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Can Brazil make cell and gene therapy costs affordable for all?

It seems as though cell and gene therapy costs continue to rise with every approval, as gene therapies in particular have taken the top spots in recent years on the list of the most expensive drugs in the world. Many companies insist that their prices are fair, as in the long run, it would cost the patient less to have a one-time therapy than it would to have continuous lifelong treatment. Although some may agree with this sentiment, it is still widely recognized that there is a significant need to make cell and gene therapies more affordable to patients. 

Now, Brazil is attempting to do just that with a unique partnership between U.S. non-profit organization Caring Cross and Fiocruz, the public health and research foundation funded by Brazil’s Ministry of Health. In this article, we take a closer look at the details of this initiative, which was announced last month.

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    A unique partnership aiming to make cell and gene therapy costs affordable in Brazil 

    The collaboration between Caring Cross and Fiocruz will focus on locally manufacturing cell and gene therapies for oncology, infectious, and genetic diseases in Brazil, including CAR-T cell therapies for leukemia, lymphoma, and HIV infection. The big idea behind this plan is for these medicines to then be available at a fraction of their cost in the U.S., where the most expensive treatment, a gene therapy called Lenmeldy, currently costs a whopping $4.25 million. 

    With an initial focus on CAR-T therapies, Brazil’s initiative will provide these therapies free of charge to patients while charging the Brazilian public health system approximately $35,000 per dose. This is roughly one-tenth of the cost of currently approved CAR-T cell products in the U.S. and Europe, where access has been plagued by challenges in manufacturing processes.

    Caring Cross, on the other hand, has developed manufacturing processes that significantly decrease the material cost of manufacturing CAR-T cell therapy products. Under the new initiative, the non-profit will be the one to provide technology, materials, and training to Bio-Manguinhos – the Fiocruz arm in charge of manufacturing vaccines, diagnostics, and biologics – so that it can manufacture CAR-T cell therapies and lentiviral vectors. The plan here is to run clinical trials for experimental therapies and then seek approval in Brazil. 

    The initial program will focus on CAR-T therapies for leukemia and lymphoma. The executive director of Caring Cross, Boro Dropulić, told Endpoints News that the first studies are expected to begin this year or in early 2025. Furthermore, Dropulić also told Fierce Pharma that he believes an approved product could be available within three years.

    Not only will the initiative enable affordable access of CAR-T cell therapies for the Brazilian public health system, but it will also allow access of critical materials and training needed to manufacture CAR-T cells for other organizations in Brazil and Latin America. 

    How cost-effective is Brazil’s goal? 

    As well as eliminating cell and gene therapy costs for patients, Brazil’s initiative is also likely to be more cost-effective for the Brazilian government in the long run. 

    “Brazilians have a unified public health system (SUS) regulated by laws that obligate the government to provide and pay the majority of treatments and diagnoses for every Brazilian citizen,” explained Carolini Kaid, chief executive officer (CEO) of Vyro Bio, a Brazilian company developing next-generation viral immunotherapies to treat aggressive, fast-growing forms of central nervous system (CNS) tumors. “Nowadays, with the development of new technologies, the cost of treatment in the same areas has become not affordable to the government.”

    Kaid pointed out that the affordability of a drug depends on the patient target and the technology developed. “If the technology delivers efficacy with one dose, and the target is a rare disease with one case per 100,000 inhabitants, it is affordable. However, if the drug does not cure the patient – thus requiring additional healthcare costs or multiple doses – it may not be cost-effective, as the government might spend the same amount on healthcare as before.”

    Providing the example of autism spectrum disorder (ASD), Kaid said that the lifetime social cost for all individuals in the U.S. with ASD identified from 1990 to 2019 is estimated to exceed $7 trillion, with the cost for an individual reaching approximately $3.6 million. “These costs are borne by the individuals, their families, their communities, and the government. In Brazil, where ASD treatment is regulated, the government spends a significant amount on treatments that do not cure the disease.”

    Therefore, by focusing on initiatives like the one between Caring Cross and Fiocruz and developing innovations within Brazil, the government can ensure more flexible pricing while also saving itself money in the long run by investing in curative treatment options. 

    Global efforts to make cell and gene therapy costs more affordable 

    This initiative by Brazil is actually one of several around the world designed to improve access to cell and gene therapies. For example, biotech companies in India, such as ImmunoACT and Immuneel, are working on developing affordable CAR-T therapies. Even in Europe, a special policy has enabled some hospitals to make their own CAR-T therapies; according to STAT news, a CAR-T therapy developed at Hospital Clínic de Barcelona in Spain won regulatory approval in the country and was reimbursed by the national health system, providing another option to patients at a price of €89,000 ($97,000), which works out as roughly a third of the list prices of the CAR-T products on the market by biopharma companies. 

    So, could Brazil’s unique initiative help to further spearhead the aim of improving the affordability of cell and gene therapies around the world?

    Kaid believes so, commenting on the fact that Brazil has already delivered thousands of vaccines, negotiating affordable prices for the Brazilian government and higher prices for private institutions and the world through Instituto Butantan.

    “We have long known how to do this; we have already achieved it with vaccines, and for cell and gene therapies, it’s just a matter of time. The world has yet to recognize Brazil’s leadership in this area.”

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