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

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: Germany
GERMANY 1
HEALTHCARE SYSTEM 1
Facts and Figures 1
Market Indicators 2
Provision and Funding 4
Statutory Health Insurance 4
Private Health Insurance 5
Healthcare Services 5
Healthcare Reform 5
PRICING 6
Prescription Drugs 6
Early Benefit Assessments 6
Rebate Negotiations Following Early Benefit Assessments 9
Market Developments 11
Mandatory Rebates 11
Voluntary Discount Agreements 12
Generic Drugs 13
Mandatory Discounts 13
Voluntary Discount Agreements 14
Hospital Drugs 15
Pricing 15
Purchasing 15
Dispensing to Out-patients 16
OTC Drugs 16
Discounts 16
REIMBURSEMENT 16
Admission to Reimbursement 16
Non-prescription Drugs 17
Lifestyle Drugs 17
Minor Illnesses 17
Unproven Therapeutic Benefit, Medical Necessity or Economic Efficiency 18
Therapeutic Recommendations 18
Off-label Drugs 19
Negative List 19
Reimbursement Categories 19
Reimbursement Prices 19
Reference Price System 19
Hospital Reimbursement 21
Formularies 21
Funding 21
Changes in Reimbursement Status 22
Changes in Reimbursement Prices 22
Price Moratorium 22
Impact of Early Benefit Assessments 23
Reference Price Revisions 23
Germany, Pharmaceutical Pricing and Reimbursement Concise Guide
v
Maximum Reimbursement Prices 24
PHARMACOECONOMICS 24
Pharmacoeconomic Requirements 24
Early Benefit Assessments 24
Benefit Assessments 25
Cost-benefit Assessments 26
PRICE BUILD UP 27
Wholesalers 27
Margins 27
Discounts 27
Direct Distribution 27
Unit-dose Products 28
Background 28
Retail Pharmacies 28
Prescription Drugs 28
Non-Prescription Drugs 29
Parallel Import Quota 30
Background 30
Dispensing Doctors 31
Sales Tax 31
COST CONTAINMENT 31
Industry Paybacks 31
Promotional Costs 31
Advertising 31
Payments to Physicians 32
Patient Co-payments 32
GKV 32
PKV 33
Prescribing Controls 34
Binding Prescribing Guidelines 34
Prescribing Conditions for Drugs Subject to Early Benefit Assessments 34
Regional Prescribing Agreements 34
Disease Management Programmes 35
Prescribing Software 36
Generics 36
Generic Substitution 37
Biosimilars 38
Rx-to-OTC Switches 39
Process 39
Recent Switches 39
OTC Market 39
Parallel Trade 40
Parallel Imports 40
Parallel Exports 40
FUTURE DEVELOPMENTS 40
Outlook 40
Germany, Pharmaceutical Pricing and Reimbursement Concise Guide
vi
Pricing Reforms Pending 40
Biosimilars Savings Potential 41
Parallel Import Dispensing Quota Controversy 41
NAMES and ADDRESSES 41

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