Global Health Technology Assessment Road Maps
South Korea – Medical Devices & Diagnostics

Updated: September 2014
Validated by: Jung-Sook Kim, Deputy Director of MoHW, Division of Health Insurance Benefits
South Korea Map

BACKGROUND

The population in South Korea is estimated to to have been around 51.14 million in 2013 and the GDP per capita in 2012 was about 22,590 USD [1]. South Korea's health care spending reached 7.4% of GDP in 2011, up from 7.1% in 2010, but the share of GDP allocated to healthcare nonetheless remains below the OECD average of 9.3% [2].

South Korea has a universal national health care system, the National Health Insurance (NHI) System; it is administered by the Ministry of Health and Welfare (MoHW) and operated by both the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) (Figure 1). The NHI system covers over 97.5% of citizens, who pay a premium and have the right to access any physician or medical institution. The remaining 2.5% of the population are covered by a Medical Aid Program for the poor.

Figure 1. National Health Insurance System

National Health Insurance System

Source: Ministry of Health and Welfare. 2013 [3]

The NHI premium rate was 5.89% in 2013, with half paid directly from payroll and the other half paid by employers. The system is primarily funded by the premiums paid (by the insured and employers), and subsidized by government. The NHI system offers a comprehensive and uniform benefits package to all those covered by the program, who have free access to medical institutions across the country, including comprehensive inpatient and outpatient services, dental services, traditional oriental medicine therapies, etc. Fee-For-Service (FFS) is the main reimbursement payment system for physicians and medical institutions. In order to reduce unnecessary surgical services, the Diagnosis-Related Group (DRG) system was introduced in January 2002 (after a pilot program from February 1997 to December 2001). The DRG program was implemented initially on a voluntary basis, but became compulsory for all medical institutions in July 2012. The DRG system is applied to inpatients classified into seven procedure groups within four surgical departments: Ophthalmology (crystalline lens surgery), ENT (tonsil and adenoid surgery), General Surgery (anal surgery, inguinal and femoral hernia surgery, appendectomy), and OB/GYN (uterus, adnexectomy, and C-section). The costs of most medical services, drugs and consumables are bundled under the DRG payment (some specific items are excluded from coverage, e.g., patient controlled analgesia, premiums for choosing better hospital accommodation, and certain medical services such as ultrasonography).

Table 1. The seven Diagnosis-Related Groups (DRGs) in four surgical departments

Classification

Department

Ophthalmology

ENT

General Surgery

OB/GYN

DRGs

- Crystalline lens
surgery

- Tonsil and
adenoidectomy

- Anal surgery
- Inguinal and
femoral hernia
surgery
- Appendectomy

- Uterus and
adnexectomy
- C-section

The medical devices and diagnostics market in Korea was estimated to be 4.075 billion USD in 2012, the 13th largest globally; about 65% of the market consists of imported products (in 2012, imported medical devices made up 71% of all reimbursed devices and diagnostics) [4]. Devices consistently make up about 4% of NHI expenditure (Table 2 and Figure 2), and about 87% of the expenditure on devices is hospital-based (Table 3). Unlike the pharmaceutical sector, MoHW applies a Negative List System to the funding of medical devices and diagnostics, and lists both reimbursed and non-reimbursed items (for which patients would pay out-of-pocket). At the end of 2012, 90% (15,929) of medical devices and diagnostics on the MoHW combined list were in the ‘reimbursed’ category and 10% (1,770) were listed as ‘non-reimbursed’.

Table 2. Annual NHI expenditure, in total and on medical devices (in billions USD; 1 USD = 1,100 Korean won)

Year

2008

2009

2010

2011

2012

Total NHI expenditure

31.85

35.85

39.69

41.89

43.85

Medical device expenditure

1.38

1.54

1.79

1.86

1.95

Ratio of medical device expenditure

4.34%

4.29%

4.52%

4.44%

4.44%

(Note: The medical device expenditure increase in 2010 was likely due to an expansion in reimbursement coverage, whereas the decrease in 2011 was probably due to the implementation of significant price cuts for spinal implants.)

Source: HIRA statistical data. 2012 [5]

Figure 2. Breakdown of National Health Insurance Expenditure in 2012
National Health Insurance Expenditure in 2012
Source: HIRA statistical data. 2012 [6]

Table 3. Medical device expenditure in 2012 by provider category

Provider category

Provider

Proportion of medical device expenditure

Number

Ratio

Total

63,922

100%

100%

Teaching hospital

44

0.07%

35.64%

General hospital

293

0.46%

30.71%

Hospital

2,816

4.40%

20.54%

Clinic

27,889

43.63%

10.34%

Others

32,880

51.44%

2.77%


Source: HIRA statistical data. 2013 [7]

Table 4. Medical device reimbursement expenditure ratio by product category (%) and compounded annual growth rate (CAGR)

Product category

2006

2007

2008

2009

2010

CAGR

Radioisotope

0.0

0.0

0.0

0.0

0.0

-10.2

Suturing and ligation devices

4.8

6.1

8.3

8.3

7.8

30.5

Trauma devices I

4.2

3.9

3.9

3.9

3.9

13.6

Trauma devices II

0.6

0.8

1.0

1.3

1.5

43.2

Artificial joint devices

14.1

14.1

14.6

14.6

13.9

15.8

Spinal fixation devices

7.2

6.6

6.1

5.7

4.9

5.4

Cardiac surgery devices

3.8

3.8

3.5

3.2

3.1

8.5

Neurosurgery devices

1.5

1.4

1.4

1.2

1.2

10.2

Ophthalmology/ENT devices

2.4

2.4

2.2

2.2

2.3

13.6

Interventional devices

27.2

28.2

27.1

26.6

25.4

13.9

Medical supplies I

21.5

16.5

14.9

14.6

13.0

2.1

Medical supplies II

6.6

6.3

6.6

6.7

5.9

12.7

Medical supplies III

3.3

5.0

5.4

6.1

5.9

33.9

Others

2.8

4.9

5.4

5.6

11.2

63.1

Total (%)

100

100

100

100

100

256.3

 

 

 

 

 

 

 


Source: HIRA publication. 2013 [7]

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Decision Makers and Decision-Making Processes Diagram

Diagram

Model description and Symbols:
The ultimate decision maker is listed at the top of the model

Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision

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DECISION-MAKERS AND INFLUENCERS

The following are the principal organizations involved in the licensing and reimbursement of medical devices and diagnostics in Korea.

Ministry of Food and Drug Safety (MFDS)
Previously known as Korea Food and Drug Administration (KFDA), MFDS grants commercial approval (i.e., a license) for medical devices or diagnostics with established safety and efficacy. It is responsible for the implementation of the regulations and standards for medical devices and diagnostics, such as product registration (based on four classifications; class I through IV), implementing quality systems, post-market surveillance, pre-market clinical study review and approval, etc.

Ministry of Health and Welfare (MoHW)
The highest health authority in designing and managing the NHI system and the final decision-maker for coverage, coding, and pricing of medical devices and diagnostics.

Health Insurance Review and Assessment Services (HIRA)
HIRA manages reimbursement coverage, coding and pricing of medical devices and diagnostics under the supervision of MoHW. In addition to these roles, HIRA has various responsibilities including medical claim reviews, appropriate medical service management, pharmaceutical reimbursement application reviews, Drug Utilization Review (DUR), on-site investigations, etc.

Medical Device Expert Evaluation Committee (MDEEC)
MDEEC is the HIRA sub-committee that makes decisions on reimbursement coverage, coding, and pricing for medical devices and diagnostics. It consists of 20 members randomly selected for every committee meeting from a pool of 300 experts and meets monthly to make decisions on manufacturers' reimbursement applications and appeals.

Procedure Expert Evaluation Committee (PEEC)
PEEC is the HIRA sub-committee that makes decisions on reimbursement coverage, coding and pricing for clinical services (i.e., physician charges for surgical procedures, consultations, diagnostic testing, etc.). It consists of 20 members randomly selected for every committee meeting from a pool of 300 experts and it meets monthly to make decisions on healthcare providers' reimbursement applications and appeals.

National Evidence-based Healthcare Collaborating Agency (NECA)
NECA is the HTA organization that assesses through systemic review methodology the safety and effectiveness of new non-pharmaceutical technologies , including associated clinical procedures, prior to HIRA considering reimbursement coverage and pricing (note: economic evaluations are excluded; for pharmaceutical products, HIRA itself undertakes the assessment of pharmacoeconomic evidence submitted by manufacturers). NECA is supervised by MoHW.

National Health Insurance Service (NHIS)
Previously known as the National Health Insurance Corporation (NHIC), NHIS is the single payer in the NHI system, managing all funds. It collects premiums from citizens and pays the claims bills submitted by health care providers.

Health Insurance Policy Deliberation Committee (HIPDC)
HIPDC is the MoHW sub-committee that makes the final decisions on all NHI policy and reimbursement matters (i.e., new policy development and execution, reimbursement coverage, coding, and pricing for all medical services, devices, diagnostics and pharmaceutical products, etc.). It consists of 25 members from various stakeholder representatives nationwide, and meets monthly.

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REGULATORY PATHWAY / MARKET APPROVAL PROCESS

Ministry of Food and Drug Safety (MFDS) is the regulatory authority that supervises and manages regulatory approval (licensing), implementation of quality management, and post-market surveillance, etc.

There are four device classes based on potential risk to human health (Table 5). The average lead-time for regulatory approval is usually 8-10 months for new product approval and 4-6 months for supplementary approval.

Table 5. Medical device classification and approval process

Classification Approval process Reviewing party

Class I : low risk

Listing

Regional MFDS office

Class II :
low / medium risk

Technical file review

Technical file review at 3rd party
Final approval at regional MFDS office

Class III :
medium / high risk

Technical file review or clinical document review

MFDS

Class IV : high risk

Technical file review or clinical document review

MFDS

The steps needed to be taken for a medical device or diagnostic to be approved for market access are outlined in Figure 3.

Figure 3. Regulatory approval process for devices

Regulatory Approval Process for devices

 

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REIMBURSEMENT AND PRICING APPROVAL PROCESS

Reimbursement Decision-Making

After the review and approval by the Ministry of Food and Drug Safety (MFDS), but before commercial launch, applications for reimbursement of a medical device must be made to the Ministry of Health and Welfare (MoHW) or the Health Insurance Review and Assessment Services (HIRA) within 30 days of MFDS regulatory approval. In most cases, applicants are manufacturers. The decision about reimbursement coverage, coding, and pricing is ultimately made by MoHW, after HIRA and its Medical Device Expert Evaluation Committee (MDEEC) review the application dossier and make a recommendation to MoHW (Table 6). Officially, the total lead-time for reimbursement approval is 150 days after an application is submitted; in reality, however, it usually takes longer (sometimes significantly longer, perhaps 1-3 years) – particularly for devices that require a new HTA (nHTA) approval (because they require reimbursement coverage, coding, and pricing reviews and decisions to be made for the device and procedure separately), and for new devices that require the establishment of reimbursement coverage guidelines (specifying indication, etc.).

Table 6. Medical device reimbursement approval process

Step

Process

Process description

1

Reimbursement application must be submitted within 30 days after MFDS approval

Application to MoHW or HIRA.
Manufacturers, medical institutions and medical societies may submit applications.

2

HIRA review

Review of appropriateness of coverage and reimbursement price.
Consideration of eligibility for reimbursement and estimation of budget impact.
Review of comparable devices already listed.
Comparison of cost-effectiveness with currently listed devices (by reviewing the application, the literature, seeking medical society opinion, etc.).
Collation of internal/external expert opinion.

3

MDEEC review

Recommendation on reimbursement coverage and price
made within 100 days of application.
Consideration of economic feasibility (i.e., substitutability and cost-effectiveness) and appropriateness for funding.

4

Health Insurance Policy Deliberation Committee (MoHW)

Confirmation of decision about reimbursement coverage and
price.

5

Publication of reimbursement approval notice

Approval notice published on MoHW website within 150 days of application submission.

HTA Requirement

When a new medical device or diagnostic, approved by MFDS, is associated with a new procedural technique (one which has not been introduced into clinical practice previously), it must undergo a new HTA (nHTA) process before HIRA will consider an application for reimbursement. The nHTA process of assessment of the safety and effectiveness of new technology was introduced by the government in 2007 as a precautionary measure. The nHTA committee of MoHW, comprised of 20 experts from various health and medical fields, assesses the safety and effectiveness of new health technologies, relying on systematic reviews provided by the Center for nHTA at NECA. During the nHTA review process (Figure 4), a new medical device or diagnostic is prohibited from accessing the market. Once nHTA approval is officially given, a manufacturer is able to apply to HIRA for reimbursement, and in due course the medical device or diagnostic is allowed to access the market.

Decisions about the coverage, coding and pricing of a new procedure associated with a new health technology must precede any reimbursement decisions about the latter. A reimbursement application for a new procedure must be submitted by the relevant medical institution along with appropriate supportive evidence (such as a general description of the procedure, foreign and domestic utilization, comparison with the most similar existing procedures, cost analysis, clinical benefits and risks, etc.) This procedure reimbursement application is reviewed by the Procedure Expert Evaluation Committee (PEEC) and a decision is made within 150 days of submission (in reality, however, it takes significantly longer than 150 days for a decision to be made).

However, in most cases, medical devices and diagnostics are not required to go through an nHTA process because they are associated with established procedures and techniques. In these cases, manufacturers can apply to HIRA for reimbursement immediately after MFDS regulatory approval.

Figure 4. The new health technology assessment (nHTA) process

New HTA Process
Source: adapted from NECA website (www.neca.re.kr) 2013 [8]

Effective July 30, 2014, the Ministry of Health and Welfare (MoHW) announced the official implementation of the Parallel Review Process for a simultaneous review in the regulatory application (MFDS) and the new Health Technology Assessment (nHTA) application (NECA). There has been plenty of criticism from the medical device industry and health care providers about the lengthy HTA review process (1 year) after regulatory approval granted by MFDS. Before this official Parallel Review Process was implemented, NECA operated a pilot Parallel Review Process (locally known as HTA One-Stop Service) with ten new technologies which were voluntarily submitted by manufacturers during October 2013 to July 2014. With the positive feedback of the pilot program, MoHW estimates to shorten the market access period ranging 3 to 12 months [9].

Applicants can appeal reimbursement decision; however, the appeal lead-time is also nominally 150 days. In accordance with the Korea-US Free Trade Agreement (KORUS FTA), which took effect on March 15th, 2012, applicants may apply for independent 3rd party review of MDEEC decisions through the Independent Review Process (IRP). MoHW reimbursement approval cannot be given until the IRP is complete. Although the outcome of an IRP is not legally binding on MoHW, the process serves as a sentinel for transparency and objectivity in government decision-making [10].

As of the end of 2012, imported medical devices made up 71% of all MoHW-listed devices [3]. Unlike the pharmaceutical sector, MoHW applies the Negative List System to medical devices (i.e., licensed products are generally funded unless specifically excluded) and lists both reimbursed and non-reimbursed (patient out-of-pocket) devices. At the end of 2012, 90% (15,929) of medical devices on the MoHW combined list were listed in the reimbursed category and 10% (1,770) were listed as non-reimbursed. A key issue is that the most important documents for a favorable reimbursement price are clinical reports supporting the safety and efficacy (effectiveness) of a new technology. HIRA instated evidence-based medicine as a principle of reimbursement policy, thus evidence of high quality is prerequisite for a favorable reimbursement decision (Table 8). Unfortunately, it is usually very difficult for applicants to generate good quality clinical and economic evidence (like a cost-effectiveness analysis) for medical devices or diagnostic technologies [11]. In addition, there are no established Korean guidelines for the economic evaluation of medical devices or diagnostics, unlike for pharmaceuticals. Therefore, ‘Value Appraisal Standard 2’ is utilized when an applicant seeks a higher price than that awarded to a previously listed device (Tables 9-11).

Reimbursement Pricing Mechanism

Usually, reimbursement decisions about new medical devices or diagnostics are made on the basis of comparison with products already on the MoHW list of reimbursed items, the procedure fee and products on the non-reimbursed list. New technologies may then be placed into one of the three categories: separate reimbursement, reimbursement included under the procedure fee (i.e., no separate reimbursement), and non-reimbursement (i.e., patients pay for the product out-of-pocket).

Separate reimbursement: a device or diagnostic is reimbursed by brand, with its own reimbursement code and price, and can be claimed for separately by providers. The reimbursement price is determined by comparing the product with those already listed and in the same functional category. Most new medical devices or diagnostics are determined at the lowest price, or 90% of the highest ceiling price, in the same functional category. However, when a new device or diagnostic is assessed as significantly superior to comparators on the list, the reimbursement price is determined by application of ‘Value Appraisal Standard 2’ (Table 9-11) and a new functional category is created.

Reimbursement included under procedure fee: the medical devices or diagnostics in this category are mostly consumables, such as syringes, disposable needles, etc., and are paid for as part of the procedure fee (which includes both the hospital fee and physician fee); they cannot be claimed for separately by providers.

Non-reimbursement: medical devices or diagnostics in this category are those which MoHW assesses as not deserving reimbursement, and must therefore be funded directly by patients, (i.e., out-of-pocket).

Table 7. ‘Reimbursed’ medical device category: reimbursement level criteria and awards.

In comparison with listed devices in the same functional category, the cost, effectiveness or clinical performance of the new device is:

In comparison with listed devices in the same functional category, the reimbursement price level awarded is:

equal or similar

90% listed price or equal lowest price

superior

equal to highest ceiling price

significantly superior

equal to highest ceiling price + Value Appraisal Standard 2 premium

inferior

less than 90% listed price or equal lowest price

Relevant functional group(s) assessed through the Revaluation System.

Equal to the functional price (e.g., all brands of drug-eluting stents would get the same price).

If a new medical device or diagnostic is innovative and dissimilar from reimbursed products in the same functional group, its reimbursement price is determined by considering various factors, e.g., manufacturing costs (import price if the product is imported), clinical effect, efficacy, economic impact, etc. In most cases, an innovative device or diagnostic is associated with an innovative procedure or interventional technique, and therefore both must undergo an nHTA evaluation before a reimbursement application is considered by HIRA.

Value Appraisal Standard

The problem of new medical devices or diagnostics being reimbursed at prices lower than those of products already listed has been the hottest topic of debate between the authorities and industry. To solve this problem, ‘Value Appraisal Standard 1’ (Table 8) was created to provide criteria by which the reimbursement price for a new device or diagnostic may be determined at the highest ceiling price already listed. MoHW recognized that, in general, incremental improvements, short life-cycles, and a lack of robust clinical evidence are characteristics of medical devices and diagnostics, and therefore allowed documents showing improvements in the ‘material, shape and size’ of a new device or diagnostic to be used to support an application for reimbursement at the highest ceiling price. The highest ceiling price is granted when the new device or diagnostic receives Level 3 improvement in two or more appraisal categories on ‘Value Appraisal Standard 1’.

Table 8. Value Appraisal Standard 1: assessment criteria for reimbursement level for new medical devices or diagnostics

Appraisal category

Factor

Level of improvement

1

2

3

4

5

None

Slight

Moderate

Significant

Considerable

Procedure

Minimizes invasiveness.
Facilitates the procedure.
Reduces procedure time.
Improves accuracy of procedure.

 

 

 

 

 

Function

Improves functions (e.g., fixation strength).
Improves biocompatibility.

 

 

 

 

 

Cost

Reduces costs of other
medical devices or drugs.
Increases device longevity due to enhanced durability.

 

 

 

 

 

Patient

Reduces pain, discomfort, etc.
Improves safety.

 

 

 

 

 

Other

Other factors.

 

 

 

 

 

Note: The highest ceiling price is granted when the new device or diagnostic receives Level 3 improvement in two or more appraisal categories. [12]

In addition, if there is clinical evidence to show that a new device or diagnostic is significantly superior to listed products (in terms of cost, effectiveness, performance, etc.), it may be granted a premium (up to 50%) over the most similar listed device by means of ‘Value Appraisal Standard 2’ (Table 9 thru 11). A device is rated by assessors with the level of improvement; none to considerable / 0-5 in 3 appraisal categories: therapeutic effects, cost effectiveness, and quality of life benefits as shown in Table 9. Those scores are then assigned a value found on Table 10. The 3 values are totaled yielding a total level of improvement score which corresponds to a percentage price premium that medical device may be increased over comparable listed products. For instance, if a device obtains the following scores from the three appraisal categories:
  • therapeutic effects: moderate level of improvement - score 12.5,
  • cost-effectiveness: significant level of improvement - score 11.25, and
  • quality of life benefits: moderate level of improvement - score 5,

The total score is 28.75 (12.5+11.25+5); this score lies in the interval ≤ 20 to <30’ in Table 11, so the premium awarded to the device is 20%.

An applicant can submit both the Common Appraisal Document and Value Appraisal Documents only if the applicant wants to have the premium price by convincing the value of the product with the Value Appraisal Documents. When an applicant submits the Value Appraisal Document, HIRA gathers KOL (key opinion leader) opinions and holds an expert group meeting to determine if the premium price can be granted with 'Value Appraisal Standard 2' criteria.

Table 9. Value Appraisal Standard 2: assessment criteria for premium reimbursement level for new medical devices or diagnostics [12]

Appraisal category

Factor

Level of improvement

1

2

3

4

5

None

Slight

Moderate

Significant

Considerable

Therapeutic effects (clinical usefulness)

Improved therapeutic effects.
Reduce complications, adverse effects or infection rates.
Reduced disease recurrence or re-intervention rates.

 

 

 

 

 

Cost-effectiveness

Increased longevity due to enhanced durability.
Reduced use and costs of other devices or medicines.
Reduced hospital stay and
treatment period.
Reduced operating time.

 

 

 

 

 

Quality of life benefits

Reduced pain/discomfort.
Increased clinical benefit.
Improved independence.

 

 

 

 

 

 

Table 10. Value Appraisal Standard 2: scoring system for assessment of premium reimbursement level for new medical devices or diagnostics [12]

Appraisal category (maximum score)

Level of improvement

1

2

3

4

5

None

Slight

Moderate

Significant

Considerable

Therapeutic effects; clinical usefulness (25)

0

6.25

12.5

18.75

25

Cost-effectiveness (15)

0

3.75

7.5

11.25

15

Quality of life benefits (10)

0

2.5

5

7.5

10

 

Table 11. Value Appraisal Standard 2: scoring system for allocation of premium reimbursement level for new medical devices or diagnostics [12]

Total level of improvement score* Percentage price premium over comparable listed products
≥10 to <20

10

≥20 to <30 20

≥30 to <40 30

≥40 to <50 40
50 50

* The total number of points scored based on the appraisal categories outlined in Table 9.

Revaluation System

The Revaluation System was introduced in 2010 with the following objectives: first, to make the current reimbursement pricing rules fairer; second, to establish more appropriate pricing rules through reclassification of functional category groups; and third, to enhance efficiency of the medical device management system. To solve the problem of the ‘90% or lowest price’ rule, a problematic issue since 2000, MoHW introduced two rules under the Revaluation System: to grant a single price to products in the same functional category group, and to grant a premium price to a product through ‘Value Appraisal Standards 1 and 2’. The Revaluation System requires manufacturers to submit the documents and dossiers listed in Table 15. Medical devices or diagnostics assessed to be significantly superior in clinical and economic aspects may be awarded a premium price (to a maximum 50%) over the single functional category value.
When the Revaluation System was introduced more than 14,000 medical devices or diagnostics were listed, which made it very difficult for MoHW to implement the process immediately [13]. Therefore MoHW developed a plan to execute the first round of the Revaluation System over three years, beginning in 2010. The revised functional category classifications and prices for medical devices and diagnostics which were revaluated in 2010, took effect in 2011.

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DATA REQUIREMENTS FOR LICENSING & REIMBURSEMENT

Documents required for regulatory submission, nHTA application, reimbursement application and appeal, and for the Revaluation System are outlined in Tables 12 to 15.


Table 12. Documents required for regulatory submission to MFDS

Technical File Review Clinical Document Review

Document review for product safety and efficacy including materials, structure, intended use, instructions for use, principles of operations, testing standards, etc.

Document review for product safety and efficacy including materials, structure, intended use, instructions for use, principles of operations, testing standards, etc. that requires clinical data as supportive documentation.

  • Comparison with predicate device
  • Mode of action
  • Safety and performance data (i.e. biocompatibility, electrical safety, stability, etc.)
  • Origin and development process
  • Usage in foreign countries

 

  • Comparison with predicate device
  • Mode of action
  • Safety and performance data (i.e. biocompatibility, electrical safety, stability, etc.)
  • Origin and development process
  • Usage in foreign countries
  • Clinical study data

 

Table 13. Documents required for nHTA applications to NECA

  • Background information about the technology and its usage
  • Target group of patients
  • Copy of MFDS approval letter
  • Information on the most similar technology already listed for reimbursement
  • Information on clinical research involving the product undertaken locally and overseas
  • Published clinical reports involving the product

 

Table 14. Evidence required for reimbursement applications and appeals to HIRA

New reimbursement application Reimbursement appeal
  • Copy of MFDS approval letter
  • Details of submitted price calculation
  • Documents about cost-effectiveness
  • Documents about foreign and domestic
    utilization of the device
  • Documents about the composition of product and its components
  • Published clinical reports involving the product
  • Other relevant material
  • Documents explaining the reasons for appeal
  • Appeal details
  • Details of appealed price calculation
  • Other relevant material

 

Table 15. Documents and dossiers required for assessment under the Revaluation System by HIRA

Common Appraisal Documents Value Appraisal Documents
  • MFDS approval letter
  • Documents on cost-effectiveness including comparison information with similar products
  • Documents on product components and
    composition, product manual
  • Product sample
  • Import price/manufacturing cost, domestic and foreign market prices
  • Evidence for clinical efficacy and effectiveness including patient benefit
  • Economic evidence including cost-effectiveness analysis
  • Documents on R&D costs
  • Documents on technology creativity and
    uniqueness
  • Foreign government / institution-issued objective document including foreign relevant regulation
  • Others

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ACRONYMS

CAGR: Compound Annual Growth Rate
DES: Drug-Eluting Stent
DRG: Diagnosis-Related Group
ENT: Ear, Nose and Throat
FFS: Fee-For-Service
GDP: Gross Domestic Product
HIPDC: Health Insurance Policy Deliberation Committee
HIRA: Health Insurance Review and Assessment Services
HTA: Health Technology Assessment
IRP: Independent Review Process
ISO: International Organization for Standardization
KFDA: Korea Food and Drug Administration (now MFDS)
KGMP: Korea Good Manufacturing Practice
KOL: Key Opinion Leader
KORUS FTA: Korea-US Free Trade Agreement
MDEEC: Medical Device Expert Evaluation Committee
MFDS: Ministry of Health and Welfare
MoHW: Ministry of Health and Welfare
NECA: National Evidence-based Healthcare Collaborating Agency
NHI: National Health Insurance
NHIC: National Health Insurance Corporation (now NHIS)
NHIS: National Health Insurance Service
nHTA: new Health Technology Assessment
OB/GYN: Obstetrics and Gynecology
OECD: Organization for Economic Cooperation and Development
PEEC: Procedure Expert Evaluation Committee
R&D: Research and Development

SUGGESTED READING

Korean Ministry of Health & Welfare. Available from: http://english.mw.go.kr/front_eng/index.jsp [Accessed December 28, 2013].

Health Insurance Review & Assessment Service (brochure December 2011). Available from: http://www.hira.or.kr/eng/news/01/__icsFiles/afieldfile/2012/04/29/2011_HIRA_Brochure.pdf [Accessed November 23, 2013].

European Observatory on Health Systems and Policies. Republic of Korea HiT (2009). Available from:
http://www.euro.who.int/en/about-us/partners/observatory/health-systems-in-transition-hit-series/countries-and-subregions/republic-of-korea-hit-2009 [Accessed December 28, 2013].

Jirawattanapisal T, Kingkaew P, Lee TJ, Yang MC. Evidence-based decision-making in Asia-Pacific with rapidly changing health-care systems: Thailand, South Korea, and Taiwan. Value Health. 2009 Nov-Dec; 12 Suppl 3:S4-11.

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USEFUL LINKS

HIRA: http://www.hira.or.kr/eng/
MFDS: http://www.mfds.go.kr/eng/index.do?nMenuCode=7
MoHW: http://english.mw.go.kr/front_eng/jc/sjc0108mn.jsp?PAR_MENU_ID=100314&MENU_ID=10031401
NECA: http://neca.re.kr/eng/
NHIS: http://www.nhis.or.kr/static/html/wbd/g/a/wbdga0101.html

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REFERENCE

  1. Statistics Korea
    http://rcps.egov.go.kr:8081/jsp/stat/ppl_stat_jf.jsp
    http://data.worldbank.org/indicator/NY.GDP.PCAP.CD
  2. Ministry of Health and Welfare Statistical Year Book 2013
    http://stat.mw.go.kr/front/statData/mohwAnnalsWpView.jsp?menuId=14&bbsSeq=1&nttSeq=21132&nttClsCd=01&searchKey=&searchWord=&nPage=1
  3. Ministry of Health and Welfare.
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AUTHORS & CONTRIBUTORS

Authors:
Sang-Soo Lee, MBA, Corporate Affairs Director, Medtronic Korea, Co., Ltd. Seoul, South Korea
Eugene Salole, PhD, MPH, Principal, Value-Based Access Pty Ltd, Sydney, Australia

Contributor:
Ji-Yoon Park, RAC, Senior Regulatory Affairs Specialist, Medtronic Korea, Co., Ltd. Seoul, South Korea

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