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AstraZeneca PLC Release: New Data Demonstrate RSV Immunoprophylaxis With SYNAGIS (Palivizumab) May Result In Reduced Overall Costs In Preterm Infants Born At 29-32 wGA Who Are Less Than Three Months Of Age

Published: Mar 28, 2017

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced new results data which evaluated the cost-effectiveness of SYNAGIS® (palivizumab) for respiratory syncytial virus (RSV) in preterm infants 29-34 weeks gestational age compared to those who did not receive SYNAGIS.1 These results, derived from age-specific information on the incidence and cost of RSV hospitalization and cost of SYNAGIS, demonstrated that SYNAGIS may reduce overall costs in infants born at 29-32 weeks gestational age who are <3 months of age over a one-year period.1 These data were presented as a poster at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2017 in Denver, CO.

“Our modeling indicates that RSV prophylaxis with SYNAGIS improves outcomes and may reduce costs when administered to preterm infants born at 29-32 weeks gestational age prior to three months of age.”

RSV prophylaxis with SYNAGIS in preterm infants born at 29-34 weeks gestational age who are >3 months of chronologic age reduced RSV hospitalization outcomes but increased overall costs.1 Children with chronic lung disease of prematurity or hemodynamically significant congenital heart disease were not studied. These populations have risks of severe RSV disease above those observed with otherwise healthy preterm infants.2

Dr. Ryan Hansen, lead study investigator, School of Pharmacy, University of Washington, Seattle, WA, said: “Our modeling indicates that RSV prophylaxis with SYNAGIS improves outcomes and may reduce costs when administered to preterm infants born at 29-32 weeks gestational age prior to three months of age.”

RSV is a highly contagious, seasonal virus that affects nearly 100% of infants and can lead to serious lung infection and hospitalization in high-risk infants.3,4,5 SYNAGIS is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.6 Safety and efficacy were established in children with bronchopulmonary dysplasia, infants with a history of premature birth (=35 weeks gestational age), and children with hemodynamically significant congenital heart disease.6 Safety and efficacy have not been established in other populations.6 The most common adverse reactions are fever and rash.6

IMPORTANT SAFETY INFORMATION

The recommended dose of SYNAGIS is 15 mg/kg of body weight given monthly by intramuscular injection. The first dose of SYNAGIS should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.

The efficacy of SYNAGIS at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.

SYNAGIS is contraindicated in children who have had a previous significant hypersensitivity reaction to SYNAGIS. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to SYNAGIS. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to SYNAGIS. The relationship between these reactions and the development of antibodies to SYNAGIS is unknown. If a significant hypersensitivity reaction occurs with SYNAGIS, its use should be permanently discontinued. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of SYNAGIS. As with any intramuscular injection, SYNAGIS should be given with caution to children with thrombocytopenia or any coagulation disorder. Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.

Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) and injection site reactions have been reported.

Please see full Prescribing Information for Synagis, including Patient Information.

NOTES TO EDITORS

About “Cost-Effectiveness of Palivizumab Prophylaxis by Gestational and Chronologic Age Among Infants at Increased Risk of Hospitalization for Respiratory Syncytial Virus”

These data were derived from a four-state Markov cohort model which applied seasonal risk of RSV with and without palivizumab and accrued costs (palivizumab prophylaxis and RSVH) over a one-year time horizon from the healthcare payer perspective. Cohorts, or subgroups of infants were defined using combined categories of gestational age (29–30, 31–32, and 33–34 weeks gestational age) and chronologic age (<3, 3–6, and >6 months).1 Previously published rates of RSV hospitalization were modelled and RSV hospitalization costs were estimated from 2014–2015 Marketscan health insurance claims data.7,8,9,10,11 Mean palivizumab treatment costs were estimated by predicting infant weight over time using Fenton preterm infant growth charts and applying the appropriate costs using FDA-approved dosing.12 The incremental costs and incremental cost-effectiveness ratios associated with palivizumab prophylaxis in the nine cohorts were estimated and evaluated by both one-way and probabilistic sensitivity analyses.1

About SYNAGIS

SYNAGIS is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia, infants with a history of premature birth (=35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The recommended dose of SYNAGIS is 15 mg/kg of body weight given monthly by intramuscular injection. The first dose of SYNAGIS should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.

About RSV

RSV is a contagious, seasonal respiratory virus that nearly 100% of children will contract, at varying levels of severity, by the age of two and most will recover from within one to two weeks.3,4,5 In certain high-risk babies, however, RSV can lead to a serious lung infection and hospitalization.7,13 Preterm infants are at increased risk of developing severe RSV disease because their lung volume is significantly less than that of full-term infants, and their airways are smaller and narrower than those of a baby born at term.14

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

  1. Hansen RN, McLaurin KM, Sullivan SD. Cost-Effectiveness of Palivizumab Prophylaxis by Gestational and Chronologic Age Among Infants at Increased Risk of Hospitalization for Respiratory Syncytial Virus. Poster Number J19. Poster presented at Academy of Managed Care Annual Meeting 2017, March 27-30, 2017.
  2. Welliver RC. Review of Epidemiology and Clinical Risk Factors for Severe Respiratory Syncytial Virus (RSV) Infection. J Pediatr. 2003; 143:S112-S117.
  3. Glezen WP, Taber LJ, Frank AL, Kasel JA. Risk of Primary Infection and Reinfection with Respiratory Syncytial Virus. Am J Dis Child. 1986; 140:543-546.
  4. Centers for Disease Control and Prevention. Infection and Incidence. http://www.cdc.gov/rsv/about/infection.html. Accessed March 20, 2017.
  5. Hall CB, Weinberg GA, Iwane MK, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. N Engl J Med. 2009; 360:588-598.
  6. SYNAGIS® [package insert]. Gaithersburg, MD: MedImmune, LLC.
  7. Boyce TG, et al. Rates of hospitalizations for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000; 137:865-70.
  8. Stevens TP, et al. Respiratory Syncytial Virus and Premature Infants Born at 32 Weeks' Gestation or Earlier: Hospitalization and Economic Implications of Prophylaxis. Arch Pediatr Adolesc Med. 2000; 154(1):55-61.
  9. Ambrose CS, et al. Respiratory syncytial virus disease in preterm infants in the U.S. born at 32-35 weeks gestation not receiving immunoprophylaxis. Pediatr Infect Dis J. 2014; 33(6):576-82.
  10. Winterstein AG, et al. Appropriateness of Age Thresholds for Respiratory Syncytial Virus Immunoprophylaxis in Moderate-Preterm Infants: A Cohort Study. JAMA Pediatr. 2013; 167(12):1118-24.
  11. Farber H, et al. Observed Effectiveness of Palivizumab for 29–36-Week Gestation Infants. Pediatrics. 2016; 138(2):e20160627.
  12. Shahabi A, et al. Variation in Cost of Palivizumab Prophylaxis and the Implications for Policy Considerations. Poster Presented at AMCP Nexus 2016, October 3-6 2016.
  13. Centers for Disease Control and Prevention. Preterm Birth. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. Accessed March 20, 2017.
  14. Langston C, Kida K, Reed M, Thurlbeck WM. Human lung growth in late gestation and in the neonate. Am Rev Respir Dis. 1984; 129:607-613.

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