Health Care Resource Utilization of Late Premature Versus Term Infants With Bronchiolitis.

It is controversial whether it is cost-beneficial for late preterm infants to receive respiratory syncytial virus prophylaxis. This study compares community and hospital health care resource utilization (HCRU) of late premature infants (33-36 weeks gestational age) with term infants (>36 weeks gestational age) hospitalized with bronchiolitis. This was a retrospective, population-based, observational study spanning a 9-year period (2004-2012). HCRU data were obtained from the Health Maintenance Organization "Clalit" and included duration of hospitalization, physician visits, laboratory tests, and treatments. Compared with term infants, late preterm infants had significantly longer duration of hospitalization and higher admission rates to pediatric intensive care unit. They also had higher rates of mean outpatients clinic visits, total outpatient clinic and specialist visits, blood chemistry, and virology testing. HCRU of term infants with bronchiolitis was also substantial, indicating that they also can greatly benefit from respiratory syncytial virus prophylaxis. These findings can guide stakeholders in decisions concerning the prevention of bronchiolitis and will be useful in performing further cost-benefit analysis.

Pediatric Readmissions After Hospitalizations for Lower Respiratory Infections.

BACKGROUND AND OBJECTIVE: Lower respiratory infections (LRIs) are among the most common reasons for pediatric hospitalization and among the diagnoses with the highest number of readmissions. Characterizing LRI readmissions would help guide efforts to prevent them. We assessed variation in pediatric LRI readmission rates, risk factors for readmission, and readmission diagnoses. METHODS: We analyzed 2008-2009 Medicaid Analytic eXtract data for patients <18 years of age in 26 states. We identified LRI hospitalizations based on a primary diagnosis of bronchiolitis, influenza, or community-acquired pneumonia or a secondary diagnosis of one of these LRIs plus a primary diagnosis of asthma, respiratory failure, or sepsis/bacteremia. Readmission rates were calculated as the proportion of hospitalizations followed by ≥1 unplanned readmission within 30 days. We used logistic regression with fixed effects for patient characteristics and a hospital random intercept to case-mix adjust rates and assess risk factors. RESULTS: Of 150 590 LRI hospitalizations, 8233 (5.5%) were followed by ≥1 readmission. The median adjusted hospital readmission rate was 5.2% (interquartile range: 5.1%-5.4%), and rates varied across hospitals (P < .0001). Infants (patients <1 year of age), boys, and children with chronic conditions were more likely to be readmitted. The most common primary diagnoses on readmission were LRIs (48.2%), asthma (10.0%), fluid/electrolyte disorders (3.4%), respiratory failure (3.3%), and upper respiratory infections (2.7%). CONCLUSIONS: LRI readmissions are common and vary across hospitals. Multiple risk factors are associated with readmission, indicating potential targets for strategies to reduce readmissions. Readmission diagnoses sometimes seem related to the original LRI.

Cost effectiveness of a protocol using palivizumab in preterm infants.

OBJECTIVE: The main objective was to evaluate the cost-effectiveness of protocol use of palivizumab in premature established by consensus in our Hospital comparing it based on the recommendations of various Scientific Societies. As a secondary objective risk factors and severity of hospitalized patients attending the established protocol in our Hospital were analyzed. METHODS: The study period was 4 seasons with the expanded protocol (retrospective data) versus 2 with restricted or agreed protocol (prospective data). The perspective of the study was the Health System, including the costs of hospitalization and palivizumab our center. The calculation of the effectiveness was determined with the admission rate of premature patients stratified by weeks of gestational age <29, <32; and <35. For the analysis of risk factors and severity in patients admitted seasons with the new protocol are collected prospectively clinical data and environmental and social factors. RESULTS: In the range of gestational age <29 years old and <32 greater effectiveness of the extended protocol was not demonstrated against the consensus. Only more effective for EG <35 in the accumulated data and comparing seasons 12/13 and 08/09 to 13/14 for individual data was observed. This range has an associated incremental cost effectiveness ratio of € 53 250,07 (range: € 14 793,39 to € 90 446,47 for singles data and € 50 525,53 (€ 28 688.22 to € 211 575,65) for accumulated. The establishment of this protocol in our center meant an average saving per season € 169 911,51. A cost-effectiveness of the extended protocol appropriate relationship is found if the cost of palivizumab per patient was less than € 1 206,67 (calculated for maximum use of the vial) and a higher rate of hospitalization of 9.21%. Children entering the season with the new protocol (season 12/13 and 13/14) are 63.4% in children under 3 months and 90% are term infants who do not belong to any population at risk, while many of them have associated risk factors you vary as have school-age siblings, rural residence, parental smoking, poor educational background of parents, lack of artificial feeding and family history of allergy. CONCLUSIONS: The consensus protocol has not been a significant increase in hospitalization rates in preterm infants <32 weeks gestational age patients. In those <35 has been observed a higher rate of hospitalization, with a very unfavorable cost-effectiveness for all clinical scenarios valued relationship.

Objetivo: El objetivo principal fue evaluar el coste-efectividad del protocolo de uso de palivizumab en prematuros instaurado por consenso en nuestro hospital comparándolo con el basado en las recomendaciones de diferentes sociedades científicas. Como objetivo secundario se analizaron los factores de riesgo y gravedad de los pacientes hospitalizados atendiendo al protocolo establecido en nuestro centro.Material y métodos: El periodo de estudio fue de cuatro temporadas con el protocolo ampliado (datos retrospectivos) frente a dos con el protocolo restringido o consensuado (datos prospectivos). La perspectiva del estudio fue la del sistema sanitario, incluyendo los costes de hospitalización y del palivizumab en nuestro centro. El cálculo de la efectividad se determinó con la tasa de ingresos de pacientes prematuros estratificados por semanas de edad gestacional: < de 29, <32 y <35. Para el análisis de los factores de riesgo y gravedad en pacientes ingresados en las temporadas con el nuevo protocolo se recogen, de forma prospectiva, datos clínicos y factores ambientales y sociales. Resultados: En los estratos de edad gestacional <29 y <32 no se demostró una mayor efectividad del protocolo ampliado frente al consensuado. Solamente se objetivó una mayor efectividad para EG<35 en los datos acumulados y al comparar las temporadas 08/09 con la 12/13 y 13/14 para datos individuales. Este estrato lleva asociado un cociente coste eficacia incremental de 53.250,07 € (rango: 14.793,39 € a 90.446,47 € para los datos individuales y 50.525,53 € (28.688,22 € a 211.575,65 €) para los acumulados. La instauración de este protocolo en nuestro centro supuso un ahorro medio por temporada de 169.911,51 €. Se constata una relación coste-efectividad adecuada del protocolo ampliado si el coste del palivizumab por paciente fuese menor de 1.206,67 € (calculados para el máximo aprovechamiento del vial) y para una tasa de hospitalización mayor de 9,21%. Los niños que ingresan en las temporadas con el nuevo protocolo (temporada 12/13 y 13/14) son en un 63,4% niños menores de 3 meses y el 90% son neonatos a término que no pertenecen a ninguna población de riesgo, mientras que muchos de ellos tienen asociados varías factores de riesgo como tener hermanos en edad escolar, residencia rural, padres fumadores, escasa formación académica de los progenitores, ausencia de lactancia artificial e historia familiar de alergia.Conclusiones: El protocolo consensuado no ha supuesto un aumento significativo en las tasas de hospitalización en los pacientes prematuros <32 semanas de EG. En aquellos <35 se ha observado una mayor tasa de hospitalización, con una relación coste-efectividad muy desfavorable para todos los escenarios clínicos valorados.

Prevenção de Infecções pelo Vírus Sincicial Respiratório (VSR): uso do palivizumabe / Respiratory Syncytial Vírus (RSV) infection prevention: palivizumab use

Introdução: o vírus sincicial respiratório (VSR) pode causar quadros graves de bronquiolites e pneumonias, principalmente em grupos de risco como prematuros, cardiopatas e portadores de pneumopatias. O palivizumabe (PVZ) trouxe grande avanço na prevenção dessa doença e, devido ao alto custo, a Secretaria de Estado da Saúde de Minas Gerais (SES-MG) disponibiliza o produto aos grupos de alto risco. Objetivo: orientar os pediatras quanto à prevenção da infecção pelo VSR com orientações práticas sobre a prescrição do PVZ em MG. Métodos: são apresentados os critérios de inclusão para o uso dessa medicação em MG segundo portaria do Ministério da Saúde de 2013, como também os procedimentos adequados para a prescrição e fornecimento segundo normas da SES-MG. Resultados e conclusões: o conhecimento sobre o uso do PVZ para a prevenção do VSR e dos fluxos adequados para a prescrição e aplicação dessa medicação é fundamental para a prevenção da bronquiolite, portanto, deve ser amplamente divulgado entre os pediatras. Dessa forma, poderá ocorrer a redução dos casos graves, diminuindo a prevalência de sequelas e óbitos por essa doença.(AU)

Introduction: Respiratory Syncytial Vírus (RSV) can cause severe cases of bronchiolitis and pneumonia especially in risk groups such as premature neonates, cardiac patients and children with lung disease. Palivizumab (PVZ) has been successfully used in the prevention of this disease and due to the high cost, the Health's Secretary of Minas Gerais (SESMG) provides the product to high-risk groups. Objective: guide pediatricians regarding the prevention of RSV infection with practical guidelines for the prescription of PVZ in MG. Methods: Here are the inclusion criteria for the application of this medication in MG following the guidelines of the Ministry of Health in 2013, as well as the proper procedures for the prescription and supply according to standards of SES-MG. Results and Conclusions: Knowledge about the use of PVZ for the prevention of RSV and about the guidelines for prescription and application of this medication are key to the prevention of bronchiolitis, therefore should be widely disseminated to pediatricians. Thus may occur the reduction of severe cases decreasing the prevalence of sequelae and deaths from this disease.(AU)

An official American Thoracic Society proceedings: work-related asthma and airway diseases. Presentations and discussion from the Fourth Jack Pepys Workshop on Asthma in the Workplace.

Work-related asthma is a common occupational lung disease. The scope of the Fourth Jack Pepys Workshop that was held in May 2010 went beyond asthma to include discussion of other occupational airway diseases, in particular occupationally related chronic obstructive pulmonary disease (COPD) and bronchiolitis. Aspects explored included public health considerations, environmental aspects, outcome after diagnosis, prevention and surveillance, and other work-related obstructive airway diseases. Consistent methods are needed to accurately estimate the comparative burden of occupation-related airway diseases among different countries. Challenges to accomplishing this include variability in health care delivery, compensation systems, cultural contexts, and social structures. These factors can affect disease estimates, while heterogeneity in occupations and workplace exposures can affect the underlying true prevalence of morbidity. Consideration of the working environment included discussion of practical methods of limiting exposure to respiratory sensitizers, methods to predict new sensitizers before introduction into workplaces, the role of legislated exposure limits, and models to estimate relative validity of various ameliorative measures when complete avoidance of the sensitizer is not feasible. Other strategies discussed included medical surveillance measures and education, especially for young individuals with asthma and new workers about to enter the workforce. Medical outcomes after development of sensitizer-induced occupational asthma are best following earlier diagnosis and removal from further exposure, but a subset may be able to continue working safely provided that exposure is reduced under close follow-up monitoring. It was recognized that occupationally related COPD is common but underappreciated, deserving further study and prevention efforts.

Economic evaluation of palivizumab in children with congenital heart disease: a Canadian perspective.

BACKGROUND: Respiratory syncytial virus (RSV) is a common cause of bronchiolitis in infants. In children with congenital heart disease (CHD), it is associated with significant morbidity and mortality. Palivizumab is a monoclonal antibody that reduces the number of RSV-associated hospitalizations in children with CHD. We sought to assess cost savings and cost-effectiveness of palivizumab in children < 2 years old with hemodynamically significant CHD in a provincially administered RSV prophylaxis program. METHODS: A cohort of children who received palivizumab (N = 292) from 2003-2007 was compared to a historical cohort of children (N = 412) from 1998-2003 who met the eligibility criteria for palivizumab prior to initiation of the prophylaxis program. Direct and indirect costs and benefits were determined. RESULTS: The direct and indirect costs in the historical cohort were $838 per patient season compared to $9130 per patient season in the palivizumab cohort. Risk of admission was reduced by 42%, and days in hospital were reduced by 83%. The incremental cost of the RSV prophylaxis program was $8292 per patient for 1 RSV season. The incremental cost to prevent 1 day of hospitalization was $15,514. The cost of palivizumab accounted for 87.9% of the cost of prophylaxis. CONCLUSIONS: Palivizumab is clinically effective; however, the cost was exceptionally high relative to the outcomes in this population. Given the financial constraints in a public health care setting, more strict criteria for patient selection or reduced drug costs would improve the cost-effectiveness of RSV prophylaxis.

Fine particulate matter pollution linked to respiratory illness in infants and increased hospital costs.

There has been little research to date on the linkages between air pollution and infectious respiratory illness in children, and the resulting health care costs. In this study we used data on air pollutants and national hospitalizations to study the relationship between fine particulate air pollution and health care charges and costs for the treatment of bronchiolitis, an acute viral infection of the lungs. We found that as the average exposure to fine particulate matter over the lifetime of an infant increased, so did costs for the child's health care. If the United States were to reduce levels of fine particulate matter to 7 percent below the current annual standard, the nation could save $15 million annually in reduced health care costs from hospitalizations of children with bronchiolitis living in urban areas. These findings reinforce the need for ongoing efforts to reduce levels of air pollutants. They should trigger additional investigation to determine if the current standards for fine-particulate matter are sufficiently protective of children's health.

Impact of palivizumab on RSV hospitalizations for children with hemodynamically significant congenital heart disease.

The objective of this study was to evaluate the impact of palivizumab prophylaxis on respiratory syncytial virus (RSV) hospitalizations among children with hemodynamically significant congenital heart disease (CHD). In 2003, the American Academy of Pediatrics (AAP) revised the bronchiolitis policy statement and recommended the use of palivizumab in children <24 months old with hemodynamically significant CHD (HS-CHD). California statewide hospital discharge data from years 2000-2002 (pre-AAP policy revision) were compared to those from years 2004-2006 (post-AAP policy revision). Hospitalizations due to RSV bronchiolitis for children <2 years of age were identified by IDC-9 CM codes 4661.1, 480.1, and 079.6 as the Principal Diagnosis. Children with CHD and children with HS-CHD were identified by the codiagnoses. The overall RSV hospitalization rate was 71 per 10,000 children <2 years of age. Of all RSV hospitalizations, 3.0% were among children with CHD, and 0.50% among children with HS-CHD. HS-CHD patients accounted for 0.56% of RSV hospitalizations in 2000-2002, compared to 0.46% RSV hospitalizations in 2004-2006. That represents a 19% reduction in RSV hospitalizations among HS-CHD patients after 2003. The 19% decrease in RSV hospitalizations equates to seven fewer hospitalizations (76 hospital days) per year among HS-CHD patients. We conclude that, since the recommendation of palivizumab for children with HS-CHD in 2003, the impact on RSV hospitalizations in California among HS-CHD patients has been limited. Considering the high cost of palivizumab administration, the cost-benefit of RSV prophylaxis with palivizumab warrants further investigation.

The potential impact of prophylaxis against bronchiolitis due to the respiratory syncytial virus in children with congenital cardiac malformations.

AIMS: To determine the number of infants in the Mersey and North West regions with congenital cardiac disease for whom palivizumab may be appropriate, and to examine the potential impact of introducing prophylaxis with palivizumab on these patients and their economic management. METHODS: We identified those infants deemed to be at high risk, matching the population recently studied by the Cardiac Synagis Group, from the database of the cardiology department of the hospital. The number of patients under the care of the paediatric cardiologists admitted to Alder Hey Hospital with respiratory syncytial viral bronchiolitis over the last three seasons was identified from hospital coding records, and the database of the cardiology department. RESULTS: There are 131 patients at high risk each year. Of these, over the last three "bronchiolitis seasons", 39 infants have been admitted to the hospital with bronchiolitis due to the respiratory syncytial virus. This represents a hospitalisation rate of 10 per cent, as was seen in the study of the Cardiac Synagis Group. Using a monthly dose of 15 milligrams per kilogram for five doses, the cost per patient is 2,650 pounds sterling for the season. To treat the 131 patients seen at Alder Hey, therefore, would cost 346,800 pounds each year. Applying the reductions in hospitalisation identified in the study by the Cardiac Synagis Group to our population would produce an expected reduction in patients hospitalised from 13 to 7 per year, reducing the total length of stay in our hospital wards from 169 to 76 days, and in the paediatric intensive care unit from 93 to 21 days. This amounts to a potential saving of 190,800 pounds per year. Reducing transfers to more distant paediatric intensive care units for referrals refused because of lack of beds could save an additional 50,000 pounds. DISCUSSION: We estimate the net cost of introducing palivizumab for this population to be 106,000 pounds per year. There would, of course, be additional costs involved in setting up this service, as well as additional savings and benefits. This cost is comparable with other new biologic therapies now routinely used in the United Kingdom, such as etanercept for juvenile arthritis. There are, currently, no other obvious therapies that have the potential to reduce admissions to hospital and intensive care during the winter months, when beds are at their most scarce.

Economic analysis of palivizumab in infants with congenital heart disease.

OBJECTIVE: Palivizumab has been shown to reduce the number of respiratory syncytial virus (RSV)-related hospitalizations by 45% in children with congenital heart disease (CHD). The American Academy of Pediatrics has recommended that infants with hemodynamically significant CHD be considered for palivizumab. However, the economic implications of palivizumab prophylaxis in the CHD population have not been evaluated. In the present study, we sought to examine the cost savings and cost utility of RSV prophylaxis with palivizumab in children with CHD. METHODS: Probabilities of hospitalization and efficacy of prophylaxis were based on published results. Costs of hospitalization were derived from a published analysis of bronchiolitis hospitalization costs from a consortium of children's hospitals. A hypothetical cohort of 10,000 CHD patients (half of whom would receive palivizumab) was created to calculate cost-savings and cost-utility. To assess cost utility, we assumed that by reducing hospitalization, palivizumab would reduce RSV-related hospital mortality, generally reported to be 3% in CHD patients. Sensitivity analysis was performed. RESULTS: On the basis of a protocol of 5 monthly doses of palivizumab, the cost of prophylaxis for 1 RSV season was calculated as 6160 dollars per patient. After accounting for impact on direct and indirect costs of hospitalization, administration of palivizumab to 5000 CHD patients would result in a net loss of 20,415,753 dollars. If one assumes that palivizumab confers a survival benefit, then the cost of life-year saved is 100,338 dollars and cost of quality-adjusted life-year saved is 114,337 dollars. CONCLUSIONS: The cost of palivizumab prophylaxis was high relative to benefits realized. Given the large number of CHD patients who might be considered candidates for RSV prophylaxis (>6000 patients per year in United States) routine use of palivizumab in young children with hemodynamically significant CHD needs to be evaluated further.

Direct cost analyses of palivizumab treatment in a cohort of at-risk children: evidence from the North Carolina Medicaid Program.

OBJECTIVE: Use of palivizumab prophylactic therapy reduces the occurrence of hospitalizations for serious respiratory syncytial virus (RSV) lower respiratory tract infections in at-risk infants. The direct cost-benefit of palivizumab prophylaxis for infants who are born at 32 to 35 weeks' estimated gestational age (EGA) during their first year of life has not been systematically examined. The objective of this study was to compare the direct costs of palivizumab prophylaxis and RSV treatment in infants who were born at 32 to 35 weeks EGA and received and did not receive palivizumab. METHODS: A cohort study was performed of infants who were younger than 1 year and were enrolled in an enhanced primary care case management model within the North Carolina Medicaid Program. Comparisons were made between infants who received (Synagis prophylaxis group) and did not receive palivizumab (nonprophylaxis group) during the study period. Cost was examined using the sum of Medicaid paid services for prophylaxis with palivizumab and treatment for RSV infections that occurred between October 1, 2002, and May 31, 2003. The Anderson framework was used to specify the regression cost models to compare the participants who received (Synagis prophylaxis) and did not receive (nonprophylaxis group) palivizumab. The primary outcomes were actual 7-month seasonal costs and standardized seasonal costs adjusting for the varied months of infant participation. RESULTS: The study sample included 185 Synagis prophylaxis and 182 nonprophylaxis participants who met the inclusion criteria. The average per-person total cost of RSV care and prophylaxis was 5117 dollars for the Synagis prophylaxis group and 371 dollars for the nonprophylaxis group. Five hospitalizations occurred in the prophylaxis group, and 12 occurred in the nonprophylaxis group (odds ratio: 0.27). No deaths occurred in either group. CONCLUSIONS: Palivizumab administered to infants who were born at 32 to 35 weeks' EGA did not provide direct cost savings related to hospitalization or ambulatory care in a Medicaid population. The primary difference in cost between the groups was attributable to the palivizumab prophylaxis.

[Potential impact and cost-efficacy of bronchiolitis prophylaxis with palivizumab in preterm infants with a gestational age of less than 33 weeks]. / Impacto potencial y análisis coste-eficacia de la profilaxis con palivizumab, en la prevención de bronquiolitis, en prematuros menores de 33 semanas de gestación.

INTRODUCTION: Respiratory syncytial virus (RSV) is the main cause of bronchiolitis in children aged less than 2 years. The effectiveness of palivizumab has recently been reported in several clinical trials. OBJECTIVE: The aim of this study was to evaluate the hypothetical impact of a treatment strategy using palivizumab for the prevention of bronchiolitis in premature infants. METHODS: Neonates born in our hospital between January 1995 and December 1998 who were admitted for bronchiolitis were included. Using information from the Impact-RSV study, the effects and impact of different cut-off points in the gestational age of the study group were measured. Cost-effectiveness analysis included the cost of hospitalization as well as the direct cost of palivizumab prescriptions. RESULTS: Of 7,766 newborn infants, 56 had a gestational age of < or =32 weeks. Of these, bronchiolitis was diagnosed in eight infants (14.28%), and RSV was isolated in seven (14.28%). After hypothetical prophylaxis in premature infants the best results were obtained in the group with a gestational age of 30 weeks. In this group the relative risk of admission for bronchiolitis was 12.1 (95% CI: 4.8-30.5) and treatment would be required in nine infants to avoid one admission (cost Euros 12,915), with a cost 3.8 times greater than the current cost, without prophylaxis. CONCLUSIONS: Measurement of the impact and cost-effectiveness analysis of palivizumab prophylaxis provides a useful method for determining recommendations for the prevention of bronchiolitis in premature infants.

Palivizumab in prevention of bronchiolitis: new preparation. Moderate efficacy in some infants.

(1) RSV infection, the main cause of bronchiolitis, can necessitate hospitalisation, especially of infants at risk, i.e. those with a history of prematurity or bronchodysplasia. No drug prevention has been available. (2) Palivizumab, a monoclonal antibody directed against respiratory syncytial virus (RSV), is now marketed for preventing respiratory tract infection by RSV in certain infants. (3) The evaluation dossier barely answers the questions raised by the use of this drug. (4) The results of six trials suggest that the optimal dose is 15 mg/kg palivizumab by monthly injection throughout the seasonal epidemic period. (5) A double-blind trial in 1 502 infants either aged less than 6 months and born prematurely (35 weeks of gestation or earlier), or aged under 2 years with a history of bronchopulmonary dysplasia, has shown that, relative to a placebo, palivizumab reduces the hospitalisation rates by 5% in absolute values. It does not influence mortality or the need for mechanical ventilation. (6) Given the lack of relevant trials, we do not know if palivizumab is effective in infants with immunodeficiency or congenital heart diseases. We do not know, either, whether the definition of groups at risk used in the only relevant trial is appropriate. (7) No serious adverse effects attributable to palivizumab were reported in clinical trials. (8) Treatment with palivizumab is costly.