Exploratory analysis of the economically justifiable price of nirsevimab for healthy late-preterm and term infants in Colombia.

INTRODUCTION: Respiratory syncytial virus infection is the leading cause of lower respiratory infection globally. Recently, nirsevimab has been approved to prevent respiratory syncytial virus (RSV) infection. This study explores the economically justifiable price of nirsevimab for preventing RSV infection in Colombia's children under 1 year of age. MATERIALS AND METHODS: A static model was developed using the decision tree microsimulation to estimate the quality-adjusted costs and life years of two interventions: a single intramuscular dose of nirsevimab versus not applying nirsevimab. This analysis was made during a time horizon of 1 year and from a societal perspective. RESULTS: The annual savings in Colombia associated with this cost per dose ranged from U$ 2.5 to 4.1 million. Based on thresholds of U$ 4828, U$ 5128, and U$ 19 992 per QALY evaluated in this study, we established economically justifiable drug acquisition prices of U$ 21.88, U$ 25.04, and U$ 44.02 per dose of nirsevimab. CONCLUSION: the economically justifiable cost for nirsevimab in Colombia is between U$ 21 to U$ 44 per dose, depending on the willingness to pay used to decide its implementation. This result should encourage more studies in the region that optimize decision-making processes when incorporating this drug into the health plans of each country.

SOCIAL LISTENING AND GOOGLE TRENDS AS TOOLS FOR ESTIMATING PUBLIC AWARENESS OF RESPIRATORY SYNCYTIAL VIRUS.

Respiratory Syncytial Virus (RSV) imposes a large disease burden on a global level. Public awareness of RSV is important to support preventive interventions. In this study, Google Trends and a social listening tool, Brand24, were compared for measuring changes in public awareness levels of RSV. Google Trends is recommended for future research, as it is more sensitive, cost-free and open access.

Health care costs of hospitalization of young children for respiratory syncytial virus infections: a population-based matched cohort study.

BACKGROUND: Respiratory syncytial virus (RSV) infection poses a substantial clinical burden among infants and young children. We sought to determine the health care costs of hospitalizations attributable to RSV in Ontario, Canada, from the health care payer perspective. METHODS: For this population-based matched cohort study, we identified children younger than 24 months who were or were not hospitalized with RSV infections in 2006-2016. We performed a cost-of-illness analysis using linked administrative health data, with subjects stratified by gestational age and congenital heart disease, and propensity score-matched on established risk factors. The primary outcome was attributable health care costs per patient, reflecting the difference in direct medical costs between the groups, calculated to 12 months postdischarge in 2020 Canadian dollars. RESULTS: We identified 14 608 RSV-infected children, matched to 72 040 controls. The adjusted attributable cost of hospitalized RSV was $134 931 900 over 10 years, or $9240 per patient (95% confidence interval [CI] $8790-$9690). Health care costs escalated 3 days before hospitalization, and persisted up to 12 months after discharge. Increased costs were associated with major comorbidities, but not extreme premature birth. The highest mean attributable cost per patient was in the presence of hemodynamically significant heart disease ($60 110, 95% CI $26 700-$93 060). Infants born at 36-43 weeks' gestation constituted the greatest overall cost burden at $117 886 720. INTERPRETATION: Although the greatest direct medical costs per patient hospitalized with RSV infection are among children with cardiac disease, the greatest overall cost burden is from children born at or near term, who are not targeted by current prophylaxis strategies. The substantial attributable health care costs of RSV can inform cost-effectiveness analyses of novel RSV vaccines and prioritization of health care resources.

Economic and disease burden of RSV-associated hospitalizations in young children in France, from 2010 through 2018.

BACKGROUND: Respiratory syncytial virus (RSV) is the main cause of infant and child hospitalizations. The study objective is to estimate the RSV-associated hospitalizations and economic burden in young children in France to inform future preventive strategies. METHODS: We conducted a retrospective analysis of RSV-associated hospitalizations data from the French Hospital database (PMSI-MCO) which covers the entire French population. All children aged < 5 years hospitalized with RSV ICD-10 codes (J210, J219, J45, J121, J205, R062) from 2010 to 2018, were included. Descriptive analyses were conducted by RSV seasons (Oct to March), by respiratory years (July to June) and per age groups. RESULTS: On average 45,225 RSV-associated hospitalizations (range: 43,715 - 54,616) per season was reported in France, 69% among children < 1 year old. This represents 28% of all-cause hospitalizations that occurred among children < 1 year old, and less than 10% of all-cause hospitalizations in older children. Number of RSV-associated hospitalizations were similar for infants born during (Oct-March) or outside (April-September) their first RSV season. The highest risk being reported for infants born from September through November. The associated hospitalization cost increased between 2010 - 11 and 2017-18, from €93.2 million to €124.1 million, respectively, and infants < 1 year old represented 80% of the economic burden. CONCLUSION: RSV is an important cause of child hospitalization in France. The burden on healthcare system is mainly driven by < 1 year olds, and preventive strategies should be implemented before the first RSV season.

Hospitalizations for Respiratory Syncytial Virus and Vaccine Preventable Infections following Pediatric Heart Transplantation.

OBJECTIVE: To determine the risk factors for acquiring a respiratory syncytial virus (RSV) and vaccine-preventable infections (R/VPI) in pediatric heart transplant recipients and the associated morbidity and hospital resource use. STUDY DESIGN: Patients <18 years who underwent heart transplantation from September 2003 to December 2018 at hospitals using the Pediatric Health Information System database were identified. Their transplant hospitalization and subsequent hospitalizations for R/VPI through December 2018 were analyzed. Risk factors for R/VPI hospitalizations were evaluated using negative regression binomial models adjusted for demographic and clinical confounders. Total hospital costs were adjusted for 2018 US$. RESULTS: Of 3815 transplant recipients, 681 (17.9%) had an R/VPI hospitalization during 23 746 available person-years of follow-up. There were 984 R/VPIs diagnosed during 951 hospitalizations, and 440 (44.7%) occurred the first year after transplantation. The most common causes were RSV (n = 380; 38.6%), influenza (n = 265; 26.9%), and pneumococcus (n = 105; 10.7%). In adjusted analyses, there was an increased risk of R/VPI hospitalization in patients requiring mechanical circulatory support before transplantation, patients receiving induction with ≥2 immunosuppressive agents, and patients <2 years in the first year after transplantation. The median length of stay for an R/VPI hospitalization was 4 days (IQR, 2-8 days) with a median total cost of $11 081 (IQR, $6215-$24 322). CONCLUSIONS: Hospitalization for R/VPIs occurred frequently after heart transplantation and were associated with significant costs. Potential strategies to minimize R/VPI include expanding vaccine use through accelerated immunization schedules, further studies of use of palivizumab beyond 2 years of age, and immunogenicity monitoring after vaccination with re-immunization based on guidelines.

European data sources for computing burden of (potential) vaccine-preventable diseases in ageing adults.

BACKGROUND: To guide decision-making on immunisation programmes for ageing adults in Europe, one of the aims of the Vaccines and InfecTious diseases in the Ageing popuLation (IMI2-VITAL) project is to assess the burden of disease (BoD) of (potentially) vaccine-preventable diseases ((P)VPD). We aimed to identify the available data sources to calculate the BoD of (P)VPD in participating VITAL countries and to pinpoint data gaps. Based on epidemiological criteria and vaccine availability, we prioritized (P) VPD caused by Extra-intestinal pathogenic Escherichia coli (ExPEC), norovirus, respiratory syncytial virus, Staphylococcus aureus, and pneumococcal pneumonia. METHODS: We conducted a survey on available data (e.g. incidence, mortality, disability-adjusted life years (DALY), quality-adjusted life years (QALY), sequelae, antimicrobial resistance (AMR), etc.) among national experts from European countries, and carried out five pathogen-specific literature reviews by searching MEDLINE for peer-reviewed publications published between 2009 and 2019. RESULTS: Morbidity and mortality data were generally available for all five diseases, while summary BoD estimates were mostly lacking. Available data were not always stratified by age and risk group, which is especially important when calculating BoD for ageing adults. AMR data were available in several countries for S. aureus and ExPEC. CONCLUSION: This study provides an exhaustive overview of the available data sources and data gaps for the estimation of BoD of five (P) VPD in ageing adults in the EU/EAA, which is useful to guide pathogen-specific BoD studies and contribute to calculation of (P)VPDs BoD.

Risk Factors for Respiratory Syncytial Virus Lower Respiratory Tract Infections: Evidence from an Indonesian Cohort.

Although risk factors for hospitalization from a respiratory syncytial virus (RSV) are well known, RSV lower respiratory tract infections (LRIs) in the community are much less studied or understood, especially in developing countries. In a prospective, cohort study we studied factors predisposing Indonesian infants and children under 5 years of age to developing RSV LRIs. Subjects were enrolled in two cohorts: a birth cohort and a cross-sectional cohort of children <48 months of age. Subjects were visited weekly at home to identify any LRI, using the World Health Organization's criteria. RSV etiology was determined through analysis of nasal washings by enzyme immunoassay and polymerase chain reaction. Risk factors for the development of the first documented RSV LRI were identified by multivariate analysis using logistic regression and Cox proportional hazard modeling. Of the 2014 children studied, 999 were enrolled within 30 days of birth. There were 149 first episodes of an RSV. Risk factors for an RSV LRI were poverty (p < 0.01), use of kerosene as a cooking fuel (p < 0.05), and household ownership of rabbits and chickens (p < 0.01). Our findings suggested that in a middle-income country such as Indonesia, with a substantial burden of RSV morbidity and mortality, lower socioeconomic status, environmental air quality, and animal exposure are predisposing factors for developing an RSV LRI.

Respiratory Syncytial Virus-associated Acute Otitis Media in Infants and Children.

Despite recent declines in the incidence of acute otitis media (AOM), more than 5 million cases and 5-6 million primary AOM visits still occur in young children in the United States, resulting in $4.4 billion direct medical costs annually. Our aims in this review are to describe the role of respiratory syncytial virus (RSV) in the etiology of AOM, discuss the prospect of prevention of RSV-associated AOM through immunization, and suggest future research strategies to assess the impact of immunization on RSV-associated AOM.

Inferring antenatal care visit timing in low- and middle-income countries: Methods to inform potential maternal vaccine coverage.

BACKGROUND: The timing of antenatal care (ANC) visits directly affect health intervention coverage and impact, especially for those interventions requiring strict gestational age windows for administration, such as maternal respiratory syncytial virus (RSV) vaccine. Existing nationally representative population-based surveys do not record the timing of ANC visits beyond the first, limiting the availability of reliable data around timing of subsequent ANC visits in most low- and middle-income countries (LMICs). Here, we describe a model that estimates the timing of ANC visits by gestational age using publicly available multi-country survey data. METHODS AND FINDINGS: We used the Demographic and Health Surveys (DHS) data from 69 LMICs. We used several factors to estimate the timing of subsequent ANC visits by gestation age: the timing of the first ANC visit (ANC1) in a given pregnancy, derived from the DHS; the country's reported average ANC coverage at each ANC visit (ANC1 through the fourth ANC visit [ANC4]); and the World Health Organization's guidance on recommended ANC visit. We then used the timing of ANC visit by gestation age to predict the coverage of a potential maternal RSV vaccine administered at 24-36 weeks of gestation. We calculated the maternal immunization coverage by summing the number of eligible women vaccinated at any ANC visit divided by the total number of pregnant women. We find, in general, countries with higher ANC1 coverage were predicted to have higher vaccination coverage. In 82% of countries, the modeled vaccine coverage is less than ANC4 coverage. CONCLUSIONS: The methods illustrated in this paper have implications on the precision of estimating impact and programmatic feasibility of time-critical interventions, especially for pregnant women. The methods can be easily adapted to vaccine demand forecasts models, vaccine impact assessments, and cost-effectiveness analyses and can be adapted to other maternal interventions that have administration timing restrictions.

The health and economic burden of respiratory syncytial virus associated hospitalizations in adults.

BACKGROUND: Respiratory syncytial virus (RSV) is increasingly recognized as an important cause of illness in adults; however, data on RSV disease and economic burden in this age group remain limited. We aimed to provide comprehensive estimates of RSV disease burden among adults aged ≥18 years. METHODS: During 2012-2015, population-based, active surveillance of acute respiratory infection (ARI) hospitalizations enabled estimation of the seasonal incidence of RSV hospitalizations and direct health costs in adults aged ≥18 years in Auckland, New Zealand. RESULTS: Of 4,600 ARI hospitalizations tested for RSV, 348 (7.6%) were RSV positive. The median (interquartile range) length of hospital stay for RSV positive patients was 4 (2-6) days. The seasonal incidence rate (IR) of RSV hospitalizations, corrected for non-testing, was 23.6 (95% confidence intervals [CI] 21.0-26.1) per 100,000 adults aged ≥18 years. Hospitalization risk increased with age with the highest incidence among adults aged ≥80 years (IR 190.8 per 100,000, 95% CI 137.6-244.0). Being of Maori or Pacific ethnicity or living in a neighborhood with low socioeconomic status (SES) were independently associated with increased RSV hospitalization rates. We estimate RSV-associated hospitalizations among adults aged ≥18 years to cost on average NZD $4,758 per event. CONCLUSIONS: RSV infection is associated with considerable disease and economic cost in adults. RSV disproportionally affects adult sub-groups defined by age, ethnicity, and neighborhood SES. An effective RSV vaccine or RSV treatment may offer benefits for older adults.

Cost-analysis of Withdrawing Immunoprophylaxis for Respiratory Syncytial Virus in Infants Born at 33-35 Weeks Gestational Age in Quebec: A Multicenter Retrospective Study.

BACKGROUND: In 2015, the Quebec Ministry of Health limited palivizumab prophylaxis for respiratory syncytial virus (RSV) in premature infants to those born at <33 weeks gestational age (wGA), unless other indications were present. We compared RSV-related costs for 2 seasons before the change (2013-2014, 2014-2015) and 2 seasons after (2015-2016, 2016-2017) in premature infants 33-35 wGA. METHODS: Using payer and societal perspectives, costs associated with hospitalizations for RSV and lower respiratory tract infection (LRTI) in infants born at 33-35 wGA were estimated. Inputs were from a 2013-2017 retrospective cohort study in 25 Quebec hospitals of RSV/LRTI hospitalizations among infants <6 months old at the start of, or born during, the RSV season. Resource utilization data (hospital stay, procedures, visits, transportation, out-of-pocket expenses and work productivity) were collected from charts and parent interviews allowing estimation of direct and indirect costs. Costs, including palivizumab administration, were derived from provincial sources and adjusted to 2018 Canadian dollars. Costs were modeled for preterm infants hospitalized for RSV/LRTI pre- and postrevision of guidelines and with matched term infants hospitalized for RSV/LRTI during 2015-2017 (comparator). RESULTS: Average total direct and indirect costs for 33-35 wGA infants were higher postrevision of guidelines ($29,208/patient, 2015-2017; n = 130) compared with prerevision ($16,976/patient, 2013-2015; n = 105). Total costs were higher in preterm infants compared with term infants (n = 234) postrevision of guidelines ($29,208/patient vs. $10,291/patient). CONCLUSIONS: Immunoprophylaxis for RSV in infants born at 33-35 wGA held a cost advantage for hospitalizations due to RSV/LRTI.

Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis.

BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of acute lower respiratory infection (ALRI) in young children aged <5 years. METHODS: We aimed to identify the global inpatient and outpatient cost of management of RSV-ALRI in young children to assist health policy makers in making decisions related to resource allocation for interventions to reduce severe morbidity and mortality from RSV in this age group. We searched 3 electronic databases including Global Health, Medline, and EMBASE for studies reporting cost data on RSV management in children under 60 months from 2000 to 2017. Unpublished data on the management cost of RSV episodes were collected through collaboration with an international working group (RSV GEN) and claim databases. RESULTS: We identified 41 studies reporting data from year 1987 to 2017, mainly from Europe, North America, and Australia, covering the management of a total of 365 828 RSV disease episodes. The average cost per episode was €3452 (95% confidence interval [CI], 3265-3639) and €299 (95% CI, 295-303) for inpatient and outpatient management without follow-up, and it increased to €8591(95% CI, 8489-8692) and €2191 (95% CI, 2190-2192), respectively, with follow-up to 2 years after the initial event. CONCLUSIONS: Known risk factors (early and late preterm birth, congenital heart disease, chronic lung disease, intensive care unit admission, and ventilator use) were associated with €4160 (95% CI, 3237-5082) increased cost of hospitalization. The global cost of inpatient and outpatient RSV ALRI management in young children in 2017 was estimated to be approximately €4.82 billion (95% CI, 3.47-7.93), 65% of these in developing countries and 55% of global costs accounted for by hospitalization. We have demonstrated that RSV imposed a substantial economic burden on health systems, governments, and the society.

Health and economic burden of respiratory syncytial virus (RSV) disease and the cost-effectiveness of potential interventions against RSV among children under 5 years in 72 Gavi-eligible countries.

BACKGROUND: Respiratory syncytial virus (RSV) frequently causes acute lower respiratory infection in children under 5, representing a high burden in Gavi-eligible countries (mostly low-income and lower-middle-income). Since multiple RSV interventions, including vaccines and monoclonal antibody (mAb) candidates, are under development, we aim to evaluate the key drivers of the cost-effectiveness of maternal vaccination and infant mAb for 72 Gavi countries. METHODS: A static Multi-Country Model Application for RSV Cost-Effectiveness poLicy (MCMARCEL) was developed to follow RSV-related events monthly from birth until 5 years of age. MCMARCEL was parameterised using country- and age-specific demographic, epidemiological, and cost data. The interventions' level and duration of effectiveness were guided by the World Health Organization's preferred product characteristics and other literature. Maternal vaccination and mAb were assumed to require single-dose administration at prices assumed to align with other Gavi-subsidised technologies. The effectiveness and the prices of the interventions were simultaneously varied in extensive scenario analyses. Disability-adjusted life years (DALYs) were the primary health outcomes for cost-effectiveness, integrated with probabilistic sensitivity analyses and Expected Value of Partially Perfect Information analysis. RESULTS: The RSV-associated disease burden among children in these 72 countries is estimated at an average of 20.8 million cases, 1.8 million hospital admissions, 40 thousand deaths, 1.2 million discounted DALYs, and US$611 million discounted direct costs. Strategy 'mAb' is more effective due to its assumed longer duration of protection versus maternal vaccination, but it was also assumed to be more expensive. Given all parameterised uncertainty, the optimal strategy of choice tends to change for increasing willingness to pay (WTP) values per DALY averted from the current situation to maternal vaccination (at WTP > US$1000) to mAB (at WTP > US$3500). The age-specific proportions of cases that are hospitalised and/or die cause most of the uncertainty in the choice of optimal strategy. Results are broadly similar across countries. CONCLUSIONS: Both the maternal and mAb strategies need to be competitively priced to be judged as relatively cost-effective. Information on the level and duration of protection is crucial, but also more and better disease burden evidence-especially on RSV-attributable hospitalisation and death rates-is needed to support policy choices when novel RSV products become available.

Approaches to use the WHO respiratory syncytial virus surveillance platform to estimate disease burden.

The World Health Organization (WHO) recently completed the first phase of a RSV surveillance pilot study in fourteen countries (two to three in each WHO region) building on the Global Influenza Surveillance and Response System (GISRS). This active surveillance strategy had several objectives including understanding RSV-related health burden in a variety of settings. A range of approaches can be used to estimate disease burden; most approaches could not be applied by participating countries in the WHO surveillance pilot. This article provides the recommendations made by WHO for strengthening and expanding the scope of the RSV surveillance in the next phase to enable burden estimation.

Impact of the 2014 American Academy of Pediatrics Immunoprophylaxis Policy on the Rate, Severity, and Cost of Respiratory Syncytial Virus Hospitalizations among Preterm Infants.

OBJECTIVE: This study examined the rate, severity, and cost of respiratory syncytial virus (RSV) hospitalizations among preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after a 2014 change in the American Academy of Pediatrics policy for RSV immunoprophylaxis. STUDY DESIGN: Preterm (29-34 wGA) and term infants born from July 2011 to March 2017 and aged < 6 months were identified in a U.S. commercial administrative claims database. RSV hospitalization (RSVH) rate ratios, severity, and costs were evaluated for the 2011 to 2014 and 2014 to 2017 RSV seasons. Postpolicy changes in RSVH risks for preterm versus term infants were assessed with difference-in-difference (DID) modeling to control for patient characteristics and temporal trends. RESULTS: In the DID analysis, prematurity-associated RSVH risk was 55% greater in 2014 to 2017 versus 2011 to 2014 (relative risk = 1.55, 95% confidence interval: 1.10-2.17, p = 0.011). RSVH severity increased among preterm infants after 2014 and was highest among those aged < 3 months. Differences in mean RSVH costs for preterm infants in 2014 to 2017 versus 2011 to 2014 were not statistically significant. CONCLUSION: RSVH risk for preterm versus term infants increased after the policy change, confirming previous national analyses. RSVHs after the policy change were more severe, particularly among younger preterm infants.

Healthcare resource utilization and costs in the 12 months following hospitalization for respiratory syncytial virus or unspecified bronchiolitis among infants.

Aims: To examine healthcare resource utilization (HRU) and costs within 12 months after hospitalization for respiratory syncytial virus (RSVH) or unspecified bronchiolitis (UBH) in infants.Materials and methods: Infants born July 1, 2009-June 30, 2015 were identified in the MarketScan Medicaid and Commercial databases and were assigned to one of three cohorts: RSVH (with/without UBH), UBH, or comparator (no RSVH or UBH). Each infant was identified as pre-term (5 groups) or term (2 groups) based on weeks gestational age (wGA). Index dates were the first admission dates for RSVH or UBH infants and were randomly assigned to comparator infants based on time from birth to index in the RSVH cohort. HRU, all-cause costs, and incremental cost differences between hospitalized and comparator infants were assessed over 12 months post-index with and without the index hospitalization. Results were propensity score weighted to balance pre-index characteristics across hospitalization cohorts.Results: This study identified 15,872 RSVH infants, 6,081 UBH infants, and 986,087 comparator infants in the Medicaid population and 5,755 RSVH infants, 1,888 UBH infants, and 696,302 comparator infants in the commercial population. HRU in follow-up was greater for RSVH and UBH infants relative to comparator infants in both populations, including hospitalizations (commercial: 7.4%, 11.0%, 1.7%; Medicaid: 12.3%, 15.3%, 3.2%) and emergency department visits (commercial: 33.0%, 33.3%, 17.2%; Medicaid: 65.8%, 68.5%, 51.4%). HRU was highest among RSVH and UBH infants born at <29 wGA. Hospitalized infants had numerically higher follow-up costs than comparator infants, with incremental differences reaching $19,896 among Medicaid UBH infants and $37,417 among commercial RSVH infants.Limitations: RSV/UB may be miscoded in claims data.Conclusions: Infants hospitalized for RSV or UB largely had greater subsequent HRU and costs in the first year after index hospitalization than comparator infants. Absolute and incremental follow-up costs relative to comparator infants were highest among infants <29 wGA.

Long-term Assessment of Healthcare Utilization 5 Years After Respiratory Syncytial Virus Infection in US Infants.

BACKGROUND: Respiratory syncytial virus (RSV) is the primary cause of respiratory tract infections in infants; however, current burden estimates report only the short-term effects of acute infection. METHODS: Infants with RSV infection and ≥24 months of continuous enrollment were retrospectively identified from the Truven MarketScan database (1 January 2004-30 September 2015). Exposed infants (n = 38 473) were propensity score matched to nonexposed controls (n = 76 825) by baseline characteristics and gestational age. Five-year cumulative all-cause, asthma/wheezing, and respiratory event-related hospitalization rates and physician and emergency department healthcare-resource utilization rates were assessed. RESULTS: During follow-up, RSV-infected cohorts had higher average all-cause cumulative hospitalization rates, compared with controls, with values of 79.9 hospitalizations/100 patient-years (95% confidence interval [CI], 41.7-118.2) for 213 early premature infants (P < .001), 18.2 hospitalizations/100 patient-years (95% CI, .8-35.7) for 397 premature infants (P = .04), 34.2 hospitalizations/100 patient-years (95% CI, 29.1-39.2) for 4446 late premature infants (P < .001), and 16.1 hospitalizations/100 patient-years (95% CI, 14.9-17.4) for 33 417 full-term infants (P < .001). Cumulative rates of physician and emergency department visits were also higher for RSV-infected infants. Asthma/wheezing accounted for 10%-18% of total 5-year physician visits. CONCLUSIONS: Infant RSV infection has a significant long-term healthcare-resource utilization impact across gestational ages for at least 5 years after infection, most of it in the first 2 years. Systematically collecting healthcare-resource utilization data will be important for cost-effectiveness evaluations of RSV interventions in planned or ongoing trials.

Direct medical costs of RSV-related bronchiolitis hospitalizations in a middle-income tropical country.

INTRODUCTION AND OBJECTIVES: With the objective of making informed decisions on resource allocation, there is a critical need for studies that provide accurate information on hospital costs for treating respiratory syncytial virus (RSV)-related bronchiolitis, mainly in middle-income countries (MICs). The aim of the present study was to evaluate the direct medical costs associated with bronchiolitis hospitalizations caused by infection with RSV in Bogota, Colombia. MATERIAL AND METHODS: We reviewed the available electronic medical records (EMRs) for all infants younger than two years of age who were admitted to the Fundacion Hospital de La Misericordia with a discharge principal diagnosis of RSV-related bronchiolitis over a 24-month period from January 2016 to December 2017. Direct medical costs of RSV-related bronchiolitis were retrospectively collected by dividing the infants into three groups: those requiring admission to the pediatric ward (PW) only, those requiring admission to the pediatric intermediate care unit (PIMC), and those requiring to the pediatric intensive care unit (PICU). RESULTS: A total of 89 patients with a median (IQR) age of 7.1 (3.1-12.2) months were analyzed of whom 20 (56.2%) were males. Overall, the median (IQR) cost of infants treated in the PW, in the PIMC, and in the PICU was US$518.0 (217.0-768.9) vs. 1305.2 (1051.4-1492.2) vs. 2749.7 (1372.7-4159.9), respectively, with this difference being statistically significant (p<0.001). CONCLUSIONS: The present study helps to further our understanding of the economic burden of RSV-related bronchiolitis hospitalizations among infants of under two years of age in a middle-income tropical country.

Economic-Burden Trajectories in Commercially Insured US Infants With Respiratory Syncytial Virus Infection.

BACKGROUND: This study evaluates the long-term respiratory syncytial virus (RSV) burden among preterm and full-term infants in the United States. METHODS: Infants with birth hospitalization claims and ≥24 months of continuous enrollment were retrospectively identified in the Truven MarketScan Commercial Claims and Encounters database for the period 1 January 2004-30 September 2015. Infants with RSV infection in the first year of life (n = 38 473) were matched to controls (n = 76 825), and remaining imbalances in the number of individuals in each group were adjusted using propensity score methods. All-cause, respiratory-related, and asthma/wheezing-related 5-year average cumulative costs were measured. RESULTS: Early premature (n = 213), premature (n = 397), late premature (n = 4446), and full-term (n = 33 417) RSV-infected infants were matched to 424, 791, 8875, and 66 735 controls, respectively. After 2 years since RSV diagnosis, all-cause cumulative costs for RSV-infected infants as compared to those for controls increased by $22 081 (95% confidence interval [CI], -$5800-$42 543) for early premature infants, by $14 034 (95% CI, $5095- $22 973) for premature infants, by $10 164 (95% CI, $8835-$11 493) for late premature infants, and by $5404 (95% CI, $5110-$5698) for full-term infants. The 5-year RSV burden increased to $39 490 (95% CI, $18 217-$60 764), $23 160 (95% CI, $13 002-$33 317),$13 755 (95% CI, $12 097-$15 414), and $6631 (95% CI, $6060-$7202), respectively. The RSV burden was higher when stratified by inpatient and outpatient setting and respiratory-related and asthma/wheezing-related costs. CONCLUSIONS: The RSV burden extends across cost domains and prematurity, with the greatest burden incurred by the second year of follow-up. Findings are useful in determining the cost-effectiveness of RSV therapies in development.

Impact of the 2014 American Academy of Pediatrics recommendation and of the resulting limited financial coverage by the Italian Medicines Agency for palivizumab prophylaxis on the RSV-associated hospitalizations in preterm infants during the 2016-2017 epidemic season: a systematic review of seven Italian reports.

BACKGROUND: The only pharmacologic prophylaxis against respiratory syncytial virus (RSV) infection in preterm infants is the humanized monoclonal antibody palivizumab. After the 2014 modification of the American Academy of Pediatrics (AAP) recommendations, the Italian Medicines Agency (AIFA) limited the financial coverage for palivizumab prescriptions to otherwise healthy preterm infants with < 29 weeks of gestational age (wGA) aged < 12 months at the beginning of the 2016-2017 RSV season. However, due to the effect on disease severity and hospitalizations following this limitation, shown by several Italian clinical studies, in November 2017 AIFA reinstated the financial coverage for these infants. In this systematic review, we critically summarize the data that show the importance of palivizumab prophylaxis. METHODS: Data from six Italian pediatric institutes and the Italian Network of Pediatric Intensive Care Units (TIPNet) were retrieved from the literature and considered. The epidemiologic information for infants 29-36 wGA, aged < 12 months and admitted for viral-induced acute lower respiratory tract infection were retrospectively reviewed. RSV-associated hospitalizations were compared between the season with running limitation, i.e. 2016-2017, versus 2 seasons before (2014-2015 and 2015-2016) and one season after (2017-2018) the AIFA limitation. RESULTS: During the 2016-2017 RSV epidemic season, when the AIFA limited the financial coverage of palivizumab prophylaxis based on the 2014 AAP recommendation, the study reports on a higher incidences of RSV bronchiolitis and greater respiratory function impairment. During this season, we also found an increase in hospitalizations and admissions to the Pediatric Intensive Care Units and longer hospital stays, incurring higher healthcare costs. During the 2016-2017 epidemic season, an overall increase in the number of RSV bronchiolitis cases was also observed in infants born full term, suggesting that the decreased prophylaxis in preterm infants may have caused a wider infection diffusion in groups of infants not considered to be at risk. CONCLUSIONS: The Italian results support the use of palivizumab prophylaxis for otherwise healthy preterm (29-36 wGA) infants aged < 6 months at the beginning of the RSV season.