Drug Evaluation Committee 2009-15 Burden of Costs for Drugs for Adverse Events (Interpretation of Notification Concerning Costs of Uninsured Combination Therapy) (Part 1)
Related classification: Other
First published: Jul 2009
Revised publication date: December 2021
Question
In a clinical trial, there was a case in which it was pointed out at the time of insurance assessment that a drug prescribed for an adverse event that occurred (not falling under the same class of drugs) was not covered by insurance claims. As the basis for this, it was claimed that they were not covered by insurance claims and were borne by the company, based on the following underlined statement in Article 3.2 of the "Concerning Specified Medical Treatment Expenses for Clinical Trials," a January 31, 1997 notice from the Medical Division of the Health Insurance Bureau of the Ministry of Health and Welfare.
The company claims that the insurance claims are not covered based on the following underlined items in Article 3, Paragraph 2 of the "Notice on the Reimbursement of Specific Medical Expenses for Clinical Trials The sponsor shall also bear the costs of tests and diagnostic imaging related to diseases unrelated to the clinical trial (including those belonging to other departments), as well as the costs of medication and injections related to drugs that have the same expected indications or effects as those of the drug under study, if they are performed during the clinical trial period. The same treatment shall apply to costs related to illness caused by side effects of investigational drugs, etc. ".
As stated on page 10, Explanation 6. Concomitant medications (medication and injections) to be borne by the company (see below) in the "Explanation of the Specific Medical Care Cost System for Clinical Trials, March 2003," we have interpreted that the sponsor does not bear the costs for medications prescribed for adverse events.
'While the company would bear the cost of the tests and diagnostic imaging for any purpose, for medication and injections, the company would bear the cost of concomitant medications used for the same purpose as the intended efficacy of the investigational drug, and insurance would provide benefits for all other medications.
For example, for an investigational drug that is intended to shrink tumors, the insurance will pay for any antiemetic or painkiller that is used concomitantly when this patient vomits or is in severe pain. If the trial is to test the efficacy of the drug in combination with another anticancer drug, the company would pay for the combination drug (the other anticancer drug) because it is being used for the same purpose."
What is the Pharmaceutical Manufacturers Association's (PMA) position on the interpretation of the underlined part above?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The sponsor is responsible for the costs of tests, diagnostic imaging, medication and injections of drugs that have the same efficacy or effect as the expected efficacy or effect of the drug in question for diseases caused by adverse reactions to the investigational drug, etc. In other words, the sponsor is responsible for the costs of medication, injections, and injections of drugs other than the above. In other words, costs required for medication and injections of drugs other than those mentioned above are covered by insurance claims.
Supplement
Please also refer to Q&A 10 of "Uninsured Combination Medical Care Expenses for Clinical Trials Explanation and Q&A" (January 2015, Jihosha) and Q219 of "Sending of Questionable Interpretation Materials (Part 1)" (March 31, 2016, Ministry of Health, Labor and Welfare, Health Service Bureau, Medical Division, Administrative Communication).
Reason for revision of opinion
The description was reviewed and the opinion text was partially revised.