Economic Analysis of the Use of Anti-DFS70 Antibody Test in Patients with Undifferentiated Systemic Autoimmune Disease Symptoms.

OBJECTIVE: In patients with antinuclear antibodies (ANA) and undifferentiated features of systemic autoimmune disease, the coexistence of monospecific anti-dense fine speckled 70 (anti-DFS70) antibodies is associated with a lower risk of progression to overt disease. Therefore, they might help in correctly classifying ANA- positive patients and avoiding unnecessary followup diagnostic procedures. The aim of this study was to analyze the economic effect of the introduction of the anti-DFS70 antibody test in a hospital setting. METHODS: A case-control study was performed to detect monospecific anti-DFS70 antibodies in ANA-positive subjects with undifferentiated features (cases, n = 124) and with a defined systemic autoimmune disease (controls, n = 290). Based on current clinical practice, a decision tree was developed to represent the disease course of patients with undifferentiated features in the subsequent 3 years. A budget impact analysis (BIA) was performed to estimate the effect of implementing the screening for anti-DFS70 antibodies in the case group on the total costs. A sensitivity analysis was conducted to calculate the effect of the uncertainty of the input variables on the results. RESULTS: Among the 124 patients in the case group, 5 (4.0%) tested positive for anti-DFS70 antibodies versus 4/290 (1.4%) in the control group (p = not significant). The mean cost per patient under the current clinical practice decreased from €3274 to €3192 in our scenario. The BIA reports cost savings of €10,128. CONCLUSION: The introduction of anti-DFS70 antibody test would avoid unnecessary followup diagnostic procedures and minimize the use of health resources generated by suspicion of a potential systemic autoimmune disease.

Cost-Effectiveness of Low-Field Intraoperative Magnetic Resonance in Glioma Surgery.

OBJECT: Low-field intraoperative magnetic resonance (LF-iMR) has demonstrated a slight increase in the extent of resection of intra-axial tumors while preserving patient`s neurological outcomes. However, whether this improvement is cost-effective or not is still matter of controversy. In this clinical investigation we sought to evaluate the cost-effectiveness of the implementation of a LF-iMR in glioma surgery. METHODS: Patients undergoing LF-iMR guided glioma surgery with gross total resection (GTR) intention were prospectively collected and compared to an historical cohort operated without this technology. Socio-demographic and clinical variables (pre and postoperative KPS; histopathological classification; Extent of resection; postoperative complications; need of re-intervention within the first year and 1-year postoperative survival) were collected and analyzed. Effectiveness variables were assessed in both groups: Postoperative Karnofsky performance status scale (pKPS); overall survival (OS); Progression-free survival (PFS); and a variable accounting for the number of patients with a greater than subtotal resection and same or higher postoperative KPS (R-KPS). All preoperative, procedural and postoperative costs linked to the treatment were considered for the cost-effectiveness analysis (diagnostic procedures, prosthesis, operating time, hospitalization, consumables, LF-iMR device, etc). Deterministic and probabilistic simulations were conducted to evaluate the consistency of our analysis. RESULTS: 50 patients were operated with LF-iMR assistance, while 146 belonged to the control group. GTR rate, pKPS, R-KPS, PFS, and 1-year OS were respectively 13,8% (not significative), 7 points (p < 0.05), 17% (p < 0.05), 38 days (p < 0.05), and 3.7% (not significative) higher in the intervention group. Cost-effectiveness analysis showed a mean incremental cost per patient of 789 € in the intervention group. Incremental cost-effectiveness ratios were 111 € per additional point of pKPS, 21 € per additional day free of progression, and 46 € per additional percentage point of R-KPS. CONCLUSION: Glioma patients operated under LF-iMR guidance experience a better functional outcome, higher resection rates, less complications, better PFS rates but similar life expectancy compared to conventional techniques. In terms of efficiency, LF-iMR is very close to be a dominant technology in terms of R-KPS, PFS and pKPS.

Optimisation of cardiac resynchronisation therapy device selection guided by cardiac magnetic resonance imaging: Cost-effectiveness analysis.

BACKGROUND: A recent study showed that the presence and characteristics of myocardial scar could independently predict appropriate implantable cardioverter-defibrillator therapies and the risk of sudden cardiac death in patients receiving a de novo cardiac resynchronisation device. DESIGN: The aim was to evaluate the cost-effectiveness of cardiac magnetic resonance imaging-based algorithms versus clinical practice in the decision-making process for the implantation of a cardiac resynchronisation device pacemaker versus cardiac resynchronisation device implantable cardioverter-defibrillator device in heart failure patients with indication for cardiac resynchronisation therapy. METHODS: An incidental Markov model was developed to simulate the lifetime progression of a heart failure patient cohort. Key health variables included in the model were New York Heart Association functional class, hospitalisations, sudden cardiac death and total mortality. The analysis was done from the healthcare system perspective. Costs (€2017), survival and quality-adjusted life years were assessed. RESULTS: At 5-year follow-up, algorithm I reduced mortality by 39% in patients with a cardiac resynchronisation device pacemaker who were underprotected due to misclassification by clinical protocol. This approach had the highest quality-adjusted life years (algorithm I 3.257 quality-adjusted life years; algorithm II 3.196 quality-adjusted life years; clinical protocol 3.167 quality-adjusted life years) and the lowest lifetime costs per patient (€20,960, €22,319 and €28,447, respectively). Algorithm I would improve results for three subgroups: non-ischaemic, New York Heart Association class III-IV and ≥65 years old. Furthermore, implementing this approach could generate an estimated €702 million in health system savings annually in European Society of Cardiology countries. CONCLUSION: The application of cardiac magnetic resonance imaging-based algorithms could improve survival and quality-adjusted life years at a lower cost than current clinical practice (dominant strategy) used for assigning cardiac resynchronisation device pacemakers and cardiac resynchronisation device implantable cardioverter-defibrillators to heart failure patients.

[Duration of the Reimbursement Process in Spain for Innovative Drugs Approved by the European Medicines Agency during the Period 2008-2013]. / Duración del proceso de financiación en España de los fármacos innovadores aprobados por la Agencia Europea del Medicamento: 2008-2013.

BACKGROUND: In Spain, the decision of Price and Reimbursement (P&R) of a new drug must be taken between 180-270 days. The objective of this study was to assess the reimbursement timing in Spain for innovative drugs approved by the European Medicines Agency (EMA) between January 2008 and December 2013 and to explore the potential impact of drug's price on this time. METHODS: Drugs approved were extracted from EMA's website, authorization dates in Spain from the Spanish Agency (AEMPS) and, P&R dates and prices from Nomenclátor and BotPlus. Depending on days from approval to reimbursement, drugs were quick (<180), on time (180-270) and delayed (>270). Depending on posology: chronic or acute. Depending on dispensing conditions: retail or hospital drugs. It was calculated: median, maximum, minimum, first, and third quartiles of time until reimbursement. RESULTS: 431 drugs were approved by EMA; 285 were innovative, from them 147 were approved by the AEMPS and reimbursed: 103 chronic and 44 acute. Median price/day was €2.44 for chronic and €21 for acute. From 2008-2011, 80% of drugs were reimbursed, in 2012 21% and in 2013 17%. Time from approval to reimbursement move from 230 days in 2009 to 431 days in 2013. From the 139 drugs with reimbursement date 33 were quick, 44 on time and 62 delayed. CONCLUSIONS: The median time from approval by the EMA of innovative drugs since the reimbursement in Spain in 2013 is double that of 2008. The main driver of delays in the process of P&R seems to be the budget impact of the drug instead of its unit price.

Direct medical costs of liquid intravenous immunoglobulins in children, adolescents, and adults in Spain.

The aim of this study was to determine health care resource utilization and direct medical costs in Spanish patients treated with intravenous immunoglobulins (IVIGs) in 2009. Cost-of-illness analyses were performed to estimate direct medical costs of patients treated with IVIGs. Prevalence data were obtained from the Spanish Primary Immunodeficiency registry. A semi-structured questionnaire was used to collect data on health care resource utilization and patient distribution. Drug, administration, and premedication costs were considered from the payer's perspective. Separate analyses were conducted for children and adolescents versus adults. The numbers of children and adolescents with replacement therapy were 724, with immunomodulation 243, and with allogeneic bone marrow transplantation 30. The numbers of adult patients were, respectively, 3450, 1134, and 172. Mean annual costs for children and adolescents were 6293 € with Privigen, 6292 € with Kiovig, 6939 € with Flebogamma, and 6559 € with Octagamocta. For adults, estimations were 17 106 € with Privigen, 17 103 € with Kiovig, 18 077 € with Flebogamma, and 17 423 € with Octagamocta. Direct medical costs for IVIGs were approximately 91.8 million €. Drug costs represented 94% of total costs. The choice for a certain IVIG treatment depends on individual patient characteristics and cost considerations.

Duración del proceso de financiación en España de los fármacos innovadores aprobados por la Agencia Europea del Medicamento. 2008-2013 / Duration of the reimbursement process in Spain for innovative drugs approved by the European Medicines Agency during the period 2008-2013

Fundamentos: En España la decisión de precio y financiación (PyF) de un nuevo medicamento debe tomarse entre 180 y 270 días. El objetivo de este estudio fue valorar el tiempo hasta la financiación en España de los medicamentos innovadores aprobados por la Agencia Europea de Medicamentos (EMA) entre enero 2008 y diciembre 2013 y explorar el impacto potencial del precio del fármaco sobre este tiempo. Métodos: Los medicamentos aprobados se obtuvieron de la web de la EMA, las fechas de autorización de la Agencia Española del Medicamento (AEMPS) y las fechas del PyF y los precios del Nomenclátor y BotPlus. Según los días desde la aprobación hasta la financiación se clasificó a los medicamentos en rápidos (<180), en plazo (180-270) y con demora (>270). Según la duración del tratamiento en crónicos o agudos. Y según las condiciones de dispensación: de farmacia u hospital. Del tiempo transcurrido hasta la financiación, se calculó la mediana, el máximo, el mínimo así como el primer y tercer cuartiles. Resultados: Durante el período de estudio fueron aprobados por la EMA 431 medicamentos, de los cuales 285 eran innovadores. De estos 147 fueron aprobados por la AEMPS y financiados: 103 para tratamientos crónicos y 44 para agudos. La mediana del precio/día fue de 2,44€ para crónicos y 21€ para agudos. De 2008-2011 fueron financiados el 80% , en 2012 el 21% y en 2013 el 17%. El tiempo hasta la financiación pasó de 230 días en 2009 a 431 en 2013. Los 139 medicamentos con fecha de financiación fueron: 33 rápidos, 44 en plazo y 62 con demora. Conclusiones: La mediana del tiempo desde la aprobación por la EMA de los medicamentos innovadores hasta su financiación en España en 2013 es el doble que en 2008. El motor principal de los retrasos en el proceso de PyF parece ser el impacto presupuestario del fármaco más que su precio unitario (AU)

Background: In Spain, the decision of Price and Reimbursement (P&R) of a new drug must be taken between 180-270 days. The objective of this study was to assess the reimbursement timing in Spain for innovative drugs approved by the European Medicines Agency (EMA) between January 2008 and December 2013 and to explore the potential impact of drug’s price on this time. Methods: Drugs approved were extracted from EMA’s website, authorization dates in Spain from the Spanish Agency (AEMPS) and, P&R dates and prices from Nomenclátor and BotPlus. Depending on days from approval to reimbursement, drugs were quick (<180), on time (180-270) and delayed (>270). Depending on posology: chronic or acute. Depending on dispensing conditions: retail or hospital drugs. It was calculated: median, maximum, minimum, first, and third quartiles of time until reimbursement. Results: 431 drugs were approved by EMA; 285 were innovative, from them 147 were approved by the AEMPS and reimbursed: 103 chronic and 44 acute. Median price/day was €2.44 for chronic and €21 for acute. From 2008-2011, 80% of drugs were reimbursed, in 2012 21% and in 2013 17%. Time from approval to reimbursement move from 230 days in 2009 to 431 days in 2013. From the 139 drugs with reimbursement date 33 were quick, 44 on time and 62 delayed. Conclusions: The median time from approval by the EMA of innovative drugs since the reimbursement in Spain in 2013 is double that of 2008. The main driver of delays in the process of P&R seems to be the budget impact of the drug instead of its unit price (AU)

Coste real de las transfusiones sanguíneas en España / Cost of blood transfusion in Spain

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