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Pharmaceutical Pricing and Reimbursement in Japan, 2008


Description: Introduction

The pharmaceutical industry faces challenging times in the Japanese market. The government has expressed its desire to reward the development of innovative medicines and has promised more-generous price premiums for innovative drugs. At the same time, the government strictly controls launch prices and continues to erode prices throughout the product life cycle. There are, however, pricing changes effective in 2008 that could signal the beginning of pricing reforms that promote therapeutic innovation.

Get the Answers You Need to Shape Your Strategy

- Japan has the world’s second-largest pharmaceutical market, and the world’s largest price-controlled pharmaceutical market. How do the country’s governing agencies control the prices of newly launched prescription drugs? What types of postmarketing price cuts are in place to curb pharmaceutical expenditures?

- The reimbursement prices of new drugs in Japan are determined by confi dential negotiations between the manufacturer and the Japanese Ministry of Health, Labor, and Welfare as soon as the drug wins regulatory approval. What methods are used to calculate drug reimbursement prices? What criteria are used by the governing agencies to determine the pricing method for a given drug?

- The Japanese market for generics has begun to grow steadily, albeit slowly. What factors account for the modest market share of generics in Japan? Which pharmaceutical companies are looking to capitalize on the growing demand for generics in Japan? What is the government doing to improve the generics supply and the reputation of the generics industry among patients and medical professionals?

Scope

- Overview: organization and funding of the Japanese healthcare system; soaring growth of the country’s healthcare expenditures; prescription drug prices in Japan compared with other major markets.
- Price setting: initial pricing of branded drugs; similar-effi cacy pricing methods; price premiums; cost calculation method; foreign price adjustment rule.
- Postmarketing price changes: the government’s biennial National Health Insurance price revisions; price cuts for long-listed drugs; repricing in response to market expansion.
- Promoting the use of generics: evolution of the Japanese generics market; recent changes in the generics market; use of generics in hospitals; measures to improve the generics supply; increasing competition in the Japanese generics market.


Contents: Executive Summary
Strategic Considerations
Stakeholder Implications
Overview
Organization and Funding of the Healthcare System
Healthcare Expenditures
Pharmaceutical Prices in Japan
Price Setting
Initial Pricing of Branded Prescription Drugs
Similar-Effi cacy Comparison Methods
Price Comparators
Price Premiums
“Me-Too” Drugs
Cost Calculation Method
Foreign Price Adjustment Rule
Postmarketing Price Changes
Biennial Price Revision
Price Cuts for Long-Listed Drugs
Repricing in Response to Market Expansion
Promoting the Use of Generics
Evolution of the Japanese Generics Market
Recent Changes in the Generics Market
Generics Substitution
Use of Generics in Hospitals
Measures to Improve the Generics Supply
Increasing Competition in the Japanese Generics Market
Health Technology Assessment
Outlook for the Japanese Pricing and Reimbursement Environment

Tables

1. Japanese Prices of Best-Selling Drugs as a Percentage of U.S. and European Average Prices, 2006
2. Prices of Leading Biologics in the Major Markets as a Percentage of U.S. Prices, 2006
3. Changes to the Hierarchy of National Health Insurance Price Premiums in Japan
4. Price Premium Trends, June 2004-December 2007
5. Comparison of Average Foreign Prices with Japanese List Prices Using the Cost Calculation Method, April 2006-December 2007
6. Drugs Repriced in Response to Market Expansion, 2000-2008
7. Key Trends in the Japanese Prescription Drug Market: Implications for the Pharmaceutical Industry

Figures

1. Annual Growth Rates in Japanese Healthcare Expenditures and Gross Domestic Product, 2000-2005
2. Japanese Population Trends, 2000-2050
3. Pharmaceutical Spending as a Percentage of Total Healthcare Expenditures, 1991-2004
4. Average Prices of Leading Biologics, Small-Molecule Drugs, and Pharmaceuticals Overall in the Major Markets as a Percentage of U.S. Prices, 2006
5. Procedure for Setting National Health Insurance Reimbursement Prices for New Prescription Drugs
6. Methods Used for Pricing New Drugs in Japan, June 2002-December 2007
7. Criteria for Determining the Pricing Method Used for New Prescription Drugs
8. Percentage of New Drugs Awarded Price Premiums for Therapeutic Advances, June 2002- December 2007
9. Average Biennial Price Revisions, 1994-2008
10. Price Adjustment Range, 1994-2008
11. Generics’ Share of the Japanese Pharmaceutical Market, 2002-2006
12. Generics’ Impact on Hospital Drug Expenditures, 2004-2006


Companies Mentioned - Astellas - Bayer - Chugai Pharmaceutical - Chuikyo (Central Social Insurance Medical Council) - Daiichi-Sankyo - Genzyme - GlaxoSmithKline - Health Policy Bureau - Kirin - Kissei Pharmaceutical - Kokumin Kaihokenseido (National Health Insurance [NHI] system) - Kyorin - Kyowa Pharmaceutical - Lupin - Meiji Seika Kaisha - Mitsubishi - Mylan Seiyaku - Nichi-iko - Nidek - Nihon Pharmaceutical Industry - Nippon Chemiphar - Nippon Universal Pharmaceutical - Nippon Zenyaku Kogyo - Novartis - Novo Nordisk - Pfi zer - Ranbaxy Laboratories - Sandoz - Sanofi -Aventis - Sawai - Taiyo Yakuhin - Takeda - Tanabe-Mitsubishi - Teijin - Teva Pharmaceutical - Towa - Toyamakagaku - Yakka Santei Soshiki (Drug Pricing Organization [DPO]) - Yoshitomi - Zydus Pharma


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