Novartis poised to launch CAR-T therapy Kymriah in Japan after gaining insurance coverage

Japan's Central Social Insurance Medical Council on Wednesday approved coverage of Novartis' Kymriah (tisagenlecleucel) for young people with acute lymphoblastic leukaemia (ALL) and adults with diffuse large B-cell lymphoma (DLBCL), setting an official price for the CAR-T therapy of 33.5 million Japanese yen ($306 361). Kymriah gained approval from Japan's Ministry of Health, Labour and Welfare (MHLW) in these indications in March.

Coverage of Kymriah is set to begin on May 22, with the MHLW estimating that 216 patients in the country will be eligible to receive the therapy per year, potentially generating annual revenue of 7.2 billion yen ($65.8 million) for Novartis. Despite first being approved in the US in 2017, global sales of Kymriah stood at only $76 million last year, with the company facing a number of hurdles, particularly in meeting commercial specifications in DLBCL.

However, a Novartis spokesman noted that the US specification problem is not an issue in Japan. "Our cell viability commercial specifications in the EU, Switzerland, Australia, Canada and Japan are now aligned with those from our clinical trials," the spokesman said, adding "we intend to continue to engage with the [FDA] to change our commercial viability specifications in the [US]."

Despite the "disappointment" with the issues in the US, where Kymriah is priced at $475 000 for ALL and $373 000 for DLBCL, Novartis noted that comparable safety and efficacy has been seen even with batches that fail to meet FDA specifications. "We continue to optimise our process and make incremental gains as we work toward our ultimate goal of providing this transformative product to patients in both indications, and have been able to deliver Kymriah to the majority of patients," the company said.

Meanwhile, last month, the US Centers for Medicare and Medicaid Services issued a proposal that would see an increase in payments for CAR-T cell therapies, such as Kymriah and Gilead Sciences' Yescarta (axicabtagene ciloleucel). The move is designed to address concerns that the current CAR-T payment structure is "inadequate and might be impacting access to care."

 For related analysis, see ViewPoints: Novartis' blockbuster conveyor belt approaches a key inflection point.

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