CurrentUnitedHealthcarePolicy CSPA2025D0005C

Synagis (Palivizumab) (for Pennsylvania Only)

Pennsylvania-specific UnitedHealthcare medical benefit drug policy for palivizumab (Synagis) prophylaxis to prevent serious lower respiratory tract RSV disease in high-risk pediatric patients, specifying clinical criteria, seasonality, dosing limits, exclusions, and applicable procedure/diagnosis codes.

Policy Summary

PayerUnitedHealthcare

PolicySynagis (Palivizumab) (for Pennsylvania Only)

Policy CodePolicy CSPA2025D0005C

Change TypeCoverage criteria revised; seasonality guidance updated; supporting info refreshed

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument gestational age, age at start of RSV season, evidence of CLD or hemodynamically significant CHD, ongoing need for medical support, and prior receipt of Beyfortus or Enflonsia.

POLICY UPDATE CHANGES

Coverage criteria updated to add 'Enflonsia (clesrovimab-cfor)' to the exclusion for prior treatment during or entering the current RSV season.

Revised Additional Information language regarding geographic variability of RSV seasonality (tropical climates and Alaska) and provider ability to adjust administration schedules based on local epidemiology.

Background, Clinical Evidence, and References sections updated to reflect current information.

1CPT code listed

~70+ICD-10 diagnosis codes referenced

5Maximum monthly doses per RSV season

15 mg/kgMaximum dose per administration

Coverage Summary & Stance

Coverage stance: covered_with_criteria. Scope: Pennsylvania-specific UnitedHealthcare medical benefit drug policy for palivizumab (Synagis) prophylaxis to prevent serious lower respiratory tract RSV disease in high‑risk pediatric patients, specifying clinical criteria, seasonality, dosing limits, exclusions, and applicable procedure/diagnosis codes. Effective date: December 1, 2025. Policy number: CSPA2025D0005C.

Medically Necessary (Proven) Criteria for Synagis prophylaxis

Covered when ALL of the following are met:

Timing and dosing requirements
- Seasonal timing: Administered during RSV 'season' as defined by CDC surveillance reports (NREVSS Interactive Dashboard) or state or local health departments to confirm the start of the RSV 'season'
  Requests for additional doses outside of the typical RSV season will be reviewed on a case-by-case basis based on CDC surveillance reports or state/local health department recommendations.
- Dose per administration limit: Monthly dose of Synagis does not exceed 15 mg/kg per dose<= 15 mg/kg
  Operational dosing limit
- Maximum doses per season: Dosage of Synagis does not exceed 5 monthly doses per single RSV 'season'<= 5 doses
  Maximum 5 doses per season
- NICU / hospital first-dose counting: Infants in a neonatal intensive care unit who qualify for prophylaxis may receive the first dose 48 to 72 hours before discharge to home or promptly after discharge; if the first dose is administered in the hospital, it is counted as the first of up to 5 doses for the season
  If first dose given in hospital, it counts as first of up to 5 doses
ONE of the following high-risk clinical situations must be present
- Prematurity: Infants born before 29 weeks, 0 days' gestation who are < 12 months of age at the start of RSV 'season'
- Chronic Lung Disease (CLD) - first year: Chronic Lung Disease (CLD): Age 0 to < 12 months — preterm infants born < 32 weeks, 0 days' gestation who required > 21% oxygen for at least the first 28 days after birth
- Chronic Lung Disease (CLD) - second year: Chronic Lung Disease (CLD): Age ≥ 12 to < 24 months — preterm infants born < 32 weeks, 0 days' gestation who required at least 28 days of oxygen after birth and who continue to require supplemental oxygen, diuretics, or chronic systemic corticosteroid therapy within 6 months of the start of the second RSV 'season'
  Requires continued need for medical support
- Hemodynamically significant Congenital Heart Disease (CHD): Congenital Heart Disease (hemodynamically significant CHD): Age 0 to < 12 months — infants and children born within 12 months of onset of RSV 'season' who will most likely benefit, including those with acyanotic heart disease receiving medication to control congestive heart failure and who will require cardiac surgical procedures, and those with moderate to severe pulmonary hypertension
Exclusion - prior receipt of other RSV prophylaxis: Patient has not previously received treatment with Beyfortus (nirsevimab-alip) or Enflonsia (clesrovimab-cfor) during or entering the current RSV 'season'
Exclusion criterion to avoid overlapping prophylaxis during same season

Unproven / Not Covered Situations

Synagis is considered unproven (not supported) for the following situations:

CLD without continued support in second year: Infants with CLD who do not continue to require medical support in the second year of life
Hemodynamically insignificant heart disease: Infants and children with hemodynamically insignificant heart disease (examples listed: secundum ASD, small VSD, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation, PDA)
Corrected cardiac lesions: Infants with cardiac lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure

Applicable Codes

Covered Procedure CodeCPTCovered

90378

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

Relevant Diagnosis Codes (listed for reference)ICD-10

D81.0	Severe combined immunodeficiency [SCID] with reticular dysgenesis
D81.1	Severe combined immunodeficiency [SCID] with low T- and B-cell numbers
D81.2	Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
D81.6	Major histocompatibility complex class I deficiency
D81.7	Major histocompatibility complex class II deficiency
D81.82	Activated Phosphoinositide 3-kinase Delta Syndrome [APDS]
D81.89	Other combined immunodeficiencies
D81.9	Combined immunodeficiency, unspecified
D83.0	Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
D83.2	Common variable immunodeficiency with autoantibodies to B- or T-cells

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Provider Actions & Billing Guidance

Prior Authorization

Medical necessity review required for Synagis outside standard criteria

Requests for palivizumab administered outside standard policy criteria will undergo a medical necessity review on a case‑by‑case basis.

Additional doses outside the RSV season
Doses greater than 15 mg/kg per administration
More than 5 monthly doses in a single RSV season
Use in persons not defined as high‑risk by the policy

Documentation Required

Document gestational age and clinical status

Document the infant's gestational age, the infant's age at the start of the RSV season, evidence of chronic lung disease or hemodynamically significant congenital heart disease, ongoing need for medical support (supplemental oxygen, diuretics, or chronic systemic corticosteroids), and whether the patient received Beyfortus (nirsevimab‑alip) or Enflonsia (clesrovimab‑cfor) during or entering the current RSV season.

Clinical Evidence & Definitions

61%Reduction in wheezing days in first year (MAKI trial; preterm 33–35 wks)

11.2%Recurrent wheeze in palivizumab group vs 20.9% placebo

Professional guidance: the AAP updated recommendations on July 8, 2025 that nirsevimab is considered first‑line and palivizumab is no longer routinely recommended, though palivizumab may still be used for certain high‑risk infants when appropriate; ACIP has recommended clesrovimab (Enflonsia) provisionally as an option for prevention in eligible infants and previously recommended nirsevimab (Beyfortus) for many infants who would have received palivizumab. RSV seasonality and surveillance: timing for initiating prophylaxis should follow CDC NREVSS data or state/local health department guidance. Definitions: RSV 'season' onset — first of 2 consecutive weeks with mean % positive antigen ≥10% OR mean % positive PCR ≥3%; offset = last week with antigen ≥10% OR PCR ≥3%. Hemodynamically significant CHD — acyanotic heart disease receiving medication to control congestive heart failure, moderate to severe pulmonary hypertension, or other defects likely to benefit from immunoprophylaxis.

Background & Policy Context

Palivizumab (Synagis) is a humanized monoclonal antibody produced by recombinant DNA technology for prophylaxis against RSV in high‑risk pediatric patients. RSV seasonality is monitored via CDC NREVSS surveillance data and NREVSS‑based season definitions guide timing of prophylaxis; regional variability may require providers to adjust administration schedules based on local epidemiology. Professional guideline context: AAP and ACIP recommendations now favor nirsevimab as first‑line for many infants, and palivizumab is no longer routinely recommended but remains an option for qualifying high‑risk infants. Scope note: this policy applies to Pennsylvania only.

Key thresholds and operational limits

Dose per administration<= 15 mg/kg per dose

Maximum doses per RSV season<= 5 monthly doses per single RSV 'season'

If first dose given in hospitalFirst in-hospital dose counts as first of up to 5 doses for the season (subsequent in-hospital doses also count)

Season onset definition (NREVSS/CDC)Season onset = first of 2 consecutive weeks with mean % positive antigen >=10% OR mean % positive PCR >=3% (whichever occurs first)

Revision History

12/01/2025revisionLatest

Coverage criteria revised to replace the prior exclusion that referenced only Beyfortus (nirsevimab-alip) with an exclusion that now names Beyfortus or Enflonsia (clesrovimab-cfor) as prior treatments during or entering the current RSV season (i.e., patient has not previously received treatment with Beyfortus or Enflonsia during or entering the current RSV 'season').

12/01/2025revision

Additional Information updated to emphasize geographic variability in RSV seasonality and explicitly note that providers can adjust administration schedules based on local epidemiology; clarifies seasonality differences in tropical climates and unpredictability/longer duration in Alaska and reiterates NREVSS/CDC season definitions.

12/01/2025

Policy Summary

PayerUnitedHealthcare

PolicySynagis (Palivizumab) (for Pennsylvania Only)

Policy CodePolicy CSPA2025D0005C

Change TypeCoverage criteria revised; seasonality guidance updated; supporting info refreshed

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument gestational age, age at start of RSV season, evidence of CLD or hemodynamically significant CHD, ongoing need for medical support, and prior receipt of Beyfortus or Enflonsia.

On This Page

Congenital airway or neuromuscular disease: Age 0 to < 12 months — infants/children with neuromuscular disease or congenital airway anomaly that impairs ability to clear secretions from lower airway (ineffective cough)

Immunocompromised children < 24 months of age: children receiving cancer chemotherapy or severely immunocompromised (e.g., hematopoietic stem cell transplant or solid organ transplant) — prophylaxis may be administered though efficacy is unknown

Cystic fibrosis with qualifying indications: Cystic fibrosis (CF) with other qualifying indications: Age 0 to < 12 months — CF infants with clinical evidence of CLD and/or nutritional compromise (failure to thrive defined as weight-for-length < 10th percentile)

Continued severe lung disease manifestations in second year of life (age ≥ 12 to < 24 months): previous hospitalization for pulmonary exacerbation in the first year of life; persistent chest imaging abnormalities when stable; weight-for-length less than the 10th percentile

Mild cardiomyopathy:

Infants with cardiomyopathy sufficiently mild that they do not require pharmacotherapy

Children in second year unless proven indications met: Children in the second year of life unless otherwise indicated in proven criteria above

Routine prophylaxis - Down syndrome: Routine prophylaxis in children with Down syndrome (unless qualifying heart disease, CLD, airway clearance issues, or prematurity <29 weeks GA is present)

Routine prophylaxis - cystic fibrosis: Routine prophylaxis in children with cystic fibrosis (unless qualifying indications noted in proven indications above are present)

Post-breakthrough hospitalization dosing: Administration of monthly Synagis prophylaxis after an infant/child has experienced a breakthrough RSV hospitalization during the current season if child had met criteria for palivizumab

Asthma prevention or wheeze reduction: Prophylaxis for primary asthma prevention or to reduce subsequent episodes of wheezing

Absence of support makes second-year prophylaxis unproven: Supplemental oxygen, diuretics, or chronic systemic corticosteroid therapy within 6 months of the start of the second RSV 'season' (absence of these may make second-year prophylaxis unproven)

Documentation alone insufficient: Documentation that decisions regarding Synagis prophylaxis for infants with cyanotic heart defects in the first year of life were made in consultation with a pediatric cardiologist

Listed as unproven — documentation alone without other qualifying elements insufficient

Postoperative dosing after bypass or ECMO: Postoperative dosing after cardiac bypass or ECMO: a postoperative dose should be administered for children who still require prophylaxis and who have undergone surgical procedures (policy notes this as consideration but overall use in some contexts remains unproven)

Cardiac transplant during season - consideration: Children who undergo cardiac transplantation during the RSV 'season' may be considered for Synagis prophylaxis (policy lists as a consideration)

Prevention of nosocomial disease: Synagis prophylaxis for prevention of nosocomial disease

Outside season or excessive dosing or populations: When Synagis is administered outside of the RSV 'season', in doses greater than needed, in excess of 5 doses per RSV 'season', or to persons other than defined high-risk groups

Requests outside of this criteria will be reviewed for medical necessity on a case-by-case basis.

Treatment of symptomatic RSV disease

Gestational age at birth
Patient age at start of RSV season
Clinical evidence of CLD or hemodynamically significant CHD
Current need for oxygen, diuretics, or systemic steroids
Prior receipt of Beyfortus or Enflonsia during/entering current RSV season

Billing Rule

Report Synagis with CPT 90378

Report palivizumab using CPT code 90378 (respiratory syncytial virus monoclonal antibody, recombinant, for intramuscular use, 50 mg, each). Units billed and number of doses must reflect the 15 mg/kg per‑dose limit and the maximum of up to 5 monthly doses per single RSV season.

CPT 90378 (50 mg unit)
Bill units consistent with 15 mg/kg dosing limit
Maximum of 5 monthly doses billed per RSV season

Denial Risk

Claims risk for non-qualifying indications or dosing

Claims may be denied if Synagis is provided outside the defined RSV season, administered in excess of 5 doses per season, given at doses exceeding 15 mg/kg per administration, or used for populations or indications the policy lists as unproven.

Administration outside the RSV 'season'
More than 5 monthly doses in a single RSV season
Doses > 15 mg/kg per administration
Use in non‑high‑risk populations or unproven indications listed in policy

Season offset definition (NREVSS/CDC)Season offset = last week with mean % positive antigen >=10% OR mean % positive PCR >=3% (whichever occurs last)

Operational limits - amberMaximum dose per administration: 15 mg/kg

Operational limits - amberMaximum monthly doses per RSV season: 5

Background, Clinical Evidence, and References sections refreshed and updated; prior policy version CSPA2024D0005B archived.