Medical Policy: 05.01.08
Original Effective Date: September 1998
Reviewed: July 2015
Revised: September 2014
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Wellmark Blue Cross and Blue Shield has contracted with Hy-Vee Pharmacy Solutions (HPS) as our preferred specialty pharmacy vendor for Synagis® for the 2014-2015 respiratory syncytial virus (RSV) season. Effective immediately, all network providers will be required to obtain Synagis through one of our two specialty pharmacy vendors (HPS or CVS Caremark, with HPS being preferred) for the 2014-2015 RSV season.
Synagis will still require prior authorization (PA); Wellmark's PA criteria will continue to follow the recommendations of the American Academy of Pediatrics (AAP), which were most recently published in the July 2014 issue of Pediatrics. Wellmark's pharmacy benefit manager, Catamaran, will continue to review all PA requests to ensure that the criteria is met.
The following is a general outline of how Synagis can be requested and obtained for the 2014-2015 RSV season, with HPS as the preferred specialty pharmacy vendor:
- Provider identifies a Wellmark member who may benefit from Synagis immunoprophylaxis this season.
- Provider completes the Wellmark/HPS Synagis enrollment form (link provided under Prior Approval section below) and faxes to HPS at (866) 823-9966 with any additional supporting clinical documents (e.g., care notes, NICU discharge summary, etc.).
- HPS staff works directly with Catamaran in determining whether the member qualifies for Synagis treatment per Wellmark's PA criteria.
- If the member qualifies for Synagis therapy (as outlined in the Policy section below), HPS will make contact with the provider and member to coordinate delivery and monthly shipments.
Many benefits can be realized by utilizing HPS for Synagis acquisition this RSV season.
Providers receive the added benefit of:
- Integrated coordination and communication of the Synagis prior authorization (PA) process through HPS
- Decreased administrative and financial burden of acquiring, storing, and billing Synagis
- Convenient Synagis delivery to the office or patient's home, as requested.
- Coordination of home health nurse visits when a patient requires Synagis injections in the home
- Automatic coordination of monthly injections to maximize patient adherence
- Case management services to monitor dosage and patient adherence
- A direct HPS support line for questions relating to the procurement of Synagis: (866) 823-9868
Eligible members will:
- Potentially incur less out-of-pocket expense for Synagis as a result of the contracted rate with HPS (depending on the member's benefit design)
- Have access to convenient Synagis delivery to their home or provider's office. Home health nurse visits can be arranged to provide Synagis within the member's home.
- Receive automatic coordination of refills to ensure monthly injections are received in a timely manner
- Receive assistance from HPS in determining insurance benefits, enabling them to better anticipate the out-of-pocket costs associated with Synagis therapy. Additionally, HPS will help identify patient assistance programs for those who may be eligible.
- Have access to a 24/7 telephone line to an RSV clinical specialist for Synagis-related questions/concerns
- Receive a customized RSV/Synagis® Wellness Kit
The intent of the Synagis® (palivizumab) drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies. Synagis is a recombinant humanized monoclonal antibody which exhibits neutralizing and fusion-inhibitory activity against respiratory syncytial virus (RSV). Synagis is approved by the Food and Drug Administration (FDA) for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients considered to be high risk for developing complications from RSV disease. Safety and efficacy were established in infants with bronchopulmonary dysplasia ([BPD], now more commonly referred to as chronic lung disease of prematurity [CLD]), infants with a history of premature birth and children with hemodynamically significant congenital heart disease (CHD). The primary benefit of immunoprophylaxis with Synagis is a reduction in RSV related hospitalizations; no prospective, randomized controlled trials have demonstrated a significant reduction in mortality or long-term respiratory outcomes. The safety and efficacy of Synagis have not been established for the treatment of RSV disease. Synagis is administered by intramuscular injection at a dose of 15 mg/kg once every 30 days during RSV season.
Prior approval is required. Submit a prior approval/treatment request now .
I. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in infants who were born at less than 29 weeks' gestation (28 weeks, 6 days and earlier) AND who are younger than 12 month of age at the onset of RSV season.
Approval will be for a maximum of 5 doses.
II. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in preterm infants and children born before 32 weeks gestation (31 weeks, 6 days and earlier) with chronic lung disease of prematurity (CLD) defined as a greater than 21% oxygen requirement for at least 28 days after birth when the following criteria are met:
- The patient is younger than 12 months of age at the onset of RSV season
- The patient is younger than 24 months of age at the start of RSV season AND has required medical therapy (e.g. supplemental oxygen, bronchodilators, diuretics, corticosteroid therapy) in the 6 months prior to the start of the second RSV season
Approval will be for a maximum of 5 doses.
III. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in infants and children with congenital heart disease (CHD) who are less than 12 months of age at the onset of RSV season when the following criteria are met:
- The patient has a diagnosis of hemodynamically significant congenital heart disease (CHD) including ONE the following:
- Acyanotic heart disease for which the patient is receiving medication to treat congestive heart failure AND will require cardiac surgical procedures
- Moderate to severe pulmonary hypertension
- Cyanotic heart disease - in consultation with a pediatric cardiologist
Approval will be for a maximum of 5 doses.*
*For children with heart disease meeting the above criteria, an additional postoperative dose of palivizumab may be considered medically necessary following cardiopulmonary bypass or the conclusion of extracorporeal membrane oxygenation.
IV. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in infants and children younger than 24 months of age at the onset of RSV season that have undergone cardiac transplantation during RSV season.
Approval will be for a maximum of 5 doses
V. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in infants with congenital abnormalities of the airways or neuromuscular disease that compromises the handling of secretions when the patient is younger than 12 months of age at the onset of RSV season.
Approval will be for a maximum of 5 doses.
VI. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in infants and children younger than 24 months of age who are profoundly immunocompromised (e.g. including those who have undergone solid organ transplant, hematopoietic stem cell transplant, receving chemotherapy) during the RSV season.
Approval will be for a maximum of 5 doses.
VII. Synagis® (palivizumab) may be considered medically necessary for use as immunoprophylaxis for RSV in infants and children with a diagnosis of cystic fibrosis and meet the following criteria:
- The patient is less than 12 months of age at the onset of RSV season and have ONE of the following:
- Clinical evidence of CLD
- Nutritional compromise
- The patient is less than 24 months of age at the onset of RSV season and have ONE of the following:
- Manifestations of severe lung diease defined as a previous hospitalization for pulmonary exacerbation in the first year of life or an abnormal chest radiography or chest computed tomography that persist when stable
- Weight for length less than 10th percent
VIII. Synagis is considered not medically necessary for patients who do not meet the criteria set forth above.
Each year in the United States an estimated 75,000 to 125,000 infants and susceptible toddlers are hospitalized for RSV related illness and 200-400 deaths are attributed to RSV. Hospitalization rates are highest in the first year of life, occurring at annual rates of 16.9 per 1000 for infants in the 0-5 month age range, and 5.1 per 1000 for those in the 6-11 month age range. In addition to hospitalizations, RSV illness results in a significant number of both emergency department and pediatric office visits.
While most children will have been exposed to RSV by the time they reach two years of age, the illness generally manifests as an upper respiratory infection and rarely poses significant harm. Children born premature and those with specific medical conditions have been identified as being most vulnerable to severe RSV infection, which can require hospitalization. Although severe disease occurs more frequently among high risk infants and toddlers, the majority of RSV-related hospitalizations and deaths occur in children without an underlying high-risk condition.
At this time, there is not a vaccine to prevent RSV and treatment primarily involves supportive measures. In the United States, Synagis® (palivizumab) is the only product available as immunoprophylaxis. In studies, palivizumab has been shown to reduce hospitalization rates in high-risk patient populations. According to the two large randomized controlled trials, for which palivizumab approval is based, palivizumab demonstrated a reduction in hospitalization rates by ~50 percent, which was associated with numbers needed to treat (NNT) of 16 (for those born premature), 20 (for those with chronic lung disease of prematurity or CLD), and 23 (for those with hemodynamically significant congenital heart disease or CHD). There is no evidence palivizumab affects mortality associated with RSV infection. Given the high cost of immunoprophylaxis with palivizumab, identifying those most likely to benefit and timing the administration to align with the RSV season is critical to ensure its most cost effective use. The American Academy of Pediatrics (AAP) has established recommendations for palivizumab, defining those most likely to benefit based on the available evidence; their recommendations serve as the foundation for this drug policy. In July 2014 the AAP released updated guidance that was considerably more restrictive in nature. The Academy makes clear their recommendations was not based on cost, but instead “driven by the limited clinical benefit derived from palivizumab prophylaxis”.
In most areas of the United States, the usual time for the beginning of the RSV outbreaks occurs in November/December, peaking in January/February, with outbreaks ending in March/April. RSV season may commence earlier or persist later in certain communities. Variations in the timing and intensity of RSV from season to season and among different communities may arise from several factors including weather conditions that affect virus virility, and population factors such as population density and immunity, which may affect the likelihood of transmission.
Regardless of the month when the first dose is administered, the AAP guidelines make clear the recommendation for a maximum of 5 doses for the entire RSV season. Results from clinical trials indicate that 5 monthly doses provide more than 6 months of protective serum antibody concentration, which provides adequate coverage for an RSV season. Specifically, the AAP states the following: ”For qualifying infants who require 5 doses, a dose beginning in November and continuation for a total of 5 monthly doses will provide protection for most infants through April and is recommended for most areas of the United States.”. Administration of more than 5 monthly doses is NOT recommended within the continental United States.
Due to the small probability of a second RSV hospitalization occuring in the same season (<0.5%), immunoprophylaxis with Synagis should be discontinued in any infant or child who experiences a breakthrough RSV hospitalization.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 90378 Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular use, 50 mg, each
- Synagis® (palivizumab) [package insert]. Gaithersburg, MA: MedImmune, Inc; April 2012.
- American Academy of Pediatrics (AAP) Red Book 2012. Report of the Committee on Infectious Diseases. Respiratory Syncytial Virus Chapter. 29th Ed. Elk Grove Village, IL: AAP; 2012. Accessed on August 10, 2012. Available at: http://aapredbook.aappublications.org/content/1/SEC131/SEC249.body?sid=1ecd49df-e50b-43c1-b104-cf8b694d8f1b. Accessed on August 10, 2012.
- Langley GF, Anderson LJ. Epidemiology and prevention of respiratory syncytial virus infections among infants and young children. Pediatr Infect Dis J. 2011; 30(6): 510-517.
- Policy Statement - Modified recommendations for the use of palivizumab for prevention of respiratory syncytial virus infection. Committee on Infectious Diseases. Pediatrics. 2009; 124: 1694-1701.
- Feltes TF, Cabalka AK, Meissner C, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003:143(4):532-540.
- The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102(3):531-537.
- American Academy of Pediatrics (AAP). Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics. 2014; 134(2):415-420.
Date Reason Action
September 2010 Annual review Policy renewed
October 2011 Annual review Policy renewed
August 2012 Annual review Policy renewed
July 2013 Annual review Policy renewed
September 2014 Annual review Policy revised
July 2015 Annual review Policy renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.