As Korean digital therapeutic device companies, including Welt and Aimmed, prepare to enter the U.S. market, an American expert has advised them to go beyond getting approvals and prove cost-effectiveness to land the market successfully.

Jennifer Goldsack, president of the U.S. Digital Medicine Society (DMS), made this and other points at the 3rd International Relay Seminar on New Medical Technology Evaluation on Thursday last week.

The National Evidence-based Health Collaborating Agency (NECA) organized the workshop with the theme of “Strategies to Enter the U.S. Digital Therapeutic Device Market.”

In a lecture, Ms. Goldman introduced the U.S. Food and Drug Administration's efforts to guide digital healthcare, including digital therapeutic devices and the Transitional Coverage for Emerging Technologies (TCET) program.

She noted that the FDA’s approval does not mean that digital health technology is ready for market. Instead, makers must demonstrate cost-effectiveness, including clinical value, to digital healthcare tech providers and payers through the Center for Medicare and Medicaid Services (CMS), the public healthcare agency that determines reimbursement levels.

Goldsack pointed out that the TCET system in the U.S. is a temporary enrollment program that generates evidence for as long as it takes to determine Medicare reimbursement and that CMS has different clinical evidence requirements for reimbursement decisions.

She added that a limitation of TCET is that the technologies that can be selected are extremely limited, and digital therapeutic devices are not eligible.

Goldsack noted that for technologies, such as digital therapeutic devices, it is difficult to identify innovations in the short term. Therefore, makers must have multi-faceted considerations to demonstrate the value of the technology and provide training for proper prescribing and clinical application to improve clinical workflows.

A government official added explanations.

"In November 2021, the Medicare Coverage of Innovative Technology (MCIT) system was canceled in the U.S. due to the difficulty of injecting insurance finances for medical devices without verified evidence of safety and efficacy. Immediately, however, TCET was announced through close cooperation between the FDA and CMS," said Shin Chae-min, head of the New Medical Technology Evaluation Division. "It will also be necessary for relevant ministries and organizations in Korea to continue to work closely.”

NECA planned to hold an International Relay Seminar on New Medical Technology Evaluation of Digital Therapeutic Devices on five occasions and held two seminars in July.

It will host the fourth seminar in a webinar this Friday.

The host has invited Tamir Singer from the U.K. National Health Service (NHS) to listen to strategy to enter the British market. Singer will also introduce the U.K. digital healthcare system, the role of the NHS, and the insurance coverage system for digital healthcare, including digital therapeutic devices.