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Organization :
Ministry of Health and Welfare
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Regulation :
National Health Insurance Act
Grievance
(Background)
Recently, the requirements have been partially revised to add tuberculosis treatments to the list of drugs for which economic evaluation data can be omitted. In order to ensure accessibility to new drugs for patients with rare diseases who are in the blind spot of health insurance coverage, it is needed to ease and expand the requirements for drugs that can be omitted from submission.
(Grievance)
Request to amend the law in case of rare disease medicines when used for a disease recognized by the committee as having no equivalent product or treatment and which significantly reduces the quality of life
Resoultion and Results
(Resolution)
Recently, the requirements have been partially revised to add tuberculosis treatments to the list of drugs for which economic evaluation data can be omitted, but economic evaluation data are still required to ensure accessibility to new drugs for patients with rare diseases who are in the blind spot of health insurance coverage. OFIO requested to relax and expand the drug requirements that can be omitted from submission of economic evaluation data.
(Result)
In the Article 6-2 of 「Regulations on Assessment Criteria and Procedures, etc. for Medical Care Benefit Eligibility, etc. of Medicines」, provisions were amended to allow the omission of economic evaluation data in the case of medicines used in pediatric patients, and to reduce evaluation period for such medicines (Jan. 01, 2023)
