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Pharmaceutical Pricing & Distribution in Japan, 2010 Update

Published: Oct 2011 | No Of Pages: 60 | Published By: JustPharmaReports.com
The author’s 2008 major title ‘Pharmaceutical Pricing & Distribution in Japan’ was described by PhRMA Japan as ‘a superb report…to understand Japan there is nothing better’. His new report packs all the essentials needed to optimise market access and life cycle management into 60 pages and offers tremendous value. Completely updated, it explains all the latest changes to the NHI pricing rules, including the important new price premium for developing new drugs/new indications.
 
  • New drug pricing and price revision processes made completely clear, with all formulae used and many up-to-date examples
  • Incorporates all pricing rule changes coming into effect from April 2010 with forecast of further reforms in FY 2012
  • Written by an acknowledged expert on the Japanese market with 23 years’ experience
  • Fully researched through interviews conducted in Tokyo with industry experts, government officials and local consultants. Lots of insight.
  • Feature on diagnosis procedure combination hospital reimbursement
  • Key role of wholesalers and how they are paid clarified
 
At $80+ billion, Japan represents the world’s second-largest pharmaceutical market, one no serious global company can afford to ignore. The environment for developing, marketing and distributing prescription medicines is dominated by price, but the complex processes involved have often been opaque to outsiders. Now there is no excuse for ignorance. 
 
Whether the challenge is entering the Japanese market for the first time, moving up the all-important ranking there by market share, or negotiating with a local in-licensing partner, this report is designed to help you get a complete grasp of Japanese pricing and reimbursement.
1. Launch Price Setting
1.1 Market Overview 
1.2 Introductory NHI Pricing 
1.3 Outline of Procedure
1.4 Data Requirements 
1.5 Summary of Methodology 
1.6. Similar Efficacy Comparison Method I
1.6.1 Price Comparator 
1.6.2 Price Premiums 
1.7 Similar Efficacy Comparison Method II 
1.8 Cost Calculation 
1.9 Inter-specification Adjustment
1.10 Inter-formulation Adjustment 
1.11 Fixed Dose Combinations
1.12 Other Line Extensions 
1.13 Foreign Price Adjustment
1.14 Minimum Prices
1.15 Pharmacoeconomics 
1.16 Generics 
1.17 Biosimilars 
1.18 OTCs 
1.19 Commercial Sources for NHI Price Information
 
2. Price Revision Processes
2.1 Drug Price Margin 
2.2 Biennial Revision
2.2.1 Market Price Survey
2.2.2 Revision Timetable
2.2.3 Calculation of New Tariff Price 
2.2.4 Impact on Manufacturers
2.3 Repricing 
2.3.1 Calculation Methods
2.3.2 Repricing History
2.4 Long-term Listed Brands 
2.5 Correction Premiums 
2.6 New Premium for Development of New Drugs/New Indications 
2.6.1 Qualifying Criteria 
2.6.2 Qualifying Products
2.6.3 Post Patent Expiry
2.6.4 Demands on Companies 
2.7 Pharmaceutical Development Support Center 
 
3. Flat Sum Reimbursement
3.1 Clinic Dialysis
3.2 Diagnosis Procedure Combinations
3.2.1 Coverage 
3.2.2 Impact on Drug Use
3.2.3 High-cost Drug Exclusions 
 
4. Pricing Down the Distribution Chain
4.1 Wholesaling 
4.2 Paying Wholesalers 
4.2.1 Traditional Practices 
4.2.2 Wholesale Margin and Rebates
4.3 Pharmacies 
4.4 Paying Pharmacies 
4.4.1 Basic Dispensing Fee 
4.4.2 Supplementary Dispensing Fees 
4.4.3 Drug Cost 
4.4.4 Fees for Cognitive Services
 
5. Issues to Address in FY 2012 Pricing Reform 
1.1 Top-10 foreign-affiliated companies, 2009 
1.2 Breakdown of 2010 NHI drug tariff 
1.3 Number of new products awarded price premiums, 1996-2002 
1.4 Number of new products awarded price premiums, 2006-2009
1.5 Formulation categories for pricing purposes
1.6 Generic penetration by volume, 2005-2009
1.7 First-listed generics, 2000-2010 
1.8 Leading generic companies
2.1 Change in average drug price margin, 1989-2009
2.2 NHI drug price revisions, 1981-2010
2.3 Breakdown of drug price revisions by numbers of products affected
2.4 Products subject to downwards repricing,, 1982-2010 
2.5 Additional price cuts for long-term listed brands, 2002-2010
2.6 Number of products receiving premium for developing new drugs/indications
2.7 Companies with most premiums for developing new drugs/indications
2.8 Examples of new drugs/new indications required for Japanese development 
2.9 PDSA development projects, 2010 
4.1 Leading wholesalers, FY 2009
4.2 Decline in average wholesale primary margin, 1999-2009 
4.3 Share of price agreements concluded, 2006-2010 
4.4 Market share evolution by customer type, 2004-2009 
4.5 Top-10 chain pharmacies, 2008
1.1 NHI pricing process for new drugs 
2.1 Diagrammatic representation of price impact of new premium 
4.1 Diagrammatic representation of wholesale margin & rebates 
Glossary of Abbreviations and Acronyms 4.1 Diagrammatic representation of wholesale margin & rebates 
Glossary of Abbreviations and Acronyms 
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