'The Country's First DTx Prescription' May Begin as Early as Next Month

AimMed's Insomnia DTx 'Somz'
Approved for Innovative Medical Technology Implementation
Choosing Non-Reimbursement... "Advantages for Medical Staff"

As early as next month, the first domestic prescription of a digital therapeutic device (DTx) is expected to take place.

Aimed's digital therapeutic device (DTx) for insomnia, 'Somz'
[Photo by Aimed]

AimMed, the developer of Somzz, an insomnia DTx and the 'first domestic DTx,' announced on the 17th that it received approval for the implementation of Somzz as an innovative medical technology from the Korea Health Industry Development Institute on the 13th. Accordingly, AimMed plans to enter the 'research execution' phase to generate clinical evidence for the innovative medical technology and aims to start prescribing Somzz to actual patients at six hospitals as early as next month.

This approval for Somzz's innovative medical technology implementation came about six months after the Ministry of Health and Welfare's new medical technology evaluation notice in March. Jin-Hwan Im, CEO of AimMed, said, "We have made great efforts over the past six months and humbly accepted advice and criticism from government agencies and advisory groups. Although it is not at a satisfactory level, we accept it as natural since it is the first time, and we intend to proceed cautiously yet smartly, step by step, to create the optimal DTx that satisfies both the medical community and patients without rushing."

Somzz is scheduled to meet patients at the departments of psychiatry of six institutions: Seoul National University Hospital, Korea University Anam Hospital, Samsung Seoul Hospital, Severance Hospital, Yongin Severance Hospital, and Wonju Yonsei Medical Center. All Institutional Review Board (IRB) reviews at these institutions are expected to be completed within this month, followed by insurance review, with actual prescription cases anticipated as early as the end of next month or early December.

Kyung-Ho Jung, head of the DTx division at AimMed, explained, "To this end, we are closely cooperating with each implementing institution and the contract research organization (CRO), Evertree. Since the restriction on medical departments was lifted through the re-notification of the new medical technology evaluation last month, we plan to expand next year to departments that frequently prescribe sleeping pills, such as neurology, family medicine, internal medicine, and otolaryngology, in addition to psychiatry."

Im Jin-hwan, CEO of AimMed
Photo by AimMed

The research execution of Somzz's innovative medical technology is expected to be conducted on a non-reimbursable basis. Currently, the Health Insurance Review and Assessment Service (HIRA) has decided to grant companies the option of non-reimbursable or 10% selective reimbursement for temporary registration of DTx. CEO Jin-Hwan Im previously stated at the Korean Society of Sleep Medicine's autumn academic conference last month, "While reimbursement has its advantages, I believe non-reimbursement has more benefits," and revealed plans to start with the non-reimbursable track.

Im explained the specific reason as "Non-reimbursement is advantageous for medical staff." Unlike typical product markets, the medical market considers not only the end consumer, the patient, but also the medical institutions and staff who prescribe DTx as important consumers. Since DTx sales cannot occur without a doctor's prescription, the strategy is interpreted as focusing first on this aspect to broaden the base.

HIRA plans to disclose the non-reimbursable amounts per medical institution on its website even if prescriptions are made on a non-reimbursable basis, mandate claims for prescription details such as dosage frequency to monitor misuse, and review restrictions on non-reimbursable prescriptions if actual issues arise.

This content was produced with the assistance of AI translation services.