Subject: Synagis 1988-A SGM P2023a
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indication
Synagis is indicated for the prevention of serious lower
respiratory tract disease caused by respiratory syncytial virus
(RSV) in pediatric patients:
• with a history of premature birth (less than or equal to 35
weeks gestational age) and who are 6 months of age or
younger at the beginning of RSV season,
• with bronchopulmonary dysplasia (BPD) that required
medical treatment within the previous 6 months and who
are 24 months of age or younger at the beginning of RSV
season,
• with hemodynamically significant congenital heart disease
(CHD) and who are 24 months of age or younger at the
beginning of RSV season
Limitations of Use:
The safety and efficacy of Synagis have not been established
for treatment of RSV disease.
B. Compendial Uses
1. RSV prophylaxis in infants with congenital abnormalities
of the airway or neuromuscular disease that compromise
handling of respiratory secretions
2. RSV prophylaxis in immunocompromised pediatric
patients
3. RSV prophylaxis in pediatric patients with cystic fibrosis
who have evidence of chronic lung disease or nutritional
compromise in the first year of life
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Authorization of up to 5 doses per RSV season may be granted
for the prevention of serious lower respiratory tract disease
caused by RSV when a member has any of the following
diagnoses and meets the criteria pertaining to the diagnosis:
1. Prematurity
2. Chronic lung disease (CLD) of prematurity
3. Congenital heart disease (CHD) (See Appendix B)
4. Congenital airway abnormality
5. Neuromuscular condition
6. Immunocompromised children
7. Cystic fibrosis
A. Prematurity
All of the following criteria are met:
1. Member’s gestational age is < 29 weeks, 0 days.
2. Member’s chronological age at the start of RSV season is
< 12 months.
B. CLD of prematurity
ALL of the following criteria must be met:
1. Member’s gestational age is < 32 weeks, 0 days.
2. Requirement for > 21% oxygen for at least the first 28
days after birth.
3. Member meets either of the following criteria:
i. Member’s chronological age at the start of their first
RSV season is < 12 months.
ii. Member’s chronological age at the start of the
subsequent RSV season is < 24 months and the
member continues to require medical support (e.g.,
chronic corticosteroids, diuretic therapy,
supplemental oxygen) during the 6-month period
prior to the start of the RSV season.
C. CHD
All of the following criteria are met:
1. CHD is hemodynamically significant.
2. Member meets either of the following criteria:
i. Member’s chronological age at the start of RSV
season is < 12 months.
ii. Member’s chronological age at the start of RSV
season is between 12 to 24 months and the member
will be undergoing cardiac transplantation during the
RSV season.
D. Congenital airway abnormality
All of the following criteria must be met:
1. The condition compromises handling of respiratory
secretions.
2. Member’s chronological age at the start of RSV season is
< 12 months.
E. Neuromuscular condition
All of the following criteria must be met:
1. The condition compromises handling of respiratory
secretions.
2. Member’s chronological age at the start of RSV season is
< 12 months.
F. Immunocompromised children
All of the following criteria must be met:
1. Member is profoundly immunocompromised during the
RSV season (e.g., SCID, stem cell transplant, bone
marrow transplant)
2. Member’s chronological age at the start of the RSV
season is <24 months
G. Cystic Fibrosis
Either of the following criteria must be met:
1. Member’s chronological age at the start of the RSV
season is < 12 months and the member has evidence of
CLD or nutritional compromise
2. Member’s chronological age at the start of RSV season is
between 12 to 24 months and the member has
manifestations of lung disease (e.g., hospitalizations for
pulmonary exacerbations) or weight for length less than
the 10th percentile
III. OTHER
For all off-season Synagis requests, authorization of 1 dose per
request, up to a maximum of 5 doses per RSV season, may be
granted if the RSV activity for the requested region is ≥ 10%
(with rapid antigen testing) or ≥ 3% (with real-time polymerase
chain reaction (PCR) test) within 2 weeks of the intended dose
according to the CDC National Respiratory and Enteric Virus
Surveillance System (NREVSS).3 The local health department or
the CDC NREVSS will be consulted to assess the RSV activity for
that region or state
(http://www.cdc.gov/surveillance/nrevss/rsv/index.html). Other
Specialty Guideline Management criteria apply.
CVS Caremark PBM Synagis Season will be from November 1st
to March 31st. Other health plans may differ.
IV. EXCLUSIONS
Coverage will not be provided for members who have received
Beyfortus (nirsevimab-alip) in the same RSV season.
V. APPENDIX
Appendix A: Recommended Use of Synagis for Prevention
of RSV Infection
Recommendations from the American Academy of Pediatrics for
the prevention of RSV infection with Synagis are summarized in
Table below.2 Synagis should be administered intramuscularly at
a dose of 15 mg/kg once per month beginning prior to the onset
of the RSV season,1,2 which typically occurs in November.2
Because 5 monthly doses of Synagis will provide more than 6
months of serum Synagis concentrations above the desired
serum concentration for most infants, administration of more
than 5 monthly doses is not recommended within the continental
United States.2
Table. Recommended Use of Synagis for Prevention of RSV Infection
|
Prematurity
|
• Preterm infants born < 29 weeks, 0 days of gestation who are younger than 12
months at the start of the RSV season
|
|
Congenital Heart
Disease
|
• Infants and children < 12 months of age with hemodynamically significant CHD
• Those most likely to benefit from prophylaxis include:
º Infants with acyanotic heart disease who are receiving medication to control
congestive heart failure and will require cardiac surgical procedures
º Infants with moderate to severe pulmonary hypertension
• Infants and children < 24 months of age who undergo cardiac transplantation
during the RSV season
|
|
Chronic Lung Disease
of Prematurity
|
• For the first RSV season during the first year of life:
Preterm infants who develop CLD of prematurity defined as:
º Gestational age < 32 weeks, 0 days AND
º Requirement for > 21% oxygen for at least the first 28 days after birth
• For the second RSV season during the second year of life:
Preterm infants who:
º Satisfy the above definition of CLD of prematurity AND
º Continue to require medical support* for CLD during the 6-month period prior
to the start of the second RSV season
|
|
Congenital Abnormality
of the Airway/
Neuromuscular
Condition
|
• Infants who have either a significant congenital abnormality of the airway or a
neuromuscular condition that compromises handling of respiratory secretions
for the first year of life
|
|
Immunocompromised
children
|
• Children younger than 24 months of age who are profoundly
immunocompromised during the RSV season
|
|
Cystic Fibrosis
|
•For the first year of life, children with clinical evidence of CLD and/or nutritional compromise
•For the second year of life, children with manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable) OR weight for length less than the 10th percentile.
|
Abbreviations: CHD = congenital heart disease; CLD = chronic lung disease (formerly bronchopulmonary dysplasia); RSV = respiratory syncytial virus.
* Medical support includes supplemental oxygen, diuretic therapy, or chronic corticosteroid therapy.
Appendix B: Examples of Congenital Heart Anomalies*
• Atrial or ventricular septal defect
• Patent ductus arteriosus
• Coarctation of aorta
• Tetralogy of Fallot
• Pulmonary or aortic valve stenosis
• D-Transposition of great arteries
• Hypoplastic left/right ventricle
• Truncus arteriosus
• Total anomalous pulmonary venous return
• Tricuspid atresia
• Ebstein’s anomaly
• Pulmonary atresia
• Single ventricle
• Double-outlet right ventricle
*Must be hemodynamically significant. See Table above for examples of infants and children who are most likely to benefit from Synagis.
Place of Service:
Outpatient
The above policy is based on the following references:
- Synagis [package insert]. Waltham, MA: Sobi Inc; November 2021.
- American Academy of Pediatrics. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. 2014;134(2):415-20.
- Rose EB, Wheatley A, Langley G, Gerber S, Haynes A. Respiratory Syncytial Virus Seasonality — United States, 2014–2017. MMWR Morb Mortal Wkly Rep 2018;67:71–76. DOI: https://dx.doi.org/10.15585/mmwr.mm6702a4. Accessed April 28, 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
November 20, 2023
