The State of Gene Therapy in Stop Loss

Mehb Khoja

All right, welcome back to Firm & Final everybody. And for today’s topic, it’s the state of gene therapy. And I have with me today three wonderful guests. We have Ashley Hume who is the president of Emerging Therapy Solutions. We have Kelly Munger who is the Head of US Health at PartnerRe. And we have Brooks Wildasin, who is the Chief Product and Innovation Officer at Havarti Risk.

And for my very first question, I want to ask you guys, why are you so into gene therapy? What do you guys do today that has you connected to gene therapy? Kelly, why don’t we start with you?

Kelly Munger

Sure. PartnerRe is a big reinsurer and stop loss carrier, right? And, so we wake up every day thinking about large, complicated claims and gene cell therapies they fall right into that bucket. So that’s definitely why we’re interested in it. And our clients are very interested in it.

Mehb Khoja

Yeah, Ashley, how about you?

Ashley Hume

Well, at ETS, it is a huge part of our focus. So we work on catastrophic claims for things like transplant. But cell and gene therapy has really been our focus over the course of the last six years since we started the company. And personally, I just think it’s wildly cool science. And I think, you know, it’s pretty incredible that as a market, we are moving from treating disease to, in theory, curing it.

So it’s just really cool science.

Mehb Khoja

And Brooks, how about you?

Brooks Wildasin

Yeah thanks, Mehb. So here at Havarti Risk, we are primarily an actuarial consulting firm. And with this, these types of therapies, it’s a large actuarial consideration across different types of payor clients. So, you know, health plans down to self-funded employers, Medicaid and Medicare as well. So I’d say, I have both a personal and kind of professional interest in the science, having been in the cell and gene therapy space kind of since the inception, working alongside pharmaceutical manufacturers, and so got to really experience the market from that side of things before delving deeper into the impact on the payer community at large.

And as I think about cell and gene therapy overall, the impact to our health care ecosystem is just so massive and going to continue to evolve. And so I like to stay as close to the topic as possible and evolutions. And, you know, it’s something that I can sit and read about for hours and not even think about it as a job.

Mehb Khoja

Sit around and read about it, think about it for hours. Now, the reality is the four of us have known each other for like years, and we’ve been in that gene therapy and cell therapy circles for many, many years. So I’m going to take you guys back to 2019. And at that time there were two gene therapies in the market.

It was Luxturna and Zolgensma. And the big fear was that Roctavian was going to be coming out in 2020. That had all the insurers and reinsurers kind of going crazy. It was supposed to come out August of 2020 at the low, low price point of $4.5 million, and then it was delayed. And then COVID happened, and then Roctavian got delayed again.

And then finally it came out in June of ’23 with a reduced price tag, $2.9 million. But since that time, we just haven’t seen the level of utilization that we thought. How do we get this wrong about Roctavian?

Ashley Hume

Well, first of all, I’m just going to say it was originally Valrox, remember?

Mehb Khoja

That’s right. Yeah.

Ashley Hume

That’s right. So yep, I don’t know that I’ve ever heard the marketing story behind that and why they switched to Roctavian. But that’s a side note. Well, I can start with where things maybe went sideways. I think, you know, it’s interesting because people put so much focus and emphasis on hemophilia and so much else is happening in gene therapy.

But you’re right. It was the first, you know, big scary gene therapy for the market because it had, you know, a huge prevalence. And people were afraid that every single hemophiliac was going to jump in line and get this therapy the minute that it hit the market. And what we learned was that the target market for, you know, the hemophilia gene therapy was a college age guy.

And the lifestyle expectations and impact for that college age guy did not outweigh the value that they might have received from receiving the gene therapy.

Mehb Khoja

So go into this into more detail because it comes down to booze, right?

Ashley Hume

Yeah. They can’t drink alcohol. And I mean, they can’t have unprotected sex. Like these are big lifestyle decisions for a 20 something year old guy, you know, because the work happens in their liver and that’s, you know, those are risks that they have to be cognizant of. And there’s a ton of follow up and other things that they have to do. If they receive the therapy and you know, they’re not in contact sports anymore. So they’re not, you know, much of a risk or as much of a risk for a bleed. And they’re a really great therapies that have been on the market for a long time that they’re used to taking, and it’s just not a risk people are willing to take.

That coupled with the fact that, you know, you look at the pipeline, especially then, and there was a whole bunch of therapies in development for hemophilia, and are you going to get the first one or are you going to wait until there’s more on the market and then evaluate?

Brooks Wildasin

Yeah and just to underscore that point that Ashley made, talking about it from the science perspective, especially with AAV based gene therapies, and this isn’t specific to Roctavian, but that pipeline is critical from a patient sentiment perspective. If you are to take one of these therapeutics and the next therapy comes for that disease state and uses the same viral vector, your body will have built up antibodies to the viral vector, and you likely will not even be able to use another therapy as an option.

So the lifestyle changes I completely agree with Ashley, but then also just thinking about what the future could hold and decisions you might want to make down the line, especially if something comes out with a stronger degree of efficacy.

Mehb Khoja

Kelly, what about the reinsurers? Because everybody was worried about this. And when you think about hemophilia, that’s the one line item that every stop loss carrier and reinsurer is lasering and excluding. How were reinsurers thinking about that particular therapy back in 2019?

Kelly Munger

Yeah, I think it was really scary. And you hit it on the head with these are claims that we’re already lasering and, you know, worried about and seeing big claims and paying big claims on hemophiliacs. So, you know, it was something that was a big concern. And I think going into this, there was so much that we didn’t know, right?

We had to make assumptions. We were making guesses. And, you know, that’s what insurance and reinsurance pricing and underwriting is about. Right? We take what we know. We try to make some guesses, we make some assumptions and things. And you know, we got a lot of things wrong because I think we all assumed we’d see more of these claims than we did.

And, you know, even now, I don’t think we’ve paid a hemophilia gene therapy claim. So the frequency hasn’t been there and the take up rate hasn’t been there. But at the time for us, our margin, you know, a few of these claims eat up our margin really quickly. So we’re concerned about it.

And things like supply chain issues and these hospital logistics and all of that. I mean we didn’t think about that. So I just think there were a lot of unknowns.

Mehb Khoja

I think it’s good to acknowledge that we got it wrong. I think the entire actuarial community amongst like stop loss and reinsurance, they all basically got it wrong. I think we all aired on the side of conservatism. Exactly what you said, Kelly, it just takes one of those claims to wipe away the margin that’s already compressed in this environment.

And so you just couldn’t take that chance. And so that meant a lot of lasering. That meant a lot of increase in reinsurance expenses. But all the other things you said also had a lot to do with the slow utilization of that particular therapy. I guess, tell me what you guys think about COVID and how did that impact the approval, timing, and process for gene therapies?

Kelly Munger

I think it was a huge distraction, all the way across the board.

So for patients, right, for the trials, for the hospitals, for, you know, for reinsurers and stop loss carriers, we were focused on COVID and what was happening. So I just think it was a really big distraction, which go ahead, Brooks, you’re probably going to talk about some of the some of the other impacts on the manufacturing side.

Brooks Wildasin

Yeah, absolutely. I think one of the biggest impediments was the FDA’s ability to get into the manufacturing facilities and validate protocols and quality control. And, you know, really all the variables that are outside of just the drug, the treatment itself, with regard to manufacturing and because they couldn’t travel, they couldn’t get into the facilities, at least for a period of time during COVID, that dramatically delayed their ability to review applications and, you know, assess the safety and efficacy of the therapeutics.

So even with accelerated approval mechanisms and things in place, if they can’t get in and actually validate the manufacturing processes, then they can’t approve therapies. And I mean, frankly, that impacted therapeutic development across the board beyond just selling gene therapies. But I do think it had a disproportionate impact to selling gene therapies as well.

Ashley Hume

Well, and I take it back even a step further, like patients couldn’t go to the hospital to participate in clinical trials. And so even the overall pipeline was pushed back. So absolutely true, everything that Brooks just referenced around the FDA and the I mean, they were also really busy with vaccines and everything else that was happening at the time.

But in general, like every isolation bed was taken and every resource had been redeployed, like the clinical trials themselves suffered significant delays. And so we’re just starting to see some of the therapies. We just recently actually because we’re going through a marketing exercise right now, we just recently looked at some slides from 2019 and 2020, and our pipeline projections from 2019 to 2020 were still not wrong.

Like a lot of those are right now going through the process of approval, because they were delayed and they had to get to whatever numbers they needed to get to be able to submit their BLAs. So I think we’re still feeling the effects of COVID.

Mehb Khoja

Okay. But COVID started in roughly March of 2020. I think everybody started coming out of COVID times, let’s say summer of 2022. And somewhere between that time and let’s say the start of ’23, we probably have seen roughly ten therapies approved post-COVID. And there’s now treatments for hemophilia B and sickle cell, beta thalassemia, Duchenne muscular dystrophy. The average costs have actually gone up.

The price tags have gone up. What was originally an average price point of $2 to $2.5 million is now $3 to $4 million. But the utilization is still not there of even of these more recent therapies. What’s the difference that we’re seeing between the therapies that came to market before COVID and those therapies that came to market after COVID?

Brooks Wildasin

I’ll jump in again here. Pre-COVID, many of the therapies that were approved were more on the, fit more into the cell therapy bucket, specifically with our CAR-Ts, which tended to have lower price points out of the gate than the gene therapies. And we’ve seen that pricing be contained even further in some cases, especially given competition in the markets.

I also think that pre-COVID, the therapies that were approved in one case with Luxturna had a very small patient population, and so they had to right size the price tag there. I also think that, some of the increased work and research done by organizations like ICER to help to prove the value of the therapeutics using various metrics, quantitative, and qualitative, has in some cases impacted the ability to price a little bit higher.

Lastly there, I think some of the R&D expenses associated with the therapies that were approved post COVID were much, much higher in that they had been under investigation in clinical trials for significant periods of time, I mean, in some cases up to a decade. So when you think about the investment that had to be made, along with some of those other qualitative and quantitative variables, that you can read about in some of the ICER publications, that’s being reflected in the prices that we’re seeing today.

And then lastly, layer on minimal competition in, at least in most of the disease states, it represents the ability to charge a little bit more for these therapeutics.

Mehb Khoja

Absolutely.

Kelly Munger

We’re starting to see too, post-COVID, more mark up on the provider side. So you know being hospital side. So really that’s impacting the cost as well. So not only are the average wholesale prices higher, but the actual cost that comes through is much higher too.

Mehb Khoja

Yeah, you’re talking about like the cost of administration. When a hospital, they get the ingredient which might be the wholesale acquisition cost $3 or $4 million. But then they’re adding another expense to that for them to actually administer and then make a margin on their work.

Kelly Munger

Right. And sometimes that’s quite large actually.

Ashley Hume

Yeah. We’ve seen variability I mean significant variability to like pass through up to, I mean we had a claim recently come through at $12 million for $3 million drug. Now obviously there’s going to be discounts and things like that. But if it’s PPO contract and it’s 80% of charges, I mean that’s insane.

Mehb Khoja

Then that’s the charge.

Ashley Hume

Yep.

Mehb Khoja

Yeah. And no stop loss carrier or reinsurer wants to see one of those types of claims. Now I don’t want to like belabor this point about low utilization, but here in the news recently, it just feels like gene therapy has taken another blow. Right. So in the past couple of months, we’ve seen Pfizer is exiting both hemophilia A and B.

Bluebird Bio, they make, I think, three different gene therapies. They’re looking for ways to sell their company because the utilization on beta thalassemia and sickle cell just hasn’t been there. So what is the future of gene therapy. Is this a thing? Is it going to happen? Or is all that time we spent in those gene therapy circles for the past eight years going to waste?

Ashley Hume

I just want to make one comment before we answer your specific question. Just, you know, we started the conversation talking about hemophilia. You’re absolutely right. I think it’s been less than a dozen across A and B, that have been treated at least that we’ve heard about, anecdotally. And, you know, that’s very true for hemophilia.

But when you look at the utilization for SMA, for Zolgensma, or if you look at Elevidys for Duchenne, I mean, that’s I think something that’s really important for people to keep in mind about gene therapy is hemophilia gene therapy was essentially an elective gene therapy. But if you have a child born with SMA, or if you have a child with Duchenne, you’re absolutely going to get that gene therapy if you can. If that patient’s qualified, they’re getting it.

And we’ve seen significant utilization of those two therapies. And I think too just, you know, keeping with kind of pre-COVID versus post, when you think about Zolgensma, you know, when it was first approved, it wasn’t on the RUS panel. And so it would be months before these kids would be treated. And now it’s on the RUS panel in all 50 states and they get treated right away.

Yeah. Right. And I think that when longer term studies come out, we’ll see differences in efficacy as a result. So I think you know we can’t… that’s what’s so cool and unique and different and challenging and wild and keeps us all very busy about gene therapy is that every single one of them is different. And we have to kind of address them individually because they don’t have the same sets of challenges. I went down a different road. It may have been, probably didn’t answer your question, but I still think it’s coming.

Kelly Munger

Yeah, I expect that the therapies we’re still going to see these right into the future and we’re going to see more and more of them. I do think, though, that the manufacturers are learning, right. And they may focus in different areas or, you know, we may see some different things than we’ve seen in the past. They’ve also had an education process here, right. I don’t think they’re going away.

Brooks Wildasin

Yeah. And I also think that modalities of delivery and different technologies are going to further amplify the velocity of, not just the pipeline, but adoption over time. So looking at one of the newer approved therapies, which leverages tumor infiltrating lymphocytes, TIL therapies, and can treat solid tumors. Most people when they think about cell and gene therapy, especially in the CAR-T space, they hear oncology, right.

And hematology, which that’s what those therapies initially were treating were blood cancers. But 80% or so of cancer in the United States or excuse me, in the world is actually solid tumors. So as new technologies and even adaptations of things like CAR-T come about to treat those types of cancer. Now we’ve got a whole different stratosphere of numbers to play with because you’ve got, you know, much larger populations.

To the extent that these therapeutics come out and maybe are approved higher than a fourth line out of the gate, that’s going to have a sizable impact on exposure and utilization.

Mehb Khoja

Yeah, I agree with that. I think precision medicine is here to stay. And this is like the future of medicine. Right. And gene therapies have been studied for over 20 years now. And they just started coming to market like five, six, seven years ago. And so that wave is absolutely coming. We need to be ready for that.

What type of solutions are needed in the market to protect from cell and gene therapy, the risk exposure, as well as what individuals need in order to get treatment? What do we need in the market? What’s missing?

Ashley Hume

I mean, we provide solutions to the market for cell and gene therapy management. We have a full end to end solution for payers and employers to outsource it to us because it you know, as I referenced a few minutes ago, it is that complex. Every one of these therapies is unique, and every one of these therapies has its own set of considerations from a patient throughput perspective, from a Centers of Excellence perspective, from, right patient, right place, right time, right therapy.

And so they do require special handling. They aren’t the type of program that you just want to have kind of bundled into your existing, you know, care management protocols. And so I think having specialized support for these incredibly complex, expensive therapies that also have the potential for life changing impacts for these patients is just really critical. And you know, nobody wants to invest in something, you know, that isn’t going to be carefully managed.

Which brings me to my last point, and then I bet Brooks will want to comment on this. Also just the infrastructure for the warranty programs or value based contracting, so that people feel good about it, investing in therapies that don’t have long term data or durability.

Mehb Khoja

Brooks, why don’t you tell us what a warranty or value based contract is before you comment?

Brooks Wildasin

Sure. So, you know, value based contracts or value based agreements, those have been around for years and years and typically are mechanisms that are negotiated between a payer and a pharmaceutical manufacturer to guarantee some degree of outcome. And like I said, those have been around for years. The concept of warranties or modified outcomes based contracts is relatively new to the market.

I mean, within the last five years or so, the intent of a warranty construct is actually to bring some insurance rigor to those contracts so that it’s not purely a contractual liability, but has a little bit more of a guarantee around it with an insurance backbone, if you will. And some of the reasons why value based agreements have struggled so much in the market is that they are negotiated on a one off basis and also not typically available to payers of all types and sizes.

So, you know, they are very labor intensive to put in place. So pharma itself doesn’t, you know, have the capacity to go out and negotiate with every payer in the market. And so typically makes those types of contracts available through either GPO arrangements or with larger regional health plans in general. The influx of some of these other models, be it outcomes based contracts or even warranties, is that it reduces the burden on the negotiation, so allows for creating kind of a can structure with an infrastructure that can support it in terms of monitoring in a much more seamless fashion versus everyone having to stand up their own way to manage a VBA.

And I absolutely agree with Ashley that more of those types of mechanisms are going to be necessary as more therapeutics come about, because we have to also remember, these clinical trials are typically run even in the larger disease states with very small patient populations. I mean, we’re talking 10, 25, maybe 35 in certain circumstances. And so understanding the true efficacy and durability of those therapeutics. There’s just not usually a lot of evidence right out of the gate.

And so in absence of the real world evidence collection, which will occur over time with the long term follow up protocols, there has to be other mechanisms to help, not offset, but protect the investment, if you will.

Mehb Khoja

Yeah. So we need help for the patient to know where to go to get the treatment. If they get the treatment and it doesn’t work, we want a piece of that money back flowing somehow from whoever paid for it, whoever backstopped the cost of that money to flow back. That’s the purpose of VBC. What about like, insurance products?

Kelly, are the current insurance products that we have today, you know, in terms of self-funded community, the stop loss product and in medical reinsurance, are those products enough to cover the risk of gene therapy?

Kelly Munger

I think we’ll see some continued evolution. Right. There has been some. But for example, you know, there’s a lot of self-funded employers that are really large that don’t buy stop loss today that probably should and will want to buy, maybe a gene therapy only stop loss cover or something like that. And there’s not really a lot of that in the market.

I also think there are entities that maybe buy at certain levels today, either on an access basis, they want to buy lower levels, even different structures of reinsurance. Right. Maybe I’m a health plan and I think I’m going to have, you know, ten claims and I can afford, you know, 14, you know, but what if I have more than that?

And so some different structures on the reinsurance, I think. And then, you know, the other thing that’s a big issue and it’s a challenge for all sides is known claims and people with known diagnoses. Right. And how do we handle that. You know, that’s a big issue, impacts us as reinsurers and stop loss carriers, but it also impacts the clients. Right. So if you’re a self-funded employer and you have somebody with Duchenne, you know, you can’t necessarily afford a $3 million claim, right? So, that’s a big issue. And we just, you know, it’s a tough one to solve. But we have to work together and solve that.

Mehb Khoja

All right. So here’s a controversial topic. The government should cover the cost of gene therapy. Is that the right way to think about it? What do you guys think?

Kelly Munger

Well, I think the government, you know, right now, we’ve got Medicare and Medicaid, right. And there’s a lot of challenges there for the government. Right. I mean, there’s a huge spend, and we’re trying to reduce the cost, and they’re trying to push that risk into the private market. And, you know, there’s already a lot going on in the government risk space.

So on the one hand it could be a risk pool, right. That could go over everybody. But on the other hand I think they’ve got a lot on their plate already from a cost standpoint.

Ashley Hume

I would agree. And I think, you know, I think Mehb you’re thinking kind of along the lines of like ESRD. Could it be something along those lines.

Mehb Khoja

Like a shared like a shared expense after some time.

Ashley Hume

In theory. But what’s going to happen when there’s 100 of these on the market or 150? I mean, so first of all, it would take 5 or 10 years for that to actually come to fruition. And then when it does, by then there could be literally hundreds of these as we get into sort of, you know, the cell therapy space moving into autoimmune and some of the other, kind of therapeutic areas people are looking at.

So then we’re at a point where such a significant portion of folks are going to have conditions that would end up in this pool, that it kind of defeats the purpose, because then what are we insuring? So, yeah, I think that’s the challenge is just kind of speed to getting something stood up. And then the speed of development of these therapies.

Brooks Wildasin

I agree with Ashley. Well, actually with both Ashley and Kelly, I think that there probably are alternative structures that maybe could be driven to some degree by the government. And I’m going to go way back in time and think about, like the hep C model, if you will, in some of the hep C therapies came out. Not every state adopted the models that ended up working. But, some sort of subscription based fee that was offered ultimately by manufacturers that could bridge the gap, if you will.

I don’t think in our current state, even within the next couple of years, that that type of model is necessarily going to work. But there will be a time to Ashley’s point with some of these more prevalent disease states that impact, you know, hundreds of thousands, if not millions of Americans. We will have to start to think through different solutions, and that’s going to require multiple people at the table.

What I do not think is that one of the government agencies can sit down and come up with a solution in a box, it’s going to require collaboration and the economics are going to have to work for everybody involved as well. So there’s definitely a solution and a potential government intervention at some point. But I think we’re years away from that at this point.

Mehb Khoja

Okay. Well this has been a great discussion so far. I’m going to get you guys out of here with one more question. You know, most of the audience for this podcast is stop loss and reinsurance professionals. So give me a prediction of what you think gene therapy means to the stop loss and reinsurance industry for this year and going into next year.

Mehb Khoja

Kelly, why don’t we start with you?

Kelly Munger

Well, I would say we know a lot more. I started out by saying there were a lot of things we didn’t know, right? And we had to try to guess and it made us nervous. We went from trying to limit the risk and avoid, not really avoid but, be sure we understood and could size the risks, so to speak.

To now we’re trying actually to write more of this risk actually. Right. Because we have more information, we have some data, we have some experience. So actually, I think we’ve come a long way in really a fairly short amount of time. Still, there are a lot of things we don’t know, still a lot of uncertainty. Still a lot of risks there. Right. But I feel like we’re in a much better spot today than we were a few years ago.

Mehb Khoja

Okay, Brooks, how about you?

Brooks Wildasin

Yeah, I agree with Kelly in terms of the current state, there’s a lot more knowledge out there. Better underwriting mechanisms, better actuarial modeling overall and just a higher, slightly higher degree of comfort with the risk as it sits today. One variable that I think is going to impact things as we move forward is that in many cases, especially in the self-insured community, they’re not covering these therapeutics within their plan designs.

And that’s definitely shifted over time. More people covering the therapies, but at some point here in the relatively near future, covering or not covering will not even be a question. You will absolutely have to cover the therapeutics, especially in these Life-Saving instances. I’m sure we’ve all seen the increase in news coverage on X, Y, and Z self-insured employer that wasn’t covering the therapies or maybe just made a plan design change within the last couple of months.

And then they have twins born with SMA that have to get treated that been beyond just the news coverage. But that type of, coverage is huge and, you know, can be very detrimental to organizations. So what I predict is that we’re going to see more and more especially self-insured employers covering these therapeutics, doing so in a meaningful way, with proper plan design and medical policies.

And that’s going to actually increase the exposure as well. That is going to impact stop loss and reinsurance in different ways. So, continuing to pay attention to what’s being covered by whom and how, and appropriately to Kelly’s point, underwriting it, can’t run away from it, but underwriting it and doing so in an appropriate fashion is going to be a trend that we continue to see increase over the next couple of years.

Mehb Khoja

Great. Ashley, why don’t you bring us home?

Ashley Hume

Yeah. I think just exposure wise, this year’s going to look a lot like last year. I think it’s going to be very similar. However, I think in aggregate it will continue to push people towards one or the other perspective. So Brooks just referenced folks not covering cell and gene therapies, even if exposure looks similar this year as it did last year, it’s still those lightning strikes that are happening over and over.

And the more lightning strikes that happen, the more people hear about it, the more they become concerned. So they’re either going to exclude it or they’re going to buy stop loss or some sort of a carve out risk product. So I think we’re going to we’re going to see continued interest in this space. I do expect a lot of different types of like alternative funding mechanisms and things like that to continue to, kind of come to fruition.

Some of the folks that have things in development will be able to launch those this year. But the other thing that I think that people should kind of keep an eye on and certainly something that we watch regularly, a lot of what happened, you know, we talked about the impact of COVID and how that impacted ramp in the number of cases that were of, you know, happening around the market, once COVID sort of settled down and normalized and these therapies were approved, now we’re seeing a lot of issues from an access perspective with just provider capacity issues.

And so there’s a lot of different, you know, factors that impact that. But one of them is just like, you know, sort of the impact on aggregate receivables for facilities. And can they afford to take title of these therapies.

And then once they can do they have room for them, can they schedule them? You know, these are incredibly complex procedures to administer. And so those types of issues, I can tell you because we work with all of these centers, like those are getting resolved. These centers are preparing themselves to be able to administer these therapies. And when that happens, you know, if there’s a facility that right now can’t see any patients for whatever reason, but they fix that issue, whatever it is, they’ve got patients queued up.

We know that there are organizations all over the place that have patients queued up. So I do expect that we’ll see some of that happening, especially as we move through the rest of ’25. And then the last thing that I’ll mention is there’s a huge push right now to get especially CAR-T into the community setting. And so when that happens, you know, this big push towards outpatient CAR-T, that’s going to open up just a huge amount of bandwidth.

And so, you know, you might see that CAR-T exposure continues to increase and that gene therapy stays steady. But, you know, we’re hearing of more and more patients being dosed for sickle cell. Like I think we’ll end up seeing double the number as we move forward. So all of that’s going to continue to happen.

And eventually we are going to hit that hockey stick sort of trajectory.

Mehb Khoja

Yeah and I’ll just add my two cents here. I do think there’s going to be some reversion to the mean. I do think that that utilization is going to catch up. You know, again our community here is mostly stop loss and reinsurance folks. And stop loss carriers have been struggling for the past few years, and there hasn’t really been a lot of gene therapy during that time.

And so when that wave hits, we’ve already seen a couple of stop loss carriers exit the market in the past six months. I think we’re going to see a reinsurer or two exit this space as well. And then I think terms and conditions on the types of policies are going to have to change in order to meet what the market needs are.

Brooks, I see you have one more comment you want to make.

Brooks Wildasin

Yeah I just wanted to underscore one other thing that that Ashley referenced too. The provider capacity is one thing, but also the manufacturing capacity, you know, early on and especially with CAR-Ts but now even with gene therapies and the manufacturers only have so many slots that they can use within their manufacturing facilities. And we’ve watched especially in CAR-T, over time, you know, as the processes matured and the just overall manufacturing facilities got better at bringing these therapeutics to market, that increased availability.

And when it increased availability to Ashley’s point, there are patients waiting, in some cases. So, with each new therapy that comes about, there’s, for lack of a better term, a learning curve, it doesn’t matter how well you plan for it from a manufacturing perspective, it still takes a little while to get everything ironed out within the process.

So a lot of times when these therapeutics launch, we won’t see uptake or that very first case for at least six months or longer. The one difference there was Sarepta that was, you know, really prepared when they launched with Elevidys. But many of the therapies, especially if they’re utilizing a novel technology, CRISPR, for example, or even the till therapies that I referenced earlier, it takes some time to really hit the runway.

And so as they get more efficient after the therapies are approved, that’s going to increase availability and capacity as well. But it won’t happen overnight.

Mehb Khoja

It takes time to go from development to pipeline. It takes time to get FDA approved. It takes time from the time of approval to the time of market uptake, and then it takes time for the claims to actually be utilized. And all that said, precision medicine is here to stay, so we’re going to end it right there for today.

Thank you Brooks, thank you Ashley, and thank you Kelly, and thank you for joining us for another edition of Firm & Final, we’ll see you next time.