Uncertainty regarding approval and insurance coverage for therapeutic apps
First written in FY2022. 7 of 15 entries say "Mitigated", first in FY2023. Latest entry: FY2026.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
6 other companies' latest entry also says "Mitigated".
- FY2026MitigatedAnnual report
「In May 2026, reimbursement listing for the “サスメド insomnia disorder app Medcle®” was approved by the Central Social Insurance Medical Council, and sales began in June 2026.」
For the insomnia disorder app, approval of reimbursement listing and the start of sales reduced some of the uncertainty regarding approval and reimbursement listing. However, risks related to the speed of adoption and sales remain. - FY2026-H1RestatedAnnual report
「The Ministry of Health, Labour and Welfare approved this application on 2 September 2025, and the Company submitted its request for reimbursement coverage on 4 September. Preparations for reimbursement listing and product launch are currently proceeding in parallel.」
Following approval for partial changes to the manufacturing and marketing approval and submission of the request for health insurance coverage, the Company has continued preparations for health insurance coverage and product launch. Health insurance coverage itself has not yet been secured. - FY2025MitigatedAnnual report
「Following approval of this application, we submitted a request for health insurance coverage on 4 September. We are currently proceeding in parallel with preparations for health insurance coverage and product launch.」
For the app for insomnia, the Company obtained approval for partial changes to the manufacturing and marketing approval, which is a prerequisite for health insurance coverage, and submitted a request for coverage. Health insurance coverage itself has not yet been secured, and the risk remains. - FY2025-H1RestatedAnnual report
「The Company had been proceeding with the health insurance coverage process. However, because the health insurance medical materials system was revised in the fiscal 2024 revision of medical service fees, the Company applied in August 2024 for partial changes to the manufacturing and marketing approval, and is proceeding with preparations for health insurance coverage and product launch.」
After health insurance coverage was deferred, the Company applied for partial changes to the manufacturing and marketing approval and has continued preparations for health insurance coverage and product launch. - FY2024MaterialisedAnnual report
「Although reimbursement listing was deferred during discussions on the fiscal 2024 medical fee schedule revision, the Company consulted with relevant authorities and submitted an application in August 2024 for approval of partial changes to the approved marketing authorization particulars in order to resume the reimbursement listing process.」
Regarding the uncertainty over health insurance coverage previously described as a risk, the Company stated that coverage was in fact deferred in the fiscal 2024 revision of medical service fees. - FY2024-Q3RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and is currently preparing for reimbursement coverage and product launch.」
Although obtaining approval for the therapeutic app for insomnia has continued to reduce part of the approval risk, coverage by health insurance and product launch remain in the preparation stage. - FY2024-Q2RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and is currently preparing for reimbursement coverage and product launch.」
Although obtaining approval for the therapeutic app for insomnia has continued to reduce part of the approval risk, coverage by health insurance and product launch remain in the preparation stage. - FY2024-Q1RestatedAnnual report
「The Company obtained marketing authorization from the Ministry of Health, Labour and Welfare for the Application on 15 February 2023 and is currently preparing for reimbursement coverage and product launch.」
Although obtaining approval for the therapeutic app for insomnia has continued to reduce part of the approval risk, coverage by health insurance and product launch remain in the preparation stage. - FY2023MitigatedAnnual report
「The main challenge that the Company must address in its DTx product business in order to expand its business and earnings going forward is to reliably obtain medical device approval for each therapeutic app under development, and to secure health insurance coverage at a level sufficient to generate adequate earnings. The therapeutic app for insomnia has already received manufacturing and marketing approval.」
Approval risk has been partly reduced for the therapeutic app for insomnia, but approval of the other apps and securing health insurance coverage at an adequate level remain ongoing challenges. - FY2022First statedAnnual report
「In addition, if the use of therapeutic apps or systems developed by the Company is not approved by the regulatory authorities, it may become difficult to launch them or provide services using them to other companies. Furthermore, even if approval is obtained, the Company's financial condition and operating results could be significantly affected if the products are not covered by health insurance or are not assigned reimbursement rates at the expected level.」
The Company describes separately the risks of failing to obtain approval, launch the products, secure health insurance coverage, or achieve the planned reimbursement rates.