CONTENTS
- 1. Health Insurance Reimbursement Listing | Concept and Legal Basis
- - Legal Basis
- - Decision-Making Structure
- 2. Health Insurance Reimbursement Listing | Composition and Actual Listing Structure
- - Main Components of the Health Insurance Reimbursement Listing
- - Main Items Actually Listed
- - Features of the Health Insurance Reimbursement Listing Structure
- 3. Health Insurance Reimbursement Listing | Listing Procedure and Administrative Structure
- - Procedure
- - Roles by Institution
- 4. Health Insurance Reimbursement Listing | Evaluation Criteria
- - Main Evaluation Factors
- - Economic Evaluation and the Application Structure of the Risk-Sharing Agreement
- 5. Health Insurance Reimbursement Listing | Legal Nature and Procedural Issues
- - Features as a Discretionary Act
- - Procedural Issues
- 6. Health Insurance Reimbursement Listing | Related Risks and Points to Note
- - Risk of Listing Failure and Removal
- - Risk of Drug Price Reduction and Reevaluation
- - Issues of Conditional Reimbursement and Application Restrictions
- - Points to Note in Practice
- 7. Health Insurance Reimbursement Listing | Need for Legal Review
- - Daeryun's Strategy
1. Health Insurance Reimbursement Listing | Concept and Legal Basis
The Health Insurance Reimbursement Listing is a list of pharmaceuticals recognized as medical care benefits under the National Health Insurance, and it is managed through the “List of Reimbursable Drugs and Upper Price Limits” announced by the Minister of Health and Welfare.
A pharmaceutical placed on this list becomes eligible for health insurance coverage, and the patient pays only a fixed percentage of the cost as a co-payment.
Legal Basis
(1) The following medical care benefits shall be provided for the disease, injury, childbirth, and the like of the insured and their dependents.
1. Examination and testing
2. Supply of pharmaceuticals and treatment materials
3. Treatment, surgery, and other care
4. Prevention and rehabilitation
5. Hospitalization
6. Nursing
7. Transfer
The legal basis is found in Article 41 of the National Health Insurance Act, its Enforcement Decree, and the “Rules on the Standards for Medical Care Benefits under the National Health Insurance.”
These provisions direct the Minister of Health and Welfare to set the scope and standards of medical care benefits, and whether a pharmaceutical is reimbursed is likewise decided within this statutory framework.
Decision-Making Structure
The key decisions on the Health Insurance Reimbursement Listing rest with the Drug Reimbursement Evaluation Committee.
This committee brings together a range of stakeholders, including medical and pharmaceutical experts, health economics experts, government officials, and patient and consumer groups.
Decisions are reached through a structure in which roughly 20 members participate and a majority vote is required.
This composition and voting method can be seen as a system meant to reflect diverse perspectives and to support reasonable decisions.
2. Health Insurance Reimbursement Listing | Composition and Actual Listing Structure
A notable feature of the Health Insurance Reimbursement Listing is its ingredient-based standard and its multiple-product structure for identical ingredients.
In other words, for a single ingredient, products from several pharmaceutical companies are listed at the same time, and each product carries a separate upper price limit.
Main Components of the Health Insurance Reimbursement Listing
• Product Name
• Company Name
• Specification
• Upper Price Limit
• Prescription/Over-the-Counter Classification
Main Items Actually Listed
Active Ingredient Name | Product Name | Company Name | Specification | Upper Price Limit |
zolpidem tartrate 10mg | Zolpisin Tab | Myungin Pharm | 1 tablet | 113 KRW |
zolpidem tartrate 10mg | Zolptop Tab | Whanin Pharm | 1 tablet | 146 KRW |
zolpidem tartrate 10mg | Stilnox Tab | Handok | 1 tablet | 173 KRW |
zolpidem tartrate 10mg | Zolpiram Tab | Hanmi Pharm | 1 tablet | 174 KRW |
zolpidem tartrate 10mg | Zolpione Tab | Hana Pharm | 1 tablet | 174 KRW |
Features of the Health Insurance Reimbursement Listing Structure
1) Listing of Multiple Products within the Same Ingredient
To reflect the structure of the generic drug market, products are listed separately by each pharmaceutical company even for the same ingredient.
2) Differences in Upper Price Limits
Even for the same ingredient, the upper price limits are set at different levels.
This reflects the outcome of drug price negotiations and policy factors.
3) Formation of a Market Competition Structure
Because multiple products exist at the same time, price competition develops and efficiency in health insurance finances can be secured.
3. Health Insurance Reimbursement Listing | Listing Procedure and Administrative Structure
The Health Insurance Reimbursement Listing is decided through the procedure set out below.
Procedure
Roles by Institution
Institution | Role |
HIRA | Clinical and economic evaluation |
Evaluation Committee | Determination of reimbursement eligibility |
NHIS | Drug price negotiation |
Ministry of Health and Welfare | Final announcement |
4. Health Insurance Reimbursement Listing | Evaluation Criteria
Whether an item is added to the Health Insurance Reimbursement Listing is decided under the “Criteria and Procedures for Evaluating Whether a Pharmaceutical Is Eligible for Medical Care Benefits.”
Main Evaluation Factors
Criterion | Description |
Clinical Usefulness | Therapeutic effect and safety |
Cost-Effectiveness | Therapeutic effect relative to cost |
Financial Impact | Burden on insurance finances |
Substitutability | Necessity relative to existing treatments |
Economic Evaluation and the Application Structure of the Risk-Sharing Agreement
Within the Health Insurance Reimbursement Listing, the cost-effectiveness evaluation includes a step that quantitatively analyzes the therapeutic effect relative to cost as compared with equivalent treatments.
High-priced anticancer drugs and treatments for rare diseases often struggle to meet the general cost-effectiveness standards, so a separate Risk-Sharing Agreement may apply.
Under a Risk-Sharing Agreement, the drug price is adjusted on certain conditions, or the pharmaceutical company bears part of the cost depending on the therapeutic effect.
This approach helps preserve patient access to treatment while keeping the burden on health insurance finances under control.
5. Health Insurance Reimbursement Listing | Legal Nature and Procedural Issues
The Health Insurance Reimbursement Listing is an administrative act that decides whether a particular pharmaceutical is eligible for medical care benefits, and it may amount to an administrative disposition under administrative law.
This is so because a pharmaceutical company's ability to enter the market and the cost borne by patients change directly depending on whether reimbursement is granted.
Because such a decision weighs a range of factors together, however, it falls within an area where the administrative agency is granted broad discretion.
Features as a Discretionary Act
A decision on the Health Insurance Reimbursement Listing has the following features.
• It includes an economic evaluation that weighs effect relative to cost
• It involves policy judgment about the sustainability of health insurance finances
Given this structure, the administrative agency holds broad judgment authority within a certain scope, and the courts likewise tend to defer to it.
Procedural Issues
In disputes over the Health Insurance Reimbursement Listing, procedural legality, rather than the substantive judgment, often serves as the key standard of review.
The main issues are set out below.
• Whether fairness and objectivity were secured during the deliberation process
• Whether the submitted materials were reviewed thoroughly
In particular, where a stakeholder took part in composing the committee, or where the deliberation was carried out as a mere formality, a procedural defect may be recognized.
6. Health Insurance Reimbursement Listing | Related Risks and Points to Note
Even after an item is added to the Health Insurance Reimbursement Listing, that status does not last permanently and may shift with various policy changes.
In practice, therefore, continuous management and response are necessary.
Risk of Listing Failure and Removal
If a pharmaceutical is not added to the Health Insurance Reimbursement Listing, its market entry is effectively restricted.
In many cases, listing is denied when the cost-effectiveness standard is not met.
Insufficient submitted materials or weak clinical evidence in the evaluation process also act as major factors leading to removal.
Risk of Drug Price Reduction and Reevaluation
Even after an item is added to the Health Insurance Reimbursement Listing, a drug price reduction or reevaluation may follow.
• Price adjustment due to a heavier financial burden
• Reevaluation of clinical usefulness
In this process, the upper price limit may be changed or the reimbursement criteria may be narrowed.
Issues of Conditional Reimbursement and Application Restrictions
Some pharmaceuticals are listed as conditional reimbursement, with reimbursement recognized only for a specific patient group or treatment condition.
In such cases, questions of interpretation may arise about the scope of application, and both medical institutions and pharmaceutical companies need an accurate understanding of it.
Points to Note in Practice
When relying on the Health Insurance Reimbursement Listing, the following points must be confirmed.
• Compare and analyze the price structure within the same ingredient
• Account for the chance of change driven by drug price policy and financial shifts
Taking these points together, the Health Insurance Reimbursement Listing is best understood as a policy tool that calls for continuous analysis and management.
7. Health Insurance Reimbursement Listing | Need for Legal Review
Because the Health Insurance Reimbursement Listing ties directly to the market entry of pharmaceutical companies and medical institutions, it calls for a structural understanding and a strategic approach that go beyond simply confirming whether an item is listed.
The Medical, Bio, and Healthcare Group of Daeryun LLC provides practice-oriented response strategies across the entire process, from the pre-listing stage through evaluation response, drug price negotiation, and subsequent disputes.
Daeryun's Strategy
• Response to HIRA evaluation and design of supplementary materials
• Development of arguments in response to deliberation by the Drug Reimbursement Evaluation Committee
• Development of a drug price negotiation strategy and review of conditions
• Administrative response and litigation support relating to listing denial or drug price reduction
If you need to develop a listing strategy or a response in connection with the Health Insurance Reimbursement Listing, 🔗Schedule a Legal Consultation with a Medical Attorney to receive a professional review and strategic advice.
