CurrentMass General Brigham Health PlanPolicy N/A

Palivizumab (Synagis) for RSV prophylaxis

This policy governs prior authorization and quantity limits for Synagis (palivizumab) used to prevent severe RSV disease in pediatric members under the Mass General Brigham Health Plan pharmacy benefit; it applies to commercial/exchange members and specialty pharmacy dispensing.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPalivizumab (Synagis) for RSV prophylaxis

Policy CodePolicy N/A

Change TypeMaterial coverage update — new exclusion for prior Enflonsia exposure

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization through a contracted specialty pharmacy and document diagnosis category plus supporting clinical details.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate members will not be approved for Synagis if they received a dose of Enflonsia in the current RSV season.

Previously added restriction that members will not be approved for Synagis if they received a dose of Beyfortus in the current RSV season.

5 dosesmaximum approvals per RSV season

15 mg/kgdosing frequency

Nov–Aprtypical RSV season

Commercial/Exchangeplan applicability

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Coverage Criteria for Synagis (palivizumab)

Covered indications and specific criteria

Authorization may be granted when the member has one of the listed diagnoses and meets the associated criteria:

Covered diagnoses

A. Prematurity
- A.1: Member's gestational age is < 29 weeks, 0 days.< 29 weeks
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- A.2: Member's chronological age at the start of RSV season is < 12 months.< 12 months
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B. CLD of prematurity
- B.1: Member's gestational age is < 32 weeks, 0 days.< 32 weeks
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- B.2: Requirement for > 21% oxygen for at least the first 28 days after birth.> 21% oxygen for ≥28 days
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- B.3: Either: (i) age < 12 months at start of first RSV season OR (ii) age < 24 months at start of subsequent RSV season and continues to require medical support during the 6 months prior to season.
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C. CHD
- C.1: CHD is hemodynamically significant.
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- C.2: Either: (i) age < 12 months at start of RSV season OR (ii) age 12–24 months and will undergo cardiac transplantation during RSV season.
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D. Congenital airway abnormality: All of the following criteria must be met: (1) condition compromises handling of respiratory secretions; (2) age < 12 months at start of RSV season.
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E. Neuromuscular condition: All of the following criteria must be met: (1) condition compromises handling of respiratory secretions; (2) age < 12 months at start of RSV season.
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F. Immunocompromised children: All of the following criteria must be met: (1) member is profoundly immunocompromised during RSV season (e.g., SCID, stem cell transplant, bone marrow transplant); (2) age < 24 months at start of RSV season.
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G. Cystic Fibrosis: Either: (1) age < 12 months at start of RSV season and evidence of CLD or nutritional compromise OR (2) age 12–24 months at start of RSV season with manifestations of lung disease or weight-for-length < 10th percentile.
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All indications for palivizumab (Synagis) that are not specifically listed in this policy — including uses outside the FDA‑approved pediatric indications and the compendial uses described herein — are considered experimental/ investigational and are not medically necessary for coverage.

Synagis will not be approved for members who have received a dose of Beyfortus or Enflonsia during the current RSV season. Requests meeting this condition will be denied.

Use of Synagis for treatment of established RSV disease is not supported; the safety and efficacy have not been established for treatment of active RSV infection.

Key Clinical Thresholds and Coding-Relevant Values

Gestational age thresholds

Prematurity thresholdMember's gestational age is < 29 weeks, 0 days.

CLD threshold (gestational age)Member's gestational age is < 32 weeks, 0 days.

Oxygen requirement for CLD criteriaRequirement for > 21% oxygen for at least the first 28 days after birth.

Chronological age at start of RSV season

Typical cutoff for most indicationsMember's chronological age at the start of RSV season is < 12 months.

Extended age for CLD (subsequent seasons)Member's chronological age at the start of a subsequent RSV season can be < 24 months if continuing to require medical support during the prior 6 months.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization and Specialty Pharmacy

Synagis (palivizumab) is subject to Prior Authorization and must be obtained through the contracted specialty pharmacy when applicable under the pharmacy benefit for Commercial/Exchange members.

Prior Authorization required under the pharmacy benefit for Commercial/Exchange members
Specialty pharmacy dispensing required where designated
Contact — Pharmacy Benefit: Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step therapy is not required for this product.

Background on Palivizumab and Policy Scope

Synagis (palivizumab) is a recombinant monoclonal antibody used as prophylaxis to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in specified high‑risk pediatric populations. It is indicated for prevention (not treatment) in groups such as certain premature infants, children with chronic lung disease of prematurity, and those with hemodynamically significant congenital heart disease.

Definitions and Supporting Clinical Terms

RSV prophylaxis indication — FDA pediatric summary

Premature infants (FDA)Infants with history of premature birth (≤35 weeks gestational age) who are ≤6 months of age at the beginning of RSV season.

Bronchopulmonary dysplasia (BPD)/CLD (FDA)Children with BPD that required medical treatment within the previous 6 months who are ≤24 months of age at the beginning of RSV season.

Hemodynamically significant CHD (FDA)Children with hemodynamically significant congenital heart disease who are ≤24 months of age at the beginning of RSV season.

Medical support (for CLD)

Definition of medical supportMedical support includes supplemental oxygen, diuretic therapy, or chronic corticosteroid therapy.

Context for CLD eligibility

Policy Summary

PayerMass General Brigham Health Plan

PolicyPalivizumab (Synagis) for RSV prophylaxis

Policy CodePolicy N/A

Change TypeMaterial coverage update — new exclusion for prior Enflonsia exposure

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization through a contracted specialty pharmacy and document diagnosis category plus supporting clinical details.

SourceLink

On This Page

Extended age for CHD and immunocompromised/transplantMember's chronological age at the start of RSV season may be up to 24 months for hemodynamically significant CHD (if transplant planned) and for profoundly immunocompromised children.

Documentation Required

Required clinical documentation

Authorization requests must include documentation that supports the diagnosis category and the specific clinical criteria met for the member (see Coverage Guidelines and Criteria). For members new to the plan within the past 90 days, include documentation of ongoing treatment with the requested medication (excluding samples or manufacturer patient assistance program supply).

Documented diagnosis category (e.g., prematurity, CLD of prematurity, CHD, congenital airway abnormality, neuromuscular condition, immunocompromised status, cystic fibrosis)
Supporting clinical details required for the diagnosis (e.g., gestational age, chronological age at RSV season start, relevant clinical assessments, test results)
For members new to plan (≤90 days): evidence of current treatment with the requested medication (not samples or manufacturer assistance)

Denial Risk

Prior exposure to other RSV monoclonal products

Requests will be denied if the member has received a dose of Beyfortus or Enflonsia during the current RSV season; approvals are limited to up to 5 doses per RSV season and off-season dosing criteria apply (see Limitations).

Maximum approvals: up to 5 doses per RSV season (RSV season generally November–April)
Do not approve Synagis if member received Beyfortus or Enflonsia during the current RSV season
Off-season authorization: single-dose approvals per request up to 5 doses per season if regional RSV activity ≥10% (rapid antigen) or ≥3% (PCR) within 2 weeks per CDC NREVSS

Continued requirement for medical support during the 6 months prior to the RSV season allows some children with CLD to qualify up to <24 months of age.

Examples included in policy tableTable explicitly lists supplemental oxygen, diuretic therapy, and chronic corticosteroids as qualifying medical support measures.