springer International Publishing Switzerland.

Orofino J.,Cellerix | Soto J.,Pfizer | Casado M.A.,Pharmacoeconomics and Outcomes Research Iberia | Oyagez I.,Pharmacoeconomics and Outcomes Research Iberia
Applied Health Economics and Health Policy | Year: 2010

Background: Orphan drugs are indicated for the treatment of rare diseases which, in the EU, are defined as those with a prevalence of < 5 per 10 000 inhabitants. Characteristically, these diseases negatively affect health-related quality of life and may be life threatening. The EU has passed legislation to encourage pharmaceutical companies to invest in research programmes into rare diseases, with the aim of developing new, safe and effective orphan drugs. Objectives: To describe the status of orphan drugs in five countries in the EU (France, Germany, the UK, Italy and Spain), estimate the mean annual cost per patient and indication of these orphan drugs, and determine the associated cost of these drugs in comparison with overall spending on drugs in each country (year 2007 values). Methods: The analysis was limited solely to costs of orphan drugs with sales data available for 2007. The mean annual cost per patient was estimated using recommended regimens for maintenance dose and duration from the summary of product characteristics. Likewise, the ratio between annual costs per patient for treatment of each disease and its prevalence was calculated. Sales data were available for at least one of the countries studied for 38 of the 44 orphan drugs authorized by the European Medicines Agency. Only 21 products had data available for all five countries studied. Results: Germany was the country with access to the largest number of orphan drugs (36), followed by the UK (34), Spain (28), France (27) and Italy (25). The mean annual cost per patient and indication of the 38 orphan drugs on the market ranged widely from h331 to h337 501. It appears that orphan drugs indicated to treat diseases with a prevalence of < 2 per 10 000 inhabitants have higher annual per-patient costs than those indicated to treat diseases with a higher prevalence. The percentage of total drug spending accounted for by orphan drugs in 2007 was 1.7% in France, 2.1% in Germany, 1.0% in the UK, 1.5% in Italy and 2.0% in Spain, with an average overall percentage of 1.7% for these five countries. Conclusions: In 2007, spending on orphan drugs in five European countries was acceptable in terms of the percentage of these countries overall drug expenditure. Mean annual costs per patient of orphan drugs varied widely, with costs being related to the prevalence of the disease for which the product is indicated. © 2010 Adis Data Information BV. All rights reserved.

la Rosa R.S.-D.,Teva Pharma SLU | Sabater E.,Pharmacoeconomics and Outcomes Research Iberia | Casado M.A.,Pharmacoeconomics and Outcomes Research Iberia
Revista de Neurologia | Year: 2011

Aim. To assess the budget impact of the treatment for relapsing remitting multiple sclerosis (RRMS), interferons, and glatiramer acetate, from the National Health System perspective in Spain. Patients and methods. A budget impact model was designed to compare the cost of RRMS treatment in different settings, using a five year time-horizon, considering different percentages of administration of each medication. A reference setting o base case using all the available first line treatments (interferons and glatiramer acetate) was compared with five alternatives scenarios excluding each one of these treatments. The cost analysis (euros, year 2010) includes direct medical resources (drugs, administration, visits, disease management, diagnostic tests). Unitary cost data was obtained from the health costs database e-Salud and drugs catalogue. Results. Considering a cohort of 22 255 patients with RRMS, the mean global budget impact per year would be 260 775 470 euros in the base case. The setting that excluded glatiramer acetate increases the budget impact in a 3.23% (372 euros per patient per year). Pharmacological costs were the key drivers of total cost (90%). Conclusion. The use of glatiramer acetate in the first-line-treatment of RRMS patients is a cost-saving strategy, which may decrease the budget impact from the National Health System perspective in Spain. © 2011 Revista de Neurología.

Gines J.,Hospital Universitario Son Espases | Sabater E.,Pharmacoeconomics and Outcomes Research Iberia | Martorell C.,Hospital Universitario Son Espases | Grau M.,Pharmacoeconomics and Outcomes Research Iberia | And 2 more authors.
Clinical and Translational Oncology | Year: 2011

Objectives To evaluate the magnitude of benefit obtained by taxanes as adjuvant treatment of breast cancer and to assess the best method for their administration. Material and methods We performed a systematic search of phase III randomised clinical trials that included patients with non-metastatic breast cancer in whom comparisons were chemotherapy (CT) containing a taxane (docetaxel or paclitaxel) vs. CT without taxanes (first-generation trials), or CT with taxane in both treatment arms (secondgeneration trials), administered after surgery. The parameters of efficacy evaluated were disease-free survival (DFS) and overall survival (OS). The data obtained in the first generation trials (number of relapses and deaths) were submitted to a meta-analysis. The odds ratio (OR) combined with DerSimonian and Laird (OR DL) and 95% confidence interval (95%CI) were calculated. Further, an analysis was performed of those trials that included only patients with nodal involvement (N+). In both cases, the results were also analysed as a function of the taxane used, and with indirect comparisons between the two. The second-generation trials were analysed to assess the optimum method of administration. Results A total of 17 trials were selected for the metaanalysis (30,672 patients). The OR DL was 0.82 (95%CI: 0.76-0.88) for DFS and 0.83 (95%CI: 0.75-0.91) for OS. In N+ patients the results were 0.80 (95%CI: 0.74-0.86) and 0.79 (95%CI: 0.69-0.89), respectively. Docetaxel and paclitaxel significantly increased the DFS and OS. In our indirect comparison, the benefit of docetaxel on OS was significantly superior to that obtained with paclitaxel in N+ patients (OR: 0.79; 95%CI: 0.63-0.98). Conclusions The administration of adjuvant CT-based taxanes reduces the risk of relapse and death. This reduction is superior in clinical trials that included only N+ patients. With the available evidence, it would appear that the best method of administering paclitaxel is weekly and for docetaxel tri-weekly.

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