엠디웍스코리아

Concept and types of therapeutic materials

The National Health Insurance Act does not define "therapeutic materials" by statute, but the term refers to consumable materials used in medical treatment that have obtained approval (certification) or notification from the MFDS or under related laws and regulations and have been recognized and publicly notified by the Minister of Health and Welfare in accordance with applicable rules and procedures.

Types of therapeutic materials

① Consumable medical devices such as artificial joints, excluding medical equipment under the Medical Devices Act
② Quasi-drugs under the Pharmaceutical Affairs Act, such as gauze and bandages
③ Selected consumer goods (e.g., hair clippers for hair removal)

National Health Insurance listing of therapeutic materials

Overview

All therapeutic materials are classified as covered benefits or non-covered items
Items not publicly notified as non-covered are treated as covered benefits

When to apply

The date of product approval, certification, or notification by the Commissioner of the MFDS
The date the technology is first used after public notification of new health technology assessment results
Within 30 days from the date you are notified as an existing technology in the benefit coverage / non-covered status (existing technology) confirmation

Outcomes

Public notification by the Ministry of Health and Welfare

Individual fee (separate calculation): insurance code, upper payment limit, etc.
Procedure fee inclusion (no separate calculation): included in procedure fee
Non-covered: non-covered code
Selective benefit: insurance code, upper limit, patient copayment rate, etc.

Therapeutic material determination procedure

STEP 01	STEP 02	STEP 03	STEP 04	STEP 05	STEP 06	STEP 07
Application	Practical review	Therapeutic material expert committee Within 15 days	Notice to applicant Within 30 days	No objection	National Health Insurance Policy Deliberation Committee	Public notification

If the applicant disagrees

After notice to the applicant, one of the following three routes may be selected.

Submission of comments: Applicant submits comments (within 50 days) > Expert committee re-deliberation (within 30 days) > Re-notice to applicant

Request for re-evaluation: Request re-evaluation (within 60 days) > Expert committee re-deliberation (within 30 days) > Re-notice to applicant

Request for independent review: Request independent review (within 30 days) > Expert committee re-deliberation (within 100 days) > Re-notice to applicant (within 7 days)

Value assessment

Definition

Under Articles 3 and 4 of the Criteria for Determination and Adjustment of Procedures, Therapeutic Materials, etc., when a product subject to determination or adjustment is evaluated—through supporting evidence—as having improved clinical utility, cost-effectiveness, or technological innovation compared with already listed items for the same purpose, a premium may be added within the price range of those existing items.

Breakthrough value assessment: demonstrated with clinical literature; 10–100% premium
Technical improvement value assessment: demonstrated with technical documentation; 10–50% premium

Assessment content

Breakthrough value assessment: clinical utility (efficacy/effect improvement, adverse events, quality of life), cost-effectiveness, technological innovation
Technical improvement value assessment: clinical utility (functional improvement, ease of procedure), cost-effectiveness, technological innovation

Applying assessment results

Premium rates are applied by total score band
An additional 5% premium may be applied when clinical trials are conducted and clinical literature is submitted at research hospitals or clinical trial centers designated by the Minister of Health and Welfare