Effectiveness Of Palivizumab Research Articles

The cost effectiveness of palivizumab in term Inuit infants in the Eastern Canadian Arctic

Introduction: Canadian, Inuit, full term infants have the highest rate of respiratory syncytial virus (RSV) infection globally, which results in substantial costs associated hospitalisation.Methods: Decision-analytical techniques were used to estimate the incremental cost-effectiveness ratio (ICER) for palivizumab compared to no prophylaxis for Inuit infants of all gestational age. The time horizon was that of life-time follow-up, and costs and effectiveness were discounted at 5% per year. Costs (2007 CAD$) for palivizumab, hospitalisation (including medical evacuation, intensive care unit [ICU]), physician visits, and transportation were calculated based on the Canadian payer's perspective. Benefits on decreasing RSV hospitalisation were expressed as quality-adjusted life-years (QALYs). One-way and probabilistic sensitivity analysis (PSA) were conducted, varying: mortality rates, utilities, length of stay in hospital and ICU.Results: For all of Baffin Island infants (<1 year), the ICER was $39,435/QALY. However, when infants were grouped by age and area of residence, those residing in Iqaluit (<1 year) had an ICER of $152,145/QALY, while those residing in rural areas (outside of Iqaluit) had an ICER of $24,750/QALY. Prophylaxis was a dominant strategy (cost saving) for rural infants under 6 months of age, with the PSA demonstrating that it was dominant 98% of the time.Conclusions: The ICERs suggested that palivizumab is a cost-effective option for the prevention of RSV for Inuit infants on Baffin Island compared to no prophylaxis. Palivizumab is highly cost effective in Arctic infants <1 year of age specifically residing outside of Iqaluit and is a dominant strategy for those under 6 months of age in rural areas. However, palivizumab is not cost effective compared to no treatment for infants of all ages residing in Iqaluit.

Cost effectiveness of palivizumab for RSV prevention in high-risk children in the Netherlands

Background: Respiratory syncytial virus (RSV) is a common pathogen that is the leading cause of lower respiratory tract infections in young children. High-risk children are at risk of severe infection, which may require hospitalisation. RSV is also associated with a high risk for respiratory morbidity and mortality, which may have long-term clinical and economic consequences.Objective: To assess the cost effectiveness of palivizumab, a humanised monoclonal antibody, used as prevention against severe respiratory syncytial virus (RSV) infection requiring hospitalisation, in the indication of preterm infants and infants with preterm/bronchopulmonary dysplasia and in the second indication of children with congenital heart disease in the Dutch healthcare setting.Methods: A decision-tree model was used to estimate the cost effectiveness of palivizumab, used as a preventative treatment against severe respiratory syncytial virus (RSV) infection, in high-risk groups of children in the Netherlands. The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. Data sources included published literature, the palivizumab pivotal trials, official price/tariff lists and national population statistics. The study was conducted from the perspective of society in the Netherlands.Results: The use of palivizumab results in undiscounted incremental cost-effectiveness ratios of €12,728/QALY and €4,256/QALY in the in preterm/bronchopulmonary dysplasia and congenital heart disease indications, respectively. Inclusion of indirect costs leads to even more favourable cost-effectiveness outcomes. The study is limited by a number of conservative assumptions. It was assumed that palivizumab only affects the occurrence of RSV hospitalisation and does not influence the severity of the RSV infection. Another assumption was that international clinical trial data and data on utilities could be applied to the Dutch healthcare setting.Conclusion: Palivizumab provides cost-effective prophylaxis against RSV in high-risk infants. The use of palivizumab in these children results in positive short- and long-term health-economic benefits.

Cost effectiveness of palivizumab in children with congenital heart disease in Germany

Objectives: To assess the cost effectiveness of palivizumab, a humanised monoclonal antibody, used as prevention against severe respiratory syncytial virus (RSV) infection requiring hospitalisation, in infants with haemodynamically significant congenital heart disease (CHD) in the German healthcare setting.Study design: A decision-tree model was used to estimate the cost effectiveness of palivizumab for a hypothetical cohort of patients. The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. Data sources included published literature, the palivizumab pivotal trials, official price/tariff lists and national population statistics. The study was conducted from the perspective of society (primary analysis) and the healthcare purchaser (secondary analysis).Results: From the societal perspective, use of palivizumab results in an incremental cost-effectiveness ratio (ICER) of €2,615 per quality-adjusted life-year (QALY) without discounting, which increases to €9,529/QALY after discounting. From the perspective of the German healthcare purchaser, use of palivizumab results in an ICER of €4,576/QALY without discounting, which increases to €16,673/QALY after discounting. Probabilistic sensitivity analyses confirmed the robustness of the model. The study is limited by a number of conservative assumptions. It was assumed that palivizumab only affects the occurrence of RSV hospitalisation and does not influence the severity of the RSV infection. Another assumption was that international clinical trial data and data on utilities could be applied to the German healthcare setting.Conclusion: This analysis showed that palivizumab represents a cost-effective means of prophylaxis against severe RSV infection requiring hospitalisation in infants with haemodynamically significant CHD.

Cost–effectiveness of palivizumab in infancy

Respiratory syncytial virus is the most common cause of bronchiolitis, a lower respiratory tract infection occurring in infancy. It is responsible for several rehospitalizations, substantial morbidity and occasional deaths in the UK every year. Palivizumab is a recombinant monoclonal antibody that has been shown to reduce hospitalizations in infected infants. It is licensed for high-risk infants, primarily those born pre-term or with chronic pulmonary or cardiac conditions. Palivizumab is expensive, but several economic analyses have determined highly discrepant costs. This article reviews the limitations of the available efficacy and economic data, and highlights problems in interpretation and extrapolation. We also present the results of a cost–effectiveness analysis relevant to populations of high-risk infants in the UK.

Cost Effectiveness of Palivizumab for Respiratory Syncytial Virus Prophylaxis in High-Risk Children

To assess the cost effectiveness of palivizumab (a preventative treatment against severe respiratory syncytial virus [RSV] infection) in children at high risk of hospitalisation, i.e. preterm infants < or = 35 weeks gestation, children with bronchopulmonary dysplasia (BPD) and children with congenital heart disease (CHD). A decision tree model was developed employing data sources from the published literature, palivizumab clinical trials, official UK price/tariff lists and national population statistics. The comparator was no prophylaxis. The primary perspective of the study was that of the UK NHS. In a societal perspective scenario analysis, the future lost productivity of a child resulting from RSV-related mortality (indirect costs) was also included. The cost of administration of palivizumab, hospital care for RSV infections and the cost of asthma treatment were included. The analysis was based on a lifetime follow-up period in order to capture the impact of palivizumab on long-term morbidity and mortality resulting from an RSV infection. The primary efficacy outcome in the palivizumab clinical trials was the number of RSV hospitalisations avoided, which was extrapolated to effectiveness outcomes, i.e. number of life-years gained and number of QALYs. Costs and effects were discounted by 3.5%. In preterm infants and children with BPD, prophylaxis with palivizumab compared with no prophylaxis had an incremental cost-effectiveness ratio (ICER) of 7042 pounds/QALY without discounting outcomes, increasing to 16,720 pounds/QALY after discounting. In babies with CHD, the use of palivizumab resulted in an ICER of 2427 pounds/QALY without discounting outcomes and 6664 pounds/QALY after discounting. One-way sensitivity analyses and probabilistic sensitivity analyses confirmed the robustness of the model. A scenario analysis showed that the inclusion of indirect costs leads to further improvement in the cost-effectiveness outcomes for palivizumab. This study suggests that palivizumab prophylaxis against severe RSV infection in children at high risk may be cost effective from the NHS perspective (vs no prophylaxis), and that the positive clinical and economic benefits may persist beyond one RSV season.

Stable Isotope Tagging of Epitopes

Identification of peptides presented in major histocompatibility complex (MHC) class I molecules after viral infection is of strategic importance for vaccine development. Until recently, mass spectrometric identification of virus-induced peptides was based on comparative analysis of peptide pools isolated from uninfected and virus-infected cells. Here we report on a powerful strategy aiming at the rapid, unambiguous identification of naturally processed MHC class I-associated peptides, which are induced by viral infection. The methodology, stable isotope tagging of epitopes (SITE), is based on metabolic labeling of endogenously synthesized proteins during infection. This is accomplished by culturing virus-infected cells with stable isotope-labeled amino acids that are expected to be anchor residues (i.e. residues of the peptide that have amino acid side chains that bind into pockets lining the peptide-binding groove of the MHC class I molecule) for the human leukocyte antigen allele of interest. Subsequently these cells are mixed with an equal number of non-infected cells, which are cultured in normal medium. Finally peptides are acid-eluted from immunoprecipitated MHC molecules and subjected to two-dimensional nanoscale LC-MS analysis. Virus-induced peptides are identified through computer-assisted detection of characteristic, binomially distributed ratios of labeled and unlabeled molecules. Using this approach we identified novel measles virus and respiratory syncytial virus epitopes as well as infection-induced self-peptides in several cell types, showing that SITE is a unique and versatile method for unequivocal identification of disease-related MHC class I epitopes.

The European Forum for Clinical Management: prophylaxis against the respiratory syncytial virus in infants and young children with congenital cardiac disease

A recent, randomised, double-blind, placebo-controlled trial has demonstrated the effectiveness of palivizumab (Synagis) for prophylaxis against infection by the respiratory syncytial virus in 1,287 young children with congenital cardiac disease. Guidelines for the use of palivizumab in these children considered to be at high risk were published by the American Academy of Pediatrics, followed by similar guidelines from the British Paediatric Cardiac Association, and recommendations from a number of other individual countries, including Canada, Germany, Spain, and France. In May, 2004, further discussion was held between a group of 15 paediatric cardiologists at a European forum for clinical management held in Munich, Germany. The objective of this forum was to define optimal recommendations on prevention of infection by the respiratory syncytial virus in infants and young children with congenital cardiac disease, appropriate to the clinical needs and style of those practising in paediatrics in individual countries. Participants were invited because of their knowledge of the therapeutic area, and for their experience of using palivizumab for prophylaxis against the respiratory syncytial virus in children with congenitally malformed hearts. Measures to educate the carers of children with such congenital malformations on precautions against infection by the respiratory syncytial virus were discussed, along with the many different aspects of best practice for therapeutic prophylaxis with palivizumab. The most appropriate timing of prophylaxis, recommendations for which children are most likely to benefit from prophylaxis, and suggested protocols were among the issues covered. The recommendations resulting from the discussions are presented in this paper, as a step towards reaching consensus.

Factors impacting compliance with palivizumab prophylaxis

To the Editors: Palivizumab prophylaxis has proved effective in the prevention of serious respiratory syncytial virus (RSV) illness in high risk preterm infants. 1–3 Palivizumab is a humanized IgG antibody with a half-life of 17 to 20 days; therefore for optimal prevention it is crucial that palivizumab injections be administered every 30 days to maintain protective serum concentrations of anti-RSV antibody throughout the RSV season. A palivizumab outpatient prophylaxis program was initiated in 2000 in our tertiary level neonatal intensive care unit at the Anna Meyer Children’s Hospital of Florence, Italy. During the subsequent three respiratory seasons (November through April of 2000 to 2001, 2001 to 2002, 2002 to 2003), 156 high risk infants were prophylaxed according to the inclusion criteria for prophylaxis recommended by the American Academy of Pediatrics 4 and the Italian Neonatology Society. 5 We have retrospectively identified factors impacting compliance with the prophylaxis program. Compliance was defined as the receiving of all recommended palivizumab doses and was determined by comparing the actual number of injections given with the projected number an infant would receive. For each child we reviewed medical records and recorded demographic data. Several families (n = 16) were foreign-born and did not speak Italian. The overall compliance rate with all recommended doses of palivizumab throughout the three respiratory seasons was 86%. No demographic or neonatal characteristics seemed to impact compliance except for younger age at the beginning of the prophylaxis. Families with younger children were more compliant than those with older children (P < 0.05). We speculate that the family’s perception of their child’s health gradually changes with their growth and that the larger children were perceived as being healthier and therefore not requiring prophylaxis. Further evaluation is needed. We found that the strongest predictor for poor compliance was being foreign-born and nonnative speakers (P < 0.01). The overall compliance rate in foreign parents was 56%. The factors resulting in poor compliance in non-native speakers may include cultural differences and biases, ignorance or misunderstanding of clinical instructions, misperception of RSV illness severity and inadequate time spent on educating and informing these families. 6 In our opinion the most important characteristic was the difference in language and, related to this, our difficulties to communicate effectively. The use during the first 2 years of nonmedical translators was of little help in improving compliance with palivizumab, and we speculate that lack of medical training can lead to inadequate education and clarification of RSV risk and the importance of prophylaxis. For the third RSV prophylaxis season a letter was also included that explained the risks of RSV infection and the benefits of palivizumab prophylaxis for nonnative families. The addition of letters for nonnative families and their physicians improved compliance from 80% to 88%. This suggests a positive effect of written information and reinforcement by family health care providers. In Italy 4.2% of the population are immigrants; this is 1.0% less than the average in other European countries. 7 These families, often poor and living in crowded conditions, may bring additional risk factors for severe RSV illness. In Italy medication and health care for children is funded by the Public Health System, and this fact did not pose a barrier to compliance in this study. Italian law allows parents to have free days from work to care for their children’s health. As a result poor compliance was not thought to be job-related. Because the effectiveness of palivizumab in preventing severe RSV illness is highly dependent on compliance with the monthly injection regimen during the RSV season, we suggest that more innovative and effective approaches should be developed to overcome the barriers of an effective and compliant prophylaxis regimen. Maria Serenella Pignotti, M.D. Giuseppe Indolfi, M.D. Gianpaolo Donzelli, M.D., Ph.D. Acknowledgments. Our grateful thanks to the following for their contribution in preparing this paper: J. R. Groothuis, Global Medical Director Immunoscience Development, Abbott Laboratories; R. Merolla, Medical Manager, Abbott Laboratories; and G. M. Barbarotto, Senior Associate, Medical Communications, Abbott Laboratories.

Impacto potencial y análisis coste-eficacia de la profilaxis con palivizumab, en la prevención de bronquiolitis, en prematuros menores de 33 semanas de gestación

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

Effectiveness of Palivizumab Therapy for RSV

Pulmonology| April 01 2001 Effectiveness of Palivizumab Therapy for RSV AAP Grand Rounds (2001) 5 (4): 37–38. https://doi.org/10.1542/gr.5-4-37-a Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Effectiveness of Palivizumab Therapy for RSV. AAP Grand Rounds April 2001; 5 (4): 37–38. https://doi.org/10.1542/gr.5-4-37-a Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search toolbar search search input Search input auto suggest filter your search All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: palivizumab Source: Sorrentino M, Powers T, The Palivizumab Outcomes Study Group. Effectiveness of palivizumab: evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. Pediatr Infect Dis J. 2000;19:1068–1071. This report from the Palivizumab Outcomes Study Group (POSG) provides an update on the outcome of humanized mouse monoclonal antibody (palivizumab) therapy for respiratory syncytial virus (RSV) in the first year of general use following the issuance of recommendations based on the IMpact-RSV trial.1,2 The authors did a retrospective chart review of all 1839 children who received palivizumab at 9 US centers during the 1998 to 1999 RSV season when this drug was first available for use outside a clinical trial. Criteria for use were not reported and, presumably, varied among centers. Patients were grouped according to gestational ages by whether or not they had chronic lung disease (CLD). Gestational age was not available for 209 (11.4%) patients. Patients receiving at least 1 dose were included in the study with the mean number of doses reported as 3.7 (86% of projected doses administered). For the 1839 patients who received palivizumab prophylaxis the rate of RSV hospitalization was 2.3%; for those <28 wks, 3.4%; 28 to 31 wks, 2.0%; 32 to 35 wks, 1.4%; >35 wks, 0%, and 4% for CLD patients. The mean length of stay for RSV hospitalization for these patients was 8.7 days (±13.9 days). The POSG conclude that their study had a lower hospitalization rate than the IMpact-RSV trial in which hospitalizations were reduced by 55%, 39% and 80% for all children, CLD and prematurity (defined as <36 weeks gestational age) respectively, but note that because the current POSG study did not include a control group a direct comparison could not be made. Research grant support from the manufacturer of palivizumab (MedImmune) was acknowledged. This article was sent by MedImmune, Inc to some pediatricians. Lack of a control group in this study and no report of the incidence of RSV in the general population during the study season do not allow for a conclusion regarding the effectiveness of this agent. Editorials relating to the original IMpact-RSV study pointed out the differences in reporting a relative risk reduction of 55% versus an absolute risk reduction of 5.8%.3 When reviewing alternative methods of reporting the same results, relative risk reduction can be misleading, especially if there is a small effect reported in a sample population. A more representative value is the absolute risk reduction, from which the number of patients that need to be treated (NNT) to have 1 patient benefit from treatment can be determined [NNT =1/(risk in the control group minus risk in the treatment group)]. In the case of the IMpact-RSV study, 17 patients need to be treated to prevent 1 hospital admission, while no differences in morbidity or mortality were reported. At $1200 per vial given monthly over the course of the 5-month RSV season, a cost analysis noted that the expense of prophylaxis was about... You do not currently have access to this content.

Effectiveness of palivizumab: evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. The Palivizumab Outcomes Study Group.

Respiratory syncytial virus (RSV) remains a significant cause of morbidity, especially in premature infants and immunocompromised children, resulting in approximately 100 000 hospitalizations annually. A study was performed to evaluate the outcomes of those given palivizumab (Synagis; MedImmune, Inc., Gaithersburg, MD) during the 1998 to 1999 RSV season, its first season in general use. A retrospective chart review of 1839 patients from 9 United States sites was conducted, representing all patients given palivizumab at each site. Those evaluated were to have a gestational age of < or =35 weeks, were to be <2 years old at their first injection and were to have received at least one dose of palivizumab (humanized monoclonal antibody against RSV) between September, 1998, and May, 1999. Gestational age, comorbidities, frequency of injections, hospitalizations and length of hospital stays were assessed. The antigen- or culture-positive RSV hospitalization rates for those given prophylaxis were 2.3% (42 of 1839) overall, 16/399 (4.0%) with chronic lung disease of infancy and 26 of 1227 (2.1%) born prematurely without chronic lung disease of infancy. Twenty-six patients had a gestational age of >35 weeks and were included in the analysis. Only 2.3% of children receiving palivizumab prophylaxis were hospitalized with RSV lower respiratory infection. This compares favorably with the rates observed in the pivotal trial (IMpact-RSV trial in 1996 to 1997), in which prophylaxis reduced hospitalization from 10.6% in the placebo group to 4.8% in those children receiving prophylaxis.