Use Of Palivizumab Research Articles

Respiratory Syncytial Virus-associated hospitalization in premature infants who did not receive palivizumab prophylaxis in Italy: a retrospective analysis from the Osservatorio Study.

BackgroundDue to different social and epidemiological factors, the eligibility criteria to receive palivizumab prophylaxis may be different between countries, especially in “otherwise healthy” late preterm infants.MethodsWe analyzed an Italian database of young children referred to emergency departments for acute lower respiratory tract infection (ALRI) during the RSV season over a four year period, when the use of palivizumab as prophylaxis for RSV disease was not widespread in premature infants. The demographic and environmental characteristics and the RSV positivity (RSV+) in hospitalized and not-hospitalized patients were compared. In the data analysis we divided children according to their chronologic age (age) and their week gestational age (wGA).ResultsOut of the 100 children evaluated, 68 were infants (≤12 month-age): 7.5 and 20.6 % were in the <29 and 29- < 32 wGA groups respectively, and 72.0 % in the 32- < 35 wGA group. Positive hospitalized-to-not-hospitalized ratios were found in all three wGA groups, progressively decreasing (from 4.0 to 1.2), with increasing wGA (p = 0.35). The percentage of hospitalized infants that were also RSV+ was also progressively decreasing (from 40.0 to 28.6 % and 18.4 %) with increasing wGA (p = 0.43). In the >12 month-age group (N = 32), there was positive hospitalized-to-not-hospitalized ratio only in the <29 wGA group with a low RSV+ frequency (<29 %) in all wGA groups. In the ≤12 month-age group, 41 infants were evaluated with a ≤6 month-age and 27 with a >6–12 month-age. A positive hospitalized-to-not-hospitalized ratios was found in all wGA groups in ≤6 month-age infants, despite a low RSV+ frequency in the 29- < 32 and 32- < 35 wGA group. In the >6-12 month-age group, all infants with a <29 and 29- < 32 wGA were hospitalized with a relatively high RSV+ frequency whilst the 32- < 35 wGA group showed a negative hospitalized-to-not-hospitalized ratio with a lower RSV+ frequency.ConclusionsThe hospitalized-to-not-hospitalized ratios and RSV+ frequency in the first 12 months of age in infants born prematurely confirm the vulnerability of these children for clinically important RSV infection, most notably in the <32 wGA category.

Use of palivizumab with other infection control measures to control respiratory syncytial virus outbreaks in neonatal care units.

No guidelines exist on the use of palivizumab during outbreaks of Respiratory Syncytial Virus (RSV) in Neonatal Intensive Care Units (NICUs). We aimed to describe an outbreak of RSV in NICU settings and the role of palivizumab in controlling the outbreak. The index case was a 30-day-old premature infant. During the outbreak, 13 cases of RSV were confirmed by RT-PCR. All infants in the NICU received palivizumab after RSV diagnosis. Of the 13 cases, seven were male; and the median (interquartile) of birth weight was 1585 (IQR: 1480-1705) g. All cases were premature under 34-weeks-gestation. Age at onset of disease varies between 10 and 160 days. Only four cases occurred after administering palivizumab and applying other infection control measures. During nosocomial outbreaks of RSV, administration of palivizumab to all infants in NICU appears to be rational and may help contain outbreaks.

Guidelines for palivizumab prophylaxis in infants and young children at increased risk for respiratory syncytial virus infection in Saudi Arabia.

Respiratory syncytial virus (RSV) is a leading cause of serious seasonal lower respiratory tract infections (LRTI) in high-risk infants and children, with epidemics occurring annually in Saudi Arabia from October to March.Premature infants born at less than 29 weeks gestation with chronic lung disease or those with significant congenital heart disease who have RSV infection are more likely to be hospitalized and have increased morbidity and mortality. Palivizumab (Synagis®, Medimmune) is a humanized monoclonal antibody for the prevention of severe LRTI by RSV in high-risk children. The current use of Palivizumab in Saudi Arabia is not regulated and does not meet approved standards.This clinical practice policy statement was developed by the Ministry of Health and is supported by the National Immunization Technical Advisory Group (NITAG) in Saudi Arabia. It is based on available national and international data on the use of Palivizumab for the prevention of severe LRTI caused by RSV in high-risk pediatric patients. These guidelines were solicited and endorsed by two Saudi societies: The Neonatology and the Pediatric Infectious Diseases Societies.

Revised recommendations concerning palivizumab prophylaxis for respiratory syncytial virus (RSV).

Respiratory Syncytial Virus infections are one of the leading causes of severe respiratory diseases that require hospitalization and, in some cases, intensive care. Once resolved, there may be respiratory sequelae of varying severity. The lack of effective treatments for bronchiolitis and the lack of vaccines for RSV accentuate the role of prevention in decreasing the impact of this disease.Prevention of bronchiolitis strongly relies on the adoption of environment and the hygienic behavior measures; an additional prophylactic effect may be offered, in selected cases, by Palivizumab, a humanized monoclonal antibody produced by recombinant DNA technology, able to prevent RSV infection by blocking viral replication.After many years the Italian Society of Neonatology, on the basis of the most recent scientific knowledge, has decided to revise recommendations for the use of palivizumab in the prevention of RSV infection.

Anti-RSV prophylaxis efficacy for infants and young children with cystic fibrosis in Ireland.

RationaleThere is limited evidence supporting the routine use of palivizumab in paediatric cystic fibrosis (CF) patients to reduce respiratory syncytial virus (RSV) infection and related hospitalisation. Despite this, anti-RSV prophylaxis is increasingly common. This is the first report from Ireland regarding palivizumab outcomes for children with CF, under 2 years old, despite the greatest prevalence of CF globally.MethodsAn audit was performed at a tertiary hospital in Ireland’s mid-West to document all children with CF, <24 months old, who received palivizumab over a five year period and comparision made with all eligible children for the prior five year period who had not received the product (also CF patients). Palivizumab was administered to both cohorts in their first year of life. Hospitalisation rates were compared using Fisher’s exact test. Incidence of RSV and Pseudomonas aeruginosa infection was recorded.ResultsA total of 19 patients who received palivizumab were included in the study; comparision was made with a retrospective control group of 30 patients. Prophylactic palivizumab did not prevent hospitalisation for 10/19 patients, 3 of whom were affected by RSV. This was significantly greater than in the control group, where no hospitalisations were recorded (p < 0.0001). P. aeruginosa was isolated in one case from the study cohort, while no P. aeruginosa was detected in the control group.ConclusionsThis study, the first of its kind from Ireland where CF prevalence is highest, does not provide unequivocal support for prophylactic use of palivizumab in CF patients under 2 years. Despite being derived from a small sample size, based on these data and complementary clinical observation, we have discontinued such prophylaxis. However, should reported incidence of RSV-related hospitalisation increase, there is scientific plausibility for appropriately powered, randomised, controlled trials of palivizumab.

Anti-RSV prophylaxis efficacy for infants and young children with cystic fibrosis in Ireland

Rationale: There is limited evidence supporting the routine use of palivizumab in paediatric cystic fibrosis (CF) patients to reduce respiratory syncytial virus (RSV) infection and related hospitalisation. Despite this, anti-RSV prophylaxis is increasingly common. This is the first report from Ireland regarding palivizumab outcomes for children with CF, under 2 years old, despite the greatest prevalence of CF globally.&#x0D; Methods: An audit was performed at a tertiary hospital in Ireland’s mid-West to document all children with CF, &lt;24 months old, who received palivizumab over a five year period and comparision made with all eligible children for the prior five year period who had not received the product (also CF patients). Palivizumab was administered to both cohorts in their first year of life. Hospitalisation rates were compared using Fisher’s exact test. Incidence of RSV and Pseudomonas aeruginosa infection was recorded.&#x0D; Results: A total of 19 patients who received palivizumab were included in the study; comparision was made with a retrospective control group of 30 patients. Prophylactic palivizumab did not prevent hospitalisation for 10/19 patients, 3 of whom were affected by RSV. This was significantly greater than in the control group, where no hospitalisations were recorded (p &lt; 0.0001). P. aeruginosa was isolated in one case from the study cohort, while no P. aeruginosa was detected in the control group.&#x0D; Conclusions: This study, the first of its kind from Ireland where CF prevalence is highest, does not provide unequivocal support for prophylactic use of palivizumab in CF patients under 2 years. Despite being derived from a small sample size, based on these data and complementary clinical observation, we have discontinued such prophylaxis. However, should reported incidence of RSV-related hospitalisation increase, there is scientific plausibility for appropriately powered, randomised, controlled trials of palivizumab.

Re-evaluating the New Committee on Infectious Diseases Recommendations for Palivizumab Use in Premature Infants.

Re-evaluating the New Committee on Infectious Diseases Recommendations for Palivizumab Use in Premature Infants.

Preventing hospitalizations for respiratory syncytial virus infection.

Respiratory syncytial virus infection is the leading cause of lower respiratory tract infections in young children. Palivizumab has minimal impact on RSV hospitilization rates as it is only practical to offer it to the highest risk groups. The present statement reviews the published literature and provides updated recommendations regarding palivizumab use in children in Canada.

12: Lean Management and Just-in-Time Ordering Reduces Palivizumab Wastage in a Provincial RSV Prophylaxis Program

Immunoprophylaxis with palivizumab is recommended for infants at high risk of RSV-related hospitalization. Palivizumab is an expensive sole-sourced biologic pharmaceutical available in single dose vials which expires 6 h upon reconstitution, resulting in potentially high rates of drug wastage. Palivizumab has a short shelf life and requires cold-chain storage making left-over inventory costly and undesirable. Principles of Lean production and Just-In-Time production can be applied to minimize wastage and costs. To describe the outcome of Lean management and Just-In-Time inventory control in the operations of a provincial RSV immunoprophylaxis program. The Manitoba RSV Immunoprophylaxis Program (MB RSVP) coordinates the use of palivizumab for eligible patients in the province of Manitoba, Canada, a region of 650,000 square km with population of 1.27 million. Yearly PDCA cycles using Lean management principles have resulted in a centralized provincial coordinating centre that manages RSV immunoprophylaxis including patient enrolment, coordination of injection through a network of health care providers (to allow for cohorting and vial sharing), just-in-time ordering and shipping of palivizumab to clinic sites, and continuious inventory tracking. Dosing reports from sites function as a Kanban system triggering future shipment of palivizumab. Regular discussion with all involved in the Program fosters involvement, problem solving, and continuous improvement. The overall objective is limitation of wastage while maximizing patient benefit. Over three seasons (2011–2014), the MB RSVP enrolled and organized RSV immunoprophylaxis for 868 patients with over 3500 doses provided. The Program was effective in limiting wastage of palivizumab (mg of drug ordered but not given to patient) to 10% (range 8.4% to 12.8% per year). Just-in-time ordering reduced left over inventory from 157 vials (in 2012) to 75 vials (in 2014) resulting in a decreased inventory carrying cost from $118,000 to $56,000 Canadian respectively ($752/50 mg). Using Lean business management principles and Just-In-Time inventory control resulted in minimum wastage of palivizumab and decreased yearly left-over inventory of palivizumab in a provincial RSV prophylaxis program.

Update of recommendations on the use of palivizumab as prophylaxis in RSV infections

The Standards Committee of the Spanish Neonatology Society (SENeo) considers that the new document from the American Academy of Pediatrics, including recommendations for palivizumab use to prevent serious infections produced by the Respiratory Syncytial Virus (RSV), provides no new scientific evidence which would justify the modification of the current recommendations of the SENeo. However, some adjustments to the criteria of the existing recommendations are proposed to reduce the cost of the drug by its correct and judicious management.

Safety and pharmacokinetics of extended use of palivizumab in Saudi Arabian infants and children.

Background:The peak season of respiratory syncytial virus (RSV) infections in warmer climates may extend beyond the typical five-month RSV season of temperate regions. Additional monthly doses of palivizumab may be necessary in warmer regions to protect children at high risk for serious infection by the RSV.Methods:In a Phase II, single-arm, single-center, non-comparative, open-label, prospective study conducted in Saudi Arabia, children at high risk for RSV infection received up to seven monthly injections of palivizumab (15 mg/kg) during the 2000–2001 RSV season. Key enrollment criteria were no previous exposure to palivizumab and gestational age ≤35 weeks, ≤6 months of age at enrollment, or chronic lung disease and ≤24 months of age at enrollment. We wished to assess the safety, immunogenicity, and pharmacokinetics of palivizumab as an extended seven-dose regimen.Results:Of 18 enrolled patients, 17 patients received seven palivizumab injections. Seven adverse events (AEs) occurred in five patients. Bronchiolitis was the most commonly reported AE. Six serious AEs occurred in four patients. No AEs were considered related to palivizumab. Trough levels of palivizumab in serum were >40 μg/mL in most patients after the first injection and in 16/18 and 14/17 patients after the fourth and sixth injections, respectively. Except for one patient at one visit, the anti-palivizumab titer was <1:10 at all visits.Conclusion:These data suggest that an extended palivizumab regimen of up to seven monthly doses during the RSV season exhibited an acceptable safety profile in children at high risk for RSV infection in Saudi Arabia.

A Multi-Institutional Survey of Practice Guidelines for Respiratory Syncytial Virus (RSV) Infection in Pediatric Patients Following Hematopoietic Stem Cell Transplant (HSCT)

RSV is a common infection in infancy and childhood. Mortality from RSV is reported to be < 0.5% in healthy children in comparison to 10-12.5% in children following HSCT (1. Chavez-Bueno S et al. Pediatr Infect Dis J 2007 26:1089-1093). There is currently no standard for management of RSV in pediatric patients with hematologic malignancies/HSCT. Many institutions have their own protocols for managing these patients. Symptomatic management is common and the use of antiviral (AV)-ribavirin, Immunomodulators like palivizumab (PVZ) and IVIG is widely debated & inconsistent in practice.Ribavirin is a guanosine analogue with AV activity. It may be administered orally (PO), intravenously (IV) or aerosolized (AR). AR is approved by Food and Drug Administration (FDA) for treatment of RSV in high-risk (HR) infants and children. In the adult HSCT setting, retrospective data has shown the benefit of AR for RSV, for both decreasing the likelihood of progression from upper respiratory infection (URTI) to lower respiratory tract infection (LRTI) and reduction in RSV-related mortality (Shah JN et al. Blood 2011; 117:2755-2763). However in the pediatric HSCT setting the benefit of AR is less clear. AR is expensive and a known teratogenic. Healthcare workers, parents, others caring for the patient stand to be exposed to Ribavirin. The delivery mechanisms to the lower airways are inefficient. AR tends to clog the endotracheal tube and cannot be used with high frequency oscillators. Ribavirin has side effects such as sudden deterioration of respiratory response. AR therapy poses many challenges and is not always feasible.PVZ is a 95% humanized and 5% murine monoclonal antibody that provides both neutralizing and fusion-inhibitory activity against RSV. It binds to the linear epitope of the Fusion glycoprotein in the A antigen site. PVZ is FDA approved for the prevention of RSV related LRTI in HR pediatric patients. In the HSCT setting, PVZ has been utilized off-label both for prophylaxis and treatment of RSV. PVZ +/- AR has been shown to be effective in decreasing morality among HR children including those requiring HSCT (1). The treatment of pediatric patients requiring HSCT has been derived from adult protocols due to a lack of randomized clinical trials in children. A recent retrospective analysis showed a reduction in mortality and progression to LRTI in 59 pediatric cancer patients with RSV when PVZ was added to the treatment regimen. (Chemaly RF et al. J Pediatr Hematol Oncol 2014; 36 (6): e376-81).To evaluate the current practice, our institution surveyed several hospitals to determine institutional standards of care for treating HSCT patients with RSV (both adults and children). Responses are shown in Table 1.Table 1Hospital, patient population (Adult/Pediatric/Both)ARPO RibavirinPVZ TreatmentPVZ prophylaxis1, AY - InpatientsY - OutpatientsNN2,BY (Pre-engraftment, severe LRTI)Y (Post-engraftment, URTI, mild LRTI)N?3, AY NNN4, PY – 5 (URTI) vs. 7days (LRTI)NY (LRTI/URTI High risk)Y in <2yr5, ANY NNA6, AY (Critical)Y NNA7, ANY [Moderate, severe immune deficiency (SID)]NNA8, PY (HR + URTI/LRTI)NY (LRTI w high risk)Y <2yr9, AY Y (URTI w No HR) NN10, BY NNNY =Used, N=Not used,?=Unsure, NA=Not ApplicableThe cost of medications commonly used to treat RSV infections is shown in Figure 1. [Display omitted] Survey Findings:PO ribavirin was commonly used to treat RSV URTI in responding hospitals. AR was used to treat severe LRTI. Engraftment status (pre vs. post) was used to classify severity of immunodeficiency and determine treatment. PVZ use for treatment is uncommon among the responding hospitals (2/10).Practice at our institutionLow-risk patients with RSV (>30 days post-HSCT, minimal immunosuppression, URTI) receive only supportive care and close monitoring. Patients with RSV-LRTI or those with URTI at HR for progression (< 30 days post-HSCT, low lymphocyte counts, on immunosuppression) may be considered for AR +/- PVZ. In the last 5 years we have had 20 patients with RSV, 3 were diagnosed with RSV pre-transplant and 17 post-transplant, 1 reactivated after transplant and there was 1 death related to RSV.ConclusionDue to variance in practice and costs of therapies, further studies are needed to standardize treatment for children post-HSCT with RSV to reduce morbidity and mortality. In addition a stratification algorithm to better characterize those most likely to benefit from current treatment should be considered. DisclosuresOff Label Use: Multi institutional survey regarding the use of Palivizumab and Ribavirin in the treatment of RSV..

Use of palivizumab is underestimated in the Swedish Prescribed Drug Register - implications for register-based drug studies.

BackgroundRegister studies are a valuable tool, when monitoring the safety of drugs. The Swedish Prescribed Drug Register (PDR) was established in 2005 and keeps records of all prescribed drugs dispensed in community pharmacies. Drugs prescribed in-hospital are not registered on an individual level, which may hamper the validity of register-based studies on drugs potentially administered in-hospital.ObjectiveThe objective was to assess the ability of the PDR to identify children treated with the monoclonal antibody palivizumab, which is used for prophylaxis against respiratory syncytial virus (RSV) infection in children.MethodsPalivizumab exposure as filled prescriptions recorded in the PDR was assessed by indication of treatment (preterm-born children, bronchopulmonary dysplasia, or hemodynamically significant heart disease) and presented as numbers and proportions. For a random sample of children with an indication for treatment and without record of palivizumab exposure in the drug register, numbers and proportions by indication of treatment as noted in medical records were presented. The extent of underreporting in the drug register was estimated by indication for treatment.ResultsThrough the national health registers, 2,317 children were identified as being at risk for severe infection with RSV infection and 75% had no records indicating palivizumab exposure in the PDR. In a random sample of 176 children at high risk for RSV infection and with no records of palivizumab prescription fills in the PDR, 47% had been treated with palivizumab according to medical records. The PDR underestimated palivizumab treatment with 49% in children born preterm, 42% in children with bronchopulmonary dysplasia, and 23% in those with a hemodynamically significant heart disease.ConclusionOur findings underline the need of improving the information in the Swedish national registers concerning drugs administered in-hospital.

Updated Guidance for Palivizumab Prophylaxis

Dr Brady has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device. The American Academy of Pediatrics recently published an updated policy statement on the use of palivizumab for respiratory syncytial virus (RSV) prophylaxis.1,2 This updated guidance is based on new information about the effects of gestational age and other risk factors on the incidence of RSV hospitalizations. Overall, there has been a decline in the incidence of hospitalizations for bronchiolitis in the United States.3 Among infants …

Actualización de las recomendaciones de la Sociedad Española de Neonatología para la utilización del palivizumab como profilaxis de las infecciones graves por el virus respiratorio sincitial

The Standards Committee of the Spanish Neonatology Society (SENeo) considers that the new document from the American Academy of Pediatrics, including recommendations for palivizumab use to prevent serious infections produced by the Respiratory Syncytial Virus (RSV), provides no new scientific evidence which would justify the modification of the current recommendations of the SENeo. However, some adjustments to the criteria of the existing recommendations are proposed to reduce the cost of the drug by its correct and judicious management.

PIH36 - Cost-Effectiveness of Palivizumab Use in High Risk Children From Brazilian Health System Perspective

PIH36 - Cost-Effectiveness of Palivizumab Use in High Risk Children From Brazilian Health System Perspective

The prevention of respiratory syncytial virus infection

Respiratory syncytial virus (RSV) is the most significant cause of acute respiratory tract infections in infants and young children worldwide. RSV accounts for approximately 70% of hospitalizations for bronchiolitis and 40% of pneumonia among infants <1 year of life. RSV infection seems to be associated with recurrent wheezing during the first decade of life and impaired respiratory health-related quality of life in adults [1]. Universal prevention of RSV infection is based on environmental prophylaxis aimed at minimizing the spread of the virus good hand hygiene in the home, and limiting direct contact of high-risk children with other children and adults with respiratory tract infections. Exposure to tobacco smoke should be avoid in family with infants, breastfeeding should be encouraged. Pharmacological prophylaxis is based on the administration of palivizumab (Synagis ®, MedImmune) during the epidemic period to the children at risk [2]. Palivizumab is a humanized monoclonal antibody directed to an epitope in the A antigenic site of F protein of RSV. It is designed to provide passive immunity against RSV and thereby prevent or reduce the severity of RSV infection [2]. The aim of this work is to provide Italian neonatologists shared recommendations regarding palivizumab use in premature and other at-risk infants in the light of new emerging evidence. The peak incidence of severe RSV disease occurs between 2 and 3 months of age. The risk of serious RSV illness is highest among preterm neonates, children with chronic lung disease, congenital heart disease [3,4]. The children with the above mentioned clinical conditions, particularly in cases of hospitalization, are more likely to require admission to an intensive care unit and need mechanical ventilation. In addition they have high rates of re-hospitalization for lower respiratory tract infections [5,6]. Therefore, all these categories of infants are likely to benefit from prophylaxis, and have been included in the recommendations. Specific recommendations are provided according to gestational age at birth RSV infections occur most frequently during the period between October-March. According to this observation, prophylaxis with Palivizumab is indicated in this 5-6 months long seasonal window of RSV infection. The duration of prophylaxis (up to one year or up to two years of life during the seasonal period) depends on the underlying condition. Palivizumab is clinically effective; however, the cost is very high. In our opinion strict criteria for patient selection and reduced drug costs would improve the cost-effectiveness of the prophylaxis [7].

Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection.

Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. This policy statement updates and replaces the recommendations found in the 2012 Red Book.

Clarifying Costs and Benefits of Respiratory Syncytial Virus Immunoprophylaxis

In response to recent studies demonstrating that palivizumab use in moderate preterm infants may decrease subsequent wheezing, Meissner and Kimberlin1 discuss costs associated with palivizumab but make multiple statements that may not be consistent with the best available evidence.The stated hospitalization cost of $8530 (2009$) is not representative of respiratory syncytial virus (RSV) hospitalizations among palivizumab-eligible infants; it is the average cost of bronchiolitis hospitalizations among US children <2 years.2 Using the same source, the Kids’ Inpatient Database, the average RSV hospitalization (International Classification of Diseases, Ninth Revision, Clinical Modification 079.6, 466.11, 480.1) cost for all infants was $14 832 (2009$). Among high-risk infants, costs of RSV hospitalization and associated care through 12 months of age range from $20 160 to $39 399 (2010$).3The authors also state the number needed to treat (NNT) with palivizumab to prevent 1 RSV hospitalization for most infants ranges from 19 to 170. In the Canadian Pediatric Society’s RSV prevention position statement, high-quality NNT estimates range from 12 to 23 depending on the population. Lower quality estimates from studies of health care utilization databases, such as those referenced by the authors, often yield higher NNTs due to underdiagnosis of RSV and limited use of RSV-specific codes.Meissner and Kimberlin1 state that RSV hospitalizations are becoming less common among children eligible for palivizumab, citing a 17% decrease in bronchiolitis hospitalization rates from 2000 to 2009 among US children <2 years.2 However, Hasegawa et al2 also found a 34% increase in children with high-risk conditions from 2000 to 2009. According to a personal communication with Dr Hasegawa, the hospitalization rate among children at high risk rose by 29%. This increase despite palivizumab use is not surprising given that most children at high risk do not receive palivizumab and use has declined since 2006.Concerning the cost of palivizumab, the authors state that rebates may modify the cost, but the cost presented does not incorporate rebates. Federally mandated rebates for Medicaid recipients and discounts for 340B-eligible organizations have resulted in ∼40% reduction in palivizumab cost for ∼60% of palivizumab recipients, as described in a recent publication3 and a Centers for Disease Control and Prevention analysis at the June 23, 2010, Advisory Committee on Immunization Practices.Finally, the authors state that mortality reduction cannot be included in palivizumab analyses because it has not been demonstrated in randomized trials. However, mortality reductions are commonly included in cost-effectiveness studies even without statistically significant differences in randomized trials. Two examples include an economic evaluation of pediatric influenza vaccination conducted by the Centers for Disease Control and Prevention and investigators from Harvard University, as well as the UK Health Technology Assessment of palivizumab.4 There is no evidence to support the authors’ statement that “adverse long-term outcomes such as death are not prevented by passive immunotherapy.”Cost-effectiveness analyses of palivizumab should consider all downstream costs and savings and use the best available evidence. As the authors state, quality of life and other factors must be considered. Calculating cost per quality-adjusted life-year gained is the recommended approach to understand the benefits of an intervention relative to costs and enables comparison with other health interventions.5

Respiratory syncytial virus and palivizumab: Where are we in 2014?

Respiratory syncytial virus and palivizumab: Where are we in 2014?