The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel was approved for use in Japan in March 2019, and a government panel recently set the price for the one-time treatment: 33.5 million yen, or $305,800.
The drug is intended for the treatment of young patients with acute lymphocytic leukemia (ALL) and adult patients with diffuse large B cell lymphoma (DLBCL). In the U.S., tisagenlecleucel is approved for the same indications, but costs $475,000 as an ALL treatment and $373,000 as a DLBCL treatment.
Novartis, the manufacturer of tisagenlecleucel, hopes that this decision will help the drug overcome hurdles that it is facing in the U.S. market, such as meeting commercial specifications for cell viability. The company said it hopes that the agent could treat up to 216 Japanese patients per year, generating an estimated 7.2 billion yen, or $65.7 million, in annual sales.