PhRMA's Narasimhan Asks Japan To Reform Pricing Policies
Phase I Waiver Plan 'Very Positive'
Pointing to what it says is decreased R&D in Japan in contrast to the global market, PhRMA has again urged the country to revise its drug pricing policies and support innovation, while cautiously welcoming new moves to waive a requirement for Phase I trials in the country.
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The new measure aims to attract more bioventure-oriented products into the Japanese market. The country has been easing requirements for local Phase I trials gradually over the past decade.
Japan's latest batch of product approvals includes high-profile Alzheimer's drug Leqembi (lecanemab), along with Alhemo (concizumab) for hemophilia, Phozevel (tenapanor) for hyperphosphatemia and others. Eyes are now on the shape of use guidelines and monitoring requirements for Leqembi, along with how its extended NHI reimbursement pricing process will develop. All going well, it could reach the market by the end of the year.