1. Health Technology Assessment (HTA): a European perspective
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The bottom line: For payers facing tough financial crunches across Europe, Health Technology
Assessment (HTA) is becoming increasingly important. Not only is HTA influencing reimbursement, it is
having an impact on price and market access. And it’s not surprising. With greater scrutiny over the
clinical and financial value of drugs, medical devices and procedures, HTA is increasingly being accepted
around the world. The European situation is somewhat different: existing across multiple borders, the
‘Europeanisation’ agenda of HTA has sparked debates about European-wide standards, the possibility of
a single agency governing HTA and the need for formalized cooperation. Report Overview In Health
Technology Assessment (HTA): a European perspective, FirstWord examines the current role of HTA in

2. Europe, from its impact on reimbursement and pricing to market access. The report focuses on the
experiences of five European nations, reviewing the history of HTA and the key agencies in each. Written
by an expert health economist and with insight from experts from NICE, EUnetHTA , the EMA and leading
pharmaceutical companies, the report reveals the problems, pitfalls and—most importantly—the
potential of a harmonized approach to HTA in Europe. Key features Detailed examination of the role of
HTA in European pricing, reimbursement and market access An overview of the role of HTA in Germany,
France, Italy, Spain and the UK Country-by-country breakdown of key agencies Expert insight into the
‘Europeanisation’ of HTA and its key challenges Review of the potential and pitfalls Key Benefits Full
overview the role of HTA in Europe Insights from experts in the European Medicines Agency, the
National Institute for Health and Clinical Excellence and leading pharmaceutical companies
Comprehensive references to key literature Key Questions Asked What role does HTA play in pricing,
reimbursement and market access? What is the current state of play with HTA across Europe? What
changes are happening in HTA and what is their impact? Does one size fit all in terms of transferability
and adaptability? What are the pitfalls, problems and potential of HTA in Europe? Who Should Read This
Report Market Access directors & managers Health Economics professionals Pharmacoeconomics
professionals Health Outcomes / Outcomes Research professionals Health Technology Assessment
professionals Health Policy professionals Pricing & Reimbursement teams Government and regulatory
affairs analysts Government and regulatory affairs analysts Key quotes “HTA is not the only game in
town.” – Keiron Sparrowhawk of PriceSpective “There is the situation of the UK, where the whole pricing
and reimbursement system is experiencing a change. The idea is to integrate the HTA system, particularly
NICE, into an overarching pricing system more explicitly, much more explicitly than at present.” – Günter
Harms, Market Access & Public Affairs Director, Shire Human Genetic Therapies “There is a lot of
difference in the governance across Europe, which ultimately leads to quality of HTA. An important
aspect is of course the independence of the assessment from the appraisal and ultimately the decision
on a certain price. That's very, very different country by country and region by region.” – Ansgar
Hebborn, Global Head, Payer and HTA Programme Policy, Roche Expert Views Alicia Granados, MD.
Senior Director Global HTA Strategy, GMA Genzyme Andrea Rappagliosi, Vice President European
Government Affairs & Head of Brussels Office, GlaxoSmithKline Andrew Hobbs, Managing Director, Pope
Woodhead and Associates Limited Ansgar Hebborn, Global Head, Payer and HTA Programme Policy,
Roche Brian Lovatt, Chief Executive Officer, Vision Healthcare Clare McGrath, Senior Director HTA Policy,
Pfizer David Grainger, Global Public Policy Director, Lilly Finn Børlum Kristensen, Director, EUnetHTA
Secretariat and Chair, EUnetHTA Executive Committee Günter Harms, Market Access & Public Affairs
Director, Shire Human Genetic Therapies Hans Georg Eichler, Senior Medical Officer, European Medicines
Agency Kalipso Chalkidou, Director of International Division, National Institute for Health and Clinical
Excellence Karen Facey, Evidence based health policy consultant and non-executive Director at NHS
Health Scotland, and Chair of the HTAi Interest Group for Patient/Citizen Involvement in HTA Mel Walker,
Senior Director Value Expert Engagement & Collaborations, GlaxoSmithKline Rito Bergemann, Medical
Director, HTA Strategy Global HEOR, Abbott Steven Flostrand, Principal, Pricing & Market Access, IMS
Health Ulf Staginnus, Head of Pricing & Health Economics Europe, Novartis and author of
www.healtheconomicsblog.com Vivek Muthu, Chief Executive, Bazian Keiron Sparrowhawk, Partner,
PriceSpective
Table of Contents :

3. Executive summary
Biosimilar drugs in Europe
What are biosimilars?
Generics and biosimilars – similarities and differences
Biosimilars available so far in Europe
The market opportunities for biosimilars in Europe
The biologics patent cliff will have an impact on the market
Market types for biosimilars will differ across Europe
Geographic markets for biosimilars will vary across Europe
In Italy, prescriptions are fulfilled by brand
In France and Spain, drugs are discounted to targets
In the UK, biosimilar uptake is driven by NICE
In Germany, biosimilars uptake is good but varies by drug type
Biosimilar uptake will vary by molecule and indication across Europe
Epoetin uptake may have been slowed by immunogenicity issues
Filgrastim uptake has been faster in Europe
Biosimilar use is likely to vary between chronic and episodic treatment
There may be a resistance to switching patients on established treatments
Hospital physicians may be more likely to use biosimilars than primary care physicians
Biosimilars will have an impact in cost-sensitive markets
The paediatric population may be reluctant to take up biosimilars
The challenges for biosimilars in Europe
The biosimilars challenge: Gaining approval in Europe
The EU regulatory process for biosimilars
Biosimilar regulations will be a steep learning curve
Will regulations be fair and balanced on all points?
The biosimilars challenge: Overcoming development and manufacturing hurdles
Biologics are highly variable by nature
Variations can cause issues with immunogenicity
The biosimilars challenge: Overcoming patent hurdles
The biosimilars challenge: Gaining stakeholder trust
Payers can be a major driver for biosimilars uptake
Physicians will be key gatekeepers for biologics and biosimilars
Patients may be cautious about biosimilars
The defensive position: Originator companies will try to limit biosimilar uptake
Lifecycle management can maintain market share
Lack of automatic substitution will protect originator drugs
Exclusivity provisions and patents will protect originator drugs
Originator companies can exploit loyalty to maintain market share
Focusing on quality, safety and efficacy claims can maintain loyalty
Using marketing, sales and healthcare professional training to attract and keep market share
Protecting the market through degree of similarity – is a biosimilar really similar?
Competitive pricing and rebate agreements will keep cost-sensitive customers
The offensive position: breaking into a new market

4. Pricing is the key differentiator for biosimilars
Knowing the market will help gain market share
Information and education: defending biosimilars against the naysayers
Sales, marketing and account management: Market share through talking to the payers
Education for healthcare professionals: Market share through talking to the physicians
Gaining market share by adding value: Devices and formulations
Making the biosimilar easier to use: Devices
Making the biosimilar easier to handle: formulations
Protecting biosimilars through patents
The company landscape: Opportunities for companies in biosimilars
Generics companies will be key players
Collaboration and licensing in the biosimilars market
Collaborations between generics companies – bringing together development and marketing
Collaborations between generic and originator companies combines know-how and manufacturing
capabilities
Geographic collaborations allows access to wider markets
Looking into biosimilars deal data
Biosimilar deals by volume
Biosimilar deals by value
Biosimilar deals by type
Biosimilar deals by indication
Biosimilar deals: Deal case studies
Biopharma company signs agreement to access biosimilars
Generics company signs agreement to fill pipeline
What’s next for biosimilars in Europe?
Monoclonal antibodies will be a dramatic entry to the biosimilars market
Biobetters could ‘follow-on’ from biosimilars
Biobetters will follow a different route of approval
The US: Changing the biosimilars environment
Conclusion
Acknowledgements
Bibliography
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