Overview

This document addresses the use of Beyfortus (nirsevimab), a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor approved by the Food and Drug Administration (FDA) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and pediatric individuals up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. In August 2023, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) provided recommendations on the use of Beyfortus for prevention of RSV lower respiratory tract disease.

Coding

References

Clinical Criteria

Document History

First RSV Season Prophylaxis

• Infants aged <8 months born during or entering their first RSV season are recommended to receive one dose of Beyfortus
• 50 mg for infants < 5 kg and 100 mg for infants 5 kg or greater

Second RSV Season Prophylaxis

• Children aged 8–19 months who are at increased risk of severe RSV disease and entering their second RSV season are recommended to receive one 200 mg dose of Beyfortus:
• Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season
• Children with severe immunocompromise
• Children with cystic fibrosis who have manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight-for-length <10th percentile
• American Indian and Alaska Native children

In September 2023, ACIP recommended use of maternal vaccination with Abrysvo during 32 through 36 weeks gestation to prevent RSV lower respiratory tract infection in infants. ACIP advised that either maternal vaccination or Beyfortus is recommended for RSV prevention in infants but both agents in combination are not needed in most cases. Specific information about national and regional RSV trends, especially pertaining to the peak variations in Florida and Alaska, is available from the National Respiratory and Enteric Virus Surveillance System (NREVSS) at: http://www.cdc.gov/surveillance/nrevss/rsv/index.html.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Beyfortus (nirsevimab)

Requests for Beyfortus (nirsevimab) may be approved if the following criteria are met:

1. Individual is using for the prevention of respiratory syncytial virus (RSV);
2. Individual is less than 8 months of age and has not previously received a dose of Beyfortus (ACIP);
3. Individual meets one of the following:

• Infant's mother did not receive maternal RSV vaccination with Abrysvo OR vaccination status is unknown;
• Infant's mother did receive maternal RSV vaccination with Abrysvo; AND

• Infant was born less than 14 days after mother received RSV vaccination; OR
• Infant’s mother may not mount an adequate immune response to vaccination due to an immunocompromising condition OR has a condition associated with reduced transplacental antibody transfer (including HIV infection); OR
• Infant has undergone cardiopulmonary bypass; OR
• Infant is at substantial increased risk for severe RSV disease (including hemodynamically significant congenital heart disease, intensive care admission and requiring oxygen at discharge);

4. Individual is 8 – 19 months of age and entering their second RSV season (ACIP); AND
5. Individual meets one of the following criteria:

• Documentation is provided indicating the individual was a preterm infant born at less than 32 weeks, 0 days gestation who required at least 28 days of oxygen after birth AND continues to require medical intervention within 6 months of the start of the second RSV season (including supplemental oxygen, chronic corticosteroid therapy or diuretics); OR
• Documentation is provided indicating cystic fibrosis with severe lung disease (history of hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable) or weight for length less than tenth percentile; OR
• Documentation is provided indicating profoundly immunocompromised (including severe combined immunodeficiency, advanced acquired immunodeficiency syndrome, undergoing organ or hematopoietic stem cell transplant, or an absolute lymphocyte count of less than 100 cells/mm3); OR
• Individual is an American Indian; OR
• Individual is an Alaska Native.

Requests for Beyfortus (nirsevimab) may not be approved for the following:

1. Treatment of RSV; OR
2. Individual has received five doses or more of Synagis (palivizumab) during the same RSV season; OR
3. May not be approved when the above criteria are not met and for all indications.

Approval duration: Beyfortus approval is limited to shortly before or during RSV season as determined by CDC surveillance data (http://www.cdc.gov/surveillance/nrevss/rsv/index.html) or local health department. One dose may be approved during the months of October through March

Quantity Limits

Beyfortus (nirsevimab) Quantity Limits

• Drug
• Beyfortus (nirsevimab) 50 mg/0.5 mL
• Beyfortus (nirsevimab) 100 mg/mL

Dosing Limit

• First RSV season: one 50 mg syringe if less than 5 kg
• First RSV season: one 100 mg syringe if 5 kg or greater
• Second RSV season: two 100 mg syringes

Quantity Limit

• One syringe, one time only
• Two syringes per 6 months

One additional dose may be approved for individuals undergoing cardiac surgery with cardiopulmonary bypass.

Override Criteria

1. First RSV season

• If surgery is within 90 days of receiving Beyfortus, may approve additional dose based on current body weight (one 50 mg syringe if less than 5 kg OR one 100 mg syringe if 5 kg or greater).
• If surgery is more than 90 days after receiving Beyfortus, may approve one 50 mg syringe.
• If surgery is within 90 days of receiving Beyfortus, may approve two 100 mg syringes.
• If surgery is more than 90 days after receiving Beyfortus, may approve one 100 mg syringe.

2. Second RSV season

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• 90380
• 90381
• 96372

ICD-10 Diagnosis

• Z23
• Z29.11

Document History

Revised: 11/17/2023