Novartis’ CAR-T Therapy Kymriah Priced at $305,000 Included in Japan’s National Health Insurance

As the first CAR-T therapy approved in Japan, Novartis’s Kymriah has recently been included in Japan’s National Health Insurance (NHI) reimbursement list, with a price set at $305,000. The NHI-approved indications are for the treatment of pediatric acute lymphoblastic leukemia and diffuse large B-cell lymphoma in adults aged 25 years or younger. According to Japan’s Ministry of Health, Labour and Welfare (MHLW), Kymriah will become the most expensive drug covered by the national health insurance system in Japan.

In April 2018, Novartis submitted an application to Japanese regulatory authorities for the use of Kymriah in treating certain types of leukemia and lymphoma. Clinical trials conducted in Japanese patients demonstrated that the therapy was effective in approximately 80% of patients with B-cell acute lymphoblastic leukemia and in approximately 50% of patients with diffuse large B-cell lymphoma. In March this year, Japan approved Kymriah for the treatment of CD19-positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia and CD19-positive r/r diffuse large B-cell lymphoma.

It is understood that Kymriah will be covered under Japan’s High-Cost Medical Care Benefit system within the public health insurance scheme. Under this system, patients’ out-of-pocket expenses typically account for 10–30% of the total treatment cost, with a monthly cap on individual liability. With Kymriah now successfully included in Japan’s national health insurance coverage, the majority of treatment costs for patients will be reimbursed. However, due to the drug’s high price, concerns have been raised about its potential adverse impact on the financial sustainability of Japan’s health insurance system.

According to Nikkei Asia Review, although the price of $305,000 makes Kymriah the most expensive drug in Japan's public insurance system, it is still significantly discounted compared to the United States, where the list price reaches as high as $475,000. However, considering factors such as the impact on healthcare finances, Japanese authorities may compare the cost and effectiveness of treatments before making a comprehensive decision on whether to lower the price.

According to projections by Japan’s Ministry of Health, Labour and Welfare, approximately 216 patients currently receive Kymriah treatment annually for the two approved indications, with total expenditures reaching $65.7 million. Relatively speaking, this is a small market; however, given that Kymriah’s first-quarter sales amounted to only $45 million, Novartis is not concerned about the scale of the Japanese market. On the contrary, the company is actively implementing a series of initiatives to boost the drug’s sales.

It is reported that the manufacturing process of CAR-T therapy is highly complex. It initially involves healthcare providers collecting the patient’s own immune cells, which are then processed and engineered before being reinfused into the patient to combat tumor cells. During this process, Kymriah may contain some non-functional, inactive therapeutic cells, potentially resulting in suboptimal treatment efficacy.

According to Reuters, Novartis is still actively communicating with the FDA to resolve this issue, but Novartis stated that even if it does not comply with FDA regulations, the company believes the drug has sufficient safety and efficacy.

Novartis and the FDA are currently at an impasse, while its competitor Gilead’s CAR-T therapy, Yescarta, is performing well. Financial reports show that Yescarta’s sales reached $96 million in the first quarter, a 19% increase from the previous fourth quarter. It is widely believed that its inclusion in Japan’s national health insurance coverage may boost sales growth for Kymriah. (Compiled by Fan Dongdong, Sina Medicine)

Reference Source:

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