Pricing and Reimbursement in Generics - European Austerity Measures and Healthcare Cost Containment Puts Innovation-Driven Pharma Companies under Pressure

Summary

GBI Research, the leading business intelligence provider, has released its latest research “Pricing and Reimbursement in Generics - European Austerity Measures and Healthcare Cost Containment Puts Innovation-Driven Pharma Companies under Pressure”. The report provides a comprehensive overview of the healthcare expenditure, healthcare regulatory system, and pricing and reimbursement process with key data, information and analysis of pricing and reimbursement decisions, across 19 countries. The report closely scrutinizes the major changes in generic drugs-related pricing and reimbursement in the 19 countries over recent years and whose impact will be felt in the near future. It also describes the efforts taken by the governing bodies in shaping the pricing and reimbursement policies of generic drugs.

GBI Research has found that expenditure towards healthcare has shown an increasing trend in most of the countries due to rising costs, resulting in budget deficits. In order to save costs, many countries have adopted reference pricing as it helps lower drug costs. Plans to increase generic drug prescription and low-cost generic drug use are being implemented in order to tackle budget deficits. Austerity measures that include price cuts and rebate reforms have been introduced in some of the countries with a view to generate maximum savings within a given period of time. These steps are being taken to build sufficient funds for future investment purposes. In most countries the focus has shifted to generic drugs as they have been successful in bringing these countries out of crisis; the countries have reformed their pricing and reimbursement structure accordingly.

Scope

- A detailed study of the healthcare systems in the US, France, Germany, the UK, Italy and Spain, the Czech Republic, Poland, Austria, Romania, Hungary, Norway, Sweden, Finland, Denmark, Japan, Australia, China and India.

- Analysis of the pricing and reimbursement mechanisms for the countries covered in the report.

- Key trends that follow from the recent changes brought about in the pricing and reimbursement system.

- An understanding of the possible major challenges brought about by the enactment of changes in the pricing and reimbursement scenario for the countries covered in the report.

Reasons to buy

- Build an understanding of the generic drugs-related key pricing and reimbursement mechanisms for the countries covered in the report.

- Optimize your investment through identification and understanding of the changes in the generic drugs regulatory mechanisms, and pricing and reimbursement scenario for the countries covered in the report.

- Develop effective business strategies related to new drug launches through the analytical insight gained from key trends in pricing and reimbursement scene for the countries covered in the report.

- Negotiate better with government agencies to maximize reimbursement of generic drugs by understanding the mechanisms.

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 5

1.2 List of Figures 6

2 Pricing and Reimbursement in Generics - Introduction 7

2.1 GBI Research Report Guidance 8

3 Pricing and Reimbursement in Generics - The US 9

3.1 Health Insurance 10

3.1.1 Health Insurance Coverage 10

3.1.2 Health Insurance Providers 10

3.2 Major Agencies Involved 12

3.3 Structure of Regulatory System 12

3.4 Pricing of Generics in the US 12

3.4.1 340B Drug Pricing Program 14

3.5 Reimbursement of Generics in the US 15

3.5.1 Health Insurance Companies 16

3.5.2 Pharmacy Benefit Managers 16

3.5.3 Reimbursement Programs in the US 17

3.6 Case Study 20

3.6.1 Pricing and Reimbursement in Oncology 20

3.7 Key Trends 20

3.7.1 Increased Availability of Generic Drugs 20

3.7.2 Patient Protection and Affordable Care Act to Tackle Soaring Prescription Drug Prices 21

3.7.3 Significant Decrease in Average Price of Generic Drugs 23

3.7.4 Generic Drugs Rebates to be Aligned for Medicare and Medicaid 23

3.7.5 Lower FEHB Drug Costs 24

3.7.6 Medicare Part D Changes in Standard Benefit Parameters 24

3.7.7 Cost-sharing of Generic Drugs 26

3.7.8 Penalty for Anemia Drug Overuse 27

3.7.9 Generic Price War at Retail Sector 27

3.8 Major Challenges 28

3.8.1 Medicare Part B Drug Pricing Does Not Accurately Reflect Market Price 28

3.8.2 Renewal of Medicaid Drug Payment Policy 28

3.8.3 Proposed Cuts in Medicare Part B Reimbursement 28

3.8.4 New Trend in Free Trade Agreements Could Affect Healthcare Programs 29

4 Pricing and Reimbursement in Generics - The Top Five Countries of Europe 30

4.1 The UK 30

4.1.1 Pricing and Reimbursement Process 31

4.1.2 Key Trends 31

4.1.3 Major Challenges 32

4.2 France 32

4.2.1 Pricing and Reimbursement Process 33

4.2.2 Key Trends 35

4.2.3 Major Challenges 37

4.3 Germany 37

4.3.1 Pricing and Reimbursement Process 38

4.3.2 Key Trends 40

4.3.3 Major Challenges 40

4.4 Italy 41

4.4.1 Pricing and Reimbursement Process 42

4.4.2 Key Trends 42

4.4.3 Major Challenges 44

4.5 Spain 44

4.5.1 Pricing and Reimbursement Process 45

4.5.2 Key Trends 45

4.5.3 Major Challenges 47

5 Pricing and Reimbursement in Generics - Eastern Europe 48

5.1 Czech Republic 48

5.1.1 Pricing and Reimbursement Process 48

5.1.2 Key Trends 49

5.1.3 Major Challenges 50

5.2 Poland 50

5.2.1 Pricing and Reimbursement Process 51

5.2.2 Key Trends 51

5.2.3 Major Challenges 52

5.3 Austria 53

5.3.1 Pricing and Reimbursement Process 53

5.3.2 Key Trends 54

5.4 Romania 54

5.4.1 Pricing and Reimbursement Process 54

5.4.2 Key Trends 55

5.4.3 Major Challenges 56

5.4.4 Case Study 57

5.5 Hungary 57

5.5.1 Pricing and Reimbursement Process 58

5.5.2 Key Trends 59

5.5.3 Major Challenges 60

6 Pricing and Reimbursement in Generics - Scandinavia 61

6.1 Norway 61

6.1.1 Pricing and Reimbursement Process 61

6.1.2 Key Trends 64

6.2 Sweden 64

6.2.1 Pricing and Reimbursement Process 64

6.2.2 Major Challenges 66

6.3 Finland 66

6.3.1 Pricing and Reimbursement Process 67

6.4 Denmark 69

6.4.1 Pricing and Reimbursement Process 69

6.4.2 Key Trends 71

7 Pricing and Reimbursement in Generics - Asia-Pacific 72

7.1 Japan 72

7.1.1 Pricing and Reimbursement Process 72

7.1.2 Key Trends 74

7.1.3 Major Challenges 74

7.2 Australia 74

7.2.1 Pricing and Reimbursement Process 75

7.2.2 Key Trends 76

7.2.3 Major Challenges 77

7.3 China 77

7.3.1 Pricing and Reimbursement Process 79

7.3.2 Key Trends 82

7.3.3 Major Challenges 83

7.4 India 85

7.4.1 Pricing and Reimbursement Process 86

7.4.2 Key Trends 90

7.4.3 Major Challenges 90

8 Pricing and Reimbursement in Generics - Appendix 92

8.1 Market Definitions 92

8.2 Abbreviations 92

8.3 Research Methodology 96

8.3.1 The US 96

8.3.2 Top Five Countries of Europe 97

8.3.3 Eastern Europe 97

8.3.4 Scandinavia 97

8.3.5 Asia-Pacific 98

8.4 Contact Us 98

8.5 Disclaimer 98

8.6 Sources 98

1.1 List of Tables

Table 1: Pricing and Reimbursement in Generics, The US, Average Retail Coinsurance Rates, By Tier (%), 2009 16

Table 2: Pricing and Reimbursement in Generics, The US, Reimbursement Programs, 2011 17

Table 3: Pricing and Reimbursement in Generics, The US, State Discount Programs, 2011 19

Table 4: Pricing and Reimbursement in Generics, The US, Annual Price Index Change in Prescription Drugs (%), 2008-2010 21

Table 5: Pricing and Reimbursement in Generics, The US, Annual Retail Price Index Change in Generic Drugs (%), 2008-2010 23

Table 6: Pricing and Reimbursement in Generics, The US, Medicare Part D Changes in Standard Benefit Parameters ($), 2008-2012 25

Table 7: Pricing and Reimbursement in Generics, The US, Generic Drug Cost-Sharing (%), 2011-2020 26

Table 8: Pricing and Reimbursement in Generics, The UK, Healthcare Expenditure, 2009 30

Table 9: Pricing and Reimbursement in Generics, France, Healthcare Expenditure, 2009 32

Table 10: Pricing and Reimbursement in Generics, Germany, Healthcare Expenditure, 2009 37

Table 11: Pricing and Reimbursement in Generics, Italy, Healthcare Expenditure, 2009-2010 41

Table 12: Pricing and Reimbursement in Generics, Spain, Healthcare Expenditure, 2009 44

Table 13: Pricing and Reimbursement in Generics, Czech Republic, Healthcare Expenditure, 2009 48

Table 14: Pricing and Reimbursement in Generics, Poland, Healthcare Expenditure, 2009 50

Table 15: Pricing and Reimbursement in Generics, Austria, Healthcare Expenditure, 2009 53

Table 16: Pricing and Reimbursement in Generics, Austria, Box Model for Reimbursement, 2011 53

Table 17: Pricing and Reimbursement in Generics, Hungary, Healthcare Expenditure, 2009 57

Table 18: Pricing and Reimbursement in Generics, Norway, Healthcare Expenditure, 2009 61

Table 19: Pricing and Reimbursement in Generics, Norway, Reimbursement Categories of Medicines, 2011 63

Table 20: Pricing and Reimbursement in Generics, Sweden, Healthcare Expenditure, 2009 64

Table 21: Pricing and Reimbursement in Generics, Sweden, Retail Sales Price, 2011 65

Table 22: Pricing and Reimbursement in Generics, Sweden, Patient Co-payments, 2011 65

Table 23: Pricing and Reimbursement in Generics, Finland, Healthcare Expenditure, 2009-2010 66

Table 24: Pricing and Reimbursement in Generics, Denmark, Healthcare Expenditure, 2009 69

Table 25: Pricing and Reimbursement in Generics, Denmark, Reimbursement Thresholds, 2011 70

Table 26: Pricing and Reimbursement in Generics, Japan, Healthcare Expenditure, 2009 72

Table 27: Pricing and Reimbursement in Generics, Japan, Trend in Revision Rates of Reimbursement Prices, 1992-2008 73

Table 28: Pricing and Reimbursement in Generics, Australia, Healthcare Expenditure, 2009 74

Table 29: Pricing and Reimbursement in Generics, Australia, Pharmacy Mark-up Price for PBS Medicines, 2011 75

Table 30: Pricing and Reimbursement in Generics, Australia, Wholesale Mark-up Price for PBS Medicines, 2011 76

Table 31: Pricing and Reimbursement in Generics, India, Effect of Jan Aushadhi Shops on Medicines, 2011 88

1.2 List of Figures

Figure 1: Pricing and Reimbursement in Generics, The US, Other Private and Government Insurance, 2011 11

Figure 2: Pricing and Reimbursement in Generics, The US, Distribution Channel Logistics and Pricing, 2011 13

Figure 3: Pricing and Reimbursement in Generics, The US, Comparison Between Fee for Service, HMO and PPO, 2011 15

Figure 4: Pricing and Reimbursement in Generics, The US, Annual Price Index Change in Prescription Drugs (%), 2008-2010 21

Figure 5: Pricing and Reimbursement in Generics, The US, Annual Retail Price Index Change in Generic Drugs (%), 2008-2010 23

Figure 6: Pricing and Reimbursement in Generics, The US, Standard Medicare Part D Benefit, 2011-2020 24

Figure 7: Pricing and Reimbursement in Generics, The US, Generic Drug Cost-Sharing (%), 2011-2020 26

Figure 8: Pricing and Reimbursement in Generics, France, LFSS, 2011 34

Figure 9: Pricing and Reimbursement in Generics, Norway, Stepped Price System, 2011 62

Figure 10: Pricing and Reimbursement in Generics, China, Healthcare Regulatory Bodies and their Roles, 2011 78

Figure 11: Pricing and Reimbursement in Generics, India, Factors Determining the Pricing of a Drug, 2011 86