HTA Assessment in Germany, Spain, the UK and the EU
National HTA systems, pricing and harmonisation efforts from Joint Action 3
- Evidence generation - Harmonised early advice in Europe? Jointly produced European HTAs?
- Real-World Evidence and authorities' acceptance
- Medicines evaluation in Germany, Spain, the UK and Ireland
- Early access possibilities in Europe
- From HTA to pricing
This distinguishes our event
Aims and objectivesHTA/value assessment is an essential tool in many national European healthcare systems.
This conference provides thorough insights into the national procedures in Germany, Spain, the UK and Ireland. It also provides a sound update on European harmonisation efforts in terms of harmonised early advice or joint HTAs.
Early access availability, pricing and pricing strategies will round off the conference, enabling you to optimise your market access strategy for the various European markets.
Who should attend?This conference addresses the needs of employees in the pharmaceutical industry responsible for market access activities in the various national European markets.
Those involved in value-assessment preparation and pricing activities will benefit particularly from this conference.
Detailed programmeDay1: 09:00 - 17:30 conference
Day 2: 09:00-15:00
- Joint Action 3 at a glance
- Results of public consultation
- Rapid REA - 2017 insights
- Participation of EUnetHTA in EMA's initiatives
- The current status of early dialogues
- Cooperation of the national HTA agencies
- Harmonised early advice in Europe?
- Post-launch evidence
- Registers and the register data in HTAs
- Generating Real-World Evidence after the HTA - acceptance by the authorities
11:00 Coffee break
- From early dialogues to early assessment
- The German position on HTA harmonisation in the EU - early dialogues in Europe
- Current changes after the latest AMNOG reform
- Electronic patient health records
- Data from patient organisations
- Patient-reported and patient-centred outcomes
- How to use the possibilities
- Jointly produced HTAs - tools
- Production process
- Stakeholder involvement
- Decentralisation and division of labour (activity centres)
16:00 Coffee break
- Who's who in medicines evaluation in Spain
- How does HTA influence market access for medicines?
- The Catalan model for equity access to drugs and the role of HTAs
17:30 End of day one
- Precondition: unmet medical need?
- Named-patient programmes
- National differences such as the French ATU and the UK EAMS
- Implications of early access schemes for HTA and pricing at a later stage
- Horizon scanning in the UK
- HTA trends in the UK and Ireland
- Evolution of NICE technology appraisal,HST and further programmes
- Specialised conditions - what happens when NICE HTA does not apply?
- Predicting the implications of BREXIT
11:00 Coffee break
- Launch sequencing and pricing strategy in Europe
15:00 End of conference
LL.M. Secretary General Since 2009, Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and works as lawyer in his own law firm in Düsseldorf (www.natz-law.com). From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany with a special focus on discount agreements and licensing of pharmaceuticals. Dr. Natz also was working in the field of competition law with the European Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.
Nähere Informationen finden Sie hier.
Scientific Advisor, Pharmaceuticals Department
Director Health Economics & Outcomes Research
EUnetHTA JA3 WP4 Co-Lead Project Management
Advisor to HAS' President | International Affairs
Head of Pharmaceuticals Department The G-BA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany.
Director of Pharmacy and Medicines of CSC
Director Market Access & Government Affairs
Associate Director Service Development
Mercure Hotel MOA BerlinStephanstr. 41
Phone: +49 30 394043-0
Fax: +49 30 394043-999
- Experts from various national HTA bodies discuss the current challenges and perspectives
- Focus on European harmonisation efforts and national peculiarities
- First-hand information on Joint Action 3 proceedings
Comment of September 2015
High quality of speakers, good discussion opportunities, relevant content
Dompé farmaceutici S.p.A.
Comment of September 2015
Gemeinsamer Bundesausschuss (G-BA)
Comments of September 2016
I would recommend the quality of the speakers
BIOGEN France SAS, France
I would recommend the possibility to get the latest information
Interessting discussions as well as a future outlook were made
I would fully recommend this conference to my colleagues
I would recommend the seminar because for the specific audience, i.e. HTA professionals
Good insights in processes
Off-Label Use in EuropeThis seminar addresses the different legal situations and the handling of off-label use in Europe
Special issues in Europe: National rules regarding authorisation and reimbursement of off-label use
22.11.2017 in Düsseldorf