1. HOME /
  2. 2023年 12月

2023年 12月 の投稿一覧

  • 2023.12.22

Alzheimer’s Disease Drug “LEQEMBI” Listed at NHI Drug Price in Japan＜Estimated Peak Sales: 99 Billion Japanese Yen＞

According to the news article (アルツハイマー病治療薬「レケンビ」20日収載へ…ピーク時売り上げ986億円予測｜トピックス | AnswersNews (ten-navi.com)) released by AnswersNews date 13/Dec/2023, the National Health Insurance (NHI) drug price for “LEQEMBI” (lecanemab) has been set, using the cost accounting method, at 45,777 Japanese yen for a 200 mg 2 mL vial and 114,443 Japanese yen for a 500 mg 5 mL vial. The drug is administered at a dose of 10 mg per kg of body weight bi-weekly, and the annual drug cost for a patient weighing 50 kg would be approximately 2.98 million yen. The number of patients treated annually with “LEQEMBI” is expected to peak at 32,000. The peak sales are expected to reach 98.6 billion yen on an NHI price basis in the ninth year of its launch (i.e. FY2031). The NHI drug price calculation was based on the following factors: (1) the drug has a novel mechanism of action; (2) clinical trials have demonstrated clinically significant efficacy, even in patients who have had an inadequate response/refractory to existing treatments; and (3) it is the first drug that has been shown to inhibit the progression of dementia. As a result, a price premium for its usefulness was granted to LEQEMBI’s drug price.

  • 2023.12.03

Japan’s Strategy to Attract U.S. Biotech Ventures: Addressing Regulatory Misconceptions and Augmenting Market Attractiveness

The news “厚労省・城医薬局長　米バイオベンチャー誘致でドラッグ・ロス解消「まずは審査の誤解を解くところから」 | ニュース | ミクスOnline (mixonline.jp))” was released by MixOnline on 16/Nov/2023. The article discusses the efforts of Japan’s Ministry of Health, Labour and Welfare (MHLW) to attract U.S. biotech ventures to the Japanese market and mitigate the issue of drug lag/loss. Katsufumi Jo, Director of the Pharmaceutical Safety and Environmental Health Bureau at the MHLW, underscored the importance of dispelling misconceptions about Japan’s pharmaceutical regulatory and drug pricing systems, which have deterred these ventures from entering into the Japanese market. To bridge the gap in communication between Japanese regulatory agencies and global biotech companies, the MHLW plans to establish a representative office of the Pharmaceuticals and Medical Devices Agency (PMDA) in the U.S. to provide accurate information and consultations in English about Japan’s pharmaceutical regulations. This will enable regulatory consultations with PMDA in the U.S., including conducting clinical trials in Japan. The MHLW’s initiative to establish the PMDA’s U.S. office not only aims to reduce drug lag/loss but also seeks to position Japan as a more appealing and advantageous landscape for international biotech collaborations, ultimately benefiting the pharmaceutical landscape both domestically and internationally.