Drug Evaluation Committee 2011-31 Coverage of the uninsured concomitant therapy fee system (Interpretation of the Notice on Uninsured Combination Therapy Fees)
Related classification: Other
Date of first publication: November 2011
Question
We have a question regarding the explanatory note in the Pharmaceutical Manufacturers Association of Japan document "Regarding the uninsured concomitant therapy cost system for medical treatment related to drug trials," which was issued in March 2011.
As for [Points to be Noted] 9) on page 9, "4. Scope of 'Examinations and Diagnostic Imaging' to be borne by the Company," the current situation is that the costs of examinations and diagnostic imaging at medical institutions other than the site of the clinical trial are borne by the patient (insurance benefit), even if they are within the "clinical trial period. Does this commentary mean that the costs of tests and diagnostic imaging at other institutions must be divided between the company's share and insurance benefits if they are within the "clinical trial period"?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The uninsured combined medical care reimbursement system is only applicable when the sponsor has concluded a contract as the medical institution conducting the clinical trial. Therefore, as you understand, the costs of examination and diagnostic imaging at a medical institution unrelated to the implementation of the clinical trial are covered by insurance even during the clinical trial period.
This example is based on the assumption that tests that cannot be performed at the investigational site are outsourced to other facilities. In such cases, the sponsor can bear the costs of tests and diagnostic imaging during the clinical trial period by concluding an outsourcing agreement as the facility that performs the tests.