Drug Evaluation Committee 2011-23 Cost sharing of drugs for the treatment of adverse events (Interpretation of the Notice on the Cost of Uninsured Combination Therapy) (Part 2)
Related classification: Other
First published: Sep 2011
Revised publication date: December 2021
Question
The hospital has billed insurance for adverse events arising from clinical trials if the costs do not correspond to the costs of medication and injections for drugs with indications or effects similar to the expected indications or effects of the drugs covered by the clinical trial. However, some people believe that the cost of treatment for adverse events occurring in a clinical trial cannot be covered by insurance and should be borne entirely by the sponsor. Please let us know if there is any notice or other information that clearly states whether or not treatment for adverse events occurring in a clinical trial can be considered an insured treatment.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Q219 of the "Sending of Questionable Interpretation Materials (Part 1)," an administrative communication of the Medical Division, Health Bureau, Ministry of Health, Labour and Welfare, dated March 31, 2008, states the following.
(Question) How are uninsured medical expenses paid for medical treatment related to side effects, etc. that occur in a clinical trial?
(A) In principle, medical treatment related to adverse reactions, etc. that occur in a clinical trial is also covered by insurance benefits, and is treated in the same way as medical treatment related to a clinical trial as long as it is during the period of the clinical trial.
Therefore, the sponsor is responsible for the cost of medication and injections of drugs that have the same efficacy as the expected efficacy of the investigational drug (the same drug with the same effect) administered during the trial period for the treatment of adverse events.
Please also refer to the past Opinion 2009-15, as well as Q&A 10 of "Uninsured Combination Medical Care Expenses for Clinical Trials: Commentary and Q&A" (January 2015, Jiho) and the notes in Section 2.3.2.1 (6).
Reason for revision of opinion
The description was reviewed and the opinion text was partially revised.