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Off-label use

In connection with drug lag problem (there is substantial delay in marketing approval of new drugs in Japan, comparing with FDA, EMEA), off-label use of already approved drugs has been raised as a problem in Japan. In order to solve this problem, it has been thought that concerned MAHs (marketing authorization holders) need to apply for label extension to PMDA (Japanese authority), after appropriate clinical trials could be conducted. But I think this is ineffective solution and practically impossible.
The said solution has originated from an unspoken assumption; all reimbursement of drug costs should be made based solely on what was written in package insert (approved indication). But it has been legally allowed to deviate from the written indication by a ministry ordinance called 'Showa 55 notification'. So even though it is legally allowed to deviate from the written indication, why can the off-label use problem exist in Japan? Firstly because many HCPs (healthcare providers) aren't aware of the 'Showa 55 notice'. Secondly because there is some uncertainty whether the drug cost can be surely reimbursed by the payer. In Japanese system, the eligibility of reimbursement is decided by a reviewer of health insurer, and their decision can differ by each prefecture. Eventually, the description in the package insert has been regarded as solely justification in the reimbursement. And the revision of the labeling (package insert) has been thought as the solution.
Separately, even though the labeling could be revised, its revision cannot catch up with medical advance. The actual dosage and usage of drugs may change in real medical practice, having a new knowledge in medical community. In very advanced field, this tendency of evolving change is significant.
Given above, my practical solution for this off-label use is to make the health insurer have their own formulary which should be the basis of reimbursement decision. The root problem is the 'package insert' has been considered as the sole document for indications.

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後発薬のことでしょ。
君、なんとかして。

投稿: jacky | 2010年1月12日 (火) 00時50分

> Jackyさん

わかりにくい話題を英語で書いて誤解を招きました。「適応外」使用の問題を書いたんです。もうちょっとわかりやすい英語を書く練習をしないといけないですね。
# 未だ英語には困ってるんで、練習ついでに書いて、推敲もせずにアップロードしてるんで許して下さい。:-)

投稿: 夢見るK | 2010年1月17日 (日) 13時14分

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