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Sanofi website Follow on XTwo articles summarized below support immunizing infants with Beyfortus® (nirsevimab-alip) 50mg and 100mg Injection prior to birth hospitalization discharge. The first article, Protecting Newborns From RSV: Opening A Reimbursement Pathway, discusses establishing a payment pathway to facilitate reimbursement for immunization. The second article, Successful Implementation of Nirsevimab and Factors Influencing Uptake in Neonatal Care, presents a successful model at Lucile Packard Children’s Hospital Stanford for overcoming clinical and socioeconomic barriers to ensure infants receive immunization prior to discharge. Further details are provided below.
These papers represent the views of the authors, not AHIP. The publication, distribution, or posting of these papers by AHIP does not constitute a guaranty of any product or service by AHIP.
Protecting Newborns From RSV: Opening A Reimbursement Pathway
Protecting newborns from respiratory syncytial virus (RSV) is a critical public health issue yet the traditional reimbursement model may not support RSV immunization in the birth hospital, the preferred site of care. RSV is seasonal, with infections peaking at certain times throughout the year. A typical RSV season runs roughly from fall through spring, with some exceptions, such as in Florida and Hawaii, where the RSV season may start earlier. Since 2023, Beyfortus has been recommended by the Centers for Disease Control and Prevention (CDC) for routine use for newborns born during the RSV season (October through March for most of the continental US). Beyfortus may be administered prior to discharge from the birth hospital or in a follow-up office visit, but, according to CDC guidance, administration during the birth hospitalization is preferred to ensure optimal immunization rates.
The traditional newborn payment bundle is a barrier to access because case rates do not adequately account for the cost of Beyfortus. This hinders timely and equitable access, particularly for newborns with commercial insurance but also for those with Medicaid, as hospitals may be reluctant to deliver the treatment without clear reimbursement pathways.
In the Health Affairs Forefront article Protecting Newborns From RSV: Opening A Reimbursement Pathway, the authors suggest access to this critical preventive care can be resolved by paying hospitals for Beyfortus on a fee-for-service basis separate from the newborn payment bundle.
Successful Implementation of Beyfortus and Factors Influencing Uptake in Neonatal Care
Following FDA approval of Beyfortus, and recommendations from the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP), the study details a universal immunization campaign at Lucile Packard Children’s Hospital Stanford. The campaign targeted all eligible infants discharged from the newborn nursery, intermediate care nursery (ICN), and neonatal intensive care unit (NICU), achieving a high uptake rate with 71% of eligible infants receiving immunization before discharge.
Key strategies for successful implementation included early stakeholder engagement, multidisciplinary collaboration, and proactive logistic planning. The approach serves as a model for other institutions to ensure equitable access to Beyfortus and address both clinical and socioeconomic barriers. Click here to read more.
INDICATION
Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:
- Neonates and infants born during or entering their first RSV season.
- Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season
IMPORTANT SAFETY INFORMATION
Contraindication
Beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.
Warnings and Precautions
- Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following Beyfortus administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.
- Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%).
Please see full Prescribing Information.
Please click here for more information on opening newborn reimbursement pathways for Beyfortus.