Yesterday, the Oswaldo Cruz Foundation (Fiocruz) signed agreements to begin its Strategy for Advanced Therapies, with the aim of making gene therapies more accessible and, consequently, expanding their availability through the Unified Health System (SUS). The project receives funding from the Ministry of Health, through the Growth Acceleration Program (PAC).
Gene therapies aim to manipulate genetics to combat various diseases, such as cancer, autoimmune diseases, AIDS and genetic syndromes. Currently, there are several of these therapies in use, with 15 of them authorized by the National Health Surveillance Agency (Anvisa) for use in Brazil, while hundreds are being studied around the world.
However, the high cost of these therapies represents a major obstacle. For example, treatment for Duchenne muscular dystrophy, a progressive and irreversible condition, can cost up to R$15 million, a similar amount to treatment for hemophilia A.
SUS
According to Fiocruz, it is estimated that in the next five years between R$4 billion and R$14.5 billion will be spent annually on these treatments, if the amount charged by pharmaceutical companies is maintained.
The provision of these treatments in private health units is inaccessible to those who do not have sufficient financial resources. On the other hand, offering these treatments free of charge through the SUS is very costly for the public coffers.
Fiocruz’s proposal, through its Institute of Immunobiological Technology (Bio-Manguinhos), is to develop and make gene therapies available at a cost of around 10% of the current cost.
Early stage
The initial phase of development of these treatments will have the support of the North American non-profit organization Caring Cross, which will transfer technology to the Brazilian institute.
The Minister of Health, Nísia Trindade, emphasized that the guidance is that these therapies developed by the Fiocruz strategy be incorporated into the SUS. Furthermore, she highlighted the significant tenfold reduction in the cost of currently available treatments, which represents a tenfold increase in access to these therapies.
The first project of the Strategy for Advanced Therapies involves the reprogramming of the body’s defense cells to combat hematological cancers, such as lymphomas and acute leukemias, in partnership with the National Cancer Institute (Inca), which is already carrying out research in this area.
Therapy
This therapy, called CAR-T, consists of inserting specific genes into T lymphocytes (defense cells), making them more effective in identifying and destroying cancer cells. The cost of this treatment, currently around R$2 million, can be reduced to R$200,000 with the initiative of Fiocruz and Inca.
Clinical trials to validate this therapy should begin by the end of this year, in the United States and Brazil. With the therapy validated, it is planned to install modular laboratories in hospitals in different regions of Brazil, allowing the decentralization of these treatments.
Minister Nísia Trindade highlighted that reducing the cost of gene therapies will benefit not only Brazil, but also other countries in Latin America and Africa.
(With Agência Brasil).
