Early Experiences With Nirsevimab: Perspectives From Newborn Hospitalists Free

Nirsevimab is the most expensive childhood immunization the CDC recommends, with a per-dose cost of $495 in the private sector and $395 in the Vaccine for Children (VFC) program. For comparison, the hepatitis B and influenza vaccines cost between $14 and $30 per dose.⁸  A federal program, VFC provides free, recommended immunizations for children who are uninsured, certain underinsured children, children enrolled in Medicaid, and American Indian or Alaska Native.⁹  Since its enactment, VFC has been effective and successful in increasing immunization rates for children. Although 86% of pediatrician offices participate in the VFC program, only 10% of birthing hospitals participated at the start of the nirsevimab rollout.¹⁰  To participate in VFC, hospitals were historically required to stock all ACIP-recommended vaccines and physician offices to carry both VFC as well as private stocks of vaccines. Given the significant financial burden placed on hospitals, clinics, and physician offices to purchase nirsevimab, requirements were relaxed by VFC to allow (1) birthing hospitals to carry a limited formulary of vaccines (and not all ACIP-recommended vaccines) and (2) physician offices serving Medicaid-eligible children to bypass purchasing private stocks of niservimab.¹¹ 

While attempting to minimize cost barriers, another problem emerged: a high demand for nirsevimab with a limited supply. On October 17, 2023, ordering nirsevimab through the VFC program was put on hold.¹²  Then, on October 23, 2023, the CDC announced a limited supply of nirsevimab with the 100-mg formulation unavailable for ordering via any route. Sanofi, nirsevimab’s drug manufacturer, stated its close collaboration with the CDC and a commitment to equitable dose distribution through both the VFC and private markets. Meanwhile, the CDC reported anticipating similar RSV hospitalization rates as those seen in the “tripledemic” of 2022–2023, with the Children’s Hospital Association preparing for such a surge through collaboration with community hospitals to maximize pediatric beds, supplies, and workforce.^13,14 

Pediatric providers and facilities have been tasked with dual challenges of navigating nirsevimab shortages and developing a strategy to afford its large upfront costs. To aid in purchasing decisions, the AAP recommended that hospitals and practices consider payer mix, cash availability, and anticipated family acceptance of nirsevimab.¹⁵  Exacerbated by shortages, these purchasing considerations present potential for inequity because of variation in who is able to order nirsevimab, who it will be delivered to, which patient populations will have access to it, which families will consent to it, which insurance companies will pay for it, and when it will be paid for.

Although the eligibility criteria for nirsevimab includes all infants aged <8 months during their first RSV season and children aged 8 to 19 months at increased risk for severe RSV disease, interim more restrictive recommendations were issued by the CDC because of the limited supply.¹⁶  Within the authors’ institutions, some hospitals are able to offer nirsevimab to all eligible infants, whereas others have targeted implementation efforts to higher risk groups, with similar variation in accessibility at affiliated outpatient sites. It is likely that the inconsistencies among a group of tertiary-care, university-based hospitals are only a small sample of the variability present on the national scale.

The multidisciplinary teamwork needed to ensure all eligible infants receive nirsevimab requires pediatric hospitalist involvement as experts in both hospital operations and newborn care. On a local and institutional level, pediatric hospitalists can work with unit leaders, staff, pharmacy, and information technology to ensure that policies and workflow logistics are in place. By implementing lessons learned from the COVID-19 vaccine rollout regarding allocation frameworks, disadvantage indices, vaccine hesitancy, and considerations of equity, hospitalists and local leaders have a responsibility to adapt best practices to protect those most vulnerable to RSV.¹⁷  Decreased availability of pediatric hospital beds and an increasing dependance on major tertiary referral centers makes it important to advocate for nirsevimab prioritization to resource limited settings.¹⁸  Hospitalists can inform policymakers with up-to-date experiences and direct feedback from patients and families while the CDC can support pediatricians by making further prioritization recommendations during shortages. As nirsevimab is distributed, additional studies are needed to determine and monitor cost efficacy and value. Increased transparency as to how VFC doses are being allocated can also aid in planning on a local level. In addition, pediatric hospitalists can collaborate with obstetric providers to increase awareness and utilization of the maternal RSV vaccine.

The current nirsevimab shortage provides an opportunity to cultivate public–private partnerships. The joint AAP and CDC advocacy efforts with regards to nirsevimab have been important steps in increasing availability.¹²  More than 3 months ago, the AAP recommended adding nirsevimab into bundled payments for newborn hospitalization to ease medical center financial strain in purchasing nirsevimab and to “ensur[e] that infants born during RSV season can receive it before they leave the hospital.”⁸  Support for pediatrician practices and health care institutions to purchase nirsevimab in advance while awaiting reimbursements is another important element of an improved state.

In the future, pediatricians and leadership groups can synergistically advocate for lower manufacturer immunization prices. After experiences with the 2022–2023 pediatric respiratory surge, it is important to mobilize available nirsevimab doses as soon as possible. Although Sanofi notes that there was an “aggressive supply plan built to outperform past pediatric immunization launches,” an “unprecedented demand” for nirsevimab highlights the complex factors involved in a national immunization campaign and the need for additional advocacy and involvement of pediatric hospitalists.^19,20  In an era of mistrust in the health care system, the inadequate nirsevimab rollout to date is a missed opportunity to capitalize on an initial enthusiastic response toward immunization and protection of infants.