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  3. > IMS Pharmaceutical Pricing & Reimbursement Concise Guide: South Korea

The Pharmaceutical Pricing & Reimbursement Concise Guides are established as the definitive reference and training text for P&R professionals around the world, drawing on the long-standing expertise of the IMS pricing and reimbursement specialists to provide industry players and decision makers with a thorough understanding of the rules and regulations governing P&R in international markets. This report covers key developments in P&R, market access, cost containment, trade margins and healthcare issues.

Table Of Contents

IMS Pharmaceutical Pricing and Reimbursement Concise Guide: South Korea
SOUTH KOREA1
HEALTHCARE SYSTEM1
Facts and Figures 1
Market Indicators2
Provision and Funding 4
Healthcare Coverage4
Regulation4
Provision5
PRICING5
Prescription Drugs5
Price/Volume Agreements5
New Drugs Developed in South Korea7
Pricing by Dosage 8
Drugs Subject to Generic Competition 8
Independent Review8
Consultative Group on Pricing8
Other Developments8
Generic Drugs 8
Pricing Rules8
Improved New Drugs9
Regulations Clarifying Pricing for Combination Off-patent Originals/Generics 10
Biosimilars 10
Hospital Drugs10
Pricing10
Procurement 10
RSDE11
OTC Drugs 11
REIMBURSEMENT 11
Admission to Reimbursement 11
Procedure 11
Criteria 13
Information Requirements 13
Reimbursement Restrictions 14
Combination Drugs14
Alternative Mechanisms 14
Orphan Drugs/Cancer Treatments 14
Stakeholder/Patient Participation in Decision Making16
Independent Review16
Reimbursement Categories 16
Reimbursement Prices17
Hospital Reimbursement17
Formularies17
Funding17
Changes in Reimbursement Status 18
Status Changes 18
South Korea, Pharmaceutical Pricing and Reimbursement Concise Guide
v
HIRA Reviews18
Reimbursement Review 19
Reclassification of Some ‘Low-cost' Drugs 19
Punishment for Illegal Rebating20
Changes in Reimbursement Prices 20
Off-patent Originals 20
Actual Transaction Pricing20
RSDE21
Punishments for Illegal Rebates22
Reimbursement Review 22
Price/Volume Agreements23
Risk-sharing Agreements 23
Products Formerly Classified as Low-cost Drugs23
Triennial Price Re-evaluation 23
PHARMACOECONOMICS24
Pharmacoeconomic Requirements24
Guidelines24
Oncology/Orphan Drugs24
Ministry Review25
PRICE BUILD UP 25
Wholesalers 25
Margins 25
Background25
Retail Pharmacies 26
Margins 26
Background26
Dispensing Doctors 27
Sales Tax 27
COST CONTAINMENT 28
Industry Paybacks28
Promotional Costs28
Patient Co-payments29
Pharmaceuticals 29
Healthcare 30
Co-payment Ceiling 31
Prescribing Controls31
Monitoring and Controls 31
Electronic Media 31
High-cost Products 32
Reimbursement Restrictions 32
Incentives32
Hospital Prescribing Controls 33
Dual Punishment 33
Generics33
Market33
Substitution33
Generic Prescribing 34
South Korea, Pharmaceutical Pricing and Reimbursement Concise Guide
vi
Bioequivalence 34
Patent Linkage34
Rx-to-OTC Switches 35
Procedure 35
Recent Switches35
Mass-market OTC 36
OTC Market 36
Parallel Trade36
FUTURE DEVELOPMENTS 36
Outlook36
Pricing36
Reimbursement 38
Pharmacy Sector 38
NAMES and ADDRESSES 39

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