The 2023 revision of drug prices in Japan has been announced,
with 600 drugs being eligible for the price maintenance premium (PMP) and 1,100 drugs eligible for the unprofitable drug reassessment. The PMP will provide an additional 0.1% to 1.0% premium for the first three years of sale for drugs that meet certain criteria, such as those that have been approved for the first time in Japan or that have a significant therapeutic effect. Meanwhile, there assessment of unprofitable products aims to reduce the gap between drug prices in Japan and those in other countries. For products that have not been profitable for three years or more, the government will calculate the costs of manufacturing, distribution, and sales, and adjust the price accordingly. This re-evaluation is expected to increase the prices by an average of 2.7%. This revision aims to support companies developing new drugs and improve the financial standing of companies involved in the manufacturing of unprofitable drugs. Cancer and rare disease drugs are expected to be the main focus, with their prices increase.
Overall, the revision aims to ensure the sustainability of Japan’s healthcare system by promoting the development of innovative drugs while also addressing issues of affordability and access to healthcare options.
【ビジュアル解説】600品目に新薬創出加算、不採算品再算定で1100品目引き上げ…23年度薬価改定 | AnswersNews (ten-navi.com)
Sanofi’s LIBTAYO, Cemiplimab IV, was approved in December 2022
based on results of global Ph 3 EMPOWER-Cervical 1 study, of which duration was around 6 years. This is the 3rd approval for PD-1 inhibitor in Japan following Opdivo and Keytruda. It was approved to treat patients with advanced or recurrent cervical cancer whose diseases progressed after chemotherapy, and that means Keytruda has been already approved for advanced or recurrent cervical cancer in Japan.
While precedent Opdivo and Keytruda have been approved for wide indications, LIBTAYO’s future positioning and strategic challenges to compete with 2 giants would become a big topic in Japan.
Study of Cemiplimab in Adults With Cervical Cancer – Full Text View – ClinicalTrials.gov
Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent Cervical Cancer | Regeneron Pharmaceuticals Inc.
CSL Behring’s BERINERT SC was approved for prevention of acute hereditary angioedema attacks, HAE, in September 2022.
Efficacy and safety of the product based on results of COMPACT study, global Ph 3, COMPACT extension study and Japanese Ph 3 study were evaluated by PMDA. The duration of Japanese Ph 3 study was around 10 months.
According to the quarterly price listing report published in October 2022, BERINERT SC was priced based on TAKHZYRO, marketed by Takeda since March 2022, that means it was given the same price as TAKHZYRO’s in terms of daily price. CSL Behring expects 36M USD as peak sales in the 4th year treating 139 HAE patients.
In Japan, drug pricing is regulated by the government because Japan has a universal healthcare system and the government controls healthcare expenditure including drug costs.
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) – Full Text View – ClinicalTrials.gov
CSL Receives Authorization in Japan for prevention of Acute HAE attacks (cslbehring.com)