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

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: France
FRANCE .1
HEALTHCARE SYSTEM..1
Facts and Figures ..1
Market Indicators2
Provision and Funding ...5
Overview..5
Statutory Health Insurance System.5
Complementary Health Insurance...6
Funding7
Background..7
Healthcare Reform Law...8
PRICING...8
Prescription Drugs..8
Overview..9
Standard Pricing Procedure 9
Accelerated Pricing Procedure..10
Health Economic Evaluation..13
Conditional Pricing.13
Pricing Agreements ...14
Price Caps .16
Hepatitis C Drugs ..16
Price Levels ...16
Generic Drugs ..16
Pricing Rules..16
Pricing Procedure ..17
Hospital Drugs..17
T2A System ...17
T2A Exclusions and Liste de Retrocession ...17
ATU/post-ATU ...19
Actual Prices..19
OTC Drugs ...19
Reimbursed OTCs .19
Non-reimbursed OTCs ..19
REIMBURSEMENT 20
Admission to Reimbursement ..20
Patient Participation...20
Role of the CT20
Application Process ...21
Medical Benefit Rating Systems23
Assessment ...24
Decision.24
Final Decision 25
Restricted Reimbursement 25
Proposed New Evaluation System 26
Reimbursement Categories .26
Full Reimbursement ..26
Standard Reimbursement..26
Proposed Changes27
Reimbursement Prices.27
Reference Price Reimbursement System .27
Hospital Reimbursement..28
Hospital Supply Authorisation28
Formularies29
Funding..30
Changes in Reimbursement Status .33
Five-year Reviews .33
Exceptional Reviews .34
Changes to Reimbursed Indications .35
Reimbursement Rate Changes .35
Delistings ...36
Changes in Reimbursement Prices .36
European Price Guarantee36
Five-year Reviews .38
Off-patent Originals and Generics .39
Price Consistency..40
Targeted Price Cuts...40
Other Price Cuts/Revisions ...41
Price Increases..42
PHARMACOECONOMICS.42
Pharmacoeconomic Requirements..42
Mandatory HE Evaluations 42
Other HE Evaluations 45
PRICE BUILD UP ...45
Wholesalers .45
Margins ..45
Discounts ...46
Social Security Contribution ..46
Background47
Drug Shortages .47
Supply Chain Investigation 48
Retail Pharmacies 48
Margins ..48
Discounts ...50
Background50
Dispensing Doctors ..52
Sales Tax .52
COST CONTAINMENT ..52
Industry Paybacks52
Turnover-based Tax ..52
Clause de Sauvegarde ..52
Conventions System..54
Hepatitis C Medicines55
Temporary Use Drugs ...56
Promotional Costs56
Promotion-based Tax 56
Advertising.57
Sales Reps 58
Sunshine Act..58
Patient Co-payments58
Pharmaceuticals 58
Out-patient Care 60
In-patient Care...62
Prescribing Controls.63
Prescribing Targets ...63
Guidelines..64
Exception Drugs 64
Feedback ...64
Campaigns.65
Prescribing Restrictions.65
Off-label Prescribing ..65
Generics...66
National Action Plan ..66
Generic Substitution ..66
INN Prescribing .68
Prescribing Targets ...68
Generic and Off-patent Price Cuts 68
Biosimilars .69
Rx-to-OTC Switches 69
Switches 69
Easier Patient Access to OTCs .69
OTC Sales .69
Parallel Trade...70
Parallel Exports .70
Parallel Imports..70
FUTURE DEVELOPMENTS ..70
Outlook.70
LFSS 2017.70
Liste en Sus ...73
Generic Pricing ..73
Reimbursement Rates...73
Pharmacy Convention ...73
Accord Cadre.73
Proposed New Evaluation Systems ..74
NAMES and ADDRESSES 75

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