Palivizumab for the prevention of respiratory syncytial virus infection

Alexander L. Rogovik; Bruce Carleton; Alfonso Solimano; Ran Goldman

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who gives the vaccine
BASMA HANNA

Published on: 19 October 2010
Rebuttal: palivizumab for the prevention of respiratory syncytial virus infection
Krista L. Lanct�

Published on: 30 August 2010

Published on: (19 October 2010)
Page navigation anchor for who gives the vaccine
who gives the vaccine
BASMA HANNA, family physician
Who gives the vaccine to infants? in office or hospital setting? Community public place? And is it free or does it cost the parents some money? How much?

Competing Interests: None declared.
Published on: (30 August 2010)
Page navigation anchor for Rebuttal: palivizumab for the prevention of respiratory syncytial virus infection
Rebuttal: palivizumab for the prevention of respiratory syncytial virus infection
Krista L. Lanct�, Executive Director
Other Contributors:
Dear editor:
In the article on palivizumab for the prevention of respiratory syncytial virus infection, Dr. Rogovik et al. summarized current literature on palivizumab safety, efficacy, use, and cost-effectiveness (1). The primary objectives were to determine the indications for use of palivizumab and if it can be used for treatment of respiratory syncytial virus (RSV) infections.
Though the recomme...
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Dear editor:
In the article on palivizumab for the prevention of respiratory syncytial virus infection, Dr. Rogovik et al. summarized current literature on palivizumab safety, efficacy, use, and cost-effectiveness (1). The primary objectives were to determine the indications for use of palivizumab and if it can be used for treatment of respiratory syncytial virus (RSV) infections.
Though the recommendations for palivizumab use from the Canadian Paediatric Society (2) are summarized, the discussion largely focuses on recommendations from the American Academy of Pediatrics (3) which is disappointing given the significant research contributions to this field by the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) and other Canadian investigators. As mentioned in the Canadian guidelines, there are important differences between the two position statements due to unique epidemiology, geography, and practice settings, in addition to different healthcare and drug costs. Recommendations for infants in the 32 to 35 week gestational age (GA) group are the most divergent, with Canadian guidelines recommending localized policies in each province and territory, considering risk factors and the available risk-scoring tool (4,5). These recommendations are omitted from the authors’ summary table, and the differences between Canadian and American indications and rationale for the use of palivizumab in this specific sub-population are not discussed. This is important since this cohort of infants are at similar risk to infants <32 weeks GA with regard to RSV hospitalization, incurred morbidities during their hospital stay and subsequent healthcare resource utilization (6-10). Moreover, the authors quote the use of one risk factor and a maximum of 3 doses for 32- 35 weeks GA infants born 3 months before or during the RSV season. There is ample evidence that more than 1 risk factor determines RSV hospitalization in this group of infants (4,11-13) and that the use of 1-3 doses of palivizumab during an entire RSV season is an untested strategy in randomized controlled trials (14,15) and is not supported by the pharmacokinetics and therapeutic efficacy of the drug through the earlier Phase I/II and IMpact trials (14,16).
The authors include a brief overview of palivizumab cost- effectiveness analyses. However, their survey of the literature is limited to only one paper, a UK-specific analysis (17), which is discussed in detail. Palivizumab cost-effectiveness analyses may have limited generalizability between countries as healthcare costs and cost- effectiveness standards can differ (18). None of the available Canadian analyses (19-22) are included in the discussion of cost-effectiveness or risk factors. Additionally, the variation in results and indications, even among the analyses cited, is not addressed. For example, Nuijten et al. concludes that palivizumab is cost-effective for preterm infants and those with bronchopulmonary dysplasia (BPD) or chronic heart disease (CHD) (23), while Reeve et al. only examined a group of infants of low birth weight and concluded that it is not cost-effective (24). A recent comprehensive review of the literature demonstrated that while results vary between countries and indications, palivizumab is often cost effective for use in high-risk populations, especially those with multiple environmental risk factors (22).
Furthermore, a major issue in Canada which merits more attention is the use of palivizumab in Aboriginal populations. Palivizumab has been shown to be cost-effective for term Inuit infants in remote Northern communities (21) due to especially high rates of RSV infection and hospitalization costs (20). The number needed to treat (NNT) in Igloolik, Arctic Bay, Grise Fjord and Hall Beach (20) varied from 2.5-3.7 unlike the IMpact randomized controlled trial. The Canadian Paediatric Society has also recognized the need for research in remote First Nations and Métis communities (2). While Inuit infants are included in the summary of usage guidelines, the authors do not discuss Aboriginal infants in the text or mention this population as an important possible risk factor for RSV infection.
In summary, the information in this article is incomplete and key Canadian references have been excluded. A comprehensive overview of the indications for which palivizumab is effective and cost-effective which encompasses Canadian data and focuses on guidelines published by the Canadian Paediatric Society for our urban and rural populations would be far more beneficial and informative for family physicians.
Kelly A. Smart
Medical Outcomes and Research in Economics (MORE®) Group, Sunnybrook Health Sciences Centre, Toronto, Ontario; Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario
Krista L. Lanctôt, PhD
Medical Outcomes and Research in Economics (MORE®) Group, Sunnybrook Health Sciences Centre, Toronto, Ontario; Departments of Psychiatry and Pharmacology/Toxicology, University of Toronto, Toronto, Ontario
Bosco A. Paes, MB BS FRCPI FRCPC
Division of Neonatology, Department of Pediatrics, McMaster Children’s Hospital, Hamilton, Ontario
References
1. Rogovik AL, Carleton B, Solimano A, Goldman R. Palivizumab for the prevention or respiratory syncytial virus infection. Can Fam Physician. 2010;56:769-772.
2. Samson L. Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Paediatr Child Health 2009;14:521-526.
3. Committee on Infectious Diseases. From the American Academy of Pediatrics: Policy statements--Modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. 2009;14:521-526.
4. Sampalis J, Langley J, Carbonell-Estrany X, et al. Development and validation of a risk scoring tool to predict respiratory syncytial virus hospitalization in premature infants born at 33 through 35 completed weeks of gestation. Med Decis Making. 2008;28:471-480.
5. Paes BA, Steele S, Janes M, Pinelli J. Risk-Scoring Tool for respiratory syncytial virus prophylaxis in premature infants born at 33-35 completed weeks' gestational age in Canada. Curr Med Res Opin. 2009(25(7)):1585-1591.
6. Boyce TG, Mellen BG, Mitchel EFJ, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in medicaid. J Pediatr. 2000(137):865-870.
7. Law BJ, MacDonald N, Langley J, et al. Severe respiratory syncytial virus infection among otherwise healthy prematurely born infants: What are we trying to prevent? Paediatr Child Health. 1998;3:402- 404.
8. Horn S, Smout R. Effect of prematurity on respiratory syncytial virus hospital resource use and outcomes. J Pediatr. 2003;143:S133-141.
9. Willson D, Landrigan C, Horn S, et al. Complications in infants hospitalized for bronchiolitis or respiratory syncytial virus pneumonia. J Pediatr 2003;143:S142-149.
10. Sampalis J. Morbidity and mortality after RSV-associated hospitalizations among premature Canadian infants. J Pediatr 2003;143:S150 -156.
11. Law BJ, Langley JM, Allen U, et al. The Pediatric Investigators Collaborative Network on Infections in Canada study of predictors of hospitalization for respiratory syncytial virus Pediatr Infect Dis J. 2004;23:806-814.
12. Figueras-Aloy J, Carbonell-Estrany X, Quero-Jiménez J, et al. FLIP-2 Study: Risk factores linked to Respiratory Syncytial Virus infection requiring hospitalization in premature infants born in Spain at a gestational age of 32 to 35 weeks. Pediatr Infect Dis J. 2008;27(9):788- 793.
13. Carbonell-Estrany X, Figueras Aloy J, Law BJ. Infección Respiratoria Infantil por Virus Respiratorio Sincitial Study Group; Pediatric Investigators Collaborative Network on Infections in Canada Study Group. Identifying risk factors for severe respiratory syncytial virus among infants born after 33 through 35 completed weeks of gestation: different methodologies yield consistent finding. Pediatr Infect Dis J. 2004;23:S193-201.
14. IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monolconal antibody, reduces hospitalization from syncytial virus infection in high-risk infants. Pediatrics. 1998;102:531- 537.
15. Feltes T, Cabalka A, Meissner H, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. Cardiac Synagis Study Group. J Pediatr 2003;143:532-540.
16. Sàez-Llorens X, Castaño E, Null D, et al. Safety and pharmacokinetics of an intramuscular humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. The MEDI-493 Study Group. Pediatr Infect Dis J. 1998;17(9):787-791.
17. Wang D, Cummins C, Bayliss S, Sandercock J, Burls A. Immunoprophylaxis against respiratory syncytial virus (RSV) with palivizumab in children: a systematic review and economic evaluation. Health Technology Assessment. 2008;12(36).
18. Morris SK, Dzolganovski B, Beyene J, Sung L. A meta-analysis of the effect of antibody therapy for the prevention of severe respiratory syncytial virus infection. BMC Infect Dis. 2009;9:106.
19. Lanctôt KL, Masoud S, Paes BA, et al. The cost-effectiveness of palivizumab for respiratory syncytial virus prophylaxis in premature infants with a gestational age of 32-35 weeks: a Canadian-based analysis. . Current Medical Research and Opinion. November 11, 2008 2008;24(11):3223 -3237.
20. Banerji A, Lanctôt KL, Paes BA, et al. Comparison of the cost of hospitalization for respiratory syncytial virus disease versus palivizumab prophylaxis in Canadian Inuit infants. Pediatr Infect Dis J. 2009;28(8):702-706.
21. Tam DY, Banerji A, Paes BA, Hui C, Tarride J-E, Lanctôt KL. The cost-effectiveness of palivizumab for term Inuit infants in the Eastern Canadian Arctic. Journal of Medical Economics. 2009 2009;12(4):361-370.
22. Smart KA, Paes BA, Lanctôt KL. The cost-effectiveness of palivizumab: a systematic review of the evidence. J Med Econ. 2010;13(3):453-463.
23. Nuijten MJC, Wittenberg W, Lebmeier M. Cost Effectiveness of Palivizumab for Respiratory Syncytial Virus Prophylaxis in High-Risk Children. Pharmacoeconomics. 2007 2007;25(1):55-71.
24. Reeve CA, Whitehall JS, Buetnner PG, Norton R, Reeve DM, Francis F. Cost-effectiveness of respiratory syncytial virus prophylaxis with palivizumab. Journal of Paediatrics and Child Health. 2006;42:253-258.
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Competing Interests: None declared.