Reimbursement priorities in blood cancers. Not only CAR-T

• Every year in Poland, nearly 9,000 new cases of blood cancer are diagnosed, and 150,000 people live with the disease. Experts indicate which drugs currently require the most urgent reimbursement
• In the case of multiple myeloma, such a need, according to experts, is the reimbursement of CAR-T therapy.
• CAR-T therapy should also be available in aggressive lymphomas for patients who are refractory to first-line therapy or who relapse rapidly and are not eligible for autologous transplantation
• In acute lymphoblastic leukemia, reimbursement of the bispecific antibody, blinatumomab, is pending from the first line of treatment. It is currently available for refractory, relapsed patients or patients with positive residual disease

Every year in Poland, nearly 9,000 new cases of blood cancer are diagnosed, and 150,000 people live with the disease. As experts point out, there has been enormous progress in Polish patients' access to modern therapies for blood cancers in the last few years, but this does not mean there is no need for reimbursement.

In myeloma, the most urgent need, according to experts, is the reimbursement of CAR-T therapy : ide-Sel (Abecma) and cilta-sel (Carvykti). Initially, these therapies were registered for administration after three lines of treatment, which gave up to a three-year period without disease progression. Currently, they are registered from the second line of therapy.

- This is one of the most important reimbursement priorities for 2025, but the possibility of using treatment regimens in myeloma consisting of drugs that are already reimbursed is also important. In the case of patients resistant to lenalidomide, this involves a combination of daratumumab with carfilzomib and dexamethasone and an isatuximab, carfilzomib, dexamethasone regimen - said Prof. Ewa Lech-Marańda , national consultant in the field of hematology, at a press conference.

Reimbursement needs are also visible in follicular lymphoma , a cancer requiring multiple lines of treatment. As indicated by experts, the existing possibility of using mosunetuzumab should be supplemented by the possibility of treatment with another bispecific antibody, epcoritamab, in patients with relapsed or refractory disease. This will allow for individualization of therapy.

Patients with aggressive lymphomas also count on CAR-T therapy. At the moment, it is reimbursed, but only for patients in good general condition who can undergo bone marrow transplantation. However, two clinical studies show that CAR-T can be safely used also in patients who are not candidates for autologous transplantation.

- CAR-T therapy is currently available for younger patients without comorbidities. It should also be available for patients with resistance to first-line treatment or with rapid relapse who are not eligible for autologous transplantation - noted Prof. Lech-Marańda.

Prof. Tomasz Wróbel , Head of the Department of Hematology, Cellular Therapies and Internal Medicine at the Piast Śląskie Medical University in Wrocław, drew attention to the reimbursement needs in mantle cell lymphoma .

- Recently published study results have shown that the use of ibrutinib in the first line, in combination with immunochemotherapy, allows for better results than with autologous transplantation. If ibrutinib were used in the first line, some patients would not need a transplant - he noted.

The experts also commented on the situation in acute lymphoblastic leukemia , where a breakthrough was brought about by the use of a bispecific antibody, blinatumomab. It is currently available for refractory, relapsed or residual positive disease patients. However, the results of the studies show that the need for availability exists from the first line of treatment.

- Adding blinatumomab in the first line, as a consolidation treatment, extends the relapse-free period, extends the overall survival time and reduces the risk of death by almost 60% - emphasized Prof. Ewa Lech-Marańda.

When it comes to chronic lymphocytic leukemia , experts estimate that there are no “blank spots” in access to drugs.

- However, there is a need to make drug programs more flexible. For example, changing one BTK inhibitor to another, in the event of serious adverse events, requires clarification. Currently, in such cases, we end the treatment, wait for the disease to progress and only then give the patient the second BTK inhibitor. This is not the optimal solution - assessed Prof. Krzysztof Giannopoulos , president of the Polish Society of Hematologists and Transfusionists.

The expert also pointed to the need to reimburse luspatercept from the first line of treatment for all patients with low-risk myelodysplastic syndromes (MDS) who require transfusions. As he said, administering the drug earlier better protects the patient from such a need.

Prof. Giannopoulos added that access to the transfusion-reducing drug momelotinib is also very much needed for patients with myelofibrosis .

As Mateusz Oczkowski , deputy director of the Department of Drug Policy and Pharmacy at the Ministry of Health, pointed out, there is practically no reimbursement announcement that does not include new hemato-oncological drugs.

- There are only a few new reimbursement applications now, and three of them concern CAR-T therapy - he informed.

- In 2024, we refused only 4 percent of applications. We still have a reserve of about 4 percent of the budget for reimbursement, we encourage you to submit applications - said director Oczkowski.

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