AmeriHealth is announcing the Synagis^® (palivizumab) distribution program for the 2015-2016 respiratory syncytial virus (RSV) season, which is November through March in the northeastern United States. RSV is the most common cause of bronchiolitis and pneumonia among children younger than one year.

During the RSV season, AmeriHealth will approve the monthly administration of Synagis^® (palivizumab) for infants and children, in accordance with the current recommendations from the American Academy of Pediatrics (AAP). These recommendations are subject to change based on updated recommendations as outlined in the AAP policy statement and Red Book^®.

Medical necessity criteria for coverage

Synagis^® (palivizumab) is a humanized monoclonal antibody that provides passive immunity against RSV. It is intended to decrease the morbidity and mortality associated with RSV lower respiratory tract disease in high-risk infants and children.

Immune prophylaxis using Synagis^® (palivizumab) is considered medically necessary and covered for a maximum of five doses during the RSV season for infants and children who have any of the following high-risk conditions (according to the AAP criteria):

• chronic lung disease (CLD) of prematurity;
• history of preterm birth (born before 29 weeks, 0 days) for infants who are younger than 12 months at the start of the RSV season;
• congenital heart disease;
• severe neuromuscular disease;
• congenital abnormalities of the airway;
• cystic fibrosis with nutritional compromise and/or CLD;
• immunocompromised status (e.g., due to transplantation or chemotherapy).

An additional postoperative dose of Synagis^® (palivizumab) is considered medically necessary and covered for infants or children younger than 24 months who are medically stable, meet any of the AAP criteria for immune prophylaxis, and have undergone one of the following procedures during RSV season:

• surgical procedures that use cardiopulmonary bypass;
• cardiac transplantation.

If an infant or child receiving monthly prophylaxis with Synagis^® (palivizumab) experiences a breakthrough RSV hospitalization, then continued monthly prophylaxis with Synagis^® (palivizumab) is not considered medically necessary due to the low likelihood of a second RSV hospitalization during the same season.

Synagis^® (palivizumab) is not effective in the treatment of RSV disease, and it is not approved for this indication.

How to obtain Synagis^® (palivizumab) for office use

Synagis^® (palivizumab) is covered under the member?s medical benefit. For the 2015-2016 RSV season, it is mandatory for all participating providers to obtain Synagis^® (palivizumab) through ACRO Pharmaceutical Services.

The following guidelines apply when ordering Synagis^® (palivizumab):

• The RSV Enrollment Form must include sufficient clinical information to meet our Synagis^® (palivizumab) medical policy criteria, which are based on current AAP recommendations.
• Providers can go to the ACRO Pharmaceutical Services website to download the RSV Synagis Rx Form. Providers should fax completed forms to 1-877-381-3806.
• Since AmeriHealth pays ACRO Pharmaceutical Services directly, providers neither pay for doses ordered through ACRO Pharmaceutical Services nor receive reimbursement for the actual pharmaceutical.
• Synagis^® (palivizumab) will generally be approved for office administration only, unless a patient is receiving home nursing services for a separate indication.
• Upon approval of the request, Synagis^® (palivizumab) will be shipped to the provider?s office monthly during RSV season. Shipping for the 2015-2016 RSV season begins on Wednesday, October 28, 2015, through Thursday, March 31, 2016. Up to five doses (one dose every 30 days) will be shipped per member.

To learn more

Review Medical Policy #08.00.22l: Immune Prophylaxis for Respiratory Syncytial Virus (RSV) to learn more. Visit our Medical Policy Portal, select Accept and Go to Medical Policy Online, select the Commercial tab, and then type the policy name or number in the Search field.

Note: MedImmune, LLC, the makers of Synagis^® (palivizumab), has a voluntary program called RSV Connection^?. However, AmeriHealth does not participate in this program.