Miércoles 13 de Diciembre 2017

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

Guía de Regalos

New health economic study for SYNAGIS (palivizumab) presented at the
Academy of Managed Care Pharmacy Annual Meeting 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 ❤ 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.

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.

Contacts

AstraZeneca
Michele Meixell, +1 302-885-2677
or
Abigail
Bozarth, +1 302-885-2677