CurrentCignaPolicy IP0321

Palivizumab (Synagis) for RSV Prophylaxis

Criteria and coverage policy for use of palivizumab (Synagis) to prevent severe RSV in high-risk infants and young children under Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyPalivizumab (Synagis) for RSV Prophylaxis

Policy CodePolicy IP0321

Change TypeSelected Revision (non‑material)

Effective DateDec 15, 2024

Next Review DateN/A

Key ActionObtain prior authorization with documentation that the individual meets the specific policy criteria before Synagis administration.

SourceLink

POLICY UPDATE CHANGES

Updated review date, disclaimer, refreshed background and references, addition of change history.

15 mg/kgrecommended dose per administration

up to 5initial authorization duration (months)

90378listed HCPCS code

12/15/2024date of selected revision

2024references year

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Coverage Criteria for Palivizumab (Synagis)

Medically Necessary Indications

Covered when ONE of the following is met:

Chronic Lung Disease (CLD)/Bronchopulmonary dysplasia: Individual meets ONE of the following: A) If <12 months at start of RSV season AND BOTH: i) born before 32 weeks, 0 days gestation; ii) required supplemental oxygen for at least the first 28 days after birth; OR B) If 12-24 months at start of RSV season AND ALL: i) born before 32 weeks, 0 days gestation; ii) required supplemental oxygen for at least the first 28 days after birth;age and gestational age as stated

Preserves nested AND/OR logic from policy

Congenital Heart Disease (CHD): Individual meets ALL of the following: A) Individual is less than 12 months of age at the start of the RSV season; B) Individual meets ONE of: i) hemodynamically significant cyanotic congenital heart disease; OR ii) ALL: a) acyanotic heart disease; b) receiving medication to control heart failure; c) will require cardiac surgical procedures; OR iii) moderate to severe pulmonary hypertension; OR iv) BOTH: a) hemodynamically significant congenital heart defects adequately corrected by surgery; b) continues to require medication for congestive heart failure; C) Medication is being prescribed by, or in consultation with, a pediatric cardiologist, neonatologist, or pulmonologist.age <12 months

Includes specialist consult requirement

Premature Birth: Individual meets BOTH of the following: A) Individual is less than 12 months of age at the start of RSV season; B) Individual was born before 29 weeks, 0 days gestation.born <29w0d

Anatomic Pulmonary Abnormalities or Neuromuscular Disorder: Individual meets BOTH of the following: A) Individual is less than 12 months of age at the start of RSV season; B) Individual has a congenital abnormality of the airway or a neuromuscular disease (for example, cerebral palsy, muscular dystrophy, Tay Sachs, spinal muscular atrophy) that compromises the handling of respiratory secretions.age <12 months

Immunocompromised: Individual meets ALL of the following: A) Individual is less than 24 months of age at the start of RSV season; B) Individual is or will be profoundly immunocompromised (for example, severe combined immunodeficiency or severe acquired immunodeficiency syndrome) during the RSV season; C) Medication is being prescribed by, or in consultation with, an immunologist or an infectious diseases specialist.age <24 months

Includes specialist consult requirement

Cardiac Transplant: Individual meets ALL of the following: A) Individual is less than 24 months of age at the start of RSV season; B) Individual has undergone or will undergo cardiac transplantation during the current RSV season; C) Medication is being prescribed by, or in consultation with, a cardiologist, neonatologist, pulmonologist, or transplant physician.age <24 months

Cystic Fibrosis: Individual meets BOTH of the following: A) ONE of: i) If <12 months at start of RSV season AND ONE of: a) born before 32 weeks, 0 days gestation and required supplemental oxygen for at least the first 28 days after birth; b) nutritional compromise as evidenced by weight for length less than the 10th percentile on a pediatric growth chart; OR ii) If 12-24 months at start of RSV season AND ONE of: a) manifestations of severe lung disease (history of hospitalization for pulmonary exacerbation, abnormal chest x-ray or chest CT); b) nutritional compromise as evidenced by weight for length less than the 10th percentile on a pediatric growth chart; B) Medication is being prescribed by, or in consultation with, a pulmonologist.age and nutritional/clinical criteria as stated

CF criteria require pulmonology involvement

Alaska Native or American Indian: Individual meets BOTH of the following: A) Individual is less than 12 months of age at the start of RSV season; B) Individual is Alaska Native or American Indian (Navajo, White Mountain Apache).age <12 months; specified populations

Any use of palivizumab (Synagis) that is not explicitly listed in this policy is considered experimental, investigational, or unproven. Examples include routine prophylactic use for individuals with cystic fibrosis or Down syndrome who do not meet the specific policy criteria, treatment of established RSV disease, and concurrent/duplicate seasonal administration with Beyfortus (nirsevimab) as described in the policy.

Routine use of Synagis in individuals with cystic fibrosis or Down syndrome who do not meet the specific qualifying indications in this policy is not supported and is therefore not medically necessary. The policy notes limited evidence of reduced RSV hospitalization in these groups and refers to guideline recommendations that routine prophylaxis in cystic fibrosis is not recommended unless other indications are present.

Provider Actions, Prior Authorization, and Prescribing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for palivizumab (Synagis). Providers must request prior authorization and document that the individual meets the specific policy medical necessity criteria (age, gestational age, oxygen/medical support requirements, underlying diagnoses, and any specialist consultation requirements) listed in the policy.

Prior authorization required for Synagis (palivizumab) per policy IP0321 (effective 2024-12-15).
No specific step therapy requirements or quantity limits are specified in the referenced policy chunks.
No explicit authorization or denial triggers are stated in the provided chunks beyond meeting (or not meeting) the medical necessity criteria.
No additional documentation requirements are specified in these chunks beyond demonstrating that the individual meets the policy criteria.

Note

Synagis vs Beyfortus Sequencing

Synagis (palivizumab) should not be administered in the same RSV season after Beyfortus (nirsevimab) has been given. If Beyfortus is administered during the season, do not give Synagis later that season. If Synagis was started and fewer than five Synagis doses were given, the infant should receive a single dose of Beyfortus and no further Synagis doses should be administered. If Synagis was given in a prior RSV season and the child is eligible in a subsequent season, Beyfortus should be used in the later season if available.

If Beyfortus administered first in the season → do not give Synagis later that season.
If Synagis started and < 5 doses given → give one dose of Beyfortus, then stop Synagis.
If Synagis was used in prior season, use Beyfortus in subsequent eligible season when available.

Denial Risk

Conditions Not Covered / Experimental

Use of Synagis outside the listed policy indications is considered experimental, investigational, or unproven. Examples include routine prophylaxis for cystic fibrosis or Down syndrome when policy criteria are not met, treatment of established RSV disease, and other uses not specified as medically necessary in this policy.

Routine Synagis prophylaxis for cystic fibrosis patients who do not meet the policy criteria is not covered.
Use for Down syndrome without meeting qualifying criteria is not covered.
Synagis is not approved or recommended for treatment of established RSV infection; prophylactic use should be discontinued after a breakthrough RSV hospitalization.

Prior Authorization

Specialist Prescribing / Consultation Requirements

Specialist prescribing or consultation requirements apply for specific high-risk conditions. Ensure prescriptions are by, or in consultation with, the appropriate specialist as stated in the medical necessity criteria.

Congenital heart disease: prescribe by or in consultation with a pediatric cardiologist, neonatologist, or pulmonologist.
Immunocompromised individuals and cardiac transplant recipients: prescribe by or in consultation with an immunologist, infectious diseases specialist, cardiologist, neonatologist, pulmonologist, or transplant physician as specified.
Cystic fibrosis: prescribe by or in consultation with a pulmonologist.

Documentation Required

Documentation Requirements

No additional documentation requirements are specified in the provided policy chunks beyond demonstrating that the individual meets the stated medical necessity criteria and any specialist consultation/prescribing requirements.

Document clinical evidence that the patient meets the applicable age, gestational age, oxygen/support, or comorbidity criteria.
Document specialist consultation or co-signature when required by the indication.

Note

Operational Notes

There are no step therapy rules or explicit prior-authorization-to-denial triggers described in the referenced chunks; coverage determinations are based on whether the individual meets the policy medical necessity criteria and the sequencing rules with Beyfortus.

No step therapy rules appear in the provided chunks.
Authorization or denial depends on meeting the policy criteria; no separate, explicit denial triggers are listed in these chunks.

OpenPayer

Palivizumab (Synagis) for RSV Prophylaxis

Coverage Criteria for Palivizumab (Synagis)

Coding and Season Thresholds

Provider Actions, Prior Authorization, and Prescribing Requirements

Background

Definitions