Unmet Needs in the Management of Moderate-to-Severe Psoriasis in Spain: A Multidimensional Evaluation.

Psoriasis is a chronic, systemic inflammatory disease that affects the skin, with a high impact on patients' quality of life. The aim of this study was to identify and determine the relative importance of unmet needs in the management of moderate-to-severe psoriasis in Spain, from a multi-stakeholder perspective. A mixed method-approach was used to collect information, design a questionnaire and a discrete-choice exercise, and elicit the unmet needs through a multidisciplinary committee composed of 12 experts. A total of 65 unmet needs were identified and categorized into 4 areas: clinical, patient-related, decision-making process, and social. Decision-making process unmet needs were perceived as the most pressing ones, followed by social, clinical and patient-related. Individually, the need to incorporate outcomes that are important to the patients and to have treatments that achieve total clearance with a rapid onset of action and long-term persistence were the most important unmet needs.

Clinical and economic consequences of ozenoxacin vs. other topical antibiotics for the treatment of impetigo: a real-life study in Spain.

Background: Impetigo is a common dermatological paediatric infection that can be treated with topical antibiotics: the common are mupirocin (MUP), fusidic acid (FA) and, most recently, ozenoxacin (OZ). Aim: This study assesses the clinical and economic consequences of the use of OZ vs. MUP and vs. FA for the treatment of impetigo in routine clinical practice in Spain. Methods: This is a retrospective observational study using real-life data from electronic medical records of patients with impetigo who started treatment with OZ, MUP or FA (maximum follow-up: 3 months; n = 10,974). We compared treatment duration, comorbidities, use of systemic medication, complications, utilization of resources and associated costs across treatments (p<0.05). Cost-effectiveness of OZ was assessed from a social perspective. Complication rates and treatment duration were the effectiveness measures. Results: Mean age was 12.6 (standard deviation [SD]: 16.6) years; 48.6% were male; treatment: 9.3% (OZ), 56.4% (MUP), 34.5% (FA). The percentage of patients ending treatment after 2 weeks was 87.6% (OZ) vs. 83.2% (MUP) vs. 82.4% (FA); p<0.001; complication rates were 1.8% (OZ), 3.3% (MUP) and 3.2% (FA), p<0.001; mean costs were €158 (OZ), €265 (MUP) and €287 (FA), p<0.001. Conclusions: OZ is a cost-effective and dominant alternative for the treatment of impetigo.

Health-related quality of life of patients diagnosed with COPD in Extremadura, Spain: results from an observational study.

BACKGROUND: COPD is a high prevalence chronic disease that involves large reductions of health-related quality of life (HRQL) of patients. This study aims to describe the HRQL of patients with COPD in Extremadura (Spain). METHODS: This is a cross-sectional observational study carried out using a representative sample of patients diagnosed with COPD in Extremadura. The inclusion criteria were patients of legal age, diagnosed with COPD at least 12 months prior to the visit, residing in Extremadura, with electronic medical records available for the 12 months prior to the visit and providing informed consent. The intervention aimed to elicit HRQL indicators obtained from two validated questionnaires: EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L), and St. George's Respiratory Questionnaire-COPD (SGRQ-C). The main outcome measures were general HRQL (utility and visual analogue scale) and specific quality of life of COPD patients (total score and three component scores: Symptoms, Activity, and Impacts). Stepwise multiple regression analysis was applied to evaluate the association of EQ-5D-5L and SGRQ-C with respect to clinical and sociodemographic characteristics of the patients. RESULTS: We recruited 386 patients (mean age 71.8 ± 10.3 years, 76.2% males). In the EQ-5D-5L, participants reported greater problems with respect to mobility (56.5%) and pain/discomfort (48.2%). The mean utility was 0.72 ± 0.31, and the SGRQ-C total score was 40.9 ± 25.0. The results of both questionnaires were associated with number of exacerbations in the last 12 months, level of COPD severity, gender, and education level of the patient (p < 0.05). CONCLUSIONS: The results for both utility and total SGRQ-C score indicate that having suffered exacerbations in the last year, presenting a higher level of severity, being a woman, and having a low education level are related to worse HRQL in patients with COPD.

Social economic costs of COPD in Extremadura (Spain): an observational study.

Purpose: COPD has been associated with a high number of comorbidities and a relatively high level of health care resource utilization. This study aimed to estimate the social economic impact of COPD in the autonomous community of Extremadura (Spain) in 2015. Patients and methods: This is a retrospective observational study carried out using a representative sample of patients diagnosed with COPD in Extremadura. Sociodemographic data, data on health care resource utilization, formal and informal care received by the patients, and loss of labor productivity in the last 12 months were collected through an electronic data collection platform. Direct health care costs were estimated using the bottom-up approach, costs of informal care were assessed using the substitution method, and labor productivity losses were calculated using the human capital method. Results: A sample of 386 patients was obtained (mean age: 71.8±10.3 years, males: 76.2%). The results show an average annual cost per patient of 3,077 euros. Direct health care costs represented 43.8% (1,645 euros), direct non-health care costs amounted to 38.3% (1,440 euros), and labor productivity losses represented 17.9% (672 euros) of the average annual cost. The total annual cost of patients with COPD in Extremadura reached 36.2 million euros in 2015. Conclusion: COPD poses a significant burden for the health care system and the society of Extremadura. The implementation of preventive and control measures could result in a substantial reduction in the economic impact.

The Impact of Severe Obesity on Healthcare Resource Utilisation in Spain.

BACKGROUND: Obesity is not only a health problem but also a source of increased monetary expenditures. The objectives of this study were to analyse the use of healthcare resources in the Spanish adult population with class II obesity and above (BMI ≥35 kg/m2) and to compare it with other BMI groups. METHOD: We used the Spanish National Health Survey, a longitudinal population-based survey (n = 18,682), to analyse healthcare resource utilisation by BMI groups. Adjusted and unadjusted logistic regression models were used to calculate odds ratios (OR) for healthcare use among class II and over obese subjects versus normal BMI. RESULTS: Persons with BMI ≥35 are more likely to attend general practitioner (GP)'s consultations (17%), to visit the emergency department (26%), to consume medications (36%), to be hospitalised (49%), to require nursing consultations (61%) and to require psychology consultations (83%). The proportion of obese people receiving home visits is 2.6 times higher than among normal BMI. After controlling for sex and age groups, people with severe obesity (BMI ≥35 kg/m2) were more prone to requiring home care visits (OR 2.3; CI [1.3; 4.2]), GP visits (OR 2.1; CI [1.5; 3.0]), psychologist visits (OR 1.96; CI [1.3; 2.99]), emergency service visits (OR 1.5; CI [1.2; 1.8]), nurse visits (OR 1.46; CI [1.2; 1.9]) and hospitalisations (OR 1.43; CI [1.1; 1.9]) and after also adjusting for relevant comorbidities like hypertension, diabetes and cardiovascular diseases: GP visits (OR 1.85; CI [1.3; 2.7]), psychologist visits (OR 1.8; CI [1.2; 2.7]), specialised care visits (OR 0.92; CI [0.7; 1.2]) and physiotherapist visits (OR 0.7; CI [0.5; 1.0]). CONCLUSIONS: Severe obesity significantly increases healthcare resource utilisation in Spain. The results shed light on the real magnitude of the burden of obesity in Spain.

Social economic costs of type 1 diabetes mellitus in pediatric patients in Spain: CHRYSTAL observational study.

AIMS: To estimate the social-economic costs of Type 1 Diabetes Mellitus (T1DM) in patients aged 0-17years in Spain from a social perspective. METHODS: We conducted a cross-sectional observational study in 2014 of 275 T1DM pediatric outpatients distributed across 12 public health centers in Spain. Data on demographic and clinical characteristics, healthcare utilization and informal care were collected from medical records and questionnaires completed by clinicians and patients' caregivers. RESULTS: A valid sample of 249 individuals was analyzed. The average annual cost for a T1DM patient was €27,274. Direct healthcare costs were €4070 and direct non-healthcare cost were €23,204. Informal (familial) care represented 83% of total cost, followed by medical material (8%), outpatient and primary care visits (3.1%) and insulin (2.1%). Direct healthcare cost per patient statistically differed by glycated haemoglobin (HbA1c) level [mean cost €4704 in HbA1c ≥7.5% (≥58mmol/mol) group vs. €3616 in HbA1c<7.5% (<58mmol/mol) group)]; and by the presence or absence of complications and comorbidities (mean cost €5713 in group with complications or comorbidities vs. €3636 in group without complications or comorbidities). CONCLUSIONS: T1DM amongst pediatric patients incurs in considerable societal costs. Informal care represents the largest cost category.

Women with urinary incontinence in Spain: Health-related quality of life and the use of healthcare resources.

OBJECTIVES: To describe Health-Related Quality of Life (HRQOL) and healthcare resource utilization in women aged 60 and over in Spain. DESIGN: Descriptive analysis of primary data from the Spanish National Health Survey, 2012. MAIN OUTCOME MEASURES: Utility indices were obtained through the EQ5D5L questionnaire included in the survey, and utilization rates of consultations, hospitalizations, emergency services, and medication intake. HRQOL and utilization rates were systematically compared between women diagnosed with UI, women diagnosed with other chronic conditions (OCC) and healthy women of the same age. RESULTS: Utility indices were 0.47 in UI women versus 0.78 and 0.96 in women diagnosed with OCC and healthy women, respectively. Each year 351,675 Quality Adjusted Life Years are lost in Spain due to UI in the population of women aged 60 and over. Resource utilization of these women was significantly higher than that of other women. CONCLUSIONS: UI has a larger impact on both HRQOL and healthcare consumption in women who are aged 60 and over, than OCC. Appropriate treatment of UI might entail an important gain in terms of HRQOL and a significant reduction in healthcare consumption in Spain.

Quality of life and use of health care resources among patients with chronic depression.

PURPOSE: This study estimates the health-related quality of life and the health care resource utilization of patients diagnosed with chronic depression (CD) in Spain. PATIENTS AND METHODS: We used the Spanish National Health Survey 2011-2012, a cross-sectional survey representative at the national level, that selects people aged between 18 and 64 years (n=14,691). We estimated utility indices through the EuroQol five-dimensional descriptive system questionnaire included in the survey. We calculated percentage use of health care resources (medical visits, hospitalizations, emergency services, and drug consumption) and average number of resources used when available. A systematic comparison was made between people diagnosed with CD and other chronic conditions (OCCs). The chi-square test, Mann-Whitney U-test, and Kruskal-Wallis test were used to determine the statistical significance of differences between comparison groups. Multivariate analyses (Poisson regression, logistic regression, and linear regression) were also carried out to assess the relationship between quality of life and consumption of health care resources. RESULTS: Approximately, 6.1% of the subjects aged between 18 and 64 years were diagnosed with CD (average age 48.3±11 years, 71.7% females). After controlling for age, sex, and total number of comorbidities, a diagnosis of CD reduced utility scores by 0.09 (P<0.05) vs OCCs, and increased the average number of hospitalizations by 15%, the average number of days at hospital by 51%, and the average number of visits to emergency services by 15% (P<0.05). CD also increased the average number of visits to secondary care by 14% and visits to general practitioners by 4%. People with CD had a higher probability of consuming drugs than people with OCCs (odds ratio [OR]: 1.24, P<0.05), but only 38.6% took antidepressants. CONCLUSION: People with CD had significantly lower health-related quality of life than people with OCCs. CD was associated with increased hospital length of stay and involved a higher consumption of emergency services and drugs than OCCs.

Análisis coste-efectividad del tratamiento con presión positiva continua de la vía aérea en el síndrome de apnea-hipopnea durante el sueño (SAHS) moderado-grave / Cost-effectiveness of Continuous Positive Airway Pressure Treatment in Moderate-Severe Obstructive Sleep Apnea Syndrome

Introducción: El síndrome de apnea-hipopnea durante el sueño (SAHS) supone un gran impacto socioeconómico. El objetivo de este estudio es evaluar el coste-efectividad del tratamiento del SAHS con presión positiva continua de la vía aérea superior (CPAP) y estimar la influencia que tiene el cumplimiento de la CPAP. Métodos: Estudio retrospectivo de «casos cruzados» de 373 pacientes SAHS tratados con CPAP. Se calcularon variaciones en costes, puntuación en el test de Epworth y calidad de vida relacionada con la salud (cuestionario EQ-5D) entre el año previo al tratamiento y el año después del mismo. Se estimó la ratio de coste-efectividad incremental (RCEI) para el primer año de tratamiento y se realizó una proyección para el segundo año bajo distintos escenarios de efectividad y costes. Resultados: La puntuación de la escala visual analógica del cuestionario EQ-5D aumentó en 5 puntos y el test de Epworth disminuyó en 10 puntos al año del tratamiento con CPAP, con una ganancia media en años de vida ajustados por calidad (AVAC) de 0,05 por paciente y año (p < 0,001): 0,07 en cumplidores y -0,04 en no cumplidores. La RCEI fue de 51.147 €/AVAC durante el primer año de tratamiento con CPAP y de 1.544 €/AVAC el segundo año. Conclusión: El tratamiento con CPAP en pacientes con SAHS moderado-grave mejora la calidad de vida de los pacientes cumplidores y es coste-efectivo a partir del segundo año

Introduction: The socioeconomic impact of obstructive sleep apnea-hypopnea syndrome (OSAHS) is considerable. The aim of this study was to evaluate the cost-effectiveness of treating OSAHS with continuous positive airway pressure (CPAP) and the impact of CPAP compliance. Methods: This was a retrospective, case-crossover study of 373 patients with OSAHS receiving CPAP. We compared changes in costs, Epworth score and health-related quality of life (EQ-5D questionnaires) between the year before treatment and the year after treatment. The incremental cost-effectiveness ratio (ICER) for the first year of treatment was estimated, and projections were made for the second year, using different effectiveness and cost scenarios. Results: The visual analog scale score for the EQ-5D questionnaire increased by 5 points and the Epworth score fell by 10 points during the year of CPAP treatment. Mean gain in quality-adjusted life years (QALY) was 0.05 per patient per year (P < .001): 0.07 among compliers and -0.04 among non-compliers. ICER was €51,147/QALY during the first year of CPAP treatment and €1,544/QALY during the second year. Conclusion: CPAP treatment in patients with moderate-severe OSAHS improves the quality of life of compliant patients, and is cost-effective as of the second year

Coste-efectividad de una unidad monográfica de asma / Cost Effectiveness of Outpatient Asthma Clinics

INTRODUCCIÓN: Las unidades monográficas de asma (UMA) son consultas hospitalarias implementadas para lograr una mejoría clínica de los pacientes. Este estudio analiza su impacto sobre el control del asma y su coste-efectividad en comparación con las consultas ordinarias. MÉTODOS: Estudio de casos cruzados que incluyó a todos los pacientes que fueron atendidos por primera vez en la UMA de Lugo durante 2012. Se definió el «periodo-caso» como los 365días que siguieron a la primera visita en la UMA, y el «periodo-control» como los 365días que la antecedieron. Se calcularon los cambios en indicadores clínicos relevantes para el control del asma y se estimó la relación de coste-efectividad incremental (RCEI) por cada paciente adicional que fue controlado y por cada año de vida ajustado por calidad (AVAC). RESULTADOS: El porcentaje de pacientes (n = 83, edad media 49 ± 15,2 años; 60,2% mujeres) controlados aumentó del 41 al 86%. El resultado del test de control del asma mejoró desde 18,7 ± 4,6 hasta 22,6 ± 2,3 (p < 0,05) y el FEV1 se elevó desde 81,4% ± 17,5 hasta 84,4% ± 16,6 (p < 0,05). Las exacerbaciones, hospitalizaciones y visitas a urgencias disminuyeron un 75, un 78 y un 75%, respectivamente. La utilización de combinaciones CI/LABA decreció del 79,5% al 41%. El uso de otros fármacos aumentó: anticolinérgicos del 3,6 al 16,9%, CI en monoterapia del 3,6 al 45,8%, y omalizumab del 0 al 6%. Las RCEI por paciente controlado y por AVAC ganado fueron de 1.399 y 6.876 €, respectivamente (perspectiva social). CONCLUSIONES: La atención en una UMA es coste-efectiva y tiene un impacto beneficioso sobre el control del asma

INTRODUCTION: Asthma clinics (AC) are hospital outpatient services specialising in the management of asthma. In this study, we analysed the impact of these clinics on asthma management and their cost effectiveness in comparison with standard outpatient services. METHODS: A case cross-over study in which all new patients seen in the AC of Lugo in 2012 were included. The case period was defined as one year following the first visit to the AC; the control period was defined as the preceding year. We calculated changes in clinical quality indicators for asthma management, and estimated the incremental cost-effectiveness ratio (ICER) for each additional patient treated and for each quality-adjusted life year (QALY) RESULTS: The number of patients (n = 83, mean age 49 ± 15.2 years; 60.2% women) managed in the AC increased from 41% to 86%. The Asthma Control Test score increased from 18.7 ± 4.6 to 22.6 ± 2.3 (p < 0.05) and FEV1 increased from 81.4% ± 17.5 to 84.4% ± 16.6 (p < 0.05). The number of exacerbations, hospitalisations and visits to accident and emergency fell by 75%. The number of patients given combination LABA + ICS therapy fell from 79.5% to 41%. The use of other drug therapy increased: anticholinergics, from 3.6% to 16.9%; ICS in monotherapy, from 3.6% to 45.8%; and omalizumab, from 0% to 6%. ICERs per patient managed and per QALY gained were €1,399 and €6,876, respectively (social perspective). CONCLUSIONS: Treatment in ACs is cost-effective and beneficial in asthma management

Cost-effectiveness of Continuous Positive Airway Pressure Treatment in Moderate-Severe Obstructive Sleep Apnea Syndrome. / Análisis coste-efectividad del tratamiento con presión positiva continua de la vía aérea en el síndrome de apnea-hipopnea durante el sueño (SAHS) moderado-grave.

INTRODUCTION: The socioeconomic impact of obstructive sleep apnea-hypopnea syndrome (OSAHS) is considerable. The aim of this study was to evaluate the cost-effectiveness of treating OSAHS with continuous positive airway pressure (CPAP) and the impact of CPAP compliance. METHODS: This was a retrospective, case-crossover study of 373 patients with OSAHS receiving CPAP. We compared changes in costs, Epworth score and health-related quality of life (EQ-5D questionnaires) between the year before treatment and the year after treatment. The incremental cost-effectiveness ratio (ICER) for the first year of treatment was estimated, and projections were made for the second year, using different effectiveness and cost scenarios. RESULTS: The visual analog scale score for the EQ-5D questionnaire increased by 5 points and the Epworth score fell by 10 points during the year of CPAP treatment. Mean gain in quality-adjusted life years (QALY) was 0.05 per patient per year (P<.001): 0.07 among compliers and -0.04 among non-compliers. ICER was €51,147/QALY during the first year of CPAP treatment and €1,544/QALY during the second year. CONCLUSION: CPAP treatment in patients with moderate-severe OSAHS improves the quality of life of compliant patients, and is cost-effective as of the second year.

Cost Effectiveness of Outpatient Asthma Clinics.

INTRODUCTION: Asthma clinics (AC) are hospital outpatient services specialising in the management of asthma. In this study, we analysed the impact of these clinics on asthma management and their cost effectiveness in comparison with standard outpatient services. METHODS: A case cross-over study in which all new patients seen in the AC of Lugo in 2012 were included. The case period was defined as one year following the first visit to the AC; the control period was defined as the preceding year. We calculated changes in clinical quality indicators for asthma management, and estimated the incremental cost-effectiveness ratio (ICER) for each additional patient treated and for each quality-adjusted life year (QALY) RESULTS: The number of patients (n=83, mean age 49 ± 15.2 years; 60.2% women) managed in the AC increased from 41% to 86%. The Asthma Control Test score increased from 18.7 ± 4.6 to 22.6 ± 2.3 (p<0.05) and FEV1 increased from 81.4% ± 17.5 to 84.4% ± 16.6 (p<0.05). The number of exacerbations, hospitalisations and visits to accident and emergency fell by 75%. The number of patients given combination LABA+ICS therapy fell from 79.5% to 41%. The use of other drug therapy increased: anticholinergics, from 3.6% to 16.9%; ICS in monotherapy, from 3.6% to 45.8%; and omalizumab, from 0% to 6%. ICERs per patient managed and per QALY gained were €1,399 and €6,876, respectively (social perspective). CONCLUSIONS: Treatment in ACs is cost-effective and beneficial in asthma management.

Cost-utility analysis of certolizumab pegol versus alternative tumour necrosis factor inhibitors available for the treatment of moderate-to-severe active rheumatoid arthritis in Spain.

BACKGROUND: Certolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy. This study evaluatedthe cost-utility of certolizumab pegol versusTNF-inhibitors plus methotrexate in the treatment of moderate-to-severe RA in Spain. METHODS: A Markov cohort health state transition model was developed to evaluate the cost-utility (costs and quality-adjusted life years [QALYs]) of certolizumab pegol versus other TNF-inhibitors licensed in Spain in 2009. Efficacy was measured using the American College of Rheumatology (ACR) responses at 6 months, based on adjusted indirect comparisons from published clinical trials. Utilities were derived from EQ-5D data from certolizumab pegol RA clinical trials. Clinical history and resource use data came from published literature. Unit costs were taken from Spanish databases or published data (cost year 2009). Base case analyses were conducted from the payer perspective, with a lifetime horizon, 3.5 % annual discounting rates for costs and outcomes, and 3 % inflation rate for 2009 onwards. One-way sensitivity analyses were conducted. RESULTS: The average lifetime costs for certolizumab pegol, etanercept, adalimumab (every 2 weeks and weekly) and infliximab (3 mg/kg and 5 mg/kg) in combination with methotrexate were €140,971, €141,197, €139,148, €164,741, €136,961 and €152,561, respectively. The QALYs gained were 6.578, 6.462, 6.430 (for both adalimumab doses), 6.430, and 6.318 (for both infliximab doses), respectively. At a €30,000/QALY willingness-to-pay threshold, certolizumab pegol plus methotrexate dominated adalimumab weekly, etanercept, and infliximab 5 mg/kg, and was cost-effective versus adalimumab every 2 weeks and infliximab 3 mg/kg (all with methotrexate), with estimated ICERs of €12,346/QALY and €15,414/QALY, respectively. Certolizumab pegol monotherapy was more cost-effective versus adalimumab, and less expensive with similar health gains versus etanercept (6.416 QALYs vs 6.492). Univariate analysis showed ICERs to be sensitive to changes in time horizon, ACR response time point, baseline Heath Assessment Questionnaire (HAQ) score, and rate of HAQ-disability index deterioration after discontinuing treatment. CONCLUSIONS: This analysis shows that certolizumab pegol is cost-effective compared with other TNF-inhibitors recommended in Spain for the treatment of RA.

Cost-utility of ranolazine for the symptomatic treatment of patients with chronic angina pectoris in Spain.

BACKGROUND: Ranolazine is an antianginal agent that was approved in the EU in 2008 as an add-on therapy for symptomatic chronic angina pectoris treatment in patients who are inadequately controlled by, or are intolerant to, first-line antianginal therapies. These patients' quality of life is significantly affected by more frequent angina events, which increase the risk of revascularization. OBJECTIVE: To assess the cost-utility of ranolazine versus placebo as an add-on therapy for the symptomatic treatment of patients with chronic angina pectoris in Spain. METHODS: A decision tree model with 1-year time horizon was designed. Transition probabilities and utility values for different angina frequencies were obtained from the literature. Costs were obtained from Spanish official DRGs for patients with chronic angina pectoris. We calculated the incremental cost-utility ratio of using ranolazine compared with a placebo. Sensitivity analyses, by means of Monte Carlo simulations, were performed. Acceptability curves and expected value of perfect information were calculated. RESULTS: The incremental cost-utility ratio was €8,455 per quality-adjusted life-year (QALY) per patient in Spain. Sensitivity analyses showed that if the decision makers' willingness to pay is €15,000 per QALY, the treatment with ranolazine will be cost effective at a 95 % level of confidence. The incremental cost-utility ratio is particularly sensitive to changes in utility values of those non-hospitalized patients with mild or moderate angina frequency. CONCLUSIONS: Ranolazine is a highly efficient add-on therapy for the symptomatic treatment of chronic angina pectoris in patients who are inadequately controlled by, or intolerant to, first-line antianginal therapies in Spain.