The inclusion of the new CAR-Ts in the national health system will put Spain on the same level as the main European countries where these treatments are already available. Countries where their patients have greater access to the latest innovations in oncohematology.

However, in Spain this situation does not exist. This is what they point to Servicemediain that Blood Cancer Awareness Monthsome Spanish associations defending rights patients with hematological cancers, especially in those rarer subtypes, with lower survival rates and where the most disruptive treatments such as CAR-T, a highly personalized treatment whereby immune system cells are modified to attack a specific tumor type, become the key to success. in most cases the disease could be cured; or at least its remission.

“If we want to be an innovative country, the first thing we need to do is, of course, quickly approve drugs that yes or yes, they save the lives of people with certain types of cancer. At the same time, its effectiveness in CAR-T therapy for hematological tumors has been fully demonstrated. They are already used even as first treatment in many European countries where they are approved. And this is done because the reality is that in 78% of cases they survive,” Marta Cardona, director of the Cris Contra El Cancer Foundation, told Servimedia. “Sometimes, to access innovative treatments, you must first undergo traditional treatments. But now they understand that this is actually a treatment: the sooner it is prescribed to the patient, the sooner he will be cured. This could even be a saving on previous treatments that the patient has to undergo even though they know it certainly won’t solve their cancer type,” he adds.

Begoña Barragán and Marcos Martínez, president and manager of the Spanish Association of Myeloma, Lymphoma and Leukemia Patients (AEAL), also agree that the main problems with access to innovation for hematological cancer patients in Spain relate to the approval and approval of the system. financing treatment in our country. “We met with delays of more than 600 days in many cases for the approval of new treatments relative to the date of EMA approval. It should be added that some drugs are approved with restrictions regarding the indications for which they are approved by the EMA.” Moreover, it happens with some drugs that their availability in our country is approved, but their funding is not approved, “thus denying access to these drugs to the majority of patients who need them, because there are very few people who have the economic ability to pay for them.” “, they note.

“The issue of approving funding for treatments in Spain is complex and many are not approved even though they have been recommended, there is no transparency on this issue. Patient associations are not informed why,” says Adela Francia, president of the Association for the Treatment of Follicular Lymphoma (ACLIF), a subtype for which there is still no cure. Although CAR-T therapy has been approved since 2022 in Europe, its funding has not yet happened in Spain, “so we do not have access to this therapy with positive results in 80% of cases.” And he adds that “it is sad to realize that there is an effective treatment available in most European countries, but we cannot access it. “When your life depends on it, people don’t understand it.”

The organizations note that some neighboring countries are quicker than others to approve these drugs, as is the case in Germany, highlighting that it is largely a bureaucratic matter, with Spain taking almost three times longer than most EU countries. approval of an oncology drug. For this reason, some of these funds have already begun signature campaigns. “We are patients who, as much as possible, come together so that they can listen to us. For example, CRIS Cancer already has almost 30,000 signatures and ACLIF is approaching 1,000, but the ministry should speed up processes when they are a matter of life and death,” says Adela Francia.

For her part, Marta Cardona notes that “it is very difficult to imagine that outside Spain, in neighboring countries, patients from France or Germany will be able to access treatment that will save their lives, but here due to bureaucratic procedures and delays in approvals , we have been waiting for more than a year for funding, which has not yet arrived.”

Delays

Cancer patients, among whom the most common are those suffering from some type of lymphoma, leukemia or myeloma – with annual incidence in Spain of about 10,000, 6,000 and 3,000 cases respectively, according to the Spanish Network of Cancer Registries. (Redekan) – there is not enough time for lengthy approvals, burdened with bureaucratic obstacles. “Many treatments that take time to be approved are indicated for patients who have no other treatment alternative and, if they do not arrive in time, they are doomed to die,” point out representatives of AEAL, an association that adds that “when the situation is analyzed, With our decision makers looking the other way, there is an urgent need to change our country’s drug approval and funding system. There is a problem that we all must address and we cannot continue to allow delays and restrictions to impact the quality and quantity of patients’ lives.”

Although research has advanced in unprecedented ways in recent years, producing approx. 60% of patients today have a good prognosisHowever, the reality is that treatment does not reach all patients, which in some cases becomes a death sentence. Although 2018 marked a before and after period with the advent of CAR-T in Europe and the launch of the National Plan of Approach to Advanced Therapies, full rollout has yet to occur, leaving Spaniards behind the queue in terms of access. to these treatment methods. “My honest opinion is that there is a lack of political will. Patients with lymphoma often feel left out of the agenda, especially patients with follicular lymphoma,” notes ACLIF.

Associations agree on many aspects such as need to find a formula so that patients can be treated to prevent patients dying in Spain due to approval delays or funding restrictions, classifying this as a top priority. “The people behind these permits need to get them passed as quickly as possible. “We are talking about treatments that save lives,” concludes Cris Contra el Cancer.