Repatha sales kicked off in Japan late last month with Amgen ($AMGN) not shy in raising sales expectations on the first quarter earnings call after reimbursement was set.
Tony Hooper, head of global commercial operations, said on the April 28 earnings call that the first PCSK9 inhibitor therapy to reach Japan was up and running with partner Tokyo-based Astellas Pharma under the local unit, Amgen Astellas BioPharma.
"In Japan we have now received pricing approval and launch activities with our partner Astellas are well underway," Hooper said.
Earlier in April, Japan's National Health Insurance program set a price of ¥22,948 ($205.37) for the treatment--setting the stage for potential peak sales of ¥49.2 billion ($440 million) at the end of the decade with 69,000 patients seen on the therapy, according to data from the Central Social Insurance Medical Council (Chuikyo).
Cooper went on to say, in response to a question from analyst Jeff Chen of Cowen and Company, that the reimbursement in Japan offers an overall set price level compared to launched in Europe.
"When you come in with larger expanded patient population groups, there's a chance in Europe you have to go back into a country-by-country negotiation," Hooper said. "In Japan, historically, that hasn't happened as much and the pricing we received in Japan seems to be a longer play-through from pricing."
Still, Japan's Ministry of Health, Labor and Welfare has cautioned doctors to limit prescriptions to high-risk cardiovascular patients that do not respond to statins.
- here's the release from Amgen