Document text
National Center for Immunization & Respiratory Diseases
Centers for Disease Control and Prevention
Nirsevimab : Implementation
Considerations
Georgina Peacock, MD, MPH, FAAP
Director, Immunization Services Division
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention (CDC)
Implementation Considerations
•Definition of Vaccine
•Cost
•Storage and Handling
•Hospital Dosing
•Outpatient Dosing
•Coding and Immunization Information Systems
•Timing of Vaccination
•2nd Year Vaccinations
•Vaccine Administration
•Safety Reporting
•Vaccine Confidence and Demand
•No statutory definition of vaccine in the statute for the Vaccines for Children (VFC) program
(section 1928 of the Social Security Act)
•No statutory definition of vaccine in the Affordable Care Act (section 2713 of PHS Act), or its
implementing regulations, which has a provision that mandates coverage of vaccine
recommendations included on CDC’s immunization schedules
•CDC has determined that nirsevimab is eligible for inclusion in the childhood immunization
schedule and Vaccines for Children programDefinition of “Vaccine”
Program For Distribution Of Pediatric Vaccines
Coverage of Certain Preventive Services Under the Affordable Care Act
•Cost of nirsevimab estimated at $495 per dose in the private sector
•If recommended by ACIP , nirsevimab will be covered by insurance and included in
the VFC program
oImportance of ensuring equitable access to nirsevimab
•However, nirsevimab cost will still be a potential implementation barrier particularly
for ambulatory practices
oIf nirsevimab included in VFC, practices must carry both VFC and private stock,
which may be challenging for some practicesCost
•Similar to other routine vaccines for children
•Administered as intramuscular injection using single -dose pre -filled syringe
oCan be administered simultaneously with other childhood vaccines
•Dosed by weight/age
o50 mg if <5 kg
o100 mg if ≥5 kg
o200 mg (2x100 mg) for high -risk children entering 2ndRSV season
•Stored in refrigerator at 2 -8◦C
•May be kept at room temperature (20 -25◦C) for up to 8 hoursNirsevimab Storage, Handling, and Administration
Source: California Department of Public Health
▪Jurisdictions may have different scope of practice statutes for who can administer
injectable therapeutics vs. vaccines
▪Scan of state laws indicates that most states allow medical assistants (who frequently
administer vaccines) to also deliver injection drugs
oHowever, organizations may have varied practicesScope of Practice Issues
American Association of Medical Assistants
▪Approximately 10% of birthing hospitals participate in the VFC program
▪Bundled payment model for newborn care
oHepatitis B vaccine more feasible to cover at ~$13 –16/dose
oWill nirsevimab be included in bundled payments?
▪Critical to ensure documentation of in -hospital nirsevimab administration in records
sent to primary care provider
oPotential challenges entering nirsevimab in the immunization information
system (IIS)
oComprehensive maternal -neonatal records will become even more critical if
maternal RSV vaccine is licensed and recommendedHospital Administration
CDC Vaccine Price List
•Communication from birthing hospital
•Communication about maternal RSV vaccine
•Initial investment by pediatricians –unsure on price and demand for nirsevimab nor
demand for new product
•Historical lag in insurance payment for new productsOutpatient Administration
•CPT coding and AMA decision around CPT codes —classified as a drug/therapeutic
•Administration codes do not include a counseling component
•Not eligible for stand -alone counseling
•Potential challenges with recording doses in Immunization Information SystemsCoding
Preparing Systems for Administering a Newly Authorized Vaccine
Across the U.S.
Timeline represents standards for vaccines. Incorporating a MAB
into vaccine systems has the potential to expand timeline due to
increased complexity.
Code set subscription services activate. CDSi resources
are published. Provider & payer systems use these for
system development & deployment .Data publication partners
(FDA, CDC, formulary vendors, & AMA)
Prepare & publish vaccine & drug code
set files for systems development
10-12+
Weeks9
WeeksBLA
Approved
2
Weeks3
Weeks4
Weeks5
Weeks6
Weeks1
Week7
Weeks
Provider & payer systems ready to record
& report vaccine administrationIIS systems prepare for
new vaccine codes
6-12+ weeks post authorizationVaccine ready for VTrckS
ordering & distribution
~2 weeks postauthorization8
Weeks
1-4+ weeks post authorization
1-4+ weeks postauthorization
1-4+ weeks post authorization
•Nirsevimab coded as a therapeutic instead of vaccine could create challenges with:
oInternal provider ordering
oProvision of a vaccine record
oInteroperability/data exchange with electronic health record (EHR) and IIS
•Forecasting (Clinical Decision -Support [CDS] for immunization)
oDosage by weight: CDS does not have access to patient weight
o2ndseason recommendations
oFuture considerations: CDS systems unable to take into account maternal
vaccination history for forecasting for infant nirsevimab immunizationIIS and Vaccine Forecasting Considerations
•Timing of vaccination based on RSV season
oTropical climates may have different/unpredictable seasonality when compared
to most of continental U.S.
•Variability in different localities
oFor example, seasonality in AK less predictable and longer duration
•Second year dosing
oHigh risk populations
oClarifying palivizumab recommendations in the setting of nirsevimab availabilitySpecial Considerations Add Complexity
•Reporting of suspected adverse events (AEs) more complicated for nirsevimab than
other immunizations:
oIf nirsevimab is administered alone, suspected AEs are reported to MedWatch
oIf nirsevimab is administered simultaneously with any vaccine, suspected AEs are
reported to the Vaccine Adverse Event Reporting System (VAERS); additional
reporting to Medwatch not neededReporting of Adverse Events by Patients and Providers
•Will physicians and public accept a new vaccine
•Occurring at the same time as commercialization of COVID -19 vaccine
and seasonal influenza administration
•Vaccine hesitancy and anticipated need for counseling around all
vaccines and products
•Efforts to weaken school immunization requirements and expand
vaccine exemptions at the state levelVaccine Confidence/Demand
•Considerations for implementation
•Risks during this season’s roll out
oTiming of availability of doses
oProvider hesitancy
oUptake
•Complexity of recommendations
oHospital vs. Outpatient
oSeasonality / Timing
oLessons learned with Hepatitis A and B
•Unintended consequencesConclusion and Discussion
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY: 1 -888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
Thank You!