New Health Technology Assessment

The New Health Technology Assessment operates on the basis of the following three statutes.

▶ National Health Insurance Act

▶ Medical Service Act

▶ Health and Medical Technology Promotion Act

A subject of the New Health Technology Assessment is a new medical technology that does not appear on the benefit or non-benefit list of the National Health Insurance. The specifics are as follows.

Whether a technology falls within this scope is determined by the Health Insurance Review and Assessment Service, which maintains the benefit and non-benefit lists of health insurance.

By contrast, the treatment of conditions that do not interfere with work or daily life (for example, cosmetic surgery, vision-correction surgery, and health check-ups undertaken at one's own request) is designated as a non-benefit item under the 'Rules on the Standards for Medical Care Benefits under the National Health Insurance,' and is therefore excluded from the subjects of the New Health Technology Assessment.

This standard assesses whether the risk factors that arise when the technology is applied to a patient, such as side effects, complications, and mortality, remain at an acceptable level.

The review weighs not only short-term risks but also data on mid- to long-term aftereffects and health impacts, and to that end, the results of domestic and international clinical studies and procedure cases serve as the basis for analysis.

This standard assesses whether the medical technology delivers a substantial medical benefit, such as improved diagnostic accuracy for the condition, a treatment effect, symptom improvement, or a better quality of life.

The focus here is on whether the technology can produce clinically meaningful results for the patient, going beyond simply 'working.'

The Ministry of Health and Welfare publicly notifies the results of the New Health Technology Assessment, which identifies the technologies whose safety and effectiveness have been recognized.

Notably, transitional measures also apply to medical technologies already in use when the public notice takes effect; for a procalcitonin quantitative test, for example, enzyme fluorescence immunoassay, fluorescence immunoassay, and chemiluminescence immunoassay are each recognized as the same technology under the public notice.

These transitional measures preserve the continuity and legality of existing medical practices, and they support the practical application of the assessment results.

▪ Applicant

Applications for evaluation come mainly from medical institutions or from manufacturers and importers of medical devices.

▪ Composition of the Review Committee

For each application received, the New Health Technology Assessment Committee forms a subcommittee under the relevant field's expert evaluation committee, and the evaluation proceeds together with relevant medical professionals and researchers.

A subcommittee may include up to 10 members.

▪ Holding of Subcommittee Meetings

Meetings are usually held three to four times, and the number may vary with the characteristics of the technology.

The general evaluation period, measured from the date the application is received to the date of public notice or notification to the applicant, runs up to 250 days.

Technologies involving in vitro diagnostic tests and genetic tests qualify for expedited evaluation, in which case the period runs up to 140 days (extendable by up to 110 days if necessary).