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Biosimilars: European Payer Perspectives

  • January 2015
  • -
  • Firstword Pharma




Cost is king when it comes to European biosimilars. One issue unites European healthcare payers: the need to provide biosimilars at the most affordable price in cash constrained health services.

Biosimilars: European Payer Perspectives is a thought-provoking and comprehensive report packed with the candid opinions of 15 leading decision makers in pricing, reimbursement, medicines management and pharmacy that present business-critical insights for both biosimilar manufacturers and originator companies.

The speed of development of biosimilars in Europe has been glacial, and the reasons are many and varied. Against a background of vigorous defence by originator companies, awareness of biosimilars, pricing regimes, discounts, biosimilar substitution, clinical confidence – or lack of it - and patient perceptions are just some of the issues which vary widely from country to country. But one thing unites healthcare payers: the need to provide these products at the most affordable price in cash constrained health services.

Biosimilars: European Payer Perspectives gives payer insights on how healthcare payers balance patient safety with clinical anxiety and the need to save money, pricing, how biosimilar manufacturers can find market voice and establish corporate reputation in the field and how much originator companies have to defend their brands.







Key Benefits

Get into the minds of leading EU healthcare payers so you can formulate plans that meet their expectations
Appreciate the critical issue of pricing, reimbursement and discounting on country-by-country basis, thereby understanding what payers see as critical to driving biosimilar market share
Address where better clinical data and educational programmes would support wider biosimilar use
Engage with the clinical and safety concerns of physicians which are limiting the use of biosimilars
Understand fully the operational structure and operating environment affecting biosimilars in 5 leading EU countries and identify opportunity areas

Answers to Critical Questions

Cost as the key driver: what expectations do EU health payers have and why is there such wide variation country to country?
Building physician confidence: what could biosimilar manufacturers do to reassure physicians that their products can be safely used instead as the branded product?
Patient safety remains a critical issue: what clinical and educational programmes would reduce fears?
When is the use of biosimilars likely to cause less physician and patient resistance and what lessons are there for developers?
How does local regulation and formulary policy impact biosimilar availability and use in each country?
What health payer views should originator companies take into account when formulating pricing strategies?

Experts Interviewed

Head of CNS Pharmacology; Porsolt SAS, France
Pharmacy Director and Health Economist; ISPOR, France
Head Pharmacist; Grenoble, France
G-BA Member & Pharmacy Director; Berlin, Germany
Head of Medicine Management & Chief Pharmacist; Munster, Germany
Pharmacist and Head of Drug Reimbursement and Quality Assurance; Hessen, Germany
Pharmacy Director; Rome, Italy
Chief of the Clinical Pharmacy, ISMETT; Rome, Italy
AIFA Member and Professor of Clinical Pharmacology; Turin, Italy
Pharmacy Director; Basque Country, Spain
Pharmacy Director; Madrid, Spain
Pharmacy director; Valencia, Spain
Head of Medicines Management and Pharmacy; NHS Islington, UK
Senior Pharmacist; Brighton and Sussex University Hospitals NHS Trust, UK
Head of Pharmacy; Neath Port Talbot Hospital, Wales (UK)




Top Takeaways

Know the concerns of healthcare payers and formulate effective strategies for pricing, education and support

Understand the pivotal role pricing plays in the adoption and use of biosimilars and how it varies from country to country

Identify the key clinical and operational challenges faced by biosimilar manufacturers

Tackle the essential requirement for establishing physician confidence, ensuring patient safety and building corporate reputation.





About FirstView Reports

FirstView Reports deliver two types of research and analysis: FirstView Advisory and FirstView Trends. FirstView Advisory reports are based on the qualitative insights of 10-15 leading experts, including treating and key opinion leading physicians, payers and industry stakeholders. FirstView Trends reports deliver insights based on quantitative market research which leverages FirstWord’s 1-million strong online physician community. FirstView Advisory and FirstView Trends reports deliver authoritative, actionable insight that can help industry professionals understand future pharma market dynamics and support effective decision making

About FirstWord Reports
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors, and your markets. Covering market access, biosimilars, medical affairs, pharma sales and marketing and therapy areas, FirstWord Reports provide timely expert views and intelligence on the challenges facing pharma today


Table Of Contents

Biosimilars: European Payer Perspectives
1.Executive summary
2.Research objectives, methodology and definitions
2.1.Objectives
2.2.Methodology
3.Biosimilars in Europe: history to present day
3.1.The birth of the biosimilar concept
3.2.Regulatory revolution paves the way
3.2.1.The overarching guideline sets the basic principles
3.2.2.The quality guideline is based on the guideline for demonstration of
3.2.3.comparability after process change for a novel biologic
3.2.4.The non-clinical and clinical guideline emphasises that studies need to
be comparative in nature, and non-EEA approved reference products
can now be used
3.2.5.Product class specific guidelines provide more information

3.3.Biosimilar approvals in Europe to date
3.4.Uptake and usage of biosimilars in Europe
3.4.1.Somatropin
3.4.2.Erythropoietin (EPO)
3.4.3.Filgrastim
3.5.Approaches to driving the use of biosimilars in Europe

3.5.1.France
3.5.1.1.Pricing and reimbursement overview
3.5.1.2.Current strategies used for biosimilars

3.5.2.Germany
3.5.2.1.Pricing and reimbursement overview
3.5.2.2.Current strategies used for biosimilars

3.5.3.Italy
3.5.3.1.Pricing and reimbursement overview
3.5.3.2.Current strategies used for biosimilars
3.5.4.Spain
3.5.4.1.Pricing and reimbursement overview
3.5.4.2.Current strategies used for biosimilars
3.5.5.United Kingdom (UK)
3.5.5.1.Pricing and reimbursement overview
3.5.5.2.Current strategies used for biosimilars
3.5.2Potential future trends, challenges and opportunities for biosimilars in Europe

4.Awareness, perceptions and comfort levels with biosimilars
4.1.Overview
4.2.Awareness of biosimilars at the payer level is generally high, but payers
believe that physician awareness of biosimilars is low
4.3.Payers believe that biosimilars need to be highly similar to the originator's
brand, but slight, clinically insignificant differences are permissible
4.4.Robust clinical experience is likely to be the key driver of physician
comfort when it comes to prescribing biosimilars
5.Drivers and resistors of biosimilar use

5.1.Overview
5.2.According to payers, cost remains the number on driver of biosimilar
usage in Europe
5.3.According to payers, physicians are the biggest barrier to the healthy
uptake of biosimilars in Europe
5.4.Payers have a higher level of trust for large, well-known, multinational
biotechnology companies which manufacture biosimilars compared to
companies that are based in developing markets

6.Critical market shaping dynamics
6.1.Overview
6.2.Payers believe switching patients from original brands to biosimilars
is justified to cut costs, but acknowledge physicians are likely to
have the final say
6.3.While most payers believe that automatic substitution for biosimilars
is essential to be able to make significant cost savings, payers
understand the challenges and potential safety implications
6.4.Indication extrapolation remains a highly contentious issue amongst
payers, with some suggesting that biosimilar manufacturers should
generate clinical data in all of the original brand's indications
6.5.Biosimilars should have the same generic name as originator brands,
but there must be an obvious linkage to the manufacturer to
support traceability
6.6.Payers argued that biosimilar manufacturers need to offer deep discounts
to drive biosimilar acceptance, and acknowledge that they'll take
cost savings from wherever they can get them

7.Future challenges, opportunities and critical success factors
7.1.Overview
7.2.The nascent biosimilars market is on a long, winding road heading
toward an uncertain future, and many challenges remain
7.3.Critical success factors for originators and biosimilar developers
in European biosimilars market
7.3.1.Critical success factors for biosimilar manufacturers
7.3.1.1.Compete on price
7.3.1.2.Focus on quality and extensive clinical data
7.3.1.3.Commit to tracking long-term safety
7.3.1.4.Provide an extensive portfolio
7.3.1.5.Educate and support

7.3.2.Critical success factors for originator companies
7.3.2.1.Compete on price
7.3.2.2.Leverage your heritage
7.3.2.3.Play fair
7.3.2.4.Innovate
8.Appendix
8.1.Definitions
8.2.Experts interviewed for this report

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