Japan OKs 1st iPS Regenerative Medicine for Insurance Coverage

Tokyo, May 13 (Jiji Press)–A Japanese health ministry council on Wednesday approved the public health insurance coverage for a regenerative medicine for Parkinson’s disease produced from induced pluripotent stem, or iPS, cells, effective from May 20. With the approval by the Central Social Insurance Medical Council, which advises the health minister, Amchepry from Japan’s Sumitomo Pharma Co. will become the country’s first iPS cell-based regenerative medicine eligible for health insurance coverage. Amchepry, a dopaminergic neural progenitor cell product, is aimed at helping improve motor action through its transplant into patients’ brains. In March, the ministry gave conditional and time-limited approval for the production and sale of Amchepry and RiHeart, a cardiomyocyte sheet from Japanese startup Cuorips Inc., linked to the University of Osaka, as the first iPS cell-based regenerative medicine products in the world. Health insurance coverage for RiHeart is expected to be approved this summer. The official price of Amchepry has been set at about 55 million yen. The actual expenses to be paid by patients will be significantly reduced thanks to the country’s system to curb out-of-pocket costs for expensive medical treatment. Created by introducing specific genes into blood, skin or other cells, iPS cells can be transformed into cells of various tissues and organs. The ministry will spend seven years collecting treatment data on Amchepry and RiHeart to consider whether to give full pharmaceutical approval for the two iPS-cell based regenerative medicine products. END [Copyright The Jiji Press, Ltd.]