Another iPS Product Approved for Public Insurance Coverage in Japan

Tokyo, July 22 (Jiji Press)–The Japanese Central Social Insurance Medical Council, which advises the health minister, on Wednesday approved the application of public health insurance to RiHeart, a cardiac muscle cell sheet that uses induced pluripotent stem, or iPS, cells, effective on Sept. 1. It is the second case of insurance coverage approval in the country for an iPS cell-derived regenerative medicine product. Created by introducing specific genes into cells of blood and skin, iPS cells are versatile cells with the ability to grow into cells of various tissues and organs. RiHeart was developed by Cuorips Inc., a startup based in the University of Osaka. Myocardial cells made from iPS cells are processed into sheets, which are stuck to the hearts of patients with severe heart failure to restore functions. Cuorips said it plans to put the product on sale in Japan this autumn. The official domestic price was set at 53.2 million yen. The actual medical expenses paid by patients will be significantly curbed, with the high-cost medical care benefit system, which caps out-of-pocket expenses, applied to the treatment. In March, the health ministry gave conditional and time-limited approval to manufacturing and sales of RiHeart and Sumitomo Pharma Co.’s Amchepry for patients with Parkinson’s disease, which became the world’s first iPS cell-based regenerative medicine products. Amchepry received public health insurance coverage in May. The ministry will decide whether it will give full-scale approvals for the two products after collecting additional treatment data over the next seven years. END [Copyright The Jiji Press, Ltd.]