CAR-T Meeting 2025 | Delving into CAR-T accessibility challenges

I was responsible for organizing the session together with Jana Pelouchova from the Czech Republic and also to chair the session. 

We had three speakers, Beatrice Casadei, she was reporting on a research that has been done in Italy, analyzing the resource consumption for the healthcare system for the hospitals for delivering the therapy and that includes supportive medications, bridging therapies, the cost of the leukapheresis, the cost of the hospitalizations, you know, all the costs that are beyond the price of the therapy itself. It’s very interesting because it can help to put in context also the investment from the healthcare system perspective and to understand also some barriers for the adoption of the therapy where this is not yet available, and also offer routes to get prepared, because the whole session was about improving access or how we can overcome the barriers currently presented to improve access and why we have so many disparities. 

Then we had Manel Juan from the clinic hospital from Spain. He’s an immunologist and has been heavily involved with the academic CAR T-cell manufacturing, point-of-care manufacturing of CAR T-cells. It’s well known, the ARI model from Spain. So he was bringing the experience of overcoming barriers for access through the point of care therapies and why this matters. So he presented the map of the European countries with all the commercially available products as of last year with the multiple hematology diseases and all the gaps we have and how point of care is helping to overcome some of those gaps. So it was a good way to see why we need both the commercial available products and the hospital exemption as a way to facilitate access, but also to promote developing capacities at country level, at hospital level. 

Then the last was Liora Bowers. She is from the OCDA, and she was presenting the country profiles that were recently released this week, and presenting the disparities in the oncology medicine access, the reasons for that disparity, observing the systemic changes that are needed at policy level, and she presented some insights specific to CAR T-cell therapy. For instance, what the issues are with referrals, what the issues are with treating the patient, with delivering the therapy, with the follow-ups and all those things. 

And at the end, there was a very nice discussion about what the key elements are that we should tackle. And one of the issues is regulatory, is at the regulatory level but also at value assessment level. It’s not enough… many times the work is done to meet regulatory criteria but not necessarily to meet value definition criteria and not to mention the lack of understanding earlier in the development of medicines what are going to be the challenges for the payers to adopt the therapies and to improve that willingness to pay or not to pay for and what are other cost implications. 

As an output of the session I just want to to say that there are currently conversations about promoting an action to really condensate all this information, to put it clear for the different stakeholders groups so we could determine a plan to improve access to CAR T-cell therapies in the near future, but also being capable to determine what are the patients more likely to get benefit from the therapy. It’s not realistic to think everybody should get it, but really being capable to do an early assessment of the patients who may benefit from the therapy versus the patients who may not benefit from the therapy, what other alternative we have for them. So we still need to do more work on prognostic factors. We still need to do more work at referrals patterns to improve them, to improve those pathways. We observed through the Beatrice Casadei presentation that there are patients that are referred, start the process, receive the leukapheresis, and at the end never get the infusion. We need to understand those gaps. Why we lose those patients in the process? It’s because manufacturing issues, it’s because progression, natural progression of the disease, it’s because it’s a change in the clinical decision making. To understand those gaps so we can map better pathways and improve readiness to adopt the therapies.

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