[Ip-health] Article in El Pais on CAR T treatments in Spain, for 50, 000 EUROS

James Love james.love at keionline.org
Tue Apr 2 05:29:35 PDT 2019


This is a Google translate of an article in El Pais.

https://elpais.com/sociedad/2019/03/06/actualidad/1551884979_711151.html

A proprietary and cheaper precision drug.

The Clinic manufactures its CAR-T cells for around 50,000 euros. In the
United States they cost more than 300,000


EMILIO DE BENITO
Madrid 14 MAR 2019 - 16:44 CET

Photo: Laboratory of the Barcelona Clinic where CAR-T cells are prepared.

The new economic threat to the healthcare system are CAR-T therapies, a
personalized medication that is custom-made for each patient and that, for
the time being, is used in cases without treatment of two types of
hematological cancer, acute lymphoblastic leukemia and diffuse large cell
lymphoma. In the United States, its cost exceeds 300,000 euros per person.
But in Spain the hospital Clínic de Barcelona has developed its own version
80% cheaper, about 50,000 or 60,000 euros, as explained by Julio Delgado,
of 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 developed a
specific plan for its development. Although for the time being it has been
tried as a last resort in two rare cancers of the blood (Delgado estimates
that it could be applied to about 300 people in Spain per year), the
European registry website for 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.

  [snip]


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.



Side bars

The American engineer Judy Perkins in 2018.

American engineer Judy Perkins in 2018. SCOTT MACINTYRE

Experimental therapy that has eliminated metastasis

"We have to unmask the pharmaceutical companies that try to abuse the
system"

Gene therapy finally reaches the future

Andalusia and Catalonia lead the implementation of personalized medicine


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