Respiratory syncytial virus immunization program for the United States: Impact of performance determinants of a theoretical vaccine

Vaccine

Volumn 31, Issue 40, 2013, Pages 4347-4354

  Régnier, Stephane A ^a,b  

^a UNIVERSITY OF NEUCHÂTEL   (Switzerland)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Clinical endpoints; Cost effectiveness; RSV; United States; Value drivers

Indexed keywords

PALIVIZUMAB; RESPIRATORY SYNCYTIAL VIRUS VACCINE;

AMBULATORY CARE; ARTICLE; ASTHMA; CAREGIVER; CHILD; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DRUG EFFICACY; DRUG SAFETY; HALF LIFE TIME; HEALTH CARE COST; HEALTH CARE UTILIZATION; HIGH RISK PATIENT; HOSPITALIZATION; HOSPITALIZATION COST; HUMAN; INFANT; INFANT MORTALITY; INFECTION PREVENTION; INFECTION RISK; MAJOR CLINICAL STUDY; NEWBORN; PRESCHOOL CHILD; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; RESPIRATORY SYNCYTIAL VIRUS INFECTION; UNITED STATES; VACCINATION; WHEEZING;

CLINICAL ENDPOINTS; COST-EFFECTIVENESS; RSV; UNITED STATES; VALUE DRIVERS;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIVIRAL AGENTS; CHILD, PRESCHOOL; COST-BENEFIT ANALYSIS; DELIVERY OF HEALTH CARE; HUMANS; IMMUNIZATION PROGRAMS; INFANT; INFANT MORTALITY; INFANT, NEWBORN; MODELS, THEORETICAL; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; RESPIRATORY SYNCYTIAL VIRUS VACCINES; RESPIRATORY SYNCYTIAL VIRUS, HUMAN; UNITED STATES;

EID: 84882849588     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.07.024     Document Type: Article

References (74)

1. Centers for Disease Control and Prevention (CDC) CDC Data & Statistics: Respiratory Syncytial Virus (RSV) Season, U.S., 2010-2011 2010, http://www.cdc.gov/Features/dsRSV/Accessed July 12, 2012.
2. Glezen W.P., Taber L.H., Frank A.L., Kasel J.A. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child 1986, 140(6):543-546.
3. Welliver R.C. Review of epidemiology and clinical risk factors for severe respiratory syncytial virus (RSV) infection. J Pediatr 2003, 143(5 suppl.):112-117.
4. Nair H., Nokes D.J., Gessner B.D., et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 2010, 375(9725):1545-1555.
5. Escobar G.J., Ragins A., Li S.X., et al. Recurrent wheezing in the third year of life among children born at 32 weeks' gestation or later: relationship to laboratory-confirmed, medically attended infection with respiratory syncytial virus during the first year of life. Arch Pediatr Adolesc Med 2010, 164:915-922.
6. American Academy of Pediatrics Respiratory Syncytial Virus Red Book. Report of the Committee on Infectious Diseases 2009, 560-569. American Academy of Pediatrics, Elk Grove Village, IL. 28th ed. L.K. Pickering, C.J. Baker, D.W. Kimberlin, S.S. Long (Eds.).
7. Meissner H.C., Bocchini J.A., Brady M.T., Hall C.B., Kimberlin D.W., Pickering L.K. The role of immunoprophylaxis in the reduction of disease attributable to respiratory syncytial virus. Pediatrics 2009, 124(6):1676-1679.
8. Paramore L.C., Ciuryla V., Ciesla G., Liu L. Economic impact of respiratory syncytial virus-related illness in the US: an analysis of national databases. Pharmacoeconomics 2004, 22(5):275-284.
9. Leader S., Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr 2003, 143(5 suppl.):S127-S132.
10. McLaurin K.K., Leader S. Growing impact of RSV hospitalizations among infants in the US 2002, 1997-2002 [Abstract 936]. Presented at: Pediatric Academic Societies Annual Meeting; May 14-17, 2005; Washington, DC.
11. American Academy of Pediatrics Committee on Infectious Diseases Modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009, 124(6):1694-1701.
12. ClinicalTrials.gov. Information on clinical trials and human research studies 2012, http://clinicaltrials.gov/ct2/results?cond=respiratory+syncytial+virus&intr=vaccine. [Accessed 20.11.2012.].
13. Bernstein D.I., Malkin E., Abughali N., Falloon J., Yi T., Dubovsky F. Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pediatr Infect Dis J 2012, 31(2):109-114.
14. Glenn G.M., Smith G., Fries L., Raghunandan R., Lu H., Zhou B., et al. Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. Vaccine 2013, 31(3):524-532.
15. Englund J.A. Passive protection against respiratory syncytial virus disease in infants: the role of maternal antibody. Pediatr Infect Dis J 1994, 13(5):449-453.
16. Driscoll F.W. Novavax and PATH announce partnership on RSV vaccine [press release]. Rockville, MD: Novavax Inc.; July 18, 2012 2012, . [accessed 30.10.12].
17. Bos J.M., Rietveld E., Moll H.A., et al. The use of health economics to guide drug development decisions: determining optimal values for an RSV-vaccine in a model-based scenario-analytic approach. Vaccine 2007, 25(39-40):6922-6929.
18. Gessner B.D. The cost-effectiveness of a hypothetical respiratory syncytial virus vaccine in the elderly. Vaccine 2000, 18(15):1485-1494.
19. Meijboom M.J., Rozenbaum M.H., Benedictus A., Luytjes W., Kneyber M.C., Wilschut J.C., et al. Cost-effectiveness of potential infant vaccination against respiratory syncytial virus infection in The Netherlands. Vaccine 2012, 30(31):4691-4700.
20. Acedo L., Díez-Domingo J., Moraño J.A., Villanueva R.J. Mathematical modelling of respiratory syncytial virus (RSV): vaccination strategies and budget applications. Epidemiol Infect 2010, 138(6):853-860.
21. Martin J.A., Hamilton B.E., Ventura S.J., et al. Births: final data for 2009. Natl Vital Stat Rep 2011, 60(1):1-70.
22. Martin J.A., Hamilton B.E., Sutton P.D., Ventura S.J., Mathews T.J., Osterman M.J. Births: final data for 2008. Natl Vital Stat Rep 2010, 59(1):3-71. 1.
23. Martin J.A., Hamilton B.E., Sutton P.D., et al. Births: final data for 2007. Natl Vital Stat Rep 2010, 58(24):1-85.
24. Centers for Disease Control and Prevention (CDC) Influenza vaccination coverage among pregnant women: United States, 2010-11 influenza season. MMWR Morb Mortal Wkly Rep 2011, 60(32):1078-1082.
25. Centers for Disease Control and Prevention (CDC) Statistics and Surveillance: U.S. vaccination coverage reported via the National Immunization Survey (NIS) 2012, http://www.cdc.gov/vaccines/stats-surv/nis/default.htm. [accessed 16.07.2012.].
26. MacLennan J.M., Shackley F., Heath P.T., et al. Safety, immunogenicity, and induction of immunologic memory by a serogroup C meningococcal conjugate vaccine in infants: a randomized controlled trial. JAMA 2000, 283(21):2795-2801.
27. Ferrera G., Cuccia M., Mereu G., et al. Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine co-administered with measles-mumps-rubella-varicella vaccine: A randomized, controlled trial in children primed according to a 2+1 schedule in infancy. Hum Vaccin Immunother 2012, 8(3):355-362.
28. Hall C.B., Weinberg G.A., Iwane M.K., et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009, 360(6):588-598.
29. Thompson W.W., Shay D.K., Weintraub E., et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003, 289(2):179-186.
30. Shay D.K., Holman R.C., Roosevelt G.E., Clarke M.J., Anderson L.J. Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children, 1979-1997. J Infect Dis 2001, 183(1):16-22.
31. Bloom B., Cohen R.A., Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2010. National Center for Health Statistics. Vital Health Stat 2011, 10(250):1-80.
32. Regnier S., Huels J. Association between respiratory syncytial virus hospitalizations in infants and respiratory sequelae: systematic Review and Meta-Analysis. Pediatr Infect Dis J 2013, 32(8):820-826.
33. Stein R.T., Sherrill D., Morgan W.J., et al. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet 1999, 354(9178):541-545.
34. Sigurs N., Aljassim F., Kjellman B., et al. Asthma and allergy patterns over 18 years after severe RSV bronchiolitis in the first year of life. Thorax 2010, 65(12):1045-1052.
35. Korppi M., Piippo-Savolainen E., Korhonen K., Remes S. Respiratory morbidity 20years after RSV infection in infancy. Pediatr Pulmonol 2004, 38(2):155-160.
36. Kind P., Dolan P., Gudex C., Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998, 316(7133):736-741.
37. Arias E. United States life tables, 2007. Natl Vital Stat Rep 2011, 59(9):1-60.
38. Gold M., Franks P., Erickson P. Assessing the health of the nation, The predictive validity of a preference-based measure and self-rated health. Med Care 1996, 34(2):163-177.
39. Lee G.M., Salomon J.A., LeBaron C.W., Lieu T.A. Health-state valuations for pertussis: methods for valuing short-term health states. Health Qual Life Outcomes 2005, 3:17.
40. Centers for Disease Control and Prevention (CDC) Respiratory syncytial virus infection (RSV): symptoms and care 2012, http://www.cdc.gov/rsv/about/symptoms.html. [accessed 18.07.2012.].
41. Kids' Inpatient Database (KID) Healthcare Cost and Utilization Project (HCUP) 2012, http://www.hcup-us.ahrq.gov/kidoverview.jsp. [accessed 8.08.2012.].
42. Kamble S., Bharmal M. Incremental direct expenditure of treating asthma in the United States. J Asthma 2009, 46(1):73-80.
43. Leader S., Yang H., DeVincenzo J., Jacobson P., Marcin J.P., Murray D.L. Time and out-of-pocket costs associated with respiratory syncytial virus hospitalization of infants. Value Health 2003, 6(2):100-106.
44. ElHassan N.O., Sorbero M.E., Hall C.B., Stevens T.P., Dick A.W. Cost-effectiveness analysis of palivizumab in premature infants without chronic lung disease. Arch Pediatr Adolesc Med 2006, 160(10):1070-1076.
45. Widdowson M.A., Meltzer M.I., Zhang X., Bresee J.S., Parashar U.D., Glass R.I. Cost-effectiveness and potential impact of rotavirus vaccination in the United States. Pediatrics 2007, 119(4):684-697.
46. US Bureau of Labor Statistics Consumer Price Index (CPI) 2012, http://www.bls.gov/cpi/ [accessed 18.07.2012.].
47. Luce B.R., Manning W.G., Siegel J.E., Lipscomb J. for the United States Public Health Service panel on cost-effectiveness in health and medicine. Estimating costs in cost-effectiveness analysis. Cost-effectiveness in health and medicine 1996, 176-213. Oxford University Press, New York. M.R. Gold, J.E. Siegel, L.B. Russell, M.C. Weinstein (Eds.).
48. Vaccines for Children Program (VFC) CDC Vaccine Price List. Prices last reviewed/updated: October 15, 2012 2012, http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-C management/price-list/index.html#f5. [Accessed 30.10.2012.].
49. MAG Mutual Healthcare Solutions Physicians' Fee and Coding Guide 2012 2012, MAG Mutual Healthcare Solutions Inc., Atlanta, GA, p. 725.
50. American Academy of Pediatrics 2007/08 AAP Medicaid Reimbursement Survey 2008, 5. American Academy of Pediatrics, Elk Grove Village, IL, http://www.aap.org/research/medreimpdf0708/49state_DC.pdf [accessed 30.10.12.].
51. Smith P.J., Lindley M.C., Rodewald L.E. Vaccination coverage among U.S. children aged 19-35months entitled by the Vaccines for Children program, 2009. Public Health Rep 2011, 126(Suppl. 2):109-123.
52. US Census Bureau Current Population Survey (CPS) Annual Social and Economic (ASEC) Supplement. Health insurance coverage status and type of coverage by selected characteristics for children under 18 (all children): 2010. 2011, http://www.census.gov/hhes/www/cpstables/032011/health/h08_000.htm. [accessed 18.07.12.].
53. GlaxoSmithKline Highlights of prescribing information 2012, http://us.gsk.com/products/assets/us_rotarix.pdf. [accessed 30.10.12.].
54. US Bureau of Labor Statistics National Compensation Survey: occupational earnings in the United States, 2010 2011, http://www.bls.gov/ncs/ncswage2010.htm#Wage_Tables [Accessed 18.07.2012.].
55. Lanctot K.L., Masoud S.T., Paes B.A., 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. Curr Med Res Opin 2008, 24(11):3223-3237.
56. US Census Bureau Current Population Survey (CPS) Annual Social and Economic (ASEC) Supplement. Wage and salary workers: people 15 years old and over by total wage and salary income in 2010, race, hispanic origin, and sex. 2011 2012, http://www.census.gov/hhes/www/cpstables/032011/perinc/new10_000.htm. [accessed 18.07.12].
57. Bilukha O.O., Rosenstein N. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2005, 54(RR-7):1-21.
58. Perrin K.M., Bégué R.E. Use of palivizumab in primary practice. Pediatrics 2012, 129(1):55-61.
59. Mahadevia P.J., Masaquel A.S., Polak M.J., Weiner L.B. Cost utility of palivizumab prophylaxis among pre-term infants in the United States: a national policy perspective. J Med Econ 2012, 15(5):987-996.
60. Astra Zeneca AstraZeneca Annual Report and Form 20-F Information 2011, http://www.astrazeneca-annualreports.com/2011/documents/pdfs/annual_report_pdf_entire.pdf. [accessed 14.05.13.].
61. Grosse S.D. Assessing cost-effectiveness in healthcare: history of the $50,000 per QALY threshold. Expert Rev Pharmacoecon Outcomes Res 2008, 8(2):165-178.
62. Krol M., Brouwer W., Rutten F. Productivity costs in economic evaluations: past, present, future. Pharmacoeconomics 2013, 31(7):537-549.
63. Centers for Disease Control and Prevention (CDC) 2012, Rotavirus: Symptoms. . [accessed 18.07.12.].
64. Ochola R., Sande C., Fegan G., et al. The level and duration of RSV-specific maternal IgG in infants in Kilifi Kenya. PLoS One 2009, 4(12):e8088.
65. Conway S.P., Dear P.R., Smith I. Immunoglobulin profile of the preterm baby. Arch Dis Child 1985, 60(3):208-212.
66. Brandenburg A.H., Groen J., van Steensel-Moll H.A., et al. Respiratory syncytial virus specific serum antibodies in infants under six months of age: limited serological response upon infection. J Med Virol 1997, 52(1):97-104.
67. Centers for Disease Control and Prevention (CDC) The National Respiratory and Enteric Virus Surveillance System (NREVSS): RSV National Trends 2013, http://www.cdc.gov/surveillance/nrevss/rsv/natl-trend.html. [Accessed 7.05.2013.].
68. Fischer G.W., Ottolini M.G., Mond J.J. Prospects for vaccines during pregnancy and in the newborn period. Clin Perinatol 1997, 24(1):231-249.
69. Wu P., Hartert T.V. Evidence for a causal relationship between respiratory syncytial virus infection and asthma. Expert Rev Anti Infect Ther 2011, 9(9):731-745.
70. Shim E., Galvani A.P. Impact of transmission dynamics on the cost-effectiveness of rotavirus vaccination. Vaccine 2009, 27(30):4025-4030.
71. Henderson F.W., Collier A.M., Clyde W.A., Denny F.W. Respiratory-syncytial-virus infections, reinfections and immunity: a prospective, longitudinal study in young children. N Engl J Med 1979, 300(10):530-534.
72. Mills J., Van Kirk J.E., Wright P.F., Chanock R.M. Experimental respiratory syncytial virus infection of adults: possible mechanisms of resistance to infection and illness. J Immunol 1971, 107(1):123-130.
73. Matheson J.W., Rich F.J., Cohet C., et al. Distinct patterns of evolution between respiratory syncytial virus subgroups A and B from New Zealand isolates collected over thirty-seven years. J Med Virol 2006, 78(10):1354-1364.
74. Zheng H., Storch G.A., Zang C., et al. Genetic variability in envelope-associated protein genes of closely related group A strains of respiratory syncytial virus. Virus Res 1999, 59(1):89-99.