Such an improvement in the effectiveness of B-cell lymphoma treatment has not been observed for 20 years

Medexpress: Many experts emphasize that in recent years we have seen great progress in access to new therapies in hematooncology in Poland. Do you share these observations?

Prof. Krzysztof Giannopoulos: Yes. I think the reimbursement list that was announced in May completes the possibilities of therapies emerging in various areas. It's worth emphasizing that the path from the decision regarding the registration of a drug (first in the US, then in Europe, that is, also in Poland) and reimbursement is getting shorter and shorter. I would emphasize two aspects here. First, reimbursement decisions are broader, that is, very close to registration (we would strive for this, for the reason that, as we know, registrations are based on phase three studies, that is, studies of the highest scientific quality). As there is a benefit of a given new therapy, we physicians as practitioners should be able to offer this type of therapy to our patients. And the second element, which is very important, is the transition of drugs from the drug program to the chemotherapy catalog. And here the decisions of May 1 of this year expand the availability of modern therapy (lymphoma therapy) and complement the drug program. As one of the experts dealing with a specific area in oncology, I must say that the dialogue with the Ministry of Health is very fruitful, that our numerous comments indicating medical needs are secured and the time for discussion has shortened in recent years. That is, much shorter time is from registration, discussion of the specifics of Polish patients, Polish population and availability of drugs.

Medexpress: In what areas do you see the most urgent need for changes in the standard of care for hemato-oncology patients?

Prof. Krzysztof Giannopoulos: I'll start with drug availability. Since May, tafasitamab has appeared in combination with lenalidomide. This is a new monoclonal antibody in lymphoma therapy, plus additions regarding therapy with lenalidomide and with an older antibody i.e. rituximab in the chemotherapy catalog. These decisions, it must be said, protect lymphoma patients, mainly aggressive ones, quite well. Of course, new studies are emerging. One of them is the Polarix trial, which showed for the first time in 20 years the benefit of treating patients with diffuse B-cell lymphoma in the first line. This is something amazing, because we know that chemotherapy in this group of patients is effective - 60 percent of them can be considered cured already after the first line of treatment. On the other hand, in a study in which immunotherapy was enhanced, that is, two immune drugs were given. One is the well-known atny-CD20 antibody. The other is a new drug, an immunotoxin i.e., vedotin polatuzumab, which, when combined with chemotherapy, shows greater efficacy after just two years of follow-up. After this follow-up period, almost 78 percent of patients are progression-free. So we hope that a large proportion of these patients will be cured. By contrast, in the immunotherapy comparison arm, it is less than 70 percent. That is, it is a thirty percent reduction in the risk of death or progression. We haven't seen such results in 20 years in this disease. It also seems that the area of indolent lymphomas will at some point require reimbursement support with new technologies, with dual-specific antibodies, that is, technologies that engage the immune system in the anti-lymphoma response. And here I am thinking of mosunetuzumab. This is a new product that has already been analyzed at the stage of the list of innovative drugs to the medical fund. Unfortunately, for the time being, the applicability is limited. We have experience within the framework of clinical trials (very positive) and we hope that in the group of patients with lymphoma lumps this therapeutic option will soon appear.

Medexpress: The May reimbursement list brought some changes in the organization of treatment for patients with lymphoma. What changes are still needed in this area?

Prof. Krzysztof Giannopoulos: The May 1 decisions applied to patients with acute myeloid leukemia. Here, accessibility was expanded - patients who are not eligible for transplantation are eligible for intensive care. You could say that this is the "gray population" between patients who we don't immediately qualify for intensive treatment or those who we will qualify for modern treatment and transplantation. And this was a very important need, which was supplemented with a drug that is very convenient because it is oral, namely azacitidine in oral form. Also, the therapeutic decisions that concerned last September were joined by those of May, and it can be said that the availability of therapy for acute myeloid leukemia is as close as possible to the European level, the highest international level. With lymphomas, I spoke about the needs that will need to be supplemented, but it is also worth noting that here, too, the situation has improved. A very large patient population is plasmocytic myeloma patients, where the decisions in January have greatly improved availability. There, there are already small unmet needs remaining, mainly concerning patients after multiple lines of treatment. One of the drugs under review is also a novel anti-CD38 antibody, isatuximab. The decisions greatly improve our treatment options. It is known that solving one area opens up new needs, because the progress in hematology, which we have seen for many years now, is dynamic. It is also worth talking about the second aspect, that is, the systemic element. This year we are already starting to talk more about a national hematology network designed to improve diagnosis and getting patients to centers if there is a need for modern treatment. But, on the other hand, we point out the need for systemic support. If a patient requires a transfusion, for example, it does not necessarily have to be in a highly specialized hematology center, but in an internal medicine department. Many procedures instead of in clinics and specialized departments can be performed on an outpatient basis. And it seems to me that this year, in which we are preparing the pilot of the national hematology network, will be very important with regard to these systemic solutions that will improve diagnosis and treatment, because these are two inseparable elements. To treat well, we must first diagnose well. Diagnosis must be precise, but on the other hand it must not overload the system. A patient for a peripheral blood test does not have to be admitted for hospitalization for several days, but it can be done on an outpatient basis.