CurrentMass General Brigham Health PlanPolicy N/A

Beyfortus (nirsevimab) — Coverage Criteria for Prevention of RSV LRTD

This policy governs coverage and prior authorization criteria for Beyfortus (nirsevimab) for prevention of RSV lower respiratory tract disease in infants and select high-risk children under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBeyfortus (nirsevimab) — Coverage Criteria for Prevention of RSV LRTD

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNov 10, 2023

Next Review Date

Key ActionObtain prior authorization for members 2 months to <24 months when they meet age and high-risk criteria and document indication, age, qualifying high-risk condition(s), and recent weight to confirm dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dosestandard approval per RSV season

6 monthsduration of approval

<8 monthscovered without PA up to age

200 mgsecond-season dose

Coverage Criteria for Beyfortus (nirsevimab)

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Authorization Criteria

Authorization may be granted when ALL of the following are met and documentation is provided:

Main criteria: Provider is requesting Beyfortus for the first or second RSV season for prevention of lower respiratory tract disease (LRTD) due to RSV.

Age requirement: Member is 28 days to <24 months of age (member is in the applicable age range for first or second RSV season).

Policy specifies prior authorization requirements for members in the specified age range

Dosing confirmation: Appropriate dosing confirmed by recent weight (recent weight must be provided to confirm appropriate dose per dosing table: <5 kg vs ≥5 kg; infants entering second RSV season receive 200 mg).

Qualifying high-risk conditions

Severely immunocompromised.
Cystic fibrosis with manifestations of severe disease.
American Indian/Alaska Native: Member is of American Indian or Alaska Native descent.
Chronic lung disease of prematurity (CLD): CLD of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the six-month period before start of RSV season or bronchopulmonary dysplasia.
Down syndrome with comorbidity: Down syndrome with comorbid congenital heart disease, chronic lung disease, airway clearance issues, or prematurity.
Congenital diaphragmatic hernia with comorbid chronic lung disease.
Airway or neuromuscular abnormality: Congenital abnormality of the airway or neuromuscular disease.
Congenital heart disease.

Additional dose condition: One additional dose beyond the standard seasonal allocation of 1 may be approved if the provider documents the member has undergone or is planned to undergo cardiopulmonary bypass.

No prior authorization is required for Beyfortus (nirsevimab) when dispensed under the pharmacy benefit for infants up to 8 months of age. The policy also states that Beyfortus is covered under the medical benefit without prior authorization. These coverage boundaries apply specifically to benefit type: pharmacy coverage without PA for infants ≤8 months and medical benefit coverage without PA where applicable.

The policy limits routine coverage to 1 dose per RSV season. Approvals are granted for a single dose with an authorization duration of 6 months from the RSV season onset date. An exception allowing an additional dose beyond the standard one-dose seasonal allocation may be approved only when the provider documents that the member underwent or is planned to undergo cardiopulmonary bypass.

Provider Actions and Requirements

Prior Authorization

Prior authorization required for 28 days to <24 months (first or second RSV season)

Prior authorization is required for requests of Beyfortus for the first or second RSV season for members 28 days to <24 months of age when documentation shows the member meets the listed high‑risk criteria. Note: Beyfortus is covered without prior authorization under the medical benefit and under the pharmacy benefit without prior authorization for infants up to 8 months of age.

PA applies to members 28 days to <24 months requesting prophylaxis for first or second RSV season.
Pharmacy benefit coverage without PA up to 8 months; medical benefit covered without PA.

Step Therapy

No step therapy required

No step therapy requirements are specified for Beyfortus; providers are not required to try another therapy before requesting authorization.

Documentation Required

Required clinical documentation

Provider must submit clinical documentation to support eligibility, including indication, exact age, qualifying high‑risk condition(s), and recent weight to confirm dosing; document cardiopulmonary bypass if requesting an additional seasonal dose.

Indication: request is for prevention of LRTD due to RSV for first or second RSV season.
Member age in the applicable range (28 days to <24 months when PA is sought).
Qualifying high‑risk condition(s) (e.g., severely immunocompromised; cystic fibrosis with severe manifestations; American Indian/Alaska Native descent; chronic lung disease of prematurity with recent medical support; Down syndrome with comorbidities; congenital diaphragmatic hernia with chronic lung disease; congenital airway abnormality or neuromuscular disease; congenital heart disease).
Recent weight to confirm appropriate dose (<5 kg, ≥5 kg, or 200 mg for infants entering second RSV season).
Documentation of cardiopulmonary bypass performed or planned if requesting >1 dose in a season.

Denial Risk

Incomplete documentation may result in denial

Requests that do not document that the member meets all listed eligibility criteria (age for season, qualifying high‑risk condition(s), and appropriate dosing with recent weight) may be denied.

Missing recent weight to confirm dose or missing documentation of the qualifying high‑risk condition increases risk of denial.
Requests for more than one dose without documentation of cardiopulmonary bypass will not be supported.

Definitions and Eligible Population

Eligible population

Primary eligible neonates/infantsNeonates and infants born during or entering their first RSV season

Eligible children up to 24 monthsChildren up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season

High-risk examplesSeverely immunocompromised; cystic fibrosis with severe manifestations; chronic lung disease of prematurity requiring recent medical support; congenital heart disease; Down syndrome with comorbidities; congenital airway or neuromuscular abnormalities; congenital diaphragmatic hernia with chronic lung disease