Study In Journal of Medical Economics Shows Palivizumab Cost Effectiveness Using FDA-approved Dosing And AAP Red Book

GAITHERSBURG, Md., Oct. 3, 2012 /PRNewswire/ -- MedImmune, the biologics arm of AstraZeneca, today announced that the Journal of Medical Economics has published a study that shows Synagis® (palivizumab) is within the acceptable range of cost effectiveness. Specifically, the study relates to Synagis' reduction in hospitalizations due to serious respiratory syncytial virus (RSV) disease among eligible preterm infant populations covered by Medicaid and private insurers in the United States when dosed in accordance with its FDA-approved label which specifies monthly dosing throughout the season. 

Such dosing recommendations are the only ones proven as safe and effective for the approved use of palivizumab and the only dosing recommendations supported by randomized, controlled clinical evidence.  In fact, the FDA-approved labeling states, "The efficacy of Synagis…dosing less frequently than monthly throughout the RSV season, has not been established."

Patient eligibility for the premature infants in the MedImmune-sponsored study used the criteria outlined in the American Academy of Pediatrics (AAP) Red Book.

"Cost effectiveness analyses are used to appraise the value and worth of a product or technology," said Parthiv Mahadevia, MD, MPH, study co-author and senior health economist and outcomes researcher at MedImmune. "The model was based on Synagis' impact on RSV hospitalization, which was the primary endpoint in the Synagis Phase III randomized controlled trials supporting FDA product approval.  The conclusion of this model found that palivizumab, when dosed consistent with the FDA-approved labeling, monthly throughout the RSV season, was either cost-saving or cost-effective for guideline-eligible infants."

RSV is the most common respiratory infection in infancy; approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday.^1,2

In most children, RSV presents mild symptoms similar to the common cold and doesn't require medical attention.

However, certain infants -- particularly premature infants and babies with congenital heart disease (CHD) and chronic lung disease (CLD) of prematurity -- are at increased risk of developing a serious infection from RSV, often requiring hospitalization.^3,4

Serious RSV infection is the leading cause of infant hospitalization in the U.S.,^5,6 and is the cause of one of every 13 pediatrician visits and one of every 38 emergency room trips.⁷

"This published study in the Journal of Medical Economics has several firsts: it is the first to use cost utility methodology for the Medicaid population, which has higher risk of RSV hospitalization; it also stratifies infants by AAP criteria and it also factors in manufacturer rebates. Previous economic analyses did not include any of those data. When these factors are taken into consideration the study found Synagis was cost effectiveness even with full season dosing," said Mahadevia.

Important Safety Information

What is Synagis® (palivizumab)?
Synagis is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children at high risk for severe lung disease from RSV.

Who should not receive Synagis?
Children should not receive Synagis if they have ever had a severe allergic reaction to it. Signs and symptoms of a severe allergic reaction could include: itchy rash; swelling of the face; difficulty swallowing; difficulty breathing; bluish color of the skin; muscle weakness or floppiness; a drop in blood pressure and/or unresponsiveness. If your child has any of these signs or symptoms of a severe allergic reaction after getting Synagis, be sure to tell your child's healthcare provider or get medical help right away.

How is Synagis given?
Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. Your child should receive their first Synagis shot before the RSV season starts to help protect them before RSV becomes active. When RSV is most active, your child will need to receive Synagis shots every 28-30 days to help protect your child from severe RSV disease for about a month. Your child should continue to receive monthly shots of Synagis until the end of RSV season. Your child may still get severe RSV disease after receiving Synagis. If your child has an RSV infection, they should continue to get their monthly shots throughout the season.

The efficacy of Synagis shots given less than monthly throughout the RSV season has not been established.

What are the side effects of Synagis?
Possible, serious side effects include severe allergic reaction which may occur after any dose of Synagis. Such reactions may be life-threatening or cause death. Unusual bruising and/or groups of tiny red spots on the skin have also been reported.

Common side effects of Synagis include fever and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort).

Please see accompanying full prescribing information, including patient information at http://www.synagis.com.

About MedImmune
MedImmune, the global biologics arm for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune's website at www.medimmune.com.

1. Glezen WP, et al. AJDC. 1986; 140: 543 – 546.
2. Centers for Disease Control and Prevention (CDC). Respiratory syncytial virus infection (RSV): frequently asked questions. http://www.cdc.gov/rsv/about/faq.html. Accessed September 26, 2011.;
3. Yeung CY, Hobbs JR. Serum-gamma-G-globulin levels in normal premature, post-mature and "small for dates"newborn babies. Lancet.1968;7557:11 67-11 70.
4. 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
5. Leader S, Kohlhase K. Ped Infec Dis J. 2002;21:629-632.
6. Shay DK, Holman RC, Newman RD, et al. JAMA. 1999;282:1440-1446.
7. Hall CB, Weinberg GA, Iwane MK, et al. N Engl J Med. 2009;360:588-598

SOURCE MedImmune