ModifiedAnthemPolicy CC-0007

Synagis (palivizumab) for RSV prophylaxis

Clinical criteria governing medical-benefit coverage and prior authorization approval of Synagis (palivizumab) for prevention of serious lower respiratory tract disease caused by RSV in pediatric patients, including dosing limits, seasonality, and contraindications relative to newer RSV monoclonal alternatives.

Policy Summary

PayerAnthem

PolicySynagis (palivizumab) for RSV prophylaxis

Policy CodePolicy CC-0007

Change TypeAdded and revised criteriacoding updates

Effective Date09/10/2025

Next Review Date

Key ActionProviders must document that the patient has not received and does not have access to Beyfortus (nirsevimab) or Enflonsia (clesrovimab-cfor) for the RSV season to qualify for Synagis prior authorization.

SourceLink

POLICY UPDATE CHANGES

Enflonsia (clesrovimab-cfor) was added to the criteria limiting use of Synagis to when alternatives are not accessible.

Updated criteria to require that the individual has not received and does not have access to Beyfortus (nirsevimab) or Enflonsia for the RSV season before Synagis may be approved.

Coding updates: HCPCS S9562 description updated and multiple ICD-10 ranges added/combined (P07.20-P07.26, P07.30-P07.35, P27.0-P27.9, D81.*, E84.*, I27.*, Q22.*, Q23.*, Q33.*, Z94.*, Z29.11).

Maximum 5 dosesSynagis doses per RSV season (standard)

15 mg/kg monthlyQuantity limit / dosing

Nov-MarSeasonality

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Synagis (palivizumab) Coverage Criteria

General pre-authorization prerequisites

Synagis may be approved only when ALL of the following baseline conditions are met:

ALL of the following

Individual has not received Beyfortus (nirsevimab) or Enflonsia (clesrovimab-cfor) for prevention of RSV lower respiratory tract disease for this RSV season.
Individual does not have access to Beyfortus (nirsevimab) or Enflonsia (clesrovimab-cfor) for prevention of RSV lower respiratory tract disease.

First RSV season — infants (maximum 5 doses)

A maximum of 5 doses may be approved during the first RSV season in the first year of life when ANY of the following are met:

ANY of the following

Born before 29 weeks, 0 days gestation (i.e., up to and including 28 weeks, 6 days) and younger than 12 months of age at the start of the RSV season.
Chronic lung disease of prematurity defined as birth at less than 32 weeks, 0 days gestation and requirement for >21% oxygen for at least 28 days after birth (excludes asthma, reactive airway disease, and cystic fibrosis without significant symptoms).
Documentation required.
Hemodynamically significant congenital heart disease (including acyanotic heart disease receiving medication to control congestive heart failure and will require cardiac surgical procedures, and infants with moderate to severe pulmonary hypertension).
Cardiology consultation recommended for cyanotic disease where indicated; documentation required.
Anatomic pulmonary abnormality (e.g., tracheal ring) or neuromuscular condition that impairs ability to clear upper airway secretions due to ineffective cough.
Documentation required.
Cystic fibrosis with clinical evidence of chronic lung disease or nutritional compromise (weight-for-length <10th percentile).
Documentation required.

Second RSV season (maximum 5 doses)

A maximum of 5 doses may be approved for the second RSV season when ALL of the following are met (second season may fall in first or second year of life):

ALL of the following

Preterm infant born at less than 32 weeks, 0 days gestation who required at least 28 days of oxygen after birth.
Continues to require medical intervention within 6 months of the start of the second RSV season, defined as supplemental oxygen, chronic systemic corticosteroid therapy, or diuretics.
Documentation required.

Children younger than 24 months (maximum 5 doses)

A maximum of 5 doses may be approved for children <24 months when ANY of the following are met:

ANY of the following

Profoundly immunocompromised status (examples: severe combined immunodeficiency, advanced AIDS, undergoing organ or hematopoietic stem cell transplant, or absolute lymphocyte count < 100 cells/mm3).
Documentation required.
Undergoing cardiac transplantation.
Documentation required.

Additional dose exception

One additional dose may be approved when ALL of the following are met:

ALL of the following

Child is younger than 24 months and has approval for a course of Synagis treatment.
Child undergoes cardiopulmonary bypass for a surgical procedure.
Single extra dose allowed post-bypass; documentation required.

Seasonality and regional exceptions

Approvals are constrained by RSV season and CDC/local surveillance; exceptions possible:

ANY of the following

Synagis approval is limited to RSV season as determined by CDC surveillance data or local health department.
Up to 5 doses may be approved during November through March (continental U.S. typical).
Initiation or additional doses outside typical season in regions with high interseasonal RSV activity may be approved on a case-by-case basis.

Not approved (exclusions)

Synagis may NOT be approved for any of the following reasons:

ANY of the following

Continued RSV prophylaxis for children who experience breakthrough RSV hospitalization (discontinue prophylaxis).
Treatment of known RSV disease.
Children who reach 24 months of age prior to the beginning of RSV season.
More than two seasons of RSV prophylaxis (unless individual is profoundly immunocompromised or undergoing cardiac transplantation).
Use for primary asthma prevention or to reduce subsequent wheezing episodes.

Key Thresholds / Limits

Dose limit15 mg/kg once monthly (quantity limit)

Maximum doses per RSV seasonUp to 5 doses (one additional dose may be approved post-cardiopulmonary bypass)

Age limitsFirst season: younger than 12 months at start of season for <29w GA criteria; Second season: approvals limited to specified ongoing medical needs and generally <24 months where specified

Immunocompromise lymphocyte countAbsolute lymphocyte count <100 cells/mm3 (example criterion for profound immunocompromise)

Oxygen dependency for CLD>21% oxygen for at least 28 days after birth

Oxygen requirement for second season eligibilityRequired ≥28 days of oxygen after birth and continued medical intervention within 6 months of second season start (supplemental O2, chronic systemic corticosteroids, or diuretics)

Nutritional compromise for CF

Relevant Procedure and Diagnosis Codes

CPTCPT

90378

Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular use, 50 mg, each (Synagis)

HCPCSHCPCS

S9562

Home injectable therapy, palivizumab, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

ICD-10 Diagnosis codes (applicable populations / documentation codes)ICD-10

D81.0-D81.9	Combined immunodeficiencies
E84.0-E84.9	Cystic fibrosis
I27.0-I27.9	Other pulmonary heart diseases
I42.9	Cardiomyopathy, unspecified
I50.9	Heart failure, unspecified
P07.20-P07.26	Extreme immaturity of newborn [less than 28 completed weeks]
P07.30-P07.35	Preterm newborn [28 completed weeks or more but less than 32 completed weeks]
P27.0-P27.9	Chronic respiratory disease originating in the perinatal period
P29.30	Pulmonary hypertension of newborn
Q20.0-Q20.9	Congenital malformations of cardiac chambers and connections

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What Providers Must Do

Prior Authorization

Prior authorization required with alternative-access documentation

Prior authorization is required and providers must document that the patient has not received and does not have access to Beyfortus (nirsevimab) or Enflonsia (clesrovimab-cfor) for this RSV season before Synagis may be approved.

90378
S9562

Documentation Required

Clinical documentation for qualifying conditions

Supply clinical documentation as applicable to support qualifying conditions: gestational age at birth, duration and percent oxygen dependence, evidence of hemodynamically significant congenital heart disease, neuromuscular or anatomic pulmonary abnormalities, cystic fibrosis severity (including weight-for-length percentile), or profound immunocompromised status.

Clinical and Policy Background

Synagis (palivizumab) is an FDA‑approved monoclonal antibody for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in select infants and children. Randomized trials demonstrate reductions in RSV‑related hospitalizations for specific high‑risk pediatric populations; epidemiologic data show the highest risk for severe RSV disease in the presence of recognized risk factors. Synagis remains a covered option when the listed clinical criteria are met and when alternatives are unavailable or inaccessible.

The American Academy of Pediatrics (AAP) has progressively narrowed routine use of palivizumab. The 2014 guidance (reaffirmed in 2019) identified specific high‑risk groups for whom prophylaxis may be beneficial, and the July 2025 AAP guidance states that Synagis is no longer routinely recommended and recommends Beyfortus (nirsevimab) for first‑ and second‑season prophylaxis where appropriate. This policy has been updated to reflect the 2025 AAP guidance and the payer preference for Beyfortus as the primary prophylactic agent.

Because newer monoclonal products have become preferred, Synagis will generally be considered only when Beyfortus (nirsevimab) or Enflonsia (clesrovimab‑cfor) has not been received and is not available to the individual for the RSV season. The document history (8/15/2025) specifically added Enflonsia to the list of alternatives and revised criteria to require documentation that Beyfortus or Enflonsia are not accessible before Synagis may be approved.

Key Defined Terms

RSV seasonThe period of elevated community RSV activity as determined by CDC NREVSS or local health department surveillance (continental U.S. typical months November through March).

Hemodynamically significant congenital heart diseaseIncludes infants with acyanotic heart disease receiving medication to control congestive heart failure who will require cardiac surgical procedures, and infants with moderate to severe pulmonary hypertension.

Chronic lung disease (CLD) of prematurityBirth at <32 weeks, 0 days gestation plus requirement for >21% oxygen for at least 28 days after birth.

Policy Changes

08/15/2025Annual review — material updateLatest

Added Enflonsia (clesrovimab-cfor) to the criteria limiting Synagis use to when alternatives are not accessible and updated criteria to require that the individual has not received and does not have access to Beyfortus (nirsevimab) or Enflonsia for the RSV season (material change).

08/15/2025Coding update

Updated HCPCS S9562 description and added/combined multiple ICD‑10‑CM ranges (including P07.20‑P07.26, P07.30‑P07.35, P27.0‑P27.9, D81.*, E84.*, I27.*, Q22.*‑Q23.*, Q33.*, Z94.*, Z29.11).