CAR T-cell cancer therapy to be approved in Japan

February 21, 2019

Tokyo--An expert panel of Japan's health ministry on Wednesday expressed its approval of the production and sales of a chimeric antigen receptor (CAR) T-cell cancer therapy.

The health minister is expected to give the final approval in the near future. This will be followed by the process to fix its price under the country's public health insurance system.

The CAR T-cell therapy is likely to join the list of drugs and treatments covered by the system as early as May, according to informed sources.

In the therapy, T-cells, a type of immune system cells, are taken out of a cancer patient and put back in after being genetically modified to attack cancer cells.

The Japanese government approval will be given to the Kymriah therapy developed by Swiss pharmaceutical giant Novartis.

Treatments involving CAR T-cells have been developed by several companies. Kymriah will be the first one to win Japanese approval.

The treatment, which is conducted with only one dose of CAR T-cells, is reported to be highly effective.

A single therapy, however, costs some 50 million yen in the United States, where the treatment became an approved therapy earlier.

In Japan, out-of-pocket costs that patients will pay are expected to range from tens of thousands to hundreds of thousands yen depending on income levels.

The rest will be covered with public funds. This raises concerns about the financial impact of the therapy on the health insurance system.

The therapy will be used on patients of B-cell acute lymphoblastic leukemia aged 25 or younger and patients of diffuse large B-cell lymphoma who cannot be cured with the existing anticancer agents. The annual number of such patients are estimated at 250. Jiji Press