Obtain prior authorization to verify guideline-based eligibility

Prior authorization is typically required to confirm that the infant/child meets guideline-based eligibility (e.g., gestational age criteria, chronic lung disease or hemodynamically significant CHD, and appropriate season timing) and that the planned number of doses (usually up to 5 per RSV season) is consistent with recommendations.

• Confirm gestational age and age at season start (e.g., <29 weeks gestation and <12 months for first-season eligibility).
• Document qualifying conditions such as CLD, hemodynamically significant CHD, neuromuscular/airway abnormalities, profound immunocompromise, or selected cystic fibrosis criteria.
• Indicate intended dosing plan (15 mg/kg IM monthly) and number of monthly doses (typically ≤5).

Document medical necessity per AAP criteria

Provide medical necessity justification demonstrating the patient meets AAP qualifying clinical criteria (for example, prematurity <29 weeks gestation and age <12 months at season start, or CLD defined by gestational age <32 weeks and >21% O2 for ≥28 days).

• If claiming CLD, include documentation of gestational age and oxygen requirement for the first 28 days after birth.
• For second-season requests, document ongoing medical support (supplemental oxygen, chronic corticosteroid, or diuretic therapy) within the 6 months before season start.

Include AAP-consistent eligibility details with prior authorization

When requesting authorization for Synagis, include documentation consistent with AAP recommendations: gestational age, presence and definition of CLD, hemodynamically significant CHD details, immunocompromise status, and planned administration (15 mg/kg IM monthly).

• Specify the AAP-defined high-risk category being claimed (e.g., preterm <29w0d, CLD, HS-CHD, neuromuscular/airway condition, profound immunocompromise <24 months).
• Include intended dosing: Synagis 15 mg/kg IM once monthly beginning prior to local RSV season onset.

Reference Aetna policy portal for prior authorization specifics

Consult the Aetna policy portal and Clinical Policy Bulletin notes for specific prior authorization processes and any administrative requirements referenced by the policy.

• Follow Aetna Clinical Policy Bulletin instructions for submission and documentation.
• Check policy history and additional information pages for updates to prior authorization procedures.

No step‑therapy sequencing; not for treatment of active RSV

No step-therapy or sequencing requirements are specified; palivizumab is prophylactic and is not used to treat active RSV infection—do not submit authorization requests as treatment for acute RSV disease.

• Do not use palivizumab as therapy for active RSV; clinical trials and reviews do not support treatment efficacy.
• No prior requirement to fail other therapies is indicated for prophylactic use.

Recognize palivizumab as adjunctive—not primary—therapy in immunocompromised patients

In immunocompromised patients, established antiviral therapy (e.g., aerosolized ribavirin) and infection-control measures are the primary treatments; palivizumab is considered adjunctive and not a first-line therapy for active infection.

• For RSV infection in immunocompromised adults/children, aerosolized ribavirin is the preferred backbone of therapy.
• Palivizumab may be considered adjunctively for prevention in high-risk immunocompromised patients but lacks randomized trial evidence for treatment.

No step therapy requirement specified

No step therapy requirements are specified in this policy for initiation of palivizumab prophylaxis.

No step therapy requirement (confirmatory)

(Duplicate) No step therapy requirements are specified in these policy sections.

Document bypass and consider postoperative 15 mg/kg dose

If the patient undergoes cardiopulmonary bypass and remains eligible for prophylaxis, document the perioperative bypass and consider administering a postoperative dose of palivizumab 15 mg/kg when the child is medically stable.

• Document occurrence of cardiopulmonary bypass and the indication for continued prophylaxis.
• Record timing and dose of the postoperative 15 mg/kg palivizumab administration.

Document dosing plan and qualifying conditions for authorization

Support authorization and dosing requests with documentation showing the intended dosing schedule (typically up to 5 monthly 15 mg/kg doses) and the qualifying clinical condition(s) that meet AAP criteria.

• Include birth gestational age and age at season start (e.g., <29w0d and <12 months for first-season eligibility).
• If claiming CLD, provide oxygen requirement history (>21% O2 for ≥28 days) and evidence of ongoing medical support if requesting a second season.

Record Synagis dosing: 15 mg/kg IM monthly starting before season

Document administration as Synagis intramuscular 15 mg/kg once monthly beginning prior to local RSV season onset; include this dosing plan in authorization requests and medical records.

• State planned start relative to regional season (e.g., beginning in November in many areas).
• Indicate the number of monthly doses planned (typically up to 5).

Follow Aetna Clinical Policy Bulletin for documentation resources

Include policy history and Clinical Policy Bulletin resources when preparing documentation; follow Aetna Clinical Policy Bulletin notes and definitions for submission and record-keeping.

• Use the Clinical Policy Bulletin as a guide for documentation requirements but consult the policy portal for full administrative details.
• Keep records of policy versions and review dates cited in submissions.

Limit routine dosing to a maximum of 5 monthly doses per season

Do not request more than five monthly doses for routine prophylaxis within the continental United States; administration beyond 5 monthly doses in a season is generally not recommended except in exceptional atypical interseason situations.

• AAP guidance states 5 monthly doses provide >24 weeks of protective concentrations for most infants.
• Consider extended dosing only during atypical regional interseason RSV activity and document regional surveillance supporting the decision.

Palivizumab is not recommended for outbreak control in health‑care settings

Do not rely on palivizumab for control of health care–associated RSV outbreaks; emphasize strict infection‑control measures instead and be aware that requests citing outbreak control without qualifying clinical indications may not be supported.

• Primary emphasis for outbreak control should be infection control and cohorting of infected infants.
• AAP states palivizumab use is not recommended to control health care–associated RSV outbreaks due to lack of rigorous supporting data.

Do not rely solely on antigen assays to define RSV season timing

Avoid using antigen-detection assay results alone to define RSV season onset/offset for prophylaxis decisions or authorization timing, because antigen assays may overestimate risk at season edges; prefer PCR-based thresholds or local surveillance data when available.

• Antigen-detection assays have low sensitivity/specificity at season onset and end and may yield high false-positive rates when prevalence is low.
• Consider PCR-based definitions (e.g., >3% RSV-positive for the first of two consecutive weeks) or state/local surveillance to determine season timing.