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  4. > IMS Pharmaceutical Pricing & Reimbursement Concise Guide: Japan

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: Japan
JAPAN 1
HEALTHCARE SYSTEM1
Facts and Figures 1
Market Indicators2
Provision and Funding 4
Employee Health Insurance 4
National Health Insurance 5
Long Life Medical Care System5
Background6
PRICING6
Prescription Drugs6
Overview7
Application 7
Assessment 8
Comparative Price Method8
Cost Calculation Method 15
International Price Referencing 18
Drugs Designed to Forestall Generic Competition 21
Fixed-dose Combination Drugs 21
Appeals22
Generic Drugs 22
Pricing Rules22
Discounts 23
Biosimilars 23
Hospital Drugs24
OTC Drugs 24
REIMBURSEMENT 24
Admission to Reimbursement 24
Application 24
Criteria 24
Assessment 25
Timelines 25
Listing 25
Access to Innovative Medicines 26
Sakigake Scheme27
Orphan Drugs 28
Reimbursement Categories 29
Reimbursement Prices29
Hospital Reimbursement29
Formularies29
Funding29
Medical Fees 30
Changes in Reimbursement Status 31
Changes in Reimbursement Prices 31
Biennial Price Revision Process31
Japan, Pharmaceutical Pricing and Reimbursement Concise Guide
v
Price Cuts Based on Actual Market Prices32
Price Cuts for Long-listed Drugs34
Price Cuts Due to Change in Indication 36
Price Cuts for Generics 36
Price Cuts Due to Market Expansion 36
Price Cuts for Drugs with High Sales by Value 37
Ad hoc Price Cuts38
Price Increases for Low-priced Drugs 38
Exemptions for Essential Drugs 38
Price Premium for the Development of New Drugs39
Price Premium for the Addition of Value after Launch 43
Impact of Cost-effectiveness Evaluations 43
PHARMACOECONOMICS44
Pharmacoeconomic Requirements44
Information Requirements 44
Guidelines45
Trial Cost-effectiveness Assessments 45
PRICE BUILD UP 47
Wholesalers 47
Margins 47
Background49
Retail Pharmacies 49
Margins 49
Dispensing Fees49
Background50
Dispensing Doctors 51
Sales Tax 51
COST CONTAINMENT 51
Industry Paybacks51
Promotional Costs52
Patient Co-payments52
Patients Aged 0-74 Years52
Patients Aged 75 and Over 54
Unapproved Treatments54
Prescribing Controls54
Price Adjustment Range54
Prescribing Fees54
Generic Prescribing 55
Generic Substitution 55
Prescribing Limits 55
Medical Claims Process 56
Flat-sum Hospital Reimbursement 56
Generics56
Generic Uptake56
Generic Substitution 56
INN Prescribing 57
Incentives57
Price Cuts for Long-listed Drugs58
Japan, Pharmaceutical Pricing and Reimbursement Concise Guide
vi
Rx-to-OTC Switches 58
Application 58
Assessment 59
OTC Drug Classes 59
Parallel Trade59
FUTURE DEVELOPMENTS 60
Outlook60
Cost-effectiveness Assessments60
Pharmacoeconomic Information Requirements 60
Sales Tax Increase Postponed60
Fiscal Policy Guidelines61
NAMES and ADDRESSES 62

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