Q（Question）

When a physician or pharmacist requests information on whether insurance reimbursement is available for off-label use of a drug, is it permissible to simply inform them that the drug is listed on the Ministry of Health, Labour and Welfare website 'On Insurance Coverage of Off-label Drugs for Which Prior Evaluation Related to Well-known Application Has Been Completed' or the Social Insurance Medical Fee Payment Fund website 'Review Information Provision Cases (Drugs)'? https://www.mhlw.go.jp/bunya/iryouhoken/topics/110202-01.html https://www.ssk.or.jp/shinryohoshu/teikyojirei/yakuzai/index.html

A（MHLW answer）

This is permissible.

So what (meaning): Informing a physician or pharmacist that a drug is listed on the MHLW or Social Insurance Medical Fee Payment Fund public websites for off-label insurance coverage is permitted. The key is limiting the information to confirming the listing; adding one's own interpretation of coverage eligibility would be a separate matter.

So why (rationale): Directing healthcare professionals to publicly available information from government agencies is an objective statement of fact, fundamentally different from a marketing authorization holder independently asserting or interpreting insurance eligibility.

Commentary — background, application, practical notes

Whether off-label use is reimbursable under public health insurance is not a matter that a marketing authorization holder can independently determine or assert; it is determined by public agencies such as the Ministry of Health, Labour and Welfare and the Social Insurance Medical Fee Payment Fund. What Q14 permits is limited to informing physicians and pharmacists of the fact that the drug is 'listed' on the relevant public website. This is a sharing of objective fact, fundamentally different in character from the manufacturer asserting or guaranteeing insurance coverage.

A typical scenario is a physician asking 'can I submit an insurance claim for this off-label use?' If the off-label use has completed the prior evaluation process related to well-known application, it will be listed on the MHLW website, and providing the URL or describing what the listing states is permitted. The same applies to the Social Insurance Medical Fee Payment Fund's 'Review Information Provision Cases (Drugs)' website: informing the physician or pharmacist that the off-label use is listed as a review information provision case is permissible.

The critical practical boundary is that the permission is specifically limited to informing about the fact of a listing. Adding an interpretation or assertion — such as 'since the well-known application process is complete, you can submit an insurance claim for this' — is not permitted. Insurance coverage determinations are ultimately made by review agencies; a marketing authorization holder independently interpreting and asserting coverage eligibility to physicians or pharmacists carries the risk of inducing erroneous insurance claims. Limiting the communication to directing healthcare professionals to where public information exists is the essential boundary that this Q&A response draws.