Immune Prophylaxis for Respiratory Syncytial Virus (RSV)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 29, 2019

Description

Palivizumab (Synagis)is a humanized monoclonal antibody produced by recombinant DNA technology directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV).

RSV causes acute upper respiratory tract infection in individuals of all ages and is one of the most common diseases of childhood.Most RSV-infected infants experience upper respiratory tract symptoms, and 20% to 30% develop lower respiratory tract disease with their first infection.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Immune prophylaxis with palivizumab (Synagis) for a maximum of five (5) doses within the RSV season (typically November through April) may be considered medically necessary for passive immunoprophylaxis against RSV when ANY of the following criteria are met:

 

  • Infants with preterm birth less than 29 weeks 0 days gestation less than or equal to 12 months of age at the start of the RSV season; or
  • Certain infants less than or equal to 12 months of age, born at less than 32 weeks 0 days with chronic lung disease (CLD) defined as a greater than 21% oxygen requirement for at least the first 28 days after birth; or
  • Children younger than 12 months of age with hemodynamically significant congenital heart disease who are most likely to benefit from immunoprophylaxis which include:
    • Infants who are receiving medication to control congestive heart failure and will require cardiac surgical procedures; or
    • Infants with moderate to severe pulmonary hypertension; or
    • Infants with cyanotic heart disease; or
  • Children less than or equal to 12 months of age born with congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions; or
  • Children younger than 24 months of age who are profoundly immunocompromised during the RSV season; or
  • Children younger than 24 months of age who are undergoing cardiac transplantation; or
  • An infant with cystic fibrosis with clinical evidence of CLD or nutritional compromise in the first year of life; the continued use of palivizumab (Synagis) prophylaxis in the second year of life may be considered medically necessary for infants with cystic fibrosis for EITHER of the following:
    • With symptoms of severe lung disease; e.g. (previous hospitalization for pulmonary exacerbation in the first year of life or an abnormal chest radiograph, computed tomography scan that persist when stable); or
    • Weight or length less than the 10th percentile.

Procedure Codes

90378

NOTE: Prophylaxis is not recommended in the second year of life on the basis of a history of prematurity alone.Prophylaxis may be considered medically necessary during the RSV season during the second year of life only for infants who meet the definition of chronic lung disease prematurity and continue to require medical support (chronic corticosteroid therapy, diuretic therapy or supplemental oxygen).

NOTE: An additional dose of palivizumab (Synagis) may be considered medically necessary for children in approved course of treatment who undergo cardiopulmonary bypass (as soon as possible after surgery even if next dose is not due based upon standard schedule) if any other medically necessary criteria are present (for example, prematurity).

Palivizumab (Synagis) for any other indication, it is considered experimental/investigational and therefore, non-covered. Available scientific evidence does not support its use for any other indication.

Procedure Codes

90378

The following groups of infants are not at increased risk of RSV:

  • Infants and children with hemodynamically insignificant heart disease (e.g., secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus); and
  • Infants with lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure; and
  • Infants with mild cardiomyopathy who are not receiving medical therapy for the condition; and
  • Children in second year of life who do not otherwise meet criteria above; and
  • Primary asthma or asthma prevention to reduce subsequent episodes of wheezing; and
  • Continued RSV prophylaxis children who experience breakthrough RSV hospitalization; and
  • For treatment in children or infants with known RSV disease; and
  • For all other indications not otherwise addressed as medically necessary, including, but not limited to, individuals with cystic fibrosis or Down syndrome who do not otherwise meet criteria above.

Palivizumab (Synagis) for any other indication, it is considered experimental/investigational and therefore, non-covered. Available scientific evidence does not support its use for any other indication.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

American Academy of Pediatrics

In 2014 the American Academy of Pediatrics published updated guidelines on palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Relevant recommendations include:

  • Palivizumab prophylaxis may be administered to infants born before 29 weeks, 0 days' gestation who are younger than 12 months at the start of the RSV season. For infants born during the RSV season, fewer than 5 monthly doses will be needed.
  • Prophylaxis is not recommended for otherwise healthy infants born at 29 weeks, 0 days' gestation or later. Infants 29 weeks, 0 days' gestation or later may qualify to receive prophylaxis on the basis of congenital heart disease (CHD), chronic lung disease (CLD), or another condition.
  • Palivizumab prophylaxis is not recommended in the second year of life on the basis of a history of prematurity alone.
  • Prophylaxis may be considered during the RSV season during the first year of life for preterm infants who develop CLD of prematurity defined as gestational age <32 weeks, 0 days and a requirement for >21% oxygen for at least the first 28 days after birth.
  • During the second year of life, consideration of palivizumab prophylaxis is recommended only for infants who satisfy this definition of CLD of prematurity and continue to require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the start of the second RSV season.
  • For infants with CLD who do not continue to require medical support in the second year of life prophylaxis is not recommended.
  • Children with hemodynamically significant CHD who are most likely to benefit from immunoprophylaxis include infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension.
  • Hospitalization rates attributable to RSV decrease during the second RSV season for all children. A second season of palivizumab prophylaxis is recommended only for preterm infants born at <32 weeks, 0 days' gestation who required at least 28 days of oxygen after birth and who continue to require supplemental oxygen, chronic systemic corticosteroid therapy, or bronchodilator therapy within 6 months of the start of the second RSV season.
  • Because 5 monthly doses of palivizumab will provide more than 6 months (>24 weeks) of serum palivizumab concentrations above the desired level for most children, administration of more than 5 monthly doses is not recommended within the continental United States. 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. If prophylaxis is initiated in October, the fifth and final dose should be administered in February, which will provide protection for most infants through March. If prophylaxis is initiated in December, the fifth and final dose should be administered in April, which will provide protection for most infants through May.
  • Qualifying infants born during the RSV season may require fewer doses. For example, infants born in January would receive their last dose in March.
  • Hospitalized infants who qualify for prophylaxis during the RSV season should receive the first dose of palivizumab 48 to 72 hours before discharge or promptly after discharge. If an infant or child who is receiving palivizumab immunoprophylaxis experiences a breakthrough RSV infection, monthly prophylaxis should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season.
  • On the basis of the epidemiology of RSV in Alaska, particularly in remote regions where the burden of RSV disease is significantly greater than the general US population, the selection of Alaska Native infants eligible for prophylaxis may differ from the remainder of the United States. Clinicians may wish to use RSV surveillance data generated by the state of Alaska to assist in determining onset and end of the RSV season for qualifying infants. Limited information is available concerning the burden of RSV disease among American Indian populations. However, special consideration may be prudent for Navajo and White Mountain Apache infants in the first year.
  • Limited data suggest a slight increase in RSV hospitalization rates among children with Down syndrome. However, data are insufficient to justify a recommendation for routine use of prophylaxis in children with Down syndrome unless qualifying heart disease, CLD, airway clearance issues, or prematurity (29 weeks, 0 days' gestation).

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code 90378 When Reported With Primary Diagnosis Code Z29.11

D72.810 D80.0 D80.1 D80.2 D80.3 D80.4 D80.5
D80.6 D80.7 D80.8 D80.9 D81.0 D81.1 D81.2
D81.89 D81.9 D83.0 D83.2 D83.8 D83.9 D84.8
D84.9 D86.0 D86.1 D86.2 D86.3 D86.81 D86.82
D86.83 D86.84 D86.85 D86.86 D86.87 D86.89 D86.9
D89.0 D89.1 D89.2 D89.3 D89.40 D89.41 D89.42
D59.43 D89.49 D89.810 D89.811 D89.812 D89.813 D89.82
D89.89 D89.9 E84.0 E84.11 E84.19 E84.8 E84.9
I27.0 I27.1 I27.20 I27.21 I27.22 I27.23 I27.24
I27.29 I27.81 I27.82 I27.83 I27.89 I27.9 I50.20
I50.21 I50.22 I50.23 I50.30 I50.31 I50.32 I50.33
I50.40 I50.41 I50.42 I50.43 I50.810 I50.811 I50.812
I50.813 I50.814 I50.82 I50.83 I50.84 I50.89 I50.9
P07.21 P07.22 P07.23 P07.24 P07.25 P07.26 P07.31
P07.32 P07.33 P07.34 P07.35 P07.36 P07.37 P07.38
P27.1 Q20.0 Q20.1 Q20.2 Q20.3 Q20.4 Q20.5
Q20.6 Q20.8 Q20.9 Q21.0 Q21.1 Q21.2 Q21.3
Q21.4 Q21.8 Q21.9 Q22.0 Q22.1 Q22.2 Q22.3
Q22.4 Q22.5 Q22.6 Q22.8 Q22.9 Q23.0 Q23.1
Q23.2 Q23.3 Q23.4 Q23.8 Q23.9 Q24.0 Q24.1
Q24.2 Q24.3 Q24.4 Q24.5 Q24.6 Q24.8 Q24.9
Q25.0 Q25.1 Q25.21 Q25.29 Q25.3 Q25.40 Q25.41
Q25.42 Q25.43 Q25.44 Q25.45 Q25.46 Q25.47 Q25.48
Q25.49 Q25.5 Q25.6 Q25.71 Q25.72 Q25.79 Q25.8
Q25.9 Q26.0 Q26.1 Q26.2 Q26.3 Q26.4 Q26.5
Q26.6 Q26.8 Q26.9 Q33.0 Q33.2 Q33.3 Q33.4
Q33.6 Z48.21 Z94.0 Z94.1 Z94.2 Z94.3 Z94.4
Z94.81 Z94.84

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