Health Technology Assessment (HTA): - A European Perspective





Published: October 2011 | 48 pgs 

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 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
Marketing research/business intelligence managers
 

Expert Views Include: 

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
 

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
 

  

Executive summary 
HTA and market access 
> What is HTA?
> How does HTA influence price, reimbursement and market access?
> HTA and price
> HTA and reimbursement
> HTA and market access
 

HTA in Europe 
> Adoption of HTA in Europe
> Germany and HTA
> History of HTA
> Key agencies
> Influence of HTA on pricing, reimbursement and market access
> France and HTA
> History of HTA
> Key agencies
> Influence of HTA on pricing, reimbursement and market access
> Italy and HTA
> History of HTA
> Key agencies
> Influence of HTA on pricing, reimbursement and market access
> Spain and HTA
> History of HTA
> Key agencies
> Influence of HTA on pricing, reimbursement and market access
> UK and HTA
> History of HTA
> Key agencies
> Influence of HTA on pricing, reimbursement and market access
> European trends
 

Key challenges for HTA across Europe 
> Building capability
> Knowledge sharing
> Unresolved differences
> Perspective
> Data that is acceptable to HTA agencies
> Methods for conducting HTA
> Process and governance
> Implementation
 

Potentials and pitfalls of Europeanisation of HTA 
> Common clinical assessment at the European level?
> Closer links between regulatory approval and HTA?
> Changing data needs
> Changing EPARs
> Risk/benefit assessment
> Changing early engagement
> Uncommon economic assessment?
> Reality check
 

Conclusions 

  

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