February 05, 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”)” was covered by Japanese health insurance* due to the “determination of necessity of administering a 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”) from February 1, 2025.

Currently, the Drug is marketed for the treatment of mild cognitive impairment due to Alzheimer's disease, and for the inhibition of the progression of mild dementia. However, the Drug can only be administered upon confirming medical findings suggestive of amyloid-β pathology using an approved diagnostic method.
In order to determine the necessity of administration of the Drug, an amyloid PET scan using a “florbetapir (¹⁸F) injection,” which is produced by this Device, is covered by insurance.
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.’”
In patients with mild cognitive impairment due to Alzheimer's disease or suspected mild dementia, findings suggestive of amyloid-β pathology for the purpose of determining the necessity of administering a “drug which is indicated for or works to treat mild cognitive impairment and delay the progression of dementia due to Alzheimer's disease (hereinafter referred to as a ‘Drug’)” must be confirmed in accordance with the guidelines for the promotion of optimal use as specified by the Ministry of Health, Labour and Welfare for Drugs. The same is true when resuming administration with the first dose of a Drug if 18 or more month have passed since discontinuation of the Drug.


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
September 13, 2024: “Approval of a partial change in intended use or effect of the ‘Radiopharmaceutical Synthesis Device MPS200Aβ,’ which is a labeled PET compound synthesis system.”
https://www.shi.co.jp/info/2024/6kgpsq000000njhh.html