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Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings

 
• By Lisa Takagi

Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.

Japan widened the scope of RWD by allowing pseudonymized data.
Japan widens scope of RWD by allowing pseudonymized data • Source: Shutterstock

Japan announced several regulatory updates in the pharmaceutical sector at the beginning of April, including a revised law that allows the wider use of real-world data (RWD).

A group of new drugs were also granted reimbursement pricing, while the country’s cost-effectiveness assessment scheme was applied to Bayer AG’s chronic kidney disease therapeutic Kerendia (finerenone) and

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