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The Worldwide Guide to Pricing & Reimbursement

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Published Date: Apr, 2013
Format: PDF
No of Pages: 146

 
 
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  • Abstract
  • Table of Contents

This new guide reviews the current state of pricing and reimbursement in 58 leading and emerging economies, and examines the policies and practices that are shaping this critical area of the pharmaceutical industry’s operating environment.

Pricing and reimbursement: a key determinant of a drug’s commercial success

Pricing and reimbursement play a vital role in determining the commercial success of a pharmaceutical product. Failure to agree pricing levels or achieve reimbursement status can mean lost revenues for companies and restricted therapy choice for clinicians and patients.

Pricing and reimbursement policy and practice has been brought into sharp focus in the current economic downturn where health payers have used pricing controls to limit drug expenditure. In the majority of countries surveyed for this report, there is some form of pricing control for pharmaceuticals that are reimbursed under the public health system, whether directly or indirectly.

Reference pricing: past it’s sell by date?

National pricing authorities employ various methods of arriving at pharmaceutical prices, such as reference pricing schemes, fixed generic price reductions, fixed wholesale and pharmacy mark-ups, or limitations on company profits. Rather than relying on one method of price control, government agencies and health insurers generally employ several tactics to minimise reimbursement costs. These may be directly enforced, or the subject of negotiation between government and industry. Reference pricing has come in for criticism, particularly in Europe, where austerity measures have reduced the cost of medicines, which in turn has affected values in related countries in the reference group.

But agreeing the price is only part of the story. Gaining reimbursement status is critical – without it the drug must be paid for out-of-pocket and many advanced biological products are beyond the reach of all except the very wealthy. Indeed, it can be argued that price controls and limited reimbursement status are effectively leading to ever more ambitious pricing for new products as companies seek to balance the cost of innovation and maintain shareholder profit.

Answering critical questions...

How does pricing and reimbursement vary between Mexico and Peru?
Which countries are employing regressive wholesale and pharmacy mark-ups and at what level?
How did the March 2012 price adjustment mechanism affect pricing in Brazil?
What is the 2013 standard patient prescription charge in Australia?
What are the regional challenges in trying to get a drug positively listed in China?
Which Middle Eastern country added 88 drugs and health technologies to its basket of reimbursable products in 2013?
How are Poland’s strict reimbursement regulations affecting pharmaceutical companies and drug wholesalers?

Comprehensive background

Free Pricing and Indirect Control
Reference Pricing
External Reference Pricing
Internal Reference Pricing
Fixed Generic Price Reductions
Wholesale and Pharmacy Mark-ups
Reimbursement Lists
Positive and Negative Lists
Essential Medicines

Detailed analysis of 58 countries

For each country there is, as appropriate, a comprehensive review of drug pricing, reference pricing, controls, policy, regulation and reimbursement systems including influencing factors such as procurement and formulary.

AMERICAS
· Argentina
· Brazil
· Canada
· Chile
· Colombia
· Mexico
· Peru
· USA
· Venezuela

EASTERN EUROPE
· Bulgaria
· Croatia
· Czech Republic
· Estonia
· Hungary
· Latvia
· Lithuania
· Poland
· Romania
· Russia
· Slovakia
· Slovenia
· Ukraine

WESTERN EUROPE
· Austria
· Belgium
· Denmark
· Finland
· France
· Germany
· Greece
· Ireland
· Italy
· Netherlands
· Norway
· Portugal
· Spain
· Sweden
· Switzerland
· United Kingdom

ASIA/PACIFIC
· Australia
· China
· India
· Indonesia
· Japan
· Malaysia
· New Zealand
· Pakistan
· Philippines
· Singapore
· South Korea
· Taiwan
· Thailand
· Vietnam

MIDDLE EAST/AFRICA
· Egypt
· Israel
· Morocco
· Saudi Arabia
· South Africa
· Turkey

Contents

FOREWORD 1
EXECUTIVE SUMMARY 3
PRICING & REIMBURSEMENT SYSTEMS 5
Free Pricing and Indirect Control 5
Reference Pricing 6
External Reference Pricing 6
Internal Reference Pricing 9
Fixed Generic Price Reductions 9
Wholesale and Pharmacy Mark-ups 10
Reimbursement Lists 10
Positive and Negative Lists 10
Essential Medicines 11
AMERICAS 12
ARGENTINA 13
Pricing 13
Price Controls in the National Medicines Policy, 2002 13
BRAZIL 14
Pricing 14
Drug Price Set-up 14
Drug Price Control 14
Reimbursement 16
PFPB 16
CANADA 17
Pricing 17
Reimbursement 17
Provincial Formularies 17
Drug Insurance Programmes 18
National Pharmaceuticals Strategy 19
CHILE 19
Pricing 19
Public Procurement 19
Reimbursement 20
COLOMBIA 20
Pricing 20
Price Regulation 20
Resolutions/Decrees Issued in 2010 21
Resolution No 04/2006 22
SISMED24
Reimbursement 24
MEXICO 25
Pricing 25
Private Sector25
Public Procurement26
Seguro Popular 26
Reimbursement 27
PERU 27
Pricing 27
Public Procurement27
Reverse Auctions 28
Public Monitoring 28
OPPF 28
Reimbursement 29
PNUM29
USA 29
Pricing 29
Public Drug Procurement29
Average Wholesale Price (AWP)30
Biologics Price Competition and Innovation Act30
Reimbursement 31
Medicaid31
Medicare31
Legislative Background 32
Bill H R 1 32
State Pricing/Reimbursement Moves 33
VENEZUELA 33
Pricing 33
Regulation33
Background to Price Control 34
Foreign Exchange Controls34
Reimbursement 35
ASIA/PACIFIC 36
AUSTRALIA 37
Pricing 37
Drug Pricing Developments37
PBS Drug Price Cuts 37
PBS Medicine Bill Reforms 38
Reference Pricing System 38
12 5% PriceReductions for New Market Entrants 39
US Free Trade Agreement 39
Reimbursement 39
PBS Reimbursement Reforms 39
Patient Co-Payments 41
CHINA 41
Pricing 41
Essential Drugs List 41
Price Reductions 42
Mandatory Licensing 42
Reimbursement 42
Patient Contributions 43
INDIA 44
Pricing 44
Drugs (Prices Control) Amendment Order and Second Amendment Order, 2006 44
National Pharmaceuticals Pricing Policy, 2012 45
Background 45
NPPP-2012 and NLEM-2011 45
Reimbursement 46
INDONESIA 46
Pricing 46
Price Changes 47
Essential Drugs List 47
Reimbursement 48
JAPAN 48
Pricing 48
Price Reductions 48
Reimbursement 48
National Health Insurance Drug Price List 49
MALAYSIA 49
Pricing 49
NEW ZEALAND 50
Pricing 50
Drug Tender Scheme 50
Reimbursement 50
Prescription Charges 51
PAKISTAN 51
Pricing 51
Drug Pricing Policy52
Medicine Tariffs Abolished52
PHILIPPINES 52
Pricing 52
Government Mediated Access Price52
Further Price Reductions, 2010 53
DoH issues Cease and Desist Orders on retailers that violate the GMAP and MRP 53
Reimbursement 54
SINGAPORE 54
Pricing 54
Reimbursement 54
SOUTH KOREA 55
Pricing 55
Key Developments55
Drug Price Cuts to Encourage Generic Competition 55
Preferential Drug Price-Cut Exemption Policy 56
Transacted Drug Price Control System 56
Separation of Prescribing and Dispensing 56
Reimbursement 57
TAIWAN 57
Pricing 57
Reimbursement 58
THAILAND 59
Pricing 59
Reimbursement 59
VIETNAM 60
Pricing 60
Price Increases60
Imported Drugs60
Drug Pricing Decree60
Cuts in Tax & Import Duties61
Reimbursement 61
CENTRAL AND EASTERN EUROPE 62
BULGARIA 63
Pricing 63
Reimbursement 64
CROATIA 65
Pricing 65
Reimbursement 65
CZECH REPUBLIC 66
Pricing 66
Reimbursement 67
ESTONIA 68
Pricing 68
Reimbursement 68
HUNGARY 69
Pricing 69
Price Freezing, the Pharma Economic Act and Subsequent Developments 69
Reimbursement 70
LATVIA 70
Pricing 70
Reimbursement 71
LITHUANIA 71
Pricing 71
Reimbursement 72
POLAND 73
Pricing 73
Reimbursement 73
ROMANIA 74
Pricing 74
Reimbursement 74
RUSSIA 75
Pricing 75
Maximum Prices 76
Price Freezes 76
Reimbursement 77
DLO Programme 77
DLO Budget 77
DLO Procurement 78
Vital & Essential Medicines List 78
SLOVAKIA 78
Pricing 78
Reimbursement 79
SLOVENIA 79
Pricing 79
Reimbursement 80
UKRAINE 80
Pricing 80
Reimbursement 81
MIDDLE EAST/AFRICA 82
EGYPT 82
Pricing 82
Reimbursement 84
ISRAEL 85
Pricing 85
Reimbursement 85
MOROCCO 85
Pricing 85
Parliamentary Drug Pricing Report86
Reimbursement 87
SAUDI ARABIA 87
Pricing 87
National Unified Procurement Company for Medical Supplies 88
Reimbursement 88
SOUTH AFRICA 88
Pricing 88
Dispensing Fees Charged by Pharmacists89
Reimbursement 89
Essential Medicines List89
TURKEY 90
Pricing 90
Price Cuts91
Reimbursement 91
WESTERN EUROPE 92
AUSTRIA 94
Pricing 94
Reimbursement 95
Erstattungskodex (EKO)95
Rational Use of Pharmaceuticals96
Prescription Charges96
BELGIUM 97
Pricing 97
Reference Price System97
Cost Control Policies97
Reimbursement 98
Patient Co-payments 99
DENMARK100
Pricing100
Medicine Prices 100
Price Index 100
Pharmacy Prices Decline 101
Reimbursement101
Executive Order 102
Reimbursement Thresholds 103
Reference Price System 103
FINLAND104
Pricing104
Reference Price System and Generic Substitution 104
Reimbursement104
Reimbursement Categories 105
Basic Reimbursement 105
Special Reimbursement 105
Patient Co-payments 106
FRANCE106
Pricing106
Reimbursement107
GERMANY108
Pricing108
Background to AMNOG 108
Industry Concerns 109
Pharmaceutical Discount Contracts 109
Generic Substitution Policies 110
Reimbursement110
GREECE110
Pricing110
Reference Price System 111
Wholesale and Retail Margins 111
Reimbursement111
IRELAND112
Pricing112
Reference Pricing and Generic Substitution 112
Wholesale Margins 113
Reimbursement113
HSE Primary Care Reimbursement Service (PCRS) 113
Prescription Charges 114
ITALY114
Pricing114
Reimbursement115
Risk Sharing 115
NETHERLANDS116
Pricing116
Pharmacy Fees 116
Reimbursement117
NORWAY117
Pricing117
Reference Pricing System 117
Generic Pricing System 118
Wholesale and Pharmacy Mark-ups 118
Reimbursement119
First-Choice Scheme 120
Patient Co-payments 120
PORTUGAL120
Pricing120
Reference Pricing System 120
Pharmacy Margins 121
Reimbursement121
SPAIN122
Pricing122
Regulatory Bodies 122
Reference Pricing System 123
Drug Price Discounts 124
Reimbursement124
Generic Prescribing 124
Pharmacy Margins 125
Patient Co-payments 125
SWEDEN125
Pricing125
Reimbursement126
Reimbursement Rates 127
SWITZERLAND127
Pricing127
Reimbursement128
UNITED KINGDOM129
Pricing129
PPRS 2009 129
Reimbursement Decisions130
Patient Access Schemes 130
Prescription Charges 130
SOURCES132

List of Tables

Countries Operating External Reference Price Systems7
Pricing & Reimbursement in the Americas 12
Pricing & Reimbursement in the Asia/Pacific Region 36
Pricing & Reimbursement in Central and Eastern Europe 62
Pricing & Reimbursement in the Middle East and Africa 82
Pricing & Reimbursement in Western Europe 92

List of Figures

Most-commonly Referenced Countries for External Pricing 8

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