Spanish Healthcare Setting Research Articles

Cost-Utility Analysis of Adjuvant Olaparib for Germline BRCA1/2-Mutated, High-Risk HER2-Negative Early Breast Cancer in Spain.

Here we estimate the cost-effectiveness of olaparib in the Spanish National Health Service (SNHS) as adjuvant treatment of early germline mutations in the BRCA1/2 genes (gBRCAm) HER2-negative (HER2neg) breast cancer (BC) with high risk of recurrence. A semi-Markov model was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a lifetime horizon. Two scenarios were compared: receiving olaparib versus standard of care (SoC) treatment. The model comprised five health states and included the clinical results of the OlympiA trial, along with the direct healthcare costs associated with the use of early BC and subsequent treatment resources (€2023). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was carried out. The introduction of olaparib as adjuvant treatment for patients with early gBRCAm HER2neg BC with high risk of recurrence could involve an incremental cost of €44,273 and €50,164, with an improvement of 1.14 and 1.28 quality-adjusted life years (QALYs) for hormone receptor-positive (HR+) and triple-negative (TN) patients, respectively. Therefore, adjuvant olaparib could be cost-effective for early gBRCAm HER2neg BC, with an incremental cost-effectiveness ratio of €38,839/QALY and €39,084/QALY for HR+ and TN patients, respectively. The results from the PSA showed that 75.7% and 82.2% of the simulations fell below the €60,000/QALY threshold. Olaparib as adjuvant treatment could be cost-effective in gBRCAm patients with early HER2neg BC in Spain.

Design and Validation of a Questionnaire to Measure Patient Experience in Relation to Hospital Nursing Care.

a questionnaire containing 29 items alongside socio-demographic questions was developed. It was distributed to 158 patients admitted to a tertiary hospital. The psychometric properties were assessed through principal components analysis and confirmatory factor analysis to evaluate construct validity, employing Cronbach's alpha to test reliability. The final tool contains 17 items grouped into 5 dimensions: interrelations, nursing care, information during hospital stay, information about patient's rights, and discharge information. Two additional questions related to pain were added. The questionnaire showed adequate validity and reliability. we describe a new tool validated and adapted to the Spanish healthcare setting with adequate validity and reliability to assess patient experience with nursing professionals during hospital stay. This tool will serve to identify areas for improvement in hospital nursing care and as an instrument in the management and supervision of nursing teams.

Economic evaluation of pharmacogenomic-guided antiplatelet treatment in Spanish patients suffering from acute coronary syndrome participating in the U-PGx PREPARE study

BackgroundCardiovascular diseases and especially Acute Coronary Syndrome (ACS) constitute a major health issue impacting millions of patients worldwide. Being a leading cause of death and hospital admissions in many European countries including Spain, it accounts for enormous amounts of healthcare expenditures for its management. Clopidogrel is one of the oldest antiplatelet medications used as standard of care in ACS.MethodsIn this study, we performed an economic evaluation study to estimate whether a genome-guided clopidogrel treatment is cost-effective compared to conventional one in a large cohort of 243 individuals of Spanish origin suffering from ACS and treated with clopidogrel. Data were derived from the U-PGx PREPARE clinical trial. Effectiveness was measured as survival of individuals while study data on safety and efficacy, as well as on resource utilization associated with each adverse drug reaction were used to measure costs to treat these adverse drug reactions. A generalized linear regression model was used to estimate cost differences for both study groups.ResultsBased on our findings, PGx-guided treatment group is cost-effective. PGx-guided treatment demonstrated to have 50% less hospital admissions, reduced emergency visits and almost 13% less ADRs compared to the non-PGx approach with mean QALY 1.07 (95% CI, 1.04–1.10) versus 1.06 (95% CI, 1.03–1.09) for the control group, while life years for both groups were 1.24 (95% CI, 1.20–1.26) and 1.23 (95% CI, 1.19–1.26), respectively. The mean total cost of PGx-guided treatment was 50% less expensive than conventional therapy with clopidogrel [€883 (95% UI, €316–€1582), compared to €1,755 (95% UI, €765–€2949)].ConclusionThese findings suggest that PGx-guided clopidogrel treatment represents a cost-effective option for patients suffering from ACS in the Spanish healthcare setting.

POSA163 Estimating the Budget Impact of the Introduction of Filgotinib for the Treatment of Ulcerative Colitis in Spain

Filgotinib is an orally administered preferential JAK1 inhibitor that has been shown to be effective in treating ulcerative colitis (UC). This study estimates the budget impact of introducing filgotinib as a new targeted synthetic UC treatment into the Spanish healthcare setting.

Olaparib as first line in BRCA-mutated advanced ovarian carcinoma: Is it cost-effective in Spain?

ObjectiveTo estimate the cost-effectiveness of olaparib after being funded by the Spanish National Health Service (SNHS) as first-line monotherapy maintenance treatment in patients with advanced high-grade serous ovarian carcinoma (HGSOC) and BRCA mutations in Spain. MethodsA semi-Markov model with one-month cycles was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a time horizon of 50 years. Two scenarios were compared: receiving olaparib vs. no maintenance treatment. The model comprised four health states and included the clinical results of the SOLO1 study, along with the direct healthcare costs associated with the use of first-line and subsequent treatment resources (2020 €). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was also carried out and a cost-effectiveness threshold of €25,000 per quality adjusted life year (QALY) was considered. ResultsThe introduction of olaparib as a first-line maintenance treatment for advanced HGSOC patients with BRCA mutations implied a cost of €131,614.98 compared to €102,369.54 without olaparib (difference: €29,245.44), with an improvement of 2.00 QALYs (5.56 and 3.57, respectively). Therefore, olaparib is cost-effective for advanced HGSOC patients with BRCA mutations, with an incremental cost-effectiveness ratio of €14,653.2/QALY. The results from the PSA showed that 92.1% of the simulations fell below the €25,000/QALY threshold. The model showed that olaparib could improve the overall survival by 2 years, vs. no maintenance treatment. ConclusionsOlaparib as first-line maintenance treatment is cost-effective in advanced HGSOC patients with BRCA mutations in Spain.

Economic impact of improving patient safety using Sugammadex for routine reversal of neuromuscular blockade in Spain

BackgroundNeuromuscular blocking (NMB) agents are often administered to facilitate tracheal intubation and prevent patient movement during surgical procedures requiring the use of general anesthetics. Incomplete reversal of NMB, can lead to residual NMB, which can increase the risk of post-operative pulmonary complications. Sugammadex is indicated to reverse neuromuscular blockade induced by rocuronium or vecuronium in adults. The aim of this study is to estimate the clinical and economic impact of introducing sugammadex to routine reversal of neuromuscular blockade (NMB) with rocuronium in Spain.MethodsA decision analytic model was constructed reflecting a set of procedures using rocuronium that resulted in moderate or deep NMB at the end of the procedure. Two scenarios were considered for 537,931 procedures using NMB agents in Spain in 2015: a scenario without sugammadex versus a scenario with sugammadex. Comparators included neostigmine (plus glycopyrrolate) and no reversal agent. The total costs for the healthcare system were estimated from the net of costs of reversal agents and overall cost offsets via reduction in postoperative pneumonias and atelectasis for which incidence rates were based on a Spanish real-world evidence (RWE) study. The model time horizon was assumed to be one year. Costs were expressed in 2019 euros (€) and estimated from the perspective of a healthcare system. One-way sensitivity analysis was carried out by varying each parameter included in the model within a range of +/− 50%.ResultsThe estimated budget impact of the introduction of sugammadex to the routine reversal of neuromuscular blockade in Spanish hospitals was a net saving of €57.1 million annually. An increase in drug acquisition costs was offset by savings in post-operative pulmonary events, including 4806 post-operative pneumonias and 13,996 cases of atelectasis. The total cost of complications avoided was €70.4 million. All parameters included in the model were tested in sensitivity analysis and were favorable to the scenario with sugammadex.ConclusionsThis economic analysis shows that sugammadex can potentially lead to cost savings for the reversal of rocuronium-induced moderate or profound NMB compared to no reversal and reversal with neostigmine in the Spanish health care setting. The economic model was based on data obtained from Spain and from assumptions from clinical practice and may not be valid for other countries.

Análisis y recomendaciones para la mejora de la gestión clínica y la atención del cáncer de mama metastásico en España

Metastatic breast cancer (MBC) is the first cause of cancer-related mortality among women and poses major challenges in clinical practice and for persons with the disease and their families. With the collaboration of a wide panel of medical oncologists and patient representatives, this project analysed the resources (planning tools, cancer registries), healthcare processes (diagnosis, treatment, palliative care) and related processes (psychosocial care, healthy lifestyles, role of patient associations) in the approach to MBC in the Spanish healthcare setting. The work carried out allowed identification a series of areas for improvement and a proposal for 42 recommendations aimed at improving healthcare quality and the care of patients with MBC and their carers organized in the following areas: cancer registries, liaison between healthcare levels, diagnosis of metastasis, communication and interpersonal skills, drug access, clinical trials, the role of nurses in MBC, palliative care, psychosocial care, and promotion of healthy lifestyles. These recommendations, drafted from an integrated perspective and based on the characteristics of the Spanish healthcare setting, provide a springboard for healthcare improvement and could be of strong value to other healthcare settings facing the same challenges in the approach to MBC.

Cost-effectiveness analysis of pharmacogenomics-guided clopidogrel treatment in Spanish patients undergoing percutaneous coronary intervention.

Clopidogrel is an antiplatelet drug given to patients before and after having a percutaneous coronary intervention (PCI). Genomic variants in the CYP2C19 gene are associated with variable enzyme activities affecting drug metabolism and hence, patients with reduced or increased enzymatic function have increased risk of bleeding. We conducted a cost-effectiveness analysis to compare a pharmacogenomics versus a non-pharmacogenomics-guided clopidogrel treatment for coronary artery syndrome patients undergoing PCI in the Spanish healthcare setting. A total of 549 patients diagnosed with coronary artery disease followed by PCI were recruited. Dual antiplatelet therapy was administrated to all patients from 1 to 12 months after PCI. Patients were classified into two groups: the Retrospective group was treated with clopidogrel based on the clinical routine practice and the Prospective group were initially genotyped for the presence of CYP2C19 variant alleles before treatment with those carrying more than one CYP2C19 variant alleles given prasugrel treatment. We collected data on established clinical and health outcome measures, including, per treatment arm: the percentage of patients that suffered from (a) myocardial infraction, (b) major bleeding and minor bleeding, (c) stroke, (d) the number of hospitalization days, and (e) the number of days patients spent in Intensive Care Unit. Our primary outcome measure for the cost-effectiveness analysis was Quality Adjusted Life Years (QALYs). To estimate the treatment cost for each patient, individual data on its resource used were combined with unit price data, obtained from Spanish national sources. The analysis predicts a survival of 0.9446 QALYs in the pharmacogenomicsarm and 0.9379 QALYs in the non-pharmacogenomics armwithin a 1-year horizon. The cumulative costs per patient were €2971 and €3205 for the Prospective and Retrospective groups, respectively. The main cost driver of total cost in both arms was hospitalization costs. The incremental cost-effectiveness ratio (ICER) was negative indicating that the PGx was a dominant option. Our data show that pharmacogenomics-guided clopidogrel treatment strategy may represent a cost-effective choice compared with non-pharmacogenomics-guided strategy for patients undergoing PCI.

PSY52 - ECONOMIC IMPACT OF IMPROVING PATIENT SAFETY USING SUGAMMADEX FOR ROUTINE REVERSAL OF NEUROMUSCULAR BLOCKADE IN SPAIN

Neuromuscular blocking (NMB) agents are often administered to facilitate tracheal intubation and prevent patient movement during surgical procedures requiring the use of general anesthetics. Incomplete reversal of NMB, can lead to residual NMB, which can increase the risk of post-operative pulmonary complications. Sugammadex is indicated to reverse neuromuscular blockade induced by rocuronium or vecuronium in adults. The aim of this study is to estimate the clinical and economic impact of introducing sugammadex to routine reversal of neuromuscular blockade (NMB) with rocuronium in Spain. A decision analytic model was constructed reflecting a set of procedures using rocuronium that resulted in moderate or deep NMB at the end of the procedure. Two scenarios were considered for 537,931 procedures using NMB agents in Spain in 2015: a scenario without sugammadex versus a scenario with sugammadex. Comparators included neostigmine (plus glycopyrrolate) and no reversal agent. The total costs for the healthcare system were estimated from the net of costs of reversal agents and overall cost offsets via reduction in postoperative pneumonias and atelectasis for which incidence rates were based on a Spanish real-world evidence (RWE) study. The model time horizon was assumed to be one year. Costs were expressed in 2019 euros (€) and estimated from the perspective of a healthcare system. One-way sensitivity analysis was carried out by varying each parameter included in the model within a range of +/− 50%. The estimated budget impact of the introduction of sugammadex to the routine reversal of neuromuscular blockade in Spanish hospitals was a net saving of €57.1 million annually. An increase in drug acquisition costs was offset by savings in post-operative pulmonary events, including 4806 post-operative pneumonias and 13,996 cases of atelectasis. The total cost of complications avoided was €70.4 million. All parameters included in the model were tested in sensitivity analysis and were favorable to the scenario with sugammadex. This economic analysis shows that sugammadex can potentially lead to cost savings for the reversal of rocuronium-induced moderate or profound NMB compared to no reversal and reversal with neostigmine in the Spanish health care setting. The economic model was based on data obtained from Spain and from assumptions from clinical practice and may not be valid for other countries.

PIN44 - ECONOMIC EVALUATION OF 60+ YEARS ADULT VACCINATION STRATEGY USING PNEUMOCOCCAL POLYSACCHARIDE VACCINE IN SPAIN

Invasive pneumococcal disease (IPD) and non bacteremic pneumococcal pneumonia (NBPP) represent an important health problem among older adult population. Currently, in Spain the use of PPV23 is recommended for all individuals above 65 years and for individuals with certain chronic diseases, and, in addition, the use of PCV13 is recommended for those with immunosuppression and with specific underlying conditions. This study was aiming to estimate the incremental cost-effectiveness ratio (ICER) of vaccinating immunocompetent adults aged 60+ with PPV23 compared to a sequential vaccination strategy (PCV13-PPV23). A Markov model was adapted to the Spanish healthcare setting to simulate incidence and consequences of NBPP and IPD. Parameters such as vaccine effectiveness, disease incidence, utilities, and costs were based on published data. The analysis was conducted from the perspective of the Spanish National Healthcare System (SNHS), with a lifetime horizon. Waning effect over time was considered for both vaccines’ effectiveness. Outcomes and costs were both discounted at 3% annually. Official list prices were used in the base case. Deterministic sensitivity analyses (DSA) were performed to explore the impact of parametric uncertainty. Additionally, the analysis assessed the ICER of starting vaccination at the age of 60 vs 65 with different strategies. The sequential vaccination strategy would prevent 3,340 cases of IPD, 14,451 cases of NBPP and 2,417 deaths related to pneumococcal disease compared to the PPV23 strategy. The sequential strategy presented a larger number of quality-adjusted life-years (QALYs) compared to PPV23 alone but also increased the total costs by more than €218 million, resulting an ICER of €42,259 per QALY gained. A sequential vaccination strategy of immunocompetent adults aged 60+ with PCV13-PPV23 would result in an improvement in health outcomes, but at a cost exceeding typical cost-effective benchmarks for Spain, compared to PPV23 alone.

National recommendations document on the follow-up of patients with renal cell carcinoma

ObjectivesThis document was developed to establish directives for the follow-up of patients with renal cell carcinoma (RCC) based on the best available scientific evidence and on expert opinions, which can help urologists in the decision-making process and standardize the criteria at the national level. Material and methodsThe methodology is based on the RAND/UCLA method. A panel of 9 experts on RCC participated in designing a thematic index, identifying and reading the available evidence, formulating recommendations and drafting the content. A validating group of 25 experts, who did not participate in the previous phases, assessed the recommendations through anonymous voting in a face-to-face consensus meeting. The recommendations that were agreed upon by 75% or more of the participants in this vote were accepted as consensus. The recommendations that did not achieve this consensus were rejected. ResultsA total of 25 recommendations were accepted as consensus. These recommendations cover the laboratory tests, clinical assessment tests and imaging tests that should be performed for patients with RCC. The presented recommendations have been adapted according to relapse risk. The current document also outlines the frequency and duration of follow-up for each patient profile. ConclusionsThe current document enables standardization of the follow-up criteria for patients with RCC treated in the Spanish healthcare setting, according to the patients’ relapse risk.

Documento nacional de recomendaciones sobre el seguimiento del paciente con carcinoma de células renales

ObjectivesThis document was developed to establish directives for the follow-up of patients with renal cell carcinoma (RCC) based on the best available scientific evidence and on expert opinions, which can help urologists in the decision-making process and standardise the criteria at the national level. Material and methodsThe methodology is based on the RAND/UCLA method. A panel of 9 experts on RCC participated in designing a thematic index, identifying and reading the available evidence, formulating recommendations and drafting the content. A validating group of 25 experts, who did not participate in the previous phases, assessed the recommendations through anonymous voting in a face-to-face consensus meeting. The recommendations that were agreed upon by 75% or more of the participants in this vote were accepted as consensus. The recommendations that did not achieve this consensus were rejected. ResultsA total of 25 recommendations were accepted as consensus. These recommendations cover the laboratory tests, clinical assessment tests and imaging tests that should be performed for patients with RCC. The presented recommendations have been adapted according to relapse risk. The current document also outlines the frequency and duration of follow-up for each patient profile. ConclusionsThe current document enables standardisation of the follow-up criteria for patients with RCC treated in the Spanish healthcare setting, according to the patients’ relapse risk.

Cost-effectiveness Analysis of Rivaroxaban versus Acenocoumarol in the Prevention of Stroke in Patients with Non-valvular Atrial Fibrillation in Spain.

Objective: The aim of this study was to evaluate, from the Spanish National Health System perspective, the cost-effectiveness of rivaroxaban (20 mg/day) versus use of acenocoumarol (5 mg/day) for the treatment of patients with non-valvular atrial fibrillation (NVAF) at moderate to high risk for stroke. Methods: A Markov model was designed and populated with local cost estimates, efficacy and safety of rivaroxaban in stroke prevention in NVAF compared with adjusted-dose warfarin clinical results from the pivotal phase III ROCKET AF trial and utility values obtained from the literature. Warfarin and acenocoumarol were assumed to have therapeutic equivalence. Results: Rivaroxaban treatment was associated with fewer ischemic strokes and systemic embolisms (0.289 vs.0.300 events), intracranial bleeds (0.051 vs.0.067), and myocardial infarctions (0.088 vs.0.102) per patient compared with acenocoumarol. Over a lifetime time horizon, rivaroxaban led to a reduction of 0.041 life-threatening events per patient, and increases of 0.103 life-years and 0.155 quality-adjusted lifeyears (QALYs) versus acenocoumarol treatment. This resulted in an incremental cost-effectiveness ratio of €7045 per QALY and €10 602 per life-year gained. Sensitivity analysis indicated that these results were robust and that rivaroxaban is cost-effective compared with acenocoumarol in 89.4% of cases should a willingness-to-pay threshold of €30 000/QALY gained be considered. Conclusions: The present analysis suggests that rivaroxaban is a cost-effective alternative to acenocoumarol therapy for the prevention of stroke and systemic embolisms in patients with NVAF in the Spanish healthcare setting.

Pharmacoeconomic evaluation of dabigatran, rivaroxaban and apixaban versus enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement in Spain.

Patients undergoing total hip replacement (THR) or total knee replacement (TKR) surgery are at high risk of developing venous thromboembolism (VTE). Thromboprophylaxis with low-molecular-weight heparin, such as enoxaparin, is standard of care in these patients. Recently, three direct oral anticoagulants (DOACs; dabigatran, rivaroxaban and apixaban), have been approved for this indication, but their cost effectiveness is still unclear as it has usually been extrapolated from surrogate venographic outcomes in clinical trials. To conduct a pharmacoeconomic evaluation of the DOACs versus subcutaneous (SC) enoxaparin for the prevention of VTE after THR or TKR surgery. A decision-tree model was developed using TreeAge Pro 2011 to compare the cost utility and cost effectiveness of the DOACs with SC enoxaparin, with separate models for THR and TKR over a 3-month postoperative time horizon from the perspective of the Spanish National Health System. The probabilities of events (symptomatic VTE, clinically relevant bleedings, heparin-induced thrombocytopenia and deaths) were derived from a systematic review and meta-analysis. We used local cost estimates (€2013) and utility values were obtained from the literature. We reported costs, quality-adjusted life-years (QALYs) and symptomatic VTE events. We conducted sensitivity analyses to evaluate parameter uncertainty. The average costs per 1,000 patients treated with enoxaparin were higher than costs incurred by dabigatran, rivaroxaban and apixaban in THR (€435,208 vs. €283,574, €257,900 and €212,472, respectively) and TKR (€336,550 vs. €219,856, €251,734 and €201,946, respectively), with cost savings ranging from €151,634 to €222,766 in THR, and from €84,816 to €134,604 in TKR. Cost differences were largely driven by differences in costs associated with drug administration. The average QALYs per 1,000 patients treated were very similar for enoxaparin, dabigatran, rivaroxaban and apixaban in THR (199.34, 198.83, 199.08 and 199.68, respectively) and TKR (198.95, 199.41, 198.75 and 199.97, respectively). Rivaroxaban (in TKR and THR) and apixaban (in THR) avoided additional symptomatic VTE events compared with enoxaparin. Sensitivity analyses generally supported the robustness of the analysis to changes in model parameters. Our model suggests, based on its underlying assumptions and data, that the DOACs are cost-saving alternatives to SC enoxaparin for the prevention of VTE after THR or TKR, in the Spanish healthcare setting.

The cost-effectiveness of paliperidone extended release in Spain

Background:Paliperidone Extended Release OROS (ER) is a new atypical antipsychotic for the treatment of schizophrenia. The objective is, based on a previously published model, to analyze the clinical and economic effects of Paliperidone ER in a Spanish setting compared to olanzapine oral and aripiprazole.Methods:An existing discrete event simulation model was adapted to reflect the treatment of schizophrenia in Spain in terms of costs, resource use, and treatment patterns. Inputs for the model were derived from clinical trial data, literature research, database analysis and interviews with local clinical experts. The time horizon is 5 years and Spanish discount rate was applied. Outputs include direct medical costs and Quality Adjusted Life-Years (QALYs). Extensive sensitivity analyses were carried out to assess the robustness of the results, using ordinary least squares analysis and cost-effectiveness scatter plots.Results:The results show that the mean incremental QALYs (95% CI) compared to olanzpine is 0.033 [−0.143, 0.304] and compared to aripiprazole 0.029 [−0.107, 0.300]. The corresponding mean incremental costs and corresponding confidence intervals are −€1425 [−€10,247, €3084] and −€759 [−€10,479, €3404], respectively. The probability that paliperidone ER is cost-saving and health gaining compared to olanzapine and aripiprazole is 76% and 72%, respectively. Paliperidone ER was estimated to have 80% and 81% probability of being cost-effective compared to olanzapine at a willingness to pay of €20,000 and €30,000 and 73% and 74% compared to aripiprazole, respectively.Limitations:Some of the modeled inter-relationships had to be based on expert opinion due to a lack of information. Also, foreign sources for the disutility of adverse events had been used due to a lack of Spanish data. Prolactin-related side-effects, indirect costs, and potential compliance advantages of paliperidone ER were not considered. It is unlikely that these limitations affected the conclusions.Conclusion:Based on differences in drug acquisition costs, side-effects, and risk of relapse, the model predicts that, in the Spanish healthcare setting, paliperidone ER dominates oral olanzapine and aripiprazole, with a probability of 76% and 72%, respectively.

Cost-effectiveness evaluation of sunitinib as first-line targeted therapy for metastatic renal cell carcinoma in Spain

INTRODUCTION Sunitinib, an oral, multitargeted receptor tyrosine kinase inhibitor, delays disease progression, with a median overall survival (OS) of more than 2 years, improves quality of life and is becoming the first-line standard of care for metastatic renal carcinoma (mRCC). PURPOSE To assess the economic value of sunitinib as fi rst-line therapy in mRCC within the Spanish healthcare system. METHODS An adapted Markov model with a 10-year time horizon was used to analyse the cost effectiveness of sunitinib vs. sorafenib (SFN) and bevacizumab/interferon-α (BEV/IFN) as first-line mRCC therapy from the Spanish third-party payer perspective. Progression-free survival (PFS) and OS data from sunitinib, SFN and BEV/IFN pivotal trials were extrapolated to project survival and costs in 6-week cycles. Results, in progression-free life-years (PFLY), life years (LY) and quality-adjusted life-years (QALY) gained, expressed as incremental cost-effectiveness ratios (ICER) with costs and benefits discounted annually at 3%, were obtained using deterministic and probabilistic analyses. RESULTS Sunitinib was more effective and less costly than both SFN (gains of 0.52 PFLY, 0.16 LY, 0.17 QALY) and BEV/IFN (gains of 0.19 PFLY, 0.23 LY, 0.16 QALY) with average cost savings/patients of €1,124 and €23,218, respectively. Using a willingness-to-pay (WTP) threshold of €50,000/QALY, sunitinib achieved an incremental net benefit (INB) of €9,717 and €31,211 compared with SFN and BEV/IFN, respectively. At this WTP, the probability of sunitinib providing the highest INB was 75%. CONCLUSION Our analysis suggests that sunitinib is a costeffective alternative to other targeted therapies as first-line mRCC therapy in the Spanish healthcare setting.

Economic Assessment of Cardiac Resynchronization Therapy

Cardiac resynchronization devices have been shown to be effective in treating heart failure. They reduce overall mortality, heart failure mortality and hospitalizations due to heart failure. The aim of this study was to compare the cost-effectiveness of cardiac resynchronization therapy (CRT) with that of optimal drug therapy (ODT) by carrying out an economic assessment in the Spanish healthcare setting. An existing model was adapted for use in the Spanish healthcare setting. The effectiveness of cardiac resynchronization therapy was determined from published systematic reviews. The costs of the various interventions were determined using a range of Spanish data sources. The model adopted the perspective of the public health system and the time horizon considered was the remainder of the patient's life. The outcome variables were life-years gained and quality-adjusted life-years (QALYs) gained. Overall, ODT, CRT and CRT with a defibrillator resulted in gains of 2.11, 2.8 and 3.19 QALYs, respectively, at a cost of €11,722, €31,629 and €52,592, respectively. Consequently, each QALY gained with CRT relative to ODT involved the consumption of €28,612 of additional resources. Similarly, the use of CRT with a defibrillator cost an additional €53,547 per QALY relative to CRT without a defibrillator. The use of CRT without a defibrillator could be a cost-effective alternative to ODT for treating heart failure in a carefully selected group of patients. The study results were sensitive to uncertainties in many of the variables used in the model.

Cost-effectiveness of pregabalin versus venlafaxine in the treatment of generalized anxiety disorder: findings from a Spanish perspective

The objective of the present study was to describe a new model of the cost-effectiveness of treatment of generalized anxiety disorder (GAD) and its application to a comparison of pregabalin versus venlafaxine extended-release (XR) from a Spanish healthcare perspective. Microsimulation techniques, including Hamilton Anxiety Scale (HAM-A) score, number of weeks with minimal or no anxiety (HAM-A ≤ 9), and quality-adjusted life-years (QALYs), were used to predict treatment outcomes for patients with moderate-to-severe GAD who would be treated with pregabalin vs venlafaxine XR. Expected levels of healthcare utilization and unit cost of care are derived from Spanish published sources. We express cost-effectiveness alternatively in terms of incremental cost per additional week with minimal or no anxiety, and incremental cost per QALY gained [in 2007 Euros (€)]. Considering costs of drug treatment only, the incremental cost [mean (95% confidence interval)] of pregabalin (vs venlafaxine XR) would be €96 (€86, €107) per additional week with minimal or no anxiety, and €32,832 (€29,656, €36,308) per QALY gained. When other medical care costs are considered, cost-effectiveness ratios decline to €70 (€61, €80) per additional week with no or minimal anxiety, and €23,909 (€20,820, €27,006) per QALY gained. We conclude that, using a new microsimulation model of the treatment of GAD, pregabalin appears to be cost-effective vs venlafaxine XR in a Spanish healthcare setting.

Pharmacoeconomic analysis of bemiparin and enoxaparin as prophylaxis for venous thromboembolism in total knee replacement surgery.

Low molecular weight heparins are effective and have a good tolerability profile as first-line prophylaxis for venous thromboembolism (VTE) in major orthopaedic surgery. However, pharmacological inequivalence within the class could lead to differences in cost-effectiveness ratios. To quantify the potential economic impact of subcutaneous bemiparin sodium 3500 IU/day compared with enoxaparin sodium 40 mg/day as prophylaxis for VTE in patients undergoing total knee replacement (TKR) surgery, considering both in-hospital and post-discharge outcomes and costs during 6 weeks of postoperative follow-up. A cost-effectiveness analysis was performed using a decision modelling approach. The results were expressed in terms of costs and incremental cost effectiveness in Euro (2002 values). The treatment costs (hospital stay, physician services, drug administration) and costs incurred due to complications such as pulmonary embolism and/or proximal deep vein thrombosis, bleeding events, wound haematoma and thrombocytopenia were considered for this analysis. The target population comprised all adult patients undergoing TKR surgery included in a previous clinical trial (n = 381). The study was conducted in the setting of the Spanish National Health System. The time horizon chosen was 6 weeks. Bemiparin provided cost savings of Euro144.48 per patient compared with enoxaparin when costs derived from treatment and complications during the 6-week postoperative period were considered (Euro4675.01 vs Euro4819.49). Pharmacy costs per patient were lower for bemiparin during hospital stay (Euro43.34 vs Euro50.20; difference, Euro-6.86) and for post-discharge prophylaxis (Euro68.63 vs Euro87.78; difference Euro-19.15). Bemiparin was calculated to avoid 42 additional VTE events per 1000 patients treated at 6 weeks. The incremental cost-effectiveness analysis indicated that bemiparin was dominant over enoxaparin, producing better outcomes and cost savings. The sensitivity analysis supported the cost effectiveness of bemiparin in all the ranges tested for complications and costs. Our model suggests, based on its underlying assumptions and data, that bemiparin may be more cost effective than enoxaparin for thromboprophylaxis in total knee replacement surgery in the Spanish healthcare setting.

Cost-benefit analysis of Haemophilus influenzae type b vaccination in children in Spain.

Invasive disease caused by Haemophilus influenzae type b (Hib), including meningitis, pneumonia, sepsis and epiglottitis, is associated with high mortality and serious neurological sequelae in children under 5 years of age. The availability of an efficacious vaccine suggests the need to perform an economic evaluation of its use. The objective of this study was to evaluate the costs and benefits of introducing a universal vaccination programme for children under 1 year of age in Spain. A cost-benefit analysis (CBA) was conducted over a 5-year period from the societal perspective in the Spanish healthcare setting. Both direct and indirect costs were included in the analysis [using 1996 Spanish pesetas (Pta); Pta126.5 = $US1 in April 1996]. The target population used for cost and benefit estimation was the 384,883 Spaniards aged 1 year or less in the last Spanish Population and Housing Census of 1991. The introduction of the universal Hib vaccination programme would imply vaccinating 346,395 children under 1 year of age, with a global expense of Pta2,444,855,910. For an average incidence of 15 cases of invasive disease per 100,000 children per year nationwide, the programme would prevent 219 cases of invasive disease and 8 deaths over a 5-year period, with a benefit of Pta2,182,868,907, a net benefit (i.e. benefit minus cost) of -Pta261,987,003, a benefit/cost ratio of 0.89 and a benefit per case prevented of -Pta1,196,288. Benefit/cost ratios above 1 would be obtained in the regions of highest incidence of invasive disease. The decision to implement a universal vaccination programme should not be based only on economic factors, but our results suggest that the economic returns of the programme for children under 1 year of age in Spain would be at least of a similar magnitude as its expenses.