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Coverage of Anti–B-Cell Therapies for Cold Agglutinin Disease


Criteria that support coverage decisions for anti–B-cell therapies for cold agglutinin disease, which are not currently FDA approved.

Neil Minkoff, MD: Let me ask you 1 more question before I bring the payers in because I’m setting up the next question with this question. Do you find it difficult to get approval to use any of these agents for your patients?

Mihir Raval, MD, MPH: I haven’t had problems getting chemotherapy-immunotherapy combination or rituximab approved for the patient when they have an actual indication for treatment because there are available data to support asking for those treatments.

Neil Minkoff, MD: Dr Lorber?

Jeremy Lorber, MD: I’m in agreement. Even though we don’t have specific FDA approvals because this is such a rare condition, because there are no FDA approvals, payers typically will pay for it based on the existing data.

Neil Minkoff, MD: Let’s bring my payers in. I’ll start with Dr Gleeson, my old colleague. You’ve heard the data. Is this a category that you’re managing for CAD [cold agglutinin disease], or are there some generalized criteria for something like a rituximab and this is just fitting into the criteria?

Jeremy Gleeson, MD: This is a rare disease, as we’ve discussed, so we don’t have specific criteria for it. Because a drug like rituximab is not FDA approved, most payers would have no problem approving it in the presence of adequate data. We expect that frequently FDA approval will be lacking for these rare diseases, and for a drug that’s widely used in other areas, that’s not an unusual situation. As long as there are adequate data to support it, I don’t think most payers would have a problem approving it.

Neil Minkoff, MD: What about you? I want to bring Dr Stephens in. What about some of the drugs or the molecules where—speaking as a former payer—we don’t have as much experience, like a daratumumab?

Kevin Stephens Sr., MD, JD: We look a lot, and we depend on the provider to provide the additional clinical support for the use of whatever chemotherapy agent they use—the symptomatology, conservative treatment that they tried first, and those kinds of things. We have a process. We call it peer to peer. With our providers reviewing the medical record, we can talk directly with the physician to see and to glean from that what’s the best thing in the best interest of the patients.

Neil Minkoff, MD: You may not know, this might be too specific, but do either of you require these drugs to be go through a specialty pharmacy sent to the patient? Or would you allow the clinic to be dispensing it, administering it, right there in the clinic?

Jeremy Gleeson, MD: We wouldn’t have any particular specialty pharmacy requirement.

Kevin Stephens Sr., MD, JD: That’s correct.

Transcript edited for clarity.

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