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INNOVATIVE CAR-T THERAPY REFUNDED IN POLAND FROM MAY 1, 2022 FOR ADULT PATIENTS WITH LYMPHOMA

From May 1, 2022 in Poland adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic treatment will receive funding for the novel CAR-T (tisagenlecleucel) therapy.

CAR-T is a breakthrough in the treatment of hematology patients. The mechanism of action of this therapy is completely different from the drugs used so far. Individualized CAR-T therapy uses the patient’s immune system. The patient’s T lymphocytes are collected and modified outside the body, thanks to which they are able to recognize cancer cells expressing a specific antigen and fight them.

CAR-T therapies are described as the most promising direction in the development of medicine in the fight against blood cancer in recent years. According to the announcement of the Polish Minister of Health, from May 1, 2022, treatment with tisagenlecleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma in certified centers will be fully financed by the Polish National Health Fund.

Lymphomas are the most common cancer of the immune system. They can differ in both the site of tumor formation and the degree of malignancy. Diffuse large B-cell lymphoma is the most common type of so-called non-Hodgkin’s lymphoma (NHL). It accounts for 30-40 percent. cases of malignant non-Hodgkin’s lymphoma, it is aggressive and difficult to treat.

CAR-T therapy may be a chance for adult patients with refractory or relapsed forms of the disease after failure of other therapeutic options. The results of the prospective JULIET study indicate that using CAR-T in 40% patients achieved complete remission of the disease. The probability of survival for 12 months was 49%. among all patients and 90 percent. in patients with a complete response to treatment. The median overall survival was 11 months.

CAR-T therapy has been successfully used for several years in most European countries. In Poland, it was performed for the first time in 2019 in an adult patient with diffuse large B-cell lymphoma. A positive reimbursement decision is an important opportunity for patients to gain access to breakthrough treatment.

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From September 1, 2021, CAR-T (tisagenlecleucel) therapy is also reimbursed for the treatment of B-cell acute lymphoblastic leukemia in patients up to 25 years of age. In Poland, a total of six facilities are currently certified by the manufacturer of this therapy (Novartis) for use in both indications. In adult patients these are: University Clinical Center of the Medical University of Warsaw – Central Clinical Hospital, Department of Hematology, Transplantology and Internal Diseases; Clinical Hospital Heliodor Święcicki, Medical University of Poznań – Department of Hematology and Bone Marrow Transplantation; National Oncology Institute Maria Skłodowskiej-Curie, National Research Institute with a branch in Gliwice – Clinic of Bone Marrow Transplantation and Oncohematology; Institute of Hematology and Transfusion Medicine in Warsaw – Department of Hematology; University Clinical Center in Gdańsk – Department of Hematology and Transplantology. In pediatric patients with refractory / relapsed B-cell acute lymphoblastic leukemia, it is the Clinic of Bone Marrow Transplantation, Oncology and Pediatric Hematology “Cape of Hope” of the University Hospital in Wrocław.

KIELTYKA GLADKOWSKI KG LEGAL comprehensively advises international clients operating in life science sector based on the EU pharma and regulatory law in activities within the most innovative pharmaceuticals as well as therapies, including gene therapy and material engineering.

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