Introduction to Regulatory Changes
According to the news (【中医協】薬価収載「年7回」に 従来は年4回、25年1月から開始 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO as of 15/May/2024, the Japanese Ministry of Health, Labour and Welfare announced at the Central Social Insurance Medical Council (Chuikyo) general assembly a significant change in the pharmaceutical regulatory landscape. In response to altering the approval timings for manufacturing and marketing of drugs, the ministry has decided to increase the frequency of Chuikyo’s drug price listing reviews from four to seven times a year, starting January 2025.
Historical Review and Approval Process
Historically, the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) two divisions have convened bi-monthly over four sessions per year – January & February, April & May, July & August, and October & November –, with March, June, September, and December serving as the “approval months.” Typically, products reviewed in, for instance, the January & February sessions, would be collectively approved in March. Subsequently, according to the “60-day & 90-day rules,” these products would undergo price listing discussions by Chuikyo, aligning with the quarterly approval schedule.
New Operational Procedures from 2025
With the new operational changes set for January 2025, reviews will follow each bi-monthly session in January, February, April, May, July, or August within three weeks respectively, with an additional combined session for approvals in October and November. Thus, the Health Insurance Bureau anticipates seven drug price listings per year. The Bureau aims to expedite regulatory approval and drug price listing processes to enable quicker patient access to new drugs.
Committee Perspectives on Faster Drug Access
Committee member Matsumoto Masato from the Federation of Health Insurance Societies emphasized the benefits of faster access to new drugs for patients and argued for increased frequency in special price recalculations. He highlighted the importance of timing over frequency in listing new drugs to quickly mitigate the financial impact on patients and health insurance. The Health Insurance Bureau acknowledged these points as subjects for future consideration.