Cost-effectiveness analysis of two treatment strategies for chronic hepatitis C before and after access to direct-acting antivirals in Spain. / Análisis coste-efectividad de dos estrategias de tratamiento para la hepatitis C crónica: antes y después del acceso a los agentes antivirales de acción directa en España.

OBJECTIVE: To evaluate the cost-effectiveness of a strategy based on direct-acting antivirals (DAAs) following the marketing of simeprevir and sofosbuvir (post-DAA) versus a pre-direct-acting antiviral strategy (pre-DAA) in patients with chronic hepatitis C, from the perspective of the Spanish National Health System. METHODS: A decision tree combined with a Markov model was used to estimate the direct health costs (€, 2016) and health outcomes (quality-adjusted life years, QALYs) throughout the patient's life, with an annual discount rate of 3%. The sustained virological response, percentage of patients treated or not treated in each strategy, clinical characteristics of the patients, annual likelihood of transition, costs of treating and managing the disease, and utilities were obtained from the literature. The cost-effectiveness analysis was expressed as an incremental cost-effectiveness ratio (incremental cost per QALY gained). A deterministic sensitivity analysis and a probabilistic sensitivity analysis were performed. RESULTS: The post-DAA strategy showed higher health costs per patient (€30,944 vs. €23,707) than the pre-DAA strategy. However, it was associated with an increase of QALYs gained (15.79 vs. 12.83), showing an incremental cost-effectiveness ratio of €2,439 per QALY. The deterministic sensitivity analysis and the probabilistic sensitivity analysis showed the robustness of the results, with the post-DAA strategy being cost-effective in 99% of cases compared to the pre-DAA strategy. CONCLUSIONS: Compared to the pre-DAA strategy, the post-DAA strategy is efficient for the treatment of chronic hepatitis C in Spain, resulting in a much lower cost per QALY than the efficiency threshold used in Spain (€30,000 per QALY).

[Cost-effectiveness of the deep vein thrombosis diagnosis process in primary care]. / Estudio coste efectividad del proceso diagnóstico de la trombosis venosa profunda desde la atención primaria.

OBJECTIVE: To analyse the cost effectiveness of the application of diagnostic algorithms in patients with a first episode of suspected deep vein thrombosis (DVT) in Primary Care compared with systematic referral to specialised centres. DESIGN: Observational, cross-sectional, analytical study. LOCATION: Patients from hospital emergency rooms referred from Primary Care to complete clinical evaluation and diagnosis. PARTICIPANTS: A total of 138 patients with symptoms of a first episode of DVT were recruited; 22 were excluded (no Primary Care report, symptoms for more than 30 days, anticoagulant treatment, and previous DVT). Of the 116 patients finally included, 61% women and the mean age was 71 years. MAIN MEASUREMENTS: Variables from the Wells and Oudega clinical probability scales, D-dimer (portable and hospital), Doppler ultrasound, and direct costs generated by the three algorithms analysed: all patients were referred systematically, referral according to Wells and Oudega scale. RESULTS: DVT was confirmed in 18.9%. The two clinical probability scales showed a sensitivity of 100% (95% CI: 85.1 to 100) and a specificity of about 40%. With the application of the scales, one third of all referrals to hospital emergency rooms could have been avoided (P<.001). The diagnostic cost could have been reduced by € 8,620 according to Oudega and € 9,741 according to Wells, per 100 patients visited. CONCLUSION: The application of diagnostic algorithms when a DVT is suspected could lead to better diagnostic management by physicians, and a more cost effective process.

Cost-Effectiveness and Cost-Utility Analysis of Ingenol Mebutate Versus Diclofenac 3% and Imiquimod 5% in the Treatment of Actinic Keratosis in Spain. / Análisis de coste-efectividad y coste-utilidad de ingenol mebutato versus diclofenaco 3% e imiquimod 5% en el tratamiento de la queratosis actínica en España.

OBJECTIVE: To perform a cost-effectiveness and cost-utility analysis of ingenol mebutate in the treatment of actinic keratosis in Spain. METHODS: We used an adapted Markov model to simulate outcomes in a cohort of patients (mean age, 73 years) with actinic keratosis over a 5-year period. The comparators were diclofenac 3% and imiquimod 5%. The analysis was performed from the perspective of the Spanish National Health System based on direct costs (2015 retail price plus value added tax less the mandatory discount). A panel of experts estimated resources, taking unit costs from national databases. An annual discount rate of 3% was applied. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The effectiveness of ingenol mebutate-with 0.192 and 0.129 more clearances gained in treatments for face and scalp lesions and trunk and extremity lesions, respectively-was superior to diclofenac's. The total costs of treatment with ingenol mebutate were lower at € 551.50 (face and scalp) and € 622.27 (trunk and extremities) than the respective costs with diclofenac (€ 849.11 and € 844.93). The incremental cost-effectiveness and cost-utility ratios showed that ingenol mebutate was a dominant strategy vs diclofenac. Ingenol mebutate also proved to be more effective than imiquimod, based on 0.535 and 0.503 additional clearances, and total costs of € 551.50 and € 527.89 for the two drugs, respectively. The resulting incremental cost-effectiveness ratio was € 728.64 per clearance gained with ingenol mebutate vs imiquimod. CONCLUSIONS: Ingenol mebutate was a dominant treatment option vs diclofenac and was efficient vs imiquimod (i.e., more effective at a higher cost, achieving an incremental cost-utility ratio of<€30000/quality-adjusted life-years).

Pros and cons of vaccination against serogroup B meningococcal disease. / Pros y contras de la vacunación frente a la enfermedad por meningococo B.

A vaccine has recently been approved in the EU against meningococcal serogroup B, the main cause of meningococcal disease. There is a fierce debate about the decision regarding a universal vaccination in infants older than 2 months, as recommended by the majority of scientific societies. In western Europe the only country to have included the universal vaccination is the United Kingdom, with a lower incidence of the disease than Ireland. Other countries have also adopted it, such as the Czech Republic, Cuba and certain regions of Italy. Numerous cost-effectiveness studies have been published regarding the vaccination with different assumptions, which have supported the decision not to implant the universal vaccination because it exceeds the will to pay for a health benefit. We discuss the pros and cons of the universal vaccination against meningococcal B, recommended by the Sociedad Española de Pediatría (Spanish Society of Paediatrics), which as yet has not been implemented.

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 analysis of universal screening for thyroid disease in pregnant women in Spain]. / Análisis coste-efectividad del cribado universal de la enfermedad tiroidea en mujeres embarazadas en España

OBJECTIVE: To assess the cost-effectiveness of universal screening for thyroid disease in pregnant women in Spain as compared to high risk screening and no screening. METHODOLOGY: A decision-analytic model comparing the incremental cost per quality-adjusted life year (QALY) of universal screening versus high risk screening and versus no screening. was used for the pregnancy and postpartum period. Probabilities from randomized controlled trials were considered for adverse obstetrical outcomes. A Markov model was used to assess the lifetime period after the first postpartum year and account for development of overt hypothyroidism. The main assumptions in the model and use of resources were assessed by local clinical experts. The analysis considered direct healthcare costs only. RESULTS: Universal screening gained .011 QALYs over high risk screening and .014 QALYS over no screening. Total direct costs per patient were €5,786 for universal screening, €5,791 for high risk screening, and €5,781 for no screening. Universal screening was dominant compared to risk-based screening and a very cost-effective alternative as compared to no screening. Use of universal screening instead of high risk screening would result in €2,653,854 annual savings for the Spanish National Health System. CONCLUSIONS: Universal screening for thyroid disease in pregnant women in the first trimester is dominant in Spain as compared to risk-based screening, and is cost-effective as compared to no screening (incremental cost-effectiveness ratio of €374 per QALY). Moreover, it allows diagnosing and treating cases of clinical and subclinical hypothyroidism that may not be detected when only high-risk women are screened.

A Cost-effectiveness Analysis of Ferric Carboxymaltose in Patients With Iron Deficiency and Chronic Heart Failure in Spain.

INTRODUCTION AND OBJECTIVES: Treatment with ferric carboxymaltose improves symptoms, functional capacity, and quality of life in patients with chronic heart failure and iron deficiency. The aim of this study was to assess the cost-effectiveness of ferric carboxymaltose treatment vs no treatment in these patients. METHODS: We used an economic model based on the Spanish National Health System, with a time horizon of 24 weeks. Patient characteristics and ferric carboxymaltose effectiveness (quality-adjusted life years) were taken from the Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure trial. Health care resource use and unit costs were taken either from Spanish sources, or from the above mentioned trial. RESULTS: In the base case analysis, patients treated with and without ferric carboxymaltose treatment acquired 0.335 and 0.298 quality-adjusted life years, respectively, representing a gain of 0.037 quality-adjusted life years for each treated patient. The cost per patient was €824.17 and €597.59, respectively, resulting in an additional cost of €226.58 for each treated patient. The cost of gaining 1 quality adjusted life year with ferric carboxymaltose was €6123.78. Sensitivity analyses confirmed the robustness of the model. The probability of ferric carboxymaltose being cost-effective (< €30 000 per quality-adjusted life year) and dominant (more effective and lower cost than no treatment) was 93.0% and 6.6%, respectively. CONCLUSIONS: Treatment with ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, is cost-effective in Spain.