Pharmaceutical Pricing and Reimbursement - Adoption of Health ...

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Pharmaceutical Pricing and Reimbursement - Adoption of Health Technology Assessments (HTA) Optimizes Drug Pricing and Accelerates Reimbursement Decision-Making

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Pharmaceutical Pricing and Reimbursement - Adoption of Health Technology Assessments (HTA) Optimizes Drug Pricing and Accelerates Reimbursement Decision-Making

Summary

GBI Research, leading business intelligence provider has released its latest research report, entitled "Pharmaceutical Pricing and Reimbursement - Adoption of Health Technology Assessments (HTA) Optimizes Drug Pricing and Accelerates Reimbursement Decision-Making". The report provides a comprehensive overview of the healthcare system and pricing and reimbursement process in the US, top five countries of Europe (the UK, Germany, France, Spain and Italy), Japan, Australia and China, with a detailed analysis of the different regulatory mechanisms used in these countries. The report closely scrutinizes the major changes in pharmaceutical pricing and reimbursement in these nations in the recent past and their impact in the near future.

Pricing and reimbursement issues are geography-specific and mostly depend upon the economic conditions of the country in question. Governments in the different countries of Europe have been adopting various measures to bring uniformity to the prices of pharmaceuticals by introducing measures such as international price referencing, pharmacoeconomic evaluations, value-based pricing, internal price referencing, price capping, risk sharing models, and positive and negative price lists. The Value Based Pricing System (VBPS), which is in the process of being adopted by the UK, will only reimburse drugs that provide value to patients. In addition, there are issues with respect to orphan drugs since there are no specific regulations governing their pricing, and pharmaceutical companies are exploiting patients by aggressively pricing these therapeutics. Pricing and reimbursement affects many players in the economic environment such as political parties, pharmaceutical companies, regulatory authorities, and patients. This report analyzes the impact of pricing and reimbursement issues on the concerned stakeholders. The report provides information on the economic situation of different countries with statistical graphs and graphs that represent the expenditure made by respective governments with respect to GDP. The report also provides information on the different pricing and reimbursement mechanisms that are being used in the current environment.

Scope

- A detailed study of the healthcare systems and roles of the key players in the respective pharmaceutical systems in the US, top five countries of Europe (the UK, Germany, France, Spain and Italy), Japan, Australia and China.

- Analysis of the major pricing and reimbursement mechanisms in each country.

- Key trends that have emerged from the recent changes brought about in pricing and reimbursement mechanisms.

- Possible major challenges brought about by the enactment of changes in the pricing and reimbursement scenes in the countries covered.

Reasons to buy

- Build an understanding of the key pricing and reimbursement mechanisms for pharmaceuticals in the key markets of Europe.

- Optimize your investment through the identification and understanding of the changes in the regulatory mechanisms for pharmaceuticals in the economies covered.

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

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 8

2 Pharmaceutical Pricing and Reimbursement ? Introduction 10

3 Pharmaceutical Pricing and Reimbursement ? Global Economic Issues 11

3.1 Trend in Global Pricing and Reimbursement Regime 11

3.2 Trend Analysis of Healthcare Expenditure Per Capita 12

3.3 Public Health Expenditure as a Percentage of Total Health Expenditure 13

3.4 Out-of-Pocket Health Expenditure as a Percentage of Private Expenditure on Health 15

3.5 Healthy Life Years beyond the Age of 65 16

4 Pharmaceutical Pricing and Reimbursement ? Global Issues 17

4.1 Reference Prices 17

4.2 International Price Referencing Adopted to Contain Healthcare Expenditure 17

4.3 Pharmaceutical Price Capping to Encourage the Use of Generic Drugs 17

4.4 Positive and Negative Price Formulary to Provide More Clarity on Drugs Covered by Health Insurance 17

4.5 Value-Based Pricing Systems and Risk-Sharing Models Evaluate Drugs Based on Value and Not Cost 18

4.6 Single Pricing Strategy in the European Union is a Debatable Issue 19

4.7 Faster Pricing and Reimbursement Decisions Ensure Quicker Medicine Access and Return on Investments 19

4.8 Issues in Pricing and Reimbursement in Orphan Drugs 19

4.9 Difficulty in Economic Evaluation of Orphan Drugs 19

5 Pharmaceutical Pricing and Reimbursement ? Pricing and Reimbursement by Geography 20

5.1 The US 20

5.1.1 Macroeconomic Factors (PEST Analysis) 20

5.1.2 Healthcare System in the Country 20

5.1.3 Healthcare Expenditure as a Percentage of GDP 21

5.1.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 22

5.1.5 Drug Pricing and Reimbursement Authorities 23

5.1.6 Issues in Pricing and Reimbursement 23

6 Top Five Countries of Europe 25

6.1 Proposal to Speed Up Pricing and Reimbursement Decisions in Europe 25

6.2 The UK 25

6.2.1 Macroeconomic Factors (PEST Analysis) 25

6.2.2 Healthcare System in the Country 26

6.2.3 Healthcare Expenditure as a Percentage of GDP 27

6.2.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 28

6.2.5 Drug Pricing and Reimbursement Authorities 29

6.2.6 Trends in Pricing and Reimbursement 29

6.3 France 31

6.3.1 Macroeconomic Factors (PEST Analysis) 31

6.3.2 Healthcare System in the Country 32

6.3.3 Total Expenditure on Healthcare as a Percentage of GDP 33

6.3.4 Private Expenditure and General Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 34

6.3.5 Drug Pricing and Reimbursement Authorities 35

6.3.6 Trends in Pricing and Reimbursement 36

6.4 Germany 37

6.4.1 Macroeconomic Factors (PEST Analysis) 37

6.4.2 Healthcare System in the Country 38

6.4.3 Total Expenditure on Healthcare as a Percentage of GDP 39

6.4.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 40

6.4.5 Drug Pricing and Reimbursement Authorities 41

6.4.6 Trends in Pricing and Reimbursement 41

6.5 Spain 42

6.5.1 Macroeconomic Factors (PEST Analysis) 42

6.5.2 Healthcare System in the Country 43

6.5.3 Total Expenditure on Healthcare as a Percentage of GDP 43

6.5.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 44

6.5.5 Drug Pricing and Reimbursement Authorities 45

6.5.6 Trends in Pricing and Reimbursement 45

6.6 Italy 46

6.6.1 Macroeconomic Factors (PEST Analysis) 46

6.6.2 Healthcare System in the Country 47

6.6.3 Total Expenditure on Healthcare as a percentage of GDP 47

6.6.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 48

6.6.5 Drug Pricing and Reimbursement Authorities and Procedures 49

6.6.6 Trends in Pricing and Reimbursement 49

7 Pharmaceutical Pricing and Reimbursement ? Asia-Pacific 51

7.1 China 51

7.1.1 Macroeconomic Factors (PEST Analysis) 51

7.1.2 Healthcare System in China 51

7.1.3 Total Expenditure on Healthcare as a Percentage of GDP 52

7.1.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 53

7.1.5 Pricing and Reimbursement Approval Process 54

7.2 Japan 55

7.2.1 Macroeconomic Factors (PEST Analysis) 55

7.2.2 Healthcare System in the Country 55

7.2.3 Total Expenditure on Healthcare as a Percentage of GDP 56

7.2.4 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 57

7.2.5 Revisions to the National Health Insurance Drug Price List 58

7.2.6 Trends in Pricing and Reimbursement 58

8 Pharmaceutical Pricing and Reimbursement ? Australia 59

8.1 Macroeconomic Factors (PEST Analysis) 59

8.2 Healthcare System in the Country 60

8.2.1 Expenditure on Healthcare as a Percentage of GDP 60

8.2.2 Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure 61

8.3 Flow Chart for Flow of Funds in Australia 62

8.4 Trends in Pricing and Reimbursement 62

8.4.1 Remuneration Issues of Section 94 Private Hospitals 62

8.4.2 Pharmacy Mark-Up Charts 63

9 Pharmaceutical Pricing and Reimbursement ? Appendix 64

9.1 Market Definitions 64

9.2 Abbreviations 64

9.3 Bibliography 65

9.4 Research Methodology 67

9.5 Healthcare System 67

9.6 Pricing and Reimbursement Process 67

9.7 Key Trends 67

9.8 Contact Us 68

9.9 Disclaimer 68

1.1 List of Tables

Table 1: Pharmaceutical Pricing and Reimbursement, Trend Analysis of Healthcare Expenditure Per Capita, ($), 2008?2010 12

Table 2: Pharmaceutical Pricing and Reimbursement, Public Health Expenditure as a Percentage of Total Health Expenditure, 2008?2010 14

Table 3: Pharmaceutical Pricing and Reimbursement, Out-of-Pocket Expenditure as a Percentage of Private Expenditure on Health, 2008?2010 15

Table 4: Pharmaceutical Pricing and Reimbursement, Healthy Life Years beyond the Age of 65 for Males and Females, 2010 16

Table 5: Pharmaceutical Pricing and Reimbursement, Healthcare Expenditure as a Percentage of GDP, The US, 2001?2010 21

Table 6: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, The US, 2001?2010 22

Table 7: Pharmaceutical Pricing and Reimbursement, Total Expenditure on Healthcare as a Percentage of GDP, The UK, 2001?2010 27

Table 8: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, The UK, 2001?2010 28

Table 9: Pharmaceutical Pricing and Reimbursement, The UK, General Price Changes (%), 2009?2013 29

Table 10: Pharmaceutical Pricing and Reimbursement, The UK, List of Treatments with Approved Patient Access Schemes, Recommended by National Institute for Clinical Excellence for Use in the National Healthcare Service, 2012 30

Table 11: Pharmaceutical Pricing and Reimbursement, List of Drugs Not to be Reimbursed from March 1, 2012, France 32

Table 12: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, France , 2001- 2010 33

Table 13: Pharmaceutical Pricing and Reimbursement, Private Expenditure and General Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, France, 2001?2010 34

Table 14: Pharmaceutical Pricing and Reimbursement, Examples of Drugs Affected by Reimbursement Cuts, France, 2011 35

Table 15: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Germany, 2001?2010 39

Table 16: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Germany, 2001?2010 40

Table 17: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Spain, 2001?2010 43

Table 18: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Spain, 2001?2010 44

Table 19: Pharmaceutical Pricing and Reimbursement, Changes in Pharmaceutical Expenditure in 2012 from 2011 (%), Spain, 2011?2012 45

Table 20: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Italy, 2001?2010 47

Table 21: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Italy, 2001?2010 48

Table 22: Pharmaceutical Pricing and Reimbursement, List of Innovative Drugs for Regions, AIFA, Italy, 2010 50

Table 23: Pharmaceutical Pricing and Reimbursement, Total Expenditure on Healthcare as a Percentage of GDP, China, 2001?2010 52

Table 24: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, China, 2001?2010 53

Table 25: Pharmaceutical Pricing and Reimbursement, Total Expenditure on Healthcare as a Percentage of GDP, Japan, 2001?2010 56

Table 26: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Japan, 2001?2010 57

Table 27: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Australia, 2001?2010 60

Table 28: Pharmaceutical Pricing and Reimbursement, and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Australia, 2001?2010 61

Table 29: Pharmaceutical Pricing and Reimbursement, Pharmacy Mark-up Chart Comparison, Australia, 2012 63

1.2 List of Figures

Figure 1: Pharmaceutical Pricing and Reimbursement, Trend Analysis of Healthcare Expenditure Per Capita, ($), 2008?2010 12

Figure 2: Pharmaceutical Pricing and Reimbursement, Public Healthcare Expenditure as a Percentage of Total Healthcare Expenditure, 2008?2010 13

Figure 3: Pharmaceutical Pricing and Reimbursement, Out-of-Pocket Healthcare Expenditure as a Percentage of Private Expenditure on Healthcare, 2008?2010 15

Figure 4: Pharmaceutical Pricing and Reimbursement, Healthy Life Years beyond the Age of 65 for Males and Females, 2010 16

Figure 5: Pharmaceutical Pricing and Reimbursement, PEST Analysis, The US, 2012 20

Figure 6: Pharmaceutical Pricing and Reimbursement, Healthcare Expenditure as a Percentage of GDP, The US, 2001?2010 21

Figure 7: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, The US, 2001?2010 22

Figure 8: Pharmaceutical Pricing and Reimbursement, PEST Analysis, The UK, 2012 25

Figure 9: Pharmaceutical Pricing and Reimbursement, Total Expenditure on Healthcare as a Percentage of GDP, The UK, 2001?2010 27

Figure 10: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, The UK, 2001?2010 28

Figure 11: Pharmaceutical Pricing and Reimbursement, PEST Analysis, France, 2012 31

Figure 12: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, France, 2001?2010 33

Figure 13: Pharmaceutical Pricing and Reimbursement, Private Expenditure and General Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, France, 2001?2010 34

Figure 14: Pharmaceutical Pricing and Reimbursement, PEST Analysis, Germany, 2012 37

Figure 15: Pharmaceutical Pricing and Reimbursement, Healthcare expenditure, ($) per inhabitant, Germany, 2011 38

Figure 16: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Germany, 2001?2010 39

Figure 17: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Germany, 2001?2010 40

Figure 18: Pharmaceutical Pricing and Reimbursement, PEST Analysis, Spain, 2012 42

Figure 19: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Spain, 2001?2010 43

Figure 20: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Spain, 2001?2010 44

Figure 21: Pharmaceutical Pricing and Reimbursement, PEST Analysis, Italy, 2012 46

Figure 22: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Italy, 2001?2010 47

Figure 23: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Italy, 2001?2010 48

Figure 24: Pharmaceutical Pricing and Reimbursement, PEST Analysis, China, 2012 51

Figure 25: Pharmaceutical Pricing and Reimbursement, Total Expenditure on Healthcare as a Percentage of GDP, China, 2001?2010 52

Figure 26: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, China, 2001?2010 53

Figure 27: Pharmaceutical Pricing and Reimbursement, PEST Analysis, Japan, 2012 55

Figure 28: Pharmaceutical Pricing and Reimbursement, Total Expenditure on Healthcare as a Percentage of GDP, Japan, 2001?2010 56

Figure 29: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Japan, 2001?2010 57

Figure 30: Pharmaceutical Pricing and Reimbursement, Formula To Calculate New Drug Price, Japan, 2012 58

Figure 31: Pharmaceutical Pricing and Reimbursement, PEST Analysis, Australia, 2012 59

Figure 32: Pharmaceutical Pricing and Reimbursement, Expenditure on Healthcare as a Percentage of GDP, Australia, 2001?2010 60

Figure 33: Pharmaceutical Pricing and Reimbursement, Private and Government Expenditure on Healthcare as a Percentage of Total Healthcare Expenditure, Australia, 2001?2010 61

Figure 34: Pharmaceutical Pricing and Reimbursement, Flow of Funds, Australia, 2012 62

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Managed_care Industry: Pharmaceutical Pricing and Reimbursement - Adoption of Health Technology Assessments (HTA) Optimizes Drug Pricing and Accelerates Reimbursement Decision-Making

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