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 |
Form | Requirements |
---|---|
(Form 3-4) Eligibility of Challenge Application |
|
-Eligibility of Challenge Application | |
-Data collection and evaluation plan | |
(Form 15) Periodic report on Challenge Application |
|
-Functions that manufacturers want to apply for Challenge Application, etc. | |
-Status of data collection | |
(Form 16) Request for withdrawal |
|
-Reason for withdrawal and current status of data collection |
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 |
Reevaluation | South Korea | Japan |
---|---|---|
CED-driven | Reevaluation for CSB: | Reevaluation for CA: |
|
|
|
-Clinical usefulness | ||
-Cost-effectiveness | ||
-Replaceability | ||
-Social demand on reimbursement | ||
Non-CED-driven | Functional category reevaluation: | Not available |
|
||
|
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 |