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Pharma Pricing and Reimbursement Outlook: Optimizing price and market access in a recessionary climate

NEW YORK, Oct. 27, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Pharma Pricing and Reimbursement Outlook: Optimizing price and market access in a recessionary climate

Determining the correct pricing and reimbursement strategy for a new product is an essential component of gaining maximum return on investment. This report gives an up to date and comprehensive review of the pricing and reimbursement environment in the seven major pharmaceutical markets and also the four high-growth emerging markets, as well as providing analysis of the most likely future scenarios in these markets' pricing and reimbursement environments. The report also provides strategic guidance on approaches that can be taken to ensure that a product achieves the most favorable pricing and reimbursement positioning

Table of Contents

Pharma pricing and reimbursement outlook

Executive Summary 10

Pricing and reimbursement in context 10

US pricing and reimbursement trends 11

European pricing and reimbursement trends 12

Pricing and reimbursement trends in Japan and the rest of the world 13

Global pricing and market access strategies 14

Pricing and market access planning 15

Chapter 1 Pricing and reimbursement in context 18

Summary 18

Introduction 19

Healthcare cost containment 19

Declining R&D productivity levels 24

Patent expiries and the impact of generics 28

The trickle-down effect of global recession 30

Pharmaceutical pricing and reimbursement outlook 32

Chapter 2 US pricing and reimbursement trends 36

Summary 36

Introduction 37

US pricing and reimbursement regulations 37

Private healthcare insurance 38

Medicare 40

Medicaid 42

Key pricing and market access issues 44

Patent expiries and generics 44

Follow-on biologics 45

Cost-effectiveness and budget impact 47

Innovative pricing agreements 48

Medicare part D impact and funding 49

President Obama's healthcare reform plans 51

Economic recession 52

Future trends in US pricing and reimbursement 53

Most likely scenario 55

Best case scenario 55

Worst case scenario 56

Chapter 3 European pricing and reimbursement trends 58

Summary 58

Introduction 59

European pricing and reimbursement regulations 59

French pricing and reimbursement regulations 62

German pricing and reimbursement regulations 65

Italian pricing and reimbursement regulations 67

Spanish pricing and reimbursement regulations 73

UK pricing and reimbursement regulations 76

Key pricing and market access issues 78

Decentralization 78

Generics 79

Parallel trade 80

Cost-effectiveness studies 81

Innovative pricing agreements 81

Economic recession 82

Future trends in European pricing and reimbursement 83

Most likely scenario 85

Best case scenario 86

Worst case scenario 86

Chapter 4 Pricing and reimbursement trends in Japan and the rest of the world 90

Summary 90

Introduction 91

Japanese pricing and reimbursement regulations 91

Key pricing and market access issues in Japan 94

Biennial price cuts 94

Generic pricing and substitution 96

Innovative drug pricing 97

Future trends in Japanese pricing and reimbursement 98

Most likely scenario 100

Best case scenario 101

Worst case scenario 101

High growth emerging pharmaceutical markets 102

Pricing and reimbursement in Brazil 104

Pricing and reimbursement in Russia 104

Pricing and reimbursement in India 105

Pricing and reimbursement in China 105

Chapter 5 Global pricing and market access strategies 108

Summary 108

Introduction 109

Local optimization 109

Price differentials 109

Market access differentials 111

Global coordination 113

Launch sequence 113

Price differentials 115

Balancing local optimization and global coordination 119

Chapter 6 Pricing and market access planning 122

Summary 122

Introduction 123

Pricing research and modeling 123

Research methodology 123

Pricing models 126

Pharmacoeconomic models 131

Pricing across the lifecycle 136

Pricing in early stage R&D 137

Pricing in late stage R&D 137

Pricing for lifecycle management 138

Pricing for pharmacoeconomic planning 138

List of Figures

Figure 1.1: Trends in healthcare spend as a proportion of GDP, 1990-2007 21

Figure 1.2: Pharmaceutical expenditure as a share of total healthcare expenditure, 1990-2007 22

Figure 1.3: R&D productivity levels, 1999-2008 25

Figure 1.4: The rising cost of new drug development, 1975-2006 27

Figure 1.5: Impact of US patent expiries for leading drugs, 2008-2013 28

Figure 1.6: Generics market share by sales value, 2003-2007 29

Figure 1.7: Quarterly GDP growth, Q4 2007 – Q2 2009 31

Figure 2.8: Projections of total Medicare Part D spending, FY2007-2016 50

Figure 2.9: Future scenarios for pharmaceutical pricing and reimbursement in the US 54

Figure 3.10: Pharmaceutical price controls in major European markets 61

Figure 3.11: Pharmaceutical reimbursement systems in major European markets 62

Figure 3.12: Italian categorization for innovative new therapies 69

Figure 3.13: Future scenarios for pharmaceutical pricing and reimbursement in the major European markets 84

Figure 4.14: The Japanese National Health Insurance system, FY2008 92

Figure 4.15: Average NHI price cuts, 1998-2008 95

Figure 4.16: Future scenarios for pharmaceutical pricing and reimbursement in Japan 99

Figure 4.17: Real GDP growth in BRIC and major markets, 2008 103

Figure 5.18: International price differentials for leading drugs, 2008 110

Figure 5.19: Market share for new products launched in last five years, 2007 112

Figure 5.20: Delays in European market access, 2007 114

Figure 5.21: External reference pricing in Europe, 2009 116

Figure 5.22: Parallel imports as a share of pharmacy sales in Europe, 2007 118

Figure 6.23: Price demand and response curves 128

Figure 6.24: Market share and revenue impact of reimbursement and formulary status 130

Figure 6.25: Budget impact modeling 135

List of Tables

Table 1.1: Trends in healthcare spend as a proportion of GDP, 1990-2007 20

Table 1.2: Number of NME and BLA approvals by the FDA, 1999-2008 24

Table 1.3: R&D expenditure by PhRMA members, 1999-2008 26

Table 4.4: NHI price premium classifications for new drugs 93

Table 6.5: Pricing across the drug development and marketing lifecycle 137

To order this report:

Pharmaceutical Industry: Pharma Pricing and Reimbursement Outlook: Optimizing price and market access in a recessionary climate

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Nicolas Bombourg
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Intl: +1 805-652-2626

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