A Real-World Evidence Study of CDK4/6 Inhibitor Treatment Patterns and Outcomes in Metastatic Breast Cancer by Germline BRCA Mutation Status.

INTRODUCTION: Limited data exist on real-world treatment patterns and the effectiveness of cyclin-dependent kinase (CDK) 4/6 inhibitors in germline BRCA (gBRCA)-mutated breast cancer. METHODS: Adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) treated with CDK4/6 inhibitor therapy between 2013 and 2018 were retrospectively selected from the Flatiron Health database. Patients with known gBRCA status were classified as mutated (gBRCAm) or wild type (gBRCAwt). Time-to-first subsequent therapy or death (TFST) and overall survival (OS) were calculated from the earliest line of therapy with a CDK4/6 inhibitor. RESULTS: Of 2968 patients with HR+/HER2- mBC receiving a CDK4/6 inhibitor, 859 (28.9%) had known gBRCA status, of whom 9.9% were gBRCAm and 90.1% gBRCAwt. Median (95% confidence interval [CI]) TFST was 10 (7-11) months in the gBRCAm group, 10 (9-11) months in the gBRCAwt group, and 11 (10-12) months in the combined gBRCAwt and unknown gBRCA group; median (95% CI) OS was 26 (21-not estimated), 37 (31-51), and 33 (31-35) months, respectively. Cox models indicated the gBRCAm group had shorter TFST (stratified hazard ratio [sHR] 1.24; 95% CI 0.96-1.59) and OS (sHR 1.50; 95% CI 1.06-2.14) than the gBRCAwt group. The gBRCAm group had shorter TFST (sHR 1.38; 95% CI 1.08-1.75) and OS (sHR 1.22; 95% CI 0.88-1.71) than the combined group. CONCLUSION: The results of this real-world study suggest that treatment outcomes with CDK4/6 inhibitors may be worse in patients with gBRCAm mBC than in their counterparts with gBRCAwt and unknown gBRCA status, suggesting potential differences in tumor biology. This result highlights the unmet need in patients with gBRCAm requiring optimized treatment selection and sequencing. Future exploration in larger samples of patients who have had biomarker testing is warranted.

Cost-effectiveness of olaparib as a maintenance treatment for women with newly diagnosed advanced ovarian cancer and BRCA1/2 mutations in the United States.

OBJECTIVE: This study evaluated the cost-effectiveness of olaparib monotherapy in the first-line maintenance setting vs. surveillance in women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation from a US third-party payer perspective. METHODS: A three-state (progression free, progressed disease, and death) partitioned survival model over a 50-year lifetime horizon was developed. Piecewise models were applied to data from the phase III trial SOLO1 to extrapolate survival outcomes. Health state utilities and adverse event disutilities were obtained from literature and SOLO1. Treatment costs, adverse event costs, and medical costs associated with health states were obtained from publicly available databases, SOLO1, and real-world data. Time on treatment was estimated using the data from SOLO1. Incremental costs per quality-adjusted life year (QALY) and life year (LY) gained were estimated. One-way deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Over a lifetime horizon, olaparib was associated with an additional 3.63 LYs and 2.93 QALYs, and an incremental total cost of $152,545 vs. surveillance. Incremental cost per LY gained and per QALY gained for olaparib were $42,032 and $51,986, respectively. The incremental cost-effectiveness ratios remained below $100,000 across a range of inputs and scenarios. In the PSA, the probability of olaparib being cost-effective at a $100,000 per QALY threshold was 99%. CONCLUSIONS: Compared to surveillance, olaparib increases both the LYs and QALYs of women with newly diagnosed advanced ovarian cancer and with a germline or somatic BRCA mutation. Olaparib offers a cost-effective maintenance option for these women from a US third-party payer perspective.

SENTINEL1: Two-Season Study of Respiratory Syncytial Virus Hospitalizations among U.S. Infants Born at 29 to 35 Weeks' Gestational Age Not Receiving Immunoprophylaxis.

OBJECTIVE: The SENTINEL1 observational study characterized confirmed respiratory syncytial virus hospitalizations (RSVH) among U.S. preterm infants born at 29 to 35 weeks' gestational age (wGA) not receiving respiratory syncytial virus (RSV) immunoprophylaxis (IP) during the 2014 to 2015 and 2015 to 2016 RSV seasons. STUDY DESIGN: All laboratory-confirmed RSVH at participating sites during the 2014 to 2015 and 2015 to 2016 RSV seasons (October 1-April 30) lasting ≥24 hours among preterm infants 29 to 35 wGA and aged <12 months who did not receive RSV IP within 35 days before onset of symptoms were identified and characterized. RESULTS: Results were similar across the two seasons. Among infants with community-acquired RSVH (N = 1,378), 45% were admitted to the intensive care unit (ICU) and 19% required invasive mechanical ventilation (IMV). There were two deaths. Infants aged <6 months accounted for 78% of RSVH observed, 84% of ICU admissions, and 91% requiring IMV. Among infants who were discharged from their birth hospitalization during the RSV season, 82% of RSVH occurred within 60 days of birth hospitalization discharge. CONCLUSION: Among U.S. preterm infants 29 to 35 wGA not receiving RSV IP, RSVH are often severe with almost one-half requiring ICU admission and about one in five needing IMV.

Characteristics and health care utilization of otherwise healthy commercially and Medicaid-insured preterm and full-term infants in the US.

PURPOSE: This study examined health care utilization and costs during the first year of life for preterm and full-term infants in the US. SUBJECTS AND METHODS: Preterm (<37 weeks gestational age [GA]) and full-term infants born 2003 to 2012 without complex medical conditions were identified in the MarketScan® Commercial and Multi-State Medicaid claims databases using ICD-9-CM diagnosis and diagnosis-related grouping codes. Inpatient and outpatient claims from birth through the first year were analyzed for preterm and full-term subgroups. Results were stratified by payer. RESULTS: There were 1,692,935 commercially insured infants (12.5% preterm) and 1,873,324 Medicaid-insured infants (13.9% preterm). The majority (>75%) of preterm infants were admitted to the neonatal intensive care unit during their birth hospitalization. Generally, mean length of stay and costs for birth hospitalizations increased with decreasing GA. The average cost of a birth hospitalization was US $62,931 (SD $134,347) for commercially insured preterm infants and $43,858 (SD $115,412) for Medicaid-insured preterm infants compared to $2,401 (SD $7,399) and $1,894 (SD $5,444) for commercially insured and Medicaid-insured full-term infants, respectively. Post-neonatal hospitalization rates increased as GA decreased (in full-term to <29 weeks GA: commercial =3.3%-19.5%; Medicaid =6.1%-26.2%). Preterm infants had greater average numbers of outpatient office visits and pharmacy claims than full-term infants. Following birth discharge, mean monthly health care costs per infant increased as GA decreased (commercial = $334 to $3,126; Medicaid = $205 to $2,473). CONCLUSION: During the first year of life, post-neonatal hospitalization rates, outpatient office visits, pharmacy claims, and monthly costs increased as GA decreased.

Impact of Respiratory Syncytial Virus-Confirmed Hospitalizations on Caregivers of US Preterm Infants.

This study assessed the impact of respiratory syncytial virus-confirmed hospitalizations (RSVH) on caregivers of high-risk preterm infants. Caregivers for infants born at 29 to 35 weeks' gestational age and hospitalized for confirmed RSV disease responded to measures of self-rated and perceived infant stress (1-7; 7 = very stressful), perceived infant health (0-100; 100 = best imaginable health), and productivity impairment. Data were collected at hospital discharge through 1 month post-discharge. Caregiver responses indicated high stress levels, poor health, and productivity loss were reported at discharge; however, steady improvements were seen through 1 month post-discharge: caregiver-rated stress (from 6 to 2), infant stress (5 to 1), caregiver-perceived infant health (64 to 84), and productivity loss (mothers: 91% to 31%; fathers: 81% to 18%). Qualitative results indicated emotional impact, family routine disruption, financial concerns, and medical concerns persisted at 1 month post-discharge. This study found the caregiver burden of RSVH persists at least 1 month beyond discharge.

Respiratory Syncytial Virus Hospitalizations among U.S. Preterm Infants Compared with Term Infants Before and After the 2014 American Academy of Pediatrics Guidance on Immunoprophylaxis: 2012-2016.

OBJECTIVE: The objective of this study was to compare risk for respiratory syncytial virus (RSV) hospitalizations (RSVH) for preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after 2014 guidance changes for immunoprophylaxis (IP), using data from the 2012 to 2016 RSV seasons. STUDY DESIGN: Using commercial and Medicaid claims databases, infants born between July 1, 2011 and June 30, 2016 were categorized as preterm or term. RSVH during the RSV season (November-March) were identified for infants aged <6 months and rate ratios (RRs) for hospitalization comparing preterm and term infants were calculated. Difference-in-difference models were fit to evaluate the changes in hospitalization risks in preterm versus term infants from 2012 to 2014 seasons to 2014 to 2016 seasons. RESULTS: In all seasons, preterm infants had higher RSVH rates than term infants. Seasonal RRs prior to the guidance change for preterm wGA categories versus term infants ranged from 1.6 to 3.4. After the guidance change, the seasonal RRs ranged from 2.6 to 5.6. In 2014 to 2016, the risk associated with prematurity of 29 to 34 wGA versus term was significantly higher than in 2012 to 2014 (P<0.0001 for commercial and Medicaid samples). CONCLUSION: In infants aged <6 months, the risk for RSVH for infants 29 to 34 wGA compared with term infants increased significantly after the RSV IP recommendations became more restrictive.

Palivizumab Prophylaxis for Respiratory Syncytial Virus: Examining the Evidence Around Value.

Respiratory syncytial virus (RSV) infection is the most common cause of lower respiratory tract infection and the leading cause of hospitalization among young children, incurring high annual costs among US children under the age of 5 years. Palivizumab has been found to be effective in reducing hospitalization and preventing serious lower respiratory tract infections in high-risk infants. This paper presents a systematic review of the cost-effectiveness studies of palivizumab and describes the main highlights of a round table discussion with clinical, payer, economic, research method, and other experts. The objectives of the discussion were to (1) review the current state of clinical, epidemiology, and economic data related to severe RSV disease; (2) review new cost-effectiveness estimates of RSV immunoprophylaxis in US preterm infants, including a review of the field's areas of agreement and disagreement; and (3) identify needs for further research.

The 2014-2015 National Impact of the 2014 American Academy of Pediatrics Guidance for Respiratory Syncytial Virus Immunoprophylaxis on Preterm Infants Born in the United States.

OBJECTIVE: This article aims to compare respiratory syncytial virus (RSV) immunoprophylaxis (IP) use and RSV hospitalization rates (RSVH) in preterm and full-term infants without chronic lung disease of prematurity or congenital heart disease before and after the recommendation against RSV IP use in preterm infants born at 29 to 34 weeks' gestational age (wGA). STUDY DESIGN: Infants in commercial and Medicaid claims databases were followed from birth through first year to assess RSV IP and RSVH, as a function of infant's age and wGA. RSV IP was based on pharmacy or outpatient medical claims for palivizumab. RSVH was based on inpatient medical claims with a diagnosis of RSV. RESULTS: Commercial and Medicaid infants 29 to 34 wGA represented 2.9 to 3.5% of all births. RSV IP use in infants 29 to 34 wGA decreased 62 to 95% (p < 0.01) in the 2014-2015 season relative to the 2013-2014 season. Compared with the 2013-2014 season, RSVH increased by 2.7-fold (p = 0.02) and 1.4-fold (p = 0.03) for infants aged <3 months and 29 to 34 wGA in the 2014-2015 season with commercial and Medicaid insurance, respectively. In the 2014-2015 season, RSVH for infants 29 to 34 wGA were two to seven times higher than full-term infants without high-risk conditions. CONCLUSION: Following the 2014 RSV IP guidance change, RSV IP use declined and RSVH increased among infants born at 29 to 34 wGA and aged <3 months.

Trends in Utilization of Outpatient Respiratory Syncytial Virus Prophylaxis with Palivizumab among Medicaid- and Commercially Insured Infants.

INTRODUCTION: Palivizumab is indicated for the prevention of respiratory syncytial virus (RSV) infection in high-risk children. Previous palivizumab utilization studies examined prior authorization claims but did not examine utilization within insured populations as a whole. This study describes outpatient palivizumab utilization trends and characterizes high-risk infants receiving palivizumab within Medicaid- and commercially insured populations. METHODS: Infants born July 1, 2003 through June 30, 2013 were identified in the MarketScan® Multistate Medicaid and Commercial claims databases. Infants with ≥ 18 months of continuous medical insurance enrollment with pharmacy benefits after birth and evidence of chronic lung disease of prematurity (CLDP), congenital heart disease (CHD), or preterm birth without CLDP or CHD were studied. Palivizumab use and demographic and clinical characteristics were measured in infant subgroups. Outpatient palivizumab utilization rates were calculated for each seasonal year (July-June) and for each infant subgroup. RESULTS: In total, 29,350 (2.1%) Medicaid-insured and 9589 (2.5%) commercially insured infants received palivizumab and had CLDP, CHD, or were born at < 37 weeks gestational age (wGA). Infants with CLDP (82%) and those < 29 wGA (78%) had the highest utilization. Decreases in utilization rates between the 2003-2004 and 2012-2013 seasons were seen among Medicaid-insured infants born at 29-36 wGA (all P < .0001), and commercially insured infants born at 31-32 wGA (P < .0001), 33-34 wGA (P = .055), 35-36 wGA (P < .0001), and with CHD (P = .003). Utilization by month was consistent across subgroups among Medicaid- and commercially insured infants, with most doses administered from November to March. CONCLUSION: Palivizumab use is targeted to a small percentage of infants who are at highest risk of hospitalization for RSV disease. Utilization declined in recent years in both Medicaid- and commercially insured infant groups. Most palivizumab doses were administered from November to March, with most infants receiving ≤ 5 doses. FUNDING: AstraZeneca.

Chronologic Age at Hospitalization for Respiratory Syncytial Virus Among Preterm and Term Infants in the United States.

INTRODUCTION: Respiratory syncytial virus (RSV) is the leading cause of hospitalization among infants in the United States, and the risk for RSV hospitalizations is greater for infants born preterm. Recent studies in preterm and term infants have shown that RSV hospitalization rates vary considerably depending on infant chronologic age. This study sought to aggregate the data available from published literature and from nationally representative databases of US infant hospitalizations to generate a composite description of the effect of young chronologic age on RSV hospitalizations among US preterm and term infants by individual month of age. METHODS: Data describing the relative incidence of RSV hospitalizations by individual month of chronologic age during the first year of life were obtained from recently published studies, the 2006-2011 National Inpatient Sample databases, and the 2006 and 2009 Kids Inpatient Databases. RESULTS: All data sources showed that ≥20% of infant RSV hospitalizations occurred in the second month of life and >50% and >75% of RSV hospitalizations were observed during the first 3 and 6 months of life, respectively. These findings were consistent for both preterm and term infants. CONCLUSION: Data from multiple sources demonstrate that the greatest risk of RSV hospitalization occurs during the first 6 months of life among US preterm and term infants. Strategies to prevent infant RSV hospitalizations should be targeted to infants during the first months of life. FUNDING: AstraZeneca.

SENTINEL1: An Observational Study of Respiratory Syncytial Virus Hospitalizations among U.S. Infants Born at 29 to 35 Weeks' Gestational Age Not Receiving Immunoprophylaxis.

Objective SENTINEL1 characterized U.S. preterm infants 29 to 35 weeks' gestational age (wGA) < 12 months old hospitalized for laboratory-confirmed respiratory syncytial virus (RSV) disease and not receiving RSV immunoprophylaxis during the 2014 to 2015 RSV season. Study Design This is a noninterventional, observational, cohort study. Results A total of 702 infants were hospitalized with community-acquired RSV disease, of whom an estimated 42% were admitted to the intensive care unit (ICU) and 20% required invasive mechanical ventilation (IMV). Earlier gestational age and younger chronologic age were associated with an increased frequency of RSV-confirmed hospitalization (RSVH), ICU admission, and IMV. Among infants 29 to 32 wGA and < 3 months of age, 68% required ICU admission and 44% required IMV. One death occurred of an infant 29 wGA. Among the 212 infants enrolled for in-depth analysis of health care resource utilization, mean and median RSVH charges were $55,551 and $27,461, respectively, which varied by intensity of care required. Outpatient visits were common, with 63% and 62% of infants requiring visits before and within 1 month following the RSVH, respectively. Conclusion Preterm infants 29 to 35 wGA are at high risk for severe RSV disease, which imposes a substantial health burden, particularly in the first months of life.

The Logistics and Coordination of Respiratory Syncytial Virus Immunoprophylaxis Use Among US Pediatric Specialists.

This study was conducted to survey US pediatric specialists about administration of respiratory syncytial virus (RSV) immunoprophylaxis, communication patterns among physicians and parents, and barriers to access. Separate surveys were sent to neonatologists, pediatricians, pediatric pulmonologists, and pediatric cardiologists. Most physicians (≥93.5%) routinely recommended immunoprophylaxis to high-risk children. Most respondents (≥71.8%) reported that >50.0% of eligible infants and young children received each monthly dose throughout the RSV season, with the first dose most commonly administered before discharge from the birth hospitalization. To ensure receipt of subsequent doses, specialists frequently scheduled a follow-up visit at the end of the current appointment. All specialists reported insurance denials as the biggest obstacle to the administration of immunoprophylaxis to high-risk children. These findings may be used to improve adherence to immunoprophylaxis by enhancing education and physician-parent communications about severe RSV disease prevention, and by reducing known barriers to use of this preventive therapy.

Perceived Risk of Severe Respiratory Syncytial Virus Disease and Immunoprophylaxis Use Among US Pediatric Specialists.

This study was conducted to assess the perception of US pediatric specialists of respiratory syncytial virus (RSV) disease risk and determine their clinical practices regarding immunoprophylaxis for high-risk children. Separate surveys were sent to neonatologists, pediatricians, pediatric pulmonologists, and pediatric cardiologists. Data were collected using structured questions requiring quantitative responses. Most neonatologists and pediatricians (>82.7%) reported a high clinical need for RSV immunoprophylaxis in preterm infants <32 weeks' gestational age. Pediatric pulmonologists and pediatric cardiologists suggested that health conditions indicative of chronic lung disease of prematurity and hemodynamically significant congenital heart disease, respectively, confer eligibility for RSV immunoprophylaxis. Agreement with the changes in the 2014 American Academy of Pediatrics guidance for RSV immunoprophylaxis was mixed among respondents from the 4 specialties. Survey findings may provide a basis to improve education about risk for severe RSV disease and evaluate changes in physician use of RSV immunoprophylaxis based on the 2014 guidance.

Modeling the Potential Impact of the 2014 American Academy of Pediatrics Respiratory Syncytial Virus Prophylaxis Guidance on Preterm Infant RSV Outcomes.

INTRODUCTION: The American Academy of Pediatrics (AAP) Committee on Infectious Diseases issued updated guidance on respiratory syncytial virus (RSV) prophylaxis in 2014. This report models the potential impact of the new guidance on RSV outcomes in preterm infants 29-34 weeks' gestational age (wGA) without chronic lung disease in the United States. METHODS: The number of preterm infants was estimated using 2012 natality data. Palivizumab utilization prior to the 2014 guidance update was estimated using 2013-2014 specialty pharmacy utilization data. Low, moderate, and high RSV hospitalization (RSVH) rates as well as average hospital length of stay, intensive care unit (ICU) admissions and mechanical ventilation (MV) frequencies were derived from published observational studies. Palivizumab efficacy was derived from two randomized clinical trials. RSV events that would be attributable to the 2014 guidance change were calculated for preterm infants 29-31 and 32-34 wGA. RESULTS: Annual number of infants 29-34 wGA surviving the neonatal period was estimated at 123,687. Of these, an estimated 44,712 (37%) would receive palivizumab based on the 2012 guidance. The annual number of RSVH among infants 29-34 wGA would increase from 3580 under the 2012 guidance to 6166 under the 2014 guidance based on moderate rates. This would result in an additional 24,440 hospitalization days, 1162 ICU admissions, and 584 MV events among this population. CONCLUSIONS: Based on published historical and contemporary data on RSVH rates in preterm infants 29-34 wGA, the 2014 AAP guidance is expected to result in additional burden to the healthcare system and families of preterm infants. The impact of the new guidance will be difficult to detect among the overall infant population, particularly in settings without routine testing for RSV, but the impact will be substantial for the small high-risk population affected by the changes. FUNDING: AstraZeneca.

A randomized, controlled trial to evaluate the effect of an anti-interleukin-9 monoclonal antibody in adults with uncontrolled asthma.

BACKGROUND: Preclinical studies suggest that interleukin-9 may be a central mediator in the development and maintenance of airway inflammation in asthma. The aim of this study was therefore to evaluate the effects of MEDI-528, an anti-interleukin-9 monoclonal antibody, in adults with confirmed uncontrolled moderate-to-severe asthma. METHODS: In this prospective double-blind, multicenter, parallel-group study, 329 subjects were randomized (1:1:1:1) to subcutaneous placebo or MEDI-528 (30, 100, 300 mg) every 2 weeks for 24 weeks, in addition to their usual asthma medications. The primary endpoint was change in mean Asthma Control Questionnaire-6 (ACQ-6) score at week 13. Secondary endpoints included weighted asthma exacerbation rates and pre-bronchodilator forced expiratory volume in 1 second (FEV1) at weeks 13 and 25, as well as Asthma Quality of Life Questionnaire scores at weeks 12 and 25 and the safety of MEDI-528 throughout the study period. The primary endpoint was analyzed using analysis of covariance. RESULTS: The study population (n = 327) was predominantly female (69%) with a mean age of 43 years (range 18-65). The mean (SD) baseline ACQ-6 score for placebo (n = 82) and combined MEDI-528 (n = 245) was 2.8 (0.7) and 2.8 (0.8); FEV1 % predicted was 70.7% (15.9) and 71.5% (16.7). Mean (SD) change from baseline to week 13 in ACQ-6 scores for placebo vs combined MEDI-528 groups was -1.2 (1.0) vs -1.2 (1.1) (p = 0.86). Asthma exacerbation rates (95% CI) at week 25 for placebo vs MEDI-528 were 0.58 (0.36-0.88) vs 0.49 (0.37-0.64) exacerbations/subject/year (p = 0.52). No significant improvements in FEV1 % predicted were observed between the placebo and MEDI-528 groups. Adverse events were comparable for placebo (82.9%) and MEDI-528 groups (30 mg, 76.5%; 100 mg, 81.9%; 300 mg, 85.2%). The most frequent were asthma (placebo vs MEDI-528, 30.5% vs 33.5%), upper respiratory tract infection (14.6% vs 17.1%), and headache (9.8% vs 9.8%). CONCLUSIONS: The addition of MEDI-528 to existing asthma controller medications was not associated with any improvement in ACQ-6 scores, asthma exacerbation rates, or FEV1 values, nor was it associated with any major safety concerns. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00968669.

Respiratory outcomes, utilization and costs 12 months following a respiratory syncytial virus diagnosis among commercially insured late-preterm infants.

OBJECTIVES: To determine, among a commercially-insured population of late-preterm infants, utilization of healthcare resources and costs during the 1 year following a diagnosis of respiratory syncytial virus lower respiratory infection (RSV LRI). METHODS: Administrative claims for non-capitated, commercially-insured infants <1 year old were used to identify infants diagnosed with RSV LRI and unspecified bronchiolitis/pneumonia (UBP). Infants were stratified by the setting of diagnosis. Infants without evidence of RSV LRI or UBP were selected as a comparison group. Economic and clinical outcomes were analyzed descriptively using propensity score weighting and logged ordinary least squares models were used to examine the relationship between RSV and costs (adjusted to 2006 USD) incurred within 1 year of RSV LRI. RESULTS: The majority of infants were 3 months or older at the time of RSV LRI or UBP diagnosis. The rate of wheezing was significantly greater for infants in the RSV LRI and UBP cohorts relative to the comparison group (p < 0.001). Infantile asthma rates were 6-9 times higher among RSV LRI and UBP infants than the comparison group. RSV LRI and UBP infants also had significantly more emergency department visits and outpatient visits than the comparison group. The marginal healthcare costs were significantly higher for RSV LRI inpatients ($24,027) and outpatients ($2703) infants than for the comparison group (all p < 0.001). CONCLUSION: Commercially insured late-preterm infants with RSV infection are at high risk for recurrent wheezing and infantile asthma during the 1-year period after the initial episode and impose a significant economic burden to the healthcare system.

Healthcare costs within a year of respiratory syncytial virus among Medicaid infants.

Limited research exists on the economic impact of respiratory syncytial virus lower respiratory infection (RSV LRI) among vulnerable infant populations. This study evaluated healthcare costs of full-term and late-preterm Medicaid infants with RSV LRI within 1 year of infection. Medicaid administrative claims were used to conduct a retrospective study of infants born 2003-2005. Full-term and late-preterm infants <1 year old were assigned to groups based on RSV LRI and unspecified bronchiolitis/pneumonia (UBP) diagnosis codes and stratified by setting of diagnosis. Infants without evidence of RSV LRI/UBP were selected as a comparison group. Economic and clinical outcomes were analyzed descriptively using propensity score weighting, and logged ordinary least squares models were used to examine relationship between RSV and costs incurred within 1 year of infection. RSV LRI and UBP infants, regardless of gestational age or healthcare setting, were more likely to experience respiratory diagnoses of wheezing and infantile asthma versus comparisons. Adjusted and weighted healthcare costs were significantly higher for all groups of RSV LRI and UBP infants relative to comparison infants (P < 0.001). Among late-preterm infants with inpatient and outpatient RSV, marginal costs compared with controls were $17,465 and $2,158, respectively. Costs for RSV LRI and UBP Medicaid infants are substantial. While much of the costs result from initial RSV episodes, higher post-episode costs and rates of respiratory events, procedures, and medications in RSV and UBP infants versus comparisons indicate long-term economic impact from infection and the impact is greater among late-preterm compared to full-term infants.

Persistence of morbidity and cost differences between late-preterm and term infants during the first year of life.

BACKGROUND: Late-preterm infants are known to have greater morbidity and costs compared with term infants during the neonatal period, but less is known about whether these differences continue beyond this period. OBJECTIVE: The purpose of this study was to examine the most common causes and costs of rehospitalization and other health care use among late-preterm and term infants throughout the first year of life. METHODS: We conducted a retrospective cohort study of late-preterm (33-36 weeks' gestation) and term infants born in 2004 with > or =1 year of enrollment in a large national US database of commercially insured members. All of the reported health care services and costs were examined from the birth hospitalization through the first year of life. RESULTS: We evaluated 1683 late-preterm and 33 745 term infants. The average length of stay of the birth hospitalization for term infants was 2.2 days, and the average cost was $2061. Late-preterm infants had a substantially longer average stay of 8.8 days and average cost of $26 054. Total first-year costs after birth discharge were, on average, 3 times as high among late-preterm infants ($12 247) compared with term infants ($4069). Late-preterm infants were rehospitalized more often than term infants (15.2% vs 7.9%). A subset of late-preterm infants that were discharged late from their birth hospitalization had the highest rates of rehospitalization and total health care costs. Higher costs during rehospitalization of late-preterm infants, especially those with a late discharge, indicate their propensity to have more severe illness. CONCLUSIONS: Late-preterm infants have greater morbidity and total health care costs than term infants, and these differences persist throughout the first year of life. Management strategies and guidelines to reduce morbidity and costs in late-preterm infants should be investigated.

Cost-effectiveness of live-attenuated influenza vaccine, trivalent in preventing influenza in young children attending day-care centres.

Vaccinating children at day-care may be a cost-effective approach for improving influenza immunization rates in this high-risk group. This study uses influenza attack-rate data from a randomized, blinded, placebo-controlled clinical trial of live-attenuated influenza vaccine, trivalent in day-care centres from two consecutive influenza seasons, one with a moderate attack rate (H1N1 dominant) and one with a high attack rate (H3N2 dominant). Costs were measured in US dollars. In the moderate attack-rate season (vaccinated, 2.2%; placebo, 13.4%), vaccination saved US$ 5.47 per child in societal costs. In the high attack-rate season (vaccinated, 4.7%; placebo, 32.1%), vaccination led to a societal costs savings of US$ 144.44 per child.