Actually South America has very limited availability. CAR Ts have been available in the United States and in Europe for maybe about six years and bispecifics now almost about two years. In South America most of the patients had access through clinical trials so now I believe only Brazil has CAR Ts approved and then Argentina and other countries only through clinical trials still. The bispecifics are moving further forward a little bit so those are approved in many of these countries and most likely are the ones that are going to be the most useful.
What are some of the challenges?
If we talk about CAR Ts in particular, these are autologous CAR Ts and so they have a lot of logistical challenges. They do really require a very sophisticated system for these therapies to be delivered. So even in the United States and in Europe the availability is not unanimous so you have to be referred to a particular centre. So there are patients that maybe live two or three hours away. So there are all these kinds of issues with that availability.
So that gets expanded even further in countries like in Latin America where you have less economic resources, less centres. So in Mexico, for example, they were talking about CAR Ts and really there are two centres in the entire country that would be able to give CAR Ts. So imagine if you’re a patient living potentially a six-hour flight from a centre. So that’s part of the problem, so the number of centres available is difficult and then the patients’ economic circumstances make it even compounded.
Bispecifics are a little bit friendlier from that standpoint. They still require a good infrastructure but you should be able to set it up a little bit easier so that more centres can participate. I think that’s why we’re seeing bispecifics really take more of a hold in Latin America than the CAR Ts.
What else can be done to speed up the introduction of these therapies?
The truth is we need more clinical trials in Latin America. So one of the problems is very much like in Europe and, again, I’m in the US so I’m a little bit different. But, as in Europe, something gets approved by the EU it doesn’t mean it’s going to be available. It also then has to be funded by the country. So in Latin America it’s very similar and so the drugs can be approved but they’re not necessarily funded. A lot of the reason for that is that there’s not enough patients from Latin America that were actually in the trials or there are no dedicated trials to address the concerns of the governing bodies. So doing trials specifically in Latin America that have an endpoint that helps them to achieve that will go a long way. Not only do you have access in the clinical trial but then hopefully when it gets approved it’s approved because it was done specifically to assist with that funding.
How do you see things changing in the next 5 years?
I think the bispecifics will be the dominant access in use in Latin America and will go beyond. Right now it’s really mostly Brazil, Argentina and possibly Mexico and I think it will go to the other countries as well. Hopefully there will be more options, right now there’s actually only one bispecific that’s approved and we know that there are already three that are approved in other parts of the world and several others coming. So the hope is that they will also have access to other bispecifics, not just one.
Is there anything else that you would like to add?
The only thing is that as someone who comes from the United States where I have availability of a lot of these drugs and I often get asked to speak in other parts of the world, it’s very frustrating to go and speak and tell people of all these things that are coming and huge advances and then someone from the audience gets up and talks about how they don’t even have approval of something that has been standard for two decades in our country. So I’m hoping that that gap will start shrinking very quickly because it would be nice if we become more of a world community and not so disparate.
