Overview
- The Central Social Insurance Medical Council approved public insurance coverage for the iPS-cell myocardial sheet ReHeart and set the reimbursement price at ¥53.2 million, with coverage to begin September 1st.
- ReHeart is a myocardial cell sheet developed by Osaka University spinout Quolips that is placed on the heart of patients with severe heart failure to help restore cardiac function.
- The Ministry of Health granted conditional, time-limited manufacturing and sales approval in March because clinical-trial cases were limited, and regulators require seven years of post-market data to decide on full approval.
- Quolips has announced plans to begin domestic sales this autumn, though the product’s long-term status will depend on the multicenter data collected during the seven-year monitoring period.
- This is the second iPS-derived product to gain insurance coverage in Japan, a precedent that raises questions about patient access, public spending, and how well real-world evidence will confirm safety and effectiveness over time.