Uterus Transplant Cost, Candidacy, & Screening Process

[Dr. Mark Hoffman]
You mentioned Mats Brännström. I remember I went to AGL one year. I think he was one of the keynote speakers. I remember being, honestly, a little confused, like, why do we need uterine transplant? At Mayo, it was obviously not part of my practice as a mix surgeon. Talk to us first about the history of uterine transplant and with that, maybe a touch on why it was started, why it's being done.

[Dr. Elliott Richards]
It's really fascinating. When you talk with the early pioneers including Mats, they had the same reaction and actually, like, why uterus transplant? That's crazy. Mats, he could certainly should speak for himself, and if you ever had the opportunity to chat with him, but my impressions from conversations with him, I got to hang out with him actually at the international conference just last fall, and was able to get the story again from him. It really was uterus transplantation in the modern era has been patient-driven and patient demand.

His story, as I understand it, truly was a patient saying, "Why can't we do this? Why can't we do uterus transplant for me?" His reaction first was like, "That's crazy." Then, as he thought about it more-- and it's been a similar story, I think, for all the early pioneers. First time hearing it being like, "This seems absolutely ridiculous," but as you learn more about the patients, and also the process, it begins to make a lot more sense. One of the goals that I have for our talk today is I hope to convince some of your more skeptical listeners that this is actually something that we should take seriously.

[Dr. Mark Hoffman]
I think he also mentioned that where he's from, it's illegal, surrogacy is illegal. I know that in the state of Kentucky, actually, surrogacy is illegal. We always think, "Oh, why don't you just throw that embryo in somebody else's uterus?" If that uterus is still in that person, in many places in the world, that's not an option. Certainly, patients have the opportunity and the autonomy to make decisions for themselves. Uterine transplants, an interesting topic, but it's also the only option for some patients as well. It's not been around very long. This is not something people have been doing for a very long time.

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[Dr. Elliott Richards]
Correct. In the '50s and '60s, there were a series of animal experiments, mostly autotransplantation, first in dogs and then in primates, removing the uterus and putting it back into the same animal. To my knowledge, there was no demonstrated pregnancies at that time. The first in the modern era uterus transplant was actually in 2000. That was in Saudi Arabia. It was a living donor. There's graft failure at about three months attributed to a thromboembolism.

Then in 2011, in Turkey, there was a deceased donor of uterus transplant that was performed by a plastic surgeon. Interestingly enough, that patient delivered just about two years ago, and so she was on immunosuppression for almost a decade. It was actually Mats Brännström who partnered with them to troubleshoot. They did some revisions of the graft, and that's thought to be the reason why they were able to ultimately achieve pregnancy. I think what's important about the Saudi Arabia and the Turkish case is that these were not done in clinical trials. They were one-offs.

The reason that the Swedish group are really considered the pioneers is they really took a systematic approach to uterus transplantation, actually starting with their own animal experiments. The first animal study showing successful pregnancy was actually in a mouse model in 2010 by Mats Brännström's group. I think Mats recognized that a big failure would set back the field, potentially even indefinitely. They were really very careful and approached it very cautiously. Unlike, unfortunately, these two first attempts that were really just, again, one-offs and, "Hey, let's just do it because we can." What I consider the modern era of uterus transplantation truly began with the Swedish group, with their clinical trial in 2013, and then their successful live birth a year later in 2014.

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[Dr. Amy Park]
I have to admit, when I first heard about uterine transplant, I was like, "Who would want to do that?" Like, "Just get a surrogate." Obviously, when you're on protocol, there's not as much cost to the patient, but it's a huge surgery. We're talking about grafts, we're talking about immunosuppressants. Just hearing about it and the sheer technical aspect and psychological aspects. Also, I have to give the pioneering surgeon so much credit because patients try and push us into things all the time. You have to be really open-minded in entertaining these seemingly impossible endeavors and that can-do spirit. Then saying, "Why not," instead of, "Why," or trying to come from a place of, "Yes." I really do have to respect that.

[Dr. Mark Hoffman]
When it comes to uterine transplant though, and this is something that, again, I think, certainly, in doing some homework for this, it's not something I learned about in residency because it was something that was being done with any regularity when I was in residency. Can you walk us through the process in terms of patient selection? Who is a candidate for uterine transplant? How are we deciding who gets them, et cetera? All the way through a pregnancy. Can you do that in a way that won't waste your whole night with it? I'm sure it's a very simple process.

[Dr. Elliott Richards]
Can I do it in a way that's concise? Yes, absolutely. Let me back up just a second though, and say that uterine transplant is an interesting time, in that, it is beginning to transition from experimental science to really a curative treatment that is on its way to being, potentially, a gold standard care for patients with absolute uterine factor infertility. In fact, the group in Dallas now has a cash pay uterus transplantation that's outside of a clinical trial. They've had three patients who have paid for uterus transplantation. University of Alabama now, they started a trial of, I believe, they're funded for 25 uterus transplants, and they elected not to do it under a clinical trial. This change is happening. Now, for us at Cleveland Clinic and at Penn, both of our centers are still doing this work through a clinical trial, but this transition is happening. It's happening because the efficacy truly has been established.

[Dr. Amy Park]
By the way, how much is the uterus transplant cost? How much are they charging?

[Dr. Elliott Richards]
It'd be great if we had Lisa Johansen on the call to speak. I believe, it's on the ballpark of around 200,000, might be 250,000. I believe that covers IVF and the pregnancy and delivery, so it's like a full package, but don't quote me. This is my understanding of the rough estimates. I'm not answering the question you first asked, but that's a big thing that our centers are working on. One thing just as another aside, it's really so wonderful being in uterus transplantation, is that it's incredibly collaborative between us, the Baylor group, the UAB group, and Penn, where we're sharing data, we're sharing things that we've learned. That's one of the things that we're working on now, is cost-effectiveness analysis. We're building some models and we hope to publish in the next year, but there's going to be some arguments that can be made especially for patients who want more than one child.

That even putting aside the lack of access to just, say, for surrogacy for a lot of people in different states, and certainly, European countries, but there may even be some economic arguments for uterus transplantation. That's getting off-topic for what you asked. In terms of walking through the whole process, I also want to say it's important to recognize who this is for. I was mentioning, setting the stage, talking about it being under the guise first of clinical research because the patients who have gone through and gotten uterus transplant, and I should say, we have over 31 babies born at this point in the United States. The vast majority of patients who have gone through, they have been Mayer-Rokitansky-Küster-Hauser or Mullerian agenesis patients, vast majority. When we look at the 5,000 people who have contacted our three centers, meaning Penn, Baylor and Cleveland Clinic, that's actually only about 20% of the applicants. Because this has really started out as a clinical research trial, we've really selected the best prognosis patients, but this doesn't reflect the actual true population that suffers from AUFI, Absolute Uterine Factor Infertility.

There's huge problems with disparities that these are most often White women, and that's not a reflection of the patients who are suffering. Particularly when you look at secondary AUFI, hysterectomy. It's estimated that as high as 15% of reproductive-age women have had a hysterectomy. We're talking, potentially, hundreds of thousands of women who might-- Of course, that doesn't mean they're all interested in carrying their own child and taking on the risks of uterus transplantation. Potentially, a huge population in the United States that might be interested. Really, it's been just a very small subset. In terms of our trial and who's selected, they go through an extremely rigorous process. With the thousands of people who have contacted our center, we've really only selected, essentially, a dozen women to be recipient candidates. The hope and goal has always been to expand access to this treatment to more women.

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[Dr. Elliott Richards]
Certainly, there was marketing and reaching out to media outlets, and so I'm not going to say there was no-- Definitely, no direct advertising, but there's definitely exposure. Beyond that, we essentially closed off our trial because we found all of our candidates relatively quickly and we still got, again, no advertising, just people finding ClinicalTrials.gov, the email address on there, and just getting hundreds and hundreds of people contacting us.

There is a lot of demand here. I think, while I'm talking about this one particular woman, and she was actually our first successful live birth, her story is, I think, so fascinating because she actually had a child through gestational surrogacy, and it was such an awful experience for her because she had such a loss of control and reproductive autonomy with what the surrogate was doing and all that goes behind that, that she wanted a second child but absolutely did not want to do gestational surrogacy again. Even though it was an option and something that she had tried before, she looked at all the risks and the unknowns, particularly at that time when she was admitted to the trial and said, "This is important enough to me and I don't want to go back to using a surrogate again."