Pulmonology Coding Alert

Question: Thank you for the respiratory syncytial virus (RSV) vaccine information provided in the reader question in Pulmonology Coding Alert, Volume 24, Issue 3. Has there been an announcement regarding the vaccine approval?

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Answer: Yes. On May 3, 2023, the U.S. Food and Drug Administration announced the first approved RSV vaccine. The Arexvy RSV vaccine was developed by GlaxoSmithKline Biologicals and is approved for administration in patients 60 years of age and older to help prevent lower respiratory tract disease (LRTD) caused by RSV.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in the FDA’s press release announcing the vaccine approval.

The FDA analyzed data from an “ongoing, randomized, placebo-controlled clinical study in the U.S. and internationally” with individuals 60 years of age and older. The main clinical study examined the safety and efficacy of a single dose, and the participants will remain in the study through three seasons of RSV, so researchers can assess the vaccine’s effectiveness as well as how safe and effective additional vaccinations will be.

According to the FDA, the study involved 25,000 participants with half receiving the vaccine and the other half receiving a placebo. The participants receiving the Arexvy vaccine experienced an 82.6 percent reduction in the risk of developing RSV-associated LRTD and a 94.1 percent reduction in the risk of developing severe RSV-associated LRTD.

The FDA also approved Abrysvo on May 31, 2023, which is a second RSV vaccine from Pfizer. According to the manufacturer, Abrysvo is a bivalent prefusion vaccine, whereas the Arexvy vaccine is made with a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3).

In a May 5, 2023, Category I Vaccine Code early release, the AMA published 90679 (Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use) to the AMA website and made the code effective as of May 3, 2023. This code joins 90678 (Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use) as the only two RSV vaccine product codes in the CPT^® code set.

However, even though there are approvals and created CPT^® codes, the vaccines are not ready for distribution.

Post-approval, the CDC is required to meet and provide recommendations, such as which locations can distribute and to whom (i.e., all persons over 60 years old or those with certain conditions).

If the recommendations are provided without a prolonged delay, the vaccine could be available later this year. This also gives the payers enough time to address their coverage policies.

Resources: Read the Arexvy FDA press release at www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine and the Abrysyo approval letter at www.fda.gov/media/168890/download.