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Active substances for the treatment of:

Lymphocytic leukaemia

Obejmuje przewlekłą białaczkę limfocytową (PBL) i ostrą białaczkę limfoblastyczną (ALL)

Name of active substance (medicine) The European Society for Medical Oncology (ESMO). Published scientific research demonstrates that the observance of such scientific community guidelines has a positive impact on patient survival rates. Is it included in
the European standard  of treatment (according to ESMO)?
Access status (National Health Fund reimbursement) Additional information
Clofarabine The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis. EPAR/SmPC Drug programme
Dasatinib The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Dasatinib is indicated for the treatment of adult patients with: - Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. EPAR/SmPC Drug programme
Nelarabine The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support these indications is based on limited data. EPAR/SmPC Drug programme
6-mercaptopurine monohydrate The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement 6-mercaptopurine monohydrate is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. EPAR/SmPC Drug programme
Blinatumomab The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement Blinatumomab is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Blinatumomab is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. EPAR/SmPC Drug programme
Ponatinib The drug in this indication is not refunded No reimbursement Ponatinib is indicated in adult patients with • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. EPAR/SmPC
Pegaspargase The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement Pegaspargase is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients. EPAR/SmPC Drug programme
Asparaginase The drug in this indication is not refunded No reimbursement Asparaginase is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults. EPAR/SmPC
Obinutuzumab The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Obinutuzumab in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. EPAR/SmPC Drug programme
Idelalisib The drug in this indication is not refunded No reimbursement Idelalisib is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): • who have received at least one prior therapy, or • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. EPAR/SmPC
Ibrutinib The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Ibrutinib as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Ibrutinib as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. EPAR/SmPC Drug programme
Venetoclax The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Venetoclax in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: • in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or • in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. EPAR/SmPC Drug programme
Inotuzumab ozogamicin The drug in this indication is not refunded No reimbursement Inotuzumab ozogamicin is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22- positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+ ) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). EPAR/SmPC
Tisagenlecleucel The drug in this indication is not refunded No reimbursement Tisagenlecleucel is indicated for the treatment of: - Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. EPAR/SmPC
Rituximab The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement Chronic lymphocytic leukaemia (CLL): rituximab in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy. EPAR/SmPC Drug programme
Imatinib The drug in this indication is refunded in accordance with the ESMO guidelines Full reimbursement Imatinib is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. - adult patients with relapsed or refractory Ph+ ALL as monotherapy. EPAR/SmPC Drug programme