Authored by Dr. Brian Koffman
On 3/22/2024, the US FDA authorized a new pre-exposure prophylaxis (PrEP) to prevent COVID-19 infection in those with CLL and other immune-compromising conditions.
The Ongoing Need in the Immunocompromised Community for COVID-19 Protection
While outcomes for COVID-19 infection have significantly improved for all, including the immunocompromised, the risks of severe disease, hospitalizations, long-COVID, and even death remain higher for those with chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL / SLL), and others with impaired immunity.
Emergency Use Authorization of Pemivibart (PEMGARDA, also formerly VYD222)
Invivyd announced on March 22, 2024, the emergency use authorization of their new pre-exposure prophylaxis (PrEP) for COVID-19, pemivibart or PEMGARDA (formerly VYD222).
It’s a one-hour intravenous (IV) infusion of anti-COVID-19 monoclonal antibody with a two-hour observation period afterward. Based on the blood levels (titers) of neutralizing antibodies necessary to inhibit SARS-CoV-2, repeat dosing is needed every three months. Based on the achieved neutralizing titers, it is expected to be effective against the currently dominant circulating SARS-CoV-2 variant of concern (VOC), which is JN.1. It was also studied in the immunocompromised as it provides passive immunity and does not rely on the patient’s own immune system to respond to the vaccine.
It does have a small but real risk of anaphylaxis (life threatening allergic reaction), so discuss with your healthcare team. But this is great news overall for anyone with CLL / SLL, regardless of their treatment status.
Payment and Availability for Pemivibart (PEMGARDA)
Unlike EVUSHELD and some other prior COVID-19 therapies, the cost will not be covered by the government due to government COVID-19 program funding no longer being available. The drug itself and the charges related to the infusion will be covered under Medicare B, and it’s likely that most commercial insurers are also planning to cover it.
We expect Medicare coverage to happen very quickly. However, the timing of when commercial insurances cover pemivibart (PEMGARDA) is not certain and will vary in timing based on the insurance company.
In most cases, individual institutions or healthcare systems will need to order a supply from the distributor for their qualified patients and will then decide how it is distributed.
Because it will demand more than three hours in an infusion clinic (aka “chair time”) and needs a healthcare team prepared to handle a rare but potentially life-threatening reaction, available timeslots for dosing may not be easy to come by for some time, even after it is distributed commercially.
Bottom Line on Pemivibart (PEMGARDA) for COVID-19 Prevention
We encourage you to discuss with your healthcare team if and how it might fit into your care. If obtaining the infusion is something you and your provider feel is right for you, be prepared. You may need to make multiple phone calls to find it and advocate for your care.
Here is the link to the press release: INVIVYD ANNOUNCES FDA AUTHORIZATION FOR EMERGENCY USE OF PEMGARDA (FORMERLY VYD222) FOR PRE-EXPOSURE PROPHYLAXIS (PREP) OF COVID-19
Here is the link to the fact sheet for patients and care partners: Fact Sheet for Patients, Parents, and Caregivers Emergency Use Authorization (EUA) of PEMGARDA (pemivibart) for Coronavirus Disease 2019 (COVID-19).
Receiving a COVID-19 PrEP monoclonal antibody such as pemivibart serves as an added layer of protection in addition to vaccination, masking, and handwashing. It is another way to feel safer in the world despite our impaired immunity, similar to what was enjoyed when EVUSHELD was effective. PEMGARDA holds promise to be a durable way to improve our odds against symptomatic COVID-19.
