Max Brosa

Cost-Effectiveness of Sacral Neuromodulation Compared to Botulinum Neurotoxin A or Continued Medical Management in Refractory Overactive Bladder

OBJECTIVES This study assessed the cost-effectiveness and health-care budget impact of sacral neuromodulation (SNM) in refractory idiopathic OAB-wet patients in Spain. METHODS A 10-year Markov analytic model was developed to estimate quality-adjusted life-years (QALYs) gained and incontinence episode avoided associated with SNM therapy compared with botulinum neurotoxin A (BoNT-A) or continued optimized medical treatment (OMT). RESULTS At 10 years, the cumulative costs of SNM, BoNT-A, and OMT were €29,166, €29,458, and €29,370, respectively, whereas the QALYs for SNM, BoNT-A, and OMT are 6.89, 6.38, and 5.12, respectively. Consequently, incremental cost-effectiveness ratios (ICERs) for SNM demonstrate that although the initial costs for SNM are higher than those for the other treatments, decreasing follow-up costs coupled with consistently greater effectiveness in the long term make SNM the economically dominant option at 10 years. Sensitivity analyses suggest that 99.7% and 99.9% (for SNM vs. BoNT-A and OMT, respectively) of the 1000 Monte Carlo iterations fall within the €30,000 cost-effectiveness threshold, considered to be acceptable in Spain. The 10-year incremental cost per incontinence episode avoided for SNM also makes this therapy the dominant option compared to BoNT-A or OMT. Additionally, the estimated budget impact of the gradually increased referral for SNM for the management of OAB patients in Spain is small. CONCLUSIONS As a treatment option for refractory idiopathic OAB, at 10 years, SNM provides a considerable possibility of symptom and quality-of-life improvement and is cost-effective compared to BoNT-A or continued OMT.

Treatment patterns, use of resources, and costs of advanced non-small-cell lung cancer patients in Spain: results from a Delphi panel

IntroductionApproximately 80–85% of lung cancer patients are diagnosed with non-small-cell lung cancer (NSCLC), of which 50% of patients present with advanced or metastatic disease. The objective of this study was to describe treatment patterns, use of resources and costs associated with treating advanced or metastatic NSCLC patients in Spain.MethodsA two-round Delphi consensus panel of clinical experts was carried out to describe local clinical patterns based on treatment algorithms from SEOM and ASCO treatment guidelines. The panel consisted of 19 oncologists and 1 hospital pharmacist, who were asked during the first round to define therapeutic pathways for NSCLC by the patients’ performance status, age and histology; to quantify the use of resources associated with the preparation and administration of anticancer pharmacotherapy; management of adverse events associated with anticancer pharmacotherapy; and best supportive care (BSC). The second round was used to try to reduce the variability of responses in some questions and to further describe differences between intravenous and oral therapy. 2009 unit costs were applied to the use of resources described by the clinical experts. The perspective of the study was from the Spanish National Healthcare System.ResultsPerformance status guided therapy decision and led to differences in costs. Patients with a performance status of 0–2 were expected to receive anticancer pharmacotherapy while patients with a performance status of 3–4 received BSC including analgesics and corticosteroids. Anticancer pharmacotherapies containing cisplatin or carboplatin were used preferably in first-line treatment, while the usual second- and third-line treatments were docetaxel, erlotinib or pemetrexed monotherapy. The importance of the cost of anticancer pharmacotherapy as a proportion of total healthcare costs was higher for combination therapies containing bevacizumab or pemetrexed. The anticancer pharmacotherapies associated with adverse events like febrile neutropenia or infection increased the total treatment cost. Administration costs were more relevant in regimens containing cisplatin and were low for orally administered therapies. The total cost per patient with advanced or metastatic NSCLC from starting anticancer therapy until death was estimated to be between zs11,301 and zs32,754 depending on the number of treatment lines received.ConclusionsIn the treatment of advanced or metastatic NSCLC, healthcare costs are impacted by line of treatment, patient performance status, type of administration of therapy and adverse event management.

Cost-effectiveness of citicoline versus conventional treatment in acute ischemic stroke

In the framework of an integral assessment (effectiveness and cost) of the use of neuroprotection in stroke, a cost-effectiveness study was conducted to compare the potential advantages of citicoline with conventional therapy (without neuroprotection or placebo) in patients with acute ischemic stroke. The literature was searched for systematic reviews and meta-analyses evaluating the effectiveness of citicoline versus placebo in the hospital setting and during 12 weeks after discharge from hospital. Data on the use of resources were obtained from a panel of experts of four acute-care teaching hospitals in Spain. The study was performed from the perspective of the Spanish National Health System. Two meta-analyses were included (Cochrane Stroke Review Group and a pooling analysis). Treatment with citicoline resulted in 99 or 50 more patients recovered per 1000 patients treated (depending on selection criteria of the Cochrane study and the pooled analysis), with average cost savings between €101.2 and €126.4 per patient treated of the type of those included in the Cochrane study. In patients with acute ischemic stroke, treatment with placebo was more expensive and less effective in the scenarios of inpatient care and inpatient plus outpatient care after discharge from the hospital.

Pharmacoeconomics of Cyclamen europaeum in the management of acute rhinosinusitis

To carry out a pharmacoeconomic analysis of Cyclamen europaeum (CE) in the management of acute rhinosinusitis (ARS) in Spain using data from the PROSINUS (PROspective epidemiological study of the diagnosis and treatment of acute rhinoSINUSitis) study.

Development of a population-based cost-effectiveness model of chronic graft-versus-host disease in Spain.

BACKGROUND Chronic graft-versus-host disease (cGvHD) is the leading cause of late nonrelapse mortality (transplant-related mortality) after hematopoietic stem cell transplant. Given that there are a wide range of treatment options for cGvHD, assessment of the associated costs and efficacy can help clinicians and health care providers allocate health care resources more efficiently. OBJECTIVE The purpose of this study was to assess the cost-effectiveness of extracorporeal photopheresis (ECP) compared with rituximab (Rmb) and with imatinib (Imt) in patients with cGvHD at 5 years from the perspective of the Spanish National Health System. METHODS The model assessed the incremental cost-effectiveness/utility ratio of ECP versus Rmb or Imt for 1000 hypothetical patients by using microsimulation cost-effectiveness techniques. Model probabilities were obtained from the literature. Treatment pathways and adverse events were evaluated taking clinical opinion and published reports into consideration. Local data on costs (2010 Euros) and health care resources utilization were validated by the clinical authors. Probabilistic sensitivity analyses were used to assess the robustness of the model. RESULTS The greater efficacy of ECP resulted in a gain of 0.011 to 0.024 quality-adjusted life-year in the first year and 0.062 to 0.094 at year 5 compared with Rmb or Imt. The results showed that the higher acquisition cost of ECP versus Imt was compensated for at 9 months by greater efficacy; this higher cost was partially compensated for (€517) by year 5 versus Rmb. After 9 months, ECP was dominant (cheaper and more effective) compared with Imt. The incremental cost-effectiveness ratio of ECP versus Rmb was €29,646 per life-year gained and €24,442 per quality-adjusted life-year gained at year 2.5. Probabilistic sensitivity analysis confirmed the results. The main study limitation was that to assess relative treatment effects, only small studies were available for indirect comparison. CONCLUSION ECP as a third-line therapy for cGvHD is a more cost-effective strategy than Rmb or Imt.

Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain.

Objective: The aim of this study is to conduct a cost–effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. Methods: An analytical decision-making model was constructed to compare whether 5-FU/SA was a cost-effective option compared with cryotherapy from the perspective of the Spanish National Health System with a time horizon of 6 months. Costs were expressed in 2014 euros. Results: The cost of patients with hyperkeratotic actinic keratosis treated with 5-FU/SA or cryotherapy was €266 and €285, respectively. 5-FU/SA was associated with higher rates of treatment success and, consequently, more quality-adjusted life years, than cryotherapy. Therefore, 5-FU/SA was the dominant treatment, as it was associated with a lower treatment cost and greater effectiveness than cryotherapy. Conclusions: Economically, 5-FU/SA was a dominant option compared with cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain.

Orphan drugs revisited: cost–effectiveness analysis of the addition of mifamurtide to the conventional treatment of osteosarcoma

Introduction: Mepact® (mifamurtide) is the first drug approved for the treatment of high-grade resectable non-metastatic osteosarcoma in patients aged 2–30 in the last 20 years. It follows a randomized clinical trial showing a statistically-significant and clinically-relevant decrease in the risk of death without compromising safety. Aim: This study assessed the cost–effectiveness and budget impact of mifamurtide. Methods: The economic evaluation was done on a hypothetical cohort of young patients under the age of 30 with high-grade, non-metastatic, resectable osteosarcoma. Standard chemotherapy without mifamurtide was used as comparator. A Markov model was adapted using Spanish costs and the results of the INT-0133 Phase III study. The analysis has been carried out from the perspective of the Spanish National Health Service, with a time horizon of up to 60 years in the base analysis. Results: The observed greater efficacy of mifamurtide in the trial translates into a gain of 3.03 (undiscounted) and 1.33 (discounted) quality-adjusted life years at an additional cost of €102,000. The estimated budgetary impact of using mifamurtide in 10–100% of the potential population would cost €671,000 and €6.7 million respectively. Conclusion: The cost per quality-adjusted life years gained with mifamurtide in Spain is in the low band (<€100,000) of the iCERs obtained by other orphan drugs and would have a limited and affordable cost in Spain.

Análisis coste-efectividad de rivaroxabán en la prevención de la enfermedad tromboembólica venosa en España

ResumenIntroducción: La enfermedad tromboembólica venosa (ETV) es una enfermedad frecuente y grave que causa un gran impacto sobre el Sistema Nacional de Salud (SNS). El objetivo del presente estudio ha sido realizar un análisis coste-efectividad de rivaroxabán frente a enoxaparina en la prevención de la ETV en pacientes sometidos a cirugía ortopédica mayor en España, desde la perspectiva del SNS. Métodos: Un modelo farmacoeconómico de rivaroxabán frente a enoxaparina permitió replicar los resultados de los estudios RECORD y modelar los costes y efectos a 5 años de la ETV en dos cohortes de pacientes: pacientes sometidos a artroplastia total de cadera (ATC) y pacientes sometidos a artroplastia total de rodilla (ATR). El análisis tomó la perspectiva del SNS, expresando los costes en € de 2008, y descontando costes y efectos al 3% anual. Resultados: Rivaroxabán fue más efectivo que enoxaparina (16 y 29 episodios sintomáticos de ETV menos por cada 1.000 pacientes en ATC y ATR, respectivamente), lo que se tradujo en una moderada ganancia en términos de años de vida ajustados por calidad (AVAC) (11 y 22 AVA C ganados por cada 1.000 pacientes tratados en ATC y ATR, respectivamente). Rivaroxabán presentó un coste total menor que enoxaparina (ahorro por paciente de 30 € y 151 €, en ATC y ATR, respectivamente). Los resultados del análisis de sensibilidad probabilístico mostraron la robustez del análisis a cambios en los parámetros principales del modelo. Conclusiones: La reducción de la incidencia de la ETV, con consecuencias económicas importantes a corto y medio plazo, hace que rivaroxabán sea una opción no sólo más efectiva sino también menos costosa que enoxaparina.AbstractIntroduction: Venous thromboembolic disease (VTE) is a common and serious disease that causes a great impact on the National Health System (NHS). The aim of this study was to perform a cost-effectiveness analysis of rivaroxaban versus enoxaparin in preventing VTE in patients undergoing major orthopedic surgery in Spain from the perspective of the NHS. Methods: A decision analytic model of rivaroxaban versus enoxaparin was used to replicate the short-term results of the RECORD studies and to model the 5-year costs and outcomes of VTE in two cohorts of patients: patients undergoing total hip replacement (THR) and patients undergoing total knee replacement (TKR). The analysis was conducted from the perspective of the NHS. All costs were in euros of 2008. Costs and effects were discounted at a rate of 3% annually. Results: Rivaroxaban was more effective than enoxaparin (16 and 29 fewer symptomatic events per 1,000 patients in THR and TKR, respectively), which resulted in a moderate gain in terms of quality-adjusted life year (QALY) (11 and 22 QALYs gained per 1000 patients treated in THR and TKR, respectively). The lower incidence of complications also resulted in a lower total cost for rivaroxa-ban over enoxaparin, showing cost savings of € 30 and € 151 (for THR and TKR respectively). The results of the probabilistic sensitivity analysis showed the robustness of the analysis when changing the main parameters of the model. Conclusions: Reducing the incidence of VTE, with major economic consequences in the short and medium term, makes rivaroxaban an option not only more effective but also less costly compared with enoxaparin.

Economic evaluation of tramadol/paracetamol in the management of pain in patients with osteoarthritis in Spain

Abstract Objective To compare the costs of treating osteoarthritis (OA) pain using combination tramadol/paracetamol tablets, Non-Steroidal Anti-Inflammatory Agents (NSAID) alone or NSAID plus proton pump inhibitors (PPI) from the perspective of the Spanish National Health System. Methods A decision-analytical model was constructed to analyze the cost associated with three treatment strategies over 6 months. A cost-minimization approach was used, which considered data related to resource use, medication costs and costs for the treatment of adverse events. Results In the base-case analysis, costs for 6 months of treatment of OA pain using tramadol/paracetamol were €232.86, compared with €274.60 for NSAID + PPI and €133.75 for NSAID alone. This provided a savings of €41.74 per patient over 6 months for tramadol/paracetamol compared with NSAID + PPI and a cost increase of €99.11 compared with NSAID alone. When renal adverse events associated with NSAID were considered, tramadol/paracetamol was cost saving compared with all NSAID-based regimens (saving €140.02 vs NSAID alone, €280.86 vs NSAID + PPI). Conclusion Based on the results of a theoretical decision-analytic model, the data obtained may suggest that tramadol/paracetamol is cost saving compared with NSAID + PPI for the treatment of OA pain over a period of 6 months. Tramadol/paracetamol is also cost saving compared with treatment with NSAID alone if considering renal adverse events

Análisis de minimización de costes de fludarabina (Beneflur®) oral vs. vía intravenosa en España

Introduction: Various international studies have shown that fl udarabine is effective, safe, and effi cient for treating B-cell chronic lymphocytic leukemia (B-CLL). The purpose of the present study was to carry out a cost-minimization analysis for two alternative forms of fl udarabine (oral and intravenous) used to treat B-CLL in Spain. Methods: The presence of clinical evidence about the treatment equivalence of the two options being compared (oral fl udarabine vs. intravenous fl udarabine) led us to carry out a cost-minimization analysis. A pharmacoeconomic model was constructed to compile data from the literature and experts’ opinions in order to determine the use of health resources associated with the treatment; unit costs were obtained from Spanish databases. The analysis contemplated two perspectives: that of the national health service, which includes only direct health costs, and the social perspective, which also includes the indirect costs that result from loss of productivity. Results: Although fludarabine in its oral form has a higher purchase price than generic intravenous fl udarabine does, increased administration costs for the latter, which is used in hospitals, mean that oral fl udarabine use produces total savings of €1,908 and €1,292 for single-drug therapy and combined therapy with cyclophosphamide, respectively. Including indirect costs increased the savings associated with the oral form of the drug. Conclusions: In B-CLL patients, treatment with oral fl udarabine has a lower cost than treatment with intravenous fludarabine, in both single-drug therapy and combined therapy. Various sensitivity analyses confi rmed these results and showed that oral fl udarabine should be the treatment of choice for B-CLL in Spain, unless contraindicated.