Colorado Rocky Mountain Health Plans Synagis Coverage

Coverage Criteria for Palivizumab (Synagis)

Proven (Covered) Indications — when ALL conditions met

Covered when ALL of the following are met:

Timing and dosing: Administered during RSV season as defined by CDC/NREVSS or state/local health departments; monthly dose does not exceed 15 mg/kg per dose; total doses do not exceed 5 monthly doses in a single RSV season; first dose given in hospital before discharge counts toward the season total.15 mg/kg; ≤ 5 doses per season

If first dose is administered in hospital (48–72 hours before discharge or promptly after discharge), it counts as the first of up to 5 doses for the season.

Clinical high-risk situations (one required): One of the following clinical situations must be present: prematurity (infants born before 29 weeks, 0 days gestation who are < 12 months of age at start of RSV season); chronic lung disease (CLD)/bronchopulmonary dysplasia meeting age- and treatment-specific criteria; hemodynamically significant congenital heart disease in infants/children born within 12 months of season onset and expected to benefit from immunoprophylaxis; other high-risk categories described in policy (e.g., select immunocompromised children, select cystic fibrosis cases, certain airway or neuromuscular disorders).

See policy text for age- and condition-specific qualifications (e.g., CLD criteria for second-year prophylaxis, CF with manifestations of severe lung disease, cardiology consultation for cyanotic defects).

Evidence summary and guidance (informational)

Clinical evidence outcomes and advisory recommendations summarized in the policy (no explicit stepwise coverage algorithm in this document segment):

Evidence on clinical outcomes: Palivizumab probably results in little to no difference in mortality and in adverse events; probably results in a slight reduction in respiratory-related hospitalizations (RR 0.80); may reduce RSV infection (RR 0.33, low-certainty) and reduces wheezing days in certain preterm infants (MAKI trial).

Certainty of evidence varies by outcome (high to low); MAKI trial showed reduction in wheezing days among preterm infants (33–35 wks).

Professional and federal guidance relevance: AAP (July 8, 2025) considers nirsevimab first-line and no longer routinely recommends palivizumab; ACIP recommended nirsevimab (Aug 3, 2023) for eligible infants and provisionally recommended clesrovimab (June 26, 2025) as an option for infants younger than 8 months born during or entering their first RSV season.

Guidance may affect preferred product choices for prophylaxis and availability may influence use of palivizumab.

FDA labeling note: Synagis (palivizumab) is FDA-approved for prevention of serious lower respiratory tract disease caused by RSV in specified high-risk pediatric populations; safety and efficacy for treatment of RSV disease have not been established.

Routine prophylaxis with palivizumab (Synagis) is considered not medically necessary for children with Down syndrome unless they have an additional qualifying condition such as hemodynamically significant congenital heart disease, chronic lung disease, airway clearance impairment, or prematurity as specified in the policy. Similarly, routine use in persons with cystic fibrosis is not supported unless other proven indications are present (for example, prior hospitalization for severe lung disease) described in the covered indications.

Additional situations considered unproven and potentially non-covered include administration after a breakthrough RSV hospitalization in the current season, prophylaxis outside the defined RSV season, dosing above 15 mg/kg per month, or more than 5 doses in a single RSV season, and use for primary asthma prevention or to reduce future wheezing episodes.

Palivizumab is FDA-approved for prevention of serious lower respiratory tract disease caused by RSV in specific high-risk pediatric populations, but FDA approval alone is not a basis for coverage. Coverage decisions must reference plan, federal, or state contractual requirements and the policy’s clinical criteria.

The safety and efficacy of Synagis have not been established for treatment of symptomatic RSV disease; requests for palivizumab as a treatment (rather than prophylaxis) are considered unsupported by the evidence in this policy.

Use of Synagis for infants with hemodynamically insignificant heart disease (examples include small secundum atrial septal defects, small ventricular septal defects, mild pulmonic or aortic stenosis, patent ductus arteriosus, and mild coarctation) is considered unproven/not medically necessary.

Infants whose cardiac lesions have been adequately corrected by surgery do not routinely qualify for prophylaxis unless they continue to require medications for congestive heart failure or meet other proven high-risk criteria described in the policy.

The American Academy of Pediatrics updated guidance on July 8, 2025, and now considers nirsevimab the first-line recommended product for RSV prevention in infants and children. In that guidance the AAP notes that palivizumab is no longer routinely recommended, which the policy reflects when considering preferred agents and the relative role of palivizumab.

If first-line agents are unavailable (for example, due to a shortage), the policy indicates palivizumab may be considered per the documented coverage criteria; otherwise routine use is generally not supported.

Coding and Dosing Information

Covered CPT CodesCPTCovered

90378

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

Applicable ICD-10 Codes (selected list)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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inv-09: Maximum monthly dose

Maximum monthly dose15 mg/kg per dose

Dosing frequencyAdministered as monthly injections (no more frequently than every 28–30 days)

Hospital-administered first doseFirst dose given 48–72 hours before discharge or promptly after discharge counts as first monthly dose

inv-10: Maximum doses per RSV season

Maximum doses per RSV seasonDoes not exceed 5 monthly doses per single RSV season

Counting inpatient dosesAny doses administered in the hospital are included in the maximum 5-dose series

Provider Requirements and Authorization Rules

Prior Authorization

Verify plan-specific prior authorization

Prior authorization may be required by the member’s benefit plan. Verify plan-specific prior authorization requirements and any plan, state, or federal contractual limitations before ordering or administering Synagis.

Check the member’s benefit plan and state/federal program terms for prior authorization rules and coverage limits.
If there is a conflict between this policy and the member’s federal/state/contractual plan, the federal/state/contractual requirements govern.

Denial Risk

Situations that may trigger denial

Coverage may be denied when Synagis is provided outside of defined parameters. Confirm the patient and dosing meet plan criteria before administration.

Administration outside of the RSV season as defined by CDC/NREVSS or local public health surveillance may be denied.

Background and Drug Information

Palivizumab (Synagis) is a humanized monoclonal antibody with neutralizing activity against respiratory syncytial virus (RSV) and is used for immunoprophylaxis to prevent serious lower respiratory tract disease in select high-risk infants and young children. RSV is a leading cause of hospitalization in U.S. infants, with the highest risk concentrated in the youngest age groups (particularly 0–2 months).

When determining eligibility and timing for prophylaxis, clinicians should document administration during the local RSV season as defined by CDC/NREVSS or state/local public health surveillance and adhere to dosing limits of ≤ 15 mg/kg per monthly dose and no more than 5 doses during a single RSV season.

Definitions and Key Terms

inv-20: RSV season (NREVSS/MMWR definition)

Season onset definition (NREVSS/MMWR)First of two consecutive weeks when mean percent positive for RSV antigen ≥10% OR PCR ≥3% (whichever occurs first), using statistically significant specimen volumes

Season offset definitionLast week during which mean percent positive by antigen ≥10% OR PCR ≥3% (whichever occurs last)

Geographic variabilityTiming, peak, and duration of RSV activity vary by region; tropical areas and Alaska may have different or unpredictable seasons

inv-21: FDA indication (Synagis)

FDA-approved indication (summary)Prevention of serious lower respiratory tract disease caused by RSV in high-risk pediatric patients

Included populationsChildren with chronic lung disease of prematurity (treated within previous 6 months) ≤24 months at season start; infants born ≤35 weeks GA and ≤6 months at season start; children with hemodynamically significant congenital heart disease ≤24 months at season start

OpenPayer

Palivizumab (Synagis) prophylaxis for RSV — Medical Necessity and Coverage Criteria

Coverage Criteria for Palivizumab (Synagis)

Coding and Dosing Information

Provider Requirements and Authorization Rules

Background and Drug Information

Definitions and Key Terms