Health Technology Assessment (HTA): a European perspective
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.
Scope
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.
Highlights
“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.”
– Gunter 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
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.
Scope
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.
Highlights
- 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
- 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
- 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?
- 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
“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.”
– Gunter 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 Borlum Kristensen, Director, EUnetHTA Secretariat and Chair, EUnetHTA Executive Committee
- Gunter 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
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
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
