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

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

GlobalData’s Market Access, Pricing and Reimbursement of Oncology Medicines in the 5EU 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.

Companies mentioned

Alliance

Amgen

Aop Orphan Pharmaceuticals

Ariad Pharmaceuticals

Array BioPharma

AstraZeneca

Astellas

Biocon

Biogaran

Boehringer Ingelheim

Bristol-Myers Squibb

Celgene

Celltrion

CTI BioPharma

Dendreon

Difa Cooper

Eisai

Eli Lilly

Erytech Pharma

Genzyme

Gilead

Helsinn Birex

Industrial Farmaceutica Cantabria

Ipsen

Janssen-Cilag

Jazz Pharmaceuticals

Johnson & Johnson

Kedrion

Kern Pharma

Kite

Kyowa Kirin

Laboratorios Inibsa

Mabion

Meda

Medac

MedImmune

MolMed

MSD

Mundipharma

Mylan

Napp Pharmaceuticals

Nektar Therapeutics

Northwest Biotherapeutics

Novartis

Oasmia Pharmaceutical

Ono Pharmaceutical

Orphelia Pharma

Pharma Mar

Pierre Fabre Médicament

Pfizer

Puma Biotechnology

Regeneron

Roche

Sandoz

Sanofi

Sunesis Europe

Takeda

XBiotech 

Table of Contents

Table of Contents (PowerPoint Deck)

1. Preface

1.1 Table of Contents

1.2 Abbreviations

1.3 Related Reports

1.4 Upcoming Related Reports

2. Executive Summary

2.1 Key Findings

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

3. Overview of Market Access, Pricing and Reimbursement

3.1 Cancer in Europe

3.2 What is Market Access?

3.3 Marketing Authorization

3.4 Marketing Authorization for Early Patient Access

3.5 Cancer Medicines Approved Through EMA Access Schemes

3.6 Health Technology Assessments (HTAs)

3.7 Clinical Endpoints in Oncology

3.8 Scientific and Value Assessment of Oncology Medicines in HTAs

3.9 Patient Reported Outcomes in HTAs

3.10 EU Pricing and Reimbursement – Overview

3.11 EU Pricing and Reimbursement – Pricing Models

3.12 EU Pricing and Reimbursement – Agreements

3.13 Valuing New Medicines

3.14 EU Pricing and Reimbursement – Cost-containment measures

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

3.16 The role of the payer in market access

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

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

4.2 Healthcare Systems of the 5EU

4.3 Health-Related Statistics in the 5EU

4.4 France

4.5 Germany

4.6 Italy

4.7 Spain

4.8 United Kingdom

4.9 Summary

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

5.1 Overview of Oncology Medicines

5.2 Immuno-oncology Therapies

5.3 Biosimilars

6. Current and Future Outlook

6.1 Unmet Needs and Current Issues in Oncology

6.2 Market Trends in Oncology

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

6.4 Drivers and Barriers in Oncology Drug Development and Market Access

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

6.6 Pipeline Pre-Registration Oncology Drugs in Europe

7. Appendix

7.1 Research Methodology

7.2 Primary Research

7.3 About the Authors

7.4 About GlobalData

7.5 Contact Us

7.6 Disclaimer

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