ModifiedCentenePolicy N/A

Palivizumab (Synagis) — RSV Prophylaxis (Pediatrics/Neonatology)

Clinical coverage policy governing use of palivizumab (Synagis) for prevention of serious lower respiratory tract disease caused by RSV in pediatric patients; applies to Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyPalivizumab (Synagis) — RSV Prophylaxis

Policy CodePolicy N/A

Change TypeMaterial clinical updates and operational clarifications

Effective DateAug 1, 2009

Next Review DateN/A

Key ActionSubmit documentation showing the patient meets the specified approval criteria and dosing/seasonal limits when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Clarification that overlap of two seasons due to elevated interseasonal RSV activity does not preclude receiving more than 5 consecutive doses (6 doses if cardiopulmonary bypass).

Redirection to Beyfortus (nirsevimab) per ACIP and AAP recommendations and requirement that member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine for the current season.

Updated Appendix D and timing guidance to reflect AAP/ACIP 2024 recommendations about nirsevimab availability and timing of administration (October through end of March in most continental US).

Added clarification regarding maternal vaccine exclusion if administered 9 14 days to delivery per ACIP/AAP recommendations.

Added step therapy bypass for Illinois per IL HB 5395.

up to 5max doses / RSV season

6max if CP bypass

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Palivizumab (Synagis)

inv-01: Initial Approval — Preterm Infants

Covered when ALL of the following are met:

Initial Approval for Preterm Infants: 1) Diagnosis of preterm infant with gestational age ≤29 weeks; 2) Age at onset of RSV season ≤12 months; 3) Request is for RSV prophylaxis; 4) Member must use Beyfortus (nirsevimab) if available unless contraindicated or clinically significant adverse effects are experienced; 5) Confirm supply constraints to bypass Beyfortus requirement (see Appendix D); 6) Medical justification supports requests for prophylaxis outside the identified regional RSV season when applicable; 7) Member has not been hospitalized with RSV disease during the current RSV season; 8) Dose does not exceed 15 mg/kg IM once a month; 9) For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine (including maternal RSV vaccination administered ≤14 days before delivery for relevant preterm infants).

inv-02: Initial Approval — Chronic Lung Disease of Prematurity (BPD/CLD)

Covered when ALL of the following are met:

CLD/BPD Criteria: 1) Diagnosis of chronic lung disease of prematurity (bronchopulmonary dysplasia) defined as requirement for 21% supplemental oxygen for ≥28 days after birth; 2) Gestational age ≤32 weeks; 3) Age <12 months at onset of RSV season OR age 12 to 24 months who continue to require supplemental oxygen, chronic corticosteroid therapy, bronchodilator therapy, or diuretic therapy within 6 months of season start; 4) Request is for RSV prophylaxis; 5) Member must use Beyfortus (nirsevimab) if available unless contraindicated or clinically significant adverse effects are experienced; 6) Confirm supply constraints to bypass Beyfortus requirement (see Appendix D); 7) Medical justification supports requests for prophylaxis outside the identified regional RSV season when applicable; 8) Member has not been hospitalized with RSV disease during the current RSV season; 9) Dose does not exceed 15 mg/kg IM once a month; 10) For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine.

inv-03: Initial Approval — Hemodynamically Significant Congenital Heart Disease (CHD)

Covered when ALL of the following are met:

CHD Criteria: 1) Age and diagnosis at onset of RSV season meeting one of the following: a) <12 months and receiving medication to control congestive heart failure and will require a cardiac surgical procedure; b) <12 months with acyanotic heart disease meeting specified criteria or with moderate to severe pulmonary hypertension; c) up to 24 months if undergoing cardiac transplantation or cardiopulmonary bypass during the current RSV season; d) cyanotic heart defect with prophylaxis recommended by a pediatric cardiologist; 2) Request is for RSV prophylaxis; 3) Member must use Beyfortus (nirsevimab) if available unless contraindicated or clinically significant adverse effects are experienced; 4) Confirm supply constraints to bypass Beyfortus requirement (see Appendix D); 5) Medical justification supports requests for prophylaxis outside the identified regional RSV season when applicable; 6) Member has not been hospitalized with RSV disease during the current RSV season; 7) Dose does not exceed 15 mg/kg IM once a month; 8) For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine; 9) Approval duration: up to 5 doses per RSV season (6 doses if cardiopulmonary bypass).

inv-04: Initial Approval — Other High-Risk Conditions (Anatomic Pulmonary Abnormalities, Neuromuscular Disorders, Immunocompromised, Cystic Fibrosis, Alaska Native/American Indian)

Covered when ALL of the following are met:

Other High-Risk Conditions: 1) Diagnosis of one of the following high-risk conditions: anatomic pulmonary abnormality or neuromuscular disorder that impairs airway secretion clearance; infant who will be profoundly immunocompromised during RSV season (e.g., SOT/HSCT, chemotherapy, severe combined immunodeficiency); cystic fibrosis with severe lung disease or nutritional compromise; or Alaska Native/selected American Indian infant as specified; 2) Age criteria as specified by condition (typically ≤12 months, or up to 24 months for profoundly immunocompromised or condition-specific allowances); 3) Request is for RSV prophylaxis; 4) Member must use Beyfortus (nirsevimab) if available unless contraindicated or clinically significant adverse effects are experienced; 5) Confirm supply constraints to bypass Beyfortus requirement (see Appendix D); 6) Medical justification supports requests for prophylaxis outside the identified regional RSV season when applicable; 7) Member has not been hospitalized with RSV disease during the current RSV season; 8) Dose does not exceed 15 mg/kg IM once a month; 9) For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine; 10) For cystic fibrosis, clinical evidence of nutritional compromise or manifestations of severe lung disease required per policy.

inv-05: Continued Therapy

Covered when ALL of the following are met:

Continued Therapy Conditions: 1) Member is currently receiving palivizumab via the Centene benefit or previously met initial approval criteria; 2) Request is for RSV prophylaxis; 3) Member must use Beyfortus (nirsevimab) if available unless contraindicated or clinically significant adverse effects are experienced; 4) Confirm supply constraints to bypass Beyfortus requirement (see Appendix D); 5) Member will not reach 24 months of age at the start of the RSV season; 6) Medical justification supports requests for prophylaxis outside the identified regional RSV season when applicable; 7) Member has not received 5 Synagis doses in the current RSV season (6 doses if cardiopulmonary bypass) yet; 8) Member has not been hospitalized with RSV disease during the current RSV season; 9) For the current RSV season, member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine; 10) If request is for a dose increase, the new dose does not exceed 15 mg/kg IM once a month.

inv-06: Continued Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy: Member has prior authorization meeting initial criteria; approval duration up to 5 doses per RSV season (6 doses if cardiopulmonary bypass). Overlap of two seasons does not preclude receiving more than 5 consecutive doses when clinically indicated.up to 5 doses (6 if CP bypass)

Doses are monthly at 15 mg/kg IM.

inv-07: Redirection/Preference — Coverage/redirection considerations

Coverage/redirection considerations:

Redirection to Nirsevimab: If nirsevimab (Beyfortus) is available and recommended by ACIP/AAP, it should be used for eligible children; if nirsevimab is not available, palivizumab (Synagis) may be administered. For the current RSV season, member should not have previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine; providers may need to document supply constraints to bypass redirection.nirsevimab availability and prior receipt exclusion

Document medical justification for use outside the typical regional RSV season and confirm member has not previously received nirsevimab or other RSV prophylaxis for the current season.

The safety and efficacy of Synagis (palivizumab) have not been established for the treatment of active RSV disease. Synagis is indicated for prophylaxis to prevent serious lower respiratory tract disease caused by RSV in specified pediatric populations, not for treatment of documented RSV infection.

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless the requester provides sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy for the member’s line of business (see CP.CPA.09, HIM.PA.154, or CP PMN.53 as applicable). If the requested use is not listed in the Diagnoses/Indications section, refer to the off‑label or non‑formulary policies identified in this document for the correct authorization pathway.

Per ACIP and AAP guidance incorporated into this policy, prophylaxis is excluded when a maternal RSV vaccine was administered within ≤ 14 days before delivery. Documentation that maternal vaccination occurred earlier than 14 days before delivery is required to rule out this exclusion and support coverage when other criteria are met.

Requests for indications, ages, or dosing regimens that are not specifically listed in the Diagnoses/Indications section must follow the applicable off‑label or non‑formulary policies. Providers should submit clinical documentation demonstrating medical rationale and supporting evidence per the referenced off‑label policy for the member’s line of business to permit consideration.

Use of Synagis for indications that are not supported by FDA approval or by this policy, and without adequate off‑label justification and documentation, may be considered not medically necessary and denied. Refer to the specified off‑label and non‑formulary policies for required documentation and review criteria.

Coding and Dose Limits

Referenced CodesCPT | HCPCS

90378	Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular.
S9562	Home injectable therapy, palivizumab or other monoclonal antibody for RSV, including administrative services, professional pharmacy services, care coordination, and all necessary equipment.

(document note)mixed

No codes listed

Coding Implicationsmixed

No codes listed

inv-15: Dose limit — Does not exceed 15 mg/kg once a month by IM administration

Dose limit (per administration)Does not exceed 15 mg/kg once a month by intramuscular (IM) administration.

Rounding guidanceSee Appendix E for dose rounding guidelines.

ApplicabilityApplies to initial and continued therapy dosing across covered indications per policy criteria.

inv-16: Seasonal dose count — Up to 5 doses per RSV season (6 doses if cardiopulmonary bypass in CHD)

Standard seasonal limitUp to 5 doses per RSV season.

Exception — cardiopulmonary bypassUp to 6 doses in the RSV season if member undergoes cardiopulmonary bypass.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and dosing limits

Prior authorization required. Requests must include documentation that the patient meets all specified initial or continued therapy criteria and dosing limits. Approval duration for most indications is up to 5 doses per RSV season (6 doses allowed if cardiopulmonary bypass). Dose does not exceed 15 mg/kg IM once monthly; requests for dose increases must not exceed this limit.

Approval duration: up to 5 doses per RSV season (6 doses if cardiopulmonary bypass).
Dose limit: 15 mg/kg IM once monthly (see Appendix E for rounding).
Prior authorization required for initial and continued therapy requests.

Prior Authorization

Prior authorization impacted by IL HB 5395

Illinois-specific statutory change (IL HB 5395) has added a step therapy bypass for Illinois HIM requests effective 1/1/2026. Implement prior authorization processes to allow the step therapy bypass in Illinois cases and confirm applicability for the member's state/product.

Step therapy bypass applies to Illinois HIM requests per IL HB 5395 (effective 1/1/2026).

Background

Palivizumab (brand name Synagis) is a recombinant humanized monoclonal antibody with activity against respiratory syncytial virus (RSV) intended for prevention of serious lower respiratory tract disease caused by RSV in specified pediatric patients. FDA indications include certain premature infants, infants and children with bronchopulmonary dysplasia/chronic lung disease of prematurity, and children with hemodynamically significant congenital heart disease up to 24 months of age; the product’s labeling also states that the safety and efficacy have not been established for treatment of RSV disease.

Definitions and Abbreviations

inv-33: Palivizumab (Synagis) — definition as recombinant humanized monoclonal antibody for RSV prophylaxis

DefinitionPalivizumab (Synagis) is a recombinant humanized monoclonal antibody with activity against respiratory syncytial virus (RSV) used for prophylaxis of serious lower respiratory tract disease in specified pediatric patients.

Indicated populations (FDA)Includes certain premature infants, children with bronchopulmonary dysplasia (BPD)/chronic lung disease of prematurity, and those with hemodynamically significant congenital heart disease up to 24 months of age.

LimitationSafety and efficacy have not been established for treatment of active RSV disease (use is prophylactic).

inv-34: Abbreviations — BPD, CLD, FDA, RSV, etc.

BPDBronchopulmonary dysplasia.

CLD

Revision History and Policy Changes

2025-07-15addedLatest

Added step therapy bypass for Illinois per IL HB 5395 (state-specific exemption to redirection to nirsevimab).

2025-01-17clarified

Operationalized maternal vaccine timing exclusion: clarified that maternal RSV vaccination administered ≤14 days before delivery excludes the infant from palivizumab during the current season per ACIP/AAP guidance.

2024-10-26

Policy Summary

PayerCentene

PolicyPalivizumab (Synagis) — RSV Prophylaxis

Policy CodePolicy N/A

Change TypeMaterial clinical updates and operational clarifications

Effective DateAug 1, 2009

Next Review DateN/A

Key ActionSubmit documentation showing the patient meets the specified approval criteria and dosing/seasonal limits when requesting prior authorization.

SourceLink

On This Page

Denial Risk

Non‑FDA approved indication

Requests for uses that are non‑FDA approved and not addressed in this policy may be denied unless sufficient off‑label justification and supporting evidence are submitted. Refer to the off‑label use policies for the appropriate line of business when applicable.

If indication is not listed in policy, provide clinical evidence of efficacy and safety per off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (HIM), CP PMN.53 (Medicaid).
For drugs not on formulary, follow non‑formulary policies (see chunk 19).

Documentation Required

Supporting clinical documentation

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, pediatric cardiology consultation, medical director consultation for Alaska Native/Other American Indian infants, and other relevant clinical records) demonstrating the member meets all approval criteria, including seasonality rationale and prior RSV prophylaxis history.

Office chart notes, labs, consultation notes, and other clinical information to verify criteria.
Document that member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine for the current RSV season (including maternal RSV vaccination within 14 days of delivery).
Medical director consultation required for Alaska Native/Other American Indian infants when requests fall outside standard criteria.

Documentation Required

Documentation expectations

Documentation must reflect adherence to ACIP/AAP timing guidance (including maternal vaccine exclusions), justify any use outside region‑identified RSV season (see Appendix D), and confirm supply constraints if requesting bypass of Beyfortus redirection. Failure to submit required documentation may result in denial.

Medical justification required for prophylaxis outside identified regional RSV season; consult local/state health departments and Appendix D for season timing.
Confirm supply constraints to bypass Beyfortus redirection if claiming unavailability.
Failure to provide documentation that member meets approval criteria may lead to denial.

Step Therapy

Step therapy / product preference

Step therapy / product preference: members must use Beyfortus (nirsevimab) when available unless contraindicated or clinically significant adverse effects occur. Confirm supply constraints prior to bypassing this requirement; where Beyfortus redirection applies, document attempts or rationale.

Member must use Beyfortus if available unless contraindicated or adverse effects.
Confirm and document supply constraints per Appendix D before approving alternative agents.
Beyfortus redirection aligns with ACIP/AAP recommendations; implementers should follow updated guidance.

Step Therapy

Step therapy / redirection to nirsevimab

Step therapy / redirection to nirsevimab (Beyfortus) must be applied per ACIP/AAP recommendations; document supply availability or constraints. For Illinois HIM requests, honor the IL HB 5395 bypass beginning 1/1/2026 — do not require the Beyfortus step for those Illinois HIM members.

Redirection to Beyfortus per ACIP/AAP — require Beyfortus trial when available.
If Beyfortus is unavailable, document supply constraints per Appendix D to permit alternative therapy.
IL HB 5395 creates a statutory bypass for Illinois HIM requests effective 1/1/2026; do not apply step therapy redirection for those members.

inv-35: Exclusion when maternal vaccination administered ≤ 14 days before delivery per ACIP/AAP — definition/operational note

Maternal vaccine timing exclusionFor the current RSV season, palivizumab is not indicated if the infant’s mother received an RSV vaccine within 14 days before delivery (maternal vaccination administered ≤ 14 days before delivery).

Source guidanceThis operational exclusion aligns with ACIP/AAP recommendations and is reflected in the policy language and appendices.

Provider documentation expectationDocumentation should reflect adherence to ACIP/AAP timing guidance for maternal vaccination relative to delivery when assessing eligibility.