CAR-T Meeting 2025 | Hospital exemption as a route for patient access to CAR-T therapy in Spain

So, from my side, hospital exemption, I think it’s the only way that we have in the academic centers to be able to obtain some kind of approval. It’s a local approval for our patients, the way to be able to have this capacity to treat our patients – that is always the purpose of the hospitals and people working in the hospital. And in Spain the development of this hospital exemption rule needs to demonstrate efficacy before acceptance even with the numbers in just one center lower than when you make a more general clinical trial, but the data should be similar at least to the ones that have been used for other people asking for authorization. Finally we have an authorization for our patients. At the same time, our Spanish health system allows us to have reimbursement, and by this way we can continue to increase the data of our patients and in this moment we have been able to arrive, in the case of ARI-0001, to almost 300 people have been treated in several diseases but mainly in B-ALL where we have authorization but also with ARI-0002 recently we arrived for more than 150 patients treated. So we are able to treat patients to have capacity of following the evaluation of the product after demonstrating that the product has a clear effect. And this is the way that in Spain it’s allowed to develop this hospital exemption. And now I think that seven products are already approved under hospital exemption in Spain, and two of them are our CAR-T because others are other kinds of advanced therapies that have been also tested and demonstrate some efficacy.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.