(BPT) - “The size of a soda pop can,” is how Crystal and Marshall Diehl describe their daughter Audrey’s tiny, 12-ounce body, when she was born 15 weeks premature in March 2010. With the odds stacked against her, little Audrey made great strides to grow and develop during her 93-day stay in the Neonatal Intensive Care Unit (NICU) in Duluth, Minnesota where the Diehls lived. When Audrey’s parents were finally allowed to bring her home, they were warned that although Audrey had grown significantly and appeared healthy, preterm birth impacts the functioning of many internal organs and is associated with increased health risks.
There are an alarming number of preterm births in the US, with more than half a million babies born prematurely (before 37 weeks gestation) each year.1 Preemies have underdeveloped lungs and a lesser amount of the vital antibodies needed to stave off infections, often requiring specialized medical attention. Because of this, they are not as well-equipped as full-term babies to fight off common viruses, such as RSV (respiratory syncytial virus).2,3
RSV is a very common and contagious, seasonal virus that occurs in epidemics each fall through spring.4 The virus is spread very easily through coughing, sneezing and touching, and is contracted by nearly 100% of children by age 2.5,6,7 In most babies, symptoms of RSV disease often mimic the common cold, but RSV can lead to a severe lower respiratory tract infection, often requiring hospitalization.2,3,8 In fact, severe RSV disease is the leading cause of hospitalization for babies during the first year of life, resulting in up to 125,000 infants hospitalized each year in the US.9,10,11
RSV usually causes mild to moderate cold-like symptoms, but in some infants it can cause a serious lung infection.2,3 Signs and symptoms of RSV disease that parents should not ignore include: persistent coughing or wheezing; rapid, difficult or gasping breaths; blue color on the lips, mouth or fingernails; and a fever.5,6
The Diehls were told about Audrey’s increased risk for severe RSV disease while in the NICU, and as soon as she arrived home, they took every precaution they had learned to keep her safe. This included keeping Audrey secluded as much as possible, limiting visitors (especially children, who tend to carry germs) and ensuring that anyone who came into contact with Audrey had washed their hands.12
Audrey’s doctors explained that for certain babies at high risk of developing severe RSV disease, a preventive medication was also available to help protect against the infection. Synagis® (palivizumab) is an FDA-approved medication that provides virus-fighting substances called antibodies that help prevent severe RSV disease.13 Monthly dosing throughout the RSV season can help prevent RSV-related hospitalization in high-risk babies; therefore, it’s important to get the shot every 28-30 days during the RSV season.13
Following the doctor’s recommendations, Audrey’s parents applied for monthly Synagis injections to help protect her during the RSV season, which would begin in November 2010 when Audrey was just six months old. Without explanation, however, Audrey was denied coverage.
“Marshall and I couldn’t understand why Audrey wasn’t granted access to a medicine the doctor prescribed to help keep her safe from a virus that could be so dangerous to her vulnerable lungs," said Crystal Diehl.
Oftentimes, cost is cited as a reason insurance companies deny coverage of Synagis. But denying a high-risk infant a full series of monthly doses can put a baby at risk of costly RSV-related hospitalization.13
Knowing it was vital for Audrey to receive Synagis, Crystal and Marshall called their insurer every day for weeks. “I was in tears during countless calls to the insurance company because I knew she needed the medication,” said Crystal. “My doctor said if Audrey developed severe RSV disease, she could have been hospitalized.”
With support from doctors, nurses, and hospital and union representatives, the insurance company agreed to cover Synagis shots for Audrey after weeks of pressure. While her family’s story has a happy ending, Crystal wants to make sure other parents are aware of RSV and know that they too can speak up and be an advocate for their child’s health.
“Parents of preemies need to be informed about the dangers of severe RSV disease,” said Crystal. “If there’s a chance your child may be at high risk, it’s very important to ask a doctor if they may be eligible for Synagis this RSV season.”
For more information on RSV and Synagis, please visit Synagis.com. To learn more about Synagis reimbursement and MedImmune’s assistance programs, please call 1-877-480-8082.
MedImmune’s Access 360 team is dedicated to helping patients gain access to Synagis. Access 360 offers patients and their providers support in understanding and addressing coverage and reimbursement barriers.
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 them 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 RSV season to help prevent severe disease from new RSV infections.
The effectiveness 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).
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2 Yeung CY, Hobbs JR. Serum-gamma-G-globulin levels in normal premature, post-mature and ?small for dates? newborn babies. Lancet.1968;7557:1167-1170.
3 Langston C, Kida K, Reed M et al. Human lung growth in late gestation and in the neonate. Am Rev Respir Dis. 1984;129:607-613.
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10 Shay KD et al. Bronchiolitis-Associated Mortality and Estimates of Respiratory Syncytial Virus-Associated Deaths among US Children, 1979-1997. JID 2001;183:16-22
11 Stockman LJ, Curns AT et al. Respiratory Syncytial Virus-associated Hospitalizations Among Infants and Young Children in the United States, 1997–2006. Ped Infect Dis J 2012;31(1):5-9.
12 CDC “Transmission and Prevention” available at http://www.cdc.gov/rsv/about/transmission.html. Access August 22, 2012.
13 SYNAGIS (palivizumab) for Intramuscular Use. MedImmune LLC. RAL-SYNV15.April 2012.
