An advisory panel to the health minister on Wednesday approved Sumitomo Pharma*s Parkinson*s disease treatment Amchepry, which costs ?55.3 million ($350,600) per patient, to be covered under the national healthcare program.
The approval marks the first commercialized medical product in the world derived from iPS cells, which are created by reprogramming adult cells such as blood or skin cells into a versatile state capable of developing into different tissue types.
Insurance coverage will begin May 20, with treatment expected to be available this fall, according to media reports.
Parkinson*s disease, which causes body stiffness and tremors in the limbs, is a brain disorder that damages neurons in the brain that produce the neurotransmitter dopamine.
Amchepry uses nerve cell precursors created from donor-derived iPS cells. During the procedure, surgeons make small openings in the skull and inject the cells into multiple locations in the putamen, a region of the brain involved in motor control.
The transplanted cells are expected to develop into dopamine-producing neurons, increasing dopamine secretion and improving motor function.
The product received conditional and time-limited approval from the health ministry in March, allowing its manufacture and sale based on confirmed safety data and indications of effectiveness.
Sumitomo Pharma will collect additional treatment data for both products over the next seven years until the current approval expires, and then seek full approval from the advisory panel, in accordance with the ministry*s regenerative medicine framework.
Despite the high listed price, out-of-pocket costs for patients are expected to be far lower, through the country*s subsidies for designated intractable diseases and its high-cost medical care benefit system, which caps monthly medical expenses based on factors such as age and income.
The health ministry has also decided to approve coverage for biotechnology company SanBio*s regenerative medicine product Akuugo for traumatic brain injuries, which costs ?72.7 million per treatment.
Akuugo has been shown to repair nerve cells in the brain damaged by traffic accidents and falls, among others, and improves motor paralysis. According to media reports, the treatment is the world*s first that can be expected to regenerate brain tissue.
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