Market Access, Pricing and Reimbursement of Oncology Medicines in the 5EU

Market Access, Pricing and Reimbursement of Oncology Medicines in the 5EU


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Executive Summary

Market Access, Pricing and Reimbursement of Oncology Medicines in the 5EU

Summary

Market access of oncology medicines is increasingly challenging due to the rising cost of new and innovative medicines, more stringent scientific and value assessments and economic pressures on national budgets and health systems. Although, 5EU markets have implemented patient access schemed to ensure early access to innovative oncology medicines with high unmet need, the increasing requirements for improved clinical benefits and better cost-effectiveness of medicines has resulted in more stringent pricing and reimbursement of medicines leading to access issues such as delays in patient access due to negotiations.

In this report, GlobalData provides an overview of market access, pricing and reimbursement in the 5EU (France, Germany, Italy, Spain and UK) including key KOL and payers perspectives throughout. KOLs and Payers also provide insights into the market access trends, challenges, drivers and barriers. KOLs and Payers also provide insights on unmet needs in oncology and overall current and future outlook.

Scope

The report combines key opinion leader and payer insight with in-house analyst expertise and research to provide an insight-rich look at market access in the 5EU. Components of the report include-

- Overview of Market Access, Pricing and Reimbursement-What is market access and what are the key concepts and components for pharmaceutical market access of oncology medicines in Europe.

- Market Access, Pricing and Reimbursement in the 5EU-What are the key components of the healthcare systems, pharmaceutical markets and the regulatory framework in each of the 5EU concerning approval, pricing and reimbursement and patient access of cancer medicines in the 5EU

- Market access of new and innovative oncology therapies in the 5EU and related case studies-Which oncology medicines have experience market access issues when entering the EU market and what are the market access challenges and opportunities for new and innovative oncology medicines, immuno-oncology therapies and biosimilars.

- Current and Future Outlook-What are the unmet needs and current issues in oncology, what are the market trends, what changes are expected over the next 5-10 years, what are the drivers and barriers in oncology drug development and market access, what is the current thinking on the high cost and uncertain value of oncology medicines what are the late stage pipeline oncology medicines and their likelihood of experiencing market access issues.

Reasons to buy

- Develop business strategies by understanding the challenges and opportunities for market access in oncology in the 5EU

- Reinforce market access capabilities by understanding the key concepts for the scientific and value assessment and appraisal of pharmaceuticals.

- Be acquainted with national marketing authorization, HTA, pricing, reimbursement and patient access architectures and policies.

- Drive revenues by understanding the unmet needs and market trends for new and innovative medicines likely to impact the oncology market in the future.



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Table of Contents

1. Preface 2

1.1 Table of Contents 3

1.2 Abbreviations 5

1.3 Related Reports 11

1.4 Upcoming Related Reports 12

2. Executive Summary 13

2.1 Key Findings 14

2.2 KOL and Payer Insights on Market Access, Pricing and Reimbursement in Oncology in the 5EU 15

3. Overview of Market Access, Pricing and Reimbursement 16

3.1 Cancer in Europe 18

3.2 What is Market Access? 19

3.3 Marketing Authorization 20

3.4 Marketing Authorization for Early Patient Access 21

3.5 Cancer Medicines Approved Through EMA Access Schemes 22

3.6 Health Technology Assessments (HTAs) 23

3.7 Clinical Endpoints in Oncology 24

3.8 Scientific and Value Assessment of Oncology Medicines in HTAs 25

3.9 Patient Reported Outcomes in HTAs 27

3.10 EU Pricing and Reimbursement-Overview 28

3.11 EU Pricing and Reimbursement-Pricing Models 29

3.12 EU Pricing and Reimbursement-Agreements 30

3.13 Valuing New Medicines 31

3.14 EU Pricing and Reimbursement-Cost-containment measures 32

3.15 Cost-containment Measures of Oncology Medicines in the Healthcare System 33

3.16 The Role of the Payer in Market Access 34

4. Market Access, Pricing and Reimbursement in the 5EU 37

4.1 Demographic and Socio-economic Factors in Healthcare in the 5EU 39

4.2 Healthcare Systems of the 5EU 40

4.3 Health-Related Statistics in the 5EU 41

4.4 France 43

4.5 Germany 57

4.6 Italy 68

4.7 Spain 82

4.8 UK 92

4.9 Summary 108

5. Market access of new and innovative oncology therapies in the 5EU and related case studies 113

5.1 Overview of Oncology Medicines 115

5.2 Immuno-oncology Therapies 121

5.3 Biosimilars 131

6. Current and Future Outlook 139

6.1 Unmet Needs and Current Issues in Oncology 141

6.2 Market Trends in Oncology 145

6.3 Market Changes in Oncology Over the Next 5-10 years 146

6.4 Drivers and Barriers in Oncology Drug Development and Market Access 148

6.5 The Issue of High Prices and Uncertain Value of Oncology Drugs 150

6.6 Pipeline Pre-Registration Oncology Drugs in Europe 151

7. Appendix 155

7.1 ResearchMethodology 156

7.2 Primary Research 157

7.3 About the Authors 158

7.4 About GlobalData 160

7.5 Contact Us 161

7.6 Disclaimer 162

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