Table 1. The Reimbursement and Pricing Categories for Medical Technologies in Japan and South Korea (41), (42).

From: Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea

Category South Korea Japan
Coverage Reimbursed Comparing the technologies with those already listed and placed in the same “functional category,” which has similarity in material, feature, size, etc. B1 category: placed in the existing functional classification
B2 category: placed in the existing functional classification with definition change
B3 category: placed in the existing category with improvement premium with conditional period
If the new technology is considered superior to the listed technologies, “Value Appraisal Standard” Innovation Track and Technology Improvement Track are applied for premium pricing and a new functional category is created C1 category: premium pricing with new functional category creation
C2 category: new functional category with new procedure code or only new procedure code
R category: evaluation of remanufactured technologies (reprocessed technologies with new functional category)
Funded under the procedure (technical) fee (integrated fee schedule of hospital and physician fees) Low-cost disposable and reusable instruments are paid under procedure fees A1 category: placed in the existing technical fees that are not linked to the specific procedure fee codes
A2 category: placed in the existing technical fees that are linked to the specific procedure fee code
A3 category: placed in the existing procedure fees, but change the condition of the fees
Noncoverage Cosmetic, not cost-effective or not clinically essential technologies F category: Not suitable for reimbursement coverage
Table 2. The Challenge Application (CA) Form and Requirements in Japan (43).

From: Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea

Form Requirements
(Form 3-4)
Eligibility of Challenge Application
  • Manufacturers must submit this form to request eligibility for the Challenge Application program while they submit the dossier at an initial reimbursement application
  • Contents:
 -Eligibility of Challenge Application
 -Data collection and evaluation plan
(Form 15)
Periodic report on Challenge Application
  • Manufacturers must submit this form to the expert panel at a minimum of 2 years periodically
  • Contents:
 -Functions that manufacturers want to apply for Challenge Application, etc.
 -Status of data collection
(Form 16)
Request for withdrawal
  • If there is a legitimate reason, such as difficulty in collecting data, manufacturers can request withdrawal of eligibility of their Challenge Application
  • Once withdrawal is accepted, periodic reporting is unnecessary
  • Contents:
 -Reason for withdrawal and current status of data collection
Table 3. The Evaluation Criteria for the Selective Benefit Program in South Korea (35).

From: Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea

Aspects Consideration elements
Clinical usefulness ①In case of proven clinical effectiveness:
 -If clinical effectiveness is proven equal or higher as an important clinical indicator when compared to alternative reimbursed items
 -If it is used for direct therapeutic purposes as an essential material in medical technologies
 -If increased diagnostic accuracy is proven and improved therapeutic outcome is expected in a diagnostic test
②In case of proven improvement in medical process and it is expected to bring improved treatment outcomes:
 -If it is expected to bring improved treatment outcomes with improved medical processes, although there is not enough reasonable evidence when compared to alternative reimbursed items
 -If it is expected to bring improved treatment outcomes with proving improvement of convenience in medical technologies
 -If it is difficult to be expected to bring improved treatment outcomes, but the increase of the diagnostic accuracy is proven
③In case of proven improvement in medical process, but it is not expected to bring improved treatment outcomes or the improvement in medical processes is not proven:
 -In case of medical technologies, if the improvement of convenience is proven, but it is not expected to bring improved treatment outcomes, or the improvement of convenience is not proven
 -In case of diagnostic tests, if the diagnostic accuracy is not proven
Cost-effectiveness ①In the case it is cost-effective:
 -If its effectiveness is similar or improved compared to alternative reimbursed items with the same costs or reduced costs
②In the case it is not cost-effective or it is unclear:
 -If its effectiveness is similar or improved compared to alternative reimbursed items with high costs
 -Its effectiveness is low compared to alternative reimbursed items
Replaceability ①Irreplaceable cases:
 -If there are no reimbursed items available for patient
 -If there are no reimbursed items available for patients as an essential material for treatment
②Replaceable case:
 -If there are reimbursed items that are available for patients
 -If it is implemented for support of existing items
 -If there are reimbursed items available for patients as an essential material for treatment
 -If it is used additionally according to the decision of users but not essential for the treatment
Social demand on reimbursement ①In case there is high social demand on reimbursement:
 -Considering the detailed assessment factors comprehensively, if there are high social interests and great power of influence for reimbursement
②In case there is low social demand on reimbursement
 -Considering the detailed assessment factors comprehensively, if there is low social interest and great power of influence for the reimbursement
Table 4. Comparison of Reevaluation Method of Medical Technology in Japan and Korea.

From: Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea

Reevaluation South Korea Japan
CED-driven Reevaluation for CSB: Reevaluation for CA:
  • Consider four components
  • The process for reevaluation after granting CA eligibility is similar to that of C1 category application regardless of initial application categories
 -Clinical usefulness
 -Cost-effectiveness
 -Replaceability
 -Social demand on reimbursement
Non-CED-driven Functional category reevaluation: Not available
  • Review cost, effectiveness, and performance of listed items
  • Adjust reimbursement price with the weighted average by applying claim volumes and prices
Table 5. The Comparison of Challenge Application (CA) and Conditional Selective Benefit (CSB).

From: Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea

Category CA in Japan CSB in South Korea
Authority in charge MHLW MoHW/HIRA
Applicant Manufacturers MoHW/HIRA
Target of evaluation STMs New procedures and medical technologies
Responsibility of evidence generation (data collection) Manufacturers Healthcare providers
Reevaluation period Depending on protocol* Designated by the MoHW/HIRA (usually 3-5 years)**
Patient financial burden (patient copayment) Relatively low (e.g., 30%) High (e.g., 80% patient copayment rates)
Expected administrative measures after reevaluation Create new functional category and premium pricing Relieve patient copayment rates or reduced prices
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