Market Overview

AstraZeneca Announces New Data Showing US Preterm Infants at Significantly Greater Risk of RSV Hospitalizations Following 2014 Guidance Change


Data demonstrate a greater increase in RSV hospitalization risk
during the 2015-2016 RSV season compared to recently published data from
the prior season

AstraZeneca today announced new results of a study that investigated
respiratory syncytial virus (RSV) hospitalization risk and costs during
the 2014-2016 RSV seasons compared to the 2012-2014 RSV seasons. Results
of the study were presented as a poster on Wednesday, October 18 at the
Academy of Managed Care Pharmacy (AMCP) Nexus meeting in Dallas, TX.
This study is the first national analysis of serious RSV disease in US
preterm infants from the two seasons following the 2014 American Academy
of Pediatrics (AAP) guidance that recommended against the use of RSV
immunoprophylaxis in preterm infants born at 29-34 weeks gestational age
(wGA). The 2014 guidance asserted that 29-34 wGA infants were not at a
significantly increased risk of RSV hospitalization relative to
full-term (FT) infants.

The study demonstrated that RSV immunoprophylaxis use declined
dramatically in preterm infants born at 29-34 wGA in 2014-2016 relative
to 2012-2014, consistent with recommendations in the 2014 guidance.
Associated with this decline, RSV hospitalization risks increased among
infants 29-34 wGA who were <6 months of age for both Commercial-insured
and Medicaid-insured infants. Preterm infants 29-34 wGA who were <6
months of age were approximately 2.5 to 5 times more likely to be
hospitalized than FT infants in 2014-2015, which increased to
approximately 3.5 to 5.5 times more likely in 2015-2016. These risks
were higher than those observed in seasons prior to the guidance change.

This study confirms and extends the results of a recently published
study that similarly demonstrated a significant national increase in RSV
hospitalizations among infants 29-34 wGA who were <3 months of age
during the 2014-2015 RSV season compared to the previous four seasons.

Greg Keenan, Vice President, US Medical Affairs, AstraZeneca said: "The
results from this study emphasize that preterm infants are at
substantially elevated risk of RSV hospitalization compared to full-term
infants. As a science-led organization, AstraZeneca remains committed to
partnering with the academic community to conduct research that
characterizes and ultimately reduces the burden of disease for this
vulnerable population of patients."

The study examined national US Commercial and Medicaid insurance claims
databases containing data from more than 1.5 million claims of infants
<1 year of age. In addition to the increased RSV hospitalization risks
among preterm infants, the study found that RSV hospitalization costs
were also higher. The average RSV hospitalization cost during the
2014-2016 RSV seasons for Commercial infants <3 months of age at first
RSV hospitalization was $17,416 for FT infants and $39,174 for infants
29–34 wGA. The average cost for Medicaid infants <3 months of age at
first RSV hospitalization was $9,824 for FT infants and $22,316 for
infants 29-34 wGA. RSV hospitalizations were identified using ICD-9-CM
diagnosis codes on inpatient claims; confirmatory laboratory results
were not available for this study, as insurance claims databases do not
provide these results.

Utilization of inpatient RSV immunoprophylaxis among infants <3 months
of age discharged from their birth hospitalization during the RSV season
is not recorded in claims databases, and this could impact rates of RSV
hospitalization in this subgroup. RSV immunoprophylaxis use prior to
discharge would be expected to reduce RSV hospitalization rates in
infants <3 months of age.

Dr. Mitchell Goldstein, from Loma Linda University Children's Hospital,
Loma Linda, CA and the lead author of the study, said: "RSV is the
leading cause of hospitalization for infants in their first year of life
in the United States and can be especially severe for preterm infants
during the first months of life. These data build on previous studies
and should prompt additional discussion of the importance of RSV
prevention efforts among these high-risk infants. This is an important
topic among advocates for preterm infant health and the health care


About the study

Between July 1, 2012 and June 30, 2016, RSV hospitalization risks were
evaluated during the RSV season of each year. Rates were calculated per
100 infant-seasons. RSV hospitalization costs for the 2014–2016 seasons
were averaged separately for FT and preterm infants by age at first RSV

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 and continue to be recommended for RSV

Results of the study were presented as a poster on Wednesday, October 18
at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting in Dallas,

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. In certain high-risk
babies, however, RSV can lead to a serious lung infection and
hospitalization. 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.

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
and follow us on Twitter @AstraZenecaUS.

US-15496 10/17

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