January 25, 2021

A proprietary and cheaper precision drug | Society

A proprietary and cheaper precision drug | Society

The new economic threat to the health system are CAR-T therapies, a customized medication that is made to measure for each patient and that, for the moment, is used in cases without treatment of two types of hematologic cancer, acute lymphoblastic leukemia and diffuse large cell lymphoma. In the United States, its cost exceeds 300,000 euros per person. But in Spain Hospital Clínic de Barcelona has developed its own version 80% cheaper, about 50,000 or 60,000 euros, as explained by Julio Delgado, from the hospital's Hematology service.

CAR-T cells are made from the lymphocytes (white blood cells) T of each patient, adding a gene that helps them identify the tumor cells to destroy them. Unlike other gene therapies, they have been considered in themselves a medicine. But a very special one: it can not be manufactured in series. It has to be elaborated for each person who will need it. Hence, its initial price.

This medicine is so promising that the Ministry of Health has drawn up a specific plan For their develpment. Although at the moment it has been tried like last remedy in two cancers of the little frequent blood (Delgado calculates that it could be applied to about 300 people in Spain to the year), the web of European registry of clinical trials has 24 entries, and in the world (ClinicalTrials.gov) There are more than 700.

Last resort to the first line

The most dangerous, economically speaking, of the treatments with CAR-T cells will be their generalization. Currently, they are approved for two hematologic cancers and only when all other options have failed (basically, chemotherapy and bone marrow transplantation). "We went from having expectations of cure from 0% to 40% or 50%," says Julio Delgado, haematologist at Hospital Clínic de Barcelona.

But as in cancer research, it is already being tested whether these treatments of last resort work applied in previous phases of the evolution of the disease, combined with chemotherapy and surgery or by themselves. This is usual in oncology. The idea is that if a drug works in desperate conditions, it can do it also and better before.

In addition, although the CAR-T, a modification of the immune system, are designed to attack cancer cells, their nature opens a huge capacity for future profits, as shown by the trials that are already underway, from infectious processes to autoimmune .

But its price scares. Last Monday, after the meeting of the Interterritorial Council (the coordinating and planning body of the national health system that brings together the ministry and the councils of the communities), the representative of Galicia, Jesús Vázquez Almuíña, put them as an example of the need to review health financing. And is that at the US price, only the cells to treat 300 people would mean more than 90 million hospitals, 1.5% of everything they spend on medicines, according to the latest data from Health.

And if the possible utilities were expanded, the cost would be even greater. On Monday the Health Minister, Maria Luisa Carcedo, admitted the price effect, but insisted on one aspect: these cells heal people who previously had no choice.

Luis Alejandro Latorre is a clear example. She has an acute lymphoblastic leukemia that was diagnosed in 2014. "I started with chemotherapy, I had a relapse; then came the bone marrow transplant, I had another relapse. " On March 2, 2018, almost a year ago, he underwent treatment with CAR-T cells at the Clínic. "Since then I'm great," he says bluntly.

The improvement has been such that Latorre has been able to resume his studies, which practically stopped the four years he spent between chemotherapy and hospitalizations. "Apart from the controls, I make a normal life," he says by telephone from Barcelona, ​​where he lives with his mother. "Now I'm preparing the access test to a higher cycle. The step clearly, and then, to study Corporate Image and Personal Counseling, "says convinced.

The key to the reduction achieved by the Clínic is in a variant in the virus that must introduce its DNA into cells. This modification is what allows you to use it without having to wait for the patent to expire (or without having to pay the rights to use it), explains Delgado.

30 patients per year

Of course, the researcher admits, the creators of the original therapy claim that the one they have developed is not as effective, but the data is not yet conclusive. Until now, in Spain the technique has been used in about 80 cases, according to the Spanish Society of Hematology and Hemotherapy (SEHH), but always in clinical trials. Now, the Clinic launches a program to treat about 30 people a year, among its patients and pediatricians, which will come, basically, from the Sant Joan de Déu hospital, also in Barcelona.

Delgado says that they will make their development available to any other center that wants to use it, and that is why they have not patented it and will not do it. "But then the permission to manufacture their own cells has to be processed by them," he says.

The doctor does not rule out that other Spanish centers follow the same path. It warns that the requirements are complicated (you have to have the facilities prepared to handle cells and create genetically modified viruses), but you are sure that others will do it. It will be the way that the utility of the CAR-T is attached a price that makes them affordable.


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