Purpose
The
purpose of this communication is to provide notice regarding the updated
coverage criteria for respiratory syncytial virus vaccine (Abrysvo)
retroactively effective to October 22, 2024 for Commercial members.
Background
Each year in the United States, respiratory syncytial virus (RSV) causes increased hospitalizations and deaths in infants and older adults. In most regions of the United States and other areas with similar climates, RSV season typically starts during the fall and peaks in the winter. Immunization administration schedules may be adjusted based on the local RSV activity in the community due to the variability of the timing of the onset, peak, and decline of RSV within a region.
US FEDERAL DRUG ADMINISTRATION (FDA) APPROVAL
On May 31, 2023, RSV vaccine (Abrysvo) was FDA-approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
On August 22, 2023, RSV vaccine (Abrysvo) was FDA approved for pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.
On October 22,2024, RSV vaccine (Abrysvo) was FDA approved for the prevention of lower respiratory tract disease caused by RSV in individuals 18 to 59 years of age.
Coverage Statement
Retroactively effective
to October 22, 2024, respiratory syncytial virus vaccine (Abrysvo) is
considered medically necessary and, therefore, covered as a
one-time dose regimen for non-pregnant individuals 18
to 59 years of age as a non-routine vaccination.
NOTE: Refer to the routine coverage section of the 08.01.04 Routine/Nonroutine policy for additional coverage information for other indications.
EXPERIMENTAL/INVESTIGATIONAL
Retroactively effective to October
22, 2024, respiratory syncytial virus vaccine
(Abrysvo) is considered experimental/investigational and, therefore, not
covered for non-pregnant individuals younger than 18 years of
age.
Coding
THE FOLLOWING CODE REPRESENTS RESPIRATORY
SYNCYTIAL VIRUS VACCINE (ABRYSVO)
90678