New Data Demonstrate RSV Immunoprophylaxis With SYNAGIS® (palivizumab) May Result in Reduced Overall Costs in Preterm Inf...
March 28 2017 - 9:00AM
Business Wire
New health economic study for SYNAGIS
(palivizumab) presented at the Academy of Managed Care Pharmacy
Annual Meeting 2017
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.
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
- 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.
- Welliver RC. Review of Epidemiology and
Clinical Risk Factors for Severe Respiratory Syncytial Virus (RSV)
Infection. J Pediatr. 2003; 143:S112-S117.
- 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.
- Centers for Disease Control and
Prevention. Infection and Incidence.
http://www.cdc.gov/rsv/about/infection.html. Accessed March 20,
2017.
- 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.
- SYNAGIS® [package insert].
Gaithersburg, MD: MedImmune, LLC.
- Boyce TG, et al. Rates of
hospitalizations for respiratory syncytial virus infection among
children in Medicaid. J Pediatr. 2000; 137:865-70.
- 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.
- 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.
- 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.
- Farber H, et al. Observed Effectiveness
of Palivizumab for 29–36-Week Gestation Infants. Pediatrics. 2016;
138(2):e20160627.
- 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.
- Centers for Disease Control and
Prevention. Preterm Birth.
http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm.
Accessed March 20, 2017.
- 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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