October 10, 2018
Synagis® - Information for 2018-2019

Applicable to: Mercy Care Complete Care, Mercy Care RBHA, Mercy Care Long Term Care and Division of Developmental Disabilities
In preparation for the 2018/2019 RSV season we would like to take this opportunity to answer some common questions regarding our approval guidelines for Synagis ® . These guidelines are based on the 2012 American Academy of Pediatrics (AAP) Red Book criteria and recent updated guidance by the AAP Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. RSV season typically begins on November 1st and continues through March of the following year. The end of the RSV season will be determined by rates of positive viral cultures at regional reference labs and via communication with regional specialists. The AAP recommends a maximum of 5 doses during RSV season, and some children will receive less than 5 doses.

Please note that Synagis® does not completely prevent RSV disease but has been shown to reduce the risk of hospitalization attributed to RSV lower respiratory tract disease. Please continue to encourage all of your families with young children to practice good hygiene, avoid crowds during the winter season, and to obtain all of the recommended immunizations, including influenza.

Criteria for Synagis ® prophylaxis:
  • Infants in the first year of life born before 29 weeks 0 days’ gestation
  • Children in the first year of life with chronic lung disease (CLD) of prematurity (formerly known as bronchopulmonary dysplasia or BPD) defined as birth at less than 32 weeks 0 days’ gestation and a requirement for more than 21% oxygen for at least 28 days after birth
  • Children in the second year of life who have CLD of prematurity and required supplemental oxygen for at least 28 days after birth and who continue to require medical therapy (supplemental oxygen, bronchodilator, diuretic, or corticosteroids) for the CLD
  • Children in the first year of life with hemodynamically significant congenital heart disease (CHD), including:  
  • infants with cyanotic heart disease
  • infants with moderate to severe pulmonary hypertension
  • infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures
  • Children younger than 2 years who undergo cardiac transplantation during the RSV season

**Additional circumstances for which Synagis ® prophylaxis may be considered:
  • Children in the first year of life with anatomical abnormalities of the airways/respiratory system or neuromuscular condition that impairs the ability to clear respiratory secretions from the upper airways
  • Children younger than 24 months who will be profoundly immunocompromised during the RSV season (e.g., severe combined immunodeficiency or severe acquired immunodeficiency syndrome, acute myeloid leukemia/acute lymphoblasticleukemia, hematopoieticstem cell transplant recipients

Please Note:
  • All families should be educated about ways to reduce exposure, thorough hand washing, good hygiene, and avoiding overcrowded places.
  • CLD does NOT include children with a diagnosis of asthma.
  • Hemodynamically significant CHD does NOT include:
  • infants and children with hemodynamically insignificant heart disease (e.g., secundum atrial septal defect, small ventricular septal defect, pulmonicstenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus).
  • infants with lesions adequately corrected by surgery who do not continue to require medication for congestive heart failure.
  • infants with mild cardiomyopathy who are not receiving medical therapy for the condition.
  • children the second year of life not undergoing cardiac transplantation.
  • There has not been a recommendation established to administer RSV prophylaxis to children with cystic fibrosis (CF).
  • If any infant or young child receiving monthly palivizumab prophylaxis experiences abreakthrough RSV hospitalization, monthly prophylaxis should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season(<0.5%).

What information must be included with a request?
The Synagis Prior Authorization Form can also be found on the Mercy Care Plan website by clicking on the link.

Where should I submit requests for Synagis ® ?
Please Fax the completed form to Los Niños at 602-424-2149 for all are as except those not located near a Los Niños Synagis ® clinic. Los Niños will coordinate and administer the medication.
For areas not near to a Los Niños Synagis ® clinic, such as Sierra Vista/Douglas, please fax the completed form to CVS/Caremark Specialty Pharmacy at 1-800-323-2445 to obtain the medication for administration in your office. The contact number for providers is 1-800-238-7828, option 6.

If you have any questions, please call Mercy Care Plan at 602-263-3000 and follow the prompt to the PA queue line.
Thank you for your participation and for the quality care you provide to our members.

American Academy of Pediatrics. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

AAP Committeeon Infectious Diseases and Bronchiolitis Guidelines Committee Pediatrics 2014;134;415 http://pediatrics.aappublications.org/content/134/2/415

American Academy of Pediatrics Red Book: 2012 Report of the Committee on Infectious Diseases. Pickering LK, ed. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

Aetna clinical policy bulletin 0318 http://www.aetna.com/cpb/medical/data/300_399/0318.html