Announced details
Treatment of insomnia disorder. Non-pharmacological treatment based on CBT-I.
The app is intended to achieve a therapeutic effect on insomnia symptoms through 9 weeks of use. Improvement in insomnia has been shown to persist after the treatment intervention ends. The quantified improvement rate is Not disclosed.
The company obtained marketing approval and submitted an application for insurance coverage. Reimbursement listing was approved at the General Meeting of the Central Social Insurance Medical Council, an advisory body to the Minister of Health, Labour and Welfare.
The Ministry of Health, Labour and Welfare is a government ministry. The General Meeting of the Central Social Insurance Medical Council is the council’s general meeting; the council is an advisory body to the Minister of Health, Labour and Welfare.
Approval number: 30500BZX00033000. Insurance coverage date: 1 June 2026. Expiration date: Not disclosed.
A smartphone app used over a period of 9 weeks.
Reimbursement price: ¥24,100. Applicable technical fees: B005-14 Program Medical Device, etc., Guidance and Management Fee, 90 points; initiation-period supplement, 50 points.
The impact on results for the fiscal year ending June 2026 is currently under review. The company plans to disclose the impact promptly based on future sales trends and other factors.
The company does not address Contract Value.
| Item | Details |
|---|---|
| Names of Products / Services Covered | SUSMED Insomnia Disorder App Medcle |
| Counterparty | Ministry of Health, Labour and Welfare; General Meeting of the Central Social Insurance Medical Council |
| Counterparty overview | The Ministry of Health, Labour and Welfare is a government ministry. The General Meeting of the Central Social Insurance Medical Council is the council’s general meeting; the council is an advisory body to the Minister of Health, Labour and Welfare. |
| Relationship with the Company | The company obtained marketing approval and submitted an application for insurance coverage. Reimbursement listing was approved at the General Meeting of the Central Social Insurance Medical Council, an advisory body to the Minister of Health, Labour and Welfare. |
| Offering price | Reimbursement price: ¥24,100. Applicable technical fees: B005-14 Program Medical Device, etc., Guidance and Management Fee, 90 points; initiation-period supplement, 50 points. |
| Launch date | 1 June 2026 (insurance coverage and scheduled launch date) |
| Applicable area | Treatment of insomnia disorder. Non-pharmacological treatment based on CBT-I. |
| Registration number and expiry date | Approval number: 30500BZX00033000. Insurance coverage date: 1 June 2026. Expiration date: Not disclosed. |
| Location scale | A smartphone app used over a period of 9 weeks. |
| Quantitative Effects | The app is intended to achieve a therapeutic effect on insomnia symptoms through 9 weeks of use. Improvement in insomnia has been shown to persist after the treatment intervention ends. The quantified improvement rate is Not disclosed. |
| Impact on Business Performance | The impact on results for the fiscal year ending June 2026 is currently under review. The company plans to disclose the impact promptly based on future sales trends and other factors. |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To provide patients with insomnia disorder a non-pharmacological treatment based on cognitive behavioral therapy for insomnia (CBT-I) as a new treatment option. The company also explained that improving treatment options for patients who have not responded sufficiently to existing treatments or cannot use them for safety or other reasons was another objective.