Im Jin-hwan CEO "Will Start with Non-Covered Track"
DTx Health Insurance Guidelines
Granting Companies Choice Between Non-Covered and Selective Coverage
Non-Covered Expected to Be Preferred by Medical Institutions
Coverage Has Pros and Cons Such as Credibility Assurance and Reduced Patient Burden
The prescription of the country's first digital therapeutic device (DTX) is expected to be made through non-reimbursed application rather than National Health Insurance coverage.
Im Jin-hwan, CEO of AimMed, is presenting at the Autumn Academic Conference of the Korean Society of Sleep Medicine held on the 8th at Asan Medical Center in Songpa-gu, Seoul. [Photo by Lee Chun-hee]
On the 8th, at the Autumn Academic Conference of the Korean Society of Sleep Medicine held at Seoul Asan Medical Center in Songpa-gu, Seoul, Lim Jin-hwan, CEO of Aimmed, which developed 'Somz', the first domestic DTx for insomnia, stated, "There are advantages to reimbursement, but I think non-reimbursement has more advantages," adding, "We plan to start with the non-reimbursed track first."
Last month, the Health Insurance Review and Assessment Service (HIRA) established and announced guidelines for the listing of innovative medical technologies related to DTx on health insurance. Regarding DTx, when applying for digital medical evaluation, companies will be given the option to choose either non-reimbursement or selective reimbursement (10%). HIRA plans to disclose the non-reimbursed amounts by institution on its website and mandate the submission of prescription claim details to monitor and prevent side effects such as misuse and abuse.
The industry welcomed the provision of choice but has also been deeply contemplating it. Entering reimbursement means inclusion in public insurance, which carries credibility as it is recognized by a national institution, and patients can reduce their cost burden by even 10%. However, since non-reimbursement can result in higher fees compared to reimbursement, it is analyzed that medical institutions receiving prescription fees may prefer non-reimbursed prescriptions more.
CEO Lim also explained the reason for choosing non-reimbursement: "The advantage for medical staff lies in non-reimbursement." 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 sales of DTx cannot occur without doctors prescribing them, the strategy is interpreted as focusing on this aspect first to broaden the base.
Aimmed plans to complete the review by the Evidence Generation Expert Committee soon and start the research phase for clinical evidence generation by prescribing Somz to actual patients at six tertiary medical institutions from November. Subsequently, they plan to enter the 'clinical practice' phase by expanding the scope to primary medical institutions within the first quarter of next year.
The Ministry of Food and Drug Safety approved Aimmed's 'Somz' (left) and Welt's 'Welt-I' as digital therapeutic devices (DTx) [Photo by each company]
At the same event, Shin Jae-yong, professor of preventive medicine at Yonsei University and CEO of Evertry, who gave a presentation on "The Future Direction of DTx in Korea," emphasized, "It is unthinkable without involving doctors," adding, "Since medical outcomes must be rigorously tested for trustworthiness and validity by doctors, considerations on performance, effectiveness, economic feasibility, and user perspectives are necessary." Professor Shin further advised, "There are DTx tailored to individuals, and doctors will prescribe accordingly. When considering reimbursement or non-reimbursement, one must think about to whom they are selling this."
Similarly, Welt, which received approval from the Ministry of Food and Drug Safety in April for its insomnia DTx 'Welt-I', has not yet finalized whether it will be reimbursed or non-reimbursed. Unlike Somz, which received the innovative medical technology designation notice immediately after approval, Welt-I has not yet received such a notice. A system revision is underway to remove the restriction limiting insomnia DTx prescriptions to the 'psychiatry' department, and it is expected that the notice will be issued after this revision is completed.
As they prepare to receive the notice soon and begin actual clinical prescriptions, deciding on reimbursement or non-reimbursement is a prerequisite, leading to deep deliberation. At the conference, Kang Sung-ji, CEO of Welt, who gave a presentation titled "Can DTx Open a New Era for Sleeping Pills?", conducted an impromptu show of hands among attending doctors regarding their preference for reimbursement or non-reimbursement, resulting in nearly equal numbers raising their hands.
Kang Sung-ji, CEO of Welt, is presenting at the Korean Society of Sleep Medicine Autumn Academic Conference held on the 8th at Seoul Asan Medical Center in Songpa-gu, Seoul. [Photo by Lee Chun-hee]
Meanwhile, both CEO Lim Jin-hwan and CEO Kang Sung-ji responded to speculation that the first and second DTx, both for insomnia, would compete against each other by emphasizing that "the priority is to grow the ecosystem through coexistence and collaboration." CEO Kang explained, "The first and second DTx are not competitors," and CEO Lim also stressed, "Competition is only possible once the market is formed. Creating competitors in a market that has not yet formed is a foolish act." He pointed out that the priority is to build the industry, imprint on doctors how effective DTx is, and gain understanding from patients to broaden the base.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
