Beyfortus (Nirsevimab) – RSV Prevention for Babies: Considerations for Pediatric Practice Managers and Leaders

Background

The RSV prevention, Beyfortus (nirsevimab) which is a monoclonal antibody, was approved by the FDA on July 17, 2023.  The CDC and ACIP provided recommendations which were published in the MMWR on August 25, 2023. The FDA accelerated approval of Beyfortus since the RSV prevention was categorized as “Breakthrough Therapy Designation”.  Note that Beyfortus is not a vaccine but is prevention that offers passive immunity via monoclonal antibodies that provide immediate and short term protection.     Payers started their reviews after the August 25th, 2023 MMWR publication and began publishing their reimbursement policies in September 2023.   Beyfortus provides protection for about five months and to cover RSV season (usually November – March).  Based on this, the most common approach should be to administer Beyfortus to babies born after 3/1/23 during late October through November.  The RSV prevention, per the manufacturer, will not change from year to year so the practice can use the prevention for patients until the product expires (usually about 18 months). The COVID19 vaccine changes constantly so there is limited time frame to use the vaccine.  The FLU vaccine is updated each Flu season.   Based on the product label and data for Beyfortus, it is anticipated that 99% of the use for most Pediatric practices during the 2023-2024 RSV season will be babies that were born after 3/1/23.

 

Pediatric Practice Leaders Need to Appropriately Manage the Reimbursement Model

Practices will need to stock Beyfortus for both patients that are VFC eligible and those with commercial insurance. VFC will purchase Beyfortus directly from the manufacturer, so there is almost no financial risk associated. Potential financial risks arise when dealing with the reimbursement model for private (commercial) insurances. These risks tend to be related to payer/patient coverage discrepancies and/or inconsistent front desk insurance verification prior to the service being provided.

 

Here are some factors to consider related to the recent approval of Beyfortus:

• Payers accelerated their reimbursement review and medical policy timeline. Most payers made an exception to their traditional approach since there is currently no alternative available for the prevention of RSV in babies.

• Beyfortus is higher in cost than other vaccines. Practices that have a solid plan, and consistently execute said plan, should be able to provide this RSV Prevention to patients while not losing money. Currently, Beyfortus has a higher cost ($495 catalog price) in comparison to standard vaccines. Practices will need to cover costs associated with the RSV Prevention, while maintaining a reasonable profit margin, to ensure long-term availability for the community. Note, being part of a physician buying group can provide providers with a discount on the product. For the fall of 2023, Sanofi is providing an extended prompt pay discount of 150 days on Beyfortus to allot additional time for those experiencing issues related to reimbursement.

• Pediatric practices should devise a focused plan for administering Beyfortus. There are steps that the practice management team can take to minimize risk and optimize the outcome associated with Beyfortus. See below for a more detailed overview. For the PediatricXpress system, specifically, we have designed customized tools and reports to help with this process.

Considerations for Administering Beyfortus:

1. Patients Eligible for Beyforus – The practice manager(s) or leader(s) first need to identify the patient population that are qualified for the prevention (patients entering their first RSV season; high-risk patients entering their second RSV season).
2. Research & Confirm Reimbursement – Each practice should create a comprehensive list of the payers. From this list, the practice should determine contribution by payer to total practice revenue. This provides the practice with an analytical approach in identifying the appropriate reimbursement amount per payer conditional upon associated vaccine costs.
3. Integrate Beyfortus into Appointment Process – The medical leader for the pediatric practice should determine how the administering of Beyfotus will be integrated into visits (i.e. during a scheduled well visit, separate appointment intended only for vaccination).
4. Suggestions on Calling/Scheduling  – For the patients with no scheduled well visit between the dates of October 15th and November 30th, the practice should consider scheduling them for the vaccine prior to the end of November 2023. Due to the cost of this vaccine, the practice should verify each patient’s insurance coverage at least one week prior to their scheduled appointment. 

Medical Coding & Configurations of Beyfortus:

• Five 50 mg/0.5 mL single-dose prefilled syringes in a carton – CPT code 90380 (under 5 kg weight)
• Five 100 mg/1 mL single-dose prefilled syringes in a carton – CPT code 90381 (over 5 kg weight)

Note:  CPT code for administration is 96372 – therapeutic, prophylactic, or diagnostic injection. The account managers set-up all accounts so that the NDC numbers are made available for vaccine inventory, and the CPT codes are readily available in the dropdown menu. The recommended ICD-10 code is Z29.11 – encounter for prophylactic immunotherapy for respiratory syncytial virus (RSV).

Summary:

Beyfortus is an important RSV prevention that is available for the 2023-2024 season for babies.   Pediatric practice leaders should develop a plan customized for their practice including proper monitoring of front desk team members related to eligibility of insurance and medical management approach.