CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization criteria, dosing, duration, seasonality definitions, and covered and non-covered indications for Synagis (palivizumab IM) for prevention of serious lower respiratory tract RSV disease in high-risk infants and children.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeClarified seasonality; added non‑coverage for Beyfortus overlap

Effective DateOct 2, 2024

Next Review DateN/A

Key ActionPrior authorization is recommended for medical benefit coverage; requests outside established dosing will be reviewed case-by-case and approvals are for the durations noted (1 month = 30 days).

SourceLink

POLICY UPDATE CHANGES

Policy statement updated to define RSV season onset as first 2 consecutive weeks with > 3% positive by PCR and offset as last week > 3% by PCR (removed antigen/10% language).

Added 'Use in patient who has received Beyfortus in the same RSV season' to Conditions Not Recommended for Approval.

Selected revision summary dated 10/02/2024 reflects the seasonality definition change.

5Maximum monthly doses approved

15 mg/kgStandard dose

>3% PCRSeason onset threshold

Specialist consultations required

Coverage Summary

Overview: This policy defines prior authorization criteria for Synagis (palivizumab IM) prophylaxis to prevent serious lower respiratory tract disease caused by RSV in high-risk infants and children. Coverage stance is mixed and the policy status is CURRENT.

Key dosing and limits: the recommended dose is 15 mg/kg intramuscularly once monthly, and approvals are limited to a maximum of 5 monthly doses per RSV season (fewer doses may be approved for qualifying infants born during the season).

Seasonality threshold: RSV season onset is defined as the first 2 consecutive weeks when the percentage of positive tests for RSV is > 3% by PCR, and season offset is defined as the last week with > 3% positive by PCR (policy was revised to PCR-only thresholds).

Target population and stance nuance: the policy primarily covers high-risk infants and children (e.g., those with bronchopulmonary dysplasia, specified prematurity cutoffs, and hemodynamically significant congenital heart disease). The overall coverage stance is mixed because specific clinical criteria, specialist consultation requirements, and exclusions (including overlap with Beyfortus use) guide approvals.

Threshold facts

Palivizumab dose15 mg/kg intramuscularly once monthly

Maximum monthly dosesMaximum 5 monthly doses per RSV season

RSV season PCR positivity threshold> 3% PCR (onset = first 2 consecutive weeks > 3% by PCR; offset = last week > 3% by PCR)

Prematurity cutoffs< 32 weeks, 0 days (general); specific criterion: < 29 weeks, 0 days for the born-premature indication

Oxygen requirement for BPD indication> 21% oxygen for at least 28 days after birth

Recommended Authorization Criteria (Medical Necessity)

FDA-Approved Indications - Chronic Lung Disease (Bronchopulmonary Dysplasia)

Approve for a maximum of 5 months during the RSV season if the patient meets ONE of the following (A or B):

ANY of the following

A
- Patient was born at < 32 weeks, 0 days gestation
- Patient is ≤ 12 months of age at the start of the RSV season
- Patient required > 21% oxygen for at least 28 days after birth
B

Provider Actions and Billing Impact

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage. Requests for doses outside established dosing will be reviewed case-by-case by a clinician. Approvals are provided for the duration noted; when authorized in months, 1 month = 30 days.

Prior authorization recommended for Synagis
Requests outside established dosing considered case-by-case by a clinician (Medical Director or Pharmacist)
When approval is authorized in months, 1 month = 30 days

Documentation Required

Clinical documentation for BPD and prematurity

Providers must document clinical details to support chronic lung disease (bronchopulmonary dysplasia) and prematurity indications.

Coding

DrugNDCCovered

No codes listed

Background and Evidence

Background: Synagis (palivizumab) is a monoclonal antibody indicated to prevent serious lower respiratory tract disease caused by RSV in children at high risk for severe RSV; safety and efficacy were established in children with bronchopulmonary dysplasia (chronic lung disease), certain premature infants, and those with hemodynamically significant congenital heart disease.

Guidance and Beyfortus considerations: AAP and ACIP guidance (updated 2023 and AAP Red Book 2024) address use of Beyfortus (nirsevimab) and Synagis. The AAP notes that Synagis may be used if Beyfortus is not available, and joint ACIP/AAP recommendations state that if Beyfortus is administered in a season, Synagis should not be given later that season; conversely, if Synagis was given and fewer than five doses were administered, a single Beyfortus dose may be given with no further Synagis that season.

Supply and prioritization context: CDC issued advisory guidance in the context of limited Beyfortus supply recommending prioritization of Beyfortus for infants at highest risk (e.g., < 6 months of age or with underlying high‑risk conditions) and advising programmatic adjustments (including suspension of Beyfortus in some Synagis-eligible children) to manage limited availability.

Policy change note: the policy was updated to incorporate these Beyfortus-related recommendations and explicitly added that Synagis should not be administered to infants who have already received Beyfortus in the same RSV season.

Evidence

AAP guidance updateAAP Updated Guidance July 2023 and Red Book 2024 inform policy; recommends Synagis in eligible patients and discusses Beyfortus interchangeability considerations.

Definitions & Thresholds

Definitions and Thresholds

RSV season onset (definition)First 2 consecutive weeks when weekly percent positive tests for RSV is > 3% by PCR

RSV season offset (definition)Last week that the percentage of positive tests for RSV is > 3% by PCR

Month (authorization)When approval is authorized in months, 1 month = 30 days

Thresholds listPCR positivity > 3%; Palivizumab dose 15 mg/kg IM once monthly; Maximum 5 monthly doses; Prematurity cutoffs: < 32wks and < 29wks for born-premature criterion; Oxygen requirement >21% for ≥28 days

Revision History

10/02/2024selected revisionLatest

Policy statement updated to define RSV season onset as first 2 consecutive weeks with > 3% positive by PCR and offset as last week > 3% by PCR (removed antigen/10% language) — material change.

08/21/2024annual revision

Annual revision recorded (review date 08/21/2024); Conditions Not Recommended for Approval: Use in patient who has received Beyfortus in the same RSV season was added (material change noted in history).

10/24/2023update

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeClarified seasonality; added non‑coverage for Beyfortus overlap

Effective DateOct 2, 2024

Next Review DateN/A

SourceLink

On This Page

Patient was born at < 32 weeks, 0 days gestation

Patient is ≥ 12 months of age but < 24 months of age at the start of the RSV season

Patient required > 21% oxygen for at least 28 days after birth

Patient has required medical therapy (supplemental oxygen, diuretic, or chronic corticosteroid therapy) during the 6 months before the start of the second RSV season

FDA-Approved Indications - Hemodynamically Significant Congenital Heart Disease (CHD)

Approve for a maximum of 5 months during the RSV season if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient is < 12 months of age at the start of the RSV season
B - prescriber states ONE of the following
- Patient is considered to have hemodynamically significant cyanotic congenital heart disease
- acyanotic heart disease with criteria: Patient has acyanotic heart disease and meets all of: patient is receiving medication to control heart failure; patient will require cardiac surgical procedures
- Patient has moderate to severe pulmonary hypertension
- iv: Patient has lesions that have been adequately corrected by surgery AND patient continues to require medication for congestive heart failure
C: Synagis is prescribed by or in consultation with a cardiologist or intensivist

FDA-Approved Indications - Born Prematurely

Approve for a maximum of 5 months during the RSV season if the patient meets BOTH of the following (A and B):

ALL of the following

A: Patient is ≤ 12 months of age at the start of the RSV season
B: Patient was born before 29 weeks, 0 days gestation (< 28 weeks, 6 days)

Not Recommended for Approval

Situations where coverage is not recommended:

ANY of the following

Prevention of RSV in a patient with cystic fibrosis who does not meet approval criteria (routine use not recommended)
Prevention of RSV in a patient with Down syndrome who does not meet the approval criteria (routine use not recommended unless other qualifying risk factors present)
Treatment of established RSV disease (Synagis is not recommended or approved for treatment)
Use in a patient who has received Beyfortus (nirsevimab-alip) in the same RSV season: Synagis should not be administered to infants who have already received Beyfortus
Coverage not recommended for circumstances not listed in the Recommended Authorization Criteria

Gestational age at birth
Patient age at the start of the RSV season
Oxygen requirement: > 21% oxygen for at least 28 days after birth
Prior medical therapy, if applicable (e.g., supplemental oxygen, diuretic, or chronic corticosteroid therapy within the 6 months before the second RSV season)

Documentation Required

Specialist consultation requirement for certain indications

Specialist prescription or consultation is required for certain high-risk indications; the policy specifies which specialists are needed for each indication.

Hemodynamically significant congenital heart disease (CHD): prescribed by or in consultation with a cardiologist or intensivist
Immunocompromised patients: prescribed by or in consultation with an immunologist or infectious diseases specialist
Cardiac transplant patients: prescribed by or in consultation with a cardiologist, intensivist, or transplant physician

Billing Rule

Dose and duration billing constraint

Billing and dosing instructions: palivizumab (Synagis) should be billed and administered at 15 mg/kg intramuscularly once monthly during the RSV season, for up to a maximum of five monthly doses per season. Administration of more than five monthly doses is generally not recommended within the continental United States.

Dose: 15 mg/kg IM once monthly
Approve/bill for up to 5 monthly doses per RSV season
More than five monthly doses not recommended within continental US

Denial Risk

Denial risk for Beyfortus overlap

Coverage is not recommended when the patient has already received Beyfortus (nirsevimab) in the same RSV season; Synagis should not be administered or billed in that circumstance.

Do not administer Synagis to infants who have already received Beyfortus in the same RSV season
If Beyfortus was given after fewer than 5 Synagis doses, no further Synagis should be administered

CDC seasonality analysisNational RSV seasonality analyzed July 2017–Feb 2023; PCR >3% threshold cited for defining season onset/offset.

Update added CDC Health Alert Network advisory information to the overview; no criteria changes.

09/05/2023update

Published ACIP recommendations for Beyfortus and AAP guidance were added to the overview and supportive text; no criteria changes.

08/16/2023annual revision

Annual revision recorded (review date 08/16/2023).