The Italian Medicines Agency has given the go-ahead for the reimbursement of the first CAR-T cell therapy (Chimeric Antigen Receptor T-cell) available in Italy.
The new therapy, called Kymriah (tisagenlecleucel), can be prescribed according to the indications approved by EMA and used in specialized centers selected by the Regions, for adult patients with diffuse large B-cell lymphoma (DLBCL) resistant to other therapies or in which the disease has come back after a response to standard treatments and for patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL).
CAR-T therapies represent a latest generation immunotherapeutic strategy in the fight against hematological tumors. They use white blood cells (T lymphocytes) taken from the patient and specially engineered to activate the immune system; once re-infused into the patient, they enter the bloodstream and are able to recognize cancer cells and eliminate them.
With the approval by the Board of Directors of AIFA, the procedural procedure was concluded to guarantee access to these new life-saving therapies following a negotiation marked by a spirit of responsible collaboration with the company.
"The technical and operational characteristics of this type of therapy, and above all the delicate management of the possible side effects made a different planning work necessary with respect to the past - declares the general director of AIFA Luca Li Bassi - which involved, in similar roles fundamental, all the actors of the National Health System. Punctual and attentive teamwork has made it possible to open a path that will soon guarantee access to specialist centers distributed in the various geographical areas of the national territory.
The approval through a new reimbursement model, the payment to the result (payment at results), used by AIFA for the first time, is therefore the final act of a health planning job for which - concludes Li Bassi - I intend to thank the work of the staff and Commissions of AIFA (CTS-CPR), the National Transplant Center, the Regions, the technical support of prof. Franco Locatelli, president of the Superior Council of Health, of the Scientific Societies and the direct interest of the same Minister, who encouraged and facilitated an excellent teamwork with the directions of the Ministry of Health ".
"The approval in the Board of the first CAR-T therapy - declares the president Stefano Bonaccini - marks a very important step for public health and for our NHS, which has seen a change with respect to the past around this negotiation".