In recent years, new immunotherapy treatments are causing a massive revolution in the cure of certain types of cancer. In the Present and Future of Public CAR-T seminar, organized by Salud por Derecho and the Spanish Medical Colleges Organization which took place last Wednesday with the participation of diverse experts, we placed the spotlight on innovative CAR-T therapies that modify the patient’s immune system cells to detect and destroy cancer-causing cells.
Just over a year and a half ago, two treatments of this type arrived in Spain commercialized by the pharmaceutical industry and funded by the National Health System. At the same time, a team of researchers from the Clínic and Sant Joan de Déu hospitals has been working on the development of a public CAR-T, the first of this type that has emerged within the National Health System.
In this video that we released yesterday, as part of this seminar, you can learn about the project in both hospitals.
In the seminar, we chat with Manel Juan (Clínic) and Susan Rives (Sant Joan de Déu), who are part of this team. “We had patients that were not responding to current treatments. We saw a revolutionary option in this therapy as it changes the concept of the majority of therapies that have been developed in oncology to treating patients in a personalized way”, recalled Manel Juan regarding the origin of the project.
This academic CAR-T has already been used in around fifty patients with good results, and therefore they have applied to The Spanish Agency of Medicines for its regulation under the hospital exemption clause, a petition that has still not been answered. It is precisely this regulation, insist the researchers, that is the principal challenge they are currently facing. “Cell therapy has been designated a drug, and the regulations can be very narrow. It can, at times, obstruct development. The advantage of the academic CAR-T is the immediacy and capacity to adapt to new needs, but if one has to go through all these processes, it does not get to the patient quickly”, reminds Susana Rives. “The main difficulty is our conviction that the regulations are always unmovable. There is a lack of capacity and flexibility to change the regulations for these types of therapies because they are embedded in the framework of the FDA and EMA. This type of therapy is considered a drug, but, for example, Switzerland decided that it was not, that it is a transplant or an entirely different entity”, assures Manel Juan. “If during the era of bone marrow transplants they had applied these regulations, they would not have been able to do transplants”, summarized Rives.
One of the most controversial aspects of commercial CAR-T is its high cost, which exceeds 300,000 Euros per patient. The academic CAR-T would have a price—which is still not set—that would be predictably lower. “It will be a price set by the NHS, we have estimated the costs as being well below the prices of current (commercial) treatments. The price will need to be calculated once finished. I don’t know if it will be 80 thousand or 150 thousand, but it will never exceed this figure”, assures Manel Juan.
Along these lines, Michael Schmitt, a Cellular Immunotherapy researcher at the University Hospital of Heidelberg (Germany), where they are also conducting a CAR-T cell program, recalled that “last year, 700 patients were treated with commercial CAR-T in the whole of Europe, but this is just the start. We are treating patients with lymphoma treated with third-line treatment, and there are clinical trials that will end soon, and they will be recommended as second-line treatment. This means that it will multiply by 10 times the number of patients that will be treated with CAR-T cells. In other words, 10 times the cost. The Schmitt project is the only one that works with CAR-T in Germany. The work at Cliníc and Sant Joan de Déu stand out “as a reference”, as well as the collaboration of both institutions with the Ministry of Health.
From the Ministry, we spoke with Patricia Lacruz, director-general of the Basic Portfolio of the National Health System and Pharmacy Services. Lacruz explained the advanced therapies plan that the government launched almost two years ago and for which it has received 345 applications to administer commercial CAR-T therapies to patients, of which 88% have been approved. Regarding academic CAR-T, Lacruz recalled that the plan “includes a roadmap to incorporate academic advanced therapies”. The challenge, she noted, is “to ensure that the medicines that are authorized for use continue their development and are commercialized. Opportunities need to be maximized for the clinical research of medicines with promising results”.
Vanessa López, director of Salud por Derecho and the debate moderator, recalled that “it is essential that the public impetus for academic therapies is strengthened in terms of economic resources and public policies that allow faster and efficient development. Among other things, because it is essential to guarantee access and improve the economic sustainability of the public health systems”. Serafín Romero, president of the Spanish Medical Colleges Organization, emphasized that “access is fundamental not only to healthcare services, but also to the innovation represented by advanced therapies for all patients”. Therefore, Salud por Derecho and the Spanish Medical Colleges Organization, said, “they work hand in hand to guarantee scenarios to facilitate access to innovation and advanced therapies for the entire population based on quality, safety, and efficiency”.
If you want to see the complete seminar (in Spanish), click here: