Health Ministry includes people with HIV in coverage for CAR-T therapies

The Ministry of Health has expanded coverage of CAR-T therapies to people with HIV and an undetectable viral load , who until now had been denied access due to a lack of clinical data supporting their safety and efficacy, as they have consistently been excluded from clinical trials.

The Ministry of Health has updated clinical pharmacotherapy protocols and funding criteria to allow this group access to CAR-T therapies , thereby eliminating the discriminatory barriers that still weighed on them and improving equity in the National Health System (NHS), in line with the provisions of the Social Pact for Non-Discrimination and Equal Treatment associated with HIV.

CAR-T therapies, a revolution in medicine

CAR-T (Chimeric Antigen Receptor T-Cell) is a type of cell and gene therapy in which patients become their own donors: through apheresis, a technique that allows the separation of blood components, their T lymphocytes are extracted and genetically reprogrammed so that, when they are transfused again, they can specifically recognize tumor cells and attack them.

Currently, there are seven drugs authorized and marketed in Spain , five of which are industrially manufactured - axicabtagene ciloleucel (Yescarta, by its trade name), brexucabtagene autoleucel (Tecartus), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah) and idecabtagene vicleucel (Abecma), and two of which are academically manufactured (ARI-0001 and ARI-0002H).

In March 2024, idecabtagene vicleucel was added to the pharmaceutical benefit; patients with active HIV, hepatitis B (HBV), or hepatitis C (HCV) infection are excluded, but those with controlled infection are included.

Since last March, the clinical pharmacotherapy protocols for axicabtagene ciloleucel and brexucabtagene autoleucel have been updated to allow HIV-positive people with an undetectable viral load to begin treatment.

This April, ciltacabtagene autoleucel was included in the NHS pharmaceutical benefits under the same criteria.

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