Hematology: priorities according to Prof. Ewa Lech-Marańda

What are the therapeutic priorities in hematology for the current year?

In the last 5 years, a great deal has been done in the reimbursement area in hematology - 75 new molecules have been reimbursed in 26 hematological diagnoses, both cancerous and non-cancerous. It can be said that we have entered a new era in terms of access to modern therapies, and we are providing treatment according to European standards. However, as worldwide progress in the field of hematology is very great and treatment standards are changing literally before our eyes, new needs for access to modern therapies are constantly arising.

Among the most important reimbursement needs for this year, I would place access to CAR-T therapy for patients aged 26 and over with relapsed or refractory B-cell acute lymphoblastic leukemia at the top of the list. Currently, CAR-T therapy is reimbursed under the B.65 drug program for patients with this diagnosis, but only for children and young adults up to the age of 25 - this, by the way, was the first registration indication for CAR-T therapy in B-cell precursor acute lymphoblastic leukemia. Under the same drug program, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia, we can use monoclonal antibodies, i.e. blinatumomab (bispecific antibody) or ozogamycin inoztuzumab (conjugated antibody), but there are clinical situations in which relapse occurs after treatment with antibodies, and then CAR-T therapy is the only option for these patients.

Second among reimbursement needs, I would point to access to modern bispecific antibodies for patients with B-cell lymphomas, both aggressive and indolent (so-called "slow") for refractory or relapsed disease. For patients with aggressive lymphomas, including diffuse large B-cell lymphoma (DLBCL), the European Medicines Agency (EMA) has registered two bispecific antibodies, namely epcortamab and glofitamab. These are antibodies directed ag...