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  3. > IMS Pharmaceutical Pricing & Reimbursement Concise Guide: Belgium

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: Belgium
BELGIUM 1
HEALTHCARE SYSTEM 1
Facts and Figures 1
Market Indicators 2
Provision and Funding 4
Statutory Health Insurance 4
Private Health Insurance 5
Funding 5
Regulation and Provision 5
PRICING 5
Prescription Drugs 5
Reimbursed Prescription Drugs 6
Non-reimbursed Prescription Drugs 7
Generic Drugs 7
Pricing Rules 7
Process 8
Biosimilars 8
Hospital Drugs 8
OTC Drugs 9
Non-reimbursed OTCs 9
Reimbursed OTCs 9
REIMBURSEMENT 9
Admission to Reimbursement 9
Standard Reimbursement Procedure 10
Expedited Reimbursement Procedure 13
Fast-track Procedure: Unmet Clinical Need 13
Radio-isotopes 14
Managed Entry Agreements 14
Timelines 15
Re-submission 16
Reimbursement Categories 16
Reimbursement Chapters 16
Reimbursement Categories 18
Reimbursement Prices 18
Reimbursement Price Setting 18
Reference Price Reimbursement System 19
Maximum Reimbursement Prices 21
Hospital Reimbursement 22
Formularies 22
Funding 22
Reform 23
Changes in Reimbursement Status 23
Scheduled Reviews 23
Other Reviews 24
Delistings 25
Belgium, Pharmaceutical Pricing and Reimbursement Concise Guide v
Changes in Reimbursement Prices 25
Price Reviews 25
Price Freeze 25
Price Increases 25
Voluntary Price Reductions 26
Indication Extensions 26
Mandatory Price Cuts 26
Price Cuts for Biologic Drugs 27
Reference Price System 28
Ad Hoc Price Cuts 28
PHARMACOECONOMICS 29
Pharmacoeconomic Requirements 29
Class 1 Drugs 29
Other Drugs 29
Guidelines 29
PRICE BUILD-UP 29
Wholesalers 29
Margins 29
Background 30
Retail Pharmacies 30
Margins 30
Dispensing Fee 31
Additional Fees 31
Discounts 32
Pharmacy Clawback 32
Background 32
E-pharmacy 33
Dispensing Doctors 33
Sales Tax 33
COST CONTAINMENT 34
Industry Paybacks 34
Turnover Tax 34
Subsidiary Tax 34
Orphan Drugs Tax 35
Marketing Tax 35
Per Pack Tax 35
Offsets 36
Promotional Costs 36
Promotional Spending 36
Code of Conduct 36
Visa System 36
Patient Co-payments 37
Pharmaceuticals 37
Healthcare 39
Co-payment Limit 40
Chronic Patients 41
Third-party Payment System 41
Prescribing Controls 42
Belgium, Pharmaceutical Pricing and Reimbursement Concise Guide vi
Prescribing Restrictions 42
Cost-effective Prescribing 42
INN Prescribing 43
Monitoring and Feedback 43
Prescribing Guidance 43
Midwife Prescribing 43
E-Health 44
Generics 44
INN Prescribing 44
Cheapest Medicines 45
Biosimilars 46
Rx-to-OTC Switches 46
Parallel Trade 47
FUTURE DEVELOPMENTS 47
Outlook 47
Cost containment Measures 47
Future Pact 47
Hospital Sector Reforms 48
NAMES and ADDRESSES 49

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