Kymriah, Yescarta Subject to Cost-Effectiveness Assessment-Based Price Adjustments in Japan

TOKYO, Japan – Come July 2021, Novartis’ CAR-T therapy Kymriah (tisagenlecleucel) will be subject to a 4.3% price reduction due to cost-effectiveness assessment (CEA)-induced price adjustments, according to Pharma Japan.

The Ministry of Health, Labor, and Welfare (MHLW) formulated a plan to lower prices for products with significantly high prices—categorized as an H3 medicine, Kymriah was deemed eligible for CEA-based price cuts by the Central Social Insurance Medical Council (Chuikyo).

In May 2019, Kymriah was approved at a price of JPY 33,493,407 (public price including VAT, according to data from Pricentric). To price Kymriah, Japan used a cost-based method, as there are no specific pricing policies in place for such medicines; treatments like Kymriah are grouped as “regenerative medicines.”

The CAR-T therapy initially earned a 35% utility premium for its anti-tumor effect and a 10% marketability premium for its orphan drug designation, however, the premium rate for Kymriah was reduced by 80% to just 9% under a rule introduced the year prior for drugs priced by the cost-based method that reduces launch premium rates based on the ratio of disclosed costs.

Earlier this year, Daiichi Sankyo’s CAR-T therapy Yescarta (axicabtagene ciloleucel) secured approval from the MHLW and is being priced by the comparator method of pricing, with Kymriah serving as the comparator treatment.

Yescarta will be given a national health insurance (NHI) price this month after backing from Chuikyo and be subject to a price adjustment, akin to that of Kymriah. Yescarta was categorized as an H5 product, or a product like those in categories H1-H4 and for which reference drugs used in pricing (i.e. Kymriah) are subject to CEAs.