Rejected for Evusheld?

[Podge88]

Has anyone else been rejected for Evusheld based on their antibody results? Hematologist is telling me I don't qualify because I have antibodies after 3 first Moderna doses (2100 AU). I think this is the health system policy as they're trying to prioritize patients because of low availability and that it may be available to me in the future. Just curious if anyone else has experienced this? Thank you.

[cajunjeff]

Podge, as per the language in the emergency use authorization (EUA) authorizing the use of Evusheld in the US, your hematologist is probably technically correct. Someone who is immunocompromised and has mounted an antibody response to a Covid vaccine does not qualify.

Here’s the rub though. Your hematologist is one of the few people who might read and understand the EUA. When I got my Evusheld, no one asked me if I mounted a response to the vaccines. (I did not, but my guess is the average Cll patient doesn’t know if they did or did not and never did antibody testing anyway).

It’s also worth noting that the EUA order doesn’t give any real guidance as to what qualifies as an adequate immune response to a vaccine. Your hematologist might fairly conclude that your antibody response equates to an adequate immune response, but I don’t think anyone knows for sure how predictive of protection antibody tests are for us.

My strong guess is that if you found a center with a supply of Evusheld you could get the shots with an order from a gp or walk-in clinic doctor just with proof of you having leukemia. Very few doctors understand this EUA, I had to explain it to the doctor who authorized Evusheld for me. He knew about my leukemia and that was enough for him.

There is somewhat of a moral issue involved. Should a Cll patient who has shown no antibody response to vaccines have priority over a Cll patient who did have a response in an area where there is a shortage of Evusheld? I would say yes, you triage the drug to those most at risk. It’s still a bit of a gray area to me because antibody tests can be all over the map and reasonable minds can differ over what the results of the testing actually means in terms of protection for us.

I hope that analysis helps. It’s just my layperson view of things. The best solution would me that we have an adequate supply of Evusheld such that everyone with Cll would qualify regardless of antibody testing.

One might argue you would have been better off never testing for antibodies. Would your hematologist have required an antibody test before authorizing Evusheld? I doubt many doctors would require that. The EUA doesn’t require that.

AUTHORIZED USE

EVUSHELDTM (tixagevimab co-packaged with cilgavimab) is authorized for use under an EUA for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and

- Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or

- For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

evusheld.com/?source=EVU_N_...

[Bikram21]

I’m in Boston MA and because of the shortage there are tiered groups (transplant patients etc.) and a lottery system. At this point, I’m not holding my breath.

[Dinasantos in reply to Bikram21]

Where are u looking in Mass? Have not been able to find.Thank you!

[thompsonellen]

I'm getting a shot on Monday at UC and no one has tested to see if I have antibodies. The clinic knew I produced antibodies after the second shot because they tested me as part of a trial. I did not ask for the shot, but when they said they might have one for me, I said I would take it if it were their recommendation. I don't feel a moral dilemma, though some may say I should. I am in active treatment (LP-168) and am just over 5 months out from my booster.

[Justasheet1 in reply to thompsonellen]

Ellen,

Good for you and you would meet the criteria where I received it; why wouldn’t you?

I’m attaching the form they used for me with their criteria.

Jeff

Evusheld Administration Form

[Podge88]

Thank you all for your thoughtful responses. Yes, there are many issues to consider here, and certainly I understand the health system's (current) need to prioritize patients given the shortage. I guess you can say I have "enough" antibodies, which I'm truly thankful for, but no one has ever really defined what "enough" is, knowing that there are many factors to immunity against covid. I'm going to continue pursuing to see if I am able to find a dose that doesn't take it away from someone who is in greater need. Hopefully this issue will resolve as supplies increase and it becomes more readily available. Thank you all again.

[Bikram21]

That’s ridiculous!Keep fighting the fight. All along we have been told that our antibody level didn’t matter because there was no proof that ours worked. But now SOME LOCATIONS are checking your antibodies and using that as criteria to determine whether or not you are eligible. Each location sets their own rules. My major cancer center had me in a lottery and would not give me an outside referral to another location where I had found a good supply (sound like a drug addict 😂). I contacted my primary, sent her the guidelines as to who can prescribe (any doctor or nurse practitioner)and was given the referral. I was referred to a rheumatologist (LOL)that works at the center. I had a teleconference with the rheumatologist nurse and I’m receiving the injections on Monday and no questions about antibodies. I don’t think the rheumatologist’s nurse even knew what CLL- was!

[may04cll in reply to Bikram21]

I just ask this question to my C center . They responded it was only given to persons in treatment. Well treatment for which cancer I'm wondering? I've had 3 Modera shots plus the booster(half dose). The center says I'm good to go with that. When will everyone get on the same page with this important topic?

[Bikram21 in reply to may04cll]

Probably not for a long time! It is so maddening! Keep pushing… The doctors don’t even know what to do.

[Pin57]

Hi Podge88 - I see this is your first post n an interesting one! Great question as I’m in your boat with high antibodies scores, have CLL, but havnt posed the Evusheld question/need to my CLL doc. My thinking is wouldn’t a high level of vaccine spike antibodies work just like Evusheld high level of spike antibodies?

I did get clear direction to go get antivirals (Paxlovid) should I come down with current omicron version of Covid, even having high spike antibodies, cus my CLL doc said can’t count on our CLL damaged immune system. Good to know.

Good luck on your Evusheld search, hope you score some.