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Market Access Korea - Breaking into the Developed World’s Fastest Growing Pharmaceutical Market
Description:
South Korea as a country has been an economic success story and the origin of much cutting edge technology, but its pharmaceutical market can now also be given ‘Asian tiger’ status. The past four years have seen total sales growth of 15.6%, 13.5%, 12.4% and 13.8% respectively. IMS forecasts CAGR of 6.5% from 2010 through 2015, making Korea the fastest growing developed market for medicines in the world.
Currently ranked fourth in Asia-Pacific after Japan, China and India, but ahead of Australia drug sales at manufacturer selling prices are the equivalent of USD 11 billion. If you consider that foreign innovative products did not gain access to the reimbursement system until late 1999 it is remarkable that multinational companies today hold half of the top-10 sales rankings with prescription products and in total have a 40% market share.
Modern-day Korea is trying hard to shake off its reputation for lack of transparency in reimbursement decisions and unfair business practices, with the Free Trade Agreements signed with the US and the EU cementing the internationalisation process.
With pricing and reimbursement there is still no denying the required processes are complex and multi-tiered, with major rule changes and new cost containment measures as a result of budget limitations announced in quick succession over recent years. Up to date and fully researched through local data-gathering and face-to-face interviews, Market Access Korea will explain it all, and give your company the power of Korean ginseng!
Subjects covered clearly but in detail include:
- The decision processes for new additions to the positive list and for price adjustments.
- Asia’s first reimbursement system requiring pharmacoeconomic evidence.
- Use of the new refund scheme if price negotiations break down.
- How market-based actual transaction pricing, introduced from 1 October 2010, will work and what it will mean.
- Pricing case studies.
- Generic and biosimilar pricing and its impact on original brands.
Currently ranked fourth in Asia-Pacific after Japan, China and India, but ahead of Australia drug sales at manufacturer selling prices are the equivalent of USD 11 billion. If you consider that foreign innovative products did not gain access to the reimbursement system until late 1999 it is remarkable that multinational companies today hold half of the top-10 sales rankings with prescription products and in total have a 40% market share.
Modern-day Korea is trying hard to shake off its reputation for lack of transparency in reimbursement decisions and unfair business practices, with the Free Trade Agreements signed with the US and the EU cementing the internationalisation process.
With pricing and reimbursement there is still no denying the required processes are complex and multi-tiered, with major rule changes and new cost containment measures as a result of budget limitations announced in quick succession over recent years. Up to date and fully researched through local data-gathering and face-to-face interviews, Market Access Korea will explain it all, and give your company the power of Korean ginseng!
Subjects covered clearly but in detail include:
- The decision processes for new additions to the positive list and for price adjustments.
- Asia’s first reimbursement system requiring pharmacoeconomic evidence.
- Use of the new refund scheme if price negotiations break down.
- How market-based actual transaction pricing, introduced from 1 October 2010, will work and what it will mean.
- Pricing case studies.
- Generic and biosimilar pricing and its impact on original brands.
Contents:
Executive Summary
1. Market Introduction
1.1 Healthcare System
1.2 Public Health Insurance
1.3 Private Health Insurance
2. Pharmaceutical Sector
2.1 Regulatory Affairs
2.2 Pharmaceutical Market
2.3 Industry
2.4 Controlling NHI Costs
2.5 Prospects
3. Introductory Pricing: Methodology
3.1 Historical Development
3.2 Current Process for Imported Innovative New Drugs
3.2.1 Appraisal
3.2.2 Negotiation
3.2.3 Arbitration/Refund Scheme
3.2.4 Ratification
3.3 Shortage Prevention Drugs
3.4 Line Extensions
3.5 Combination Products
3.6 Process for Other Imported New Drugs
3.7 Process for Domestically-developed Innovative New Drugs
3.8 Process for OTC Products
4. Health Technology Assessment
4.1 Pharmacoeconomic Demands for New Drugs
4.1.1 Scope
4.1.2 Criteria Applied
4.1.3 Guidelines
4.1.3.1 General considerations
4.1.3.2 Method of economic evaluation
4.2 Review of Marketed Products
4.3 Results
4.3.1 New Drugs
4.3.2 Previously Marketed Drugs
5. Introductory Pricing: Results
5.1 Reimbursement Listing Success Rate
5.2 Breakdown in Price Negotiations
5.3 Compassionate Use
5.4 Case Studies
5.4.1 Iressa
5.4.2 Fuzeon
5.4.3 Glivec
5.5 Sources for Price Information
6. Price Revision
6.1 Price-Volume Linkage
6.2 Triennial Price Re-evaluation
6.3 Review of Marketed Products
6.4 First Generic Approval
6.5 Market-based Actual Transaction Pricing
6.6 Improper Promotion
7. Demand-side Controls
7.1 Prescribing Controls
7.2 Patient Co-payment
8. Payment of Providers
8.1 Payment of Clinics
8.2 Payment of Hospitals
8.3 Payment of Pharmacies
8.4 Purchasing Incentives
8.5 Actual Transaction Prices
8.6 Market-based Actual Transaction Prices
9. Generics/Biosimilars
9.1 Patent/Other IP Right Issues
9.2 Pricing of Generics
9.3 Generic Substitution
10. Distribution
10.1 Separation of the Roles of Prescribing and Dispensing
10.2 Wholesalers
10.3 Community Pharmacies
11. Free Trade Agreements
11.1 US
11.2 EU
Tables:
1.1 Basic demographic and healthcare statistics
1.2 Financial status of NHI, 2000-2009
2.1 Clinical trials approved by KFDA, 1999-2009
2.2 KFDA process for approval of new drug
2.3 Prescription drug sales, local companies vs multinationals 2007-10
2.4 Prescription drug sales by origin of prescription 2007-10
2.5 International roll-out of new drugs reimbursed in Korea, 2003-05
2.6 Top-10 manufacturers by Rx sales by channel, 2010
2.7 Trends in pharmaceutical expenditure under NHI, 2002-09
3.1 Number A7 countries reimbursing drugs applying for Korean NHI listing
4.1 Clinical- and cost-effectiveness re-examination road map
5.1 Reimbursement listing success rates, pre- and post-DERP
5.2 Pricing and reimbursement history of Glivec in Korea, 2001-10
7.1 Patient co-payment rates
Figures:
3.1 Initial reimbursement pricing procedure
References:
Glossary of Abbreviations and Acronyms
1. Market Introduction
1.1 Healthcare System
1.2 Public Health Insurance
1.3 Private Health Insurance
2. Pharmaceutical Sector
2.1 Regulatory Affairs
2.2 Pharmaceutical Market
2.3 Industry
2.4 Controlling NHI Costs
2.5 Prospects
3. Introductory Pricing: Methodology
3.1 Historical Development
3.2 Current Process for Imported Innovative New Drugs
3.2.1 Appraisal
3.2.2 Negotiation
3.2.3 Arbitration/Refund Scheme
3.2.4 Ratification
3.3 Shortage Prevention Drugs
3.4 Line Extensions
3.5 Combination Products
3.6 Process for Other Imported New Drugs
3.7 Process for Domestically-developed Innovative New Drugs
3.8 Process for OTC Products
4. Health Technology Assessment
4.1 Pharmacoeconomic Demands for New Drugs
4.1.1 Scope
4.1.2 Criteria Applied
4.1.3 Guidelines
4.1.3.1 General considerations
4.1.3.2 Method of economic evaluation
4.2 Review of Marketed Products
4.3 Results
4.3.1 New Drugs
4.3.2 Previously Marketed Drugs
5. Introductory Pricing: Results
5.1 Reimbursement Listing Success Rate
5.2 Breakdown in Price Negotiations
5.3 Compassionate Use
5.4 Case Studies
5.4.1 Iressa
5.4.2 Fuzeon
5.4.3 Glivec
5.5 Sources for Price Information
6. Price Revision
6.1 Price-Volume Linkage
6.2 Triennial Price Re-evaluation
6.3 Review of Marketed Products
6.4 First Generic Approval
6.5 Market-based Actual Transaction Pricing
6.6 Improper Promotion
7. Demand-side Controls
7.1 Prescribing Controls
7.2 Patient Co-payment
8. Payment of Providers
8.1 Payment of Clinics
8.2 Payment of Hospitals
8.3 Payment of Pharmacies
8.4 Purchasing Incentives
8.5 Actual Transaction Prices
8.6 Market-based Actual Transaction Prices
9. Generics/Biosimilars
9.1 Patent/Other IP Right Issues
9.2 Pricing of Generics
9.3 Generic Substitution
10. Distribution
10.1 Separation of the Roles of Prescribing and Dispensing
10.2 Wholesalers
10.3 Community Pharmacies
11. Free Trade Agreements
11.1 US
11.2 EU
Tables:
1.1 Basic demographic and healthcare statistics
1.2 Financial status of NHI, 2000-2009
2.1 Clinical trials approved by KFDA, 1999-2009
2.2 KFDA process for approval of new drug
2.3 Prescription drug sales, local companies vs multinationals 2007-10
2.4 Prescription drug sales by origin of prescription 2007-10
2.5 International roll-out of new drugs reimbursed in Korea, 2003-05
2.6 Top-10 manufacturers by Rx sales by channel, 2010
2.7 Trends in pharmaceutical expenditure under NHI, 2002-09
3.1 Number A7 countries reimbursing drugs applying for Korean NHI listing
4.1 Clinical- and cost-effectiveness re-examination road map
5.1 Reimbursement listing success rates, pre- and post-DERP
5.2 Pricing and reimbursement history of Glivec in Korea, 2001-10
7.1 Patient co-payment rates
Figures:
3.1 Initial reimbursement pricing procedure
References:
Glossary of Abbreviations and Acronyms
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