RSV Prophylaxis for Infants and Children: Now Available, But Is it Accessible?

July, a month typically characterized by the relative hibernation of communicable respiratory illnesses, brought with it the U.S. Food and Drug Administration’s (FDA’s) approval of nirsevimab-alip (brand name: Beyfortus) and thus a reminder of the gearing up necessary for the respiratory disease season ahead. Nirsevimab, approved for the prevention of respiratory syncytial virus (RSV), is poised to mitigate the staggering effects of this lower respiratory tract disease. Since significant barriers remain related to distribution, accessibility, and insurance reimbursement for this drug, it is especially important for primary care RNs and nurse practitioners in clinics and medical homes to be well informed on this topic.

RSV: a significant public health burden.

RSV is primarily of concern in the youngest and most vulnerable of the pediatric population, such as those born prematurely, with chronic lung or congenital heart disease. As many of us know all too well, RSV carries significant public health burden, causing more hospitalizations than any other illness in U.S. infants and accounting for 100 to 300 deaths each year in children under five years old.

Recommendations for the new preventive antibody.

While not a vaccine by definition, nirsevimab functions similarly to one. It’s a monoclonal antibody product that provides passive immunization. The American Academy of Pediatrics (AAP) recommends that it be administered “shortly before or during” the RSV season, which roughly translates to providing the jab (via pre-filled syringe that can be administered alongside other routine immunizations) between October 1 and March 31. Local patterns of RSV activity may alter these dates slightly, so we should all keep close watch of information from the National Respiratory and Enteric Virus Surveillance System.

Per the AAP, all infants under eight months old born during or entering this first RSV season should receive the antibody. Ideally neonates will receive nirsevimab within the first week after birth during the RSV season. Infants and children who are eight through 19 months of age who are at increased risk for severe RSV disease and entering this second RSV season should also receive a dose of nirsevimab.

These recommendations are based on multicenter, placebo-controlled, randomized clinical trials (Trial 03, 04, 05) which have shown that nirsevimab confers a 75% reduction in RSV that requires medical attention, including hospitalization. The most common adverse reactions were rash, fever, and mild injection-site reactions. Considering that RSV is responsible for 2.1 million outpatient visits and 58,000 to 80,000 hospitalizations each year for children under five, nirsevimab is revolutionary. This protection lasts approximately five months, the length of a typical RSV season.

Barriers to accessibility.

Though benefits of nirsevimab are clear, actual distribution and accessibility are still murky. It is widely acknowledged that there is no existing infrastructure to ensure all pediatric patients get nirsevimab. The gaps are likely to be most profound among children who are the most vulnerable, whether due to lack of resources or high-risk medical conditions. The Centers for Disease Control and Prevention (CDC) is still working on contracts with the Vaccines for Children (VFC) program, with the goal of having nirsevimab pushed out in early October.

A crucial role for medical homes.

Few hospitals participate in the VFC program, a fact that will impede implementation of administration to neonates prior to discharge. As result, pediatric patients’ medical homes will need to lead the way in providing the injections. Communication between the infant’s place of birth and outpatient medical home will also prove critical to ensure it is clear whether a child has received nirsevimab.

Other expected barriers include the all-too-common lag in insurance payments for new products as well as coding challenges. Since nirsevimab is not a vaccine, it’ll be coded as a drug administration; codes of this nature do not include a counseling component. The AAP is lobbying for a more comprehensive code that reflects the counseling and work surrounding administration of nirsevimab—a cause we should join. This code, 96372 (injection, subcutaneous or intramuscular), is not likely to be usable until closer to the start of the RSV season.

Nirsevimab can be obtained via the Vaccine Shop. The formulation won’t change from year to year and nirsevimab has an 18-month shelf life. Expired doses will be returnable to Sanofi. The AAP offers guidance on ordering nirsevimab. Practices should start planning now in order to implement this product for the 2023-24 RSV season.

Nicole Donager DNP, CNM, FNP, teaches in the midwifery program at Shenandoah University in Virginia and practices at a primary care clinic in Missoula, Montana.