[Cost-effectiveness analysis of pneumococcal vaccination in Spain]. / Análisis de coste-efectividad de la vacunación antineumocócica en España.

OBJECTIVE: To perform a cost-effectiveness analysis of pediatric pneumococcal vaccination in Spain. METHODS: A deterministic population-based model in the form of a decision-tree with a 1-year time horizon was used to estimate the impact of vaccination with Synflorix® or Prevenar13® in children aged less than 2 years in Spain from the perspective of the National Health System. Epidemiological data were obtained from the hospital discharge minimum data set (MDS) and the literature. Data on costs were obtained from national health costs databases. The main outcomes measured were the number of cases avoided of invasive pneumococcal disease, acute otitis media (AOM) and myringotomies, and hospital admissions for pneumonia. All costs were expressed in 2010 euros. Effectiveness was measured as the number of quality-adjusted life years (QALYs) gained. RESULTS: The efficacy of Synflorix® in preventing episodes of AOM caused by non-typeable Haemophilus influenzae could lead to additional prevention of 41,513 episodes of AOM, 36,324 antibiotic prescriptions and 382 myringotomy procedures and 143 QALYs gained compared with Prevenar13®. The total vaccination cost with Synflorix® would result in savings of 22 million euros. CONCLUSIONS: Pneumococcal vaccination with Synflorix® in comparison with Prevenar13® in children aged less than 2 years old in Spain could achieve a higher number of QALYs and a substantial cost offset. Vaccination with Synflorix® would be a dominant strategy in terms of cost-effectiveness.

Clinical management of abnormal cytology test results and costs associated with the prevention of cervical cancer in Spain.

OBJECTIVE: To evaluate the clinical management of women with abnormal cervical cytology results, the associated health care resource allocation, and costs in Spain. MATERIALS AND METHODS: A retrospective, observational, multicenter study of 849 women with abnormal cervical cytology results: 162 cases of atypical squamous cells of undetermined significance (ASCUS; 19.1%), 272 cases of low-grade squamous intraepithelial lesions (LSILs; 32.0%), 369 cases of high-grade squamous intraepithelial lesions (HSILs; 43.5%), and 46 cases of cancer (5.4%). Health care resources allocated to the diagnosis and treatment of lesions for a minimum of 2 years from the first abnormal cervical cytology result were assessed from patients' charts. RESULTS: Histologic diagnosis confirmed 159 cases of cervical intraepithelial neoplasia grade 1 (CIN 1; 18.7%), 120 cases of CIN 2 (14.1%), 295 cases of CIN 3 (34.8%), and 79 cases of cancer (9.3%). Median waiting time to first intervention after an abnormal cytology result was 47 days (diagnostic range = 31-60). The most common diagnostic procedures were colposcopy and additional cytology testing. The principal therapeutic procedure was loop electrosurgical excision. The costs generated according to cytology result were (euro)1,196.80 (ASCUS), (euro)912.43 (LSIL), (euro)1,333.00 (HSIL), and (euro)6,261.30 (cancer). The costs generated according to histology results were (euro)790.10 (CIN 1), (euro)1,131.20 (CIN 2), (euro)1,181.30 (CIN 3), and (euro)7,041.70 (cancer). CONCLUSIONS: Waiting time to the first intervention may be longer than clinically desirable. Direct costs associated with the management patterns of women with abnormal cervical cytology result are high and have important economic consequences to the Spanish National Health System. These results will allow to improve the effectiveness and efficiency of future intervention strategies.

Cost-effectiveness analysis of HLA-B*5701 typing in the prevention of hypersensitivity to abacavir in HIV+ patients in Spain.

INTRODUCTION: Approximately 4% to 8% of patients with HIV-1 treated with abacavir present a hypersensitivity reaction (HSR). Various studies have shown a direct association between human leukocyte antigen (HLA)-B*5701 and HSR to abacavir. The objective of this study was to analyze whether systematic HLA-B*5701 testing to prevent HSR in patients treated with abacavir is a cost-effective option for the Spanish National Health System. METHODS: An analytical decision-making model was constructed as a decision tree model for a simulated cohort of 1000 HIV patients to evaluate whether HLA-B*5701 testing to prevent HSR to abacavir was cost effective compared with not performing the test. The parameters included in the model and the use of healthcare resources should the patient develop HSR were taken from the PREDICT-1 study and the opinion of clinical experts. The principal result obtained was the incremental cost per HSR avoided. The time horizon of the analysis was to 2 months [corrected] . All costs were expressed in 2008 Euros. RESULTS: The analysis showed that the total direct healthcare costs per patient were €1344 and €1322 with and without HLA-B*5701 testing respectively, and that 36 cases of HSR were prevented per 1000 screened patients. These results yielded a cost per HSR avoided of €630. The sensitivity analysis showed that the results were sensitive to the cost of the test, with an economic saving of €102 or a cost-effectiveness ratio of €4234. CONCLUSIONS: The model predicts that generalized use of the HLA-B*5701 test before prescribing abacavir in HIV+ patients could represent an economic saving or a limited additional cost for the National Health System which may be counterbalanced by the benefits in terms of a lower incidence of HSR.

Long-term clinical impact of introducing a human papillomavirus 16/18 AS04 adjuvant cervical cancer vaccine in Spain.

BACKGROUND: Human papillomavirus (HPV) epidemiology and screening practices vary considerably between countries and specific analyses are required to estimate the impact of HPV vaccination. This study aimed to predict the clinical benefits of introducing a bivalent HPV16/18 vaccine in Spain, where the cervical cancer (CC) incidence is 10.3 per 100 000. METHODS: A Markov model based upon the natural history of HPV and CC was developed to simulate transitions between health states, in the presence of specific screening programmes. Published data were used to reflect the Spanish situation in terms of epidemiological characteristics, screening and treatment practices. Calibration consisted of varying disease progression rates within established ranges until model predictions matched observed epidemiological data. The clinical impact of vaccinating a cohort of 12-year-old girls against HPV was assessed over their lifetime using the calibrated model. RESULTS: Vaccination of all 12-year-old girls would result in a reduction of 75% (from 0.32% to 0.08%) in the prevalence of high-grade precancerous lesions due to oncogenic HPV, and a 79% reduction in both CC cases (from 1745 to 365) and CC deaths (from 417 to 86). Assuming a vaccine coverage of 80%, the number of CC cases and deaths would decrease by 63%. Vaccination could also substantially reduce the number of screening tests and treatments required for cervical dysplasia. CONCLUSION: Our model was successfully adapted to the Spanish epidemiological environment, screening and treatment practices and predicted a substantial long-term benefit of HPV vaccination despite a low HPV prevalence in Spain.

Lifetime health consequences and cost-effectiveness of rosiglitazone in combination with metformin for the treatment of type 2 diabetes in Spain.

OBJECTIVE: To assess the lifetime diabetes health consequences and cost-effectiveness in Spain of rosiglitazone in combination with metformin for the treatment of type 2 diabetes in overweight and obese patients failing to maintain glycaemic control with metformin monotherapy compared with conventional care of metformin in combination with either sulfonylureas or bedtime insulin. RESEARCH DESIGN AND METHODS: The Diabetes Decision Analysis of Cost--Type 2 was adapted for clinical practice and healthcare funding in Spain, and was calibrated with Spanish epidemiological, healthcare resource use and cost data, taking the perspective of the Spanish National Health System. The model simulates lifetime treatment histories, complications and consequences of type 2 diabetes, and associated health outcomes and costs for age and sex-matched cohorts of 1000 overweight and obese patients. The primary health outcome measures compared are glycaemic control, time to insulin, incidence and prevalence of coronary heart disease, stroke, clinical nephropathy, ulceration and amputation, and severe visual loss, and incremental life-years and quality-adjusted life-years (QALYs). RESULTS: Rosiglitazone in combination with metformin produces better glycaemic control than conventional care of metformin in combination with either sulfonylureas or bedtime insulin in most patients, and extends the viability of combination therapy by between 6 and 13 years before requiring insulin. Rosiglitazone patients have a longer life expectancy, gaining between 106 and 175 additional life-years per 1000 patients, experience fewer episodes of coronary disease and clinical nephropathy, and live for longer periods free of complications. The improvements in morbidity and mortality are projected to yield between 134 and 238 additional QALY per 1000 patients over their lifetime. Discounted incremental cost-effectiveness ratios range from euro 9406 to euro 23,514 per QALY gained. CONCLUSION: The model predicts that rosiglitazone in combination with metformin is a cost-effective intervention for the treatment of both overweight and obese patients with type 2 diabetes when compared with conventional care in Spain.