Japan Approves Inclusion of CAR-T Therapy Kymriah in National Health Insurance with a Price Tag of Approximately ¥33.5 Million
Novartis
Drug Development and Manufacturing
According to NHK’s report today (May 15), Japan’s Central Social Insurance Medical Council approved the inclusion of Novartis’ CAR-T cell therapy product, Kymriah, in the national health insurance coverage effective May 22. The drug is priced at approximately 33.5 million yen (about 2.1 million RMB). According to Japan’s Ministry of Health, Labour and Welfare, this makes it the most expensive medication currently covered by Japan’s national health insurance system.
As the first globally approved CAR-T cell therapy, Kymriah has received approval in the United States, the European Union, and Canada. Following the successful transfer of technology for the clinical production of Kymriah by the Foundation for Biomedical Research and Innovation (FBRI) in Kobe, Japan officially approved Kymriah in March this year for the treatment of CD19-positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and CD19-positive r/r diffuse large B-cell lymphoma (DLBCL), becoming the first country in Asia to approve a CAR-T therapy.
Japan’s Ministry of Health, Labour and Welfare reviewed data from the global registrational CAR-T clinical trials JULIET and ELIANA, including studies conducted in Japan. Given the recognition of Kymriah’s efficacy in countries such as the United States and those in Europe, along with its favorable clinical trial data, the Central Social Insurance Medical Council decided at a recent meeting to include Kymriah in the national health insurance coverage starting on the 22nd of this month. This therapy enhances the ability of immune cells collected from patients to attack cancer by genetically modifying them. It is primarily indicated for patients under 25 years of age with B-cell acute lymphoblastic leukemia and for patients with diffuse large B-cell lymphoma, and is restricted to cases where anticancer drugs have proven ineffective. Due to potential side effects associated with cell therapy products, such as high fever and hypotension, Kymriah is expected to be initially available only at a limited number of hospitals.
As there is a cap on patients’ out-of-pocket medical expenses, with costs exceeding this limit covered by insurance premiums and taxes, some experts in Japan are concerned that an increase in insurance coverage for high-cost drugs could impact the financial sustainability of the national health insurance system. According to projections by Japan’s Ministry of Health, Labour and Welfare, at peak usage, the number of patients using this drug annually will reach 216, with total expenditures amounting to JPY 7.2 billion (approximately RMB 450 million).
Currently, against the backdrop of vigorous research and development of biological products utilizing immunotherapy, regenerative medicine, and gene editing, the number of high-priced pharmaceuticals in Japan is steadily increasing. For instance, when the anticancer drug Opdivo was included in the national health insurance coverage five years ago, its price was approximately 35 million yen (about 2.19 million RMB). However, as approvals for additional indications of the same drug have increased, its price has decreased to a certain extent. Opdivo was initially approved for the treatment of skin cancer, but later received approval for treating lung cancer and other conditions. Consequently, the current price of the drug has dropped to approximately 9.6 million yen (about 600,000 RMB), representing a reduction of roughly two-thirds.
Regarding Kymriah, which has recently been included in the national medical insurance coverage, it is currently not possible to predict whether new indications will be added in the future. Taking into account factors such as the impact on the financial sustainability of the health insurance system, Japan’s Ministry of Health, Labour and Welfare has introduced a new system starting this year. This system involves comparing previously available treatments with newly approved drugs in terms of cost and effectiveness, among other aspects, to comprehensively determine whether price reductions should be implemented.
References
《New Leukemia Drug Covered by Insurance: Price Per Dose Approximately 33.5 Million Yen》
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