Experts, regional governments and patients define centre referral and designation criteria for CAR-T cell therapy

Among other things, the meeting approved the centre designation criteria for administering next-generation CAR-T medicines, the procedure for evaluating applications by the group of experts of the National Health System (Spanish acronym: SNS) and the procedure for referring patients between Spanish NHS centres. Following validation, the documents will be submitted for approval at the Inter-regional Council of the Spanish National Health System.

"These criteria seek to guarantee quality, the experience of the teams that will use these techniques at hospitals and specific services and, thirdly, equality", said the Spanish minister.

Since the plan was approved in November, the groups of experts have been working to define the procedures that will guarantee equality in the use of these new therapies and the criteria for selecting the hospitals that will apply them safely and under a guarantee of quality. This first meeting represents a significant step forward in the implementation of this plan.

"We are European leaders in the incorporation of this type of therapies into the public system", said María Luisa Carcedo. "So much so that it allows us to tackle the issue with great security and negotiation strength because we have public research of which we are very proud", she added. This research is being conducted at the Hospital Clínic in Barcelona in partnership with the Instituto de Salud Carlos III [Carlos III Health Institute].

Centre selection criteria

Centre selection is based on an assessment of nine criteria for DLBCL and 10 criteria for ALL. These criteria assess specific experience (four criteria: clinical experience with CAR-T; activity in complex bone marrow transplants; activity in apheresis; activity in cell processing), quality (one/two criteria: JACIE certification; CSUR certification in bone marrow transplants in children - the latter only applies to ALL), coordination between professionals (two criteria: availability of a multi-disciplinary unit and clinical committee), public research (one criterion: pre-clinical experience with immune effector cells) and the in-house and public manufacturing of these drugs (one criterion: certification of rules on correct manufacturing from the Spanish Medicines and Healthcare Product Agency).

These treatments consist of innovative therapies with a high health and economic impact offering opportunities for certain diseases that lacked effective treatments until now.

For treatments with CAR-T cells, the therapeutic strategy consists of extracting and treating the lymphocytes from a patient in the lab. After genetically modifying them, they are then administered as medicine to combat the tumour cells.

In December, the Ministry of Health announced approval of funding for the first industrial CAR-T cell therapy within the Spanish National Health System.
The authorisation stems from its suitability in treating refractory B-precursor acute lymphoblastic leukaemia (ALL) in post-transplant relapse or in secondary or subsequent relapse in paediatric and young adult patients up to the age of 25 and for relapsing or refractory diffuse large B-cell lymphoma (DLBCL) following two or more lines of systematic treatment in adult patients.

Treatment quality and accessibility

The agreements reached today meet the principles sought by the Plan to tackle Advanced Therapies in the Spanish National Health System approved at the Inter-regional National Health System Council on 15 November; i.e. to guarantee quality and safety in the use of these medicines as well as equal access.

The working group is made up by representatives from the Ministry of Health, Consumption and Social Well-being, all regional governments and patient associations.

This first meeting was also attended by the General Secretary for Healthcare and Consumer Affairs, Faustino Blanco; the Director-General for the Basic Portfolio of Services of the National Health System and Pharmacy, Patricia Lacruz; the Director of the Spanish Medicines and Healthcare Products Agency (Spanish acronym: AEMPS), María Jesús Lamas; the Director of the Spanish National Transplant Organisation (Spanish acronym: ONT), Beatriz Domínguez; and the Director of the Carlos III Health Institute, Raquel Yotti.

Non official translation