April 01, 2025

Sumitomo Heavy Industries, Ltd. (SHI; Head Office: Shinagawa-ku, Tokyo; Representative Director, President and CEO: Shinji Shimomura; hereinafter “SHI”) announces that the amyloid PET scan using “florbetapir(¹⁸F) injection solution” manufactured using the “Radiopharmaceutical Synthesis Device MPS200Aβ (hereinafter referred to as the “Device”) will increase in range of application within Japanese health insurance* from April 1, 2025.

The Device was previously covered by insurance only "in order to determine the necessity of administration of drug indicated for the treatment of mild cognitive impairment due to Alzheimer's disease and for the prevention of progression of mild dementia (hereinafter referred to as the 'Drug')". (February 5, 2025 "Notice of Insurance Coverage of Amyloid PET Examination Using florbetapir (18F) Synthesized in a 'Radiopharmaceutical Synthesis Device MPS200Aβ’")
The Optimal Clinical Use Guidelines established by the Ministry of Health, Labour and Welfare (MHLW) now requires that the removal of amyloid-beta plaques after administration of such drugs be evaluated with amyloid PET imaging. Accordingly, insurance coverage has been expanded, and for the first time in Japan, a radiopharmaceutical synthesis device will be covered for use when “considering whether or not to terminate the Drug” and “whether or not to continue the Drug.”

This expansion of insurance coverage may lead to a reduction in the duration of treatment for drugs indicated for the prevention of mild cognitive impairment and the progression of mild dementia caused by Alzheimer's disease, thereby reducing the burden of patient visits to hospitals. It is also expected to contribute to setting appropriate doses for patients who require continuation of the Drug.

SHI will continue to focus on the further popularization development of PET testing methods to increase their convenience and range of application.

*The following is quoted from the document titled “Partial revision of ‘Important notes for implementation in accordance with the partial revision of the calculation method for medical fees, etc.’”
Amyloid PET imaging agents (in a series of tests) may be used in accordance with the Optimal Clinical Use Guidelines as specified by the Ministry of Health, Labour and Welfare for Drugs indicated for or working to treat mild cognitive impairment and delay the progression of dementia due to Alzheimer's disease (hereinafter referred to as ‘Alzheimer’s Drugs’). The same is true when considering whether to discontinue administration with an Alzheimer’s Drug, and when considering whether to continue administering an Alzheimer’s Drug for over 18 months.

Related Information
About　the　Radiopharmaceutical　Synthesis　Device　MPS200Aβ (Medical Device Approval Number 22700BZX00277000)
https://www.shi.co.jp/industrial/jp/product/medical/pet-radiopharmacy/synthesizer-mps200ab.html
February 5, 2025: Notice of Insurance Coverage of Amyloid PET Examination Using florbetapir (18F) Synthesized in a “Radiopharmaceutical Synthesis Device MPS200Aβ”
https://www.shi.co.jp/english/info/2025/6kgpsq0000003q45.html