Subject: Synagis 1988-A SGM P2024a
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 ≥ 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).
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/nrevss/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. Synagis should be administered
intramuscularly at a dose of 15 mg/kg once per month beginning prior to the onset of the RSV
season, which typically occurs in November. 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.
Table. Recommended Use of Synagis for Prevention of RSV Infection
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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:
° Infants with acyanotic heart disease who are receiving medication to control
congestive heart failure and will require cardiac surgical procedures
° 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
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• For the first RSV season during the first year of life:
Preterm infants who develop CLD of prematurity defined as:
° Gestational age < 32 weeks, 0 days AND
° 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:
° Satisfy the above definition of CLD of prematurity AND
° 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
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• 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 May 20, 2024.
- Bernstein D. Epidemiology and Genetic Basis of Congenital Heart Disease. In: Kliegman RM, St. Geme J. Nelson Textbook of Pediatrics, Edition 21. Chap. 451. Philadelphia, PA: Elsevier; 2020. Accessed April 28, 2023.
- Midgley CM, Haynes AK, Baumgardner JL, et.al. Determining the Seasonality of Respiratory Syncytial Virus in the United States: The Impact of Increased Molecular Testing. The Journal of Infectious Disease. 1 August 2017; 216(3): 345-355.
- American Academy of Pediatrics. Updated Guidance: Use of Palivizumab Prophylaxis to Prevent Hospitalization From Severe Respiratory Syncytial Virus Infection During the 2022-2023 RSV Season. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/. Updated November 17, 2022. Accessed May 21, 2024.
- Hamid, Sarah et al. Seasonality of Respiratory Syncytial Virus – United States, 2017-2023. MMWR Morb Mortal Wkly Rep 2023; 72:355-361. DOI: http://dx.doi.org/10.15585/mmwr.mm7214a1
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 03, 2024
